Procedure : 2013/0136(COD)
Document stages in plenary
Document selected : A7-0129/2014

Texts tabled :

A7-0129/2014

Debates :

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

Votes :

PV 15/04/2014 - 17.3

Texts adopted :

P7_TA(2014)0381

REPORT     ***I
PDF 1378kWORD 2184k
19 February 2014
PE 514.757v02-00 A7-0129/2014

on the proposal for a regulation of the European Parliament and of the Council on Animal Health

(COM(2013)0260 – C7-0124/2013 – 2013/0136(COD))

Committee on Agriculture and Rural Development

Rapporteur: Marit Paulsen

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS
 OPINION of the Committee on the Environment, Public Health and Food Safety
 OPINION of the Committee on Fisheries
 PROCEDURE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council on Animal Health

(COM(2013)0260 – C7-0124/2013 – 2013/0136(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2013)0260),

–  having regard to Article 294(2) and Articles 43(2) and 114(3) and Article 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0124/2013),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  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 Austrian Federal Council, 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 10 December 2013(1),

–  after consulting the Committee of the Regions,

–  having regard to Rules 55 and 37 of its Rules of Procedure,

–  having regard to the report of the Committee on Agriculture and Rural Development and the opinions of the Committee on the Environment, Public Health and Food Safety and the Committee on Fisheries (A7-0129/2014),

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

Proposal for a

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on Animal Health

on the prevention and control of animal diseases which are transmissible among animals or to humans

Amendment    2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) The impact of transmissible animal diseases and the measures necessary to control these diseases can be devastating for individual animals, animal populations, animal keepers and the economy.

(1) The impact of transmissible animal diseases and the measures necessary to control these diseases can be devastating for individual animals, animal populations, animal keepers and the economy and can have a major influence on public health and food safety.

Amendment    3

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health, as for example in the case of avian influenza and salmonella.

(2) As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health and food safety, as for example in the case of avian influenza and salmonella.

Amendment    4

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

 

(3a) Proper control of infectious animal diseases, including zoonotic diseases, is a prerequisite for a functioning single market for trade in live animals, animal products and food.

Amendment    5

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

 

(4a) Article 13 of the Treaty on the Functioning of the European Union (TFEU) recognises that animals are sentient beings. Union legislation on animal welfare requires animal owners, animal keepers and competent authorities to respect animal welfare requirements guaranteeing their humane treatment and avoiding them unnecessary pain and suffering. Such rules are based on scientific evidence and may improve animal health.

Amendment    6

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

 

(5a) With a view to making these provisions as clear as possible, and thus ensuring that they are fully and correctly implemented, a criterion and principle for organising the delegated and implemented acts adopted pursuant to this Regulation needs to be laid down.

Amendment    7

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) The Animal Health Strategy for the Union (2007– 2013) proposes that ‘Prevention is better than cure’ and was adopted by the Commission in its Communication of 19 September 2007 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions11 . It aims to put greater focus on preventive measures, disease surveillance, disease control and research, in order to reduce the incidence of animal diseases and minimise the impact of outbreaks when they do occur. It proposes the adoption of a ‘single and simplified regulatory framework for animal health’ seeking convergence to international standards while ensuring a firm commitment to high standards of animal health.

(6) The Animal Health Strategy for the Union (2007– 2013) proposes that ‘Prevention is better than cure’ and was adopted by the Commission in its Communication of 19 September 2007 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions11. It aims to promote animal health through putting greater focus on preventive measures, disease surveillance, disease control and research, in order to reduce the incidence of animal diseases and minimise the impact of outbreaks when they do occur. It proposes the adoption of a ‘single and simplified regulatory framework for animal health’ seeking convergence to international standards while ensuring a firm commitment to high standards of animal health.

__________________

__________________

11 COM (2007) 539 final.

11 COM (2007) 539 final.

Amendment    8

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

 

(7a) The Commission Communication on the new Animal Health Strategy for the European Union stresses that a joint approach should be taken to prevention and biosecurity measures, given that contagious disease agents can spread easily from one farm to another.

Amendment    9

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) In laying down those animal health rules, it is essential that considerations are given to the link between animal health and public health, the environment, food and feed safety, animal welfare, food security, economic, social and cultural aspects.

(9) In laying down those animal health rules, it is essential that considerations are given to the link between animal health and public health, the environment, food and feed safety, food security, economic, social, cultural aspects and especially animal welfare, given the interdependency of animal welfare and animal health.

Amendment    10

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) In Union legislation adopted prior to this Regulation separate animal health rules are laid down for terrestrial and aquatic animals. Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals20 lays down specific rules for aquatic animals. Yet in most cases, the main principles for good animal health governance are applicable to both groups of animal species. Accordingly, the scope of this Regulation should cover both terrestrial and aquatic animals and aligns those animal health rules where applicable. However, for certain aspects, in particular the registration and approval of establishments and the traceability and movements of animals within the Union, this Regulation adheres to the approach adopted in the past, which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health.

(19) In Union legislation adopted prior to this Regulation separate animal health rules are laid down for terrestrial and aquatic animals. Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals lays down specific rules for aquatic animals. Yet in most cases, the main principles for good animal health governance and good animal husbandry are applicable to both groups of animal species. Accordingly, the scope of this Regulation should cover both terrestrial and aquatic animals and aligns those animal health rules where applicable. However, for certain aspects, in particular the registration and approval of establishments and the traceability and movements of animals within the Union, this Regulation adheres to the approach adopted in the past, which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health.

Amendment    11

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Furthermore, the preventive and control measures for each transmissible animal disease should be "tailor-made" in order to address its unique epidemiological profile and its consequences. The preventive and control rules applying to each of them should therefore be disease specific.

(24) Furthermore, the preventive and control measures for each transmissible animal disease should be "tailor-made" in order to address its unique epidemiological profile and its consequences. The preventive and control rules applying to each of them should therefore be disease specific, and strict attention should be paid to different regional conditions.

Amendment    12

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) New hazards associated with certain diseases or species may develop in particular due to changes in the environment, the climate, animal husbandry, farming traditions but also through social changes. Scientific progress may also lead to new knowledge and increased awareness concerning existing diseases. Furthermore, diseases and species that are important today may be marginalised in the future. Therefore the scope of this Regulation should be broad and the rules laid down should be focused on diseases with high public relevance. The OIE has, with the support of the European Commission, developed a system of disease prioritisation and categorisation, by producing a study on the "Listing and categorisation of priority animal diseases, including those transmissible to humans"23 and a tool for such an exercise. This Regulation should introduce such an approach in Union legislation.

(30) New hazards associated with certain diseases or species may develop in particular due to changes in the environment, the climate, animal husbandry, farming traditions but also through social changes and changes in economic and trade relations inside and outside the Union. Unless they are totally eradicated, diseases currently confined to limited geographical areas could spread and cause economic damage over wider areas. Furthermore, scientific progress may also lead to new knowledge and increased awareness concerning existing diseases. At the same time, diseases and species that are important today may be marginalised in the future. Therefore the scope of this Regulation should be broad and the rules laid down should be focused on diseases with high public relevance. The OIE has, with the support of the European Commission, developed a system of disease prioritisation and categorisation, by producing a study on the "Listing and categorisation of priority animal diseases, including those transmissible to humans"23 and a tool for such an exercise. This Regulation should introduce such an approach in Union legislation.

__________________

__________________

23 http://www.oie.int/en/support-to-oie-members/global-studies/categorisation-of-animal-diseases/.

23 http://www.oie.int/en/support-to-oie-members/global-studies/categorisation-of-animal-diseases/.

Amendment    13

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) In order to ensure uniform conditions for the implementation of this Regulation in relation to transmissible animal diseases at Union level, it is necessary to establish a harmonised list of transmissible animal diseases ('listed diseases'). Thus implementing powers to lay down such a list should be conferred on the Commission.

(31) It is necessary to establish a harmonised list of transmissible animal diseases ('listed diseases'), which should be set out in a table in an Annex attached to this Regulation. The power to adopt acts amending or supplementing such a list should be delegated to the Commission in accordance with Article 290 TFEU.

Amendment    14

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) The prevention and control rules of this Regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question, by being susceptible to it or by acting as its vector. In order to ensure uniform conditions for the implementation of this Regulation, it is necessary to establish a harmonised list of species to which the measures for specific listed diseases should apply at Union level ('listed species') and thus implementing powers to lay down such a list should be conferred on the Commission.

(35) The prevention and control rules of this Regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question, by being susceptible to it or by acting as its vector. It is thus necessary to establish a harmonised list of species to which the measures for specific listed diseases should apply at Union level ('listed species') and which should be set out in a table in an Annex to this Regulation. The power to adopt acts amending or supplementing such a list should be delegated to the Commission in accordance with Article 290 TFEU.

Amendment    15

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(36) Based on the importance and the level of impact of a listed disease, its distribution, prevalence and incidence in the Union and the availability of disease prevention and control measures in respect of that listed disease, a different category of specific disease prevention and control rules provided for in this Regulation should apply coherently and consistently to each listed disease.

(36) Based on the importance and the level of impact of a listed disease, its distribution, prevalence and incidence in the Union, the risk of its spreading and the availability of disease prevention and control measures in respect of that listed disease, a different category of specific disease prevention and control rules provided for in this Regulation should apply coherently and consistently to each listed disease.

Amendment    16

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) In order to ensure uniform conditions for the implementation of this Regulation in relation to the disease prevention and control measures applicable to listed diseases, it is necessary to determine the application of the rules, provided for in this Regulation, to listed diseases at Union level. Thus implementing powers to lay down which listed diseases are to be subject to which rules, should be conferred on the Commission.

(37) It is necessary to determine, and lay down in a list, the application of the rules, provided for in this Regulation, to listed diseases at Union level. Such a list should be kept and updated in a table in an Annex to this Regulation. The power to adopt acts amending or supplementing such a list should be delegated to the Commission in accordance with Article 290 TFEU.

Amendment    17

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

(38) Operators, animal professionals and pet keepers working with animals are in the best position to observe and ensure the health of the animals and products under their responsibility. They should therefore hold primary responsibility for carrying out measures for the prevention and control of the spread of diseases among animals and products under their responsibility.

(38) Operators, animal professionals and pet keepers working with animals are in the best position to observe and ensure the health of the animals and products under their responsibility. They should therefore hold primary responsibility for carrying out measures for the prevention and control of the spread of diseases among animals and products under their responsibility, and should work individually and collectively to improve animal health practices.

Amendment    18

Proposal for a regulation

Recital 41

Text proposed by the Commission

Amendment

(41) Knowledge of animal health, including of disease symptoms, consequences of diseases and possible means of prevention including biosecurity, treatment and control is a prerequisite for efficient animal health management and essential in ensuring the early detection of animal diseases. Operators and other animal professionals should therefore acquire such knowledge as appropriate. That knowledge may be acquired by different means, for example formal education, but also through the Farm Advisory System existing in the agricultural sector or by informal training to which national and European farmer organisations and other organisations may be valuable contributors. Those alternative means of acquiring such knowledge should also be recognised by this Regulation.

(41) Knowledge of animal health, including of disease symptoms, consequences of diseases and possible means of prevention including biosecurity, treatment and control is a prerequisite for efficient animal health management and essential in ensuring the early detection of animal diseases. Operators and other animal professionals should therefore acquire such knowledge as appropriate. That knowledge may be acquired by different means, for example formal education, but also through the Farm Advisory System existing in the agricultural sector or by informal training to which national and European farmer organisations and other organisations may be valuable contributors. Those alternative means of acquiring such knowledge should also be recognised by this Regulation. The same may also be said of pet keepers, while bearing in mind their different position and level of responsibility.

Amendment    19

Proposal for a regulation

Recital 46

Text proposed by the Commission

Amendment

(46) The competent authority cannot always perform all the activities required to be carried out by it under this Regulation due to the limited resources. For that reason it is necessary to provide a legal basis for the delegation of the performance of those activities to veterinarians. In order to ensure that the necessary conditions are laid down for the general application of disease prevention and control measures across the Union, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect to the delegation of the performance of those activities to veterinarians and their appropriate training.

(46) The competent authority cannot always perform all the activities required to be carried out by it under this Regulation due to the limited resources. For that reason it is necessary to provide a legal basis for the delegation of the performance of those activities to veterinarians and other qualified professionals. For the same reason, it is of utmost importance that those veterinarians and professionals have no conflicts of interest. In order to ensure that the necessary conditions are laid down for the general application of disease prevention and control measures across the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect to the delegation of the performance of those activities to veterinarians and their appropriate training.

Amendment    20

Proposal for a regulation

Recital 47

Text proposed by the Commission

Amendment

(47) Optimal animal health management can only be achieved in cooperation with animal keepers, operators, other stakeholders and trading partners. To secure their support it is necessary to organise decision making procedures and the application of the measures provided for in this Regulation in a clear and transparent manner. Therefore the competent authority should take appropriate steps to keep the public informed, especially when there are reasonable grounds to suspect that animals or products may present a risk for animal or public health and when a case is of public interest.

(47) Optimal animal health management can only be achieved in cooperation with animal keepers, operators, veterinarians, animal health professionals, other stakeholders and trading partners. To secure their support it is necessary to organise decision making procedures and the application of the measures provided for in this Regulation in a clear and transparent manner. Therefore the competent authority should take appropriate steps to keep the public informed, especially when there are reasonable grounds to suspect that animals or products may present a risk for animal or public health, food safety or the environment and when a case is of public interest.

Amendment    21

Proposal for a regulation

Recital 49

Text proposed by the Commission

Amendment

(49) Early detection and a clear chain of disease notification and reporting are crucial for effective disease control. In order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority. Those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed.

(49) Early detection and a clear chain of disease notification and reporting are crucial for effective disease control. In order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to veterinarians or aquatic animal health professionals. At the same time, a professional approach to notification and reporting must be ensured, in order avoid unnecessary health scares. Those notification obligations should therefore be applicable to all operators, animal professionals and pet keepers.

Amendment    22

Proposal for a regulation

Recital 57

Text proposed by the Commission

Amendment

(57) Operators observe their animals on a regular basis and are best positioned to detect abnormal mortalities or other serious disease symptoms. Operators are therefore the cornerstone of any surveillance and essential for the surveillance undertaken by the competent authority.

(57) Operators observe their animals on a regular basis and are best positioned to detect abnormal mortalities or other serious disease symptoms. Operators are therefore the cornerstone of any surveillance and essential for the surveillance undertaken by the competent authority. In the context of this Regulation and with respect to wild animals, the role of hunters should also be recognised as instrumental in monitoring diseases due to their experience and knowledge of the diseases affecting wild animals. Similarly hunting associations and holder of hunting rights could also supplement the work of operators in monitoring wild animals.

Amendment    23

Proposal for a regulation

Recital 63

Text proposed by the Commission

Amendment

(63) Member States that are not free or are not known to be free from listed diseases which are subject to eradication measures as provided for in this Regulation, should be required to establish compulsory eradication programmes to eradicate those diseases where the eradication is compulsory in the Union, or have the possibility to establish voluntary eradication programmes, to eradicate those diseases where the eradication is envisaged in the Union, but is not compulsory. To ensure uniform conditions of general application throughout the Union, it is necessary to lay down harmonised requirements for such compulsory or voluntary eradication programmes. In order to ensure effective disease eradication, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the objectives of disease control strategies, disease control measures under the compulsory or voluntary eradication programmes and requirements of such programmes.

(63) Member States that are not free or are not known to be free from listed diseases which are subject to eradication measures as provided for in this Regulation, should be required to establish compulsory eradication programmes to eradicate those diseases where the eradication is compulsory in the Union.

Amendment    24

Proposal for a regulation

Recital 63 a (new)

Text proposed by the Commission

Amendment

 

(63a) On the other hand, there are some diseases which are of Union concern but for which it is not necessary to require Member States to eradicate the disease. Member States have the possibility to establish voluntary eradication programmes for such diseases, if they decide that eradication is important for them. Such voluntary eradication programmes would be recognised at the Union level. This programme would entail implementing certain relevant disease control measures. It may also enable the Member State, subject to approval by the Commission, to require certain guarantees when receiving animals from other Member States or from third countries, such as additional testing for the disease and assurances about those test results in a movement certificate. Their programme may also be eligible for a Union financial contribution, if the disease is listed in [the new financial regulation] and they submit an application for funding.

Amendment    25

Proposal for a regulation

Recital 63 b (new)

Text proposed by the Commission

Amendment

 

(63 b) To ensure uniform conditions of general application throughout the Union, it is necessary to lay down harmonised requirements for such compulsory or voluntary eradication programmes. In order to ensure effective disease eradication, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the objectives of disease control strategies, disease control measures under the compulsory or voluntary eradication programmes and requirements of such programmes.

Amendment    26

Proposal for a regulation

Recital 75

Text proposed by the Commission

Amendment

(75) However, control strategies for some transmissible animal diseases require prohibition or restriction of the use of certain veterinary medicinal products, as their use would hamper the effectiveness of those strategies. For example, hyper immune sera or antimicrobial agents may mask the expression of a disease, make the detection of a disease agent impossible or render a swift and differential diagnosis difficult and thus endanger the correct detection of disease.

(75) However, control strategies for some transmissible animal diseases require prohibition or restriction of the use of certain veterinary medicinal products, as their use would hamper the effectiveness of those strategies. For example, hyper immune sera or antimicrobial agents may mask the expression of a disease, make the detection of a disease agent impossible or render a swift and differential diagnosis difficult, and thus endanger the correct detection of disease, thereby significantly putting at risk public and animal health.

Amendment    27

Proposal for a regulation

Recital 76

Text proposed by the Commission

Amendment

(76) However, those control strategies may substantially vary between different listed diseases. Thus this Regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of listed diseases and for harmonised criteria for consideration when determining whether or not to use and how to use vaccines, hyper-immune sera and antimicrobials. In order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of the effective treatments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the restrictions, prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain listed diseases. In the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health, economy, society or environment, it should be possible for these measures to be adopted by the urgency procedure.

(76) However, those control strategies may substantially vary between different listed diseases. Thus this Regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of certain diseases and for harmonised criteria for consideration when determining whether or not to use and how to use vaccines, hyper-immune sera and antimicrobials. In order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of the effective treatments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the restrictions, prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain diseases. In the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health, economy, society or environment, it should be possible for these measures to be adopted by the urgency procedure.

Amendment    28

Proposal for a regulation

Recital 79

Text proposed by the Commission

Amendment

(79) Criteria for priority access to the Union antigen, vaccine and diagnostic reagent banks' resources should be established in order to ensure their effective distribution in emergencies.

(79) Criteria for priority access to the Union antigen, vaccine and diagnostic reagent banks' resources should be established in order to ensure their effective distribution in emergencies. Similarly, for those Member States which have not set up national antigen, vaccine and diagnostic reagent banks or which find that stocks are limited in the Union banks, criteria for access to the resources of other Member States should be established.

Amendment    29

Proposal for a regulation

Recital 85 a (new)

Text proposed by the Commission

Amendment

 

(85a) According to Directive 2003/99/EC, Member States is to transmit a report to the Commission every year on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance. Similarly, as part of the control plans and control programme provided for in Regulation (EU) No. XX/201X on official controls and in Regulation (EC) No 2160/2003, Member States should take strategic measures to monitor, prevent and control other infectious animal diseases, including those not listed in the Annex to this Regulation. These measures should include a strategy for good animal husbandry and responsible use of veterinary medicines.

Amendment    30

Proposal for a regulation

Recital 86 a (new)

Text proposed by the Commission

Amendment

 

(86a) Disease control measures that become necessary in the event of a disease outbreak may adversely affect biodiversity and the conservation of farm animal genetic resources. In keeping with the Convention on Biological Diversity and the EU Biodiversity Strategy, the competent authority should take account of the impact on biodiversity and farm animal genetic resources when determining the application of disease control measures.

Amendment    31

Proposal for a regulation

Recital 87

Text proposed by the Commission

Amendment

(87) The occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals. Special rules should therefore be laid down for disease control and eradication measures in wild animals where needed.

(87) The occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals, or vice versa. Special rules should therefore be laid down for disease control and eradication measures in wild animals, or, where needed, in kept animals.

Amendment    32

Proposal for a regulation

Recital 88

Text proposed by the Commission

Amendment

(88) For listed diseases, which are not highly contagious, and which are subject to compulsory eradication, the disease control measures should be implemented to prevent the spread of those listed diseases, in particular to non-infected areas. However, those measures may be more limited or different comparing to those applicable for the most dangerous listed diseases. This Regulation should therefore provide for special rules for those diseases. Member States that have a voluntary eradication programme in place, should also implement such disease control measures. However, the level and intensity of disease control measures should be proportionate and take into account the characteristics of the listed disease in question, its distribution and its significance for the Member State concerned by it and the Union as a whole.

(88) For listed diseases, which are not highly contagious, and which are subject to compulsory eradication, the disease control measures should be implemented to prevent the spread of those listed diseases, in particular to non-infected areas. However, those measures may be more limited or different comparing to those applicable for the most dangerous listed diseases. This Regulation should therefore provide for special rules for those diseases. Member States that have a voluntary eradication programme in place, should also implement such disease control measures. However, the level and intensity of disease control measures should be proportionate and take into account the characteristics of the listed disease in question, its distribution and its significance for the Member State or region concerned by it and the Union as a whole.

Amendment    33

Proposal for a regulation

Recital 105

Text proposed by the Commission

Amendment

(105) For animals that are moved between Member States a set of basic animal health requirements apply. In particular, animals may not be moved from establishments with abnormal mortalities or signs of disease of unknown cause. However, mortalities, even if abnormal, which are linked to scientific procedures authorised under Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes and which are not of infectious origin related to listed diseases, should not be a reason to prevent the movements of animals intended for scientific purposes.

