Procedure : 2013/0140(COD)
Document stages in plenary
Document selected : A7-0162/2014

Texts tabled :

A7-0162/2014

Debates :

PV 14/04/2014 - 19
CRE 14/04/2014 - 19

Votes :

PV 15/04/2014 - 17.2
CRE 15/04/2014 - 17.2

Texts adopted :

P7_TA(2014)0380

REPORT     ***I
PDF 1141kDOC 1515k
6 March 2014
PE 522.944v03-00 A7-0162/2014

on the proposal for a regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official Controls Regulation)

(COM(2013)0265 – C7-0123/2013 – 2013/0140(COD))

Committee on the Environment, Public Health and Food Safety

Rapporteur: Mario Pirillo

Rapporteur for the opinion (*):

Britta Reimers, Committee on Agriculture and Rural Development

(*) Associated committee - Rule 50 of the Rules of Procedure

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 OPINION of the Committee on Agriculture and Rural Development(*)
 PROCEDURE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC

(Official Controls Regulation)

(COM(2013)0265 - C7-0123/2013) - 2013/0140(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to Parliament and the Council (COM(2013)0265),

–   having regard to Article 294(2) and Articles 43(2), 114 and 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0123/2013),

–   having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–   having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Luxembourg National Assembly, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–   having regard to the opinion of the European Economic and Social Committee of 16 October 2013(1),

–   having regard to the opinion of the Committee of the Regions of 29 November 2013(2),

–   having regard to Rule 55 of its Rules of Procedure,

–   having regard to the report of the Committee on Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (

A7-0162/2014),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment  1

Proposal for a regulation

Title

Text proposed by the Commission

Amendment

Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)

Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)

Amendment  2

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) Union legislation provides for a set of harmonised rules to ensure that food and feed are safe and wholesome and that activities which might have an impact on the safety of the food chain or on the protection of consumers interests in relation to food and food information are performed in accordance with specific requirements. Union rules exist also to ensure a high level of human, animal and plant health and animal welfare along the food chain and in all those areas of activity where a key objective is the fight against the possible spread of animal diseases, in some cases transmissible to humans, or of pests injurious to plants or plant products, and to ensure the protection of the environment from risks that might arise from GMOs and plant protection products. Union rules also guarantee the identity and quality of plant reproductive material. The correct application of those rules, hereinafter collectively referred to as 'Union agri-food chain legislation', contributes to the functioning of the internal market.

(3) Union legislation provides for a set of harmonised rules to ensure that food and feed are safe and wholesome and that activities which might have an impact on the safety of the food chain or on the protection of consumers interests in relation to food and food information are performed in accordance with specific requirements. Union rules exist also to ensure a high level of human and animal health and animal welfare along the food chain and in all those areas of activity where a key objective is the fight against the possible spread of animal diseases, in some cases transmissible to humans, or of pests injurious to plants or plant products, and to ensure the protection of the environment from risks that might arise from GMOs and plant protection products. The correct application of those rules, hereinafter collectively referred to as 'Union agri-food chain legislation', contributes to the functioning of the internal market.

Amendment  3

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) Union legislation on plant reproductive material regulates the production with a view to placing on the market, and the placing on the market, of plant reproductive material of agricultural, vegetable, forest, fruit and ornamental species and vines. The objective of those rules is to ensure the identity, health and quality of plant reproductive material for its users, and the productivity, diversity, health and quality of the agri-food chain as well as contributing to the protection of biodiversity and the environment.

deleted

Amendment  4

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) There are a number of provisions in Union agri-food chain legislation, the enforcement of which has not, or has only partially, been governed by Regulation (EC) No 882/2004. In particular, specific official control rules were kept in place in Union legislation on plant reproductive material and in Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/200212. Plant health also largely falls outside the scope of Regulation (EC) No 882/2004 with certain rules on official controls being laid down in Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community13.

deleted

__________________

 

12 OJ L 300, 14.11.2009, p. 1.

 

13 OJ L 169, 10.7.2000, p. 1.

 

Amendment  5

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) In order to rationalise and simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, the rules applicable to official controls in specific areas should be integrated into a single legislative framework for official controls. For that purpose, Regulation (EC) No 882/2004 and other acts currently governing official controls in specific areas should be repealed and replaced by this Regulation.

(16) In order to rationalise and simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, the rules applicable to official controls should be more closely integrated, provided that they pursue the same objective with regard to control activities. For that purpose, Regulation (EC) No 882/2004 and other acts currently governing official controls in specific areas should be repealed and replaced by this Regulation.

Justification

Sector-specific control rules which pursue an objective other than maintaining food safety should not be integrated into this regulation.

Amendment  6

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) For the verification of compliance with the rules on the common organisation of the markets of agricultural products (arable crops, wine, olive oil, fruit and vegetables, hops, milk and milk products, beef and veal, sheepmeat and goatmeat and honey), a well-established and specific control system is already in place. This Regulation should therefore not apply to the verification of compliance with the provisions of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation).

(18) For the verification of compliance with the rules on the common organisation of the markets of agricultural products (arable crops, wine, olive oil, fruit and vegetables, hops, milk and milk products, beef and veal, sheepmeat and goatmeat and honey), a well-established and specific control system is already in place. This Regulation should therefore not apply to the verification of compliance with the provisions of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation), with the exception of Part II, Title II, Chapter I of that Regulation.

Justification

Regulation (EC) No 1234/2007 (Single CMO Regulation) makes provision for official controls in the agri-food sector that are to be harmonised with those of the proposed Official Controls Regulation.

Amendment  7

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) Union agri-food chain legislation entrusts the competent authorities of the Member States with specialised tasks to be carried out for the protection of animal health, plant health and animal welfare, for the protection of the environment in relation to GMOs and plant protection products, and in order to ensure the identity and a high quality of plant reproductive material. Those tasks are the public interest activities which the competent authorities of the Member States must carry out for the purpose of eliminating, containing or reducing risks which may arise for human, animal or plant health, animal welfare, or for the environment. Those activities, which include product approval, surveying, surveillance and monitoring including for epidemiologic purposes, and the eradication and containment of diseases, and other disease control tasks, are governed by the same sectoral rules which are enforced through the official controls.

(20) Union agri-food chain legislation entrusts the competent authorities of the Member States with specialised tasks to be carried out, not least for the protection of animal health, plant health and animal welfare, for the protection of the environment in relation to GMOs and plant protection products. Those tasks are the public interest activities which the competent authorities of the Member States must carry out for the purpose of eliminating, containing or reducing risks which may arise for human, animal or plant health, animal welfare, or for the environment. Those activities, which include product approval, surveying, surveillance and monitoring including for epidemiologic purposes, and the eradication and containment of diseases, and other disease control tasks, are governed by the same sectoral rules which are enforced through the official controls.

Justification

The concept of ‘other official activities' as defined in Article 2(2) should not be limited to animal health, plant health and environmental protection. It should be broadened to include all the areas set out in Article 1(2) so as to cover, by way of example, exploratory surveys conducted in the field of fair trading practices and safety.

Amendment  8

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) For the performance of official controls aimed at verifying the correct application of Union agri-food chain legislation, and of the other official activities entrusted to Member State authorities by Union agri-food chain legislation, Member States should designate competent authorities which act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality and professionalism. Competent authorities should ensure the quality, consistency and effectiveness of official controls.

(23) For the performance of official controls aimed at verifying the correct application of Union agri-food chain legislation, and of the other official activities entrusted to Member State authorities by Union agri-food chain legislation, Member States should designate competent public authorities which act in the public interest and ensure the quality, consistency and effectiveness of official controls. The designated competent authority, or authorities, should be appropriately resourced and equipped, and Member States should be able to guarantee their impartiality and professionalism by ensuring their independence from any operator operating within the agri-food chain.

Justification

It is important that those carrying out official controls do not have any conflict or interest with operators who are subject to official controls or other official activities. Member States should therefore ensure that competent authorities and other delegated bodies who are tasked with performing official controls are entirely independent from operators operating in the agri-food chain.

Amendment  9

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

 

(24a) The audits undertaken by the competent authorities, or at the request of the competent authorities, to ensure compliance with this Regulation may be based on international standards, where the requirements of those standards correspond to the requirements of this Regulation.

Justification

The competent authorities must conduct internal audits aimed at improving the way they are organised and their operations. Certain facets of the Regulation echo the requirements of ISO/IEC standards 17020 and 17065 (formerly EN 45011) and there is a need to build on the work done by the competent authorities on the basis of international standards in a globalised world.

Amendment  10

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) Operators should have a right to appeal against the decisions taken by the competent authorities, and be informed of such a right.

(25) Operators should have the right to appeal against the decisions taken by the competent authorities. The competent authorities are to inform operators of this right.

Amendment  11

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) The competent authorities should ensure that staff responsible for official controls does not disclose information acquired during the performance of such controls which is covered by professional secrecy. Unless there is an overriding interest justifying disclosure, professional secrecy should include information which would undermine the purpose of inspections, investigations or audits, the protection of commercial interests and the protection of court proceedings and legal advice. However, professional secrecy should not prevent competent authorities from disclosing factual information on the outcome of official controls regarding individual operators when the operator concerned has been allowed to comment upon it prior to the disclosure and such comments have been taken into account, or released alongside the information being divulged by the competent authorities. The need to respect professional secrecy is also without prejudice to the obligation to inform the general public where there are reasonable grounds to suspect that food or feed may present a risk for health in accordance with Article 10 of Regulation (EC) No 178/2002. The obligation for competent authorities to inform the general public in cases where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, in accordance with Article 10 of Regulation (EC) No 178/2002, and the right of individuals to the protection of their personal data as provided for in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data16 should not be affected by this Regulation.

(26) The competent authorities should ensure that, with the exception of internal reporting obligations, staff responsible for official controls does not disclose information acquired during the performance of such controls which is covered by professional secrecy. Where there is a suspicion of risk to human or animal health or of other serious breaches of food law, the competent authorities should take suitable steps to inform the public. The measures taken should be in proportion to the scale of the infringement, in particular when naming specific products or operators concerned. Factual information on the outcome of an official control regarding individual operators may be divulged when the operator concerned has been allowed to comment upon it prior to the disclosure and such comments have been taken into account and released alongside and at the same time as the information being divulged by the competent authorities. The obligation for competent authorities to inform the general public in cases where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, in accordance with Article 10 of Regulation (EC) No 178/2002, and the right of individuals to the protection of their personal data as provided for in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data16 should not be affected by this Regulation.

__________________

__________________

16 OJ L 281, 23.11.95, p. 31.

16 OJ L 281, 23.11.95, p. 31.

Justification

The competent authorities should inform the public where there is a risk to human or animal health or in the event of other serious breaches of the rules. The type of information disclosed and the way in which it is disclosed should match the scale of the infringement, in order to avoid wrongly casting a shadow on operators or penalising them for longer than is necessary to rectify the problem.

Amendment  12

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission

Amendment

 

(29a) Official controls should be performed by staff free from any conflict of interests, and in particular not engaged, directly or through a spouse, in an economic activity subject to the official controls laid down.

Amendment  13

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) To facilitate the identification of non-compliances and streamline the taking of corrective action by the operator concerned, the outcome of official controls should be recorded in a report, a copy of which should be given to the operator. Where official controls require the continuous or regular presence of the staff of the competent authorities to monitor the operator's activities, a report of each individual inspection or visit to the operator would be disproportionate. In such cases reports should be prepared with a frequency that enables the competent authorities and the operator to be regularly informed of the level of compliance and immediately notified of any identified shortcomings.

(34) To facilitate the identification of non-compliances and streamline the taking of corrective action by the operator concerned, the outcome of official controls which identify non-compliances with the rules should be recorded in a report. A copy of that report should also be given to the operator. Where official controls require the continuous or regular presence of the staff of the competent authorities to monitor the operator's activities, a report of each individual inspection or visit to the operator would be disproportionate. In such cases reports should be prepared with a frequency that enables the competent authorities and the operator to be regularly informed of the level of compliance and immediately notified of any identified shortcomings. In the interests of reducing the administrative burden, it should also be sufficient to record the outcome of official controls at border control posts in the Common Health Entry Document.

Justification

All the controls and their outcome are to be published pursuant to Article 10 of the Commission proposal, and these figures will provide information on controls that have produced satisfactory findings. Further reporting should not be necessary in these cases.

Amendment  14

Proposal for a regulation

Recital 54

Text proposed by the Commission

Amendment

(54) Member States should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities. Although operators are primarily responsible for ensuring that their activities are carried out in compliance with Union agri-food chain rules, the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each Member State to ensure effective market surveillance along the agri-food chain. Such a system is, by its very nature, complex and resource demanding and should be provided with a stable influx of resources for official controls, at a level appropriate to the enforcement needs at any given moment. To reduce the dependency of the official control system from public finances, competent authorities should collect fees to cover the costs they incur when performing official controls on certain operators and for certain activities for which Union agri-food chain legislation requires registration or approval in accordance with Union rules on the hygiene of food and feed or rules governing plant health and plant reproductive material. Fees should also be collected from operators to compensate the costs of official controls performed in view of issuing an official certificate or attestation, and costs of official controls performed by the competent authorities at border control posts.

(54) Member States should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities. Although operators are primarily responsible for ensuring that their activities are carried out in compliance with Union agri-food chain rules, the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each Member State to ensure effective market surveillance along the agri-food chain. Such a system is, by its very nature, complex and resource demanding and should be provided with a stable influx of resources for official controls, at a level appropriate to the enforcement needs at any given moment. To reduce the dependency of the official control system from public finances, competent authorities should be able to collect fees or contributions to costs to cover the costs they incur when performing official controls on certain operators and for certain activities for which Union agri-food chain legislation requires registration or approval in accordance with Union rules on the hygiene of food and feed or rules governing plant health. Fees or contributions to costs should also be collected from operators to compensate the costs of official controls performed in view of issuing an official certificate or attestation, and costs of official controls performed by the competent authorities at border control posts.

Justification

Consistent with the amendments to Chapter VI on the financing of official controls.

Amendment  15

Proposal for a regulation

Recital 56

Text proposed by the Commission

Amendment

(56) The direct or indirect refund of fees collected by the competent authorities should be prohibited as it would put operators not benefitting from the refund at a disadvantage and potentially create distortions of competition. However, in order to provide support to micro-enterprises, these should be exempted from the payment of the fees collected in accordance with this Regulation.

deleted

Amendment  16

Proposal for a regulation

Recital 60 a (new)

Text proposed by the Commission

Amendment

 

(60a) Article 32(1) of Regulation (EC) No 1829/2003 and Article 21(1) of Regulation (EC) No 1831/2003 confer respectively on the European Union reference laboratory for genetically modified food and feed and on the European Union reference laboratory for feed additives, specific tasks as part of the authorisation procedure for genetically modified food or feed, or feed additives, relating, in particular, to the testing, evaluation and validation of the method of detection or analysis proposed by applicants. Experience shows that knowledge and expertise in the testing, evaluation and validation of methods in the context of the authorisation procedure is crucial in order to provide a high-level, state-of-the-art contribution to the efficiency of official controls. Laboratories designated as such under Article 32(1) of Regulation (EC) No 1829/2003 and Article 21(1) of Regulation (EC) No 1831/2003 should therefore act as European Union reference laboratories for the purposes of this Regulation.

Justification

This is a correction to Amendment 3 of the draft report. More specifically, the reference should be to Article 21(1), and not Article 21(2), of Regulation (EC) No 1831/2003. Laboratories designated as such under Article 32(1) of Regulation (EC) No 1829/2003 and Article 21(1) of Regulation (EC) No 1831/2003 should act as European Union reference laboratories and not as official laboratories as erroneously stated in Amendment 3.

Amendment  17

Proposal for a regulation

Recital 61

Text proposed by the Commission

Amendment

(61) For the performance of official controls and other official activities on the production and marketing of plant reproductive material, and in the field of animal welfare, the competent authorities should have access to updated, reliable and consistent technical data, to research findings, new techniques and expertise necessary for the correct application of Union legislation applicable in those areas. For that purpose the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for plant reproductive material and for animal welfare.

(61) For the performance of official controls and other official activities in the field of animal welfare, the competent authorities should have access to updated, reliable and consistent technical data, to research findings, new techniques and expertise necessary for the correct application of Union legislation applicable in those areas. For that purpose the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for animal welfare.

Amendment  18

Proposal for a regulation

Recital 62

Text proposed by the Commission

Amendment

(62) In order to pursue the objectives of this Regulation and contribute to the smooth functioning of the internal market, ensuring consumer confidence in it, non-compliances with Union food chain legislation requiring enforcement action in more than one Member State should be pursued efficiently and consistently. The Rapid Alert System for Food and Feed (RASFF) established by Article 50 of Regulation (EC) No 178/2002 already enables competent authorities to rapidly exchange and disseminate information on serious direct or indirect risks to human health in relation to food or feed, or serious risks to human or animal health or to the environment in relation to feed, for the purpose of enabling rapid measures to be taken to counter those risks. However, that instrument, while allowing for timely action across all Member States concerned to counter certain serious risks along the food chain, cannot serve the purpose of enabling effective cross border assistance and cooperation between competent authorities to ensure that non-compliances with Union agri-food chain legislation which have a cross-border dimension are effectively pursued not only in the Member State where the non-compliance is first detected but also in the Member State where the non-compliance originated. In particular, administrative assistance and cooperation should enable competent authorities to share information, detect, investigate and take effective and proportionate action to pursue cross-border violations of agri-food chain rules.

(62) In order to pursue the objectives of this Regulation and contribute to the smooth functioning of the internal market, ensuring consumer confidence in it, non-compliances with Union food chain legislation requiring enforcement action in more than one Member State should be pursued efficiently and consistently. The Rapid Alert System for Food and Feed (RASFF) established by Article 50 of Regulation (EC) No 178/2002 already enables competent authorities to rapidly exchange and disseminate information on serious direct or indirect risks to human health in relation to food or feed, or serious risks to human or animal health or to the environment in relation to feed, or in the case of food fraud, for the purpose of enabling rapid measures to be taken to counter those risks. However, that instrument, while allowing for timely action across all Member States concerned to counter certain serious risks along the food chain, cannot serve the purpose of enabling effective cross border assistance and cooperation between competent authorities to ensure that non-compliances with Union agri-food chain legislation which have a cross-border dimension are effectively pursued not only in the Member State where the non-compliance is first detected but also in the Member State where the non-compliance originated. In particular, administrative assistance and cooperation should enable competent authorities to share information, detect, investigate and take effective and proportionate action to pursue cross-border violations of agri-food chain rules.

Amendment  19

Proposal for a regulation

Recital 73

Text proposed by the Commission

Amendment

(73) It is important for the performance of effective official controls and other official activities that the competent authorities in the Member States, the Commission and, where relevant, operators be able to exchange data and information related to official controls or results therefrom rapidly and efficiently. Several information systems are established by Union legislation and managed by the Commission to allow such data and information to be handled and managed through Union wide computerised and internet-based tools. A system dedicated to recording and tracing official control results is the Trade Control and Expert System (TRACES system), established by Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an integrated computerised veterinary system and currently used for the management of data and information on animals and products of animal origin and official controls thereon21. That system should be upgraded so as to allow its use for all goods for which Union agri-food chain legislation establishes specific requirements or official control modalities. Dedicated computerised systems also exist for the rapid exchange of information between Member States and with the Commission on risks which might arise in the food chain or for animal and plant health. Article 50 of Regulation (EC) No 178/2002 establishes the RASFF, Article 20 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on animal health] a system for the notification and reporting on the measures on listed diseases, and Article 97 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on protective measures against pests of plants] a system for the notification and reporting of the presence of pests and the notification of non-compliances. All such systems should work in a harmonious, consistent manner that makes use of synergies between the different systems, avoids duplications, simplifies their operation and makes them more efficient.

(73) It is important for the performance of effective official controls and other official activities that the competent authorities in the Member States, the Commission and, where relevant, operators be able to exchange data and information related to official controls or results therefrom rapidly and efficiently. Several information systems are established by Union legislation and managed by the Commission to allow such data and information to be handled and managed through Union wide computerised and internet-based tools. A system dedicated to recording and tracing official control results is the Trade Control and Expert System (TRACES system), established by Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an integrated computerised veterinary system and currently used for the management of data and information on animals and products of animal origin and official controls thereon21. That system should be upgraded and adapted so as to allow its use for all goods for which Union agri-food chain legislation establishes specific requirements or official control modalities. Dedicated computerised systems also exist for the rapid exchange of information between Member States and with the Commission on risks which might arise in the food chain or for animal and plant health. Article 50 of Regulation (EC) No 178/2002 establishes the RASFF, Article 20 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on animal health] a system for the notification and reporting on the measures on listed diseases and on food fraud, and Article 97 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on protective measures against pests of plants] a system for the notification and reporting of the presence of pests and the notification of non-compliances. All such systems should work in a harmonious, consistent manner that makes use of synergies between the different systems, avoids duplications, simplifies their operation and makes them more efficient.

__________________

__________________

21 OJ L 8, 14.1.2003, p. 44.

21 OJ L 8, 14.1.2003, p. 44.

Amendment  20

Proposal for a regulation

Recital 74 a (new)

Text proposed by the Commission

Amendment

 

(74a) In order to minimise administrative burdens and control costs and in order to allow the EU and its Member States to effectively communicate electronically in trade relations with third countries, it is necessary that when exchanging electronic certificates or other electronic data, the Commission and the competent authorities of the Member States use internationally standardised language, message structure and exchange protocols based on guidance for electronic certification in standardised World Wide Web Consortium (WC3) Extensible Markup Language (XML schemas) as well as secure exchange mechanisms between competent authorities as is provided by the UN Centre for Trade Facilitation and Electronic Business (UN/CEFACT).

Amendment  21

Proposal for a regulation

Recital 77

Text proposed by the Commission

Amendment

(77) Infringements of the rules should be subject to effective, dissuasive and proportionate sanctions at national level throughout the Union. For financial penalties applicable to intentional infringements to be sufficiently dissuasive, they should be set at a level which is likely to offset the economic advantage sought by the perpetrator through the violation. Member States should also be required to apply appropriate criminal and/or administrative penalties in cases where operators fail to cooperate during an official control.

(77) Infringements of the rules should be subject to effective, dissuasive and proportionate sanctions at national level throughout the Union. For financial penalties applicable to intentional infringements to be sufficiently dissuasive, they should be set at a level of at least double the economic advantage sought by the perpetrator through the violation. Member States should also be required to apply appropriate criminal and/or administrative penalties in cases where operators fail to cooperate during an official control.

Amendment  22

Proposal for a regulation

Recital 77 a (new)

Text proposed by the Commission

Amendment

 

(77a) Account should be taken of the specific needs of the developing countries, in particular the least developed countries, who should be given support in organising their official controls so that they can meet the criteria for the import of animals and goods into the EU.

Justification

In line with amendment proposing a new Article 128a, based on rules currently in force.

Amendment  23

Proposal for a regulation

Recital 78

Text proposed by the Commission

Amendment

(78) This Regulation covers areas that are already covered in certain acts currently in force. To avoid duplications and to establish a coherent legislative framework, the following acts should be repealed and replaced by the rules of this Regulation: Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters23; Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market24; Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market25; Council Directive 91/496/EEC; Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and Decision 90/424/EEC, and repealing Decision 88/192/EEC26; Council Directive 96/23/EC; Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products27; Council Directive 97/78/EC; Regulation (EC) No 882/2004; and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption28.

(78) This Regulation covers areas that are already covered in certain acts currently in force. To avoid duplications and to establish a coherent legislative framework, the following acts should be repealed and replaced by the rules of this Regulation: Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters23; Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market24; Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market25; Council Directive 91/496/EEC; Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and repealing Decision 88/192/EEC26; Council Directive 96/23/EC; Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products27; Council Directive 97/78/EC; Regulation (EC) No 882/2004.

__________________

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23 OJ L 351, 21.12.1989, p. 34.

23 O J L 351, 21.12.89, p. 34.

24 OJ L 395, 30.12.1989, p. 13.

24 OJ L 395, 30.12.89, p. 13.

25 OJ L 224, 18.8.1990, p. 29.

25 OJ L 224, 18.08.90, p. 29.

26 OJ L 243, 25.8.1992, p. 27.

26 O J L 243, 25.08.92, p. 27.

27 OJ L 13, 16.01.97, p. 28.

27 OJ L 13, 16.01.97, p. 28.

28 OJ L 139, 30.4.2004, p. 206.

 

Justification

To guarantee the funding of the EU reference laboratories, it is necessary to retain the Council decision. The repeal of Regulation (EC) No 854/2004 would lead to uncertainty concerning specific controls on the safety for human consumption of animal products not covered by this proposal for a regulation.

Amendment  24

Proposal for a regulation

Recital 79

Text proposed by the Commission

Amendment

(79) In order to ensure consistency, amendments should also be effected to the following acts: Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies29; Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/9730; Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum levels of pesticides in or on food and feed of plant of animal origin and amending Council Directive 91/414//EEC31; Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) 2092/9132; Regulation (EC) No 1069/2009; Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing33; Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC34; Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs35; Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes36; Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens37; Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed38; Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition39; Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production40; Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves41; Council Directive 2008/120/EC of 18 December 2008 laying down minimum standards for the protection of pigs42; Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the Community action to achieve the sustainable use of pesticides43.

(79) In order to ensure consistency, amendments should also be effected to the following acts: Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies29; Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/9730; Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum levels of pesticides in or on food and feed of plant of animal origin and amending Council Directive 91/414//EEC31; Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) 2092/9132; Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing33; Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC34; Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs35; Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes36; Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens37; Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed38; Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition39; Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production40; Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves41; Council Directive 2008/120/EC of 18 December 2008 laying down minimum standards for the protection of pigs42; Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the Community action to achieve the sustainable use of pesticides43.

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29 OJ L 147, 31.5.2001, p. 1.

29 OJ L 147, 31.5.2001, p. 1.

30 OJ L 3, 5.1.2005, p. 1.

30 OJ L 3, 5.1.2005, p. 1.

31 OJ L 70, 16.3.2005, p. 1.

31 OJ L 70, 16.3.2005, p. 1.

32 OJ L 189, 20.7.2007, p. 1.

32 OJ L 189, 20.7.2007, p. 1.

33 OJ L 303, 18.11.2009, p. 1.

33 OJ L 303, 18.11.2009, p. 1.

34 OJ L 309, 24.11.2009, p. 1.

34 OJ L 309, 24.11.2009, p. 1.

35 OJ L 343, 14.12.2012, p. 1.

35 OJ L 343, 14.12.2012, p. 1.

36 OJ L 221, 8.8.1998, p. 23.

36 OJ L 221, 8.8.1998, p. 23.

37 OJ L 203, 3.8.1999, p. 53.

37 OJ L 203, 3.8.1999, p. 53.

38 OJ L 268, 18.10.2003, p. 1.

38 OJ L 268, 18.10.2003, p. 1.

39 OJ L 268, 18.10.2003, p. 29.

39 OJ L 268, 18.10.2003, p. 29.

40 OJ L 812, 12.7.2007, p. 19.

40 OJ L 812, 12.7.2007, p. 19.

41 OJ L 10, 15.1.2009, p. 7.

41 OJ L 10, 15.1.2009, p. 7.

42 OJ L 47, 18.2.2009, p. 5.

42 OJ L 47, 18.2.2009, p. 5.

43 OJ L 309, 24.11.2009, p. 71.

43 OJ L 309, 24.11.2009, p. 71.

Justification

In line with the amendments to Article 17, the Regulation on animal by-products should not be included.

