Procedure : 2014/0255(COD)
Document stages in plenary
Document selected : A8-0075/2016

Texts tabled :

A8-0075/2016

Debates :

PV 24/10/2018 - 20
CRE 24/10/2018 - 19
CRE 24/10/2018 - 20

Votes :

PV 25/10/2018 - 13.6

Texts adopted :

P8_TA(2018)0422

REPORT     ***I
PDF 981kWORD 651k
5.4.2016
PE 549.334v03-00 A8-0075/2016

on the proposal for a regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC

(COM(2014)0556 – C8‑0143/2014 – 2014/0255(COD))

Committee on Agriculture and Rural Development

Rapporteur: Clara Eugenia Aguilera García

ERRATA/ADDENDA
AMENDMENTS
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 OPINION of the Committee on the Environment, Public Health and Food Safety
 PROCEDURE – COMMITTEE RESPONSIBLE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC

(COM(2014)0556 – C8‑0143/2014 – 2014/0255(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2014)0556),

–  having regard to Article 294(2) and Article 43 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 (C8-0143/2014),

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

–  having regard to the opinion of the European Economic and Social Committee of 21 January 2015(1),

–  having consulted the Committee of the Regions,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Agriculture and Rural Development and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0075/2016),

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

Citation 1

Text proposed by the Commission

Amendment

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

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

Justification

The legal basis for this proposal is Article 43(2) whereby the ordinary legislative procedure is used for legislation necessary for the pursuit of the objectives of the common agricultural policy.

Amendment    2

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

 

(3a) Prevention of disease is better than cure. Medicinal treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.

Amendment    3

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) As a type of feed, medicated feed falls within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council6, of Regulation (EC) No 767/2009 of the European Parliament and of the Council7, of Regulation (EC) No 1831/2003 of the European Parliament and of the Council8 and of Directive 2002/32/EC of the European Parliament and of the Council9. Specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment, personnel, manufacture quality control, storage and transport, record-keeping, complaints and product recalls, the application of procedures based on the hazard analysis and critical control points (HACCP) principles and labelling.

(6) As types of feed, medicated feed and intermediate products fall within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council6, of Regulation (EC) No 767/2009 of the European Parliament and of the Council7, of Regulation (EC) No 1831/2003 of the European Parliament and of the Council8 and of Directive 2002/32/EC of the European Parliament and of the Council9. Specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment, personnel, manufacture quality control, storage and transport, record-keeping, complaints and product recalls, the application of procedures based on the hazard analysis and critical control points (HACCP) principles and labelling.

__________________

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6 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

6 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

7 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (OJ L 229, 1.9.2009, p. 1).

7 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (OJ L 229, 1.9.2009, p. 1).

8 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

8 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

9 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).

9 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).

Amendment    4

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals.

(9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. The holder of the authorisation of the veterinary medicinal products should be responsible for compatibility assessment. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals. The inclusion rates set should as a matter of principle be geared to a farm’s average needs. To take account of the specific features of the small-scale farming sector, and in particular to enable small or remote farms to optimise livestock care, it should be permissible to retain established control systems provided that it is ensured that the prescription, production and use of medicated feed take place under the instructions and supervision of a veterinarian and are subject to an external process control.

Amendment    5

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) Homogeneous incorporation of the veterinary medicinal product into the feed is also crucial for the manufacture of a safe and efficient medicated feed. Therefore, the possibility to establish criteria, such as target values, for the homogeneity of the medicated feed should be provided for.

(10) Homogeneous distribution of the veterinary medicinal product in the feed is also crucial for the manufacture of a safe and efficient medicated feed. Therefore, the possibility to establish criteria, such as target values, for the homogeneity of the medicated feed should be provided for.

Justification

The objective is to ensure that the veterinary medicinal product is evenly distributed in the feed. ‘Distribution’ is a term used in the pharmaceutical sector.

Amendment    6

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of carry-over' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term cross-contamination' is to be considered as a contamination resulting from a carry-over or from the transfer in feed of any unintended substance. Carry-over of active substances contained in medicated feed to non-target feed should be avoided or kept as low as possible. In order to protect animal health, human health and the environment, maximum levels of carry-over for active substances contained in medicated feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority and taking into account the application of good manufacturing practice and the ALARA (As Low As Reasonably Achievable) principle. General limits should be set out in this Regulation, taking into account the unavoidable carry-over and the risk caused by the active substances concerned.