(105) For animals that are moved between Member States a set of basic animal health requirements apply. In particular, animals may not be moved from establishments with abnormal mortalities or signs of disease of unknown cause. However, mortalities, even if abnormal, which are linked to scientific procedures authorised under Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes and which are not of infectious origin related to listed diseases, should not be a reason to prevent the movements of animals intended for scientific purposes. Nonetheless, these mortalities should be registered by the competent authority.

Amendment    34

Proposal for a regulation

Recital 108

Text proposed by the Commission

Amendment

(108) As assembly operations for ungulates and poultry represent a particularly high disease risk, it is appropriate to lay down specific rules in this Regulation to protect the health of the animals involved and prevent the spread of transmissible animal diseases.

(108) As movements and assembly operations for ungulates and poultry represent a particularly high disease risk, it is appropriate to lay down specific rules in this Regulation to protect the health of the animals involved and prevent the spread of transmissible animal diseases.

Amendment    35

Proposal for a regulation

Recital 111

Text proposed by the Commission

Amendment

(111) For scientific purposes, such as research or diagnostic purposes, and in particular those authorised in accordance with Directive 2010/63/EU, it may be necessary to move animals which do not comply with the general animal health requirements laid down in this Regulation and represent a higher animal health risk. Those kinds of movements should not be prohibited or unduly restricted by the provisions of this Regulation, as this could impede otherwise authorised research activities and delay scientific progress. Nonetheless, it is essential that rules are laid down in this Regulation to ensure that movements of those animals take place in a safe manner.

(111) For scientific purposes, such as research or diagnostic purposes, and in particular those authorised in accordance with Directive 2010/63/EU, it may be necessary to move animals which do not comply with the general animal health requirements laid down in this Regulation and represent a higher animal health risk. Those kinds of movements should not be prohibited or unduly restricted by the provisions of this Regulation, as this could impede otherwise authorised research activities and delay scientific progress. Nonetheless, it is essential that rules are laid down in this Regulation to ensure that movements of those animals take place in a safe manner and are registered by the competent authority.

Amendment    36

Proposal for a regulation

Recital 121

Text proposed by the Commission

Amendment

(121) The specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals. Specific rules for such movements should therefore be laid down in this Regulation. In order to ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the detailed rules for movements of those animals. In order to ensure uniform conditions for the implementation of the animal health requirements laid down in this Regulation concerning the movements of pet animals, implementing powers should be conferred on the Commission to lay down rules concerning the disease prevention and control measures to be taken for such movements.

(121) The specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals. Such movements should therefore continue to be governed by the provisions already adopted. This will ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases. The power to adopt rules concerning the disease prevention and control measures to be taken for such movements should be conferred on the Commission in accordance with Article 290 TFEU, without prejudice to the provisions of Regulation (EU) No 576/2013.

Amendment    37

Proposal for a regulation

Recital 125

Text proposed by the Commission

Amendment

(125) When Member States take national measures concerning movements of animals and germinal products or decide to take national measures to limit the impact of transmissible animal diseases other than listed diseases within their territory, those national measures should not interfere with the rules on the internal market laid down in Union legislation. Therefore, it is appropriate to set the framework for such national measures and ensure that they remain within the limits permitted under Union law.

(125) When Member States take national measures concerning movements of animals and germinal products or decide to take national measures to limit the impact of transmissible animal diseases other than listed diseases within their territory, those national measures may only interfere with the rules on the internal market laid down in Union legislation when this is scientifically justified on the grounds of controlling infectious disease and is proportionate in relation to the risk. Therefore, it is appropriate to set the framework for such national measures and ensure that they remain within the limits permitted under Union law.

Amendment    38

Proposal for a regulation

Recital 154 – indent 19

Text proposed by the Commission

Amendment

– Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/9752 ,

deleted

__________________

 

52 OJ L 204, 11.08.2000, p. 1.

 

Amendment    39

Proposal for a regulation

Recital 154 – indent 24

Text proposed by the Commission

Amendment

– Regulation (EU) No XXX/XXXX of the European Parliament and of the Council of …. on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 [Publication office]57 ,

deleted

__________________

 

57 OJ L

 

Amendment    40

Proposal for a regulation

Recital 158

Text proposed by the Commission

Amendment

(158) In order to ensure legal certainty as regards the application of rules for identification and registration of animals, disease control measures for certain zoonoses and non-commercial movements of pet animals, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the date on which Regulations (EC) No 1760/2000, (EU) No XXX/XXX [Ex-998/2003] and (EC) No 21/2004 and Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC, 2005/94/EC and 2008/71/EC cease to apply.

(158) In order to ensure legal certainty as regards the application of rules for identification and registration of animals, and disease control measures for certain zoonoses, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the date on which Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC and 2005/94/EC cease to apply.

Amendment    41

Proposal for a regulation

Recital 160

Text proposed by the Commission

Amendment

(160) 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.

(160) It is of particular importance that the Commission carry out appropriate consultations with stakeholders 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.

Amendment    42

Proposal for a regulation

Article 1 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

This Regulation lays down rules for the prevention and control of animal diseases, which are transmissible to animals or to humans.

This Regulation lays down:

 

(a) rules for the prevention and control of animal diseases, which are transmissible to animals or to humans;

 

(b) instruments and mechanisms to facilitate progress towards the declaration of disease-free zones and territories;

 

(c) priority actions; and

 

(d) the division of responsibilities in the area of animal health.

Amendment    43

Proposal for a regulation

Article 1 – paragraph 2 – point a – point ii

Text proposed by the Commission

Amendment

(ii) the effective functioning of the internal market;

(ii) the effective functioning of the internal market, and food and feed safety;

Amendment    44

Proposal for a regulation

Article 1 – paragraph 2 – point a – point iii – introductory part

Text proposed by the Commission

Amendment

(iii) a reduction in the adverse effects on the environment of:

(iii) a reduction in the adverse effects on animal health, public health and the environment of:

Amendment    45

Proposal for a regulation

Article 1 – paragraph 2 – point a – point iii – indent 1

Text proposed by the Commission

Amendment

– certain diseases;

– certain diseases and risk factors leading up to diseases;

Amendment    46

Proposal for a regulation

Article 1 – paragraph 2 – point b – point i – indent 2 a (new)

Text proposed by the Commission

Amendment

 

- biodiversity;

Amendment    47

Proposal for a regulation

Article 1 – paragraph 2 – point b – point i – indent 4 a (new)

Text proposed by the Commission

Amendment

 

- antimicrobial resistance;

Amendment    48

Proposal for a regulation

Article 1 – paragraph 2 – point b – point i – indent 5 a (new)

Text proposed by the Commission

Amendment

 

- the need to protect and conserve rare animal breeds, and to preserve genetic diversity;

Amendment    49

Proposal for a regulation

Article 2 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) kept and wild animals;

(a) kept, non-kept and wild animals;

Amendment    50

Proposal for a regulation

Article 4 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘kept animals’ means animals which are kept by humans; in the case of aquatic animals, aquaculture animals;

(5) ‘kept animals’ means living animals which are kept by humans;

Amendment    51

Proposal for a regulation

Article 4 – paragraph 1 – point 5 a (new)

Text proposed by the Commission

Amendment

 

(5a) ‘non-kept animals of domesticated species’ means animals which are not, or are no longer, under human supervision;

Amendment    52

Proposal for a regulation

Article 4 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) 'aquaculture animals' means aquatic animals subject to aquaculture;

(7) ‘aquaculture animals’ means aquatic animals subject to techniques designed to increase production above the natural capacity of the environment in question;

 

Amendment    53

Proposal for a regulation

Article 4 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

(8) 'wild animals' means animals which are not kept animals;

(8) 'wild animals' means animals which are neither kept animals nor non-kept animals of domesticated species;

Amendment    54

Proposal for a regulation

Article 4 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) 'non-commercial movement' means any movement of pet animals which does not involve or aim, directly or indirectly, at a financial gain or a transfer of ownership;

(13) 'non-commercial movement' means movement for non-commercial purposes as defined in point (a) of Article 3 of Regulation (EU) No 576/2013;

Amendment    55

Proposal for a regulation

Article 4 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

(14) ‘disease’ means the occurrence of infections and infestations in animals, with or without clinical or pathological manifestations, caused by one or more disease agents transmissible to animals or to humans;

(14) ‘disease’ means the occurrence of infections and infestations in animals, with or without clinical or pathological manifestations, caused by one or more disease agents transmissible to animals or to humans; for the purposes of this Regulation, microorganisms that have developed resistance to antimicrobials shall also be considered a 'disease';

Amendment    56

Proposal for a regulation

Article 4 – paragraph 1 – point 20

Text proposed by the Commission

Amendment

(20) 'risk' means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse effect on animal or public health;

(20) 'risk' means the likelihood of the scientifically demonstrated or demonstrable occurrence and the likely magnitude of the biological and economic consequences of scientifically proven or provable adverse effect on animal or public health;

Amendment    57

Proposal for a regulation

Article 4 – paragraph 1 – point 21 – introductory part

Text proposed by the Commission

Amendment

(21) ‘biosecurity’ means the sum of management and physical measures designed to reduce the risk of the introduction, development and spread of diseases to, from and within:

(21) ‘biosecurity’ means the sum of management and physical measures designed to reduce the risk of the introduction, development and spread of diseases or microorganisms that have developed resistance to antimicrobials to, from and within:

Amendment    58

Proposal for a regulation

Article 4 – paragraph 1 – point 23

Text proposed by the Commission

Amendment

(23) 'animal professional' means a natural or legal person, with an occupational relationship with animals or products, other than operators or veterinarians;

does not concern the EN version

Amendment    59

Proposal for a regulation

Article 4 – paragraph 1 – point 37

Text proposed by the Commission

Amendment

(37) 'outbreak' means one or more cases in an establishment, household or other place where animals are kept or located;

(37) 'outbreak' means one or more cases in an establishment or other place where animals are kept or located;

Amendment    60

Proposal for a regulation

Article 4 – paragraph 1 – point 50 a (new)

Text proposed by the Commission

Amendment

 

(50a) 'processing establishment' means a food business approved in accordance with Article 4 of Regulation (EC) No 853/2004 for processing aquaculture animals for food purpose;

Amendment    61

Proposal for a regulation

Article 4 – paragraph 1 – point 50 b (new)

Text proposed by the Commission

Amendment

 

(50b) 'disease control aquatic food establishment' means a food business approved in accordance with Article 177 and with Title II of Part IV;

Amendment    62

Proposal for a regulation

Article 4 – paragraph 1 – point 51

Text proposed by the Commission

Amendment

(51) ‘disease control aquatic food establishment’ means a food business approved in accordance with the following provisions:

deleted

(a) Article 4 of Regulation (EC) No 853/2004, for processing aquaculture animals for food purposes;

 

(b) Article 177 of this Regulation for the slaughter of aquatic animals for disease control purposes in accordance with Title II of Part III.

 

Amendment    63

Proposal for a regulation

Article 4 – paragraph 1 – point 51 a (new)

Text proposed by the Commission

Amendment

 

(51a) "veterinarian" means a professional with a comprehensive scientific education, licensed by the legal authority, to carry out, in an independent, ethical and personally responsible capacity, all aspects of veterinary medicine, in the interest of the animals, the client and society;

Amendment    64

Proposal for a regulation

Article 4 – paragraph 1 – point 51 b (new)

Text proposed by the Commission

Amendment

 

(51b) "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 the provisions laid down in Regulation (EU) .../20.. on official controls.

Amendment    65

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) listed diseases;

(a) the diseases listed in Annex -I;

Amendment    66

Proposal for a regulation

Article 5– paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, establish a list of listed diseases, as referred to in paragraph 1(a).

2. A table of listed diseases, as referred to in point (a) of paragraph 1, is set out in Annex -I. The Commission shall be empowered to adopt delegated acts, taking due account of the opinions of the European Food Safety Authority, and after due public consultation with stakeholders and experts, in accordance with Article 253, concerning amendments to the listed diseases set out in this Annex to take account of technical and scientific progress, of the developments of relevant international standards and of the changed circumstances in public and animal health.

Amendment    67

Proposal for a regulation

Article 5 – paragraph 2 – subparagraph 2 – introductory part

Text proposed by the Commission

Amendment

That list shall comprise diseases which meet with the conditions laid down in the following points (a) and (b) of this paragraph, taking into account the criteria for listing diseases laid down in Article 6:

That table shall cover diseases which meet with the conditions laid down in the following points (a) and (b) of this paragraph, taking into account the evaluation of the criteria for listing diseases laid down in Article 6:

Amendment    68

Proposal for a regulation

Article 5 – paragraph 2 – subparagraph 2 – point a – point iii

Text proposed by the Commission

Amendment

iii) the society in Member States and where appropriate in third countries or territories;

iii) the society in Member States and regions, and, where appropriate, in third countries or territories;

Amendment    69

Proposal for a regulation

Article 5 – paragraph 2 – subparagraph 2 – point a – point iv a (new)

Text proposed by the Commission

Amendment

 

(iva) animal welfare and animal health;

Amendment    70

Proposal for a regulation

Article 5 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

deleted

Amendment    71

Proposal for a regulation

Article 5 – paragraph 2 – subparagraph 4

Text proposed by the Commission

Amendment

On duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 255(3).

Where in the case of a disease representing an emerging risk of highly significant impact, imperative grounds of urgency so require, the procedure provided for in Article 254 shall apply to delegated acts adopted pursuant to this Article.

Amendment    72

Proposal for a regulation

Article 6 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall take account of the following criteria in determining whether a disease meets the conditions to be listed in accordance with Article 5(2):

1. When modifying the list of diseases in accordance with Article 5(2), the Commission shall take account of the following criteria in determining whether a disease meets the conditions to be listed:

Amendment    73

Proposal for a regulation

Article 6 – paragraph 1 – point a – point iv

Text proposed by the Commission

Amendment

(iv) the capacity to develop resistance to treatments;

(iv) the capacity of pathogens to develop resistance to treatments with a focus on antimicrobial resistance;

Amendment    74

Proposal for a regulation

Article 6 – paragraph 1 – point e – point iii

Text proposed by the Commission

Amendment

(iii) the welfare of affected subpopulations of kept and wild animals;

(iii) the welfare of affected subpopulations of kept animals, non-kept animals of domesticated species and the health of wild animals;

Amendment    75

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning amendments to the criteria provided for in paragraph 1 of this Article to take account of technical and scientific progress and the developments of relevant international standards.

2. The Commission shall be empowered, after due public consultation with stakeholders and experts, to adopt delegated acts in accordance with Article 253 concerning amendments to the criteria provided for in paragraph 1 of this Article to take account of technical and scientific progress and the developments of relevant international standards.

Amendment    76

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. The disease specific rules for listed diseases provided for in this Regulation and the rules adopted pursuant to this Regulation shall apply to listed species.

1. The disease specific rules for listed diseases and the rules adopted pursuant to this Regulation shall apply to the species listed in Annex - I.

Amendment    77

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, establish a list of species, as referred to in paragraph 1.

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning amendments to the list of species, as referred to in paragraph 1 and set out in a table in Annex -I, to take account of technical progress, scientific developments and changed circumstances in public and animal health, after due public consultation with stakeholders and experts and taking due account of the opinions of the European Food Safety Authority.

Amendment    78

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

That list shall comprise those animal species or groups of animal species, which pose a considerable risk for the spread of specific listed diseases, taking into account the following criteria:

That list shall cover those animal species or groups of animal species, which pose a considerable risk for the spread of specific listed diseases, taking into account the following criteria:

Amendment    79

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 2 – point ca (new)

Text proposed by the Commission

Amendment

 

ca) the use of those animals for breeding, production or slaughter.

Amendment    80

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

deleted

Amendment    81

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 4

Text proposed by the Commission

Amendment

On duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 255(3).

Where in the case of a disease representing an emerging risk of highly significant impact, imperative grounds of urgency so require, the procedure provided for in Article 254 shall apply to delegated acts adopted pursuant to this Article.

Amendment    82

Proposal for a regulation

Article 8 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall, by means of implementing acts, determine the application of the disease prevention and control rules referred to in the following points to listed diseases:

1. The Commission shall be empowered to adopt delegated acts in accordance with Article 253, with due regard to the opinions of the European Food Safety Authority and after due public consultation with stakeholders and experts, modifying Annex -I and concerning the application of the disease prevention and control rules referred to in the following points to listed diseases:

Amendment    83

Proposal for a regulation

Article 8 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) listed diseases subject to rules on:

(a) listed diseases for which immediate eradication measures must be taken as soon as they are detected, subject to rules on:

Amendment    84

Proposal for a regulation

Article 8 – paragraph 1 – point b – introductory part

Text proposed by the Commission

Amendment

(b) listed diseases subject to the disease prevention and control rules on:

(b) listed diseases which should be controlled in all Member States with the long-term goal of eradicating them throughout the Union, subject to the disease prevention and control rules on:

Amendment    85

Proposal for a regulation

Article 8 – paragraph 1 – point c – introductory part

Text proposed by the Commission

Amendment

(c) listed diseases subject to the disease prevention and control rules on:

(c) listed diseases that are of relevance for certain Member States, and for which measures are needed to prevent them spreading to parts of the Union that are officially disease-free or have eradication programmes, subject to the disease prevention and control rules on:

Amendment    86

Proposal for a regulation

Article 8 – paragraph 1 – point d – introductory part

Text proposed by the Commission

Amendment

(d) listed diseases subject to the disease prevention and control rules on:

(d) listed diseases that are subject to the provisions of points (a), (b) and (c) above, and other diseases for which measures are needed to prevent them spreading on account of their introduction into the Union or movements between Member States, subject to the disease prevention and control rules on:

Amendment    87

Proposal for a regulation

Article 8 – paragraph 1 – point e – introductory part

Text proposed by the Commission

Amendment

(e) listed diseases subject to the disease prevention and control rules on:

(e) listed diseases that are subject to the provisions of points (a) and (b) above, and other diseases for which there is a need for monitoring within the Union, subject to the disease prevention and control rules on:

Amendment    88

Proposal for a regulation

Article 8 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

deleted

Amendment    89

Proposal for a regulation

Article 8 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

On duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 255(3).

Where, in the case of a disease representing an emerging risk of highly significant impact, imperative grounds of urgency so require, the procedure provided for in Article 254 shall apply to delegated acts adopted pursuant to this Article.

Amendment    90

Proposal for a regulation

Article 8 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. The Commission shall take into account the following criteria when adopting implementing acts provided for in paragraph 1:

2. The Commission shall take into account the following criteria when adopting delegated acts provided for in paragraph 1:

Amendment    91

Proposal for a regulation

Article 8 – paragraph 2 – point c

Text proposed by the Commission

Amendment

c) the availability, feasibility and effectiveness of the different sets of disease prevention and control measures provided for in this Regulation with respect to the disease.

c) the availability, feasibility and effectiveness of the different sets of disease prevention and control measures provided for in this Regulation with respect to the disease, paying strict attention to the prevailing regional conditions.

Amendment    92

Proposal for a regulation

Article 9 – paragraph 1 – point b – introductory part

Text proposed by the Commission

Amendment

(b) take appropriate biosecurity measures, taking into account the risks involved, to ensure the health of those kept animals and products and to prevent the introduction into, development and multiplication within and spread between and from such kept animals and products under their responsibility of diseases, except where that is specifically authorised for scientific purposes, as appropriate for:

(b) take appropriate biosecurity measures, assisted by professional guides to good practice, especially applying good microbiological practice, taking into account the risks involved, to ensure the health of those kept animals and products and to prevent the introduction into, development and multiplication within and spread between and from such kept animals and products under their responsibility of diseases, except where that is specifically authorised for scientific purposes, as appropriate for:

Amendment    93

Proposal for a regulation

Article 9 – paragraph 1 – point ba (new)

Text proposed by the Commission

Amendment

 

(ba) observe the principle of good animal husbandry;

Amendment    94

Proposal for a regulation

Article 9 – paragraph 1 – point bb (new)

Text proposed by the Commission

Amendment

 

(bb) ensure controlled use of veterinary medicines.

Amendment    95

Proposal for a regulation

Article 10 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Operators and animal professionals shall acquire knowledge of:

1. Operators, animal professionals and pet keepers shall acquire knowledge of:

Amendment    96

Proposal for a regulation

Article 10 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) biosecurity principles;

(b) biosecurity principles, good animal husbandry and responsible use of veterinary medicines,

Amendment    97

Proposal for a regulation

Article 10 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The knowledge provided for in paragraph 1 shall be acquired in one of the following ways:

3. The knowledge provided for in paragraph 1 shall be acquired through professional experience or training in accordance with the requirements laid down in the respective Member State. Such training can also be provided by professional organisations.

(a) professional experience or training;

 

(b) existing programmes in agricultural or aquaculture sectors that are relevant for animal health;

 

(c) formal education.

 

Amendment    98

Proposal for a regulation

Article 11 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa) advise operators about measures to minimise the risk of zoonotic diseases, food borne pathogens, residues, contaminants in order to ensure safe food;

Amendment    99

Proposal for a regulation

Article 11 – paragraph 1 – point c – point i

Text proposed by the Commission

Amendment

(i) raising animal health awareness;

(i) raising animal health and animal welfare awareness;

Amendment    100

Proposal for a regulation

Article 11 – paragraph 1 – point c – point iii a (new)

Text proposed by the Commission

Amendment

 

(iiia) continuous education on disease prevention, and the early detection and control of diseases;

Amendment    101

Proposal for a regulation

Article 11 – paragraph 1 – point c – point iii b (new)

Text proposed by the Commission

Amendment

 

(iiib) raising awareness on antimicrobial resistance and implications that might follow;

Amendment    102

Proposal for a regulation

Article 11 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(da) advise operators and animal professionals on the basis of the latest knowledge available on matters concerning protection against biological hazards and other animal health aspects that are of importance to the type of establishment and the categories and species of animals kept there.