Amendment  25

Proposal for a regulation

Article 1 – paragraph 2

Text proposed by the Commission

Amendment

2. This Regulation shall apply to the official controls performed for the verification of compliance with the following rules, whether established at Union level or by the Member States to apply Union legislation in those areas:

2. This Regulation shall apply to the official controls performed for the verification of compliance with the following rules, whether established at Union level or by the Member States to apply Union legislation in those areas:

(a) governing food and food safety, at any stage of production, the processing and distribution of food, including rules aimed at guaranteeing fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food;

(a) governing food, food safety, food quality and food wholesomeness, at any stage of production, the processing and distribution of food, including rules aimed at guaranteeing , fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food;

(b) governing the deliberate release into the environment and the contained use of GMOs;

(b) governing the deliberate release into the environment of GMOs;

(c) governing feed and feed safety, at all stages of production, processing and distribution of feed and the use of feed, including rules aimed at guaranteeing fair practices in trade and protecting consumer interests and information;

(c) governing feed and feed safety, at all stages of production, processing and distribution of feed and the use of feed, including rules aimed at guaranteeing fair practices in trade and protecting consumer health, interests and information;

(d) laying down animal health requirements,

(d) laying down animal health requirements,

(e) aiming at preventing and minimising risks to human and animal health arising from animal by-products and derived products;

(e) aiming at preventing and minimising risks to human and animal health arising from animal by-products and derived products;

(f) laying down welfare requirements for animals;

(f) laying down welfare requirements for animals;

(g) on protective measures against pests of plants;

(g) on protective measures against pests of plants;

(h) on the production, with a view to placing on the market, and placing on the market of plant reproductive material;

 

(i) laying down requirements for the placing on the market and use of plant protection products and the sustainable use of pesticides;

(i) laying down requirements for the placing on the market and use of plant protection products and the sustainable use of pesticides;

(j) governing organic production and labelling of organic products;

(j) governing organic production and labelling of organic products;

(k) on the use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed.

(k) on the use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed.

Amendment  26

Proposal for a regulation

Article 1 – paragraph 2 – point e a (new)

Text proposed by the Commission

Amendment

 

(ea) aiming at preventing and minimising antimicrobial resistance in animals and humans, as well as in the environment;

Justification

Excessive usage of veterinary medicinal products containing antibiotics has led to increasing levels of antimicrobial resistance in both animals and humans in Europe. This development poses a threat to animal and human health, as well as to the environment and the Union should thus seek ways to reduce the usage of such veterinary medicinal products. Official controls should hence aim explicitly at also reducing antimicrobial resistance.

Amendment  27

Proposal for a regulation

Article 1 – paragraph 2 – point k a (new)

Text proposed by the Commission

Amendment

 

(ka) laying down requirements on monitoring certain substances and residues thereof in live animals and animal products.

Justification

It is clear from the explanatory memorandum and recitals that monitoring certain substances and residues thereof in live animals and animal products, which was previously governed by other legislation, is now included in the Commission proposal. However, this is not specifically stated in Article 1. A reference should be inserted to remove any doubt as to the scope of the regulation.

Amendment  28

Proposal for a regulation

Article 1 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) the rules laid down in Regulation (EC) No 1234/2007;

(a) the rules laid down in Regulation (EC) No 1234/2007 in areas other than those under Part II, Title II, Chapter I of that Regulation. However, this Regulation shall apply to official controls on protected designations of origin and protected geographical indications for wine;

Justification

Regulation (EC) No 1234/2007 (Single CMO Regulation) makes provision for official controls in the agri-food sector that are to be harmonised with those of the proposed Official Controls Regulation. Regulation (EC) 1234/2007 governs official controls on protected designations of origin and PGIs for wine. As there does not seem to be any reason or technical justification for PDOs and PGIs for wine and agricultural products and foodstuffs (Regulation 1151/2012) and spirit drinks (Regulation 110/2008) not to be given comparable and uniform treatment, this is not acceptable.

Amendment  29

Proposal for a regulation

Article 1 – paragraph 4 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) the rules laid down in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for veterinary use.

Justification

This makes it clear that this Regulation does not apply to the field of veterinary medicine production.

Amendment  30

Proposal for a regulation

Article 2 – paragraph 1 – point 1 – introductory part

Text proposed by the Commission

Amendment

1) 'official control' means any form of control that the competent authorities perform for the verification of compliance with:

1) 'official control' means any form of control, also including controls of requirements for animals and goods from third countries intended for export to third countries, that the competent authorities perform for the verification of compliance with:

Amendment  31

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Text proposed by the Commission

Amendment

(b) the rules referred to in Article 1(2) to ensure the application of those rules;

(b) the rules referred to in article 1 (2), except letter g), to ensure the application of those rules.

Amendment  32

Proposal for a regulation

Article 2 – paragraph 1 – point 5 – point a

Text proposed by the Commission

Amendment

(a) the central authorities of a Member State responsible for the organisation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2);

(a) the central authorities of a Member State responsible for organising and carrying out official controls and other official activities such as issuing certificates and attestations, appointing laboratories, exchanging information in the interest of cooperation between authorities, and taking decisions on measures to remedy breaches of this Regulation and the rules referred to in Article 1(2)

Justification

It is important to stress that the competent authorities are not responsible just for the organising official controls but also for carrying them out. It is also necessary to give at least an indicative list of ‘other official activities’ in the interests of clarification.

Amendment  33

Proposal for a regulation

Article 2 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

6. 'animals' means animals as defined in point (1) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health];

6. 'animals' means animals as defined in point (1) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health] with the exception of ‘pets’;

Justification

Since pets are covered by other control provisions, they should be excluded from this definition.

Amendment  34

Proposal for a regulation

Article 2 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

14. 'plant reproductive material' means plant reproductive material as defined in point (2) of Article 3 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on the production and making available on the market of plant reproductive material];

deleted

Amendment  35

Proposal for a regulation

Article 2 – paragraph 1 – point 15

Text proposed by the Commission

Amendment

15. 'plant protection products' means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009;

15. 'plant protection products' means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009; for the purposes of this Regulation, ‘plant protection products’ also refers to the active substances referred to in Article 2(2) of Regulation (EC) No 1107/2009 and other substances or preparations referred to in Article 2(3) of that Regulation;

Justification

When the proposal for a regulation refers to ‘plant protection products’ it refers also to the active substances referred to in Article 2(2) of Regulation (EC) No 1107/2009 and other substances or preparations referred to in Article 2(3) of that regulation.

Amendment  36

Proposal for a regulation

Article 2 – point 16

Text proposed by the Commission

Amendment

16. 'alien species' means a species, subspecies or lower taxon, introduced outside its natural past or present distribution and includes any part, gametes, seeds, eggs, or propagules of such species, as well as any hybrids, varieties or breeds, that might survive and subsequently reproduce;

deleted

Amendment  37

Proposal for a regulation

Article 2 – point 25

Text proposed by the Commission

Amendment

25. 'official attestation' means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities, or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2);

25. 'official attestation' means any label, mark or other form of attestation issued by the competent authorities, or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2);

Justification

Official attestation by operators is not desirable. The official certification or attestation procedure should remain a matter solely for the official authority.

Amendment  38

Proposal for a regulation

Article 2 – paragraph 1 – point 28 – point b

Text proposed by the Commission

Amendment

(b) activities under the control of operators falling within the scope of the rules referred to in Article 1(2) and equipment, means of transport, substances and materials used to perform those activities;

(b) activities under the control of operators falling within the scope of the rules referred to in Article 1(2) and equipment, means of transport, substances, materials, plant protection products and precautionary measures used to perform those activities;

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  39

Proposal for a regulation

Article 2 – paragraph 1 – point 28 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) the documentation referred to in points a), b) and c);

Justification

A key part of inspections is to verify that the documentation complies with existing rules.

Amendment  40

Proposal for a regulation

Article 2 – point 29

Text proposed by the Commission

Amendment

29. 'border control post' means a place, and the facilities belonging to it, designated by a Member State to perform the official controls provided for in Article 45(1);

29. 'border control post' means an inspection centre, and the facilities belonging to it, designated by a Member State to perform the official controls provided for in Article 45(1);

Justification

‘Centre’ draws attention more to the function than to the location. The word ‘centre’ accords with the definitions used in Germany’s regulation on the internal market and prevention of animal diseases and in Austria’s import regulation adopted by the veterinary authority.

Amendment  41

Proposal for a regulation

Article 2 – paragraph 1 – point 30

Text proposed by the Commission

Amendment

30. 'audit' means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve objectives;

30. Does not affect English version. Linguistic amendment to German and Spanish text.

Justification

Restores the usual German and Spanish term for 'audit'.

Amendment  42

Proposal for a regulation

Article 2 – paragraph 1 – subparagraph 32 – introductory part

Text proposed by the Commission

Amendment

32. 'official veterinarian' means a veterinarian appointed by the competent authorities and appropriately qualified to perform the official controls and other official activities in accordance with:

32. ‘official veterinarian’ means a veterinarian appointed by the competent authorities and appropriately qualified to perform official controls and other official activities in accordance with:

Justification

These are official controls in general, not specific controls.

Amendment  43

Proposal for a regulation

Article 2 – paragraph 1 – point 38

Text proposed by the Commission

Amendment

38. 'delegated body' means a third party, to which the competent authorities have delegated specific official control tasks;

38. ‘delegated body’ means an independent third party, to which the competent authorities have delegated specific tasks relating to official controls and other official activities;

Justification

In order to avoid any conflict of interests, the performance of control tasks should only be delegated to third parties that are entirely independent from the operators subject to official controls. In addition to official controls, delegated bodies also carry out ‘other official activities’ as defined in Article 2(2) of the proposal for a regulation.

Amendment  44

Proposal for a regulation

Article 2 – paragraph 1 – point 39

Text proposed by the Commission

Amendment

39. 'control authority for organic products' means a public administrative organisation of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Regulation (EC) No 834/2007, including, where appropriate, the corresponding authority of a third country or operating in a third country;

39. ‘control authority for organic production’ means a public administrative organisation of a Member State to which the competent authorities have conferred, in whole or in part, their competences for inspections and certification in the organic production sector, in relation to the provisions of Regulation (EC) No 834/2007, including, where appropriate, the corresponding authority of a third country or operating in a third country;

Justification

The official controls have to ascertain whether organic production procedures have been complied with, in accordance with the provisions of Regulation (EC) No 834/2007.

Amendment  45

Proposal for a regulation

Article 2 – paragraph 1 – point 44 – introductory part

Text proposed by the Commission

Amendment

44. ‘equivalence’ or ‘equivalent’ means:

44. ‘equivalence’ or ‘equivalent’ means systems that are broadly the same and meet the same objectives;

Amendment  46

Proposal for a regulation

Article 2 – paragraph 1 – point 44 – point a

Text proposed by the Commission

Amendment

(a) the capability of different systems or measures to meet the same objectives;

deleted

Amendment  47

Proposal for a regulation

Article 2 – paragraph 1 – point 44 – point b

Text proposed by the Commission

Amendment

(b) different systems or measures capable of meeting the same objectives;

deleted

Amendment  48

Proposal for a regulation

Article 2 – paragraph 1 – point 49

Text proposed by the Commission

Amendment

49) 'transhipment' means the movement of goods subject to the official controls provided for in Article 45(1) which arrive by sea or by air transport from a third country from a vessel or aircraft and are transported under customs supervision to another vessel or aircraft in the same port or airport in preparation for onward travel;

49) 'transhipment' means the movement of goods or animals subject to the official controls provided for in Article 45(1) which arrive by sea or by air transport from a third country from a vessel or aircraft and are transported under customs supervision to another vessel or aircraft in the same port or airport in preparation for onward travel;

Amendment  49

Proposal for a regulation

Article 2 – paragraph 1 – point 53

Text proposed by the Commission

Amendment

53. 'official detention' means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators under the control of the competent authorities;

53. 'official detention' means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities;

Amendment  50

Proposal for a regulation

Article 2 – paragraph 1 – point 57 a (new)

Text proposed by the Commission

Amendment

 

(57a) “Official auxiliary” means a person qualified, in accordance with Annex III a of this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian.

Amendment  51

Proposal for a regulation

Article 3 – paragraph 1

Text proposed by the Commission

Amendment

1. For each of the areas governed by the rules referred to in Article 1(2), Member States shall designate the competent authority or authorities on which they confer the responsibility to perform official controls and other official activities.

1. For each of the areas governed by the rules referred to in Article 1(2), Member States shall have one or more competent authorities responsible for planning, organising and where necessary performing official controls.

Justification

The concept of "confer the responsibility" is not clear; as a Member State is not in itself a body or institution, a competent authority is needed for this purpose.

Amendment  52

Proposal for a regulation

Article 3 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Where, for the same area, a Member State confers the responsibility to perform official controls or other official activities on more than one competent authority, at national, regional or local level, or where the competent authorities designated in accordance with paragraph 1 are allowed by that designation to transfer specific responsibilities for official controls or other official activities to other public authorities, the Member State shall:

2. Where, for the same area, a Member State has more than one competent authority, at national, regional or local level, or where the competent authorities designated in accordance with paragraph 1 are allowed to transfer specific responsibilities for official controls to other public authorities, care shall be taken to ensure that:

Justification

A Member State cannot confer anything because nothing is assigned to it. Responsibility will have to devolve upon the competent authorities of the Member State therefore, not on the Member State itself.

Amendment  53

Proposal for a regulation

Article 3 – paragraph 2 – point a

Text proposed by the Commission

Amendment

a) put in place procedures to ensure efficient and effective coordination between all authorities involved, and the consistency and effectiveness of official controls or other official activities across its territory;

a) procedures are put in place to ensure efficient and effective coordination between all authorities involved, and the consistency and effectiveness of official controls or other official activities across the whole of its territory;

Amendment  54

Proposal for a regulation

Article 3 – paragraph 2 – point b

Text proposed by the Commission

Amendment

b) designate a single authority responsible to coordinate the cooperation and the contacts with the Commission and other Member States in relation to the official controls and other official activities performed in that area.

b) designate a single authority responsible to coordinate the cooperation and the contacts with the Commission and other Member States in relation to the official controls and other official activities performed in each of the sectors defined by the Member State, in such a way as to cover all the areas referred to in Article 1(2).

Justification

The areas defined in Article 1(2) are very broad (e.g. the area under 2(a), which covers both food safety and fair trading practices). The French authorities wish to decide for themselves which areas belong in each of the sectors for which a single authority is to be designated.

Amendment  55

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. Competent authorities responsible for the verification of compliance with the rules referred to in point (j) of Article 1(2) may confer specific official control tasks to one or more control authorities for organic products. In such cases, they shall attribute a code number to each of them.

3. Competent authorities responsible for the verification of compliance with the rules referred to in point (j) of Article 1(2) may confer specific official control tasks to one or more control authorities for organic production. In such cases, they shall attribute a code number to each of them.

Justification

The official controls have to ascertain whether organic production procedures have been complied with, in accordance with the provisions of Regulation (EC) No 834/2007.

Amendment  56

Proposal for a regulation

Article 3 – paragraph 5

Text proposed by the Commission

Amendment

5. Member States may confer to the competent authorities referred to in paragraph 1 the responsibility to carry out controls for the verification of compliance with, or for the application of, rules, including those regulating specific risks which may arise from the presence of alien species in the Union, other than those referred to in Article 1(2).

5. Member States may confer to the competent authorities referred to in paragraph 1 the responsibility to carry out controls for the verification of compliance with, or for the application of, rules, other than those referred to in Article 1(2).

Amendment  57

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission may, by means of implementing acts, determine the means by which the information referred to in paragraph 4 is to be made available to the public. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141(2).

6. The Commission may, by means of implementing acts, determine the means by which the information referred to in paragraph 4 is to be made available to the public. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141(2). The means by which the information referred to in paragraph 4 is to be made available to the public shall in any case include publication on the internet.

Amendment  58

Proposal for a regulation

Article 4

Text proposed by the Commission

Amendment

1. The competent authorities shall:

1.The competent authorities shall:

(a) have procedures and arrangements in place to ensure the effectiveness and appropriateness of official controls and other official activities;

(a) have procedures and arrangements in place to ensure the effectiveness and appropriateness of official controls and other official activities;

(b) have arrangements in place to ensure the impartiality, quality and consistency of official controls and other official activities at all levels;

(b) have arrangements in place to ensure the impartiality, independence, quality, consistency and unity of purposes of official controls and other official activities at all levels; they should be in no way connected to or dependent of the operators that they control;

(c) have arrangements in place to ensure that staff performing official controls and other official activities are free from any conflict of interest;

(c) have arrangements in place to ensure that staff performing official controls and other official activities are independent and free from any conflict of interest;

(d) have, or have access to, an adequate laboratory capacity for analysis, testing and diagnosis;

(d) have, or have access to, an adequate laboratory capacity for analysis, testing and diagnosis;

(e) have, or have access to, a sufficient number of suitably qualified and experienced staff so that official controls and other official activities can be performed efficiently and effectively;

(e) have, or have access to, a sufficient number of independent, suitably qualified and experienced staff (with regard to the control requirements under Article 1(1) and (2), so that official controls and other official activities can be performed fully, efficiently and effectively;

(f) have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls and other official activities efficiently and effectively;

(f) have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls and other official activities efficiently and effectively;

(g) have the legal powers to perform official controls and other official activities and to take the action provided for in this Regulation and in the rules referred to in Article 1(2);

(g) have the legal powers to perform official controls and other official activities and to take the action provided for in this Regulation and in the rules referred to in Article 1(2);

(h) have legal procedures in place in order to ensure that staff have access to the premises of and documents kept by operators so as to be able to accomplish their tasks properly;

(h) have legal procedures in place in order to ensure that staff have access to the premises of and documents kept by operators so as to be able to accomplish their tasks properly;

(i) have contingency plans in place, and be prepared to operate such plans in the event of an emergency, where appropriate in accordance with the rules referred to in Article 1(2).

(i) have contingency plans in place, and be prepared to operate such plans in the event of an emergency, where appropriate in accordance with the rules referred to in Article 1(2).

2. Staff performing official controls and other official activities shall:

2. Staff performing official controls and other official activities shall:

 

(-a) be officials employed by the competent authorities or by an independent public body delegated by the competent authority to perform official controls or other official activities;

(a) receive, for their area of competence, appropriate training enabling them to undertake their duties competently and to perform official controls and other official activities in a consistent manner;

(a) receive, for their area of competence, appropriate training enabling them to undertake their duties competently and to perform official controls and other official activities in a consistent manner;

(b) keep up-to-date in their area of competence and receive regular additional training as necessary;

(b) keep up-to-date in their area of competence and receive regular additional training as necessary;

(c) receive training in the subject matters set out in Chapter I of Annex II and on the obligations of the competent authorities resulting from this Regulation.

(c) receive training in the subject matters set out in Chapter I of Annex II and on the obligations of the competent authorities resulting from this Regulation.

Competent authorities shall develop and implement training programmes for the purpose of ensuring that staff performing official controls and official activities receive the training referred to in points (a), (b) and (c).

Competent authorities shall develop and implement training programmes for the purpose of ensuring that staff performing official controls and official activities receive the training referred to in points (a), (b) and (c).

3. For the purpose of ensuring that the staff of the competent authorities referred to in point (e) of paragraph 1 and in paragraph 2 have the necessary qualifications, skills and knowledge, the Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the specific qualification and training requirements of such staff, having regard to the scientific and technical knowledge necessary to perform official controls and other official activities in each of the areas referred to in Article 1(2).

 

4. When, within the services of a competent authority, more than one unit is competent to perform official controls or other official activities, efficient and effective coordination and cooperation shall be ensured between the different units.

4. When, within the activities carried out by a competent authority, more than one unit is competent to perform official controls or other official activities, efficient and effective coordination and cooperation shall be ensured between the different units.

Amendment  59

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

2. Competent authorities shall make available the results of the audits referred to in paragraph 1 to the Commission upon request.

2. Competent authorities shall make available the results of the audits referred to in paragraph 1 to the Commission upon justified request.

Justification

The Commission should have to justify why it is requesting this information in order to prevent requests for information from the Member States for no good reason.

Amendment  60

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

1. Competent authorities shall require members of their staff not to disclose information acquired when undertaking their duties in the context of official controls and other official activities which by its nature is covered by professional secrecy, subject to paragraph 2.

1. Competent authorities shall require members of their staff not to disclose, except within the competent authority, information acquired when undertaking their duties in the context of official controls and other official activities which by its nature is covered by professional secrecy.

2. Unless there is an overriding public interest in its disclosure, information covered by professional secrecy as referred to in paragraph 1 shall include information whose disclosure would undermine:

2. Unless there is an overriding public interest in its disclosure, or disclosure is required by other Union legislation, information covered by professional secrecy as referred to in paragraph 1 shall include information whose disclosure would undermine:

(a) the purpose of inspections, investigations or audits;

(a) the purpose of inspections, investigations or audits;

(b) the protection of commercial interests of a natural or legal person;

(b) the protection of commercial interests of a natural or legal person;

(c) the protection of court proceedings and legal advice.

(c) ongoing court proceedings and legal advice.

 

(ca) the decision-making process of competent authorities.

 

2a. The competent authorities, when determining whether there is an overriding public interest in disclosure, shall take into account inter alia the following elements:

 

(a) possible risks to human, animal or plant health, or to the environment;

 

(b) the nature, severity and extent of such risks, so as to ensure that disclosure is proportionate in the circumstances;

3. Paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, provided that the following conditions are met:

3. Without prejudice to Paragraphs 1 and 2, the competent authorities shall publish or make otherwise available to the public information about the outcome of official controls regarding individual operators, provided that the following conditions are met:

(a) the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to the publication or release;

(a) the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to the publication or release;

(b) the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments.

(b) the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released simultaneously and together with such comments.

 

3a. Competent authorities shall ensure that any information published or made available to the public pursuant to this Article is accurate and that, if any such information eventually proves to be inaccurate, it is appropriately rectified.

Amendment  61

Proposal for a regulation

Article 8 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency, taking account of:

1. Competent authorities shall perform official controls on all undertakings regularly, on a risk basis and with appropriate frequency, taking account of:

Justification

Concerns German version in particular. It is the undertaking rather than the individual operator that should be subject to controls.

Amendment  62

Proposal for a regulation

Article 8 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) the activities under the control of operators;

(ii) the activities and precautionary measures under the control of operators;

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  63

Proposal for a regulation

Article 8 – paragraph 1 – point a – point iv

Text proposed by the Commission

Amendment

(iv) the use of products, processes, materials or substances that may influence food or feed safety, animal health or animal welfare, plant health or plant reproductive material identity and quality, or, in the case of GMOs and plant protection products, may adversely impact on the environment;

(iv) the use of products, processes, materials, feed additives or substances that may influence food safety and wholesomeness, feed safety, animal health or animal welfare, plant health or, in the case of GMOs and plant protection products, may adversely impact on the environment;

Justification

As official controls are risk based we should be clear about what constitutes a risk. Risks related to food wholesomeness i.e. food unfit for human consumption should be included.

Amendment  64

Proposal for a regulation

Article 8 – paragraph 1 – point a – point iv a (new)

Text proposed by the Commission

Amendment

 

(iva) the potential for consumers to be misled as to the nature, quality or substance of a product and/or the potential for consumers to incur financial loss as a result of receiving misleading information from the operator.

Justification

Consumer confidence in the agri-food chain is important for the industry. Therefore, when defining 'risk' it is important that we consider the risk of consumers being misled or facing economic loss, as well as the risk to human health.

Amendment  65

Proposal for a regulation

Article 8 – paragraph 1 – point a – point iv a (new)

Text proposed by the Commission

Amendment

 

(iva) the process requirements according to article 1(2)(j);

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  66

Proposal for a regulation

Article 8 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) operators' past record as regards the results of official controls performed on them and their compliance with the rules referred to in Article 1(2);

(b) undertakings' past record as regards the results of official controls performed on them and their compliance with the rules referred to in Article 1(2);

Justification

Concerns the German version in particular, clarifying that the results of controls on undertakings rather than operators are of key importance.

Amendment  67

Proposal for a regulation

Article 8 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the reliability and results of own controls that have been performed by the operators, or by a third party at their request, for the purpose of ascertaining compliance with the rules referred to in Article 1(2);

(c) the reliability and results of own controls that have been performed by the operators, or by a third party at their request, for the purpose of ascertaining compliance with the rules referred to in Article 1(2). Transfer of information on these own controls shall be utilised as much as possible, in a manner that minimizes the burden on operators;

Amendment  68

Proposal for a regulation

Article 8 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) consumer expectations regarding nature, quality and composition of foods and goods;

Amendment  69

Proposal for a regulation

Article 8 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(da) private quality assurance schemes put in place by operators, which are certified and audited by independent and recognised certification bodies.

Amendment  70

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

2. Competent authorities shall perform official controls on a regular basis and with appropriate frequency to identify possible intentional violations of the rules referred to in Article 1(2), taking into account, in addition to the criteria referred to in paragraph 1, information regarding such possible intentional violations shared through the mechanisms of administrative assistance provided for in Title IV and any other information pointing to the possibility of such violations.

2. Competent authorities shall perform official controls on a regular basis and with appropriate frequency to identify possible intentional violations of the rules referred to in Article 1(2), to verify compliance with the requirements and process criteria according to Article 1(2)(j), taking into account, in addition to the criteria referred to in paragraph 1, information regarding such possible intentional violations shared through the mechanisms of administrative assistance provided for in Title IV and any other information pointing to the possibility of such violations.

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  71

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 in order to establish a uniform minimum frequency for carrying out the controls referred to in paragraphs 1 and 2. Where necessary, such minimum frequency, based on risk, shall be established differently for each product, process or activity that is subject to official controls pursuant to this Regulation.

Justification

It is vital to establish, at EU level, a minimum frequency of official controls for each product, process or activity that is subject to control. Minimum frequency should thus become a general principle, which will help to increase EU consumer confidence.

Amendment  72

Proposal for a regulation

Article 8 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) prior notification of the operator is necessary;

deleted

Amendment  73

Proposal for a regulation

Article 8 – paragraph 4 – point b

Text proposed by the Commission

Amendment

(b) the operator has requested such official controls.

(b) the operator has requested such official controls. Such announced controls cannot replace standard controls without prior warning.

Amendment  74

Proposal for a regulation

Article 8 – paragraph 4 – point b a (new)

Text proposed by the Commission

Amendment

 

ba. audits for verification of requirements in accordance with Article 1(2)(j) are performed.

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  75

Proposal for a regulation

Article 8 – paragraph 5

Text proposed by the Commission

Amendment

5. Official controls shall be performed as much as possible in a manner that minimises the burden on the operators.

5. Official controls shall be performed as much as possible in a manner that the administrative burden and operational disruption for operators is kept to the necessary minimum, but without this affecting the quality of the control negatively; to that end, where the same operator is subject to various official controls over the same period, the competent authority shall aggregate them. Where various official controls are applied to operators, Member States shall ensure a coordinated approach with the aim of combining existing control measures.