(12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of 'carry-over' is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term 'cross-contamination' is to be considered as a contamination resulting from a carry-over or from the transfer in feed of any unintended substance. Carry-over of active substances contained in medicated feed to non-target feed should be kept as low as possible. In order to protect animal health, human health and the environment, maximum limits for levels of carry-over for active substances contained in non-target feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority and taking into account the application of good manufacturing practice and the ALARA (As Low As Reasonably Achievable) principle. In the interim period, a general maximum limit should be set out in this Regulation, taking into account the unavoidable carry-over and the risk caused by the active substances concerned.

Amendment    7

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) Medicated feed should be marketed in sealed containers for safety reasons and to protect user's interest.

(14) Medicated feed should be marketed in sealed containers for safety reasons and to protect user's interest. However, appropriate derogations should be provided for where the application of that requirement is not necessary to protect human or animal health or consumer interests, and would represent an excessive administrative and technical burden.

Justification

Existing derogations under Article 23 of Regulation (EC) No 767/2009 for the transport of feed should be included in this regulation to ensure consistency with current transport arrangements for medicated feed in certain Member States.

Amendment    8

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) For intra Union trade of medicated feed, it should be ensured that the veterinary medicinal product contained therein has been duly authorised in the Member State of destination according to Directive 2001/82/EC.

(15) For intra-Union trade of medicated feed, it should be ensured that the veterinary medicinal product contained therein, or another veterinary medicinal product with equivalent active substances or composition, has been duly authorised in the Member State of destination in accordance with Regulation (EU) 2016/... (Veterinary Medicinal Products).

Justification

It is important not to hamper intra-Community trade in medicated feed, in particular to help farmers in Member States with small markets. In some cases, a veterinary medicinal product may not be authorised in a Member State for commercial reasons.

Amendment    9

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Feed business operators manufacturing, whether they operate in a feed mill, with a specially equipped lorry or on-farm, storing, transporting or placing on the market medicated feed and intermediate products, should be approved by the competent authority, in line with the approval system laid down in Regulation (EC) No 183/2005, in order to ensure both feed safety and product traceability. Provision should be made for a transition procedure concerning establishments already approved under Directive 90/167/EEC.

(16) Feed business operators manufacturing, whether they operate in a feed mill, with a specially equipped mobile infrastructure or on-farm, storing, transporting or placing on the market medicated feed and intermediate products, should be approved by the competent authority, in line with the approval system laid down in Regulation (EC) No 183/2005, in order to ensure both feed safety and product traceability. Provision should be made for a transition procedure concerning establishments already approved under Directive 90/167/EEC. The approval and registration procedure under Regulation (EC) No 183/2005 should take account of the specific features of primary production with a view to ensuring that in particular small or remote farms can optimise livestock care through the use of medicated feed.

Amendment    10

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission

Amendment

 

(16a) Care should be taken to ensure that the medicated feed handling requirements imposed by this Regulation and delegated and implementing acts adopted pursuant to this Regulation on feed business operators, in particular on-farm mixers, are feasible and practical.

Amendment    11

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded

(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid written or electronic veterinary prescription which has been issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law after examination of the animals to be treated or, if appropriate under applicable national law, following a proper assessment of the health status of the animals concerned. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.

Amendment    12

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

 

(17a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines.

Justification

The persons authorised to prescribe certain veterinary medicines should be determined by the relevant national authorities. Those with suitable qualifications, recognised by the Member State in which they reside, shall not be prohibited from prescribing and supplying certain veterinary medicines.

Amendment    13

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) In order to ensure a particularly prudent use of medicated feed for food-producing animals and therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-keeping by the animal holder should be provided for.

(18) In order to ensure a particularly prudent use, which means appropriate use of medicines in accordance with the prescription, of medicated feed for food-producing and non-food producing animals and therefore provide the basis for the assurance of a high level of protection of animal health and public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-keeping by the animal holder should be provided for.

Amendment    14

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use or use to enhance the performance of food-producing animals should in particular not be allowed.

(19) Taking into account the serious public health risk posed by resistance to antibiotics, it is appropriate to limit the use of medicated feed containing antibiotics for animals. Prophylactic use of medicated feed containing antibiotics should not be allowed unless such use is permitted under Regulation (EU) 2016/... (Veterinary Medicinal Products). The use of antibiotics to enhance the performance of food-producing animals should be prohibited.

Justification

See justification for the amendment on Article 16 - paragraph 2.

Amendment    15

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

 

(19a) In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as from 1 January 2006 should be strictly adhered to and properly enforced.