Amendment    103

Proposal for a regulation

Article 11 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Bee health professionals may undertake activities attributed to veterinarians under this Regulation in relation to bees and bumble bees provided that they are authorised to do so under national legislation. In that event, paragraph 1 shall apply to those bee health professionals.

Amendment    104

Proposal for a regulation

Article 11 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the qualifications of veterinarians and aquatic animal health professionals undertaking activities which fall within the scope of this Regulation.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the qualifications of veterinarians, in accordance with Directive 2005/36/EC and aquatic animal health professionals undertaking activities which fall within the scope of this Regulation.

Amendment    105

Proposal for a regulation

Article 12 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall support operators and animal professionals in acquiring, maintaining and developing the basic knowledge of animal health provided for in Article 10 through relevant programmes in agricultural or aquaculture sectors or formal education.

2. Member States shall support operators and animal professionals in acquiring, maintaining and developing the basic knowledge of animal health provided for in Article 10 through relevant programmes in agricultural or aquaculture sectors or formal education, and ensure that the necessary level of knowledge is attained.

Amendment    106

Proposal for a regulation

Article 12 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Member States shall establish the conditions under which the acquisition, maintenance and development of the basic knowledge of animal health under Article 10 by operators, animal professionals and pet owners can be ensured .

Amendment    107

Proposal for a regulation

Article 12 a (new)

Text proposed by the Commission

Amendment

 

Article 12a

 

Strategic measures for non-listed diseases

 

Member States shall take strategic measures for the monitoring, prevention and control of infectious animal diseases, including those not listed in the Annex to this Regulation, also with the aim of reducing the risk of development of antimicrobial resistance. These measures shall be adopted as part of the national control plans and control programme provided for in Article X of Regulation (EC) XX/201X on the official control of animal health or Article 5 of Regulation (EC) No 2160/2003 on the control of salmonella and other specified food-borne zoonotic agents.

Amendment    108

Proposal for a regulation

Article 12 b (new)

Text proposed by the Commission

Amendment

 

Article 12b

 

Border controls

 

Member States shall, with technical assistance at Union level as regards animal diseases listed in Annex -I to this Regulation, ensure that appropriate preventive, risk-based biosecurity measures are applied along their external borders, in cooperation with the competent authorities of the third countries concerned.

Amendment    109

Proposal for a regulation

Article 13 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The competent authority may delegate one or more of the following activities to veterinarians:

1. The competent authority may delegate one or more of the following activities to veterinarians or to qualified professional organisations:

Amendment    110

Proposal for a regulation

Article 13 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1 a. The competent authority may delegate one or more of the activities laid down in paragraph 1 to bee health professionals.

Amendment    111

Proposal for a regulation

Article 13 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the circumstances and conditions for delegating the activities provided for in paragraph 1;

(a) the circumstances and conditions for delegating the activities provided for in paragraph 1 and paragraph 1a;

Amendment    112

Proposal for a regulation

Article 13 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) minimum requirements for the training of veterinarians provided for in Article 12(1)(c).

(c) minimum requirements for the training of veterinarians provided for in Article 12(1)(c), in accordance with Directive 2005/36/EC.

Amendment    113

Proposal for a regulation

Article 14

Text proposed by the Commission

Amendment

Where there are reasonable grounds to suspect that animals or products may present a risk, the competent authority shall take appropriate steps to inform the general public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk, taking into account the nature, seriousness and extent of that risk and the public interest in being informed.

Where measures are required with respect to the probable outbreak of a disease, the competent authority shall take appropriate steps to inform the general public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk, the need to avoid spreading panic unnecessarily and extent of that risk and the public interest in being informed.

Amendment    114

Proposal for a regulation

Article 14 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

The competent authority shall adopt all the necessary measures to inform citizens on the basic principles in the field of preventing the outbreak and spread of animal diseases, with a particular focus on the risk of persons travelling outside the Union bringing disease agents into the Union.

Amendment    115

Proposal for a regulation

Article 16 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Natural and legal persons shall immediately notify:

1. Operators, animal professionals and pet keepers shall immediately notify:

Amendment    116

Proposal for a regulation

Article 16 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the competent authority in the event of an outbreak or suspicion of an outbreak of a listed disease referred to in Article 8(1)(e);

deleted

Amendment    117

Proposal for a regulation

Article 16 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a veterinarian of abnormal mortalities and other serious disease signs or significant decreased production rates with an undetermined cause in animals for further investigation, including sampling for laboratory examination when the situation so warrants.

(b) a veterinarian or aquatic animal health professional of abnormal mortalities and other serious transmissible disease signs or significant decreased production rates with an undetermined cause in animals for further investigation, including sampling for laboratory examination when the situation so warrants.

Amendment    118

Proposal for a regulation

Article 16 – paragraph 1a (new)

Text proposed by the Commission

Amendment

 

1a. Veterinarians or aquatic animal health professionals shall immediately notify the competent authority in the event of an outbreak or suspicion of an outbreak of a listed disease referred to in point (e) of Article 8(1).

Amendment    119

Proposal for a regulation

Article 16 – paragraph 1b (new)

Text proposed by the Commission

Amendment

 

1b. Doctors shall immediately inform the competent authority of any sign of a zoonotic disease.

Amendment    120

Proposal for a regulation

Article 17 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall by means of implementing acts establish which of the listed diseases referred to in in Article 8(1)(e) shall be subject to immediate notification by the Member States in accordance with paragraph 1 of this Article.

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 to establish which of the listed diseases referred to in in Article 8(1)(e) shall be subject to immediate notification by the Member States in accordance with paragraph 1 of this Article.

Amendment    121

Proposal for a regulation

Article 17 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

deleted

Amendment    122

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning amending and supplementing the requirements of paragraph 2 of this Article and reporting on other matters where necessary to ensure an efficient application of the disease prevention and control rules of this Regulation.

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning supplementing the requirements of paragraph 2 of this Article and reporting on other matters where necessary to ensure an efficient application of the disease prevention and control rules of this Regulation.

Amendment    123

Proposal for a regulation

Article 22 – point a

Text proposed by the Commission

Amendment

(a) observe the health and behaviour of animals under their responsibility;

(a) observe the health and welfare of animals under their responsibility;

Amendment    124

Proposal for a regulation

Article 22 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa) observe any changes in animal products under their responsibility, that may give rise to a suspicion of being caused by a listed disease or emerging disease;

Amendment    125

Proposal for a regulation

Article 22 – point c

Text proposed by the Commission

Amendment

(c) look for abnormal mortalities and other serious disease signs in animals under their responsibility.

(c) look for abnormal mortalities and other signs of serious transmissible disease in animals under their responsibility.

Amendment    126

Proposal for a regulation

Article 22 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) agree to animal health visits from a veterinarian for the purpose of preventing the occurence of listed diseases and emerging diseases, in accordance with the criteria laid down in Article 23; such visits shall also serve as a means of providing advice to the operator on biosecurity matters.

Amendment    127

Proposal for a regulation

Article 22 – paragraph 1a (new)

Text proposed by the Commission

Amendment

 

Operators may take part in any existing voluntary collective steps to monitor animal diseases.

Amendment    128

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian when appropriate due to the risks posed by the establishment, taking into account:

1. Operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian or other qualified professionals as appropriate due to the risks posed by the establishment, taking into account:

Amendment    129

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) the epidemiological situation in the zone or region;

Amendment    130

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Those animal health visits shall be at frequencies that are proportionate to the risks posed by the establishment.

Those animal health visits shall be at frequencies that ensure a satisfactory prevention of animal diseases and are proportionate to the risks posed by the establishment. The competent authority shall lay down detailed rules as regards the content and frequency of animal health visits for the different types of risk posed by the different types of estalishments.

Amendment    131

Proposal for a regulation

Article 23 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the detection of any signs indicative of the occurrence of listed diseases or emerging diseases;

(a) the information on signs indicative of the occurrence of listed diseases or emerging diseases;

Amendment    132

Proposal for a regulation

Article 23 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) providing information to the competent authority to complement the surveillance provided for in Article 25.

Amendment    133

Proposal for a regulation

Article 24

Text proposed by the Commission

Amendment

Article 24

deleted

Delegation of powers concerning animal health visits

 

The Commission shall be empowered to adopt delegated acts in accordance with Article 253, concerning:

 

(a) supplementing:

 

(i) the criteria laid down in Article 23(1) to be taken into account when determining:

 

- which type of establishments must be subject to animal health visits;

 

 

- the frequency of such animal health visits;

 

 

(ii) the requirements laid down in Article 23(2) as regards the content and frequency of animal health visits for the different types of establishments, to ensure that the purposes of the animal health visits are achieved;

 

(b) determining the types of establishments to be subject to animal health visits.

 

Amendment    134

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

2. The surveillance shall be designed to ensure the timely detection of the presence of the listed diseases referred to in Article 8(1)(e) and emerging diseases by collecting, collating and analysing relevant information relating to the disease situation.

2. The surveillance shall be designed to ensure the timely detection of the presence of the listed diseases referred to in Article 8(1)(e) and emerging diseases by collecting, collating and analysing relevant information relating to the disease situation. This surveillance shall complement and be based on the surveillance carried out by operators both on an individual basis and in the framework of collective voluntary programmes.

Amendment    135

Proposal for a regulation

Article 27 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) The historical experience with diseases in the Member State, zone or compartment

Amendment    136

Proposal for a regulation

Article 28 – paragraph 1 – point ba (new)

Text proposed by the Commission

Amendment

 

(ba) establishing which of the listed diseases referred to in point (e) of Article 8(1) are to be subject to surveillance programmes;

Amendment    137

Proposal for a regulation

Article 29 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) establishing which of the listed diseases referred to in Article 8(1)(e) are to be subject to surveillance programmes;

deleted

Amendment    138

Proposal for a regulation

Article 29 – paragraph 1 – point b – point i

Text proposed by the Commission

Amendment

i) the submission of surveillance programmes for information to the Commission and other Member States;

i) the submission of surveillance programmes to the Commission and other Member States;

Amendment    139

Proposal for a regulation

Article 29 – paragraph 1 – point b – point ii a (new)

Text proposed by the Commission

Amendment

 

(iia) the programme evaluation tools used by the Commission and the Member States.

Amendment    140

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States which are not free or not known to be free from one or more of the listed diseases referred to in Article 8(1)(c) and which decide to establish a programme for the eradication of that listed disease to be carried out in the animal populations concerned by it and covering the relevant parts of their territory or zones or compartments thereof ("voluntary eradication programme") shall submit it to the Commission for approval

2. Member States which are not free or not known to be free from one or more of the listed diseases referred to in Article 8(1)(c) and which decide to establish a programme for the eradication of that listed disease to be carried out in the animal populations concerned by it and covering the relevant parts of their territory or zones or compartments thereof ("voluntary eradication programme") shall submit it to the Commission for approval where:

 

(a) the Member State asks the recognition of animal health guarantees within the Union as regards movements of animals or products for that disease; or

 

(b) the voluntary eradication programme is a candidate for a Union financial contribution.

Amendment    141

Proposal for a regulation

Article 30 – paragraph 3 – subparagraph 4

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, amend or terminate where necessary eradication programmes approved in accordance with points (a) and (b). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

The Commission may, by means of implementing acts, require the Member States to amend or terminate where necessary eradication programmes approved in accordance with points (a) and (b). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

Amendment    142

Proposal for a regulation

Article 32 – point f a (new)

Text proposed by the Commission

Amendment

 

(fa) a precise indication of the various public authorities and/or private parties variously involved in the programmes, as well as clear information regarding their respective roles and responsibilities in the implementation thereof.

Amendment    143

Proposal for a regulation

Article 35 – title

Text proposed by the Commission

Amendment

Implementing powers

Implementing powers and delegation of powers concerning performance indicators

Amendment    144

Proposal for a regulation

Article 35 – point b

Text proposed by the Commission

Amendment

(b) performance indicators;

deleted

Amendment    145

Proposal for a regulation

Article 35 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2 a. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the establishment of indicators measuring the performance of compulsory or voluntary eradication programmes provided for in Articles 30, 31 and 32.

Amendment    146

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a Member State has reason to suspect that any of the conditions for maintaining its status as a disease-free Member State, or zone or compartment thereof have been breached, it shall immediately:

1. Where a Member State has reason to suspect, or is alerted by a notification from the Commission, that any of the conditions for maintaining its status as a disease-free Member State, or zone or compartment thereof have been breached, it shall immediately:

Amendment    147

Proposal for a regulation

Article 42 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) suspend movements of the listed species, for the listed disease for which it was approved or recognised for disease-free status, to other Member States, zones or compartments with a higher health status for that listed disease;

(a) take the appropriate measures based on the risk that animal movements may constitute for the disease in question;

Amendment    148

Proposal for a regulation

Article 42 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, withdraw the approval of the disease-free status of a Member State or zone granted in accordance with Article 36(3) or the recognition of the disease-free status of a compartment granted in accordance with Article 37(4) after obtaining the information from the Member State referred to in paragraph 3 of this Article that the conditions for maintaining the disease-free status are no longer met.

The Commission shall, by means of implementing acts, then immediately withdraw the approval of the disease-free status of a Member State or zone granted in accordance with Article 36(3) or the recognition of the disease-free status of a compartment granted in accordance with Article 37(4).

Amendment    149

Proposal for a regulation

Article 42 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the rules for the suspension, withdrawal and restoration of disease-free status provided for in paragraphs 1 and 2 of this Article.

5. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the measures to be taken and the investigations to be carried out by the Member State concerned as provided for in paragraphs 1 and 2 of this Article.

Amendment    150

Proposal for a regulation

Part 2 – chapter IV a (new) – title

Text proposed by the Commission

Amendment

 

CHAPTER IV a. OFFICIAL ANIMAL HEALTH LABORATORIES

Amendment    151

Proposal for a regulation

Article 42 a (new)

Text proposed by the Commission

Amendment

 

Article 42a

 

European network of official animal health laboratories

 

1. The European network of laboratories shall consist of Union reference laboratories, national reference laboratories and official animal health laboratories.

 

2. European network laboratories shall, in fulfilling their tasks and responsibilities, cooperate to ensure that the surveillance of animal diseases and control and eradication programmes provided for in this Regulation are based on state-of-the-art scientific standards and sound and reliable diagnosis.

Amendment    152

Proposal for a regulation

Article 42 b (new)

Text proposed by the Commission

Amendment

 

Article 42b

 

Union reference laboratories

 

1. The Commission shall designate Union reference laboratories for illnesses for which, owing to their impact on health or the economy, this is necessary to achieve the objectives of this Regulation.

 

2. That designation shall take the form of a public selection process that is reviewed regularly.

 

3. Union reference laboratories shall:

 

(a) operate in accordance with the standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’ and be assessed and accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008;

 

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

 

(c) have suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate;

 

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

 

(e) ensure that their staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work;

 

(f) be equipped to perform their tasks in emergency situations;

 

(g) where relevant, be equipped to comply with the biosecurity standards relating to their work and take into account the latest developments in research at national, Union and international level; be equipped to perform their tasks in emergency situations; where relevant, be equipped to comply with relevant biosecurity standards.

 

4. The Commission shall be responsible, by means of implementing acts, for establishing the specific tasks and responsibilities of the Union reference laboratories and, where necessary, the minimum requirements in terms of the facilities, equipment and personnel needed.

Amendment    153

Proposal for a regulation

Article 42 c (new)

Text proposed by the Commission

Amendment

 

Article 42c

 

National reference laboratories

 

1. Member States shall designate one or more national reference laboratories for each Union reference laboratory designated in accordance with Article 42b(1).

 

2. The national reference laboratories must meet the requirements of Article42b (2).

 

3. The Commission shall be responsible, by means of implementing acts, for establishing the specific tasks and responsibilities of the national reference laboratories and, where necessary, the minimum requirements in terms of the facilities, equipment and personnel needed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2).

Amendment    154

Proposal for a regulation

Article 42 d (new)

Text proposed by the Commission

Amendment

 

Article 42d

 

General coordination of the laboratories

 

1. The Union reference laboratories and the national reference laboratories shall, within the limits of their competencies:

 

i. ensure that the official animal health laboratories provided for in Article 42e receive updated information on the available methods.

 

ii. organise comparative tests between laboratories and insist on their active participation;

 

iii. identify and satisfy the training needs of the laboratories’ personnel.

 

iv. assess the quality and the suitability of the reagents and kits used in laboratory diagnoses, and produce and distribute reference materials.

 

2. The Union reference laboratories and the national reference laboratories shall be responsible for the general coordination of the network of animal health laboratories which come under their territorial jurisdiction.

Amendment    155

Proposal for a regulation

Article 42 e (new)

Text proposed by the Commission

Amendment

 

Article 42e

 

Official animal health laboratories

 

1. The competent authorities shall designate official laboratories to conduct laboratory analyses and diagnoses of animal diseases.

 

2. The competent authorities may only designate as an official laboratory a laboratory which:

 

(a) has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples;

 

(b) has a sufficient number of suitably qualified, trained and experienced staff;

 

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

 

(d) can deliver the results of the analysis, test or diagnosis in a timely manner;

 

(e) has a quality assurance system in place to ensure sound and reliable results from the methods used for laboratory analysis and diagnosis.

 

3. The official animal health laboratories shall work with the national reference laboratories of the Member States to ensure that their tasks and responsibilities are pursued in accordance with state-of-the-art scientific and quality standards.

Amendment    156

Proposal for a regulation

Article 43 – paragraph 2 – point c – point v

Text proposed by the Commission

Amendment

(v) emergency funds;

(v) budget resources and, where necessary, the establishment of special funds;

Amendment    157

Proposal for a regulation

Article 43 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2 a. The Member States shall consult relevant stakeholders when drawing up and updating contingency plans.

Amendment    158

Proposal for a regulation

Article 44 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) new knowledge of and developments in disease control tools.

(c) new knowledge of and developments on the listed diseases and in disease control tools.

Amendment    159

Proposal for a regulation

Article 46 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Member States may take measures concerning the use of veterinary medicinal products for listed diseases, to ensure the most efficient disease prevention or control for those diseases, provided that such measures comply with the rules on the use of veterinary medicinal products laid down in delegated acts adopted pursuant to Article 47.

The Member States shall take measures concerning the responsible use of veterinary medicinal products for infectious diseases, to ensure the most efficient disease prevention or control for those diseases, provided that such measures comply with the rules on the use of veterinary medicinal products laid down in delegated acts adopted pursuant to Article 47.

Amendment    160

Proposal for a regulation

Article 46 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Member States shall take the following criteria into consideration when determining whether or not to use and how to use veterinary medicinal products as disease prevention and control measures for a specific listed disease:

2. Member States shall take the following criteria into consideration when determining whether or not to use and how to use veterinary medicinal products as disease prevention and control measures for a specific disease:

Amendment    161

Proposal for a regulation

Article 46 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) the availability, effectiveness and risks of the veterinary medicinal products;

(c) the availability, effectiveness and risks of the veterinary medicinal products, as well as the detrimental effects of antimicrobial resistance;

Amendment    162

Proposal for a regulation

Article 46 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3 a. With the view to reduce antimicrobial resistance and in accordance with action No. 5 of the Communication from the Commission to the European Parliament and the Council – Action plan against the rising threats from Antimicrobial Resistance, Member States shall within two years after the entry into force of this Regulation, at the latest, report to the Commission on the usage of veterinary medicinal products containing antibiotics in their territory. The Union shall thereafter proceed to establish appropriate reduction targets, within three years after the entry into force of this Regulation, at the latest.

Amendment    163

Proposal for a regulation

Article 47 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) specific conditions for the use veterinary medicinal products for a specific listed disease;

(b) specific conditions for the use veterinary medicinal products for a specific disease;

Amendment    164

Proposal for a regulation

Article 47 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) risk mitigating measures to prevent the spread of listed diseases through animals treated with the veterinary medicinal products or products from such animals;

(d) risk mitigating measures to prevent the spread of diseases through animals treated with the veterinary medicinal products or products from such animals;

Amendment    165

Proposal for a regulation

Article 47 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) surveillance following the use of vaccines and other veterinary medicinal products for specific listed diseases.

(e) surveillance following the use of vaccines and other veterinary medicinal products for specific diseases.

Amendment    166

Proposal for a regulation

Article 47 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

 

(e a) provisions specifying the purpose to which animals which have undergone emergency vaccination may be put.

Amendment    167

Proposal for a regulation

Article 48 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1 a. The Commission shall ensure a fast track development and registration process for newly emerging disease agents and/or import appropriately registered animal health products.