Justification

Some sectors are subject to several official controls in the same year. Amendment to clarify that any additional inconvenience to operators occasioned by controls should be kept to an absolute minimum. In order to reduce the administrative burdens on operators, where possible, the competent authorities should take a coordinated approach to controls.

Amendment  76

Proposal for a regulation

Article 8 – paragraph 7

Text proposed by the Commission

Amendment

7. To the extent strictly necessary for the organisation of the official controls, Member States of destination may require operators who have animals or goods delivered to them from another Member State to report the arrival of such animals or goods.

7. To the extent necessary for the organisation of the official controls, Member States of destination shall require operators who have animals or goods delivered to them from another Member State to report the arrival of such animals or goods.

Justification

To increase the effectiveness of the controls, Member States shall require that any animals or goods from other Member States be reported.

Amendment  77

Proposal for a regulation

Article 9 – title

Text proposed by the Commission

Amendment

Persons, processes and activities subject to official controls

Persons, processes, activities, methods and techniques subject to official controls

Justification

Amalgamation of Articles 9 and 13 of the Commission proposal incorporating all information necessary for carrying out controls.

Amendment  78

Proposal for a regulation

Article 9 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) on animals and goods at all stages of production, processing and distribution;

(a) on animals and goods at all stages of production, processing, marketing, and distribution;

Justification

Clearer description of the food chain as a whole.

Amendment  79

Proposal for a regulation

Article 9 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) on substances, materials or objects which may influence the characteristics of animals and goods, at all stages of production, processing and distribution;

(b) on substances, materials or other objects which may influence the characteristics or health of animals and goods, at all stages of production, processing and distribution;

Amendment  80

Proposal for a regulation

Article 9 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) on operators and the activities and operations under their control, on their premises and processes, on the storage, transport, and the use of goods and the keeping of animals.

(c) on operators and the activities and operations under their control, on their premises, land, crops and processes, on the storage, transport, and the use of goods and on the keeping of animals.

Justification

The controls concern crops, too.

Amendment  81

Proposal for a regulation

Article 9 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) on all documentation, including documentation kept in electronic form, linked to the activity being performed, or to operations including transport.

Amendment  82

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

1. Competent authorities shall perform official controls with a high level of transparency and make available to the public relevant information concerning the organisation and the performance of official controls.

1. Competent authorities shall perform official controls with a high level of transparency and make available to the public relevant information concerning the organisation and the performance of official controls.

They shall also ensure the regular and timely publication of information on the following:

They shall also ensure the regular publication of information, at least once a year, on the following:

(a) the type, number and outcome of official controls;

(a) the type, number and final outcome of official controls;

(b) the type and the number of non-compliances detected;

(b) the type and the number of non-compliances detected;

(c) the cases where measures were taken by the competent authorities in accordance with Article 135;

(c) the type and number of cases where measures were taken by the competent authorities in accordance with Article 135;

(d) the cases where the penalties referred to in Article 136 were imposed.

(d) the type and number of cases where the penalties referred to in Article 136 were imposed.

Amendment  83

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

2. To ensure the uniform implementation of the rules provided for in paragraph 1 of this Article, the Commission shall, by means of implementing acts, lay down and update as necessary the format in which the information referred to in that paragraph shall be published. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141(2).

2. To ensure the uniform implementation of the rules provided for in paragraph 1 of this Article, the Commission shall provide Member States with appropriate guidance documents, including a proposal for a standardised reporting format, which shall in any case include the publication on the internet.

Amendment  84

Proposal for a regulation

Article 10 – paragraph 3

Text proposed by the Commission

Amendment

3. Competent authorities shall be entitled to publish or make otherwise available to the public information about the rating of individual operators based on the outcome of official controls, provided that the following conditions are met:

3. Competent authorities shall be entitled to publish or make otherwise available to the public information about the rating of individual operators based on the outcome of the last four official controls, provided that the following conditions are met:

(a) the rating criteria are objective, transparent and publicly available;

(a) the rating criteria are objective, transparent and publicly available;

(b) appropriate arrangements are in place to ensure the consistency and transparency of the rating process.

(b) appropriate arrangements are in place to ensure the consistency and transparency of the rating process.

 

(ba) subsequent inspections are carried out without delay if the findings are unfavourable;

Amendment  85

Proposal for a regulation

Article 10 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a. To enable rating systems to be compared from one Member State to another, the Commission shall, by means of delegated acts and in consultation with the stakeholders, lay down guidelines to establish objective criteria which shall be made available to the Member States and which they may use on a voluntary basis.

Amendment  86

Proposal for a regulation

Article 12 – title

Text proposed by the Commission

Amendment

Reports on official controls

Recording of, and reports on, official controls

Amendment  87

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Competent authorities shall draw up reports on every official control that they perform.

Competent authorities shall keep documentary records of every official control that they have performed. They shall draw up reports on controls in which this Regulation or the provisions of Article 1(2) were found to have been infringed.

Justification

To reduce the administrative workload, a report on a control should be drawn up only in those cases giving cause for complaint. The total number of controls and their outcome will be published in accordance with Article 10 of the Commission proposal.

Amendment  88

Proposal for a regulation

Article 12 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a. The outcome of official controls performed at a border control post shall be recorded in the Common Health Entry Document in accordance with Article 54(2)(b).

Justification

To avoid undue administrative work, there should not be two sets of records. Record keeping as provided for in Article 54 will suffice.

Amendment  89

Proposal for a regulation

Article 13 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Official controls shall include the following, as appropriate:

2. Official controls shall include the following:

Amendment  90

Proposal for a regulation

Article 13 – paragraph 2 – point b – point ii a (new)

Text proposed by the Commission

Amendment

 

(iia) materials intended to come into contact with food;

Amendment  91

Proposal for a regulation

Article 13 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) an examination of documents and other records which may be relevant to the assessment of compliance with the rules referred to in Article 1(2);

(e) an examination of documents, traceability records and other records which may be relevant to the assessment of compliance with the rules referred to in Article 1(2);

Amendment  92

Proposal for a regulation

Article 14 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. To the extent that this is necessary for the performance of official controls or of other official activities, operators shall, where required by the competent authorities, give staff of the competent authorities access to:

1. To the extent that this is necessary for the performance of official controls or of other official activities, operators shall, where required by the competent authorities, give staff of the competent authorities and staff of the delegated bodies, where specific official control tasks have been delegated in accordance with the provisions of Article 25, access to:

Justification

This is a correction to Amendment 18 of the draft report. The text should refer to official controls and not to risk controls, as erroneously stated in Amendment 18 of the draft report.

Amendment  93

Proposal for a regulation

Article 14 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) their documents and any other relevant information.

(d) their relevant documents and any other information, including the results of potential own tests, that is relevant for the purpose of performing such controls or activities and the control subjects listed in Article 13(2). Every operator shall be able to indicate at least each operator he is supplied by and each operator he is supplying.

Justification

For clarification and completeness.

Amendment  94

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

2. During official controls and other official activities, operators shall assist the staff of the competent authorities in the accomplishment of their tasks.

2. During official controls and other official activities, operators shall assist the staff of the competent authorities and the delegated bodies, pursuant to Article 25, in the accomplishment of their control tasks. Operators shall supply the competent authorities with sufficient quantities of samples free of charge.

Justification

In accordance with Article 25 of the proposal for a regulation, official controls may be delegated; any assistance provided by operators to the staff of the competent authorities should therefore concern also the staff of the delegated bodies.

Amendment  95

Proposal for a regulation

Article 14 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) make available all information concerning the consignment on paper or electronically.

(b) make available without delay all requested information concerning the consignment on paper or electronically.

Justification

Clarification.

Amendment  96

Proposal for a regulation

Article 14 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) establishing the modalities for access by the competent authorities to the computerised information management systems referred to in paragraph 1(b);

(a) establishing the modalities for access by the competent authorities and the delegated bodies, pursuant to Article 25, to the computerised information management systems referred to in paragraph 1(b);

Justification

In accordance with Article 25 of the proposal for a regulation, official controls may be delegated; arrangements for access to computerised information systems should therefore concern also the staff of the delegated bodies.

Amendment  97

Proposal for a regulation

Article 15

Text proposed by the Commission

Amendment

 

-1. Official controls performed to verify compliance with the rules referred to in Article 1(2) in relation to products of animal origin intended for human consumption shall always include the verification of compliance with the requirements laid down in Regulation (EC) No 852/2004 in Regulation (EC) No 853/2004 and in Regulation (EC) No 1069/2009 as applicable, and at least of the following, as appropriate:

 

(a) the design and maintenance of premises and equipment;

 

(b) personal hygiene;

 

(c) HACCP-based procedures

 

(d) own-controls procedures;

 

(e) verification of compliance by the staff with applicable requirements;

 

(f) verification of the operator’s records and of documents accompanying food, feed and any substance or material entering and leaving the establishment;

 

(g) consideration of any evidence of the presence of fraudulent practices.

1. Official controls on the production of meat shall include:

1. The official controls referred to in paragraph 1 performed in relation to the production of meat shall include:

(a) the verification, by or under the responsibility of an official veterinarian, of the health and welfare of the animals prior to the slaughter;

(a) the verification, by an official veterinarian or by an official auxiliary working under an official veterinarian's responsibility,

(b) official controls, by or under the responsibility of an official veterinarian, in slaughterhouses, cutting plants and game handling establishments, to verify compliance with the requirements applicable to:

(b) official controls, by an official veterinarian or by an official auxiliary working under an official veterinarian's responsibility, in slaughterhouses, cutting and processing plants and game handling establishments, to verify compliance with the requirements applicable to:

(i) the hygiene of meat production;

(i) the hygiene of meat production;

(ii) the presence of residues of veterinary medicinal products in products of animal origin intended for human consumption;

(ii) the presence of residues of veterinary medicinal products in products of animal origin intended for human consumption;

(iii) the handling and disposal of animal by-products and of specified risk material;

(iii) the handling and disposal of animal by-products and of specified risk material;

(iv) the health and welfare of the animals.

(iv) the health and welfare of the animals.

 

1a. For the purposes of the official controls referred to in paragraph 2:

 

(a) at least one official veterinarian shall be present during both the ante-mortem and post-mortem inspection or, in the case of game-handling establishments, during the post-mortem inspection;

 

(b) an official veterinarian or an official auxiliary shall be present, with a frequency appropriate to achieving the objectives of this Regulation, in cutting plants when meat is being worked on.

 

1b. Following the official controls referred to in paragraph 2, actions and measures in accordance with Article 135 in relation to the animals, their welfare and the destination of meat shall be taken by or under the responsibility of the official veterinarian.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning specific rules for the performance of official controls on products of animal origin intended for human consumption and on animals intended for the production of such products to verify compliance with the rules referred to in points (a), (c), (d) and (e) of Article 1(2) applicable to those products and animals, and on action to be taken by the competent authorities following official controls. Those delegated acts shall lay down rules on:

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning specific rules for the performance of official controls on products of animal origin intended for human consumption and on animals intended for the production of such products to verify compliance with the rules referred to in points (a), (c), (d) and (e) of Article 1(2) applicable to those products and animals, and on action to be taken by the competent authorities following official controls. Those delegated acts shall lay down rules on:

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36;

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36;

(b) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes;

(b) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes;

(c) the cases where and the conditions under which slaughterhouse staff may be involved in official controls, and the design and application of tests to assess their performance;

(c) the cases where and the conditions under which slaughterhouse staff appropriately qualified and trained, and employed under the control of the official veterinarian in a unit which is segregated and independent from the production units of the establishment, may assist the official veterinarian when performing the official controls referred to in paragraph 2 in relation to the production of meat from poultry and largomorphs, and the design and application of tests to assess their performance;

(d) the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph;

(d) the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph;

(e) criteria to determine when, on the basis of a risk analysis, the official veterinarian is not required to be present in slaughterhouses and game handling establishments during the official controls referred to in paragraph 1.

(e) criteria to determine, on the basis of a risk analysis, the conditions and the frequency of the official control tasks to be carried out by the official veterinarian in low throughput slaughterhouses and in game handling establishments, respecting the minimum requirement laid down in paragraph 1a (a).

Where, in cases of risks which cannot be effectively addressed in the absence of common specifications for the official controls or for the action to be taken by the competent authorities following such official controls, imperative grounds of urgency so require, the procedure provided for in Article 140 shall apply to delegated acts adopted pursuant to this paragraph.

Where, in cases of risks which cannot be effectively addressed in the absence of common specifications for the official controls or for the action to be taken by the competent authorities following such official controls, imperative grounds of urgency so require, the procedure provided for in Article 140 shall apply to delegated acts adopted pursuant to this paragraph.

3. The Commission shall take into account the following when adopting delegated acts as provided for in paragraph 2:

3. The Commission shall take into account the following when adopting delegated acts as provided for in paragraph 2:

(a) the experience gained by food business operators on the application of the procedures referred to in Article 5 of Regulation (EC) 852/2004 of the European Parliament and of the Council48;

(a) the experience gained by competent authorities and food business operators on the application of the procedures referred to in Article 5 of Regulation (EC) 852/2004 of the European Parliament and of the Council48;

(b) scientific and technological developments;

(b) scientific and technological developments;

(c) consumer expectations with regard to food composition and changes in patterns of consumption of food;

 

(d) risks to human health and animal health associated with meat and other products of animal origin intended for human consumption.

(d) risks to human health and animal health associated with meat and other products of animal origin intended for human consumption.

 

(da) consideration of any evidence of the presence of fraudulent practices.

4. Insofar as this does not prevent the achievement of the objectives of human health and animal health pursued by the rules referred to in points (a), (c), (d) and (e) of Article 1(2), applicable to products of animal origin intended for human consumption and to animals intended for the production of such products, the Commission shall also take into account the following elements, when adopting delegated acts as provided for in paragraph 2:

4. Insofar as this does not prevent the achievement of the objectives of human health and animal health pursued by the rules referred to in points (a), (c), (d) and (e) of Article 1(2), applicable to products of animal origin intended for human consumption and to animals intended for the production of such products, the Commission shall also take into account the following elements, when adopting delegated acts as provided for in paragraph 2:

(a) the need to facilitate the application of the delegated acts in small businesses;

(a) the need for the delegated acts to commensurate with the nature and the size of small businesses to demonstrate an effective application;

(b) the need to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(b) the need to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(c) the needs of food businesses situated in regions that are subject to special geographic constraints.

(c) the needs of food businesses situated in regions that are subject to special geographic constraints.

___________________________

___________________________

48 OJ L 139, 30.4.2004, p. 1.

48 OJ L 139, 30.4.2004, p. 1.

Amendment  98

Proposal for a regulation

Article 17 – title

Text proposed by the Commission

Amendment

Specific rules on official controls and on action to be taken by the competent authorities in relation to animals, products of animal origin, germinal products, animal by-products and derived products

Specific rules on official controls and on action to be taken by the competent authorities in relation to animals, products of animal origin, and germinal products

Justification

Regulation (EC) No 1069/2009 sets out detailed hygiene and control rules for the handling of animal by-products not for human consumption. That regulation should remain in place and not be converted into a delegated act.

Amendment  99

Proposal for a regulation

Article 17 – paragraph -1 (new)

Text proposed by the Commission

Amendment

 

Official controls in relation to animals shall include:

 

- the verification of measures for protection against biological and chemical hazards to human and animal health;

 

- the verification of animal welfare measures, without prejudice to the provisions of Article 18;

 

- the verification of disease control or eradication measures.

Justification

More exact description of the subject matter that might be covered by a delegated act.

Amendment  100

Proposal for a regulation

Article 17 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the performance of official controls on animals, on products of animal origin, on germinal products, on animal by-products and on derived products to verify compliance with the Union rules referred to in points (d) and (e) of Article 1(2) and on action to be taken by the competent authorities following official controls. Those delegated acts shall take account of animal health risks related to animals, products of animal origin and germinal products, and of human and animal health risks related to animal by-products and derived products, and lay down rules on:

The Commission shall be empowered to adopt legislative proposals concerning rules for the performance of official controls on animals, on products of animal origin, on germinal products, on animal by-products and on derived products to verify compliance with the Union rules referred to in points (d) and (e) of Article 1(2) and on action to be taken by the competent authorities following official controls. Those legislative proposal shall take account of animal health risks related to animals, products of animal origin and germinal products, and lay down rules on:

Justification

Removes the reference to animal by-products and derived products.

Amendment  101

Proposal for a regulation

Article 17 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2) and 36;

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Articles 10(1), 11, 12, and 34(1) and (2);

Justification

The responsibilities of the competent authorities are central to the regulation and should be dealt with in the relevant articles. To adopt wider ranging delegated acts would be too sweeping an approach, as these could subsequently influence the interpretation of much of the regulation proper.

Amendment  102

Proposal for a regulation

Article 18 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Official controls to verify compliance with the rules laying down welfare requirements for animals in case of their transport shall include:

1. In addition to the general rules on official controls provided for in Article 8, official controls to verify compliance with the rules laying down welfare requirements for animals in case of their transport shall include:

Justification

It needs to be clarified that in addition to the sectoral rules, the general rules under Article 8 of the proposal for a regulation also apply.

Amendment  103

Proposal for a regulation

Article 18 – paragraph 1 – point c – point i

Text proposed by the Commission

Amendment

(i) official controls on the fitness of the animals being transported and on the means of transport;

(i) official controls on the fitness of the animals being transported and on the means of transport to verify compliance with Chapter II and where applicable Chapter VI of Annex I to Regulation (EC) No 1/1005;

Justification

To reflect the corresponding provision in Regulation (EC) no 1/2005, which is repealed by the proposed Regulation. The corresponding provision in Regulation (EC) No 12005 on the protection of animals during transport specifies that controls of the means of transport are carried out to verify compliance with Chapter II and where applicable Chapter VI of the Regulation. The proposed Regulation on official controls repeals this aspect of Regulation 1/2005. Accordingly, it should now be included in the proposed Regulation on official controls.

Amendment  104

Proposal for a regulation

Article 18 – paragraph 1 – point c – point ii

Text proposed by the Commission

Amendment

(ii) official controls to verify that transporters comply with applicable international agreements and have valid transporter authorisations and certificates of competence for drivers and attendants;

(ii) official controls to verify that transporters comply with applicable international agreements, including the European Convention for the protection of animals during international transport and have valid transporter authorisations and certificates of competence for drivers and attendants;

Justification

It would be helpful to make it clear that the main relevant agreement is the European Convention for the protection of animals during international transport.

Amendment  105

Proposal for a regulation

Article 18 – paragraph 1 – point c – point iii a (new)

Text proposed by the Commission

Amendment

 

(iiia) following official controls under point (c) (i) of this paragraph, where the view of the competent authority is that animals are unfit for transport, they shall be unloaded, watered, fed and rested and veterinary assistance must be sought if necessary, until fit to continue their journey.

Justification

Regulation 1/2005 on the protection of animals during transport provides that if animals at an exit point from the EU are found to be not fit to continue their journey, they must be unloaded and given food, water and rest. The proposed Regulation on official controls repeats the requirement in Regulation 1/2005 that animals must be checked at exit points to verify that they are fit to continue their journey but does not specify what action should be taken in respect of animals found to be unfit.

Amendment  106

Proposal for a regulation

Article 18 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) in case of long journeys between Member States and with third countries, official controls performed at any stage of the long journey on a random or targeted basis to verify that declared journey times are realistic and that the journey complies with Regulation (EC) No 1/2005 and in particular that travel times and rest periods have complied with the limits set out in Chapter V of Annex I to Regulation (EC) No 1/2005;

Justification

Rather surprisingly Article 18 requires controls on the transport of animals prior to the journey and at exit points from the EU but not during the course of the journey.

Amendment  107

Proposal for a regulation

Article 18 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the performance of official controls to verify compliance with Union rules referred to in point (f) of Article 1(2). Those delegated acts shall take into account the animal welfare risk related to the farming activities and to the transport, slaughter and killing of animals, and shall lay down rules on:

3. The Commission shall be empowered to adopt legislative proposals concerning rules for the performance of official controls to verify compliance with Union rules referred to in point (f) of Article 1(2). Those legislative proposals shall take into account the animal welfare risk related to the farming activities and to the transport, slaughter and killing of animals, and shall lay down rules on:

Amendment  108

Proposal for a regulation

Article 18 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36;

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and Articles 4, 8, 9, 10(1), 11, 12 and 13;

Justification

The rules under Article 34 – second expert opinion – and Article 36 – designation of official laboratories – do not concern the responsibilities of the competent authorities.

Amendment  109

Proposal for a regulation

Article 18 – paragraph 3 – point f

Text proposed by the Commission

Amendment

(f) the cases and conditions where official controls to verify compliance with animal welfare requirements may include the use of specific animal welfare indicators based on measurable performance criteria, and the design of such indicators on the basis of scientific and technical evidence.

(f) the cases and conditions where official controls to verify compliance with animal welfare requirements shall include the use of specific animal welfare indicators based on measurable performance criteria, and the design of such indicators on the basis of scientific and technical evidence.

Amendment  110

Proposal for a regulation

Article 20

Text proposed by the Commission

Amendment

Article 20

deleted

Specific rules on official controls and action to be taken by the competent authorities in relation to plant reproductive material

 

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the performance of official controls on plant reproductive material in order to verify compliance with the rules referred to in point (h) of Article 1(2) applicable to such goods and on action to be taken by the competent authorities following such official controls. Those delegated acts shall lay down rules on:

 

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2) and 36;

 

(b) uniform specific requirements for the performance of official controls having regard, in addition to the criteria referred to in Article 8(1), to the risks to the health, identity, quality and traceability of certain categories of plant reproductive material or of specific genera or species;

 

(c) specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Title IV;

 

(d) the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph.

 

Amendment  111

Proposal for a regulation

Article 21 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the performance of official controls on GMOs and genetically modified food and feed performed to verify compliance with the rules referred to in points (a), (b) and (c) of Article 1(2) and on action to be taken by the competent authorities following such official controls. Those delegated acts shall take into account the need to ensure a minimum level of official controls to prevent practices in violation with those rules, and lay down rules on:

The Commission shall be empowered to adopt legislative proposals concerning rules for the performance of official controls on GMOs and genetically modified food and feed performed to verify compliance with the rules referred to in points (a), (b) and (c) of Article 1(2) and on action to be taken by the competent authorities following such official controls. Those legislative proposals shall take into account the need to ensure a minimum level of official controls to prevent practices in violation with those rules, and lay down rules on:

Amendment  112

Proposal for a regulation

Article 21 – paragraph 1 – point b – point ii

Text proposed by the Commission

Amendment

(ii) the cultivation of GMOs and the correct application of the monitoring plan referred to in point (e) of Article 13(2) of Directive 2001/18/EC and in Articles 5(5) and 17(5) of Regulation (EC) 1829/2003;

(ii) the cultivation of GMOs and the correct application of the monitoring plan referred to in point (e) of Article 13(2) of Directive 2001/18/EC and in Articles 5(5) and 17(5) of Regulation (EC) 1829/2003, including minimum measures for monitoring and surveillance of potential effects on health, animal health and the environment;

Amendment  113

Proposal for a regulation

Article 21 – paragraph 1 – point b – point iii a (new)

Text proposed by the Commission

Amendment

 

(iiia) minimum measures as regards controls and reporting which aim at avoiding the unintended presence of GMOs, in accordance with Article 26a of Directive 2001/18

Amendment  114

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the performance of official controls to verify compliance with the rules referred to in Article 1(2)(i).

The Commission shall be empowered to adopt legislative proposals concerning rules for the performance of official controls to verify compliance with the rules referred to in Article 1(2)(i).

Amendment  115

Proposal for a regulation

Article 22 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

Those delegated acts shall take into account the risks that plant protection products may represent for human health, animal health or the environment, and shall lay down rules on:

Those legislative proposals shall take into account the risks that plant protection products may represent for human health, animal health or the environment, and shall lay down rules on:

Amendment  116

Proposal for a regulation

Article 22 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage and use of plant protection products, having regard, in addition to the criteria referred to in Article 8(1), to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products;

(b) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage, parallel trade and use of plant protection products, having regard, in addition to the criteria referred to in Article 8(1), to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products;

Amendment  117

Proposal for a regulation

Article 22 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) uniform specific requirements for the establishment of a register or database concerning production, packaging and storage facilities;

Amendment  118

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In relation to the rules referred to in point (j) of Article 1(2), the delegated acts referred to in paragraph 1 shall lay down rules on:

2. The Commission shall be empowered to adopt delegated acts, in accordance with Article 27 (2) of Regulation (EC) No 834/2007, to verify compliance with the rules referred to in point (j) of Article 1(2) and on action to be taken by the competent authorities following such official controls. Those delegated acts shall lay down rules on:

Amendment  119

Proposal for a regulation

Article 23 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Articles 4, 8, 9, 10(1), 11 to 13, 34(1) and (2), and Article 36, and in addition to Articles 25, 29, 30 and 32 for the approval and supervision of delegated bodies;

(a) the specific responsibilities and tasks of the operators, the competent authorities, the delegated bodies to ensure compliance with the provisions of Regulation (EC) No 834/2007, in addition to those provided for in Articles 4, 8, 9, 10(1), 11 to 13, 34(1) and (2), and Article 36, and in addition to Articles 25, 29, 30 and 32 for the approval and supervision of delegated bodies;

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  120

Proposal for a regulation

Article 23 – paragraph 4

Text proposed by the Commission

Amendment

4. Where appropriate, the delegated acts referred to in paragraphs 2 and 3 shall derogate from the provisions of this Regulation referred to in those paragraphs.

deleted

Amendment  121

Proposal for a regulation

Article 24 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning specific rules on official controls performed on certain categories of food or feed to verify compliance with the rules referred to in points (a) to (e) of Article 1(2) and on action to be taken by the competent authorities following such official controls. Those delegated acts shall address newly identified risks which may be posed through food or feed to human or animal health or, in relation to GMOs and plant protection products to the environment, or any such risks emerging from new patterns of production or consumption of food or feed, or which cannot be effectively addressed in the absence of common specifications for the official controls and for the action to be taken by the competent authorities following such official controls, and shall lay down rules on:

1. The Commission shall be empowered to adopt legislative proposals concerning specific rules on official controls performed on certain categories of food or feed to verify compliance with the rules referred to in points (a) to (e) of Article 1(2) and on action to be taken by the competent authorities following such official controls. Those legislative proposals shall address newly identified risks which may be posed through food or feed to human or animal health or, in relation to GMOs and plant protection products to the environment, or any such risks emerging from new patterns of production or consumption of food or feed, or which cannot be effectively addressed in the absence of common specifications for the official controls and for the action to be taken by the competent authorities following such official controls, and shall lay down rules on:

Amendment  122

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

 

Article 24a

 

Specific rules on official controls and on action to be taken by the competent authorities in relation to materials and articles intended to come into contact with food.

 

The Commission may be empowered to adopt delegated acts in accordance with Article 139 concerning rules on the application of the official controls and on action to be taken by the competent authorities in relation to materials and articles intended to come into contact with food.

Justification

Materials and articles intended to come into contact with food fall within the field of application and should therefore be covered by an article laying down specific rules.

Amendment  123

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

1. Competent authorities may delegate specific official control tasks to one or more delegated bodies or natural persons in accordance with the conditions provided for in Articles 26 and 27 respectively.