Amendment    16

Proposal for a regulation

Recital 19 b (new)

Text proposed by the Commission

Amendment

 

(19b) The 'One Health' concept, endorsed by the World Health Organisation (WHO) and the World Organisation for Animal Health (OIE), recognises that human health, animal health and ecosystems are interconnected and it is therefore essential for both animal and human health to ensure prudent use of antimicrobial medicines in food-producing animals.

Amendment    17

Proposal for a regulation

Recital 19 c (new)

Text proposed by the Commission

Amendment

 

 

(19c) On 19 May 2015 the European Parliament adopted a resolution on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance.

Amendment    18

Proposal for a regulation

Article 1

Text proposed by the Commission

Amendment

This Regulation shall apply to:

This Regulation shall apply to:

(a) the manufacture, storage and transport of medicated feed and intermediate products;

(a) the manufacture, storage and transport of medicated feed and intermediate products intended for both food-producing and non-food producing animals;

(b) the placing on the market, including import, and use of medicated feed and intermediate products;

(b) the placing on the market, including import from third countries, and use of medicated feed and intermediate products intended for both food-producing and non-food producing animals;

(c) the export to third countries of medicated feed and intermediate products. However, Articles 9, 15, 16 and 17 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.

(c) the export to third countries of medicated feed and intermediate products. However, Articles 9, 15, 16 and 17 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.

Amendment    19

Proposal for a regulation

Article 1 – paragraph 1a (new)

Text proposed by the Commission

Amendment

 

 

1a. This Regulation shall not apply to finished veterinary medicinal products to be orally administered that have been approved for use via feed as oral powders (via 'top dressing') or in drinking water. The Commission shall, by ... [12 months after the date of entry into force of this Regulation], propose a specific legislative proposal on the administration of veterinary medicinal products for use via feed or in drinking water.

Amendment    20

Proposal for a regulation

Article 2 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the definitions of 'food-producing animal', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', 'labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;

(c) the definitions of 'food-producing animal', 'non-food producing animal', 'fur animal', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', 'labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;

Amendment    21

Proposal for a regulation

Article 2 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the definition of 'establishment' as laid down in Article 3 of Regulation (EC) No 183/2005;

(d) the definition of 'establishment' and 'feed business operator' as laid down in Article 3 of Regulation (EC) No 183/2005;

Amendment    22

Proposal for a regulation

Article 2 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) the definitions of 'veterinary medicinal product', 'withdrawal period', 'strength' and 'veterinary prescription' as laid down in Article 1 of Directive 2001/82/EC.

(f) the definitions of 'veterinary medicinal product', 'withdrawal period', 'strength´, 'veterinary prescription' and ´premix for medicated feedingstuffs´ as laid down in Article 1 of Directive 2001/82/EC.

Justification

The definition of the ´premix for medicated feedingstuffs´ should be amended, as the medicated premix is the veterinary medicinal product, which is an appropriate pharmaceutical form primarily authorised to be used incorporated in medicated feedingstuffs in conditions fully in compliance with the conditions of the marketing authorisation.

Amendment    23

Proposal for a regulation

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

Text proposed by the Commission

Amendment

 

(fa) the definitions of 'antimicrobials'and 'antibiotics' / 'antibacterials' as laid down in Regulation (EU) 2016/... (Veterinary Medicinal Products);

Amendment    24

Proposal for a regulation

Article 2 – paragraph 1 – point f b (new)

Text proposed by the Commission

Amendment

 

(fb) the definition of 'preventive treatment (prophylaxis' as laid down in Regulation (EU) 2016/... (Veterinary Medicinal Products);

Amendment    25

Proposal for a regulation

Article 2 – paragraph 1 – point f c (new)

Text proposed by the Commission

Amendment

 

(fc) the definition of 'control treatment (metaphylaxis)' as laid down in Regulation (EU) 2016/... (Veterinary Medicinal Products);

Amendment    26

Proposal for a regulation

Article 2 – paragraph 1 – point f d (new)

Text proposed by the Commission

Amendment

 

(fd) the definition of 'curative (therapeutic) treatment' as laid down in Regulation (EU) 2016/... (Veterinary Medicinal Products);

Amendment    27

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) 'medicated feed': a mixture of one or more veterinary medicinal products or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing;

(a) 'medicated feed': a mixture of one or more veterinary medicinal products or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing, owing to the properties brought by the medicinal part of the mixture for treating or preventing disease and owing to the properties brought by the feed part of the mixture for providing nutrition;

Amendment    28

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘intermediate product’: a mixture of one or more veterinary medicinal products with one or more feeds, intended to be used for the manufacture of medicated feed;

(b) ‘intermediate medicated feed’: a mixture of one or more veterinary medicinal products with one or more raw materials, intended to be used for the manufacture of medicated feed;

 

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment    29

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) ‘non-target feed’: feed which is not intended to contain a specific veterinary medicinal product;

(d) ‘non-target feed’: feed which is not intended to contain a veterinary medicinal product;

Justification

This definition is currently ambiguous and needs to be clarified. A non-target feed should be defined as an ordinary feed containing no veterinary medicinal products.