Amendment    168

Proposal for a regulation

Article 55 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) place the establishment, household, food and feed business or animal by-products establishment, or any other location where the disease suspicion occurs under official surveillance;

(a) place the establishment, food and feed business, transport business, livestock trading business or animal by-products establishment, or any other location where the disease suspicion occurs, under official surveillance;

Amendment    169

Proposal for a regulation

Article 55 – paragraph 1 – point b – point i

Text proposed by the Commission

Amendment

(i) the kept animals in the establishment, household, food and feed business or animal by-products establishment, or any other location;

(i) the kept animals in the establishment, food and feed business, transport business, livestock trading business or animal by-products establishment, or any other location;

Amendment    170

Proposal for a regulation

Article 55 – paragraph 1 – point b – point ii

Text proposed by the Commission

Amendment

(ii) the products in the establishment, household, food and feed business or animal by-products establishment, or any other location, where relevant for the spread of that listed disease;

(ii) the products in the establishment, food and feed business, transport business, livestock trading business or animal by-products establishment, or any other location, where relevant for the spread of that listed disease;

Amendment    171

Proposal for a regulation

Article 55 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) apply appropriate biosecurity measures to prevent the spreading of that listed disease agent to other animals or to humans;

(c) ensure that appropriate biosecurity measures are applied to prevent the spreading of that listed disease agent to other animals or to humans;

Amendment    172

Proposal for a regulation

Article 55 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) restrict the movements of kept animals, products and, if appropriate, people, vehicles and any material or other means by which the disease agent could have spread to or from the establishment, households, food and feed business establishments, animal by-products establishments or any other location where that listed disease is suspected, as far as necessary to prevent its spread of the listed disease;

(e) restrict the movements of kept animals, products and, if appropriate, people, vehicles and any material or other means by which the disease agent could have spread to or from the establishment, food and feed business establishments, transport businesses, livestock trading businesses, animal by-products establishments or any other location where that listed disease is suspected, as far as necessary to prevent its spread of the listed disease;

Amendment    173

Proposal for a regulation

Article 55 – paragraph 1 – point f – introductory part

Text proposed by the Commission

Amendment

(f) take any other necessary disease control measures, taking into account the disease control measures provided for in Section 4, concerning:

(f) take any other necessary disease control measures, taking into account the disease control measures provided for in Section 4, and ensure that any control measures spare the affected animals avoidable pain and suffering, concerning:

Amendment    174

Proposal for a regulation

Article 55 – paragraph 1 – point f – point i

Text proposed by the Commission

Amendment

(i) the application of the investigation by the competent authority provided for in Article 54(1) and disease control measures provided for in points (a) to (d) of this paragraph to other establishments, epidemiological units therein, households, food and feed businesses or animal by-products establishments;

(i) the application of the investigation by the competent authority provided for in Article 54(1) and disease control measures provided for in points (a) to (d) of this paragraph to other establishments, epidemiological units therein, food and feed businesses, transport businesses, livestock trading businesses or animal by-products establishments;

Amendment    175

Proposal for a regulation

Article 57 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) identifying contact establishments and epidemiological units therein, households, food and feed business or animal by-products establishment or any other locations where animals of listed species for the suspected listed disease may have become infected, infested or contaminated;

(c) identifying contact establishments and epidemiological units therein, food and feed business, transport business, livestock trading business or animal by-products establishment or any other locations where animals of listed species for the suspected listed disease may have become infected, infested or contaminated;

Amendment    176

Proposal for a regulation

Article 59 – title

Text proposed by the Commission

Amendment

Lifting of preliminary disease control measures where the presence of the listed disease has been ruled out

Lifting of preliminary disease control measures where the presence of the listed disease or an emerging disease has been ruled out

Amendment    177

Proposal for a regulation

Article 59

Text proposed by the Commission

Amendment

The competent authority shall continue to apply the preliminary disease control measures provided for in Article 55(1) and Article 56, until the presence of the listed diseases referred to in Article 8(1)(a) has been ruled out based on the information referred to in Article 58(1) or rules adopted pursuant to Article 58(2).

The competent authority shall continue to apply the preliminary disease control measures provided for in Article 55(1) and Article 56, until the presence of the listed diseases referred to in Article 8(1)(a) or an emerging disease has been ruled out based on the information referred to in Article 58(1) or rules adopted pursuant to Article 58(2).

Amendment    178

Proposal for a regulation

Article 60 – point a

Text proposed by the Commission

Amendment

(a) declare the affected establishment, household, food or feed business, animal by-products establishment or other location as officially infected with that listed disease;

(a) declare the affected establishment, food or feed business, transport business, livestock trading business, animal by-products establishment or other location as officially infected with that listed disease;

Amendment    179

Proposal for a regulation

Article 61 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. In the event of an outbreak of a listed disease referred to in Article 8(1)(a) in kept animals in an establishment, household, food or feed business, animal by-products establishment or any other location, the competent authority shall immediately take one or more of the following disease control measures in order to prevent the further spread of that listed disease:

1. In the event of an outbreak of a listed disease referred to in Article 8(1)(a) in kept animals in an establishment, food or feed business, transport business, livestock trading business, animal by-products establishment or any other location, the competent authority shall immediately take one or more of the following disease control measures in order to prevent the further spread of that listed disease:

Amendment    180

Proposal for a regulation

Article 61 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the killing and disposal or slaughtering of animals that may be contaminated and contribute to the spread of the listed disease;

(b) the humane killing and disposal or slaughtering of animals that may be contaminated and contribute to the spread of the listed disease, provided that this is done in such a way as to spare the animals any avoidable pain, distress or suffering;

Amendment    181

Proposal for a regulation

Article 61 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the vaccination or treatment with other veterinary medicinal products of kept animals in accordance with Article 46(1) and any delegated acts adopted pursuant to Article 47(1);

(d) the vaccination or treatment with other veterinary medicinal products of kept animals in accordance with Article 46(1) and any delegated acts adopted pursuant to Article 47(1), preferably vaccination which involves animals remaining alive and has no adverse impact on trade within the Union and with third countries;

Amendment    182

Proposal for a regulation

Article 61 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) the cleaning, disinfection, disinfestation or other necessary biosecurity measures to be applied to the affected establishment, household, food or feed business, animal by-products establishment or other locations to minimise the risk of spread of the listed disease;

(f) the cleaning, disinfection, disinfestation or other necessary biosecurity measures to be applied to the affected establishment, food or feed business, transport business, livestock trading business, animal by-products establishment or other locations to minimise the risk of spread of the listed disease;

Amendment    183

Proposal for a regulation

Article 61 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) the type of production, and epidemiological units within the affected establishment, household, food or feed business, animal by-products establishment or other location.

(b) the type of production, and epidemiological units within the affected establishment, food or feed business, transport business, livestock trading business, animal by-products establishment or other location.

Amendment    184

Proposal for a regulation

Article 61 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) the effect of the measures on farm animal genetic diversity and the need to conserve farm animal genetic resources.

Amendment    185

Proposal for a regulation

Article 61 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The competent authority shall only authorise the repopulation of the establishment, household or any other location when:

3. The competent authority shall only authorise the repopulation of the establishment or any other location when:

Amendment    186

Proposal for a regulation

Article 61 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) a sufficient period of time has elapsed to prevent re-contamination of the affected establishment, household, food or feed business, animal by-products establishment and other location with the listed disease that caused the outbreak referred to in paragraph 1.

(b) a sufficient period of time has elapsed to prevent re-contamination of the affected establishment, food or feed business, transport business, livestock trading business, animal by-products establishment and other location with the listed disease that caused the outbreak referred to in paragraph 1.

Amendment    187

Proposal for a regulation

Article 62 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authority shall extend the disease control measures provided for in Article 61(1) to other establishments, epidemiological units therein, households, food or feed businesses or animal by-products establishments, or any other location, or means of transport where the epidemiological enquiry provided for in Article 57(1), or the results of clinical or laboratory investigations or other epidemiological data give reason to suspect the spread to, from or through them of the listed disease referred to in Article 8(1)(a) for which such measures were taken.

1. The competent authority shall extend the disease control measures provided for in Article 61(1) to other establishments, epidemiological units therein, food or feed businesses, transport businesses, livestock trading businesses or animal by-products establishments, or any other location, or means of transport where the epidemiological enquiry provided for in Article 57(1), or the results of clinical or laboratory investigations or other epidemiological data give reason to suspect the spread to, from or through them of the listed disease referred to in Article 8(1)(a) for which such measures were taken.

Amendment    188

Proposal for a regulation

Article 62 – paragraph 2

Text proposed by the Commission

Amendment

2. If the epidemiological enquiry provided for in Article 57(1) shows that the likely origin of the listed disease referred to in Article 8(1)(a) is another Member State or it is likely that that listed disease has spread to another Member State, the competent authority shall inform that Member State.

2. If the epidemiological enquiry provided for in Article 57(1) shows that the likely origin of the listed disease referred to in Article 8(1)(a) is another Member State or it is likely that that listed disease has spread to another Member State, the competent authority shall inform that Member State and the Commission.

Amendment    189

Proposal for a regulation

Article 64 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The competent authority shall establish a restricted zone around the affected establishment, household, food or feed business, animal by-products establishment or other location where the outbreak of a listed disease referred to in Article 8(1)(a) in kept animals has occurred, where appropriate, taking into account:

The competent authority shall establish a restricted zone around the affected establishment, food or feed business, transport business, livestock trading business, animal by-products establishment or other location where the outbreak of a listed disease referred to in Article 8(1)(a) in kept animals has occurred, where appropriate, taking into account:

Amendment    190

Proposal for a regulation

Article 64 – paragraph 1 – subparagraph 1 – point h a (new)

Text proposed by the Commission

Amendment

 

(ha) the direct and indirect costs for the affected sectors and the economy as a whole;

Amendment    191

Proposal for a regulation

Article 64 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

The competent authority shall establish the restricted zone in a manner consistent with the principle of proportionality.

Amendment    192

Proposal for a regulation

Article 65 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the identification of establishments, households, food or feed businesses, animal by-products establishments or other locations with kept animals of listed species for that listed disease;

(a) the identification of establishments, food or feed businesses, transport businesses, livestock trading businesses, animal by-products establishments or other locations with kept animals of listed species for that listed disease;

Amendment    193

Proposal for a regulation

Article 65 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) visits to establishments, households, food or feed businesses, animal by-products establishments or other locations with kept animals of listed species for that listed disease, and where necessary examinations, sampling and laboratory examination of the samples;

(b) visits to establishments, food or feed businesses, transport businesses, livestock trading businesses, animal by-products establishments or other locations with kept animals of listed species for that listed disease, and where necessary examinations, sampling and laboratory examination of the samples;

Amendment    194

Proposal for a regulation

Article 65 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) the designation or where relevant, approval of a food business establishment for the purposes of the slaughtering of animals or the treatment of products of animal origin originating from the restricted zones;

(g) the designation or where relevant, approval of a food business establishment for the purposes of the slaughtering, using pre-stunning, of animals or the treatment of products of animal origin originating from the restricted zones;

Amendment    195

Proposal for a regulation

Article 67 – subparagraph 2 – point b

Text proposed by the Commission

Amendment

(b) the procedures for cleaning, disinfection and disinfestation provided for in Article 65(1)(f), specifying, where appropriate the use of biocidal products for those purposes;

(b) principles concerning the procedures for cleaning, disinfection and disinfestation provided for in Article 65(1)(f), specifying, where appropriate the use of biocidal products for those purposes;

Amendment    196

Proposal for a regulation

Article 69 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3 a. Animals which have undergone emergency vaccination may be used for a specific purpose in accordance with the provisions of Article 47(1)(f).

Amendment    197

Proposal for a regulation

Article 69 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

 

3 b. Where the vaccine used is certified as safe for human consumption, subsequent slaughter of non-infected, vaccinated animals should be avoided.

Amendment    198

Proposal for a regulation

Part 3 – title 2 – chapter 1 – section 5 – title

Text proposed by the Commission

Amendment

Wild animals

Wild animals and stray domestic animals

Amendment    199

Proposal for a regulation

Article 70 – title

Text proposed by the Commission

Amendment

Wild animals

Wild animals and stray domestic animals

Amendment    200

Proposal for a regulation

Article 70 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. In the event of the suspicion or official confirmation of a listed disease referred to in Article 8(1)(a) in wild animals, the affected Member State shall:

1. In the event of the suspicion or official confirmation of a listed disease referred to in Article 8(1)(a) in wild animals or stray domestic animals, the affected Member State shall:

Amendment    201

Proposal for a regulation

Article 70 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(a a) monitor the population of stray domestic animals where this is relevant for this specific listed disease;

Amendment    202

Proposal for a regulation

Article 70 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) take the necessary disease prevention and control measures to avoid the further spread of that listed disease.

(b) take the necessary disease prevention and control measures to avoid the further spread or bring about the eradication of that listed disease and ensure that any control measures spare the affected animals avoidable pain and suffering.

Amendment    203

Proposal for a regulation

Article 70 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) the affected wild animals;

(b) the affected wild animals and non-kept domestic animals;

Amendment    204

Proposal for a regulation

Article 70 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) contact between wild and kept animals and the associated risk of mutual infection;

Amendment    205

Proposal for a regulation

Article 70 – paragraph 2 – point b b (new)

Text proposed by the Commission

Amendment

 

(b b) direct contact between the affected animals and people and physical proximity to people;

Amendment    206

Proposal for a regulation

Article 71 a (new)

Text proposed by the Commission

Amendment

 

Article 71a

 

Scope of Chapter 2

 

As regards diseases listed in Article 8(1)(c), the following provisions of Chapter 2 shall apply only to Member States which have drawn up a national programme.

Amendment    207

Proposal for a regulation

Article 74 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) apply disease control measures to limit the spread of that listed disease from the affected territory, establishment, household, food or feed business, animal by-products establishment or other location;

(a) apply disease control measures to limit the spread of that listed disease from the affected territory, establishment, food or feed business, transport business, livestock trading business, animal by-products establishment or other location;

Amendment    208

Proposal for a regulation

Article 74 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the application of the preliminary disease control measures provided for in paragraph 1(a) to other establishments, epidemiological units therein, households, food or feed businesses and animal by-products establishments or other locations;

(b) the application of the preliminary disease control measures provided for in paragraph 1(a) to other establishments, epidemiological units therein, food or feed businesses, transport businesses, livestock trading businesses and animal by-products establishments or other locations;

Amendment    209

Proposal for a regulation

Article 78 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) in a Member State, area, zone or compartment that is not subject to a voluntary eradication programme provided for in Article 30(2) for that listed disease, apply, when appropriate, measures to control and prevent its spread.

deleted

Amendment    210

Proposal for a regulation

Article 78 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the kept animals affected;

(b) the kept animals affected, particularly when they belong to an endangered race or variety;

Amendment    211

Proposal for a regulation

Part 3 – title 2 – chapter 2 – section 4 – title

Text proposed by the Commission

Amendment

Wild animals

Wild animals and animals of domestic species which are not kept

Amendment    212

Proposal for a regulation

Article 80 – title

Text proposed by the Commission

Amendment

Wild animals

Wild animals and animals of domestic species which are not kept

Amendment    213

Proposal for a regulation

Article 80 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. In the event of suspicion or official confirmation of a listed disease referred to in Article 8(1)(b) in wild animals, the competent authority of the affected Member State shall:

1. In the event of suspicion or official confirmation of a listed disease referred to in Article 8(1)(b) in wild animals and animals of domestic species which are not kept, the competent authority of the affected Member State shall:

Amendment    214

Proposal for a regulation

Article 80 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In the event of an outbreak of a listed disease referred to in Article 8(1)(c) in wild animals the competent authority of the affected Member State shall:

2. In the event of an outbreak of a listed disease in wild animals and animals of domestic species which are not kept and are not covered by the provisions of Article 8(1)(b), the competent authority of the affected Member State shall:

Amendment    215

Proposal for a regulation

Article 80 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the affected wild animals;

(b) the affected wild animals and animals of domestic species which are not kept;

Amendment    216

Proposal for a regulation

Article 80 – paragraph 3 – point b a (new)

Text proposed by the Commission

Amendment

 

(b a) contact between animals living in the wild and kept animals, and the associated risk of mutual infection;

Amendment    217

Proposal for a regulation

Article 80 – paragraph 3 – point b b (new)

Text proposed by the Commission

Amendment

 

(b b) direct contact between the animals concerned and human beings, and spatial proximity to people;

Amendment    218

Proposal for a regulation

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning detailed rules supplementing the disease control measures to be taken in the event of outbreaks of a listed disease referred to in Article 8(1)(b) or (c) in wild animals as provided for in paragraph 2(b) of this Article.

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning detailed rules supplementing the disease control measures to be taken in the event of outbreaks of a listed disease referred to in Article 8(1)(b) or (c) in wild animals and animals of domesticated species which are not kept as provided for in paragraph 2(b) of this Article.

Amendment    219

Proposal for a regulation

Article 86

Text proposed by the Commission

Amendment

Article 86

deleted

Derogations from the obligation to register transporters of kept ungulates

 

By way of derogation from Article 85(1), Member States may exempt certain categories of transporters from the registration requirement, taking into account the following criteria:

 

(a) the distances over which they transport those kept terrestrial animals;

 

(b) the categories, species and number of kept terrestrial animals, which they transport.

 

Amendment    220

Proposal for a regulation

Article 87 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the types of transporters that may be exempted by the Member States from the registration requirement in accordance with Article 86 provided that the type of transport poses an insignificant risk and taking into account the criteria provided for in that Article.

deleted

Amendment    221

Proposal for a regulation

Article 89 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) the categories and species of kept terrestrial animals or germinal products in an establishment;

(a) the categories and species or races of kept terrestrial animals or germinal products in an establishment;

Amendment    222

Proposal for a regulation

Article 92 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The competent authority shall only grant approval of establishments as provided for in Article 89(1) and Article 90(a) where such establishments:

1. The competent authority shall grant approval of establishments as provided for in Article 89(1) and Article 90(a) where such establishments:

Amendment    223

Proposal for a regulation

Article 94 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Articles 89(1), Article 90 and Article 91(1).

1. The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Articles 89(1), Article 90 and Article 91(1) and deadlines for the on-the-spot inspections referred to in the paragraph below.

Amendment    224

Proposal for a regulation

Article 94 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2 a. The competent authority grants approval of an establishment where it appears, based on the application of the operator and the subsequent on-site visit of the establishment by the competent authority as provided for in paragraph 1 and 2 of this Article, that it meets all the requirements for approval provided for in Article 92(1) and the rules adopted pursuant to Article 92(2).

Amendment    225

Proposal for a regulation

Article 94 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Where that on-site visit shows that clear progress has been made but the establishment still does not meet all of those requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not exceed a total period of six months.

Where that on-site visit shows that clear progress has been made but the establishment still does not meet all of those requirements, the competent authority may prolong the conditional approval and shall provide the necessary effective guidance in order to contribute to the successful resolve of the deficiency. However, conditional approval shall not exceed a total period of six months.

Amendment    226

Proposal for a regulation

Article 95 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authority shall keep the approvals of establishments granted in accordance with Articles 92 and 94 under review.

1. The competent authority shall keep the approvals of establishments granted in accordance with Articles 92 and 94 under review. The competent authority, based on the risk factor, shall define review frequency or minimum and maximum review deadlines, as well as those instances in which such deadlines cannot be met.

Amendment    227

Proposal for a regulation

Article 96 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

It shall make that register available to other Member States and to the public.

It shall make that register available to the Commission, to other Member States and to the public.

Amendment    228

Proposal for a regulation

Article 97 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the species, categories, numbers and identification of kept terrestrial animals on their establishment;

(a) the species, categories, numbers and, where applicable, identification, of kept terrestrial animals on their establishment;

Amendment    229

Proposal for a regulation

Article 97 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) any animal health problems concerning kept animals on their establishment;

(d) treatments of animal health problems concerning kept animals on their establishment;

Amendment    230

Proposal for a regulation

Article 97 – paragraph 2

Text proposed by the Commission

Amendment

2. Establishments which are exempted from the registration requirement in accordance with Article 83 may be exempted by the Member State from the requirement to keep records of the information listed in paragraph 1 of this Article.

2. Establishments which are exempted from the registration requirement in accordance with Article 83 may be exempted by the Member State from the requirement to keep records of the information listed in paragraph 1 of this Article. Member States shall notify the Commission of any exemptions made and keep a record of all the exempted establishments on their territory.

Amendment    231

Proposal for a regulation

Article 98 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(d a) the results of clinical and laboratory tests;

Amendment    232

Proposal for a regulation

Article 98 – paragraph 2

Text proposed by the Commission

Amendment

2. Establishments which are exempted from the registration requirement in accordance with Article 84 may be exempted by the Member State from the requirement to keep records of the information listed in paragraph 1 of this Article.

2. Establishments which are exempted from the registration requirement in accordance with Article 84 may be exempted by the Member State from the requirement to keep records of the information listed in paragraph 1 of this Article. Member States shall notify the Commission of any exemptions made and keep a record of all the exempted establishments on their territory.

Amendment    233

Proposal for a regulation

Article 99 – paragraph 2

Text proposed by the Commission

Amendment

2. Transporters which are exempted from the registration requirement in accordance with Article 86 may be exempted by the Member State from the requirement to keep records of the information listed in paragraph 1 of this Article.

2. Transporters which are exempted from the registration requirement in accordance with Article 86 may be exempted by the Member State from the requirement to keep records of the information listed in paragraph 1 of this Article. Member States shall notify the Commission of any exemptions made and keep a record of all the exempted establishments on their territory.

Amendment    234

Proposal for a regulation

Article 100 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) derogations from the record keeping requirements for:

deleted

(i) operators of certain types of establishments and certain types of transporters;

 

(ii) establishments keeping, or transporters handling a small number of kept terrestrial animals or small volume of germinal products;

 

(iii) certain categories or species of kept terrestrial animals or germinal products;

 

Amendment    235

Proposal for a regulation

Article 103 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) information related to kept animals of the porcine species and the establishments keeping them;

(b) the following information related to kept animals of the porcine species:

 

(i) the establishments keeping them;

 

(ii) their movements into and from establishments;

Amendment    236

Proposal for a regulation

Article 103 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2 a. By 1 January 2018, Member States shall introduce a registration requirement for dogs. The Commission shall submit to the European Parliament and the Council by 31 July 2019 a report on the experience of the Member States with the registration and identification of dogs, with particular reference to stray animals. This report shall, if appropriate, be accompanied by a proposal concerning the minimum requirements applicable to databases pursuant to paragraph 1.