1. Competent authorities may delegate specific official control tasks to one or more delegated bodies or natural persons in accordance with the conditions provided for in Articles 26 and 27 respectively. Competent authorities shall not delegate specific official control tasks to natural persons concerning official controls performed to verify compliance with the rules referred to in point (j) of Article 1(2).

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  124

Proposal for a regulation

Article 25 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The first subparagraph shall not apply to the measures to be taken in accordance with Article 135 or with the rules provided for in point (e) of Article 23(2) following official controls performed to verify compliance with the rules referred to in point (j) of Article 1(2).

deleted

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  125

Proposal for a regulation

Article 26 – paragraph 1 – point b – point iii

Text proposed by the Commission

Amendment

(iii) is impartial and free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it;

(iii) is impartial, independent, not directly nor indirectly employed by the operator on which it is performing control activities, and otherwise free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it;

Justification

The independence of delegated bodies from operators is crucial and should be reinforced in the text.

Amendment  126

Proposal for a regulation

Article 26 – paragraph 1 – letter b – point iv a (new)

Text proposed by the Commission

Amendment

 

(iva) has sufficient powers to perform the official controls delegated to it;

Justification

A delegated body acts in the name of and on behalf of the competent authority. In performing its duties, the delegated body must exercise the powers conferred upon it by the delegating authority.

Amendment  127

Proposal for a regulation

Article 29 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) organise audits or inspections of such bodies or persons as necessary;

(a) organise periodical and unannounced audits or inspections of such bodies or persons;

Amendment  128

Proposal for a regulation

Article 29 – paragraph 1 – point b – point iia (new)

Text proposed by the Commission

Amendment

 

iia) the independence or impartiality of the delegated body or natural person have been shown to be compromised

Amendment  129

Proposal for a regulation

Article 32 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) organise audits or inspections of such bodies or persons as necessary;

(a) organise audits or inspections of such bodies or persons;

Amendment  130

Proposal for a regulation

Article 33 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In the absence of the Union rules referred to in paragraph 1, official laboratories shall use state-of-the-art methods for their specific analytical, testing and diagnostic needs, taking into account:

2. In the absence of the Union rules referred to in paragraph 1, in the context of official controls, official laboratories shall use state-of-the-art methods for their specific analytical, testing and diagnostic needs, taking into account, in the following order:

Amendment  131

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. In the context of screening, targeted screening and of other official activities, any of the methods referred to in paragraph 2 may be used in the absence of Union rules referred to in paragraph 1.

3. By way of derogation from paragraph 2, in the context of screening, targeted screening and of other official activities, any of the methods referred to in paragraph 2 may be used in the absence of Union rules referred to in paragraph 1. The same rule shall apply to the other official activities.

Amendment  132

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 36(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols.

4. Where laboratory analyses, tests or diagnoses are urgently needed, in exceptional cases due to a developing emergency situation, and none of the methods referred to in paragraphs 1 and 2 exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 36(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols.

Amendment  133

Proposal for a regulation

Article 33 – paragraph 6

Text proposed by the Commission

Amendment

6. Samples shall be taken, handled and labelled in such a way as to guarantee their legal, scientific and technical validity.

6. Samples shall be taken, handled and labelled in such a way as to guarantee their legal, scientific and technical validity. The size of the sample taken must be such as to enable a second expert opinion to be given, where necessary, should an operator so request under Article 34.

Justification

The second opinion should concern the same sample taken, which is why the sample should be large enough to enable tests or diagnosis to be carried out on it.

Amendment  134

Proposal for a regulation

Article 33 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

 

6a. As regards products of animal origin, methods have to be developed and mandatorily established aimed at identifying and tracing breeding material from cloned animals as well as descendants from cloned animals and products derived thereof.

Amendment  135

Proposal for a regulation

Article 33 – paragraph 7 – subparagraph 1 – introductory wording

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, lay down rules for:

The Commission may, by means of implementing acts, insofar as these matters are not otherwise regulated, lay down rules for:

Justification

For the field of feed, Regulation (EC) No 152/2009 on sampling and analysis procedures exists. It deals with both sampling and methods of examination. A revised version of this Regulation is due to be published shortly. The Commission can therefore only act to the extent that the relevant provisions are not already laid down elsewhere.

Amendment  136

Proposal for a regulation

Article 34 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to apply for a second expert opinion.

The competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to apply for a second expert opinion, where this is relevant and technically feasible. The operator shall bear the costs of this expert opinion.

Justification

A second expert opinion is not relevant in all cases or could be technically difficult to carry out (e.g. foreign bodies in the samples).

Amendment  137

Proposal for a regulation

Article 34 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

a) shall always entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another expert;

a) shall always entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another expert designated by the reference laboratory or, failing that, by another official laboratory which is at least equivalent;

Amendment  138

Proposal for a regulation

Article 34 – paragraph 1 – subparagraph 2 – point b – introductory part

Text proposed by the Commission

Amendment

(b) where relevant and technically feasible, having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate, shall entitle the operator to request:

(b) where relevant and technically feasible, having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate, shall entitle the operator to request and oblige the competent authorities to ensure:

Justification

It must be clear that an authority cannot reject the request from an operator out of hand.

Amendment  139

Proposal for a regulation

Article 34 – paragraph 1 – subparagraph 2 – point b – point i

Text proposed by the Commission

Amendment

(i) that a sufficient number of other samples be taken for a second expert opinion; or,

(i) that a sufficient number of samples be taken and divided into three parts for the purpose of an initial analysis and, if appropriate, a second expert opinion at the request of the operator, then another final analysis, if there is a discrepancy between the two previous ones;

Justification

A final analysis should be carried out in the case of discrepancies, so it is important to have three parts of the same sample.

Amendment  140

Proposal for a regulation

Article 34 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. Samples shall be handled and labelled in such a way as to guarantee their legal and technical validity.

Justification

It must be ensured that samples are handled properly in order to guarantee their validity.

Amendment  141

Proposal for a regulation

Article 35 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Competent authorities shall take all steps to ensure that the operators from whom the samples are ordered in accordance with paragraph 1:

2. Competent authorities, once they are in possession of the samples, shall take all steps to ensure that the operators from whom these samples are ordered in accordance with paragraph 1:

Amendment  142

Proposal for a regulation

Article 36 – paragraph 4 – point c

Text proposed by the Commission

Amendment

(c) is impartial and free from any conflict of interest as regards the exercise of its tasks as official laboratory;

(c) is independent, impartial and free from any conflict of interest as regards the exercise of its tasks as official laboratory;

Amendment  143

Proposal for a regulation

Article 36 – paragraph 4 – point e

Text proposed by the Commission

Amendment

(e) operates in accordance with the standard EN ISO/IEC 17025 on 'General requirements for the competence of testing and calibration laboratories' and is assessed and accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008.

(e) operates in accordance with the standard EN ISO/IEC 17025 on 'General requirements for the competence of testing and calibration laboratories' and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008.

Justification

The formulation ‘assessed and accredited’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  144

Proposal for a regulation

Article 36 – paragraph 5 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The scope of the assessment and accreditation of an official laboratory referred to in point (e) of paragraph 4:

The scope of the accreditation of an official laboratory referred to in point (e) of paragraph 4:

Justification

The formulation ‘assessment and accreditation’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  145

Proposal for a regulation

Article 39 – title

Text proposed by the Commission

Amendment

Derogations from the condition for the mandatory assessment and accreditation for certain official laboratories

Derogations from the condition for the mandatory accreditation for certain official laboratories

Justification

The assessment precedes the accreditation.

Amendment  146

Proposal for a regulation

Article 39 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 36(1), and assessed and accredited in accordance with the standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’ for the use of the methods referred to in point (a)(ii) of this paragraph;

(iii) that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 36(1), and accredited in accordance with the standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’ for the use of the methods referred to in point (a)(ii) of this paragraph;

Justification

The formulation ‘assessed and accredited’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  147

Proposal for a regulation

Article 39 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) laboratories carrying out analyses or tests to verify compliance with the rules on plant reproductive material referred to in point (h) of Article 1(2);

deleted

Amendment  148

Proposal for a regulation

Article 40 – title

Text proposed by the Commission

Amendment

Powers to adopt derogations from the condition for the mandatory assessment and accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories

Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories

Justification

The formulation ‘assessment and accreditation’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  149

Proposal for a regulation

Article 41 – title

Text proposed by the Commission

Amendment

Temporary derogations from the condition for the mandatory assessment and accreditation of official laboratories

Temporary derogations from the condition for the mandatory accreditation of official laboratories

Justification

The formulation ‘assessment and accreditation’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  150

Proposal for a regulation

Article 41 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) pending the assessment by, and decision of, the accreditation body.

Justification

It should be possible to designate analysis laboratories on a temporary basis to allow the accreditation body to make an assessment during the course of their operation, while ensuring the legal validity of their analytical results.

Amendment  151

Proposal for a regulation

Article 41 a (new)

Text proposed by the Commission

Amendment

 

Article 41a

 

Official controls on animals and goods entering the Union shall be organised according to risk, and may take place at border control posts in accordance with Section II of this chapter, with a view to checking compliance with the regulatory provisions specific to certain animals or goods, or at an appropriate place in accordance with Section I of this chapter.

Justification

An introductory article should be included ahead of Section I clearly setting out the principle of an overall approach to import controls depending on risk.

Amendment  152

Proposal for a regulation

Article 42 – paragraph 1 – subparagraph 2 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa) the likelihood of fraudulent practices which might deceive consumer expectation regarding nature, quality and composition of foods and goods;

Amendment  153

Proposal for a regulation

Article 45 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) products of animal origin, germinal products and animal by-products;

(b) products of animal origin, foods that contain products of animal origin, germinal products and animal by-products;

Amendment  154

Proposal for a regulation

Article 46 – point a

Text proposed by the Commission

Amendment

(a) goods sent as commercial or trade samples or as display items for exhibitions, which are not intended to be placed on the market;

deleted

Justification

Even if these are goods or animals not intended for human consumption, they can nevertheless produce viruses and bacteria. Given that the aim of the proposed regulation is to prevent, as far as possible, the spread of diseases or viruses that could cause risks to human and animal health, controls should also cover this type of goods and animals.

Amendment  155

Proposal for a regulation

Article 46 – point b

Text proposed by the Commission

Amendment

(b) animals and goods intended for scientific purposes;

deleted

Justification

Checks on animals intended for scientific purposes should be carried out at EU borders, given the possible risk to human health. Even if these are goods or animals not intended for human consumption, they can nevertheless produce viruses and bacteria. Given that the aim of the proposed regulation is to prevent, as far as possible, the spread of diseases or viruses that could cause risks to human and animal health, controls should also cover this type of goods and animals.

Amendment  156

Proposal for a regulation

Article 46 – point f

Text proposed by the Commission

Amendment

(f) pet animals as defined in point (10) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health];

deleted

Justification

Any proposal to relax on checks on pet animals entering the Union should receive proper scrutiny from the Parliament and Council. These powers are excessive given that implementation of Regulation No 998/2003 on the non-commercial movement of pet animals (including animals entering the Union) is poor, 65% of all human diseases originate in animals and 75% of animal diseases are zoonotic.

Amendment  157

Proposal for a regulation

Article 47 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Where such checks are performed on animals they shall be carried out by an official veterinarian or under his supervision.

Where such checks are performed on animals or on products of animal origin, they shall be carried out by an official veterinarian, who may be assisted by specially trained support staff whilst retaining responsibility for the checks carried out.

Justification

The official veterinarian must remain responsible for decisions on live animals and products of animal origin (meat, dairy products, etc.). In carrying out his work, a veterinarian may be assisted by support staff, but responsibility for the checks remains with him.

Amendment  158

Proposal for a regulation

Article 51 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules establishing the cases where and the conditions under which:

1. Competent authorities may perform the identity and physical checks of the animals and goods entering the Union from third countries referred to in Article 45(1) at control points other than border control posts, provided that those control points comply with the requirements provided for in article 62(3) and in the implementing acts adopted in accordance with article 62(4).

 

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules establishing the cases where and the conditions under which:

Amendment  159

Proposal for a regulation

Article 51 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) identity and physical checks on consignments of the categories of animals and goods referred to in Article 45(1) may be performed by competent authorities at control points other than border control posts provided that those control points comply with the requirements provided for in Article 62(3) and in the implementing acts adopted in accordance with Article 62(4);

deleted

Amendment  160

Proposal for a regulation

Article 51 – paragraph 1 – point c – point iii

Text proposed by the Commission

Amendment

iii) goods ordered by distance selling.

iii) small consignments sent to private individuals or acquired at a distance (by telephone, post or internet).

Justification

This proposal brings the text into line with the reference to the same topic contained in Regulation No 206/2009.

Amendment  161

Proposal for a regulation

Article 51 – paragraph 1 – letter c – point iii a (new)

Text proposed by the Commission

Amendment

 

(iiia) pet animals which meet the conditions laid down in Article 5 of Implementing Regulation (EU) No 576/2013 of the European Parliament and of the Council1a.

 

__________

 

1a Regulation (EU) No 576/2013 of the European Parliament and of the Council on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003.

Amendment  162

Proposal for a regulation

Article 52 – paragraph 2 – point a – introductory part

Text proposed by the Commission

Amendment

(a) the criteria and the procedures for determining and modifying the frequency rates of physical checks to be performed on consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 45(1) and to adjust them to the level of risk associated with those categories, having regard to:

(a) the criteria and the procedures for determining and modifying the minimum frequency rates of physical checks to be performed on consignments of the categories of animals and goods referred to in points (a), (b) and (c) of Article 45(1) and to adjust them to the level of risk associated with those categories, having regard to:

Amendment  163

Proposal for a regulation

Article 52 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) the procedures for ensuring that the frequency rates of physical checks established in accordance with point (a) are applied in a timely and uniform manner.

(c) the procedures for ensuring that the minimum frequency rates of physical checks established in accordance with point (a) are applied in a timely and uniform manner.

Amendment  164

Proposal for a regulation

Article 52 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) the frequency of physical checks for the categories of goods referred to in point (d) of Article 45(1);

(a) the minimum frequency of physical checks for the categories of goods referred to in point (d) of Article 45(1);

Amendment  165

Proposal for a regulation

Article 52 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) the frequency of physical checks for the categories of animals and goods referred to in points (e) and (f) of Article 45(1) as long as this is not already provided for in the acts referred to therein.

(b) the minimum frequency of physical checks for the categories of animals and goods referred to in points (e) and (f) of Article 45(1) as long as this is not already provided for in the acts referred to therein.

Amendment  166

Proposal for a regulation

Article 53 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Decisions on consignments of animals shall be taken by an official veterinarian or under his supervision.

Decisions on consignments of animals and products of animal origin shall be taken by an official veterinarian who may be assisted by specially trained support staff whilst retaining responsibility for the checks carried out.

Justification

The official veterinarian must continue to be responsible for decisions on live animals and products of animal origin (meat and dairy products, etc.). In carrying out his work, a veterinarian may be assisted by support staff, but responsibility for the checks remains with him.

Amendment  167

Proposal for a regulation

Article 53 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. These decisions shall be recorded in the CHED referred to in the following articles.

Justification

To make the procedure clearer.

Amendment  168

Proposal for a regulation

Article 54 – paragraph 2 – point b – point ii

Text proposed by the Commission

Amendment

(ii) communicate the information referred to in point (i) through the TRACES system.

(ii) communicate the information referred to in point (i) through or in electronic exchange with the TRACES system.

Amendment  169

Proposal for a regulation

Article 54 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. The operators and competent authorities referred to in this paragraph may also use a national information system to feed data into the TRACES system.

Amendment  170

Proposal for a regulation

Article 54 – paragraph 4

Text proposed by the Commission

Amendment

4. The competent authorities of the border control post shall finalise the CHED as soon as:

4. The competent authorities of the border control post shall record the decision on the consignment in the Common Health Entry Document as soon as all official controls required by Article 47(1) have been performed.

a) all official controls required by Article 47(1) have been performed;

 

b) the results from physical checks, where such checks are required, are available;

 

c) a decision on the consignment has been taken in accordance with Article 53 and recorded on the CHED.

 

Justification

The purpose of the amendment is to replace all of point 4 with a simpler and more easily understood wording.

Amendment  171

Proposal for a regulation

Article 56 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules establishing the cases where and the conditions under which the CHED must accompany consignments of the categories of animals and goods referred to in Article 45(1) to the place of destination.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules establishing the cases where and the conditions under which the CHED must accompany consignments of the categories of animals and goods referred to in Article 45(1) to the place of destination. A copy of the CHED shall in any case accompany consignments of the categories of animals and goods referred to in Article 45(1) to the place of destination.

Justification

A copy of the CHED must always accompany consignments of animals and goods that have been controlled to their place of destination.

Amendment  172

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

1. A Member State shall immediately suspend the designation of a border control post and order its activities to be stopped, for all or for certain categories of animals and goods for which the designation was made, in cases where such activities may result in a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, to the environment.

1. A Member State shall immediately suspend the designation of a border control post and order its activities to be stopped, for all or for certain categories of animals and goods for which the designation was made, in cases where such activities may result in a risk to human, animal or plant health or animal welfare, to the environment.

Amendment  173

Proposal for a regulation

Article 62 – paragraph 1

Text proposed by the Commission

Amendment

1. Border control posts shall be located in the immediate vicinity of the point of entry into the Union and in a place suitably equipped to be designated by the customs authorities in accordance with Article 38(1) of Regulation (EEC) No 2913/92.

1. Border control posts shall be located in the immediate vicinity of the point of entry into the Union and in a place that is suitably equipped, in accordance with Article 38(1) of Regulation (EEC) No 2913/92.

Justification

Responsibility for designating the border control posts lies with the competent veterinary/health authority, not the customs authorities.

Amendment  174

Proposal for a regulation

Article 63 – paragraph 1

Text proposed by the Commission

Amendment

1. In case of suspicion of non-compliance of consignments of the categories of animals and goods referred to in Article 45(1) with the rules referred to in Article 1(2), the competent authorities shall perform official controls in order to confirm or to eliminate that suspicion.

1. In case of suspicion of non-compliance of consignments of the categories of animals and goods referred to in Article 45(1) with the rules referred to in Article 1(2), the competent authorities shall perform official controls or delegate the responsibility to other competent authorities in order to confirm or to eliminate that suspicion.

Justification

Organic farming certification is based on a process approach. It is necessary to highlight this specificity in order to keep the current organic control system.

Amendment  175

Proposal for a regulation

Article 63 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the competent authorities have reasons to suspect fraudulent behaviour by an operator or official controls give grounds to believe that the rules referred to in Article 1(2) have been seriously or repeatedly infringed, they shall, where appropriate, and in addition to the measures provided for in Article 64(3), intensify official controls on consignments with the same origin or use as appropriate.

4. Where the competent authorities have reasons to suspect fraudulent behaviour by an operator or official controls give grounds to believe that the rules referred to in Article 1(2) have been seriously or repeatedly infringed, they shall, in addition to the measures provided for in Article 64(3), intensify official controls on consignments with the same origin or use.

Amendment  176

Proposal for a regulation

Article 64 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The competent authorities shall place under official detention any consignment of animals or goods entering the Union from third countries which does not comply with the rules referred to in Article 1(2) and refuse entry into the Union to it.

When the competent authority ascertains as a result of the official controls performed at the border control posts in accordance with Article 45, that consignments of animals and goods do not comply with the requirements under Article 1(2), it shall issue a report or a decision: ‘Non-compliant consignment’ or ‘Negative control’ which shall be recorded in the CHED. Furthermore the competent authorities shall officially detain said consignment of animals or goods and refuse entry into the Union to it.

Justification

The aim is to clarify the procedure.

Amendment  177

Proposal for a regulation

Article 64 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

As appropriate, any such consignment shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision.

As appropriate, any such consignment or part thereof shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision. The special needs of other goods shall also be borne in mind.

Justification

The aim is to clarify the procedure, while adding a clause under which part of the consignment may be rejected.

Amendment  178

Proposal for a regulation

Article 64 – paragraph 3 – introductory wording

Text proposed by the Commission

Amendment

3. Having, where possible, heard the operator responsible for the consignment, the competent authorities shall, without delay, order that the operator:

3. The competent authorities shall hear the operator responsible for the consignment. The competent authority may omit this if an immediate decision is necessary either because a delay would be dangerous or in the public interest. It shall, without delay, order that the operator:

Justification

As a matter of principle, it is always necessary – and also possible – to hear parties fairly. The conditions should therefore be precisely defined under which this legal principle may be restricted, or under which such a restriction is even imperative.

Amendment  179

Proposal for a regulation

Article 64 – paragraph 3 – point a

Text proposed by the Commission

Amendment

a) destroy the consignment in compliance, where appropriate, with the rules referred to in Article 1(2); or

a) destroy the consignment or part thereof, humanely in the case of live animals, in compliance, where appropriate, with the rules referred to in Article 1(2); or

Justification

Aims to add a clause under which part of the consignment may be rejected.

Amendment  180

Proposal for a regulation

Article 64 – paragraph 3 – point b

Text proposed by the Commission

Amendment

b) re-dispatch the consignment outside the Union in accordance with Article 70(1) and (2); or

b) re-dispatch the consignment or part thereof outside the Union in accordance with Article 70(1) and (2); or

Justification

The aim is to add a clause under which part of the consignment may be rejected.

Amendment  181

Proposal for a regulation

Article 64 – paragraph 3 – point c

Text proposed by the Commission

Amendment

c) subject the consignment to special treatment in accordance with Article 69(1) and (2) or to any other measure necessary to ensure compliance with the rules referred to in Article 1(2), and, where appropriate, destines the consignment for purposes other than those for which it was originally intended.

c) subject the consignment or part thereof to special treatment in accordance with Article 69(1) and (2) or to any other measure necessary to ensure compliance with the rules referred to in Article 1(2), and, where appropriate, destines the consignment for purposes other than those for which it was originally intended.

Justification

The aim is to add a clause under which part of the consignment may be rejected.

Amendment  182

Proposal for a regulation

Article 65 – title

Text proposed by the Commission

Amendment

Measures to be taken on animals or goods entering the Union from third countries presenting a risk

Measures to be taken in cases of an attempt to bring non-compliant consignments into the EU from third countries presenting a risk

Amendment  183

Proposal for a regulation

Article 65 – paragraph 1

Text proposed by the Commission

Amendment

Where official controls indicate that a consignment of animals or goods presents a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, to the environment, such consignment shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision.

Where official controls indicate that a consignment of animals or goods presents a risk to human or animal health, animal welfare or to the environment, such consignment shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision.

Amendment  184

Proposal for a regulation

Article 65 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) order that the operator destroy the consignment in compliance, where appropriate, with the rules referred to in Article 1(2), taking all the measures necessary to protect human, animal or plant health, animal welfare or the environment; or

(a) order that the operator destroy the consignment, humanely in the case of live animals, in compliance, where appropriate, with the rules referred to in Article 1(2), taking all the measures necessary to protect human, animal or plant health, animal welfare or the environment; or

Amendment  185

Proposal for a regulation

Article 66 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The competent authorities in the Member State where the official controls were performed shall supervise the application of the measures ordered pursuant to Article 64(3) and (5) and Article 65 to ensure that the consignment does not give rise to adverse effects on human, animal or plant health, animal welfare, or the environment, during or pending the application of those measures.

The competent authorities in the Member State where the official controls were performed shall supervise the application of the measures ordered pursuant to Article 64(3) and (5) and Article 65 to ensure that the consignment does not give rise to adverse effects on human or animal health, animal welfare, or the environment, during or pending the application of those measures.

Amendment  186

Proposal for a regulation

Article 67 – paragraph 1

Text proposed by the Commission

Amendment

1. The operator shall carry out all the measures ordered by the competent authorities in accordance with Article 64 (3) and (5) and 65 without delay and, at the latest, within 60 days from the day on which the competent authorities notified the operator of their decision in accordance with Article 64(4).

1. The operator shall carry out all the measures ordered by the competent authorities in accordance with Article 64 (3) and (5) and 65 without delay and, at the latest, in the case of products, within 60 days from the day on which the competent authorities notified the operator of their decision in accordance with Article 64(4).

Justification

The operator is given a 60-day period within which to implement out the decision of the competent authorities. For live animals, this may be too long a period.

Amendment  187

Proposal for a regulation

Article 70 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a. Member States receiving imports which have been authorised by pre-export-controls shall regularly check if the imports actually comply with EU requirements.

Amendment  188

Proposal for a regulation

Article 72 – paragraph 1 – point a

Text proposed by the Commission

Amendment

a) notify the Commission and the other Member States and operators concerned via the TRACES system in addition to seeking administrative assistance in accordance with the procedures established in Title IV;

a) notify the Commission and the other Member States and operators concerned via the TRACES system, including the measures to be applied, in addition to seeking administrative assistance in accordance with the procedures established in Title IV;

Amendment  189

Proposal for a regulation

Article 73 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. The customs authorities shall only release those consignments of animals and goods under Article 45 in respect of which the competent authority at the border control post has carried out the official controls provided for in Article 47 and issued a decision recorded in the CHED.

Justification

The aim is to fully guarantee that customs authorities take no decisions concerning consignments which are undergoing official controls.

Amendment  190

Proposal for a regulation

Article 75 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) wood packaging material;

deleted

Amendment  191

Proposal for a regulation

Article 76

Text proposed by the Commission

Amendment

General rules

General rules

1. Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities.

1. Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities. With that aim in view they shall collect fees or contributions to the costs or make resources available from general tax revenue.

2. In addition to the fees collected in accordance with Article 77, Member States may collect fees to cover costs occasioned by official controls other than those referred to in Article 77(1) and (2).

 

3. This Chapter also applies in the case of delegation of specific official control tasks in accordance with Article 25.

3. This Chapter also applies in the case of delegation of specific official control tasks in accordance with Article 25.

4. Member States shall consult the operators concerned on the methods used to calculate the fees provided for in Article 77.

4. Member States shall consult the operators concerned on the methods used to calculate the fees or contributions to the costs.

Amendment  192

Proposal for a regulation

Article 77

Text proposed by the Commission

Amendment

Mandatory fees

Mandatory fees or contributions to the costs

1. For the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls, the competent authorities shall collect fees to recover the costs they incur in relation to:

1. For the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls, the competent authorities shall collect fees or contribution to the costs to recover the costs they incur in relation to:

(a) official controls performed to verify that the following operators comply with the rules referred to in Article 1(2):

(a) official controls performed to verify that the following operators comply with the rules referred to in Article 1(2):

(i) food business operators as defined in Article 3(3) of Regulation (EC) No 178/2002 that are either registered or approved, or registered and approved, in accordance with Article 6 of Regulation (EC) No 852/2004;

(i) food business operators as defined in Article 3(3) of Regulation (EC) No 178/2002 that are either registered or approved, or registered and approved, in accordance with Article 6 of Regulation (EC) No 852/2004;

(ii) feed business operators as defined in Article 3(6) of Regulation (EC) No 178/2002 registered or approved in accordance with Articles 9 and 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene52;

(ii) feed business operators as defined in Article 3(6) of Regulation (EC) No 178/2002 registered or approved in accordance with Articles 9 and 10 of Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene52;

(iii) professional operators as defined in point (7) of Article 2 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];

(iii) professional operators as defined in point (7) of Article 2 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];

(iv) professional operators as defined in point (6) of Article 3 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on the production and making available on the market of plant reproductive material];

 

(b) the official controls performed in view of the issuance of official certificates or to supervise the issuance of official attestations;

(b) the official controls performed in view of the issuance of official certificates or to supervise the issuance of official attestations;

(c) official controls performed to verify that the conditions are met:

(c) official controls performed to verify that the conditions are met:

(i) to obtain and maintain the approval provided for in Article 6 of Regulation (EC) No 852/2004 or in Articles 9 and 10 of Regulation (EC) No 183/2005;

(i) to obtain and maintain the approval provided for in Article 6 of Regulation (EC) No 852/2004 or in Articles 9 and 10 of Regulation (EC) No 183/2005;

(ii) to obtain and maintain the authorisation referred to in Articles 84, 92 and 93 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];

(ii) to obtain and maintain the authorisation referred to in Articles 84, 92 and 93 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];

(iii) to obtain and maintain the authorisation referred to in Article 25 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on the production and making available on the market of plant reproductive material];

 

(d) official controls performed by the competent authorities at the border control posts or at the control points referred to in point (a) of Article 51(1).