Amendment    30

Proposal for a regulation

Article 2 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) 'feed business operator': any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under their control;

deleted

Amendment    31

Proposal for a regulation

Article 2 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) ‘distributor’: any feed business operator that supplies medicated feed, packaged and ready for use, to the animal holder;

(g) ‘distributor’: any feed business operator that supplies medicated feed, packaged and ready for use, to the animal holder or, in the case of medicated feed supplied for non-food producing animals, another operator authorised to distribute veterinary medicines;

Amendment    32

Proposal for a regulation

Article 2 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) ‘mobile mixer’: a feed business operator with a feed establishment consisting of a specifically equipped lorry for the manufacture of medicated feed;

(h) ‘mobile mixer’: a feed business operator with a feed establishment consisting of a mobile infrastructure specifically equipped for the manufacture of medicated feed which moves from farm to farm for the purpose of providing its services;

Justification

It is important to distinguish more clearly between the mobile mixer, which moves from farm to farm in order to produce medicated feed, and the on-farm mixer.

Amendment    33

Proposal for a regulation

Article 2 – paragraph 2 – point i

Text proposed by the Commission

Amendment

(i) ‘on-farm mixer’: a feed business operator manufacturing medicated feed on the farm of use.

(i) ‘on-farm mixer’: a feed business operator manufacturing medicated feed for exclusive use on the farm on which it is produced for food-producing animals in his or her possession;

Amendment    34

Proposal for a regulation

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

Text proposed by the Commission

Amendment

 

(ia) 'cross-contamination': a contamination resulting from a carry-over or from the transfer in feed of any unintended substance;

Amendment    35

Proposal for a regulation

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

Text proposed by the Commission

Amendment

 

(ib) ‘anti-parasites’: medicinal substance used in the treatment of parasitic diseases of varied aetiology;

Amendment    36

Proposal for a regulation

Article 2 – paragraph 2 – point i c(new)

Text proposed by the Commission

Amendment

 

(ic) 'broker': any person active in the buying or selling of medicated feed, excluding the distribution of medicated feed, which operations do not involve the physical handling of medicated feed but rather the trading thereof, independently and in the name of a physical or legal person;

Justification

A definition should be added, namely that of broker.

Amendment    37

Proposal for a regulation

Article 3

Text proposed by the Commission

Amendment

Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I.

Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with the requirements of Regulation 183/2005 and Regulation 767/2009 and the provisions of Annex I to this Regulation, where relevant for the operations carried out, and of Annex III. The requirements for the placing on the market of medicated feed shall not be applicable to on-farm mixers, including rules on labelling particulars as set out in Annex III.

Amendment    38

Proposal for a regulation

Article 3 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. A Member State may impose restrictions in order to prohibit or regulate the use of mobile mixers in its territory.

Justification

Performing checks on livestock farmers is a very complicated process, especially when they are operating in the territories of several Member States (cross-border operations).

Amendment    39

Proposal for a regulation

Article 3 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

 

1b. Distributors who supply medicated feed solely for non-food producing animals, which is manufactured and distributed in sealed bags and supplied under prescription directly to the animal holders, shall be exempt from the obligations of feed business operators.

Justification

The exemption proposed facilitates wholesale and retail (veterinary and pharmacist) distribution solely of medicated feed for pets without imposing unnecessary administrative burdens which are taken care of by the ‘feed business operator’ that actually manufactures the medicated feed. Feed business operators rules (designed to protect human food safety) would be unnecessary and over burdensome.

Amendment    40

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: ' HACCP ' ) system as provided for in Regulation (EC) No 183/2005.

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: ' HACCP ' ) system as provided for in Regulation (EC) No 183/2005. Established control systems for on-farm mixers may be retained, provided it is ensured that the HACCP principles are complied with.

Justification

In implementing Regulation (EC) No 183/2005, primary feed producers already comply with the principles of the HACCP in the records they keep. It should remain possible to use these records.