Amendment    237

Proposal for a regulation

Article 108 – title

Text proposed by the Commission

Amendment

Derogations concerning identification documents and movement documents for kept animals of the bovine, ovine and caprine species

Derogations concerning identification, identification documents and movement documents for kept animals of the bovine, ovine and caprine species

Amendment    238

Proposal for a regulation

Article 108 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

By way of derogation from Article 107 (a), Member States may exempt operators from the requirements to identify kept animals of the ovine and caprine species as laid out in Article 4 (2) in Regulation (EC) No 21/2004, replacing this with a requirement to identify those kept animals in accordance with Section A.7 of the Annex to Regulation (EC) No 21/2004, until the animal leaves the holding of birth. When the animal leaves the holding of birth, it shall be identified in accordance with Article 4(2) of Regulation (EC) No 21/2004.

Amendment    239

Proposal for a regulation

Article 112 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Pet keepers shall ensure that terrestrial pet animals of the species listed in Part A of Annex I which are moved from one Member State to another Member State:

1. Pet keepers shall ensure that terrestrial pet animals of the species listed in Part A of Annex I which are moved from one Member State to another Member State comply with the requirements of Regulation (EU) No 576/2013.

Amendment    240

Proposal for a regulation

Article 112 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) are individually identified by a physical means of identification;

deleted

Amendment    241

Proposal for a regulation

Article 112 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are accompanied by a correctly completed and updated identification document issued by the competent authority in accordance with Article 104.

deleted

Amendment    242

Proposal for a regulation

Article 112 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Pet keepers shall ensure that terrestrial pet animals of the species listed in Part B of Annex I when moved from one Member State to another Member State, and when required by rules adopted pursuant to Articles 114 and 117, are:

2. Pet keepers shall ensure that terrestrial pet animals of the species listed in Part B of Annex I when moved from one Member State to another Member State comply with the requirements of Regulation (EU) No 576/2013.

Amendment    243

Proposal for a regulation

Article 112 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) identified, either individually or in groups;

deleted

Amendment    244

Proposal for a regulation

Article 112 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) accompanied by correctly completed and updated identification documents, movement documents or other documents for identifying and tracing animals, as appropriate for the animal species concerned.

deleted

Amendment    245

Proposal for a regulation

Article 114 – point a

Text proposed by the Commission

Amendment

(a) the designation of other authorities, the authorisation of bodies or natural persons, as provided for in Article 102(4)(c);

deleted

Amendment    246

Proposal for a regulation

Article 114 – point c – point vi

Text proposed by the Commission

Amendment

(vi) identification documents for terrestrial pet animals provided for in Article 112(1)(b) or identification documents, movement documents or other documents for kept terrestrial pet animals provided for in Article 112(2)(b);

deleted

Amendment    247

Proposal for a regulation

Article 114 – point f

Text proposed by the Commission

Amendment

(f) identification and registration requirements for kept terrestrial pet animals of the species listed in Part B of Annex I and kept terrestrial animals of species other than the bovine, ovine, caprine, porcine and equine species where necessary, taking into account the risks posed by that species, to:

deleted

(i) ensure the efficient application of the disease prevention and control measures provided for in this Regulation;

 

(ii) facilitate the traceability of kept terrestrial animals, and their movements within and between Member States and their entry into the Union.

 

Amendment    248

Proposal for a regulation

Article 115 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning derogations for operators from the identification and registration requirements provided for in Articles 106, 107 and 109 and 110:

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning derogations for operators from the identification and registration requirements provided for in Articles 106, 107 and 109 and 110, provided that full traceability is ensured:

Amendment    249

Proposal for a regulation

Article 118 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) the breed;

Amendment    250

Proposal for a regulation

Article 121 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(b a) the movement complies with Council Regulation (EC) No 1/2005.

Amendment    251

Proposal for a regulation

Article 122 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Operators shall take the appropriate and necessary preventive measures to ensure that:

1. Operators shall take the appropriate and necessary preventive and health-promotion measures to ensure that:

Amendment    252

Proposal for a regulation

Article 122 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) transport operations of kept terrestrial animals do not cause the potential spread of listed diseases referred to in Article 8(1)(d) to humans and animals at places of assembly, resting and destination;

(b) transport operations of kept terrestrial animals do not cause the potential spread of listed diseases referred to in Article 8(1)(d) to humans and animals at places of assembly, loading, unloading, reloading, resting and destination;

Amendment    253

Proposal for a regulation

Article 122 – paragraph 1 – point ca (new)

Text proposed by the Commission

Amendment

 

(ca) the relevant requirements of Council Regulation (EC) No 1/2005 are taken into account.

Amendment    254

Proposal for a regulation

Article 125

Text proposed by the Commission

Amendment

Operators shall not move kept terrestrial animals to another Member State, unless the Member State of destination gives express authorisation prior to the movement in the event of animals which are intended to be slaughtered for disease eradication purposes as a part of an eradication programme provided for in Article 30(1), (2) and (3).

Operators shall not move kept terrestrial animals to another Member State, unless the Member State of destination and the Member States of transit give express authorisation prior to the movement in the event of animals which are intended to be slaughtered for disease eradication purposes as a part of an eradication programme provided for in Article 30(1), (2) and (3).

Amendment    255

Proposal for a regulation

Article 127 – point c

Text proposed by the Commission

Amendment

(c) for a period of time appropriate for those listed diseases and the species and category of ungulates or poultry to be moved, no kept ungulates or poultry have been introduced into the establishment of origin;

(c) for a period of time appropriate for those listed diseases and the species and category of ungulates or poultry to be moved, no kept ungulates or poultry have been introduced into the establishment of origin, except in cases where appropriate biosecurity measures have been taken;

Amendment    256

Proposal for a regulation

Article 128 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) residency periods provided for in Article 127(b);

 

(a) residency periods and biosecurity measures provided for in Article 127(b);

Amendment    257

Proposal for a regulation

Article 129 – paragraph 1

Text proposed by the Commission

Amendment

1. Operators of slaughterhouses receiving kept ungulates and poultry from another Member State shall slaughter those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2.

1. Operators of slaughterhouses receiving kept ungulates and poultry from another Member State shall slaughter, using pre-stunning, those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2.

Amendment    258

Proposal for a regulation

Article 130 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 123(2), operators may subject kept ungulates and poultry to a maximum of:

1. By way of derogation from Article 123(2), operators may subject kept ungulates and poultry to a maximum of three assembly operations.

(a) one assembly operation in the Member State of origin;

 

(b) one assembly operation in the Member State of passage;

 

(c) one assembly operation in the Member State of destination.

 

Amendment    259

Proposal for a regulation

Article 131 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the kept ungulates and poultry are assembled and moved to their final place of destination in another Member State as soon as possible after leaving their establishment of origin, and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to Article 132(c);

(b) the kept ungulates and poultry are assembled and moved to their final place of destination as soon as possible after leaving their establishment of origin, and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to Article 132(c);

Amendment    260

Proposal for a regulation

Article 132 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning:

The Commission shall be empowered to adopt delegated acts in accordance with Article 253, provided that such acts are based on scientific facts and due regard for the opinions of the European Food Safety Authority, concerning:

Amendment    261

Proposal for a regulation

Article 132 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the timeframe between the time of departure of the kept ungulates or poultry from their establishment of origin and their departure from the assembly operation to their final destination in another Member State as referred to in Article 131(b);

(c) the timeframe between the time of departure of the kept ungulates or poultry from their establishment of origin and their departure from the assembly operation to their final destination as referred to in Article 131(b);

Amendment    262

Proposal for a regulation

Article 140 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Operators shall not move kept terrestrial animals within a Member State or from one Member State to another Member State unless they are accompanied by an animal health certificate issued by the competent authority of the Member State of origin in accordance with Article 146(1), where the conditions referred to in the following points (a) and (b) are meet:

2. Operators shall not move kept terrestrial animals unless they are accompanied by an animal health certificate issued by the competent authority of the Member State in accordance with Article 146(1), where the conditions referred to in the following points (a) and (b) are meet:

Amendment    263

Proposal for a regulation

Article 152 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Pet keepers shall only carry out non-commercial movements of terrestrial pet animals of the species listed in Annex I from one Member State to another Member State where:

1. Pet keepers shall only carry out non-commercial movements of terrestrial pet animals of the species listed in Annex I from one Member State to another Member State in accordance with the provisions of Regulation (EU) No 576/2013.

Amendment    264

Proposal for a regulation

Article 152 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) those terrestrial pet animals are identified and accompanied with an identification document when required in accordance with Article 112 or rules adopted pursuant to Article 114(e) and Article 117;

deleted

Amendment    265

Proposal for a regulation

Article 152 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) appropriate prevention and disease control measures have been taken during that movement, to ensure that the terrestrial pet animals do not pose a significant risk for the spread of listed diseases referred to in Article 8(1)(d) and emerging diseases to kept terrestrial animals at the place of destination and during transport.

deleted

Amendment    266

Proposal for a regulation

Article 152 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the prevention and disease control measures referred to in paragraph 1(b) of this Article to ensure that the terrestrial pet animals do not pose a significant risk for the spread of diseases referred to in Article 8(1)(d) and emerging diseases to animals during transport and at the place of destination and when relevant taking into account the health status of the place of destination.

2. The Commission shall, without prejudice to the provisions laid down in Regulation (EU) No 576/2013, be empowered to adopt delegated acts in accordance with Article 253 concerning prevention and disease control measures to ensure that the terrestrial pet animals do not pose a significant risk for the spread of diseases referred to in Article 8(1)(d) and emerging diseases to animals during transport and at the place of destination and when relevant taking into account the health status of the place of destination.

Amendment    267

Proposal for a regulation

Article 152 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts lay down rules concerning the disease prevention and control measures provided for in paragraph 1 of this Article and the rules adopted pursuant to paragraph 2 thereof.

Without prejudice to the Regulation on the non-commercial movement of pet animals, the Commission may, by means of implementing acts lay down rules concerning the disease prevention and control measures provided for in paragraph 2 of this Article.

Amendment    268

Proposal for a regulation

Article 169 – paragraph 1

Text proposed by the Commission

Amendment

Where a disease other than listed diseases constitutes a significant risk for the animal health situation of kept terrestrial animals in a Member State, the Member State concerned may take national measures to control that disease, provided those measures do not:

Where a disease other than listed diseases constitutes a significant risk for the animal health situation of kept terrestrial animals in a Member State, the Member State concerned may take national measures to prevent the introduction or spread of that disease, provided those measures:

(a) hinder the movement of animals and products between Member States;

(a) only hinder the movement of animals and products between Member States when this is scientifically justified on the grounds of controlling infectious disease;

(b) exceed the limits of what is appropriate and necessary to control that disease.

(b) are proportionate in relation to the risk and do not exceed the limits of what is appropriate and necessary to control that disease.

 

Member States shall notify the Commission in advance of any proposed national measures referred to in subparagraph 1 that may affect movements between Member States.

 

Where the conditions laid down in subparagraph 1 are not fulfilled, the Commission may object to or amend the national measures referred to in subparagraph 2 of this Article by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 255(2) and shall enter into force with immediate effect.

Amendment    269

Proposal for a regulation

Article 174 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) aquaculture establishments where aquaculture animals are kept with the view to their being moved from that aquaculture establishment either alive or as products of aquaculture animal origin, however, such application shall not be required where they are solely moved either for:

(a) aquaculture establishments where aquaculture animals are kept with the view to their being moved from that aquaculture establishment either alive or as products of aquaculture animal origin.

Amendment    270

Proposal for a regulation

Article 174 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) for a direct supply for human consumption of small quantities to the final consumer; or

deleted

Amendment    271

Proposal for a regulation

Article 174 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) to local retail establishments directly supplying the final consumer.

deleted

Amendment    272

Proposal for a regulation

Article 174 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. By way of derogation from paragraph 1, the competent authority may exempt from the obligation to apply for approval operators of aquaculture establishments where aquaculture animals are solely moved either:

 

(i) for a direct supply for human consumption of small quantities to the final consumer; or

 

(ii) to local retail establishments directly supplying the final consumer,

 

provided that such movements do not pose a significant risk.

Amendment    273

Proposal for a regulation

Article 177 – title

Text proposed by the Commission

Amendment

Approval of disease control aquatic food establishments

Approval of processing establishments and disease control aquatic food establishments

Amendment    274

Proposal for a regulation

Article 177

Text proposed by the Commission

Amendment

Operators of disease control aquatic food establishments shall ensure that their establishments are approved by the competent authority to slaughter aquatic animals for disease control purposes in accordance with Article 61(1)(b), Article 62 and Articles 68(1), 78(1) and (2) and the rules adopted pursuant to Article 63 and Articles 70(3), 71(3) and 78(3).

Natural and legal persons intending to operate disease control aquatic food establishments shall ensure that their establishments are approved by the competent authority to slaughter aquatic animals for disease control purposes in accordance with Article 61(1)(b), Article 62 and Articles 68(1), 78(1) and (2) and the rules adopted pursuant to Article 63 and Articles 70(3), 71(3) and 78(3).

Amendment    275

Proposal for a regulation

Article 177 – paragraph 1

Text proposed by the Commission

Amendment

1. Operators of disease control aquatic food establishments shall ensure that their establishments are approved by the aquatic animals for disease control competent authority to slaughter purposes in accordance with Article 61(1)(b), Article 62 and Articles 68(1), 78(1) and (2) and the rules adopted pursuant to Article 63 and Articles 70(3), 71(3) and 78(3).

1. Operators of processing establishments and disease control aquatic food establishments shall ensure that their establishments are approved by the competent authority to slaughter aquatic animals for disease control purposes in accordance with Article 61(1)(b), Article 62 and Articles 68(1), 78(1) and (2) and the rules adopted pursuant to Article 63 and Articles 70(3), 71(3) and 78(3).

Amendment    276

Proposal for a regulation

Article 178 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Operators shall, for the purposes of their application for the approval of their establishment provided for in Article 174(1), Article 175, Article 176(a) and Article 177 provide the competent authority with the information on:

1. Intending operators shall, for the purposes of their application for the approval of their establishment provided for in Article 174(1), Article 175, Article 176(a) and Article 177 provide the competent authority with the information on:

Amendment    277

Proposal for a regulation

Article 178 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the categories, species and numbers of aquaculture animals on the establishment;

(c) the categories, species and numbers of aquaculture animals intended to be kept on the establishment;

Amendment    278

Proposal for a regulation

Article 178 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

 

(f a) the water supply and discharge of the establishment

Amendment    279

Proposal for a regulation

Article 182 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authority shall keep the approvals of establishments granted in accordance with Article 179(1) under review.

1. The competent authority shall keep the approvals of establishments granted in accordance with Article 179(1) under review. The competent authority, based on the risk factor, shall define review frequency or minimum and maximum review deadlines, as well as those instances in which such deadlines cannot be met.

Amendment    280

Proposal for a regulation

PART IV – Title II – Chapter 1 – Section 3 – title

Text proposed by the Commission

Amendment

Register of the competent authority of aquaculture establishments and disease control aquatic food establishments

Register of the competent authority of aquaculture establishments, processing establishments and disease control aquatic food establishments

Amendment    281

Proposal for a regulation

Article 183 – title

Text proposed by the Commission

Amendment

Register of aquaculture establishments and disease control aquatic food establishments

Register of aquaculture establishments, processing establishments and disease control aquatic food establishments

Amendment    282

Proposal for a regulation

Article 183 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) all disease control aquatic food establishments approved in accordance with Article 179(1).

(c) all processing establishments and disease control aquatic food establishments approved in accordance with Article 179(1).

Amendment    283

Proposal for a regulation

Article 186 – title

Text proposed by the Commission

Amendment

Record keeping obligation for disease control aquatic food establishments

Record keeping obligation for processing establishments and disease control aquatic food establishments

Amendment    284

Proposal for a regulation

Article 186 – paragraph 1

Text proposed by the Commission

Amendment

1. Operators of disease control aquatic food establishments subject to approval in accordance with Article 177 shall keep up-to-date records of all movement of aquaculture animals and products of animal origin obtained from such animals into and out of such establishments.

1. Operators of processing establishments and disease control aquatic food establishments subject to approval in accordance with Article 177 shall keep up-to-date records of all movement of aquaculture animals and products of animal origin obtained from such animals into and out of such establishments.

Amendment    285

Proposal for a regulation

Article 186 – paragraph 2

Text proposed by the Commission

Amendment

2. Operators of disease control aquatic food establishments shall:

2. Operators of processing establishments and disease control aquatic food establishments shall:

Amendment    286

Proposal for a regulation

Article 187 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Transporters of aquaculture animals and wild aquatic animals intended for aquaculture shall keep up-to date records on:

Transporters of aquaculture animals and wild aquatic animals intended for aquaculture or for release in a natural environment in order to replenish wild stocks shall keep up-to date records on:

Amendment    287

Proposal for a regulation

Article 193 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Operators of establishments and food business establishments receiving aquaculture animals shall:

1. Operators of establishments and food business establishments receiving aquatic animals shall, before the aquatic animals are unloaded:

Amendment    288

Proposal for a regulation

Article 193 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa) inspect the consignment for any irregularity;

Amendment    289

Proposal for a regulation

Article 193 – paragraph 1 – point b – point i

Text proposed by the Commission

Amendment

(i) the aquaculture animals received;

(i) the aquatic animals received;

Amendment    290

Proposal for a regulation

Article 193 – paragraph 2

Text proposed by the Commission

Amendment

2. In the event of any irregularity as referred to in paragraph 1(b), the operator shall isolate the aquaculture animals concerned by that irregularity until the competent authority has taken a decision regarding them.

2. In the event of any irregularity as referred to in paragraph 1(b), the operator shall not permit the aquaculture animals concerned by that irregularity to be unloaded until the competent authority has taken a decision regarding them.

Amendment    291

Proposal for a regulation

Article 196 – title

Text proposed by the Commission

Amendment

Movement of aquaculture animals intended for Member States, zones or compartments which have been declared disease free or which are subject to an eradication programme and delegated acts

Movement of kept aquatic animals intended for Member States, zones or compartments which have been declared disease free or which are subject to an eradication programme and delegated acts

Amendment    292

Proposal for a regulation

Article 196 – paragraph 1

Text proposed by the Commission

Amendment

1. Operators shall only move aquaculture animals from an aquaculture establishment for the purposes referred to in point (a) or (b) of this Article, if those aquaculture animals originate from a Member State, or zone or compartment thereof, which has been declared disease-free in accordance with Article 36(3) or 37(4) for listed diseases referred to in Article 8(1)(b) or (c) when they are of listed species for those listed diseases and the aquaculture animals are:

1. Operators shall only move kept aquatic animals from an establishment for the purposes referred to in points (a) and (b) of this Article, if those animals originate from a Member State, or zone or compartment thereof, which has been declared disease-free in accordance with Article 36(3) or 37(4) for listed diseases referred to in Article 8(1)(b) or (c) when they are of listed species for those listed diseases and the kept aquatic animals are:

Amendment    293

Proposal for a regulation

Article 196 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) intended for:

deleted

(i) an aquaculture establishment subject to:

 

– registration in accordance with Article 171: or

 

– approval in accordance with Articles 174, 175, 176 and Article 177; or

 

(ii) release into the wild.

 

Amendment    294

Proposal for a regulation

Article 196 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the species, categories, and life stage of the aquaculture animals;

(a) the species, categories, and life stage of the kept aquatic animals;

Amendment    295

Proposal for a regulation

Article 196 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) the intended use of the aquaculture animals;

(c) the intended use of the kept aquatic animals;

Amendment    296

Proposal for a regulation

Article 196 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) the place of destination of the aquaculture animals;

(d) the place of destination of the kept aquatic animals;

Amendment    297

Proposal for a regulation

Article 197

Text proposed by the Commission

Amendment

By way of derogation from Article 196(1), Member States may authorise operators to move aquaculture animals into a zone or compartment in another Member State for which an eradication programme has been established in accordance with Article 30(1) and (2) as regards the listed diseases referred to in Article 8(1)(b) and (c), from another zone or compartment for which such a programme has also been established for the same listed diseases, provided that such movement will not jeopardise the health status of the Member State, zone or compartment of destination.

By way of derogation from Article 196(1), Member States may authorise operators to move aquaculture animals into a zone or compartment within their territory for which an eradication programme has been established in accordance with Article 30(1) and (2) as regards the listed diseases referred to in Article 8(1)(b) and (c), from a zone or compartment in another Member State for which such a programme has also been established for the same listed diseases, provided that such movement will not jeopardise the health status of the Member State, zone or compartment of destination.

Amendment    298

Proposal for a regulation

Article 198

Text proposed by the Commission

Amendment

Member States may require that aquaculture animals shall only be released into the wild if they originate from a Member State, or zone or compartment declared disease-free in accordance with Article 36(1) or Article 37(1) as regards the listed diseases referred to in Article 8(1)(b) and (c) for which the species of aquaculture animals to be moved is a listed species, regardless of the health status of the area where the aquaculture animals are to be released.

Member States may require that aquatic animals shall only be released into the wild if they originate from a Member State, or zone or compartment declared disease-free in accordance with Article 36(1) or Article 37(1) as regards the listed diseases referred to in Article 8(1)(b) and (c) for which the species of aquatic animals to be moved is a listed species, regardless of the health status of the area where the aquatic animals are to be released.