(d) official controls performed by the competent authorities at the border control posts or at the control points referred to in point (a) of Article 51(1).

2. For the purposes of paragraph 1, the official controls referred to in point (a) of that paragraph shall include official controls performed to verify compliance with measures adopted by the Commission in accordance with Article 137 of this Regulation, Article 53 of Regulation (EC) No 178/2002, Articles 27(1), 29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants], Articles 41 and 144 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on the production and making available on the market of plant reproductive material] and Part VI of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health], unless the decision establishing the measures requires otherwise.

2. For the purposes of paragraph 1, the official controls referred to in point (a) of that paragraph shall include official controls performed to verify compliance with measures adopted by the Commission in accordance with Article 137 of this Regulation, Article 53 of Regulation (EC) No 178/2002, Articles 27(1), 29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants], and Part VI of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health], unless the decision establishing the measures requires otherwise.

3. For the purposes of paragraph 1:

3. For the purposes of paragraph 1:

(a) the official controls referred to in point (a) of that paragraph shall not include official controls performed to verify compliance with temporary restrictions, requirements or other disease control measures adopted by the competent authorities in accordance with Articles 55(1), 56, 61, 62, 64, 65, 68(1) and 69, and rules adopted pursuant to Articles 55(2), 63, 67 and 68(2) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health] and Article 16 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];

(a) the official controls referred to in point (a) of that paragraph shall not include official controls performed to verify compliance with temporary restrictions, requirements or other disease control measures adopted by the competent authorities in accordance with Articles 55(1), 56, 61, 62, 64, 65, 68(1) and 69, and rules adopted pursuant to Articles 55(2), 63, 67 and 68(2) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health] and Article 16 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];

(b) the official controls referred to in point (a) and (b) of that paragraph shall not include official controls performed to verify compliance with the rules referred to in Article 1(2)(j) and (k).

(b) the official controls referred to in point (a) and (b) of that paragraph shall not include official controls performed to verify compliance with the rules referred to in Article 1(2)(j) and (k).

_____________

______________

52 OJ L 35, 8.2.2005, p. 1.

52 OJ L 35, 8.2.2005, p. 1.

Amendment  193

Proposal for a regulation

Article 78

Text proposed by the Commission

Amendment

Costs

Costs

1. The competent authorities shall collect fees in accordance with Article 77 to recover the following costs:

1. The competent authorities shall be entitled, when calculating the fees or contributions to the cost in accordance with Article 77, to take the following criteria into account :

(a) the salaries of the staff, including support staff, involved in the performance of official controls, their social security, pension and insurance costs;

(a) the salaries of the staff, including support staff, insofar as they correspond to the actual costs of official controls in accordance with point(b) of article 79(1), excluding their social security, pension and insurance costs;

(b) the cost of facilities and equipment, including maintenance and insurance costs;

 

(c) the cost of consumables, services and tools;

(c) the cost of consumables, services and tools;

(d) the cost of training of staff referred to in point (a), with the exclusion of the training necessary to obtain the qualification necessary to be employed by the competent authorities;

 

(e) the cost of travel of the staff referred to in point (a), and associated subsistence costs;

(e) the cost of travel of the staff for the performance of the official controls referred to in point (a), and associated subsistence costs, calculated in accordance with Article 79 (2);

(f) the cost of sampling and of laboratory analysis, testing and diagnosis.

(f) the cost of sampling and of laboratory analysis, testing and diagnosis.

2. If the competent authorities collecting fees in accordance with Article 77 also perform other activities, only the fraction of the cost elements referred to in paragraph 1 of this Article which results from the official controls referred to in Article 77(1) shall be considered for the calculation of the fees.

2. If the competent authorities collecting mandatory fees or contributions to the costs in accordance with Article 77 also perform other activities, only the fraction of the cost elements referred to in paragraph 1 of this Article which results from the official controls referred to in Article 77(1) shall be considered for the calculation of the mandatory fees or contribution to the costs.

Amendment  194

Proposal for a regulation

Article 79

Text proposed by the Commission

Amendment

Calculation of fees

Calculation of mandatory fees or contributions to the costs

1. Fees collected in accordance with Article 77 shall be:

1. The fees or contribution to the costs collected in accordance with Article 77 shall be:

(a) established at a flat-rate on the basis of the overall costs of official controls borne by the competent authorities over a given period of time, and applied to all operators irrespective of whether any official control is performed during the reference period in relation to each operator charged; in establishing the level of the fees to be charged on each sector, activity and category of operators, the competent authorities shall take into consideration the impact that the type and the size of the activity concerned and the relevant risk factors have on the distribution of the overall costs of those official controls; or,

 

(b) calculated on the basis of the actual costs of each individual official control, and applied to the operators subject to such official control; such fee shall not exceed the actual costs of the official control performed and may be partly or entirely expressed as a function of the time employed by the staff of the competent authorities to perform the official controls.

(b) calculated on the basis of the actual costs of each individual official control, and applied to the operators subject to such official control; such fee shall not exceed the actual costs of the official control performed and may be partly or entirely expressed as a function of the time employed by the staff of the competent authorities to perform the official controls.

2. Travel costs as referred to in point (e) of Article 78(1) shall be considered for the calculation of the fees referred to in Article 77(1) in a manner that does not discriminate between operators on the basis of the distance of their premises from the location of the competent authorities.

2. Travel costs as referred to in point (e) of Article 78(1) shall be considered for the calculation of the fees or contributions to the costs referred to in Article 77(1) in a manner that does not discriminate between operators on the basis of the distance of their premises from the location of the competent authorities.

3. Where fees are calculated in accordance with point (a) of paragraph 1, the fees collected by competent authorities in accordance with Article 77 shall not exceed the overall costs incurred for the official controls performed over the period of time referred to in point (a) of paragraph 1.

3. Where the fees or contributions to the costs are calculated in accordance with point (a) of paragraph 1, the fees or contribution to the costs collected by competent authorities in accordance with Article 77 shall not exceed the overall costs incurred for the official controls performed over the period of time referred to in point (a) of paragraph 1.

Amendment  195

Proposal for a regulation

Article 80

Text proposed by the Commission

Amendment

Reduction of fees for consistently compliant operators

Reduction of fees or contributions to the costs for consistently compliant operators

Where fees are established in accordance with point (a) of Article 79(1), the rate of the fee to be applied to each operator shall be determined taking into account the operators' record of compliance with the rules referred to in Article 1(2) as ascertained through official controls, so that fees applied to consistently compliant operators are lower than those applied to other operators.

Where fees or contributions to the costs are established in accordance with Article 79(1), the rate of the fee to be applied to each operator shall be determined taking into account the operators' record of compliance with the rules referred to in Article 1(2) as ascertained through official controls, so that fees or contribution to the costs applied to consistently compliant operators are lower than those applied to other operators.

Amendment  196

Proposal for a regulation

Article 81

Text proposed by the Commission

Amendment

Application of fees

Application of fees or contributions to the costs

1. Operators shall receive proof of the payment of fees provided for in Article 77(1).

1. Operators shall receive proof of the payment of fees or contributions to the costs provided for in Article 77(1).

2. Fees collected in accordance with point (d) of Article 77(1) shall be paid by the operator responsible for the consignment or its representative.

2. Fees or contributions to the costs collected in accordance with point (d) of Article 77(1) shall be paid by the operator responsible for the consignment or its representative.

Amendment  197

Proposal for a regulation

Article 82

Text proposed by the Commission

Amendment

Article 82

deleted

Fees refunds and exemption for microenterprises

 

1. Fees provided for in Article 77 shall not directly or indirectly be refunded, unless unduly collected.

 

2. Enterprises employing fewer than 10 persons and whose annual turnover or annual balance sheet total does not exceed EUR 2 million shall be exempted from the payment of the fees provided for in Article 77.

 

3. The costs referred to in Articles 77, 78 and 79 shall not include those incurred for the performance of official controls on the enterprises referred to in paragraph 2.

 

Justification

The Commission's exemption for microenterprises is excessively broad and would exclude a considerable proportion of operators.

Amendment  198

Proposal for a regulation

Article 83

Text proposed by the Commission

Amendment

Transparency

Transparency

1. The competent authorities shall ensure the highest level of transparency of:

1. The competent authorities shall ensure the highest level of transparency of:

(a) the method and data used to establish the fees provided for in Article 77(1);

(a) the method and data used to establish the fees or contributions to the costs provided for in Article 77(1);

(b) the use of resources collected through such fees;

(b) the use of resources collected through such fees or contributions to the costs, including the number of controls performed;

(c) the arrangements in place to ensure an efficient and thrifty use of the resources collected through such fees.

(c) the arrangements in place to ensure an efficient and thrifty use of the resources collected through such fees or contributions to the costs.

2. Each competent authority shall make available to the public the following information for each reference period:

2. Each competent authority shall make available to the public the following information for each reference period:

(a) the costs to the competent authority for which a fee is due in accordance with Article 77(1), indicating the breakdown of such costs per activity referred to in Article 77(1) and per cost element referred to in Article 78(1);

(a) the costs to the competent authority for which a fee is due in accordance with Article 77(1), indicating the breakdown of such costs per activity referred to in Article 77(1) and per cost element referred to in Article 78(1);

(b) the amount of the fees provided for in Article 77(1) applied to each category of operators, and for each category of official controls;

(b) the amount of the fees or contributions to the costs provided for in Article 77(1) applied to each category of operators, and for each category of official controls;

(c) the method used to establish the fees provided for in Article 77(1), including the data and estimates used for the establishment of the flat rate fees referred to in point (a) of Article 79(1);

(c) the method used to establish the fees or contributions to the costs provided for in Article 77(1), including the data and estimates used for the establishment of the flat rate fees or contribution to the costs referred to in point (a) of Article 79(1);

(d) where point (a) of Article 79(1) applies, the method used to adjust the level of the fees in accordance with Article 80;

(d) where point (a) of Article 79(1) applies, the method used to adjust the level of the fees or contributions to the costs in accordance with Article 80;

(e) the overall amount of fees corresponding to the exemption referred to in Article 82(2).

(e) the overall amount of fees or contributions to the costs corresponding to the exemption referred to in Article 82(2).

Amendment  199

Proposal for a regulation

Article 84

Text proposed by the Commission

Amendment

Expenses arising from additional official controls and from enforcement measures

Expenses arising from additional official controls and from enforcement measures

Competent authorities shall charge fees to cover the additional costs they have incurred as a result of:

Competent authorities shall charge fees or contributions to the costs to cover the additional costs they have incurred as a result of:

(a) additional official controls:

(a) additional official controls:

(i) which have become necessary following the detection of a non- compliance during an official control performed in accordance with this Regulation;

(i) which have become necessary following the detection of a non- compliance during an official control performed in accordance with this Regulation;

(ii) performed to assess the extent and the impact of the non-compliance or to verify that the non-compliance has been remedied;

(ii) performed to assess the extent and the impact of the non-compliance or to verify that the non-compliance has been remedied;

(b) official controls performed at the request of the operator;

(b) official controls performed at the request of the operator;

(c) corrective action taken by the competent authorities, or by a third party upon request by the competent authorities, where an operator has failed to carry out corrective action ordered by the competent authorities in accordance with Article 135 to remedy the non-compliance;

(c) corrective action taken by the competent authorities, or by a third party upon request by the competent authorities, where an operator has failed to carry out corrective action ordered by the competent authorities in accordance with Article 135 to remedy the non-compliance;

(d) official controls performed and action taken by the competent authorities in accordance with Articles 64 to 67, 69 and 70, and corrective action taken by a third party upon request by the competent authorities, in cases where the operator has failed to carry out corrective action ordered by the competent authorities in accordance with Articles 64(3) and (5), 65 and 67.

(d) official controls performed and action taken by the competent authorities in accordance with Articles 64 to 67, 69 and 70, and corrective action taken by a third party upon request by the competent authorities, in cases where the operator has failed to carry out corrective action ordered by the competent authorities in accordance with Articles 64(3) and (5), 65 and 67.

Amendment  200

Proposal for a regulation

Article 85 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) official health attestations.

Justification

In line with the proposed definitions.

Amendment  201

Proposal for a regulation

Article 86 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Regarding the issuance of an official certificate for products referred to in Article 1(2) point (j), in addition to the provisions mentioned in article 85(2), the delegated body works and is accredited in accordance with standard EN ISO/IEC 17065: 2012.

Justification

The documentary evidence on organic farming is presented on the basis of a certification process based on EN ISO/IEC 17065, where all details are given. As for certification activities, the EN ISO/IEC 17065 requirements are relevant and should be therefore explicitly mentioned in the legislation.

Amendment  202

Proposal for a regulation

Article 87 – paragraph 1

Text proposed by the Commission

Amendment

1. Official certificates shall be issued by the competent authorities.

1. Official certificates shall be issued by the competent authorities or delegated bodies pursuant to Articles 25 to 32.

Justification

In accordance with Article 85(2) of the draft regulation.

Amendment  203

Proposal for a regulation

Article 87 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) be free from conflict of interest in relation to what is being certified and act impartially;

(a) be free from conflict of interest in relation to what is being certified and act independently and impartially;

Amendment  204

Proposal for a regulation

Article 88 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) enable the identification of the person who signed them;

(d) enable the identification of the person who signed them and the date of issue;

Amendment  205

Proposal for a regulation

Article 88 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) allow the verification of the link between the certificate and the consignment, lot or individual animal or good covered by the certificate.

(e) allow the easy verification of the link between the certificate, the issuing authority and the consignment, lot or individual animal or good covered by the certificate.

Amendment  206

Proposal for a regulation

Article 90 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) be drawn up in one of the official languages of the institutions of the Union;

(b) be drawn up in one of the official languages of the institutions of the Union; or in any of the official languages of a Member State;

Amendment  207

Proposal for a regulation

Article 90 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) are impartial and free from any conflict of interest in relation to what is being certified by the official attestations;

(a) are independent, impartial and free from any conflict of interest in relation to what is being certified by the official attestations;

Amendment  208

Proposal for a regulation

Article 91 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission may, by means of implementing acts, designate European Union reference laboratories in the areas governed by the rules referred to in Article 1(2) where the effectiveness of official controls also depends on the quality, uniformity and reliability of:

1. The Commission shall, by means of implementing acts, designate European Union reference laboratories in the areas governed by the rules referred to in Article 1(2) where the effectiveness of official controls also depends on the quality, uniformity and reliability of:

Amendment  209

Proposal for a regulation

Article 91 – paragraph 2 – point b

Text proposed by the Commission

Amendment

b) be reviewed regularly.

b) be reviewed regularly every five years.

Justification

The designation should be reviewed periodically, as established under other regulations.

Amendment  210

Proposal for a regulation

Article 91 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. The Commission may, where it considers appropriate, designate more than one reference laboratory for the same disease and thus promote the rotation of national laboratories meeting the requirements of paragraph 3 of this Article.

Justification

It would be useful to provide for the possibility of having a number of reference laboratories for the same assessment or disease, since this would make more resources available when needed.

Amendment  211

Proposal for a regulation

Article 91 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) be impartial and free of conflict of interests as regards the exercise of its tasks as European Union reference laboratories;

(b) be independent, impartial and free of conflict of interests as regards the exercise of its tasks as European Union reference laboratories;

Amendment  212

Proposal for a regulation

Article 91 – paragraph 3 – point g a (new)

Text proposed by the Commission

Amendment

 

(ga) where relevant, cooperate with European Union research centres and Commission services to develop high standards in methods of laboratory analysis, testing and diagnosis.

Justification

The Commission has research centres, such as the JRC, which can play a supporting role to the official laboratories of the European Union as regards the identification of analytical methods and diagnostic tests for official controls.

Amendment  213

Proposal for a regulation

Article 91 – paragraph 3 – point g b (new)

Text proposed by the Commission

Amendment

 

(gb) be able to receive a financial contribution from the Union in accordance with Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field.

Justification

This currently valid rule is also contained in the proposal for a regulation on provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material (Article 29(1)). However, according to the correlation table for this proposal, the original rule no longer features, so it has to be included again.

Amendment  214

Proposal for a regulation

Article 91 – paragraph 3 – point g c (new)

Text proposed by the Commission

Amendment

 

gc) ensure that their staff respect the confidential nature of certain subjects, results or communications.

Justification

The activities and actions of the European Union reference laboratories must be confidential, as laid down in Article 32(4)(d) of Regulation 882/2004 currently applicable .

Amendment  215

Proposal for a regulation

Article 91 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a. By way of derogation from paragraphs 1 and 2 of this Article, the reference laboratories referred to in Article 32(1) of Regulation (EC) No 1829/2003 and Article 21(1) of Regulation (EC) No 1831/2003 shall be European Union reference laboratories having the tasks and responsibilities set out in Article 92 of this Regulation, as regards, respectively:

 

(a) GMOs and genetically modified food and feed;

 

(b) feed additives.

Justification

Regulation (EC) No 1829/2003 on genetically modified food and feed and  Regulation (EC) No 1831/2003 on additives for use in animal nutrition provide for Community reference laboratories for the sectors governed by those regulations. These laboratories are not abolished by the proposal for a regulation on official controls.

Amendment  216

Proposal for a regulation

Article 92 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

 

aa) providing reference material free of charge and for unrestricted use (in respect of animal health, strains and serums) to the national reference laboratories to facilitate the adjustment and harmonisation of methods of analysis, testing and diagnosis;

Amendment  217

Proposal for a regulation

Article 92 – paragraph 2 – point b

Text proposed by the Commission

Amendment

b) coordinating the application by the national reference laboratories and, if necessary, by other official laboratories of the methods referred to in point (a), in particular, by organising regular inter-laboratory comparative testing and by ensuring appropriate follow-up of such comparative testing in accordance, where available, with internationally accepted protocols;

b) coordinating the application by the national reference laboratories of the methods referred to in point (a), in particular, by organising regular inter-laboratory comparative testing and by ensuring appropriate follow-up of such comparative testing in accordance, where available, with internationally accepted protocols; they shall inform the competent authorities of the follow-up and results of such inter-laboratory comparative testing;

Justification

This should be limited to national reference laboratories.

Amendment  218

Proposal for a regulation

Article 92 – paragraph 2 – point d

Text proposed by the Commission

Amendment

d) conducting training courses for the benefit of staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries;

d) conducting training courses free of charge for the benefit of staff from national reference laboratories and, if needed, conducting training courses for the benefit of staff from other official laboratories, as well as of experts from third countries;

Justification

It should be specified that the courses are free of charge for national reference laboratories.

Amendment  219

Proposal for a regulation

Article 92 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) assisting actively in the diagnosis of outbreaks in Member States of foodborne, zoonotic or animal diseases, or of pests of plants, by carrying out confirmatory diagnosis, characterisation and taxonomic or epizootic studies on pathogen isolates or pest specimens;

(h) assisting actively in the diagnosis of outbreaks in Member States of foodborne, zoonotic or animal diseases, by carrying out confirmatory diagnosis, characterisation and taxonomic or epizootic studies on pathogen isolates or pest specimens;

Amendment  220

Proposal for a regulation

Article 92 – paragraph 2 – point j – point i

Text proposed by the Commission

Amendment

(i) reference collections of pests of plants or reference strains of pathogenic agents;

(i) reference strains of pathogenic agents;

Amendment  221

Proposal for a regulation

Article 92 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Paragraphs 1 and 2 of this Article shall apply without prejudice to Article 32, first paragraph, of Regulation (EC) No 1829/2003 and the rules adopted under the fourth and fifth paragraphs of Article 32 of that Regulation, in addition to Article 21, first paragraph, of Regulation (EC) No 1831/2003 and the rules adopted under the third and fourth paragraphs of Article 21 of that Regulation.

Justification

Regulation (EC) No 1829/2003 on genetically modified food and feed and  Regulation (EC) No 1831/2003 on additives for use in animal nutrition provide for Community reference laboratories for the sectors governed by those regulations. These laboratories are not abolished by the proposal for a regulation on official controls.

Amendment  222

Proposal for a regulation

Article 92 a (new)

Text proposed by the Commission

Amendment

 

Article 92a

 

1. The Commission shall, by means of delegated acts, designate an EU reference laboratory for food authenticity;

 

2. Member States may designate national reference laboratories as part of a network of laboratories working within the EU.

Amendment  223

Proposal for a regulation

Article 93

Text proposed by the Commission

Amendment

Article 93

deleted

Designation of European Union reference centres for plant reproductive material

 

1. The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission, the Member States and the European Plant Variety Agency (EPVA) in relation to the application of the rules referred to in point (h) of Article 1(2).

 

2. The designations provided for in paragraph 1 shall:

 

(a) follow a public selection process;

 

(b) be reviewed regularly.

 

3. European Union reference centres for plant reproductive material shall:

 

(a) possess a high level of scientific and technical expertise in inspection, sampling and testing of plant reproductive material;

 

(b) have suitably qualified staff with adequate training in the areas referred to in point (a) and support staff as appropriate;

 

(c) possess or have access to the infrastructure equipment and products needed to carry out the tasks assigned to them;

 

(d) ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (a) and that the latest developments in research at national, Union and international level in those areas are taken into account in their work.

 

Amendment  224

Proposal for a regulation

Article 94

Text proposed by the Commission

Amendment

Article 94

deleted

Responsibilities and tasks European Union reference centres for plant reproductive material

 

The European Union reference centres designated in accordance with Article 93(1) shall be responsible, in accordance with annual or multiannual work programmes approved by the Commission for the following tasks:

 

(a) providing scientific and technical expertise, within the scope of their mission, on:

 

(i) field inspection, sampling and testing performed for the certification of plant reproductive material;

 

(ii) post-certification tests of plant reproductive material;

 

(iii) tests on standard material categories of plant reproductive material;

 

(b) organising comparative tests and field trials on plant reproductive material;

 

(c) conducting training courses for the benefit of staff of the competent authorities and of experts from third countries;

 

(d) contributing to the development of certification and post-certification test protocols for plant reproductive material, and of performance indicators for the certification of plant reproductive material;

 

(e) disseminating research findings and technical innovations in the fields within the scope of their mission.

 

Amendment  225

Proposal for a regulation

Article 95 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States in relation to the application of the rules referred to in point (f) of Article 1(2).

1. The Commission shall, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States in relation to the application of the rules referred to in point (f) of Article 1(2).

Amendment  226

Proposal for a regulation

Article 95 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) possess a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals;

(a) possess suitably qualified staff with a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals, taking ethical aspects into consideration;

Justification

Because of content overlap with Article 95(3)(b), the two paragraphs were merged.

Amendment  227

Proposal for a regulation

Article 95 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) have suitably qualified staff with adequate training in the areas referred to in point (a) and in ethical issues related to animals and support staff as appropriate;

deleted

Justification

Merged with Article 95(3)(a) because of content overlap.

Amendment  228

Proposal for a regulation

Article 96 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) coordinating a network of institutions with recognised knowledge on animal welfare that could assist the competent authorities and stakeholders in implementing relevant EU legislation.

Amendment  229

Proposal for a regulation

Article 96 – point c

Text proposed by the Commission

Amendment

(c) developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals;

(c) helping to develop and coordinate methods for the assessment of the level of welfare of animals and methods for the improvement of the welfare of animals;

Amendment  230

Proposal for a regulation

Article 96 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes;

(d) coordinating the carrying out of scientific and technical studies on the welfare of animals used for commercial or scientific purposes;

Justification

To avoid an overlap of competences with EFSA, the reference centres should be given a coordinating role, while EFSA can continue to carry out its own studies.

Amendment  231

Proposal for a regulation

Article 96 a (new)

Text proposed by the Commission

Amendment

 

Article 96a

 

Designation of European Union reference centres for the authenticity and integrity of the agri-food chain

 

1. The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States to prevent, detect and combat any intentional violations of the rules referred to in Article 1(2).

 

2. The designations provided for in paragraph 1(a) shall   follow a public selection process and be reviewed regularly.

 

3. European Union reference centres for the authenticity and integrity of the agri-food chain shall:

 

(a) possess a high level of scientific and technical expertise in the sectors governed by the rules referred to in Article 1(2) and in applied forensic science in those sectors, thus having the ability to carry out or coordinate research at the highest levels on the authenticity and integrity of goods and to develop, apply and validate the methods to be used for the detection of intentional violations of the rules referred to in Article 1(2);

 

(b) have suitably qualified staff with adequate training in the areas referred to in point (a) and the necessary support staff;

 

(c) possess or have access to the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them;

 

(d) ensure that their staff have good knowledge of international standards and practices in the subjects referred to in point (a) and that the latest research developments at national, Union and international level in those areas are taken into account in their work.

Justification

In order to combat fraud in the agri-food sector, it is deemed necessary to designate European Union reference centres for the authenticity and integrity of the agri-food chain.

Amendment  232

Proposal for a regulation

Article 96 b (new)

Text proposed by the Commission

Amendment

 

Article 96b

 

Responsibilities and tasks of European Union reference centres for the authenticity and integrity of the agri-food chain

 

1. The European Union reference centres designated under Article 96a(1) shall be responsible, in accordance with the annual or multiannual work programmes approved by the Commission, for the following activities:

 

(a) providing specific knowledge of the authenticity and integrity of goods and methods for detecting intentional violations of the rules referred to in Article 1(1), in relation to the forensic science applied to the areas governed by these rules;

 

(b) providing specific analyses designed to identify the segments of the agri-food chain that are potentially subject to intentional violations, for economic reasons, of the rules referred to in Article 1(2) and helping to develop specific official control techniques and protocols;

 

(c) where necessary, performing the tasks referred to in Article 92(2), points (a) to (g);

 

(d) where necessary, establishing and storing collections or databases of authenticated reference materials, to be used to verify the authenticity or integrity of goods;

 

(e) disseminating research findings and technical innovations in the fields within the scope of their missions.

Justification

As with the other European Union reference centres, this article sets out the responsibilities and tasks of the European Union reference centre for the authenticity and integrity of the agri-food chain.

Amendment  233

Proposal for a regulation

Article 97 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) European Union reference centres for plant reproductive material provided for in Article 93;

deleted

Justification

In accordance with the proposed deletion of Articles 93 and 94

Amendment  234

Proposal for a regulation

Article 97 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning the establishment of requirements, responsibilities and tasks for the European Union reference laboratories, the European Union reference centres for plant reproductive material and the European Union reference centres for animal welfare in addition to those laid down in Articles 91(3), 92, 93(3), 95(3) and 96.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning the establishment of requirements, responsibilities and tasks for the European Union reference laboratories, and the European Union reference centres for animal welfare in addition to those laid down in Articles 91(3), 92, 95(3) and 96.