Amendment    41

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

2. The manufacturer of medicated feed shall ensure the following:

2. The manufacturer of medicated feed shall ensure the following:

(a) the veterinary medicinal product is incorporated into the feed in accordance with Annex II;

(a) the veterinary medicinal product is incorporated into the feed in accordance with Article 15(6) and Annex II;

(b) the medicated feed is manufactured in compliance with the relevant conditions laid down in the summary of the product characteristics referred to in Article 14 of Directive 2001/82/EC, related to the veterinary medicinal products to be incorporated in the medicated feed;

(b) the medicated feed is manufactured in compliance with the relevant conditions laid down in the prescription or, in the cases referred to in Article 8 of this Regulation, in the summary of the product characteristics referred to in Article 30 of Regulation (EU) 2016/... (Veterinary Medicinal Products) related to the veterinary medicinal products to be incorporated in the medicated feed; this includes in particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed;

(c) there is no possibility of an interaction between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed;

 

(d) a feed additive for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed if it is already used as active substance in the veterinary medicinal product.

(d) a feed additive authorised as coccidiostats or histomonostats for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed if it is already used as active substance in the veterinary medicinal product;

 

(da) where the active substance in the veterinary medicinal product is the same as a substance in a feed additive contained in the feed concerned, the total content of that substance in the medicated feed shall not exceed the maximum content set out in the prescription for the veterinary medicinal product or, in the cases referred to in Article 8, in the summary of product characteristics.

Amendment    42

Proposal for a regulation

Article 5 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

 

(db) the feed used for the production of medicated feed complies with all relevant provisions of Union legislation concerning animal feedingstuffs;

Justification

The feed used for incorporation of the medicated premix - veterinary medicinal product- should have appropriate quality and conditions complying with the valid legal provisions within this area should be followed.

Amendment    43

Proposal for a regulation

Article 6 – paragraph 1

Text proposed by the Commission

Amendment

1. Feed business operators manufacturing medicated feed shall ensure the homogeneous incorporation of the veterinary medicinal product or the intermediate product into the feed.

1. Feed business operators manufacturing medicated feed shall ensure the homogeneous distribution of the veterinary medicinal product or the intermediate product in the feed.

Justification

It is important to underline that the objective here is to ensure that the veterinary medicinal product is evenly distributed in the feed. ‘Distribution’ is a term used in the pharmaceutical sector.

Amendment    44

Proposal for a regulation

Article 6 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. Feed business operators manufacturing intermediate products shall ensure the homogeneous distribution of the veterinary medicinal product in the feed.

Amendment    45

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may, by means of implementing acts, establish criteria for the homogenous incorporation of the veterinary medicinal product into the medicated feed or into the intermediate product, taking into account the specific properties of the veterinary medicinal products and of the mixing technology. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).

2. The Commission may, by means of implementing acts, establish criteria for the homogenous distribution of the veterinary medicinal product in the medicated feed or into the intermediate product, taking into account the specific properties of the veterinary medicinal products and of the manufacturing technology (such as mixing or spraying). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).

Amendment    46

Proposal for a regulation

Article 7

Text proposed by the Commission

Amendment

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid carry-over.

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to minimise carry-over in accordance with the ALARA principle, in order to avoid risk to animal health, human health or the environment.

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances.

2. The Commission is empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances in non-target feed on the basis of scientific risk assessments carried out by the European Food Safety Authority (EFSA).

Where no specific carry-over limits have been set for an active substance, the following carry-over limits shall apply:

Where no specific carry-over limits have been set for an active substance, the general carry-over limit shall be set at 3 % of the active substance in the last batch of medicated feed or of intermediate product produced before the production of the next batch of non-target feed.

(a) for antimicrobial active substances, 1% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non-target feed;

 

(b) for the other active substances, 3% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non-target feed.

 

 

2a. The Commission shall, by means of implementing acts, establish a detailed schedule listing, in order of priority, the different active substances for which specific carry-over limits must be adopted. EFSA and the European Medicines Agency (EMA) shall be consulted as the list is being compiled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).

 

By ... [two years after the date of entry into force of this Regulation], the Commission shall submit a report to the European Parliament and to the Council indicating the specific carry-over limits adopted.

Amendment    47

Proposal for a regulation

Article 7 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

 

2b. The Commission shall be empowered to adopt implementing acts in order to establish criteria in respect of:

 

(a) the definition of the batch, pursuant to this Article;

 

(b) the analytical methods that must be employed by medicated feed business operators;

 

(c) the sampling methods and analytical methods that must be employed by medicated feed business operators and the competent authorities in order to check that the specific carry-over limits have been complied with.

 

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).

Justification

It is very important to define the term « batch » in order to ensure a harmonised application of the legislation.

Amendment    48

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued. This provision shall not apply to on-farm mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with Articles 10 or 11 of Directive 2001/82/EC.