Amendment    299

Proposal for a regulation

Article 199 – paragraph 1

Text proposed by the Commission

Amendment

1. Articles 196 and 197 shall also apply to movements of wild aquatic animals intended for an aquaculture establishment or disease control aquatic food establishment subject to:

1. Articles 196 and 197 shall also apply to movements of wild aquatic animals intended for an aquaculture establishment, processing establishment or disease control aquatic food establishment subject to:

Amendment    300

Proposal for a regulation

Article 200 – title

Text proposed by the Commission

Amendment

Movement of aquaculture animals intended for Member States, zones or compartments which have been declared disease-free or which are subject to an eradication programme and delegated acts

Movement of kept aquatic animals intended for human consumption in Member States, zones or compartments which have been declared disease-free or which are subject to an eradication programme and delegated acts

Amendment    301

Proposal for a regulation

Article 200 – paragraph 1

Text proposed by the Commission

Amendment

1. Operators shall only move aquaculture animals from an aquaculture establishment for the purposes referred to in point (a) or (b) of this paragraph, if those aquaculture animals originate from a Member State, or zone or compartment thereof, which has been declared disease-free in accordance with Article 36(3) or 37(4) for listed diseases referred to in Article 8(1)(b) or (c) when they are of listed species for those listed diseases and they are:

1. Operators shall only move kept aquatic animals intended for human consumption from an establishment for the purposes referred to in point (a) or (b) of this paragraph, if those animals originate from a Member State, or zone or compartment thereof, which has been declared disease-free in accordance with Article 36(3) or 37(4) for listed diseases referred to in Article 8(1)(b) or (c) when they are of listed species for those listed diseases and they are:

Amendment    302

Proposal for a regulation

Article 200 – paragraph 2

Text proposed by the Commission

Amendment

2. By way of derogation from paragraph 1 of this Article Member States may authorise operators to introduce aquaculture animals into a zone or compartment for which an eradication programme has been established in accordance with Article 30(1) or (2) as regards the listed diseases referred to in Article 8(1)(b) and (c), from another zone or compartment for which such a programme has also been established as regards the same diseases within that Member State, provided that such movement will not jeopardise the health status of the Member State, or zone or compartment thereof.

2. By way of derogation from paragraph 1 of this Article Member States may authorise operators to introduce kept aquatic animals into a zone or compartment for which an eradication programme has been established in accordance with Article 30(1) or (2) as regards the listed diseases referred to in Article 8(1)(b) and (c), from another zone or compartment for which such a programme has also been established as regards the same diseases within that Member State, provided that such movement will not jeopardise the health status of the Member State, or zone or compartment thereof.

Amendment    303

Proposal for a regulation

Article 200 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the derogations from movement requirements provided for in paragraph 2 of this Article for those movements of aquaculture animals which do not pose significant risk of spreading of diseases due to:

3. The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the derogations from movement requirements provided for in paragraph 2 of this Article for those movements of kept aquatic animals which do not pose significant risk of spreading of diseases due to:

Amendment    304

Proposal for a regulation

Article 200 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) the species, categories, and live stage of the aquaculture animals;

(a) the species, categories, and live stage of the kept aquatic animals;

Amendment    305

Proposal for a regulation

Article 200 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the methods of keeping the aquaculture animals and type of production in the aquaculture establishments of origin and of destination;

(b) the methods of keeping the aquatic animals and type of production in the establishments of origin and of destination;

Amendment    306

Proposal for a regulation

Article 200 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) the intended use of the aquaculture animals;

(c) the intended use of the kept aquatic animals;

Amendment    307

Proposal for a regulation

Article 200 – paragraph 3 – point d

Text proposed by the Commission

Amendment

(d) the place of destination of the aquaculture animals;

(d) the place of destination of the kept aquatic animals;

Amendment    308

Proposal for a regulation

Article 205 – point b

Text proposed by the Commission

Amendment

(b) derogations from Sections 1 to 4 with the exception of Article 190(1) and (3) and Articles 191, 192 and 193 for the movements of aquatic animals referred to in point (a).

(b) derogations from Sections 1 to 4 with the exception of Article 190(1) and (3) and Articles 191, 192 and 193 for the movements of aquatic animals referred to in point (a), provided that adequate biosecurity provisions are in place to ensure that those movements do not pose a significant risk to the health status of the place of destination.

Amendment    309

Proposal for a regulation

Article 207 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) any specific conditions under which the aquaculture animals are kept;

(e) any specific conditions under which the aquatic animals are kept;

Amendment    310

Proposal for a regulation

Article 207 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) specific movement patterns of the type of aquaculture establishment and concerned species or category of aquaculture animals;

(f) specific movement patterns of the type of establishment and concerned species or category of aquatic animals;

Amendment    311

Proposal for a regulation

Article 218 – title

Text proposed by the Commission

Amendment

Self- declaration by operators for movements of aquaculture to other Member States and delegated acts

Self- declaration by operators for movements of aquatic animals to other Member States and delegated acts

Amendment    312

Proposal for a regulation

Article 218 – paragraph 1

Text proposed by the Commission

Amendment

1. Operators at the place of origin, shall issue a self-declaration document for movements of aquaculture animals from their place of origin in one Member State to the place of destination in another Member State and ensure that it accompanies such aquaculture animals, where they are not required to be accompanied by an animal health certificate provided for in Articles 208 and 209 or rules adopted pursuant to that Articles 211 and Article 214.

1. Operators at the place of origin, shall issue a self-declaration document for movements of aquatic animals from their place of origin in one Member State to the place of destination in another Member State and ensure that it accompanies such aquatic animals, where they are not required to be accompanied by an animal health certificate provided for in Articles 208 and 209 or rules adopted pursuant to that Articles 211 and Article 214.

Amendment    313

Proposal for a regulation

Article 218 – paragraph 2

Text proposed by the Commission

Amendment

2. The self-declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquaculture animals:

2. The self-declaration document provided for in paragraph 1 shall contain at least the following information concerning the aquatic animals:

Amendment    314

Proposal for a regulation

Article 218 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) a description of the aquaculture animals, the species, their quantity, weight or volume as relevant for the animals concerned;

(b) a description of the aquatic animals, the species, their quantity, weight or volume as relevant for the animals concerned;

Amendment    315

Proposal for a regulation

Article 218 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) the information needed to demonstrate that the aquaculture animals comply with the movement requirements provided for in Sections 1 to 5.

(c) the information needed to demonstrate that the aquatic animals comply with the movement requirements provided for in Sections 1 to 5.

Amendment    316

Proposal for a regulation

Article 218 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) detailed rules on the content of the self-declaration document provided for in paragraph 2 of this Article for different species and categories of aquaculture animals;

(a) detailed rules on the content of the self-declaration document provided for in paragraph 2 of this Article for different species and categories of aquatic animals;

Amendment    317

Proposal for a regulation

Article 233 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) for the reasons referred to in paragraph 1(b) of this Article, provided that the third country or territory provides appropriate guarantees that the animal health situation that gave rise to that suspension or withdrawal from that list has been resolved or no longer represents a threat to the animal or public health of the Union;

(b) for the reasons referred to in paragraph 1(b) of this Article, provided that the third country or territory provides appropriate guarantees that the animal health or public health situation that gave rise to that suspension or withdrawal from that list has been resolved or no longer represents a threat to the animal or public health of the Union;

Amendment    318

Proposal for a regulation

Article 252

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning amendments to Annexes I and II in order to take account of technical progress, scientific developments and changed circumstances in public and animal health.

The Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning amendments to the Annexes in order to take account of technical progress, scientific developments and changed circumstances in public and animal health.

Amendment    319

Proposal for a regulation

Article 253 – paragraph 1

Text proposed by the Commission

Amendment

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article and the requirement for coherent legislation that is easy to understand and apply. In order to ensure the full accessibility and the correct interpretation and application of the provisions of the delegated acts referred to in paragraph 2 of this article, the Commission is required to specify an organizational criterion to simplify the structure and the number of delegated acts it will adopt.

Amendment    320

Proposal for a regulation

Article 253 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt delegated acts referred to in Articles 4(2), 6(2), 9(2), 11(3), 13(2), 15(2), 16(3), 18(3), 24, 28, 30(4), 31(2), 34(2), 37(5), 39, 41(3), 42(5), 44(1), 47, 48(3), 53(2), 54(3), 55(2), 58(2), 63, 64(4), 67, 68(2), 70(3), 72(2), 73(3), 74(3), 76(2), 79, 80(4), 85(3), 89(3), 92(2), 96(3), 100(1), 103(2), 114, 115, 119(1), 122(2), 128(1), 129(2), 132, 133(2), 134(2), 135(3), 136(4), 137, 141(1), 143(1), 144, 146(4), 148(3), 151(1), 152(2), 154(1), 158, 159(5), 160(3), 162(2), 163(3), 164(3), 165(5), 166(3), 174(3), 179(2), 184(1), 188(1), 191(2), 196(2), 199(3), 200(3), 201(2), 202(2), 203(2), 204(3), 205, 211, 213(1), 214, 216(4), 218(3), 221(1), 222(3), 223(3), 224(5), 225(3), 229(1), 231(3), 233(3), 235, 236(1), 239(4), 240(3), 241(1), 242(2), 243(1), 244(2), 252, 259(2), 260(2) and 261(2) shall be conferred on the Commission for an indeterminate period of time from(*).

2. The power to adopt delegated acts referred to in Articles 4(2), 5(2), 6(2), 7(2), 8(1), 9(2), 11(3), 13(2), 15(2), 16(3), 17(3),18(3), 24, 28, 30(4), 31(2), 34(2), 35(2a), 37(5), 39, 41(3), 42(5), 44(1), 47, 48(3), 53(2), 54(3), 55(2), 58(2), 63, 64(4), 67, 68(2), 70(3), 72(2), 73(3), 74(3), 76(2), 79, 80(4), 85(3), 89(3), 92(2), 96(3), 100(1), 103(2), 114, 115, 119(1), 122(2), 128(1), 129(2), 132, 133(2), 134(2), 135(3), 136(4), 137, 141(1), 143(1), 144, 146(4), 148(3), 151(1), 152(2), 154(1), 158, 159(5), 160(3), 162(2), 163(3), 164(3), 165(5), 166(3), 174(3), 179(2), 184(1), 188(1), 191(2), 196(2), 199(3), 200(3), 201(2), 202(2), 203(2), 204(3), 205, 211, 213(1), 214, 216(4), 218(3), 221(1), 222(3), 223(3), 224(5), 225(3), 229(1), 231(3), 233(3), 235, 236(1), 239(4), 240(3), 241(1), 242(2), 243(1), 244(2), 252, 259(2), 260(2) and 261(2) shall be conferred on the Commission for a period of 5 years from(*). The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Amendment    321

Proposal for a regulation

Article 253 – paragraph 3

Text proposed by the Commission

 

The power to adopt delegated acts referred to in Article 229(1) shall be conferred on the Commission for a period of five years from (*).

deleted

(*)Date of entry into force of the basic legislative act or any other date set by the legislator.

 

Amendment    322

Proposal for a regulation

Article 253 – paragraph 3a (new)

Text proposed by the Commission

Amendment

 

3a. Delegated acts shall be based on the scientific evidence available and be adopted after consultation with stakeholders and experts and having taken due account of the scientific opinions of the European Food Safety Authority.

Amendment    323

Proposal for a regulation

Article 257 – paragraph 2

Text proposed by the Commission

Amendment

2. The national measures referred to in paragraph 1 shall be in accordance with the rules laid down in this Regulation and shall not:

2. The national measures referred to in paragraph 1 shall be in accordance with the rules laid down in this Regulation and shall:

(a) hinder the movement of animals and products between Member States;

(a) only hinder the movement of animals and products between Member States when this is scientifically justified on the grounds of controlling infectious disease;

(b) be in contradiction with the rules referred to in paragraph 1.

(b) not be in contradiction with the rules referred to in paragraph 1.

Amendment    324

Proposal for a regulation

Article 258 – paragraph 2 – subparagraph 1 – indent 19

Text proposed by the Commission

Amendment

– Regulation (EC) No 1760/2000,

deleted

Amendment    325

Proposal for a regulation

Article 258 – paragraph 2 – subparagraph 1 – indent 24

Text proposed by the Commission

Amendment

– Regulation (EU) No[XXX/XXX [Publication office: Number to be inserted… non-commercial movements of pet animals and repealing Regulation (EC) No 998/2003],

deleted

Amendment    326

Proposal for a regulation

Article 258 – paragraph 2 – subparagraph 1 – indent 25

Text proposed by the Commission

Amendment

– Regulation (EC) No 21/2004,

deleted

Amendment    327

Proposal for a regulation

Article 258 – paragraph 2 – subparagraph 1 – indent 29

Text proposed by the Commission

Amendment

– Directive 2008/71/EC,

deleted

Justification

Corresponds to amendment on Article 114, paragraph (b) (i)

Amendment    328

Proposal for a regulation

Article 259

Text proposed by the Commission

Amendment

Article 259

deleted

Transitional measures related to the repeal of Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004 and Directive 2008/71/EC

 

1. Notwithstanding Article 258(2) of this Regulation, Regulations (EC) No 1760/2000, and (EC) No 21/2004 and Directive 2008/71/EC shall continue to apply until the date to be determined in a delegated act adopted in accordance with paragraph 2 of this Article.

 

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 252 concerning the date on which the acts referred to in paragraph 1 of this Article shall no longer apply.

 

That date shall be the date of application of the corresponding rules to be adopted pursuant to the delegated acts provided for in Article 103(2) and Articles 114 and 115 of this Regulation.

 

Amendment    329

Proposal for a regulation

Article 261

Text proposed by the Commission

Amendment

Article 261

deleted

Transitional measures related to the repeal of Regulation (EU) No [XXX/XXX on the non-commercial movement of pet animals]

 

1. Notwithstanding Article 258(2) of this Regulation, Regulation (EU) No [XXX/XXX] shall continue to apply until the date to be determined in a delegated act adopted in accordance with paragraph 2 of this Article.

 

2. The Commission shall be empowered to adopt delegated acts in accordance to Article 253 concerning the date on which Regulation XXX/XXX shall no longer apply.

 

That date shall be the date of the application of the corresponding rules to be adopted pursuant to the delegated acts provided for in Article 114(f), and Articles 152(2) and 222(3) of this Regulation.

 

Amendment    330

Proposal for a regulation

Article 261 a (new)

Text proposed by the Commission

Amendment

 

Article 261a

 

Report to the European Parliament and the Council

 

No later than 31 December 2019, the Commission shall submit a report to the European Parliament and the Council. The Commission report shall contain a review of the impact of this Regulation, including the experience gained from its delegated powers according to Article 253 and, if appropriate, shall be accompanied by relevant proposals.

Amendment    331

Proposal for a regulation

Annex -1 (new)

 

Text proposed by the Commission

 

Amendment

Annex - I

Part 1

Diseases of terrestrial animals

Subject to rules as set out in

Article 8(1)(a)

Immediate disease control & eradication

Article 8(1)(b)

Compulsory eradication

Article 8(1)(c)

Optional “voluntary” eradication

Article 8(1)(d)

Trade

Article 8(1)(e)

Notification, reporting & surveillance

Listed species

Classical Swine Fever

X

X

0

X

X

Suidae and Tayassuidae

Bluetongue

X

X

0

X

X

All ruminants

VECTORS: Culicoides, etc.

Epizootic haemorrhagic disease of deer

X

X

0

X

X

All ruminants

 

VECTORS: Culicoides, etc.

Swine Vesicular Disease

X

X

0

X

X

Suidae and Tayassuidae

Highly Pathogenic Avian Influenza

X

X

0

X

X

Poultry, captive birds and wild birds

Low Pathogenic Avian Influenza (H5, H7)

X

X

0

X

X

Poultry and captive birds

African Swine Fever

X

X

0

X

X

Suidae and Tayassuidae

VECTORS /RESERVOIRS SOFT TICKS – Genus Ornithodorus)

Foot and Mouth Disease

X

X

0

X

X

Any domestic or wild animal of order Artylodactyla, suborders Ruminatia, Suina and Tylopoda;

(Also, some measures: Rodentia and Proboscidae)

Rinderpest

X

X

0

X

X

Ungulates

Peste des Petits Ruminants (PPR)

X

X

0

X

X

Bovidae and Suidae

 

Rift Valley Fever

X

X

0

X

X

All species of ungulates other than those of family Suidae

VECTORS: mosquitos (Aedes, Culex) midges (Culicoides)

Lumpy Skin Disease

X

X

0

X

X

Bovidae and Giraffidae

Sheep and Goat Pox (Capripox)

X

X

0

X

X

Bovidae

Contagious bovine pleuropneumonia

X

0

0

X

X

Species of the genus Bos

African Horse Sickness

X

X

0

X

X

Equidae

VECTORS: Midges: Culicoides

Equine encephalomyelitis

(Incl. EEE, WEE and equine encephalomyelitis Japanese encephalomyelitis)

X

0

0

X

X

Equidae

 

VECTORS: Mosquitoes, birds, other reservoirs…

Venezuelan equine encephalomyelitis)

X

0

0

X

X

Equidae

VECTORS: Mosquitoes, birds, other reservoirs…

West Nile Virus

0

0

0

X

X

Equidae

VECTORS: Mosquitoes

Newcastle Disease

X

X

0

X

X

Poultry, other captive birds, including pigeons

Vesicular stomatitis

X

X

0

X

X

Ungulates

Teschen Disease

X

0

0

X

X

Suidae

Glanders

0

0

0

X

X

Equidae

Dourine

0

0

0

X

X

Equidae

Equine Infectious Anaemia

0

0

0

X

X

Equidae

Rabies

 

0

0

0

X

X

Bovidae, Suidae, Ovidae, Capridae, Equidae, Carnivora and Chiroptera

 

Anthrax

0

0

0

X

X

Bovidae, Camelidae, Cervidae, Elephantidae, Equidae and Hippopotamidae

Bovine tuberculosis

 

(COMMENT: Mycobacterium tuberculosis complex : bovis, caprae)

0

X

X

(for apes and felids)

 

X

X

Mammalia, in particular Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, and Tragulidae

Brucella melitensis*

0

X

0

X

X

Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae

Brucella abortus*

0

X

0

X

X

Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae

Brucella ovis* (contagious epididymitis)

0

0

0

X

X

Antilocapridae, Bovidae, Camelidae, Cervidae, Giraffidae, Hippopotamidae and Tragulidae

Brucella suis*

0

0

X

X

X

Cervidae, Leporidae, Ovibos moschatus, Suidae and Tayassuidae

Avian chlamydiosis

0

0

0

X

X

Psittaciformes

Enzootic bovine leukosis

0

X

0

X

X

Bovine animals (including Bison bison and Bubalus bubalus)

Small Hive Beetle (Aethina tumida)

0

0

0

X

X

Apis and Bombus

Tropilaelaps mite (Tropilealaps spp.)