Amendment  235

Proposal for a regulation

Article 97 – paragraph 3

Text proposed by the Commission

Amendment

3. European Union reference laboratories and European Union reference centres shall be subject to Commission controls to verify compliance with the requirements of Articles 91(3), 92, 93(3), 95(3) and 96.

3. European Union reference laboratories and European Union reference centres shall be subject to Commission controls to verify compliance with the requirements of Articles 91(3), 92, 95(3) and 96.

Amendment  236

Proposal for a regulation

Article 98 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) be impartial and free of conflict of interests as regards the exercise of its tasks as national reference laboratories;

(a) be independent, impartial and free of conflict of interests as regards the exercise of its tasks as national reference laboratories;

Amendment  237

Proposal for a regulation

Article 98 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

 

6a. This Article shall apply without prejudice to Article 32, second paragraph, of Regulation (EC) No 1829/2003 and the rules adopted under the fourth and fifth paragraphs of Article 32 of that Regulation, in addition to Annex II to Regulation (EC) No 1831/2003 and the rules adopted under the third and fourth paragraphs of Article 21 of that Regulation.

Amendment  238

Proposal for a regulation

Article 99 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

 

fa) assist actively in the diagnosis of outbreaks on national territory of animal, foodborne or zoonotic diseases by carrying out confirmatory diagnosis, characterisation and epizootic or taxonomic studies on pathogen isolates or pest specimens, as specified for the national reference laboratories of the Union in Article 92(2)( h).

Justification

As specified for the national reference laboratories of the European Union in Article 92(2)(h).

Amendment  239

Proposal for a regulation

Article 99 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

This Article shall apply without prejudice to Article 32, second paragraph, of Regulation (EC) No 1829/2003 and the rules adopted under the fourth and fifth paragraphs of Article 32 of that Regulation, in addition to Annex II to Regulation (EC) No 1831/2003 and the rules adopted under the third and fourth paragraphs of Article 21 of that Regulation.

Amendment  240

Proposal for a regulation

Article 100 – paragraph 2

Text proposed by the Commission

Amendment

2. Administrative assistance shall include, where appropriate, participation by the competent authorities of a Member State in on-the-spot official controls that the competent authorities of another Member State perform.

deleted

Justification

Relations between Member States should be based on mutual recognition of the inspections carried out. In the event of a discrepancy, it should be for the Commission to intervene.

Amendment  241

Proposal for a regulation

Article 100 – paragraph 5

Text proposed by the Commission

Amendment

5. In order to streamline and simplify communication exchanges, the Commission shall, by means of implementing acts, establish a standard format for:

deleted

a) the requests for assistance provided for in Article 102(1);

 

b) the communication of common and recurrent notifications and responses.

 

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141 (2).

 

Justification

Experience to date has been acceptable without standard formats. This would make the procedure more complex and place undue emphasis on format. There would be more bureaucracy and more expense, since new IT tools would be required and resources would be diverted to IT staff rather than the staff carrying out controls, who are responsible for managing communications and performing the actual official controls.

Amendment  242

Proposal for a regulation

Article 100 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

 

5a. Communications between competent authorities conducted in accordance with the provisions of this title shall be without prejudice to the provisions of Commission Regulation (EU) No 16/2011 of 10 January 2011 laying down implementing measures for the Rapid Alert System for Food and Feed (RASFF) regarding communications through the RASFF system.

Justification

It is important to include a specific reference to the rapid alert system (RASFF) for certain communications between the Member State authorities which are subject to different rules to those laid down under this title.

Amendment  243

Proposal for a regulation

Article 101 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission shall, by means of implementing acts, establish the specifications of the technical tools and the procedures for communication between liaison bodies designated in accordance with paragraph 1.

deleted

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141 (2).

 

Justification

It is proposed that paragraph 7 be deleted, since it would add further to the administrative burden and costs, bearing in mind the new IT tools in Chapter IV (Information management systems) of Title VI on Union activities. Some flexibility is necessary in order to avoid diverting resources to create superfluous new IT applications, to the detriment of the specific controls themselves.

Amendment  244

Proposal for a regulation

Article 102 – paragraph 1 – point b

Text proposed by the Commission

Amendment

b) indicate within ten days from the date of receipt of the request, the time necessary to provide an informed response to the request;

b) indicate within 15 days from the date of receipt of the request, the time necessary to provide an informed response to the request;

Amendment  245

Proposal for a regulation

Article 103 – paragraph 2 – point b – introductory part

Text proposed by the Commission

Amendment

b) shall indicate within ten days from the date of receipt of the notification:

b) shall indicate within 15 working days from the date of receipt of the notification:

Amendment  246

Proposal for a regulation

Article 104 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. The other concerned Member States referred to in paragraph 1 shall, in the case of infringements of Regulation (EC) No 1/2005 on the protection of animals during transport include:

 

(a) the one that granted the authorisation to the transporter:

 

(b) where a deficiency in the means of transport is involved in the failure to observe the requirements of the Regulation, the one that granted the certificate of approval of the means of transport:

 

(c) where the driver is involved in the failure to observe the requirements of the Regulation, the one that issued the driver's certificate of competence;

Justification

Regulation 1/2005 on the protection of animals during transport specifies the Member States that must be informed in the event of an infringement. The proposed Regulation on official controls repeals this provision in Regulation 1/2005. Accordingly, it should now be included in the proposed Regulation on official controls as the term “any other concerned Member State” is too general and is open to differing interpretations.

Amendment  247

Proposal for a regulation

Article 104 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) inform all relevant, concerned stakeholders, as specified in national food safety contingency plans.

Amendment  248

Proposal for a regulation

Article 107 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Member States shall designate a single authority responsible for:

2. Member States shall designate the authority or authorities responsible for:

Justification

It is not considered appropriate to designate a single authority responsible for all the aspects referred to in paragraph 2, given their enormous variability in the different areas covered by this Regulation.

Amendment  249

Proposal for a regulation

Article 108 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Multi-annual national control plans shall contain general information on the structure and organisation of the systems of official control in the Member State concerned, and shall contain at least information on the following:

2. Multi-annual national control plans shall contain general information on the structure and organisation of the systems of official control in the Member State concerned for each of the sectors concerned and shall contain at least information on the following:

Justification

The contents of the control plans for the different sectors should not be limited to a single format or document. A catch-all document would be unclear.

Amendment  250

Proposal for a regulation

Article 109 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. such plans may be prepared in consultation with relevant operators, with a view to ensuring a risk-based approach to official controls.

Amendment  251

Proposal for a regulation

Article 109 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the emergence of new diseases, pests of plants or other risks to human, animal or plant health, animal welfare or, in the case of GMOs and plant protection products, to the environment;

(a) the emergence of new diseases, pests of plants or other risks to human or plant animal health, animal welfare or to the environment;

Amendment  252

Proposal for a regulation

Article 110

Text proposed by the Commission

Amendment

Article 110

deleted

Delegated powers for multi-annual national control plans

 

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning the multi-annual national control plans provided for in Article 107(1).

 

Those delegated acts shall lay down rules on:

 

a) criteria for the risk categorisation of the operators' activities;

 

b) priorities for official controls based on the criteria laid down in Article 8 and in the rules provided for in Articles 15 to 24;

 

c) procedures to maximise the effectiveness of official controls;

 

d) the main performance indicators to be applied by the competent authorities in assessing the multi-annual national control plan and its implementation.

 

Justification

Risk criteria, along with procedures and priorities, should be established by the Member States. It is accordingly recommended that this article be deleted.

Amendment  253

Proposal for a regulation

Article 111 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the organisation and the implementation of coordinated control plans of limited duration in one of the areas governed by the rules referred to in Article 1(2);

(a) the preparation, organisation and the implementation of coordinated control plans of limited duration in one of the areas governed by the rules referred to in Article 1(2);

Amendment  254

Proposal for a regulation

Article 111 – paragraph 1 – point b

Text proposed by the Commission

Amendment

b) the organisation, on an ad hoc basis, of the collection of data and information in relation to the application of a specific set of the rules referred to in Article 1(2) or regarding the prevalence of certain hazards.

b) the organisation, on an ad hoc basis, of the collection of data and information in relation to the prevalence of certain hazards.

Justification

It is already specified in the first subparagraph that the data and information collected are governed by the rules referred to in Article 1(2).

Amendment  255

Proposal for a regulation

Article 111 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) the role of stakeholders in the development and implementation of the coordinated control plans.

Amendment  256

Proposal for a regulation

Article 112 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the type and number of cases of non-compliance with the rules referred to in Article 1(2) detected in the previous year by the competent authorities;

(c) the type and number of cases of non-compliance with the rules referred to in Article 1(2) detected in the previous year by the competent authorities, specified per sector, and in an adequate level of detailedness;

Amendment  257

Proposal for a regulation

Article 112 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(da) the information on fees referred to in paragraph 2 of Article 83 on transparency.

Justification

Ongoing monitoring of the fees charged by the Member States is of essential importance in ensuring that the fee system does not distort competition in the EU.

Amendment  258

Proposal for a regulation

Article 113 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall make available to the public an annual report on the operation of official controls in the Member States, taking into account:

1. The Commission shall, by 31st December every second year after the entry into force of this Regulation, make available to the public an annual report on the operation of official controls in the Member States, taking into account:

Amendment  259

Proposal for a regulation

Article 113 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the annual reports submitted by the Member States in accordance with Article 112;

(a) the annual reports submitted by the Member States in accordance with Article 112, which shall include the information on fees referred to in paragraph 2 of Article 83 on transparency;

Justification

Ongoing monitoring of the fees charged by the Member States is of essential importance in ensuring that the fee system does not distort competition in the EU.

Amendment  260

Proposal for a regulation

Article 113 – paragraph 2

Text proposed by the Commission

Amendment

2. The annual report provided for in paragraph 1 may, where appropriate, include recommendations on possible improvements to official control systems in Member States and specific official controls in certain areas.

2. The annual report provided for in paragraph 1 shall include recommendations on possible improvements to official control systems in Member States and specific official controls in certain areas.

Amendment  261

Proposal for a regulation

Article 117 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may, by means of implementing acts, amend its control programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated to the Member States.

2. The Commission may, by means of implementing acts, amend its control programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated to the Member States sufficiently well in advance.

Justification

It is essential to ensure that Member States are kept properly informed, which means doing so sufficiently well in advance.

Amendment  262

Proposal for a regulation

Article 118 – paragraph 1 – point b

Text proposed by the Commission

Amendment

b) give all necessary assistance and provide all documentation and other technical support that Commission experts request to enable them to perform controls efficiently and effectively;

b) give necessary technical assistance and provide documentation and other technical support for Commission experts to enable them to perform controls efficiently and effectively;

Justification

The type of assistance to be provided by the Member States should be specified and limited to technical assistance. It is also necessary for planning purposes to take account of the circumstances in any given situation.

Amendment  263

Proposal for a regulation

Article 119 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) where applicable, the situation regarding animal health, zoonoses and plant health, and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases and pests of plants;

(f) where applicable, the situation regarding animal health, zoonoses, and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases;

Amendment  264

Proposal for a regulation

Article 120 – paragraph 1 – point h a (new)

Text proposed by the Commission

Amendment

 

(ha) the likelihood of fraudulent practices which might deceive consumer expectations regarding nature, quality and composition of foods and goods;

Amendment  265

Proposal for a regulation

Article 124 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) where relevant, results of official controls performed on animals and goods intended to be exported to the Union;

(f) where existent, results of official controls performed on animals and goods intended to be exported to the Union;

Amendment  266

Proposal for a regulation

Article 125 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) any other requirement necessary to ensure that certain animals and goods offer a level of protection of health and, as regards GMOs and plant protection products, of the environment, equivalent to that ensured by the requirements referred to in paragraph 1.

(e) any other requirement necessary to ensure that certain animals and goods comply with the requirements referred to in paragraph 1.

Amendment  267

Proposal for a regulation

Article 127 – paragraph 1

Text proposed by the Commission

Amendment

1. Where, in cases other than those referred to in Article 53 of Regulation (EC) No 178/2002, Article 249 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health] and in Articles 27(1), 29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants], there is evidence that the entry into the Union of certain animals or goods originating from a third country, a region thereof or a group of third countries, may pose a risk to human, animal or plant health or, as regards GMOs and plant protection products, to the environment, or where there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) might be taking place, the Commission shall adopt, by means of implementing acts, the measures necessary to contain such risk or put an end to the identified non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141(2).

1. Where, in cases other than those referred to in Article 53 of Regulation (EC) No 178/2002, Article 249 of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health], and in Articles 27(1), 29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants], there is evidence that the entry into the Union of certain animals or goods originating from a third country, a region thereof or a group of third countries, may pose a risk to human or animal health or to the environment, or where there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) might be taking place, the Commission shall adopt, by means of delegated acts in accordance with Article 139, the measures necessary to contain such risk or put an end to the identified non-compliance.

Amendment  268

Proposal for a regulation

Article 128 a (new)

Text proposed by the Commission

Amendment

 

Article 128a

 

Supporting developing countries

 

1. With a view to ensuring that developing countries can comply with the provisions of this Regulation, measures may be taken, and may be implemented for as long as they continue to have a demonstrable impact, to support the following activities:

 

- compliance with the conditions governing the entry into the Union of animals and goods;

 

- drafting of guidelines on the organisation of official controls on products to be exported to the Union;

 

- sending of European Union or Member State experts to developing countries to assist with the organisation of official controls;

 

- involvement of control staff from developing countries in training programmes or courses.

 

2. The Commission shall be empowered, pursuant to Article 139, to adopt delegated acts setting out provisions covering the forms of support for developing countries referred to in paragraph 1.

Justification

On the basis of existing provisions, it should still be possible in the future to support developing countries in building up their control capacities.

Amendment  269

Proposal for a regulation

Article 129 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission may organise training activities for the staff of the competent authorities and, where appropriate, for staff of other authorities of the Member States involved in investigations of possible violations of the provisions of this Regulation and of the rules referred to in Article 1(2).

The Commission shall organise training activities for the staff of the competent authorities and, where appropriate, for staff of other authorities of the Member States involved in investigations of possible violations of the provisions of this Regulation and of the rules referred to in Article 1(2).

Justification

The Commission is not authorised but instructed by the Council and Parliament.

Amendment  270

Proposal for a regulation

Article 129 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Commission may organise those activities in cooperation with Member States.

The Commission shall organise those activities in cooperation with Member States.

Justification

The Commission is not authorised but instructed by the Council and Parliament.

Amendment  271

Proposal for a regulation

Article 130 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall set up and manage a computerised information management system for the integrated operation of the mechanisms and tools through which data, information and documents concerning official controls are managed and handled ('the IMSOC').

1. The Commission shall set up and manage a computerised information management system for the integrated operation of the mechanisms and tools through which data, information and documents concerning official controls are automatically forwarded from databases in the Member States and managed and handled and automatically exchanged ('the IMSOC'), taking into account existing national systems.

Justification

A number of Member States already have, or have pledged to introduce, electronic systems to help reduce administration and improve cost effectiveness. In order to avoid needless duplication, any future information management system established by the Commission should take account of, and be compatible with, all existing systems. It should be possible to use existing databases in the Member States to forward the relevant data.

Amendment  272

Proposal for a regulation

Article 130 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. When forwarding electronic certificates or other electronic documents, the Commission and Member States shall use standard international programming languages, message structures and transmission protocols and safe transmission procedures.

Justification

System interoperability is a sine qua non for the functioning of the information management system as a whole.

Amendment  273

Proposal for a regulation

Article 130 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. When exchanging electronic data, such as electronic certificates, the Commission and the competent authorities of the Member States shall use internationally standardised language, message structure and exchange protocols.

Amendment  274

Proposal for a regulation

Article 134 – paragraph 3 – point a

Text proposed by the Commission

Amendment

a) the performance of intensified official controls on animals, goods and operators for an appropriate period;

a) the performance of intensified official controls on animals, goods and operators for an appropriate period, in keeping with the nature of the risk;

Justification

The period is adapted to the nature of the possible risk to avoid subjective interpretation.

Amendment  275

Proposal for a regulation

Article 135 – paragraph 1 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) take appropriate measures to ensure that the operator remedies the non-compliance and prevents further occurrences of it.

(b) take appropriate measures to ensure that the operator remedies the non-compliance and establishes systems to prevent further occurrences of it.

Justification

The requirement in Regulation 1/2005 is that the transporter must “establish systems to prevent” recurrence of the breaches. This is clearer wording than that proposed by the Commission.

Amendment  276

Proposal for a regulation

Article 135 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa) where the outcome of the official controls on journey logs provided for in point (i) of paragraph (b) of Article 18 (1) is not satisfactory, require the organiser to change the arrangements for the intended long journey so that it complies with Regulation (EC) No 1/2005;

Justification

To reflect the provision in regulation (EC) No 1/2005 for amending journey requirements in cases of non-compliance. Regulation 1/2005 on the protection of animals during transport provides that where a journey log (the journey plan that has to be submitted to the competent authority (CA) before undertaking long distance transport of animals) does not indicate that the Regulation will be complied with during the journey, the CA may require the arrangements for the journey to be changed. The proposed Regulation on official controls repeals this provision in Regulation 1/2005. Accordingly, it should now be included in the proposed Regulation on official controls.

Amendment  277

Proposal for a regulation

Article 135 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) order the unloading, transfer to another means of transport, holding and care of animals, quarantine periods, the postponement of the slaughter of animals;

(b) order the unloading, transfer to another means of transport, holding in suitable accommodation with appropriate care of animals, quarantine periods, the postponement of the slaughter of animals, that veterinary assistance must be sought if necessary;

Justification

It is important to be clearer about what is meant by “holding and care”. The proposed additional words are included in Regulation 1/2005 on the protection of animals during transport. The proposed Regulation on official controls repeals these words in Regulation 1/2005. Accordingly, they should now be included in the proposed Regulation on official controls.

Amendment  278

Proposal for a regulation

Article 135 – paragraph 2 – point e a (new)

Text proposed by the Commission

Amendment

 

(ea) require business operators carrying out the killing of animals or any related operations falling within the scope of Regulation (EC) No 1099/2009 to amend their standard operating procedures and, in particular, slow down or stop production;

Justification

This power is included in Regulation 1099/2009 on the protection of animals at the time of killing. The proposed Regulation on official controls repeals this power in Regulation 1099/2009. Accordingly, this power should now be included in the proposed Regulation on official controls.

Amendment  279

Proposal for a regulation

Article 135 – paragraph 2 – point j

Text proposed by the Commission

Amendment

(j) order the suspension or withdrawal of the approval of the establishment, plant, holding or means of transport concerned, or of the authorisation of a transporter;

(j) order the suspension or withdrawal of the approval of the establishment, plant, holding or means of transport concerned, or of the authorisation of a transporter or of the certificate of competence of the driver;

Justification

It is important that, in appropriate cases the certificate of competence of the driver can be suspended or withdrawn particularly if the infringement shows that the driver lacks sufficient knowledge or awareness to transport animals in compliance with Regulation 1/2005 on the protection of animals during transport.

Amendment  280

Proposal for a regulation

Article 136 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

 

Irrespective of the financial advantage sought, the severity of the penalties should also reflect the degree of risk of damage to consumers' health.

Justification

Suitably severe penalties should also be imposed in cases where the potential threat to consumers' health is serious even though the financial advantage gained by breaching the rules is small.

Amendment  281

Proposal for a regulation

Article 136 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that financial penalties applicable to intentional violations of the provisions of this Regulation and of the rules referred to in Article 1(2) at least offset the economic advantage sought through the violation.

2. Member States shall ensure that financial penalties applicable to intentional violations of the provisions of this Regulation and of the rules referred to in Article 1(2) are set at at least double the economic advantage sought through the violation.

Amendment  282

Proposal for a regulation

Article 136 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) false or misleading official certification;

(b) false or misleading official certification and declarations;

Amendment  283

Proposal for a regulation

Article 136 – paragraph 3 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) where consumers' health is damaged.

Amendment  284

Proposal for a regulation

Article 136 a (new)

Text proposed by the Commission

Amendment

 

Article 136a

 

Reporting of breaches

 

1. Member States shall ensure that competent authorities establish effective and reliable mechanisms to encourage reporting of potential or actual breaches of this Regulation and of national provisions related to this Regulation to competent authorities.

 

2. The mechanisms referred to in paragraph 1 shall include at least:

 

(a) specific procedures for the receipt of reports on breaches and their follow-up;

 

(b) appropriate protection for employees of institutions who report breaches committed within the institution against retaliation, discrimination or other types of unfair treatment at a minimum;

 

(c) protection of personal data concerning both the person who reports the breaches and the natural person who is allegedly responsible for a breach, in accordance with Directive 95/46/EC;

 

(d) clear rules that ensure that confidentiality is guaranteed in all cases in relation to the person who reports the breaches committed within the institution, unless disclosure is required by national law in the context of further investigations or subsequent judicial proceedings.

 

3. Member States shall require institutions to have in place appropriate procedures for their employees to report breaches internally through a specific, independent and autonomous channel. Such a channel may also be provided through arrangements provided for by social partners. The same protection as referred to in points (b), (c) and (d) of paragraph 2 shall apply.

Justification

This article, aiming at the protection of "whistleblowers", has been included in several legislative acts.

Amendment  285

Proposal for a regulation

Article 139 – paragraph 2

Text proposed by the Commission

Amendment

2. The delegation of power referred to in Articles 4(3), 15(2), 16, 17, 18(3), 19, 20, 21, 22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2), 60(3), 62(2), 69(3), 75(1) and (2), 97(2), 98(6), 99(2), 101(3), 106(3), 110, 111, 114(4) and 125(1), the third subparagraph of Article 132(1), Articles 133, 138(1) and (2), 143(2), 144(3), 151(3), 153(3) and 159(3) shall be conferred for an indeterminate period of time from the date of entry into force of this Regulation.

2. The delegation of power referred to in Articles 4(3), 15(2), 16, 17, 18(3), 19, 20, 21, 22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2), 60(3), 62(2), 69(3), 75(1) and (2), 97(2), 98(6), 99(2), 101(3), 106(3), 110, 111, 114(4) and 125(1), the third subparagraph of Article 132(1), Articles 133, 138(1) and (2), 143(2), 144(3), 151(3), 153(3) and 159(3) shall be conferred on the Commission for a period of 5 years from (Publications Office is to fill in the date of entry into force of this amending Act).

 

The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of identical duration unless the European Parliament or Council opposes such an extension not later than 3 months before the end of each period.

Amendment  286

Proposal for a regulation

Article 139 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. For the period during which these delegated powers are exercised, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

Justification

This paragraph is added to ensure that the Commission is required to take account of the Member States through consultation of expert working groups prior to the publication of a delegated act.

Amendment  287

Proposal for a regulation

Article 141 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That Committee is a Committee in the meaning of Regulation (EU) No 182/2011.

1. The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That Committee is a Committee in the meaning of Regulation (EU) No 182/2011. This shall apply with the exception of cases covered by Article 23, which requires the Commission to be assisted by committees set up under Regulation (EC) No 834/2007 on organic production, Regulation (EU) No 1151/2012 regarding DOP, PGI and TSG food product designations, Regulation (EC) No 1234/2007 regarding DOP and PGI wine designations and Regulation (EC) No 110/2008 regarding the geographical indications of spirit drinks.

Justification

In line with Article 23.

Amendment  288

Proposal for a regulation

Article 142 – paragraph 1 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

 

The designation of each of the European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall continue to apply until the designation, in each of the areas concerned, of a European Union reference laboratory pursuant to Article 91(2) of this Regulation.

Amendment  289

Proposal for a regulation

Article 142 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. The designation of each of the European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall continue to apply until such time as, in each of the areas concerned, a European Union reference laboratory is designated in accordance with Article 91(2) of this Regulation, without prejudice to Article 91(3a) thereof.

Amendment  290

Proposal for a regulation

Article 142 – paragraph 2

Text proposed by the Commission

Amendment

2. Regulation (EC) No 854/2004 and Directives 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC and 97/78/EC are repealed as from [Office of Publications, please insert date of entry into force of this Regulation + 3 years].

2. Directives 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC and 97/78/EC are repealed as from [Office of Publications, please insert date of entry into force of this Regulation + 3 years].

Justification

Repealing Regulation (EC) No 854/2004 would give rise to uncertainties concerning specific provisions on the suitability for consumption of animal products which cannot be dealt with by means of the proposal for a regulation under consideration here.

Amendment  291

Proposal for a regulation

Article 148

Regulation (EC) 1829/2003

Article 32

 

Text proposed by the Commission

Amendment

Regulation (EC) No 1829/2003 is amended as follows:

deleted

(a) Article 32 is amended as follows:

 

(i) the first and second subparagraphs are deleted

 

(ii) the third subparagraph is replaced by the following:

 

'Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the tasks of the European Union reference laboratory and the national reference laboratories designated in accordance with Articles 91(1) and 98(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of this Regulation] for that area.'

 

(iii) in the fifth subparagraph the words 'and the annex' shall be deleted.

 

(iv) in the sixth subparagraph the words ' and adapting the Annex' shall be deleted.

 

(b) the Annex is deleted.

 

Justification

The laboratory for genetically modified food and feed provided for in Article 32(1) of Regulation (EC) No 1829/2003 will continue to exist.

Amendment  292

Proposal for a regulation

Article 149

Regulation (EC) 1831/2003

Article 7, 21 and Annex II

 

Text proposed by the Commission

Amendment

Regulation (EC) No 1831/2003 is amended as follows:

deleted

(a) in Article 7, paragraph 3(f) is replaced by the following

 

'a written statement that three samples of the feed additive have been sent by the applicant directly to the European Union reference laboratory referred to in Article 21.'

 

(b) Article 21 is amended as follows:

 

(i) the first, third and forth paragraphs are deleted;

 

(ii) paragraph 2 is replaced by the following:

 

'Applicants for the authorisation of additives shall contribute to supporting the cost of the tasks of the European Union reference laboratory and the national reference laboratories designated in accordance with Articles 91(1) and 98(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of this Regulation] for that area.'

 

(c) Annex II is deleted.

 

Justification

The Community reference laboratory provided for in Article 21(1) of Regulation (EC) No 1831/2003 on additives for use in animal nutrition will continue to exist.

Amendment  293

Proposal for a regulation

Article 150 – paragraph 1 – point b

Regulation (EC) No 1/2005

Article 14, 15, 16, 21, 22, 23, 24, 26

 

Text proposed by the Commission

Amendment

(b) Articles 14, 15, 16, 21, 22(2), 23, 24 and 26 are deleted;

(b) Articles 14, 15, 16, 21, 22(2), 23, 24 and 26 shall continue to apply until the legislative proposals referred to in Article 18 are established;

Amendment  294

Proposal for a regulation

Article 151 – paragraph 2

Regulation (EC) No 396/2005

Article 26, 27, 30

 

Text proposed by the Commission

Amendment

2. Articles 26, 27(1) and 30 of Regulation (EC) No 396/2005 shall continue to apply until the date to be determined in the delegated act adopted in accordance with paragraph 3.