Medicated feed and intermediate products may be manufactured and stored for production-related reasons before the prescription referred to in Article 15 is issued. In such cases the nature and quantity of the medicated feed which is manufactured or stored shall be notified to the competent authority. This provision shall not apply to mobile mixers.

Amendment    49

Proposal for a regulation

Article 9 – paragraph 1

Text proposed by the Commission

Amendment

1. In addition to Article 11(1), Articles 12 and 14 of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products shall comply with Annex III to this Regulation.

1. In addition to Article 11(1) and (4), Articles 12 and 14, points (b), (d), (e) and (f) of Article 15, points (a), (d), (e), and (f) of Article 17(1), and Article 17(2) and (3) of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products, where these are not fed directly to livestock, shall comply with Annex III to this Regulation.

Amendment    50

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. Where containers are used instead of packaging material, they shall be accompanied by documents complying with paragraph 1.

2. Where containers are used instead of packages, they shall be accompanied by a document complying with paragraph 1.

Justification

We are proposing that all labelling information should be included in a single document (in a manner similar to that specified in Regulation (EC) No 767/2009). If the reference to various documents is maintained, it would make it difficult for the competent authorities to check compliance with labelling rules, and could also make it difficult to monitor the traceability of medicated feed.

Amendment    51

Proposal for a regulation

Article 9 – paragraph 3

Text proposed by the Commission

Amendment

3. Permitted tolerances for discrepancies between the labelled compositional values of a medicated feed or an intermediate product and the values analysed in official controls performed in accordance with Regulation (EC) No 882/2004 are as set out in Annex IV.

3. In addition to the tolerances listed in Annex IV to Regulation (EC) No 767/2009, the permitted tolerances for discrepancies between the labelled active ingredient content of a medicated feed or an intermediate product and the values analysed in official controls performed in accordance with Regulation (EC) No 882/2004 are as set out in Annex IV.

Amendment    52

Proposal for a regulation

Article 10

Text proposed by the Commission

Amendment

Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.

Medicated feed and intermediate products shall be placed on the market only in properly labelled and sealed packages, including sack packaging, or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused. Appropriate derogations should be provided for those instances where the application of that requirement is not necessary to protect human or animal health or consumer interests, and would represent an excessive administrative and technical burden.

Amendment    53

Proposal for a regulation

Article 11

Text proposed by the Commission

Amendment

Where the Member State of manufacture of medicated feed is not the same as the Member State where it is used by the animal holder, the veterinary medicinal product shall be authorised in accordance with Directive 2001/82/EC in the Member State of use.

Where the Member State of manufacture of medicated feed is not the same as the Member State where it is used by the animal holder, the veterinary medicinal product shall be authorised in accordance with Regulation (EU) 2016/... (Veterinary Medicinal Products) in the Member State of use or contain the same active substances and a composition, in quantitative and qualitative terms, equivalent to a veterinary medicinal product already authorised under Directive 2001/82/EC.

Justification

It is important not to hamper intra-Community trade in medicated feed, in particular to help farmers in Member States with small markets. In some cases, a veterinary medicinal product may not be authorised in a Member State for commercial reasons.

Amendment    54

Proposal for a regulation

Article 11 a (new)

Text proposed by the Commission

Amendment

 

Article 11a

 

Trade with third countries

 

Imports, from third countries, of food-producing animals which have been administered medicated feed containing antimicrobial veterinary medicinal products in order to prevent disease shall be prohibited. Similarly, imports of foodstuffs derived from those animals shall be prohibited.

Amendment    55

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority.

Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent public authority. This shall not apply to agricultural establishments which feed on-farm manufactured medicated feed to their own animals.

Amendment    56

Proposal for a regulation

Article 15

Text proposed by the Commission

Amendment

1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription and to the conditions laid down in paragraphs 2 to 6.

1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law, following a proper assessment of the health status of the animals concerned.

 

Prescriptions for medicated feed containing veterinary medicinal products which have anabolic, anti-inflammatory, anti-infectious (other than anthelmintic), anti-cancer, hormonal or psychotropic properties or substances shall only be issued by a veterinarian after a clinical examination and diagnosis.

 

For medicated feed containing antibiotics, a physical examination and diagnosis shall be carried out for every prescription issued.

 

Veterinarians or other professional persons qualified to do so in accordance with applicable national law issuing follow-up prescriptions prolonging or modifying a treatment after an initial prescription may, in exceptional cases and based on their epidemiological and clinical knowledge, decide that an additional clinical examination of the animals is not necessary.

 

The supply of medicated feed to animal holders shall also be subject to the conditions laid down in paragraphs 2 to 6.