0

0

0

X

X

Apis

American Foulbrood

0

0

0

X

X

Apis

Monkey Pox

0

0

0

0

X

Rodentia and non-human primates

Ebola

0

0

0

0

X

Non-human primates (Apes)

Aujesky's Disease

0

0

X

X

X

Pigs

Caseous Lymphadenitis (Corynebacteium pseudotuberculosis)

0

0

X

X

0

Ovine and caprine

Pulmonary Adenomatosis

0

0

X

X

0

Ovine and caprine

Paratuberculosis

0

0

X

X

0

Ovine and caprine

Maedi-visna

0

0

X

X

0

Ovine and caprine

Caprine Viral Arthritis/Encephalitis

0

0

X

X

0

Ovine and caprine

Contagious Agalactia

0

0

X

X

0

Ovine and caprine

Border Disease

0

0

0

X

0

Ovine and caprine

Infectious bovine rhinotracheitis/ infectious pustular vulvovaginitis

0

0

X

X

0

Bovine animals

Bovine [genital] campylobacteriosis – C. foetus ssp. Venerealis

0

0

0

X

0

Bovine animals

Bovine Viral Diarrhoea/Mucosal Disease

0

0

0

X

0

Bovine animals

Trichomonas foetus

0

0

0

X

0

Bovine animals

Transmissible gastroenteritis

0

0

X

X

0

Pigs

European Foulbrood

0

0

X

X

0

Bees

Echinococcus multilocularis

0

0

X

X

X

Dogs

Salmonella of animal health relevance

Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae

0

0

X

X

0

Poultry

Zoonotic Salmonellosis (other than above)

X

0

X

X

X

Poultry

(Also, some measures: pigs)

Mycoplasma gallisepticum and Mycoplasma meleagridis

0

0

X

X

X

Poultry:

M. gallisepticum – fowls and turkeys

M. meleagridis – turkeys

Tuberculosis (other than Bovine tuberculosis)**

0

0

X

X

X

Apes, felids, ruminants

Tularaemia

0

0

X

X

0

Lagomorphs

Myxomatosis

0

0

X

X

0

Lagomorphs

Rabbit haemorrhagic disease

0

0

X

X

0

Lagomorphs

Viral Enteritis (Mink)

0

0

X

X

0

Mink

Aleutian Disease (Mink)

0

0

X

X

0

Mink

Varroosis

0

0

X

X

0

Bees

Acariasis

0

0

X

X

0

Bees

Crimean Congo haemorrhagic fever

0

0

0

X

0

Ratites

TSEs (Reg 999/2001 and Dir 92/65)

Bovine Spongiform Encephalopathy

X

X

0

X

X

Bovine animals, ovine and caprine animals

Scrapie

X

X

0

X

X

Ovine or caprine animals

Chronic Wasting Disease

X

X

0

X

X

Cervidae

TSEs not BV/OV/CP

X

X

0

0

X

All animals

Zoonoses (Dir 2003/99/EC and Reg 2075/2005 for Trichinellosis)

Trichinellosis

0

0

X

X

X

Pigs, horses, wild boar and other wild animals (susceptible to Tricinella infestation)

Listeriosis

0

0

0

0

X

Not specified

Campylobacteriosis

0

0

0

0

X

Not specified

Verotoxigenic E.coli

0

0

0

0

X

Not specified

Leptospirosis

0

0

0

0

X***

Not specified

Yersiniosis

0

0

0

0

X***

Not specified

Vibriosis

0

0

0

0

X***

Not specified

Toxoplasmosis

0

0

0

0

X***

Not specified

Cryptosporidiosis

0

0

0

0

X***

Not specified

Cysticercosis

0

0

0

0

X***

Not specified

Anisakiasis

0

0

0

0

X***

Not specified

Borreliosis

0

0

0

0

X***

Not specified

Botulism

0

0

0

0

X***

Not specified

Influenza Virus

0

0

0

0

X***

Not specified

Echinococcosis [hydatidosis]

- 'echinococcosis and agents thereof'

0

0

0

0

X

Not specified

Antimicrobial Resistance (AMR) hazards (resistant microorganism and resistance determinants)

0

0

0

0

X

Poultry, pigs and bovine animals

Calicivirus

0

0

0

0

X***

Not specified

Hepatitis A virus

0

0

0

0

X***

Not specified

Viruses transmitted by arthropods

0

0

0

0

X***

Not specified

Other zoonoses and zoonotic agents

0

0

0

0

X***

Not specified

Annex - I

Part 2

Aquatic animal diseases

Subject to rules as set out in

Article 8(1)(a)

Immediate disease control & eradication

Article 8(1)(b)

Compulsory eradication

Article 8(1)(c)

Optional “voluntary” eradication

Article 8(1)(d)

Trade

Article 8(1)(e)

Notification & surveillance

Listed species

Epizootic haematopoietic necrosis

X

X

0

X

X

Rainbow trout (Oncorhynchus mykiss) and redfin perch (Perca fluviatilis)

Infection with Bonamia exitiosa

X

X

0

X

X

Australian mud oyster (Ostrea angasi) and Chilean flat oyster

(O. chilensis)

Infection with Perkinsus marinus

X

X

0

X

X

Pacific oyster (Crassostrea gigas) and Eastern oyster (C. virginica)

Infection with Microcytos mackini

X

X

0

X

X

Pacific oyster (Crassostrea gigas), Eastern oyster (C. virginica),

Olympia flat oyster (Ostrea conchaphila) and European flat oyster

(O. edulis)

2002/99 (95/70)

Taura syndrome

X

X

0

X

X

Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp

(P. stylirostris), and Pacific white shrimp (P. vannamei)

Yellowhead disease

X

X

0

X

X

Gulf brown shrimp (Penaeus aztecus), Gulf pink shrimp (P.

duorarum), Kuruma prawn (P. japonicus), black tiger shrimp (P.

monodon), Gulf white shrimp (P. setiferus), Pacific blue shrimp (P.

stylirostris), and Pacific white shrimp (P. vannamei)

Viral haemorrhagic septicaemia (VHS)

0

0

X

X

X

Herring (Clupea spp.), whitefish (Coregonus sp.), pike (Esox lucius), haddock (Gadus aeglefinus), Pacific cod (G. macrocephalus), Atlantic cod (G. morhua), Pacific salmon (Oncorhynchus spp.) rainbow trout (O. mykiss), rockling (Onos mustelus), brown trout (Salmo trutta), turbot (Scophthalmus maximus), sprat (Sprattus sprattus), grayling (Thymallus thymallus) and olive flounder (Paralichthys olivaceus)

Infectious haematopoeitic necrosis (IHN)

0

0

X

X

X

Chum salmon (Oncorhynchus keta), coho salmon (O. kisutch), Masou salmon (O. masou), rainbow or steelhead trout (O. mykiss), sockeye salmon (O. nerka), pink salmon (O. rhodurus) chinook salmon (O. tshawytscha), and Atlantic salmon (Salmo salar)

Koi herpes virus (KHV) disease

0

0

X

X

X

Common carp and koi carp (Cyprinus carpio)

Infectious salmon anaemia (ISA)

0

0

X

X

X

Rainbow trout (Oncorhynchus mykiss), Atlantic salmon (Salmo salar), and brown and sea trout (S. trutta)

Infection with Marteilia refringens

0

0

X

X

X

Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chilensis), European flat oyster (O. edulis), Argentinian oyster (O. puelchana), blue mussel (Mytilus edulis) and Mediterranean mussel (M. galloprovincialis)

Infection with Bonamia ostreae

0

0

X

X

X

Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chilensis), Olympia flat oyster (O. conchaphila), Asiatic oyster (O. denselammellosa), European flat oyster (O. edulis), and Argentinian oyster (O. puelchana)

White spot disease

0

0

X

X

X

All decapod crustaceans (order Decapoda)

Notes:

* OIE Code = in future B. abortus, B. melitensis or B. suis in one chapter, with recommandations for (according to current draft): bovids [cattle (Bos taurus, B. indicus, B. frontalis, B. javanicus and B. grunniens), bison (Bison bison and B.

bonasus) and water buffalo (Bubalus bubalis)], sheep (Ovis aries) and goats (Capra aegagrus), pigs (Sus scrofa), camelids [dromedary camel (Camelus dromedarius), Bactrian camel (Camelus bactrianus), llama (Lama glama), alpaca (Lama pacos), guanaco (Lama guanicoe) and vicuna (Vicugna vicugna)], cervids [roe deer (Capreolus capreolus), red deer (Cervus elaphus elaphus), wapiti/elk (C. elaphus canadensis), sika (C. nippon), samba (C. unicolor unicolor), rusa (C. timorensis), fallow deer (Dama dama,), white-tailed, black-tailed, mule deer (Odocoileus spp.) and reindeer (Rangifer tarandus), European hare (Lepus europaeus).

** M. tuberculosis not OIE listed; however included in Chapter 6.11. on Zoonoses transmissible form non-human primates as M. tuberculosis complex, for specific testing / treatment recommendations during quarantine

*** Optional in Directive 2003/99/EC, depending on the epidemiological situation in MS

Regulation (EU) No 142/2011 (on ABPs) defines 'serious transmissible diseases' as follows: "The diseases listed by the OIE in Article 1.2.3 of the Terrestrial Animal Health Code, 2010 edition, and in Chapter 1.3 of the Aquatic Animal Health Code, 2010 edition, shall be regarded as serious transmissible diseases for the purposes of general animal health restrictions, as provided for in Article 6(1)(b)(ii) of Regulation (EC) No 1069/2009"

Amendment    332

Proposal for a regulation

Annex 3 – point 18

Text proposed by the Commission

Amendment

[...]

deleted

Amendment    333

Proposal for a regulation

Annex 3 – point 24

Text proposed by the Commission

Amendment

[...]

deleted

Amendment    334

Proposal for a regulation

Annex 3 – point 28

Text proposed by the Commission

Amendment

[...]

deleted

(1)

Not yet published in the Official Journal.


EXPLANATORY STATEMENT

Commission proposal COM(2013) 260 on a European animal health law is intended to replace some 40 different pieces of European legislation in this field, the oldest of which dates back to 1964. Based on the priorities of Smart Regulation and taking into account scientific evidence and international norms, the aim is to establish a single, simplified, transparent and clear regulatory framework that provides for a clear and balanced distribution of roles and responsibilities between competent authorities in the Member States, EU institutions, the farming sector, animal owners and others when it comes to the monitoring, prevention and control of different animal diseases.

In recent years, Parliament has taken a position on some key issues of relevance to this proposal and has, inter alia, expressed its support for the principles that prevention is better than cure, that animal welfare is important for public health and that veterinary medicinal products should be used responsibly.(1)

Animal protection and animal health

The Commission proposal is hugely important for public health too, since approximately 70% of our infectious diseases are common to both animals and humans. The proposal is, however, not for an animal health law as such, but rather for a law on animal disease control. It deals with the prevention and control of animal diseases which are transmissible to animals or to humans. It is important to emphasise this point (which should also be reflected in the title of the regulation, so as not to be misleading), just as it is also important to clarify that this is not an animal protection law.

A European animal protection law, containing general principles on the duty of care, the division of responsibilities and educational requirements, would be of the greatest value for animals and farmers in Europe, and is something that the European Parliament has repeatedly called for. It is, however, something completely different from what the Commission has now proposed. Likewise, animal health encompasses many factors other than infectious diseases. This does not mean that animal welfare is irrelevant in this context. On the contrary. There is a clear link between animal welfare and animal and public health. This is a key approach, now called ‘One Health’, which, happily, is reflected in Article 10 of the proposal.

It is important that the new animal health law is shaped by this approach, and by the connection between good animal husbandry and good animal health. References to animal welfare should, in this connection, be made when they are relevant to animal health, such as when part of biosecurity measures. Moreover, an explicit reference should be made to Article 13 of the Treaty on the Functioning of the European Union, as was done in the proposal for a new Control Regulation (COM(2013) 265), in order to emphasise that animals are sentient beings. It is also appropriate that this Regulation reiterate the importance of good animal husbandry and the requirements arising from EU legislation on animal transport. With respect to the movement of live animals, this Regulation should be amended to the effect that the deciding factors should be the journey time and the number of assembly operations, not whether the journey crosses a national border.

Another important issue in this context is the problem of stray animals. These can also spread infectious diseases, so strong monitoring and control measures need to be taken by the competent authorities. For this reason, the definition of ‘wild animals’ in the regulation needs to be expanded to include animals that have been previously been kept but are no longer under the direct control of an owner. It is, however, important to reiterate that EU Regulation 1099/2009 of 24 September 2009 stating that animals shall be spared any avoidable pain, distress or suffering, must be taken into consideration in this context.

Predictability and flexibility

Under the proposal, the EU Commission would be given the power to supplement the content of the regulation through 106 delegated acts and 57 implementing acts. In comparison to the current legislation in this area, which involves about 600 cases of so-called comitology procedures, this is obviously a positive development. Added to that, only about half of the proposed delegated acts and implementing acts would in effect give the Commission greater power than it currently enjoys. It is obviously important that the regulation can, if necessary, be amended quickly, e.g. in the event of a disease outbreak. It also makes no sense, of course, that the Council and the European Parliament should legislate on every tiny detail of the regulations.

An appropriate balance needs to be found between predictability and flexibility. It is important that the actual text of the regulation contains the core principles and guidelines and, in that regard, the proposal should be clarified on a number of points (e.g. lists of the diseases and species covered by the regulation should be set out in annexes). While other details may well be supplemented by the Commission at a later stage, this should be subject to the condition that decisions are made on the basis of the best available science and knowledge. It is particularly important to emphasise that, as noted in recital 13 of the Commission proposal, due account should be taken of the opinions of the European Food Safety Authority. It is also important to bear in mind that the aim is for legislation that is easy to understand and apply. The Commission should therefore be required to adopt a strategic approach and to take a thematic and coherent approach to grouping any additional acts.

Overall, however, the Commission proposal is something of a ‘pig in a poke’, and it is difficult at the moment to grasp how all the rules and regulations will look and work in practice. For this reason, the Commission should be required to submit a report to the European Parliament and the Council no later than 31 December 2019. This report should contain a review of the experience of applying this Regulation and the supplementary legal acts adopted and, if appropriate, be accompanied by relevant proposals.

Antibiotic resistance

The Commission proposal focuses on rapid and effective measures to control and eradicate certain diseases, which is useful and welcome. Experience has indeed shown what the cost of outbreaks of disease, such as foot and mouth disease in 2001, can be to society as a whole, both directly (for the farmers affected) and indirectly in the form of medical expenses and loss of income from tourism, etc. However, the largest costs to society are actually caused by endemic diseases that will not be listed in this regulation. They are also the types of diseases for which antibiotics are used as part of the treatment, and which thus are relevant to the growing problem of antibiotic resistance.

It is therefore of vital importance that, without making major changes to its basic structure, this regulation also include a requirement for preventive, proactive measures to monitor and control these non-listed diseases as well. Nor is there any reason to reinvent the wheel: Member States already have multiannual plans to control animal health, in accordance with EU Regulation (EC) No 882/2004, which is now under review. Similarly, Member States have control programmes to combat salmonella and other zoonoses in accordance with EU Regulation No 2160/2003. The existing system should, with reference to the above, be supplemented by strategic measures to monitor, prevent and control infectious animal diseases, including those not listed in this regulation. These measures should include a requirement for a good animal husbandry and responsible use of veterinary medicines.

A free market – but not the free spread of disease

The EU internal market is of key importance to Europe's economy, and nobody hankers after the glory days of border controls. Ultimately, it is clear that effective control of infectious animal diseases is the best basis for a functioning single market regarding trade in live animals, animal products and food. That is why this regulation is so important. At the same time, we have to accept the fact that certain Member States or regions have been more successful than others in managing to eradicate certain diseases on their territory. In this respect, the regulation must involve some balance. We want to have a free market – but not a free market in disease. For this reason, Article 169 on national measures for terrestrial animals should be amended so that additional safeguard measures are permitted – provided that they are founded on a strictly scientific basis and are not adopted for economic reasons, such as disguised restrictions on trade.

A functioning internal market also requires good control of animals living in a country bordering the Union. This requires strict buffer zones to prevent swine fever, for example, entering the EU from neighbouring countries. Member States should therefore – with any technical assistance required at EU level as regards listed diseases – be required to take effective biosecurity measures along their borders with third countries.

(1)

cf. European Parliament resolutions of 22 May 2008 on the EU animal health strategy, of 4 July 2012 on the EU animal protection strategy and of 11 December 2012 on the EU strategy against antibiotic resistance, among others.


OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS

Mr Paolo De Castro

Chair

Committee on Agriculture and Rural Development

BRUSSELS

Subject:  Opinion on the legal basis for the proposal for a regulation of the European Parliament and of the Council on Animal Health (COM(2013)0260 – C7-0124/2013 – 2013/0136(COD))

Dear Mr Chair,

By letter of 9 January 2014, you asked the Committee on Legal Affairs, pursuant to Rule 37 of the Rules of Procedure, to give its opinion on the appropriateness of adding Article 13 TFEU to the legal basis of the proposal for a regulation of the European Parliament and of the Council on animal health, given that an amendment to this effect had been tabled in AGRI.

The proposal for a regulation on animal health (COM(2013)0260) was presented by the Commission on the basis of Article 43(2), Article 114(3) and Article 168(4)(b) TFEU and was accordingly submitted to Parliament under the ordinary legislative procedure.

Background

1. The proposal

The proposal has been put forward as a result of a review of the Union Animal Health Policy, and following the Animal Health Strategy developed in 2007. The proposed regulation lays down rules – concerning both terrestrial and aquatic animals – for the prevention and control of animal diseases which are transmissible to animals or to humans. It includes:

– provisions on the prioritisation and listing of diseases which are likely to have a significant impact (Part I);

– provisions on early detection, notification and reporting of diseases as well as surveillance, including animal health visits (Part II);

– provision on disease preparedness, awareness and control (Part III), in particular concerning the drawing up of contingency plans, vaccination, as well as control measures to be taken in the case of suspected or confirmed outbreaks of certain diseases;

– provisions on registration and approval of establishments and transporters, movements and traceability of consignments of animals, germinal products and products of animal origin (Part IV), with distinct rules for terrestrial, aquatic, and other animals;

– standards and requirements for third countries sending animals, germinal products, products of animal origin and other material that may transmit animal diseases into the Union, in order to prevent diseases being introduced, as well as requirements for export (Part V);

– emergency measures to be taken in the event of a disease emergency situation (Part VI).

2. The legal bases in question

a) Legal basis of the proposal

The proposal is based on Article 43(2), Article 114(3) and Article 168(4)(b) TFEU. Those provisions read as follows:

Article 43(2) TFEU

"2. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, shall establish the common organisation of agricultural markets provided for in Article 40(1) and the other provisions necessary for the pursuit of the objectives of the common agricultural policy and the common fisheries policy."

Article 114(3) TFEU

"3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection taking account in particular of any development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective",

Article 168(4)(b) TFEU

"4. [...] the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns: [...]

(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;"

b) Proposed change of the legal basis

AGRI has requested the opinion of the Legal Affairs Committee on the appropriateness of adding Article 13 TFEU to the legal basis of the proposal, given that an amendment (AM 69) to this end was tabled in AGRI. A parallel amendment has been tabled in ENVI (AM 192).

Article 13 TFEU reads as follows:

"In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, which respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage."

Analysis

Certain principles emerge from the case law of the Court as regards the choice of legal basis. First, in view of the consequences of the legal basis in terms of substantive competence and procedure, the choice of the correct legal basis is of constitutional importance(1). Secondly, under Article 13(2) TEU, each institution is to act within the limits of the powers conferred upon it by the Treaty(2). Thirdly, according to the case-law of the Court of Justice, "the choice of legal basis for a Community measure must rest on objective factors amenable to judicial review, including in particular the aim and the content of the measure"(3). Finally, as regards multiple legal bases, if examination of a EU measure reveals that it pursues a twofold purpose or that it has a twofold component and if one of those is identifiable as the main or predominant purpose or component, whereas the other is merely incidental, the act must be based on a single legal basis, namely that required by the main or predominant purpose or component(4). On the other hand, where a measure has several contemporaneous objectives or components which are indissolubly linked with each other without one being secondary and indirect in respect of the others, the measure must be based on the various relevant Treaty provisions(5).

The Commission put forward Article 43(2), Article 114(3) and Article 168(4)(b) TFEU and explains its choice of legal basis as follows(6):

– Article 43 TFEU provides the basis for Union legislation regarding the Common Agricultural Policy, and also became the basis for veterinary legislation, the Common Animal Health Policy being considered to be part of the common Agricultural Policy;

– Article 114 TFEU provides the legal basis for the establishment and the functioning of the internal market and the approximation of provisions in this respect;

– Article 168 TFEU on health protection refers to the protection of human health, including from causes related to animal health. It has provided the legal basis for the adoption of veterinary measures directly aimed at protecting public health.

In order to establish whether this choice of legal basis is appropriate, as the principles derived from the jurisprudence of the Court indicate, the aim and content of the proposed measure are decisive and, in case of multiple legal bases, the question whether several purposes or components of equal weight can be identified within the proposed act.

Indeed, Article 43(2) TFEU provides the general legal basis for the common agricultural policy, under which Parliament and Council establish, apart from the organisation of the agricultural markets, other measures for the pursuit of the objectives of the common agricultural and fisheries policy. The proposal mentions "to ensure [...] the rational development of the agriculture and aquaculture sectors and to increase productivity"(recital 4) as well as "the sustainable agricultural and aquaculture production" (Article 1(2)(a)(i))as one of its objectives. Furthermore, one of the decisive factors for a disease to be included in a list of diseases to which disease specific rules for the prevention and control of diseases apply is the impact of a specific disease "on the agricultural or aquaculture production or related sectors of the economy" (Article 5(a)(ii), Article 6(1) (b)(i)). Furthermore, a number of veterinary measures which the proposal in question is due to replace (cf. Article 258) were based on the previous Article 37 EC, which has now been replaced by Article 43 TFEU. The proposed regulation can therefore, as regards its aim and content, be qualified as a measure under the common agricultural policy legal basis.

As regards the internal market legal basis, Article 114 TFEU, it is to be noted that the Commission presents "to contribute to the completion of the internal market" (recital 4) and "the effective functioning of the internal market" (Article 1(2)(a)(ii)) as one of the objectives of the proposed legislation. The measures proposed indeed have a clear dimension of facilitating trade in animals and animal products within the internal market. Registration and approval of items as proposed in Part IV of the regulation are for instance classic internal market instruments. The proposed regulation therefore equally qualifies as a measure for completing the functioning of the internal market. It is thus necessary to include Article 114 TFEU in the legal basis(7).

Article 168 TFEU lays down in its paragraph 1 the general objective for the Union to ensure a "high level of human health protection". Against this background, Article 168(4) TFEU provides for specific measures to be adopted by the European Parliament and Council under the ordinary legislative procedure, i.e. harmonisation measures in order to meet common safety concerns (Article 168(4) TFEU). More specifically, Article 168(4)(b) TFEU relates to measures in the veterinary field which have as their direct objective the protection of public health.

The proposal in question addresses common safety concerns in public health matters as regards animal diseases transmissible to animals or to humans and puts forward specific veterinary measures which have as their direct objective the protection of public health. The protection of public health is repeatedly identified as one of the objectives of this regulation (recitals 2, 4, Article 5(2)(a)(i), Article 6(1)(b)(ii)). Specific health policy measures are for instance the provisions on early detection, notification and reporting of animal diseases, on disease awareness and control.

As the proposed regulation thus includes measures relating to the common agricultural policy, to the functioning of the internal market and to the protection of public health, it appears appropriate to base the proposal on the corresponding provisions under the TFEU, i.e. Article 43(2), Article 114 and Article 168(4)(b) TFEU.

As regards the possible addition of Article 13 TFEU to the legal basis, the justification to AM 69 tabled in AGRI reads as follows: "To include a specific reference to Article 13 of the TFEU, covering animal welfare". The identical AM 192 tabled in the ENVI committee quotes the content of Article 13 TFEU in its justification.