2. Articles 26, 27(1) and 30 of Regulation (EC) No 396/2005 shall continue to apply until the date of the application of the corresponding rules to be established pursuant to the legislative proposals referred to in Article 16 of this Regulation.

Amendment  295

Proposal for a regulation

Article 151 – paragraph 3

Regulation (EC) No 396/2005

Article 26, 27, 30

 

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance to Article 139 concerning the date on which Articles 26, 27(1) and 30 referred to in paragraph 2 shall no longer apply. That date shall be the date of the application of the corresponding rules to be established pursuant to the delegated acts provided for in Article 16 of this Regulation.

deleted

Amendment  296

Proposal for a regulation

Article 153 – paragraph 1 – point c – point ii

Regulation (EC) No 834/2007

Article 27 – paragraphs 3 to 6 and 8 to 14

 

Text proposed by the Commission

Amendment

(ii) paragraphs 2 to 14 are deleted;

(ii) paragraphs 3 to 6 and 8 to 14 are deleted;

Justification

The ban on delegating responsibility for supervision and auditing of other control bodies and on granting exceptions needs to remain in place.

Amendment  297

Proposal for a regulation

Article 153 – paragraph 2

Regulation (EC) No 834/2007

Article 27, 30

 

Text proposed by the Commission

Amendment

2. Articles 27 and 30(2) of Regulation (EC) No 834/2007 shall continue to apply until the date to be determined in the delegated act to be adopted in accordance with paragraph 3.

2. Paragraphs 3 to 14 of Article 27 and paragraph 2 of Article 30 of Regulation (EC) No 834/2007 shall continue to apply until the date to be determined in the delegated act to be adopted in accordance with paragraph 3.

Amendment  298

Proposal for a regulation

Article 153 – paragraph 2

Regulation (EC) No 834/2007

Article 27, 30

 

Text proposed by the Commission

Amendment

5. Articles 27 and 30(2) of Regulation (EC) No 834/2007 shall continue to apply until the date to be determined in the delegated act to be adopted in accordance with paragraph 3.

5. Articles 27(3 to 6) and (8 to 14) and 30(2) of Regulation (EC) No 834/2007 shall continue to apply until the date to be determined in the delegated act to be adopted in accordance with paragraph 3.

Amendment  299

Proposal for a regulation

Article 159 – paragraph 2

Directive 2009/128/EC

Article 8 and Annex II

 

Text proposed by the Commission

Amendment

2. Paragraph 1, the second subparagraph of paragraph 2 and paragraphs 3, 4 and 6 of Article 8 and Annex II of Directive 2009/128/EC shall continue to apply until the date to be determined in the delegated act to be adopted in accordance with paragraph 3.

2. Paragraph 1, the second subparagraph of paragraph 2 and paragraphs 3, 4 and 6 of Article 8 and Annex II of Directive 2009/128/EC shall continue to apply until the date of the application of the corresponding rules to be established pursuant to the legislative proposlas referred to in Article 22 of this Regulation.

Amendment  300

Proposal for a regulation

Article 159 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance to Article 139 concerning the date on which the provisions referred to in paragraph 2 shall no longer apply. That date shall be the date of the application of the corresponding rules to be established pursuant to the delegated acts provided for in Article 22 of this Regulation.

deleted

Amendment  301

Proposal for a regulation

Article 161 – paragraph 1 – point a – point ii

Regulation (EU) No [.…]/2013

Article 29 – paragraph 1

 

Text proposed by the Commission

Amendment

(b) the European Union reference centres for plant reproductive material referred to in Article 93 of that Regulation;

deleted

Amendment  302

Proposal for a regulation

Article 161 – paragraph 1 – point a – point ii

Regulation (EU) n. […]/2013

Article 29 – paragraph 1 – letter c a (new)

 

Text proposed by the Commission

Amendment

 

(ca) the European Union reference centres for the authenticity and integrity of the agri-food chain.

Amendment  303

Proposal for a regulation

Article 161 – paragraph 1 – point b

Regulation (EU) n. […]/2013

Article 29 a – paragraph 2

 

Text proposed by the Commission

Amendment

2. Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.'.

2. The grants referred to in paragraph 1 may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.'

Amendment  304

Proposal for a regulation

Article 162 – paragraph 1 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

 

Maximum one year after entry into force of this regulation, the Commission shall provide a comprehensive guidance document, to assist operators and national authorities to effectively implement this regulation.

Amendment  305

Proposal for a regulation

Article 162 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. Maximum five years after the entry into force of this Regulation, the Commission shall submit a report to the European Parliament and the Council to present the experience gained from the application of this Regulation and consider in particular the reduction of administrative burden on private sector and the efficiency and effectiveness of controls carried out by competent authorities.

Amendment  306

Proposal for a regulation

Article 162 – paragraph 3

Text proposed by the Commission

Amendment

3. In the area covered by the rules referred to in point (h) of Article 1(2), this Regulation, shall apply from [Office of Publications, please insert date of application of the Regulation on the production and making available on the market of plant reproductive material], with the following exceptions:

deleted

(a) Articles 93, 94 and 97 shall apply in accordance with paragraph 1;

 

(b) Article 33(1), (2) (3) and (4) shall apply from [Office of Publications, please insert date of entry into force of this Regulation + 5 years].

 

Amendment  307

Proposal for a regulation

Article 162 – paragraph 4

Text proposed by the Commission

Amendment

4. Articles 15(1), 18(1), 45 to 62 and 76 to 84, point (b) of Article 150, point (b)(i) of Article 152, point (b)(i) of Article 154, point (b)(i) of Article 155 and point (b) of Article 156 shall apply from [Office of Publications, please insert date of entry into force this Regulation + 3 years].

4. Articles 15(1), 18(1), 45 to 62 and 76 to 84, points (b) and (c)(i) of Article 152, point (b)(i) of Article 154 and point (b)(i) of Article 155 shall apply from [Office of Publications, please insert date of entry into force this Regulation + 3 years]. Point (b) of Article 150 and point (b) of Article 156 shall not apply until the delegated acts that replace them are in force.

Justification

Points (c) and (i) fall within the scope of the proposal for a regulation. Point (b) of Article 150 and point (b) of Article 156 delete important provisions of Regulation 1/2005 on the protection of animals during transport and Regulation 1099/2009 on the protection of animals at the time of killing. These deletions should not be made until the delegated acts that replace them are in force.

Amendment  308

Proposal for a regulation

Annex I – paragraph 2

Text proposed by the Commission

Amendment

For the purpose of the official controls performed by the competent authorities to verify the compliance with the rules referred to in point (g) of Article 1(2) and other official activities carried out in relation to point (g) of Article 1(2), references to third countries shall be read as references to third countries and to the territories listed in Annex I of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants], and references to the Union territory shall be read as references to the Union territory without the territories listed in that Annex.

deleted

Amendment  309

Proposal for a regulation

Annex II – chapter 1 – point 5 a (new)

Text proposed by the Commission

Amendment

 

5a. The risks posed by antimicrobial resistance to human and animal health;

Justification

Excessive usage of veterinary medicinal products containing antibiotics has led to increasing levels of antimicrobial resistance in both animals and humans in Europe. This development poses a threat to animal and human health, as well as to the environment and the Union should thus seek ways to reduce the usage of such veterinary medicinal products. The risks of antimicrobial reistance shall thus be included in the training of the staff performing official controls.

Amendment  310

Proposal for a regulation

Annex II – chapter 1 – point 6

Text proposed by the Commission

Amendment

6. The different stages of production, processing and distribution, and the possible risks to human health, and where appropriate to the health of animals and plants, to the welfare of animals, to the environment, and to the identity and quality of plant reproductive material.

6. The different stages of production, processing and distribution, and the possible risks to human health, and where appropriate to the health of animals and plants, to the welfare of animals, and to the environment.

Amendment  311

Proposal for a regulation

Annex IIIa (new)

Text proposed by the Commission

Amendment

 

Annex III a

 

OFFICIAL AUXILIARIES

 

1. The competent authority may appoint as official auxiliaries only persons who have undergone training and passed a test in accordance with the following requirements.

 

2. The competent authority must make arrangements for such tests. To be eligible for these tests, candidates must prove that they have received:

 

(a) at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas specified in paragraph 5; and

 

(b) such additional training as is required to enable official auxiliaries to undertake their duties competently.

 

3. The practical training referred to in paragraph 2(a) is to take place in slaughterhouses and cutting plants, under the supervision of an official veterinarian, and on holdings and in other relevant establishments.

 

4. Training and tests are to concern principally red meat or poultry meat. However, persons who undergo training for one of the two categories and passed the test, need only undergo abridged training to pass the test for the other category. Training and test should cover wild game, farmed game and lagomorphs, where appropriate.

 

5. Training for official auxiliaries is to cover, and tests are to confirm knowledge of, the following subjects:

 

(a) in relation to holdings:

 

(i) theoretical part:

 

– familiarity with the farming industry organisation, production methods, international trade etc. ,

 

– good livestock husbandry practices,

 

– basic knowledge of diseases, in particular zoonoses-viruses, bacteria, parasites etc.,

 

– monitoring for disease, use of medicines and vaccines, residue testing,

 

– hygiene and health inspection,

 

– animal welfare on the farm and during transport,

 

– environmental requirements - in buildings, on farms and in general,

 

– relevant laws, regulations and administrative provisions,

 

– consumer concerns and quality control;

 

(ii) practical part:

 

– visits to holdings of different types and using different rearing methods,

 

– visits to production establishments,

 

– observation of the loading and unloading of animals,

 

– laboratory demonstrations,

 

– veterinary checks,

 

– documentation;

 

(b) in relation to slaughterhouses and cutting plants:

 

(i) theoretical part:

 

– familiarity with the meat industry organisation, production methods, international trade and slaughter and cutting technology,

 

– basic knowledge of hygiene and good hygienic practices, and in particular industrial hygiene, slaughter, cutting and storage hygiene, hygiene of work,

 

– HACCP and the audit of HACCP-based procedures,

 

– animal welfare on unloading after transport and at the slaughterhouse,

 

– basic knowledge of the anatomy and physiology of slaughtered animals,

 

– basic knowledge of the pathology of slaughtered animals,

 

– basic knowledge of the pathological anatomy of slaughtered animals,

 

– relevant knowledge concerning TSEs and other important zoonoses and

zoonotic agents,

 

– knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging and transport of fresh meat,

 

– basic knowledge of microbiology,

 

– ante-mortem inspection,

 

– examination for trichinosis,

 

– post-mortem inspection,

 

– administrative tasks,

 

– knowledge of the relevant laws, regulations and administrative provisions,

 

– sampling procedure,

 

– fraud aspects;

 

(ii) practical part:

 

– animal identification,

 

– age checks,

 

– inspection and assessment of slaughtered animals,

 

– post-mortem inspection in a slaughterhouse,

 

– examination for trichinosis,

 

– identification of animal species by examination of typical parts of the animal,

 

– identifying and commenting on parts of slaughtered animals in which changes have occurred,

 

– hygiene control, including the audit of the good hygiene practices and the HACCP-based procedures,

 

– recording the results of ante-mortem inspection,

 

– sampling,

 

– traceability of meat,

 

– documentation.

 

6. Official auxiliaries are to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official auxiliary is, wherever possible, to undertake annual continuing education activities.

 

7. Persons already appointed as official auxiliaries must have adequate knowledge of the subjects mentioned in paragraph 5. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard.

 

8. However, when official auxiliaries carry out only sampling and analysis in connection with examinations for trichinosis, the competent authority need only ensure that they receive training appropriate to these tasks.

Amendment  312

Proposal for a regulation

Annex III – title

Text proposed by the Commission

Amendment

Annex III

Annex IV

Characterisation of methods of analysis

Characterisation of methods of analysis

Amendment  313

Proposal for a regulation

Annex IV – title

Text proposed by the Commission

Amendment

Annex IV

Annex V

Correlation table referred to in Article 142(3)

Correlation table referred to in Article 142(3)

(1)

Not yet published in the Official Journal

(2)

Not yet published in the Official Journal


EXPLANATORY STATEMENT

Food safety has always played a key role in Community action. Ensuring a high level of human, animal and plant health along the food chain is one of the objectives of the Union Treaty, which has led, over the years, to a body of legislation consisting of 70 legislative measures enabling the European agri-food industry to achieve internationally recognised safety and quality levels.

In the EU, the agri-food industry is the second largest sector, with total food chain production amounting to some EUR 750 billion per year, and employing over 48 million people, from primary production through to retail and catering.

As far as the food chain is concerned, official controls are a vital way of ensuring a high level of protection of human, animal and plant health and of properly implementing complex legislation throughout the food chain and giving consumers confidence. For the sectors of feed and food and animal health and welfare, controls are currently governed by Regulation (EC) No 882/2004, while those of other sectors, such as, for example, controls on residues of veterinary medicinal products in live animals, or plant health controls, are governed by specific sets of rules.

In order to establish a harmonised general framework, the proposal for a regulation encompasses, in a single regulatory text, the official controls relating to all sectors of the agri-food chain (currently split among 16 or so regulations or directives). The proposal provides an in-depth review of existing provisions, aiming to eliminate any regulatory overlapping and taking a proportional and flexible approach so as to be able to react more promptly to emergency situations, by, for example, establishing swifter procedures for the accreditation of official laboratories.

The legal framework developed by the EU up to now has, on the whole, proven to be effective in preventing and countering risks. EU products remain among the safest in the world, precisely because of the controls they have to undergo. However, the modern globalised market and, in particular, the increasingly long and complex agri-food chain, is exposing the EU to new risks and calls for constant improvement of controls along the entire chain. The following are among the main shortcomings identified in the current rules, which call for further improvement:

– the need to simplify the general legal framework, which suffers from fragmentation and overlapping, which lead to differences in interpretation and implementation at national level;

– the need for a more consistent use of the ‘risk-based controls’ principle;

– the need to resolve current uncertainties about the long-term sustainability of official controls by ensuring that they are funded steadily and consistently;

– the need to ensure that a consistent approach is taken to all sectors. Moreover, as far as fees are concerned, the way in which they are calculated needs to be made public and transparent;

– the need for more systematic and consistent use of administrative cooperation tools and computerised information management systems;

In the light of the above, your rapporteur welcomes the Commission proposal to establish a single, harmonised framework for official control procedures, thereby pursuing the objectives of the Communication on Smart Regulation in the European Union. Your rapporteur is of the view that the proposal for a regulation achieves the aim of making the entire official control system more consistent, by seeking, where possible, to leave no room for different interpretations once the regulation comes into force in the Member States.

He welcomes the integrated approach taken by the proposal for a regulation and agrees with the risk-based controls approach.

In addition, he believes that in border controls and in the meat sector, we cannot and must not lower our guard; that is why responsibility for such controls must be entrusted to highly qualified staff who are able to identify the emergence of possible risks and threats to human health.

Minimum frequency of controls

Harmonisation of the frequency of controls will provide consumers with safety guarantees. That is why your rapporteur proposes a minimum frequency, based on risk, that differs according to each product, process or activity, in order to avoid major differences between one country and another – such as those found in the dairy sector, where some countries carry out controls every ten years while others have them every year. Not only does this have an impact on the final price, but it can also affect the safety of the product placed on the market. A climate of trust therefore needs to be built for consumers, through a uniform system of controls carried out with the same frequency in each EU Member State.

Food fraud

The complex body of legislation has not, however, protected European consumers from the possibility of food fraud, as can be seen by the recent horsemeat scandal. In order, therefore, to limit the number of new cases as much as possible, your rapporteur proposes establishing European reference centres that will have the specific task of developing and validating methods to be used in the event of intentional infringements of the rules laid down in Article 1(2) of the proposal for a regulation.

Exemption of micro-enterprises and fees

While welcoming and approving the principle of exempting micro-enterprises from the payment of mandatory fees or contributions to costs, your rapporteur believes that the criteria identified are too broad and would lead to an average of 80-90% of enterprises working in the agri-food chain being exempted from payment. The consequences of this provision could lead to a reduction in the number of controls and/or an increase in fees for the enterprises whose turnover or balance sheets are higher than EUR 2 million. In your rapporteur’s view, the costs of training control staff should be excluded from the calculation of fees or contributions to costs, as those costs should be entirely borne by the competent authority in order to guarantee the quality of the service provided. Moreover, the fees or contributions to costs collected by the competent authority should fully cover the costs of the controls.

Given that there was no opportunity to hold an exchange of views before drawing up the report, your rapporteur considered it preferable to focus, for the time being, solely on the main aspects, reserving the right to take action and supplement the proposed text at a later date.


OPINION of the Committee on Agriculture and Rural Development(*) (21.1.2014)

for the Committee on the Environment, Public Health and Food Safety

on the proposal for a Regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)

(COM(2013)0265 – C7-0123/2013 – 2013/0140(COD))

Rapporteur (*): Britta Reimers

(*)           Associated committee – Rule 50 of the Rules of Procedure

SHORT JUSTIFICATION

It is essentially to be welcomed that the Commission has submitted a proposal whose purpose is to create a harmonised legal framework for the organisation and implementation of official controls throughout the food chain and to ensure uniform application throughout the EU of the provisions in force and smooth functioning of the internal market in food products.

As regards the scope of this Regulation, the Commission proposes that it should include further fields of control outside the food chain, such as plant protection products, plant health and plant reproductive material, including forestry material. This seems questionable, as neither the aim of the requisite controls nor the assessment criteria are comparable with those which apply to the food chain. The provisions concerning controls in the field of plant protection products, plant health and plant reproduction ought therefore to remain in the appropriate sector of EU law. The same applies to the proposals concerning placing the material on the market.

The Commission proposal also extends the scope of the control regulation to ‘other official activities performed by the competent authorities in accordance with this Regulation or with the rules referred to in Article 1(2)’. Under the principle of proportionality, the content and form of Union action should not exceed what is necessary to achieve the objectives of the Treaties. However, for the purpose of uniform EU legislation on official controls it is not necessary also to introduce binding EU-wide provisions concerning other official activities of the competent authority besides official controls.

The proposal for a regulation also contains clauses in all the fields of regulation that it covers empowering the Commission to adopt delegated acts, particularly in Articles 15-24 of the legislative proposal. The fields of regulation proposed by the Commission include the competence and duties of authorities, uniform requirements concerning the implementation of controls, the measures to be taken and particularly the minimum frequency of official controls. All provisions which have a substantial impact on the supervisory work of the Member States must be incorporated directly in the Regulation.

To the extent that the provisions of European regulations at least recognise powers of Member States to regulate matters of detail, there is a lack of corresponding room for manoeuvre for national legislatures. Rather, the very numerous provisions empowering the Commission to adopt delegated acts show that the proposal for a regulation far exceeds the powers conferred by Article 114 TFEU. Article 114 TFEU establishes the legal basis for the European legislature to create the internal market in food products and to regulate the way in which it is to operate. Article 114(3) TFEU stipulates that a high level of protection is required in this context. The proposal for a regulation under consideration, on the other hand, creates a legal basis for extensive binding provisions, to be adopted solely by the European legislature, concerning the administrative procedure even in fields which go beyond official controls. That is disproportionate.

Moreover, the issue of how Member States are to stop infringements of legislation goes far beyond the arrangements for ensuring the reliability of official controls in the EU or enforcing the necessary EU standards in the internal market.

With regard to the financing of official controls, it must be ensured that, in particular, the provisions concerning the setting of fees are clear and unambiguous. Only in this way can uniform implementation be attained in the Member States. In providing for the levying of fees, the red tape involved in collecting them must be kept to a minimum.

Controls connected with services of general interest are in the general public interest and are therefore a public duty, whose performance should also be financed accordingly. Only additional controls should be subject to fees. This will create an incentive to avoid additional controls and hence costs. The determination of the costs must not distort competition.

It is to be welcomed that the principle of transparency with regard to the use made of the fees collected is applied. However, this must not add significantly to red tape. It should also be set on record that the budgetary powers of the Parliaments in the Member States must not be restricted.

Ultimately, the Commission proposal will not create clearer structures. The aim should be to make the system of official controls more efficient and clearer.

AMENDMENTS

The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments into its report:

Amendment  1

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission

Amendment

 

(29a) Official controls should be performed by staff free from any conflict of interests, and in particular not engaged, directly or through a spouse, in an economic activity subject to the official controls laid down;

Amendment  2

Proposal for a regulation

Recital 54

Text proposed by the Commission

Amendment

(54) Member States should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities. Although operators are primarily responsible for ensuring that their activities are carried out in compliance with Union agri-food chain rules, the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each Member State to ensure effective market surveillance along the agri-food chain. Such a system is, by its very nature, complex and resource demanding and should be provided with a stable influx of resources for official controls, at a level appropriate to the enforcement needs at any given moment. To reduce the dependency of the official control system from public finances, competent authorities should collect fees to cover the costs they incur when performing official controls on certain operators and for certain activities for which Union agri-food chain legislation requires registration or approval in accordance with Union rules on the hygiene of food and feed or rules governing plant health and plant reproductive material. Fees should also be collected from operators to compensate the costs of official controls performed in view of issuing an official certificate or attestation, and costs of official controls performed by the competent authorities at border control posts.

(54) Member States should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities. Although operators are primarily responsible for ensuring that their activities are carried out in compliance with Union agri-food chain rules, the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each Member State to ensure effective market surveillance along the agri-food chain. Such a system is, by its very nature, complex and resource demanding and should be provided with a stable influx of resources for official controls, at a level appropriate to the enforcement needs at any given moment.

Amendment  3

Proposal for a regulation

Recital 61

Text proposed by the Commission

Amendment

(61) For the performance of official controls and other official activities on the production and marketing of plant reproductive material, and in the field of animal welfare, the competent authorities should have access to updated, reliable and consistent technical data, to research findings, new techniques and expertise necessary for the correct application of Union legislation applicable in those areas. For that purpose the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for plant reproductive material and for animal welfare.

(61) For the performance of official controls and other official activities on the production and marketing of plant reproductive material, and in the field of animal welfare, the competent authorities should have access to updated, reliable and consistent technical data, to research findings, new techniques and expertise necessary for the correct application of Union legislation applicable in those areas. For that purpose the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for plant reproductive material and for animal welfare. The structure of the reference centres for animal welfare should be based on experience gained from the EUWelNet (Coordinated European Animal Welfare Network) pilot project.

Amendment  4

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) governing food and food safety, at any stage of production, the processing and distribution of food, including rules aimed at guaranteeing fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food;

(a) governing food and food safety, at any stage of production, the processing and distribution of food, including rules aimed at guaranteeing commercial quality and fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food;

Justification

It should be explicitly stated that commercial quality control falls within the scope of the regulation so that food fraud can be prosecuted.

Amendment  5

Proposal for a regulation

Article 1 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) laying down animal health requirements;

(d) laying down animal health requirements, in particular those directly linked to operators' compliance with animal health requirements;

Justification

This amendment is intended to ensure that the proposal applies only to operators in the area of animal health, and not to the competent authorities when carrying out epidemiological surveillance and eradication programmes.

Amendment  6

Proposal for a regulation

Article 1 – paragraph 2 – point k a (new)

Text proposed by the Commission

Amendment

 

(ka) laying down requirements on monitoring certain substances and residues thereof in live animals and animal products.

Justification

It is clear from the explanatory memorandum and recitals that monitoring certain substances and residues thereof in live animals and animal products, which was previously governed by other legislation, is now included in the Commission proposal. However, this is not specifically stated in Article 1. A reference should be inserted to remove any doubt as to the scope of the regulation.

Amendment  7

Proposal for a regulation

Article 1 – paragraph 4 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) the rules laid down in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for veterinary use.

Justification

This makes it clear that this Regulation does not apply to the field of veterinary medicine production.

Amendment  8

Proposal for a regulation

Article 2 – point 5 – point a

Text proposed by the Commission

Amendment

a) the central authorities of a Member State responsible for the organisation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2);

a) the central authorities of a Member State responsible for the organisation or implementation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2);

Justification

The original wording of this definition would leave out the authorities responsible for implementing official controls.

Amendment  9

Proposal for a regulation

Article 2 – point 5 – point b

Text proposed by the Commission

Amendment

b) any other authority to which that responsibility has been conferred;

b) any other local or regional authority on which that competence has been conferred;

Justification

It is more appropriate to keep the term used in Regulation 882/04, to distinguish it from the concept of public authority used in Article 3.

Amendment  10

Proposal for a regulation

Article 2 – point 6

Text proposed by the Commission

Amendment

6. 'animals' means animals as defined in point (1) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health];

6. 'animals' means animals as defined in point (1) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health], with the exception of pet animals;

Justification

As different rules apply to controls on pets, the term ‘pet animals’ should be distinguished from ‘animals’.

Amendment  11

Proposal for a regulation

Article 2 – point 22 – point b

Text proposed by the Commission

Amendment

b) where provided for by the rules referred to in Article 1(2) – any other person, who is authorised to sign official certificates by the competent authorities;

b) where provided for by the rules referred to in Article 1(2) – any other person, who is authorised to issue and sign official certificates by the competent authorities;

Amendment  12

Proposal for a regulation

Article 2 – point 25

Text proposed by the Commission

Amendment

25. 'official attestation' means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities, or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2);

25. 'official attestation' means any label, mark or other form of attestation issued by the competent authorities, or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2);

Justification

Official attestation by operators is not desirable. The official certification or attestation procedure should remain a matter solely for the official authority.

Amendment  13

Proposal for a regulation

Article 2 – point 28 – point a

Text proposed by the Commission

Amendment

(a) animals or goods;

(a) animals, plants, plant products, other objects or goods;

Amendment  14

Proposal for a regulation

Article 2 – point 28 – point b

Text proposed by the Commission

Amendment

(b) activities under the control of operators falling within the scope of the rules referred to in Article 1(2) and equipment, means of transport, substances and materials used to perform those activities;

(b) activities under the control of operators falling within the scope of the rules referred to in Article 1(2) and equipment, means of transport, substances, materials and plant protection products used to perform those activities;

Amendment  15

Proposal for a regulation

Article 2 – point 28 – point c

Text proposed by the Commission

Amendment

(c) places where operators perform their activities;

(c) places where operators perform their activities and, when necessary, adjacent areas;

Amendment  16

Proposal for a regulation

Article 2 – point 28 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) the documentation relating to the examinations referred to in points a), b) and c)

Justification

It should be verified that the documentation complies with existing rules.

Amendment  17

Proposal for a regulation

Article 2 – point 29

Text proposed by the Commission

Amendment

29. 'border control post' means a place, and the facilities belonging to it, designated by a Member State to perform the official controls provided for in Article 45(1);

29. 'border control post' means an inspection centre, and the facilities belonging to it, designated by a Member State to perform the official controls provided for in Article 45(1);

Justification

‘Centre’ draws attention more to the function than to the location. The word ‘centre’ accords with the definitions used in Germany’s regulation on the internal market and prevention of animal diseases and in Austria’s import regulation adopted by the veterinary authority.

Amendment  18

Proposal for a regulation

Article 2 – point 30

Text proposed by the Commission

Amendment

30. 'audit' means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve objectives;

30. ‘audit’ means a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled;

Justification

This is no doubt a translation error which could cause problems of interpretation. It is therefore proposed that the wording of DIN EN ISO 19011 be used.