2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The person issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance.

2. The prescription shall contain the information set out in Article 110 of Regulation (EU) 2016/... (Veterinary Medicinal Products), supplemented by Annex V to this Regulation. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The veterinarian or another professional person qualified to do so in accordance with applicable national law issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance.

3. With the exception of medicated feed for non-food producing animals, medicated feed shall not be used for more than one treatment under the same prescription.

3. With the exception of medicated feed for non-food producing animals, medicated feed shall not be used for more than one treatment under the same prescription.

 

3a. The duration of the treatment should follow the valid summary of product characteristics (SPC) of the authorised veterinary medicinal product incorporated into the medicated feed and should not exceed three weeks in the case of medicated feed with incorporated veterinary medicinal products containing active substances with the potential to select resistance.

 

3b. In the event of the occurrence of a diagnosed disease as referred to in paragraph 5, if part of the medicated feed is left unused, it may be re-used under a new prescription, provided that it is stored in accordance with the conditions set out in the SPC.

4. The prescription shall be valid for a maximum period of six months for non-food producing animals and three weeks for food-producing animals.

4. The prescription shall be valid from the date of issuance for a maximum period of six months for non-food producing animals and three weeks for food-producing animals.

5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.

5. The prescribed medicated feed may be used only for individual animals or a group of animals examined or assessed by the veterinarian or another professional person qualified to do so in accordance with applicable national law issuing the prescription and only for a diagnosed disease. Significant and imminent health risks may be grounds for the limited and non-routine prophylactic use of vaccines and anti-parasitical treatments. The veterinarian or another professional person qualified to do so in accordance with applicable national law who issued the prescription shall verify, based on knowledge of the feeding systems in use, the possibilities of mixing and other relevant farm specificities, that the medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.

6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the veterinary medicinal product calculated on the basis of the relevant parameters.

6. The prescription shall, in line with the summary of the product characteristics of the veterinary medicinal product, indicate the inclusion rate of the active substance of the veterinary medicinal product per kilogram of medicated feed taking into account the product characteristics and, where appropriate, the geographical or season-related circumstances. The daily dose of the veterinary medicinal product shall be incorporated into that quantity of medicated feed that ensures the uptake of the daily dose by the target animal taking into consideration that the feed uptake of diseased animals might differ from a normal daily ration.

Amendment    57

Proposal for a regulation

Article 16 – title

Text proposed by the Commission

Amendment

Use in food-producing animals

Use

Amendment    58

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1.Feed business operators supplying medicated feed to the holder of food-producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed:

1. Feed business operators supplying medicated feed to the holders of food-producing and non-food producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed the quantities provided for in the prescription.

(a) the quantities provided in the prescription and

 

(b) the quantities required for one month's treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products.

 

 

The quantities required for a treatment shall be determined in accordance with the SPC included in the marketing authorisation of the veterinary medicinal product included in the prescription.

Amendment    59

Proposal for a regulation

Article 16 – paragraph 2

Text proposed by the Commission

Amendment

2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food-producing animals or to enhance their performance.

2. Medicated feed containing antibiotic veterinary medicinal products shall not be used to enhance the performance of animals. Prophylaxis with antibiotics shall not be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions. However, such prophylaxis may be permitted in very exceptional cases before a disease is diagnosed or clinical signs of disease are present on the basis of the epidemiological and clinical knowledge of the veterinarian when such use is permitted under Article 111 of Regulation (EU) 2016/... (Veterinary Medicinal Products). Metaphylaxis shall be allowed to minimise the spread of an infection within a group of animals where the presence of an infectious agent has been confirmed.

Amendment    60

Proposal for a regulation

Article 16 – paragraph 4

Text proposed by the Commission

Amendment

4. Feed business operators feeding food-producing animals with medicated feed shall keep records in accordance with Article 69 of Directive 2001/82/EC. Those records shall be kept for five years after the date of administration of medicated feed, including when the animal is slaughtered during the five-year period.

4. Feed business operators feeding food-producing animals with medicated feed shall keep records in accordance with Article 112 of Regulation (EU) 2016/…(Veterinary Medicinal Products). Those records shall be kept for three years after the date of administration of medicated feed, including when the animal is slaughtered during the three-year period. Member States shall ensure that the data in those records are collected and transferred to the Union database on veterinary medicinal products as provided for in Articles 51 and 54 of Regulation (EU) 2016/…(Veterinary Medicinal Products).

Amendment    61

Proposal for a regulation

Article 16 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

 

4a. Packaged medicated feed to be fed to food-producing animals shall be stored separately. Silos that once contained medicated feed shall be emptied before being loaded with other types of feed, and cleaned regularly.