Article 13 lays down the general principle and objective for the Union and the Member States to "pay full regard to the welfare requirements of animals" when formulating and implementing certain Union policies. It does not however provide for any specific measures or procedures to this end and is contained in Title II of the TFEU ("Provisions having general application). Thus, Article 13 TFEU defines a relevant objective and does not provide for the adoption of measures. It does not constitute a legal basis. The relevant legal basis providing for Union competence under the principle of conferral is to be derived from specific Treaty provisions, whereas the objectives laid down in Article 13 TFEU are to be taken into account when exercising these competences.

In the final analysis, it is considered that it is unnecessary for Article 13 TFEU to be included in a citation as forming part of the legal basis. Should it appear desirable for political reasons to highlight the relevance of Article 13 TFEU to the present piece of legislation, a possibility might be to make reference to this provision in the recitals as has for instance been proposed in AM 5 tabled in the ENVI committee or AM 1 tabled in the PECH committee.

In its note dated 15 January 2014 the Parliament's Legal Service equally comes to the conclusion that it is not appropriate to add Article 13 TFEU to the legal basis of the proposal.

Legal Affairs Committee recommendation

The Legal Affairs Committee considered the above question at its meeting of 21 January 2014. At this meeting, it accordingly decided, by unanimity(8), to recommend that the appropriate legal basis for the proposal for a regulation of the European Parliament and of the Council on animal health should be Article 43(2), Article 114 and Article 168(4)(b) TFEU without the addition of Article 13 TFEU.

Yours sincerely,

Klaus-Heiner Lehne

(1)

Opinion 2/00 Carthagna Protocol [2001] E.C.R. I-9713, para. 5; Case C-370/07 Commission v Council [2009] E.C.R. I-8917, paras 46-49; Opinion 1/08, General Agreement on Trade in Services [2009] ECR I-11129, para. 110.

(2)

Case C-403/05 Parliament v Commission [2007] E.C.R. I-9045, para. 49, and the case-law cited therein.

(3)

See most recently Case C-411/06 Commission v Parliament and Council [2009] E.C.R. I-7585.

(4)

Case C-42/97 Parliament v Council [1999] E.C.R. I-868, paras. 39-40; Case-C 36/98 Spain v Council [2001] E.C.R. I-779, para. 59; Case C-211/01 Commission v Council [2003] E.C.R. I-8913, para. 39.

(5)

Case C-165/87 Commission v Council [1988] E.C.R. 5545, para. 11; Case C-178/03 Commission v. European Parliament and Council [2006] E.C.R. I-107, paras. 43-56.

(6)

COM(2013)0260, Explanatory memorandum, p. 4/5.

(7)

For the sake of completeness it might appear more appropriate to mention Article 114 as a whole and not only Article 114(3) TFEU in the legal basis of the proposed regulation as Article 114 (3) TFEU does not contain a legal basis in itself but merely stipulates that the Commission, in its proposals under Article 114(1) TFEU concerning health, safety, environmental protection and consumer protection, is to take as its base a high level of protection.

(8)

The following were present for the final vote: Raffaele Baldassarre, Sebastian Valentin Bodu, Françoise Castex, Christian Engström, Marielle Gallo, Giuseppe Gargani, Lidia Joanna Geringer de Oedenberg, Sajjad Karim, Klaus-Heiner Lehne, Eva Lichtenberger, Antonio Masip Hidalgo, Alajos Mészáros, Angelika Niebler, Bernhard Rapkay, Evelyn Regner, Francesco Enrico Speroni, Rebecca Taylor, Alexandra Thein, Axel Voss, Cecilia Wikström, Tadeusz Zwiefka.


OPINION of the Committee on the Environment, Public Health and Food Safety (30.1.2014)

for the Committee on Agriculture and Rural Development

on the proposal for a regulation of the European Parliament and of the Council on Animal Health

(COM(2013)0260 – C7-0124/2013 – 2013/0136(COD))

Rapporteur: Kartika Tamara Liotard

SHORT JUSTIFICATION

The Regulation on Animal Health, in your rapporteur's opinion, will determine the future approach towards safeguarding animals' health. From a technical point of view this Regulation should aim to coordinate and simplify the existing legislation concerning animal health, in order to reduce the complexity and to ensure the correct implementation. From a substance point of view this Regulation should aim primarily to prevent, and in the worst case control, the diseases which affect animal health and human health.

The scope of the Regulation should be in line with the spirit of "prevention is better than cure", and the "One Health Approach", which is enshrined in the "Animal Health Strategy (2007-2013)" of the EU. Studies have demonstrated that there is a clear link between animal health and animal welfare, as well as a clear link between animal diseases and the agricultural practices of breeding, rearing and transporting of animals.

Current intensive farming systems and transport practices, which restrict natural movement of the animals, increase stress and increase the need for antibiotics, regrettably create the ideal conditions for pathogens to multiply. These conditions are factors that risk harm to animals' health and consequently to human health. Furthermore, reproduction methods such as cloning or the modification of the genome of the animal have resulted in adverse animal health effects, such as kidney and brain malformations, and impaired immune systems. This creates unknown risk factors with regards to a possible outbreak of a disease and/or a transfer of that disease to humans.

For your rapporteur the starting point should be a strategy of prevention which, when looking at the roots of the problem and taking the precautionary principle in mind, tries to eliminate the risk factors that create the problems that affect animal health. Each year more than 64 billion animals are born, raised and slaughtered for food globally. There is a significant interconnection between livestock farming, livestock trade and wildlife trade. Therefore, EU animal health legislation should first and foremost determine how animal disease outbreaks occur and how they can be prevented, controlled and how lessons can be learned from the disease control measures taken in the past (Avian Influenza, Food and Mouth disease, Swine Flu, BSE etc.). In your rapporteur's opinion, mass-killing of animals should only be used as a last resort.

Since 1980 more than 35 infectious diseases have emerged and 87 pathogens have been discovered that have originated from animals and were transferred onto humans entailing considerable economic costs, all of which could have been avoided.

Domestic and wild animals form part of the ecosystem and interact with each other. Maltreatment of those in whichever form, from inhumane breeding methods to forced relocation for trading reasons, have an environmental impact on the balance of the ecosystem. This creates favourable conditions for disease outbreaks, which have to be remedied by measures that may harm the biodiversity and the ecosystem balance. Your rapporteur, having previously worked in the field for the Dutch Ministry of Agriculture, can only remember too well the massive impact on the environment and society of the mass culling and subsequent disposal of carcasses during the outbreaks of Avian Influenza, Foot and Mouth Disease and the Swine Flu. Contamination of groundwater and large soot clouds from the pyres have far-reaching impacts, which are often not factored in by policy makers.

Improving animal welfare does not have to impose great penalties on business returns. The current boom in organic farming, and Member State initiatives as for instance the "Beter Leven" mark on beef, pork, poultry and eggs in the Netherlands, have showed that there is a demand amongst consumers for higher animal welfare standards which imply a better and safer food quality. Clearer consumer information on animal welfare would contribute positively.

Finally, some matters of a more procedural nature. Firstly, it is important that there is a coordinated framework on animal health. However, it is also important that Member States are able to take additional measures which are in line with this legislation, but go beyond the provisions of this legislation, when this is necessary for a quick response in a crisis.

Secondly, the rapporteur is concerned by the Commission proposing to repeal two legal instruments regarding non-commercial movements of pets and electronic identification of bovine animals and beef labelling, which recently have been adopted by the co-legislators or are currently going through the co-decision procedure. This behaviour by the Commission does not benefit legal certainty and should not be encouraged further.

Finally, although there is a significant interdependence of animal health and animal welfare, your rapporteur would not want to preclude the eventual outcome of a future proposal on animal welfare.

AMENDMENTS

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Agriculture and Rural Development, as the committee responsible, to incorporate the following amendments in its report:

Amendment    1

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114(3) and Article 168(4)(b) thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 13, Article 43(2), Article 114(3) and Article 168(4)(b) thereof,

Justification

Article 13 says: In formulating and implementing the Union’s agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage.

Amendment    2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) The impact of transmissible animal diseases and the measures necessary to control these diseases can be devastating for individual animals, animal populations, animal keepers and the economy.

(1) The impact of transmissible animal diseases and the measures necessary to control these diseases can be devastating for individual animals, animal populations, animal keepers, the public and the economy in certain regions and countries.

Amendment    3

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health, as for example in the case of avian influenza and salmonella.

(2) As recent experiences have demonstrated, transmissible animal diseases may also have a significant impact on public health, as for example in the case of Bovine Spongiform Encephalopathy (BSE), avian influenza and salmonella.

Justification

The BSE crisis is worth mentioning here because apart from being a serious animal health issue that was transmitted onto humans through food, it was also a major crisis of confidence where the public lost trust in the safety of the food chain and policy makers.

Amendment    4

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) In addition, adverse interactive effects can be observed with regard to biodiversity, climate change and other environmental aspects. Climate change may influence the emergence of new diseases, the prevalence of existing diseases and the geographic distribution of disease agents and vectors, including those affecting wildlife.

(3) In addition, adverse interactive effects can be observed with regard to biodiversity, food security, climate change, pollution and other environmental aspects. Climate change may influence the emergence of new diseases, the prevalence of existing diseases and the geographic distribution of disease agents and vectors, including those affecting wildlife.

Justification

Food security and environmental pollution are also affected by transmissible animal diseases.

Amendment    5

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) In order to ensure high standards of animal and public health in the Union, the rational development of the agriculture and aquaculture sectors and to increase productivity, animal health rules should be laid down at Union level. These rules are necessary, inter alia, to contribute to the completion of the internal market, and to avoid the spread of infectious diseases.

(4) In order to ensure high standards of animal and public health in the Union, the rational development of the agriculture and aquaculture sectors and to increase sustainable productivity, animal health rules should be laid down at Union level. These rules are necessary, inter alia, to contribute to the completion of the internal market, to avoid the spread of infectious diseases, and to enhance animal welfare.

Justification

There are numerous studies, even scientific opinions from EFSA, which prove that enhancing animal welfare benefits animal health and vice versa.

Amendment    6

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) The current Union animal health legislation consists of a series of linked and interrelated basic acts that lay down rules on animal health applying to intra-Union trade, entry into the Union of animals and products, disease eradication, veterinary controls, notification of diseases and financial support in relation to different animal species, but an overarching legal framework, providing harmonised principles across the sector is missing.

(5) The current Union animal health legislation consists of a series of linked and interrelated basic acts that lay down rules on animal health applying to intra-Union trade, entry into the Union of animals and products, disease eradication, veterinary controls, notification of diseases and financial support in relation to different animal species, but an overarching legal framework, providing harmonised principles across the sector – and geared to the sustainable development of the livestock sector and safeguarding human lives and health – is missing.

Amendment    7

Proposal for a regulation

Recital 6 a (new)</Article>

Text proposed by the Commission

Amendment

 

(6a) The Communication from the Commission on the European Union Strategy for the Protection and Welfare of Animals 2012-2015 reiterates that Article 13 of the Treaty on the Functioning of the European Union recognises animals as sentient beings and requires full regard be given to the welfare requirements of animals while formulating and enforcing EU policies. In this respect, due consideration needs to be given to the positive effect of high animal welfare standards on animal health.

Amendment    8

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) The aim of this Regulation is to implement the commitments and visions provided for in that Animal Health Strategy, including the "One health" principle, and to consolidate the legal framework for a common Union animal health policy through a single, simplified, and flexible regulatory framework for animal health.

(7) The aim of this Regulation is to implement the commitments and visions provided for in that Animal Health Strategy, including the "One health" principle, as advocated in particular by the World Organisation for Animal Health (OID), and to consolidate the legal framework for a common Union animal health policy through a single, simplified, and flexible regulatory framework for animal health.

Amendment    9

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

 

(7a) Since contagious pathogens can easily be spread from one holding to another, as the Commission stresses in its communication on a new Animal Health Strategy for the EU, a collective approach to preventive and biosafety measures should be adopted, involving all stakeholders.

Amendment    10

Proposal for a regulation

Recital 7 b (new)

Text proposed by the Commission

Amendment

 

(7b) The intensification and integration of food production and the increase of transport during production and before slaughtering is the cause of many of the infectious animal diseases that have emerged in the 20th century. This Regulation provides the base for existing methods to be carefully evaluated and reviewed in order to identify the source of problems and diseases related to animals and to take adequate measures to prevent unsustainable farming methods leading to the kind of outbreaks we have seen in the recent past.

Justification

The farming of animals has intensified over the past decades, with certain establishments housing several thousands of animals on a relatively small surface. Also, long distance transports of animals for slaughter are on the rise, where the animals are in closed confines for long periods of time. These practices create ideal circumstances for pathogens to multiply, which risks harming public and animal health.

Amendment    11

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) In laying down those animal health rules, it is essential that considerations are given to the link between animal health and public health, the environment, food and feed safety, animal welfare, food security, economic, social and cultural aspects.

(9) In laying down those animal health rules, it is essential that considerations are given to the link between animal health and public health, the environment, food and feed safety, food security, economic, social and cultural aspects, and especially animal welfare, given the interdependency of animal welfare and animal health, trying to minimize animal suffering and provide pro-active solutions to disease risks.

Amendment    12

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) In specific circumstances where a significant animal or public health risk exists but scientific uncertainty persists, Article 5(7) of the SPS Agreement which has been interpreted for the Union in the Communication from the Commission of 2 February 2000 on the precautionary principle13 allows a Member of that agreement to adopt provisional measures on the basis of available pertinent information. In such circumstances, the WTO Member is required to obtain the additional information necessary for a more objective assessment of risk and review the measure accordingly within a reasonable period of time.

(12) In specific circumstances where a significant animal or public health risk exists but scientific uncertainty persists, Article 5(7) of the SPS Agreement which has been interpreted for the Union in the Communication from the Commission of 2 February 2000 on the precautionary principle, which is enshrined in European Union law in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, allows a Member of that agreement to adopt provisional measures on the basis of available pertinent information. In such circumstances, the WTO Member is required to obtain the additional information necessary for a more objective assessment of risk and review the measure accordingly within a reasonable period of time.

Amendment    13

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Diseases occurring in wild animal populations may have a detrimental effect on the agriculture and aquaculture sectors, on public health, the environment and biodiversity. It is therefore appropriate that the scope of this Regulation should, in such cases, cover wild animals, both as potential victims of those diseases and as their vectors.

(16) Diseases occurring in wild animal populations, as for instance rabies and Batrachochytrium dendrobatidis (commonly referred to as the chytrid fungus), may have a detrimental effect on the agriculture and aquaculture sectors, on public health, the environment and biodiversity. It is therefore appropriate that the scope of this Regulation should, in such cases, cover wild animals, both as potential victims of those diseases and as their vectors.

Amendment    14

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Animal diseases are not only transmitted through direct contact between animals or between animals and humans. They are also carried further afield through water and air systems, vectors such as insects, or the semen, ova and embryos used in artificial insemination, ovum donation or embryo transfer. Disease agents may also be contained in food and other products of animal origin such as leather, fur, feathers, horn and any other material derived from the body of an animal. Moreover various other objects such as transport vehicles, equipment, fodder and hay and straw may diffuse disease agents. Therefore, effective animal health rules need to cover all paths of infection and material involved therein.

(17) Animal diseases are not only transmitted through direct contact between animals or between animals and humans. They are also carried further afield through water, soil and air systems, vectors such as insects, or the semen, ova and embryos used in artificial insemination, ovum donation or embryo transfer. Disease agents may also be contained in food and other products of animal origin such as leather, fur, feathers, horn and any other material derived from the body of an animal. Moreover various other objects such as transport vehicles, equipment, fodder and hay and straw may diffuse disease agents. Therefore, effective animal health rules need to cover all paths of infection and material involved therein.

Amendment    15

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Animal diseases may have detrimental effects on the distribution of animal species in the wild, and thus affect biodiversity. Microorganisms causing animal diseases can therefore fall within the definition of invasive alien species of the United Nations Convention on Biological Diversity. The measures provided for in this Regulation also take account of biodiversity and thus this Regulation should cover animal species and disease agents, including those defined as invasive animal species, which play a role in the transmission of, or are affected by, diseases covered by this Regulation.

(18) Animal diseases may have detrimental effects on the distribution of animal species in the wild, and thus affect biodiversity. Microorganisms causing animal diseases can therefore fall within the definition of invasive alien species of the United Nations Convention on Biological Diversity. The measures provided for in this Regulation also take account of biodiversity and thus this Regulation should cover animal species and disease agents, including those defined as invasive animal species, which play a role in the transmission of, or are affected by, diseases covered by this Regulation. This should include invasive pathogens, such as Batrachochytrium dendrobatidis, an amphibian disease listed by the World Organisation for Animal Health (OIE) and causing population declines and extinction.

Amendment    16

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) In Union legislation adopted prior to this Regulation separate animal health rules are laid down for terrestrial and aquatic animals. Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals20 lays down specific rules for aquatic animals. Yet in most cases, the main principles for good animal health governance are applicable to both groups of animal species. Accordingly, the scope of this Regulation should cover both terrestrial and aquatic animals and aligns those animal health rules where applicable. However, for certain aspects, in particular the registration and approval of establishments and the traceability and movements of animals within the Union, this Regulation adheres to the approach adopted in the past, which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health.

(19) In Union legislation adopted prior to this Regulation separate animal health rules are laid down for terrestrial and aquatic animals. Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals lays down specific rules for aquatic animals. Yet in most cases, the main principles for good animal health governance and good animal husbandry are applicable to both groups of animal species. Accordingly, the scope of this Regulation should cover both terrestrial and aquatic animals and aligns those animal health rules where applicable. However, for certain aspects, in particular the registration and approval of establishments and the traceability and movements of animals within the Union, this Regulation adheres to the approach adopted in the past, which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health.

Amendment    17

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) Union legislation adopted prior to this Regulation and in particular Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC21 also lays down basic animal health rules for other animal species not regulated in other Union acts, such as reptiles, amphibians, marine mammals, and others which are not aquatic or terrestrial animals as defined in this Regulation. Usually, such species do not represent a significant health risk for humans or other animals and therefore only a few animal health rules, if any, apply. In order to avoid unnecessary administrative burdens and costs, this Regulation should adhere to the approach adopted in the past, namely to provide the legal framework for detailed animal health rules for movements of such animals and their products to be laid down if the risks involved so require.

(20) Union legislation adopted prior to this Regulation and in particular Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC21 also lays down basic animal health rules for other animal species not regulated in other Union acts, such as reptiles, amphibians, marine mammals, and others which are not aquatic or terrestrial animals as defined in this Regulation. These species were not considered to represent a significant health risk for humans or other animals and therefore only a few animal health rules, if any, apply. Evidence of reptile and amphibian species spreading salmonella to humans and fungal pathogens (Batrachochytrium dendrobatidis) to wild amphibian populations suggest detailed rules for such species may be warranted.

__________________

__________________

21 OJ L 268, 14.9.1992, p. 54.

21 OJ L 268, 14.9.1992, p. 54.

Amendment    18

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) The keeping of pet animals, including ornamental aquatic animals in households and non-commercial ornamental aquaria, both indoors and outdoors, generally represents a lower health risk compared to other ways of keeping or moving animals on a broader scale, such as those common in agriculture. Therefore, it is not appropriate that the general requirements concerning registration, record keeping and movements within the Union apply to such animals, as this would represent an unjustified administrative burden and cost. Registration and record keeping requirements should therefore not apply to pet keepers. In addition, specific rules should be laid down for non-commercial movements of pet animals within the Union.

(21) The keeping of pet animals, including ornamental aquatic animals in households and non-commercial ornamental aquaria, both indoors and outdoors, a practice of a non-commercial nature, generally represents a lower health risk compared to other ways of keeping or moving animals on a broader scale, such as those common in agriculture. Therefore, it is not appropriate that the general requirements concerning registration, record keeping and movements within the Union apply to such animals, as this would represent an unjustified administrative burden and cost for citizens. Registration and record keeping requirements should therefore not apply to pet keepers. In addition, specific rules should be laid down for non-commercial movements of pet animals within the Union.

Amendment    19

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) For transmissible animal diseases a disease condition is usually associated with clinical or pathological manifestation of the infection. However, for the purpose of this Regulation, which aims to control the spread of and eradicate certain transmissible animal diseases, the disease definition should be wider in order to include other carriers of the disease agent.

(25) For transmissible animal diseases a disease condition is usually associated with clinical or pathological manifestation of the infection. However, for the purpose of this Regulation, which aims to control the spread of and eradicate certain transmissible animal diseases, the disease definition should be wider in order to include other carriers of the disease agent as for instance microorganisms developing resistance to antimicrobials.

Amendment    20

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) Some transmissible animal diseases do not easily spread to other animals or to humans and thus do not cause economic or biodiversity damage on a wide scale. Therefore, they do not represent a serious threat to animal or public health in the Union and can thus, if desired, be addressed by national rules.

deleted

Justification

No need to put this into the text of the Regulation, as Member States are well aware of this already.

Amendment    21

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) For transmissible animal diseases that are not subject to measures laid down at Union level, but which are of some economic importance for the private sector at a local level, the latter should, with the assistance of the competent authorities of the Member States, take actions to prevent or control such diseases, for instance through self-regulatory measures or the development of codes of practice.

(27) For transmissible animal diseases that are not subject to measures laid down at Union level, but which are of some economic importance for the private sector at a local level, Member States should have the preparedness to respond and, together with the private sector, to take actions to prevent or control such diseases, for instance through developing practical measures to avert their harmful effects and establishing self-regulatory mechanisms and developing codes of practice or exchange of best practices.

Justification

There have been countless scandals, some of which quite recently, ranging from hormones to Salmonella that clearly prove that self-