Amendment  19

Proposal for a regulation

Article 2 – point 40

Text proposed by the Commission

Amendment

40. 'control verification procedures' means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are consistent and effective;

40. 'control verification procedures' means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are effective;

Justification

According to the Commission proposal, the competent authorities are now expected to introduce not only a procedure for ensuring that official controls are effective but also one to monitor 'consistency'. Quite apart from the fact that it is not clear what this term means, it is likely to make further demands on resources, while the value of doing so is not apparent.

Amendment  20

Proposal for a regulation

Article 2 – point 46

Text proposed by the Commission

Amendment

46) 'documentary check' means the examination of the official certificates, official attestations and other document(s) including documents of a commercial nature, which are required to accompany the consignment as provided for by the rules referred to in Article 1(2), Article 54(1), or by implementing acts adopted in accordance with Articles 75(3), 125(4), 127(1) and 128(1);

46) ‘documentary check’ means the examination of the official certificates and other document(s) including documents of a commercial nature, which are required to accompany the consignment as provided for by the rules referred to in Article 1(2), Article 54(1), or by implementing acts adopted in accordance with Articles 75(3), 125(4), 127(1) and 128(1);

Justification

Checks on attestations do not form part of documentary checks but are carried out as part of identity checks.

Amendment  21

Proposal for a regulation

Article 2 – point 47

Text proposed by the Commission

Amendment

47) 'identity check' means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond with the information provided in the official certificates, official attestations and other documents accompanying it;

47) 'identity check' means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, attestations, seals and means of transport, correspond with the information provided in the official certificates, official attestations and other documents accompanying it;

Justification

Checks on attestations do not form part of documentary checks but are carried out as part of identity checks.

Amendment  22

Proposal for a regulation

Article 2 – point 56

Text proposed by the Commission

Amendment

56. 'control plan' means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed in each of the areas referred to in Article 1(2) over a period of time;

deleted

Justification

The definition of ‘control plan’ seems too far-reaching if it is supposed to cover ‘the detailed planning of official controls’. It will hardly be possible for the competent authorities to carry out the task of describing controls in detail as part of a control plan.

Amendment  23

Proposal for a regulation

Article 2 – point 57 a (new)

Text proposed by the Commission

Amendment

 

(57a)'commercial quality' means the set of properties and characteristics of a food product that result from the requirements laid down in mandatory provisions regarding the raw materials or ingredients used in its production, the processes used in its production, and the composition and presentation of the end product.

Justification

In keeping with the remarks concerning Article (1)(2)(a).

Amendment  24

Proposal for a regulation

Article 3 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) set up a single controls register by establishing a single computerised management system to ensure coordination between the bodies involved in the control and the management of the controls.

Amendment  25

Proposal for a regulation

Article 3 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

The register referred to in point (ba) shall include cross compliance controls pursuant to Regulation [xxx.2013] (CAP horizontal regulation).

Amendment  26

Proposal for a regulation

Article 3 – paragraph 5

Text proposed by the Commission

Amendment

5. Member States may confer to the competent authorities referred to in paragraph 1 the responsibility to carry out controls for the verification of compliance with, or for the application of, rules, including those regulating specific risks which may arise from the presence of alien species in the Union, other than those referred to in Article 1(2).

5. Member States may confer to the competent authorities referred to in paragraph 1 the responsibility to carry out controls for the verification of compliance with, or for the application of, rules.

Justification

Consistency with the proposed scope.

Amendment  27

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission may, by means of implementing acts, determine the means by which the information referred to in paragraph 4 is to be made available to the public. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141 (2).

deleted

Justification

This provision is superfluous. It can be left to the Member States to decide how to make the information available to the public.

Amendment  28

Proposal for a regulation

Article 4 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) have arrangements in place to ensure that staff performing official controls and other official activities are free from any conflict of interest;

(c) have arrangements in place to ensure that staff performing official controls and other official activities are free from any conflict of interest, in particular that neither they themselves nor their spouses are engaged in an economic activity subject to the official controls laid down;

Amendment  29

Proposal for a regulation

Article 4 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

In order to ensure the consistency in interpretation and execution of official controls across Member States, the training referred to in point (c) shall include participating in visits to other Member States to observe the way in which official controls are performed;

Amendment  30

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. For the purpose of ensuring that the staff of the competent authorities referred to in point (e) of paragraph 1 and in paragraph 2 have the necessary qualifications, skills and knowledge, the Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the specific qualification and training requirements of such staff, having regard to the scientific and technical knowledge necessary to perform official controls and other official activities in each of the areas referred to in Article 1(2).

deleted

Justification

It does not seem necessary to empower the Commission to adopt delegated acts concerning qualification and training requirements.

Amendment  31

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission may, by means of implementing acts, lay down rules for the conduct of the audits provided for in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141 (2).

deleted

Justification

It is not necessary for the Commission to adopt rules for the conduct of audits by means of implementing acts. Firstly, the guidelines for audits (2006/677) issued by the Commission are sufficient. Secondly, Member States have for years had systems for conducting audits and for their independent review. No implementing acts are required, therefore.

Amendment  32

Proposal for a regulation

Article 7 – title

Text proposed by the Commission

Amendment

Confidentiality obligations of the staff of the competent authorities

Confidentiality obligations of the staff at the service of the competent authorities

Justification

The competent authorities may have their own or contract staff, and the wording 'at the service of' better reflects the various administrative situations that may apply.

Amendment  33

Proposal for a regulation

Article 7 – paragraph 2 – point aa (new)

Text proposed by the Commission

Amendment

 

(aa) the protection of personal data of a natural person;

Justification

There should be a mechanism for operators to protect highly confidential information.

Amendment  34

Proposal for a regulation

Article 7 – paragraph 2 – point a b (new)

Text proposed by the Commission

Amendment

 

(ab) the protection of know-how of a natural or legal person;

(There should be a mechanism for operators to protect highly confidential information.)

Amendment  35

Proposal for a regulation

Article 7 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. Paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, provided that the following conditions are met:

3. Paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators established on their territory, provided that the following conditions are met:

Justification

The legislation in this area has not been harmonised and this power should be restricted to national territory.

Amendment  36

Proposal for a regulation

Article 8 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency, taking account of:

1. Competent authorities shall perform official controls on operators at suitable intervals, in line with the risks that may arise in relation to the area concerned, with appropriate frequency, and taking account of:

Justification

If a risk analysis is carried out in advance, there is no reason to perform controls on 'all' operators, which would require a huge budget.

Amendment  37

Proposal for a regulation

Article 8 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) animals and goods;

(i) animals, pests, plants, plant products, other objects and goods;

Amendment  38

Proposal for a regulation

Article 8 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) the location of the activities or operations of operators;

(iii) the location of the activities or operations of operators, including the place of origin;

Amendment  39

Proposal for a regulation

Article 8 – paragraph 4 – point b

Text proposed by the Commission

Amendment

(b) the operator has requested such official controls.

deleted

Justification

This contradicts the Commission's position to date, according to which controls must be unannounced. As a result of this option, wealthier undertakings might apply for controls for which fees will be levied, thus gaining advantages over other undertakings, particularly as regards making the results of official controls transparent.

Amendment  40

Proposal for a regulation

Article 8 – paragraph 5

Text proposed by the Commission

Amendment

5. Official controls shall be performed as much as possible in a manner that minimises the burden on the operators.

5. Official controls shall be performed as much as possible in a manner that minimises the burden on the operators. Where various official controls are applied to operators, Member States shall ensure a coordinated approach with the aim of combining existing control measures. An independent appeal process should be available for operators who can reasonably claim, with evidence, to have suffered extensive and unnecessary burden.

Amendment  41

Proposal for a regulation

Article 9 – point a

Text proposed by the Commission

Amendment

(a) on animals and goods at all stages of production, processing and distribution;

(a) on animals, plants, plant products, use of plant protection products and goods at all stages of production, processing, placing on the market and distribution;

Amendment  42

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

2. To ensure the uniform implementation of the rules provided for in paragraph 1 of this Article, the Commission shall, by means of implementing acts, lay down and update as necessary the format in which the information referred to in that paragraph shall be published. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141 (2).

deleted

Justification

No uniform EU format is needed in order to inform the public. What matters is the extent of the information made public, not its form.

Amendment  43

Proposal for a regulation

Article 10 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Information submitted to the Commission by the competent authorities as provided for in paragraph 1 of this Article shall be available for publication or otherwise accessible to the public.

Justification

Having all Member States' reports accessible in one place aids with transparency.

Amendment  44

Proposal for a regulation

Article 10 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. Competent authorities shall be entitled to publish or make otherwise available to the public information about the rating of individual operators based on the outcome of official controls, provided that the following conditions are met:

3. Competent authorities shall be entitled to publish or make otherwise available to the public information about the rating of individual operators established on their territory based on the outcome of official controls, provided that the following conditions are met:

Justification

This power should be limited to national operators.

Amendment  45

Proposal for a regulation

Article 11 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Those procedures shall cover the subject areas for control procedures set out in Chapter II of Annex II and contain detailed instructions for staff performing official controls.

Those procedures shall cover the subject areas for control procedures set out in Chapter II of Annex II and contain instructions for staff performing official controls.

Justification

Staff carrying out controls should be allowed the requisite scope to make assessments based on specialist knowledge.

Amendment  46

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

2. Competent authorities shall have procedures in place to verify the consistency and effectiveness of official controls and other official activities that they perform.

2. Competent authorities shall have procedures in place to verify the effectiveness of official controls and other official activities that they perform.

Justification

There are a series of possible ways of achieving ‘consistency’ in official controls (meaning that the same situations are controlled in the same way). However, it may be assumed that more far-reaching checking procedures are implied here, which will involve the use of additional resources, while the benefits are not apparent.

Amendment  47

Proposal for a regulation

Article 11 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings in the consistency and effectiveness of official controls and other official activities;

(a) take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings in the effectiveness of official controls and other official activities;

Justification

It is not clear what is meant by the term ‘consistency’. However, this is likely to entail the use of additional resources, while the benefits are not apparent.

Amendment  48

Proposal for a regulation

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

1. Competent authorities shall perform official controls using control methods and techniques that shall, as appropriate, include screening, targeted screening, verification, inspections, audits, sampling, analysis, diagnosis and tests.

1. Competent authorities may perform official controls using appropriate control methods and techniques that shall, as appropriate, include, for example and not exclusively, screening, targeted screening, verification, inspections, audits, sampling, analysis, diagnosis and tests.

Amendment  49

Proposal for a regulation

Article 13 – paragraph 2 – point b – point i

Text proposed by the Commission

Amendment

(i) primary producers' installations and other businesses, including their surroundings, premises, offices, equipment, installations and machinery, transport and their animals and goods;

(i) primary producers' installations and other businesses, including their surroundings, premises and other areas, offices, equipment, installations and machinery, transport and their animals, plants, plant products, other objects, plant protection products and goods;

Amendment  50

Proposal for a regulation

Article 14 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) their animals and goods;

(c) their animals, plants, plant products, other objects, plant protection products and goods;

Amendment  51

Proposal for a regulation

Article 14 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) their documents and any other relevant information.

(d) their documents and any other relevant information relating to the official control to be carried out.

Amendment  52

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

2. During official controls and other official activities, operators shall assist the staff of the competent authorities in the accomplishment of their tasks.

2. During official controls and other official activities, operators shall assist the staff of the competent authorities in the accomplishment of their control tasks.

Amendment  53

Proposal for a regulation

Article 16 – point a

Text proposed by the Commission

Amendment

(a) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks related to non-authorised substances and to the non-authorised use of authorised substances;

(a) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific risks related to non-authorised substances and to the non-authorised use of authorised substances;

Amendment  54

Proposal for a regulation

Article 17 – point b

Text proposed by the Commission

Amendment

(b) uniform specific requirements for the performance of official controls, and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the need to address specific hazards and risks to animal health by means of official controls performed to verify compliance with disease prevention and control measures laid down in accordance with the rules referred to in point (d) of Article 1(2);

(b) uniform specific requirements for the performance of official controls, and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the need to address specific risks to animal health by means of official controls performed to verify compliance with disease prevention and control measures laid down in accordance with the rules referred to in point (d) of Article 1(2);

Amendment  55

Proposal for a regulation

Article 18 – paragraph 1 – point c – point i

Text proposed by the Commission

Amendment

(i) official controls on the fitness of the animals being transported and on the means of transport;

(i) official controls on the fitness of the animals being transported and on the means of transport to verify compliance with Chapter II and where applicable Chapter VI of Annex I to Regulation (EC) No 1/2005;

Justification

To reflect the corresponding provision in Regulation (EC) No 1/2005, which is repealed by the proposed Regulation.

Amendment  56

Proposal for a regulation

Article 18 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

Where in the view of the competent authority, following official controls under point (c) (i), animals are unfit for transport, they shall be unloaded, watered, fed and rested until fit to continue their journey.

Justification

Whilst the proposed Regulation requires that animals must be checked at exit points to verify that they are fit to continue their journey, it does not specify what action should be taken in respect of animals found to be unfit

Amendment  57

Proposal for a regulation

Article 19 – point b

Text proposed by the Commission

Amendment

(b) uniform specific requirements for the performance of official controls on the introduction into and movement in the Union of particular plants, plant products and other objects subject to the rules referred to in point (g) of Article 1(2) and uniform minimum frequencies of such official controls having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance;

(b) uniform specific requirements for the performance of official controls on the introduction into and movement in the Union of particular plants, plant products and other objects subject to the rules referred to in point (g) of Article 1(2) and uniform minimum frequencies of such official controls having regard, in addition to the criteria referred to in Article 8(1), to the specific risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance;

Amendment  58

Proposal for a regulation

Article 22 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) uniform specific requirements for inspections on pesticide application equipment and uniform minimum frequency of such controls;

(c) uniform specific requirements for inspections on pesticide application equipment used on a large scale and likely to affect human health and uniform minimum frequency of such controls;

Justification

The checking of all pesticide application equipment would create a huge administrative burden. Equipment used on a small scale and shown to have no adverse effects on human health should accordingly be exempt from such checks.

Amendment  59

Proposal for a regulation

Article 22 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Article 135(2) or additional measures to those provided for in that paragraph;

deleted

Amendment  60

Proposal for a regulation

Article 24 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each category of food and feed and the different processes it undergoes;

(b) uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls, having regard, in addition to the criteria referred to in Article 8(1), to the specific risks which exist in relation to each category of food and feed and the different processes it undergoes;

Amendment  61

Proposal for a regulation

Article 25 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The first subparagraph shall not apply to the measures to be taken in accordance with Article 135 or with the rules provided for in point (e) of Article 23(2) following official controls performed to verify compliance with the rules referred to in point (j) of Article 1(2).

The first subparagraph shall not apply to the measures to be taken in accordance with Article 135 or with the rules provided for in point (e) of Article 23(2) and point (e) of Article 23(3) following official controls performed to verify compliance with the rules referred to in points (j) and (k) of Article 1(2).

Justification

In the second paragraph of this article, the delegation of specific official control tasks by the competent authorities is permitted in the field of organic farming for the measures to be taken in case of proven non-compliance. In this context, it is difficult to understand why this is not also permitted for PDOs, PGIs and TSGs, which use the same reference standard for delegation (EN ISO 17065). It is therefore requested that they be included.

Amendment  62

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 establishing specific official control tasks that may not be delegated in order to preserve the independence or the core functions of the competent authorities.

deleted

Justification

Articles 15 to 24 empower the Commission to adopt delegated acts pursuant to Article 139. It is not desirable that rules on the implementation of controls should be instituted only by means of delegated acts. The rules adopted in this way will have a massive impact on the budgets of the Member States which is unpredictable and also incalculable.

Amendment  63

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. Where competent authorities delegate specific official control tasks for the verification of compliance with the rules referred to in point (j) of Article 1(2) to one or more delegated bodies, they shall attribute a code number to each delegated body and designate authorities responsible for their approval and supervision.

4. Where competent authorities delegate specific official control tasks for the verification of compliance with the rules referred to in points (j) and (k) of Article 1(2) to one or more delegated bodies, they shall attribute a code number to each delegated body and designate authorities responsible for their approval and supervision.

Justification

It is difficult to understand why this only applies to organic farming and not to other products bearing quality markers. They should be included.

Amendment  64

Proposal for a regulation

Article 26 – paragraph 1 – point b – point iii

Text proposed by the Commission

Amendment

(iii) is impartial and free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it;

(iii) is impartial, independent from the operator being controlled and free from any conflict of interest as regards the exercise of the specific official control tasks delegated to it;

Amendment  65

Proposal for a regulation

Article 26 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

Staff of the delegated body shall be required not to disclose information acquired when undertaking their duties in the context of official controls and other official activities which by its nature is covered by professional secrecy.

Justification

It is important to include the confidentiality requirement for the delegated bodies, as this is already required of staff of the competent authorities involved in official controls.

Amendment  66

Proposal for a regulation

Article 33 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In the absence of the Union rules referred to in paragraph 1, official laboratories shall use state-of-the-art methods for their specific analytical, testing and diagnostic needs, taking into account:

2. In the absence of the Union rules referred to in paragraph 1, official laboratories shall preferably use state-of-the-art methods for their specific analytical, testing and diagnostic needs, taking into account:

Justification

Use should be preferable and not compulsory.

Amendment  67

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 36(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols.

4. Where laboratory analyses, tests or diagnoses are urgently needed, in exceptional cases due to a developing emergency situation, and none of the methods referred to in paragraphs 1 and 2 exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 36(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols.

Amendment  68

Proposal for a regulation

Article 33 – paragraph 7 – subparagraph 1 – introductory wording

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, lay down rules for:

The Commission may, by means of implementing acts, insofar as these matters are not otherwise regulated, lay down rules for:

Justification

For the field of feed, Regulation (EC) No 152/2009 on sampling and analysis procedures exists. It deals with both sampling and methods of examination. A revised version of this Regulation is due to be published shortly. The Commission can therefore only act to the extent that the relevant provisions are not already laid down elsewhere.

Amendment  69

Proposal for a regulation

Article 34 – paragraph 1 – subparagraph 2 – point b – point i

Text proposed by the Commission

Amendment

(i) that a sufficient number of other samples be taken for a second expert opinion; or,

(i) that a sufficient number of samples be taken and divided into three parts for the purpose of an initial analysis and, if appropriate, a second expert opinion at the request of the operator, then another final analysis, if there is a discrepancy between the two previous ones;

Justification

A final analysis should be carried out in the case of discrepancies, so it is important to have three parts of the same sample.

Amendment  70

Proposal for a regulation

Article 35 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Competent authorities shall take all steps to ensure that the operators from whom the samples are ordered in accordance with paragraph 1:

2. Competent authorities, once they are in possession of the samples, shall take all steps to ensure that the operators from whom these samples are ordered in accordance with paragraph 1:

Amendment  71

Proposal for a regulation

Article 36 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples;

deleted

Justification

Compliance with the requirement will be checked by the accreditation body as part of the procedure for accreditation pursuant to EN ISO/IEC 17025.

Amendment  72

Proposal for a regulation

Article 36 – paragraph 4 – point b

Text proposed by the Commission

Amendment

(b) has a sufficient number of suitably qualified, trained and experienced staff;

deleted

Justification

Compliance with the requirement will be checked by the accreditation body as part of the procedure for accreditation pursuant to EN ISO/IEC 17025.

Amendment  73

Proposal for a regulation

Article 36 – paragraph 4 – point c

Text proposed by the Commission

Amendment

(c) is impartial and free from any conflict of interest as regards the exercise of its tasks as official laboratory;

deleted

Justification

Compliance with the requirement will be checked by the accreditation body as part of the procedure for accreditation pursuant to EN ISO/IEC 17025.

Amendment  74

Proposal for a regulation

Article 36 – paragraph 4 – point e

Text proposed by the Commission

Amendment

(e) operates in accordance with the standard EN ISO/IEC 17025 on 'General requirements for the competence of testing and calibration laboratories' and is assessed and accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008.

(e) operates in accordance with the standard EN ISO/IEC 17025 on 'General requirements for the competence of testing and calibration laboratories' and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008.

Justification

The formulation ‘assessed and accredited’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  75

Proposal for a regulation

Article 36 – paragraph 5 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The scope of the assessment and accreditation of an official laboratory referred to in point (e) of paragraph 4:

The scope of the accreditation of an official laboratory referred to in point (e) of paragraph 4:

Justification

The formulation ‘assessment and accreditation’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  76

Proposal for a regulation

Article 36 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

 

5a. When competent authorities designate a private laboratory to carry out the laboratory analyses, tests and diagnoses on samples taken during official controls, this designation shall not be considered as a delegation of tasks and therefore need not comply with the provisions of chapter III of this Title.

Justification

The analysis, testing and diagnosis by private laboratories is not considered to be a delegation of tasks, as only part of one of the official control actions is performed, in this case only one of the expert tests, so this cannot be regarded per se as the delegation of official control.

Amendment  77

Proposal for a regulation

Article 37 – paragraph 3

Text proposed by the Commission

Amendment

3. Official laboratories shall make available to the public the list of methods used for analyses, tests or diagnoses performed in the context of official controls and other official activities.

deleted

Amendment  78

Proposal for a regulation

Article 39 – title

Text proposed by the Commission

Amendment

Derogations from the condition for the mandatory assessment and accreditation for certain official laboratories

Derogations from the condition for the mandatory accreditation for certain official laboratories

Justification

The assessment precedes the accreditation.

Amendment  79

Proposal for a regulation

Article 39 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. By derogation from point (e) of Article 36(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfil the condition provided for in that point:

1. By derogation from point (e) of Article 36(4), competent authorities may designate the following as official laboratories, or laboratories acting under official supervision, irrespective of whether they fulfil the condition provided for in that point:

Justification

The word 'official' may be misleading as the scope of this article should also encompass private accredited laboratories.

Amendment  80

Proposal for a regulation

Article 39 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 36(1), and assessed and accredited in accordance with the standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’ for the use of the methods referred to in point (a)(ii) of this paragraph;

(iii) that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 36(1), and accredited in accordance with the standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’ for the use of the methods referred to in point (a)(ii) of this paragraph;

Justification

The formulation ‘assessed and accredited’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  81

Proposal for a regulation

Article 40 – title

Text proposed by the Commission

Amendment

Powers to adopt derogations from the condition for the mandatory assessment and accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories

Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories

Justification

The formulation ‘assessment and accreditation’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  82

Proposal for a regulation

Article 41 – title

Text proposed by the Commission

Amendment

Temporary derogations from the condition for the mandatory assessment and accreditation of official laboratories

Temporary derogations from the condition for the mandatory accreditation of official laboratories

Justification

The formulation ‘assessment and accreditation’ is incomprehensible. As part of the accreditation procedure, the national accreditation body performs extensive audits (evaluations). Thus the testing laboratory is ‘assessed’ before being accredited.

Amendment  83

Proposal for a regulation

Article 46 – point a

Text proposed by the Commission

Amendment

(a) goods sent as commercial or trade samples or as display items for exhibitions, which are not intended to be placed on the market;

(a) goods sent as commercial or trade samples or as display items for exhibitions;

Justification

Passing on a commercial sample or display item for an exhibition to somebody else already constitutes placing on the market as defined in Article 3(8) of Regulation (EC) No 178/2002.

Amendment  84

Proposal for a regulation

Article 46 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) animals and goods intended for scientific purposes;

deleted

Justification

Checks on animals intended for scientific purposes should be carried out at EU borders, given the possible risk to human health.

Amendment  85

Proposal for a regulation

Article 46 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) pet animals as defined in point (10) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health];

deleted

Justification

Allowing the Commission to relax checks on pet animals entering the Union could have a huge impact upon animal health and welfare. Any such proposals should receive proper scrutiny from the Parliament and Council.

Amendment  86

Proposal for a regulation

Article 47 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authorities shall perform official controls on the consignments of the categories of animals and goods referred to in Article 45(1) upon arrival of the consignment at the border control post. Those official controls shall include documentary, identity and physical checks.

1. The competent authorities shall perform official controls on the consignments of the categories of animals and goods referred to in Article 45(1) upon arrival of the consignment at the border control post. Those official controls shall take account of both previous compliance and the possible risks posed and may include documentary, identity and physical checks.

Amendment  87

Proposal for a regulation

Article 47 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Where such checks are performed on animals they shall be carried out by an official veterinarian or under his supervision.

Where such checks are performed on animals or on products of animal origin, they shall be carried out by an official veterinarian or under his supervision.

Justification

The official veterinarian must remain responsible for decisions on live animals and products of animal origin (meat, dairy products, etc.).

Amendment  88

Proposal for a regulation

Article 51 – paragraph 1 – point c – point iii a (new)

Text proposed by the Commission

Amendment

 

(iiia) pets travelling with their owners.

Justification

That competent authorities may assign certain specific tasks to customs authorities or other public authorities is laid down. Checking pets travelling with their owners should be included in these tasks.

Amendment  89

Proposal for a regulation

Article 53 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. These decisions shall be recorded in the Common Health Entry Document referred to in Article 54.

Justification

To make the procedure clearer.

Amendment  90

Proposal for a regulation

Article 54 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. The competent authorities of the border control post shall finalise the CHED as soon as:

4. The competent authorities of the border control post shall record the decision on the consignment in the Common Health Entry Document as soon as all official controls required by Article 47(1) have been performed.

Justification

The purpose of the amendment is to replace all of point 4 with simpler and more easily understood wording.

Amendment  91

Proposal for a regulation

Article 54 – paragraph 4 – point a

Text proposed by the Commission

Amendment

a) all official controls required by Article 47(1) have been performed;

deleted

Justification

The purpose of the amendment is to replace all of point 4 with simpler and more easily understood wording.

Amendment  92

Proposal for a regulation

Article 54 – paragraph 4 – point b

Text proposed by the Commission

Amendment

b) the results from physical checks, where such checks are required, are available;

deleted

Justification

The purpose of the amendment is to replace all of point 4 with simpler and more easily understood wording.

Amendment  93

Proposal for a regulation

Article 54 – paragraph 4 – point c

Text proposed by the Commission

Amendment

c) a decision on the consignment has been taken in accordance with Article 53 and recorded on the CHED.

deleted

Justification

The purpose of the amendment is to replace all of point 4 with simpler and more easily understood wording.

Amendment  94

Proposal for a regulation

Article 56 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules establishing the cases where and the conditions under which the CHED must accompany consignments of the categories of animals and goods referred to in Article 45(1) to the place of destination.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules establishing the cases where and the conditions under which the CHED must accompany consignments of the categories of animals and goods referred to in Article 45(1) to the place of destination. A copy of the CHED shall in any case accompany consignments of the categories of animals and goods referred to in Article 45(1) to the place of destination.

Justification

A copy of the CHED must always accompany consignments of animals and goods that have been controlled to their place of destination.

Amendment  95

Proposal for a regulation

Article 57 – paragraph 4

Text proposed by the Commission

Amendment

4. The Member State shall delay designating the border control post until the favourable outcome of the control has been communicated to it by the Commission.

deleted

Amendment  96

Proposal for a regulation

Article 62 – paragraph 1

Text proposed by the Commission

Amendment

1. Border control posts shall be located in the immediate vicinity of the point of entry into the Union and in a place suitably equipped to be designated by the customs authorities in accordance with Article 38(1) of Regulation (EEC) No 2913/92.