Amendment    62

Proposal for a regulation

Article 17 – title

Text proposed by the Commission

Amendment

Collection systems of unused or expired products

Collection systems of expired products

Amendment    63

Proposal for a regulation

Article 17

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription.

Member States shall develop appropriate collection systems in cooperation with the operators of the sector for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription and is unable to store it in effective conditions for re-use as set out in the SPC. The collected material shall be disposed of in accordance with existing national or Union legislation. Member States shall ensure that manufacturers of medicated feed and farmers are informed as regards where to find collection points for expired products and how to get their expired medicated feed to those collection points.

Amendment    64

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

Business operators shall provide data needed for calculation of the volume of the sales of veterinary medicinal products incorporated into the final medicated feed to the competent national authority of the Member State.

 

Member States shall collect relevant and comparable data on the volume of sales of medicated feed containing antimicrobial active substances.

 

Member States shall send data on the volume of sales of medicated feed containing antimicrobial active substances to the competent European authority.

 

That European authority shall analyse the data and publish an annual report.

Justification

According to the Action Plan of the European Commission, monitoring of the sales/use of antimicrobials containing products is highly recommended. It is therefore considered as beneficial to define rules for such monitoring in the case of medicated feedingstuffs, which contains antimicrobials creating huge part of the total consumption of veterinary antimicrobials.

Amendment    65

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. The delegation of power referred to in Articles 7 and 18 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

2. The power to adopt delegated acts referred to in Articles 7 and 18 shall be conferred on the Commission for a period of five years from the date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Justification

The European Parliament, in all legislative acts, follows the principle that delegation of powers is conferred on the European Commission for a fixed time period.

Amendment    66

Proposal for a regulation

Annex 1 – section 2 – point 1 – paragraph 2

Text proposed by the Commission

Amendment

A qualified person responsible for the manufacture of medicated feed and intermediate products and a qualified person responsible for quality control shall be delegated.

The qualified persons responsible for the manufacture and quality control operations shall have qualifications or specific skills in the field of veterinary medicine. The qualified persons responsible for the manufacture and quality control operations shall not prescribe medicated feed intended to be manufactured or inspected in the establishments in which they work.

Amendment    67

Proposal for a regulation

Annex 1 – section 2 – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Any person entering a manufacturing area shall wear protective equipment that is appropriate for the operations performed therein. Operators shall ensure that their hands do not come into direct contact with unprotected products or with any machinery that has come into contact with such products.

Amendment    68

Proposal for a regulation

Annex 1 – section 3 – point 2

Text proposed by the Commission

Amendment

2. Technical or organisational measures shall be taken to avoid any cross-contamination and errors, to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products.

2. Technical or organisational measures shall be taken to minimise any cross-contamination and errors, to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products.

Amendment    69

Proposal for a regulation

Annex 1 – section 3 – point 3

Text proposed by the Commission

Amendment

3. The presence of undesirable substances within the meaning of Directive 2002/32/EC and of other contaminants in relation to human and animal health shall be monitored, and appropriate measures to minimise this presence shall be taken.

3. The presence of undesirable substances within the meaning of Directive 2002/32/EC in relation to human and animal health shall be monitored, and appropriate measures to minimise this presence shall be taken.

Justification

The reference to ‘other contaminants’ is very unclear. Those contaminants are not identified.

Amendment    70

Proposal for a regulation

Annex I – section 3 – point 4

Text proposed by the Commission

Amendment

4. The products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoid any cross-contamination.

4. The products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoid or minimise any carry-over.

Amendment    71

Proposal for a regulation

Annex I – section 6 – point 2 – point i

Text proposed by the Commission

Amendment

(i) information on the person who has issued the prescription, including at least his name and address.

(i) for the distributor who supplies to the animal holder information on the veterinarian or another professional person qualified to do so in accordance with applicable national law who has issued the prescription, including at least his name and address.

Amendment    72

Proposal for a regulation

Annex 1 – section 7 a (new)

Text proposed by the Commission

Amendment

 

Section 7a

 

OPERATIONS CARRIED OUT BY THIRD PARTIES

 

1. Any subcontracted activity shall be covered by an appropriately defined, agreed upon and monitored contract so as to avoid any misunderstandings that could lead to work or products of an insufficient quality. A written contract shall be drawn up between the subcontracting party and the subcontractor in order to clearly establish each party's obligations. The contract shall clearly set out the ways in which the qualified persons responsible for manufacture, transport and quality control operations are to fulfil their responsibilities.

 

2. A written contract shall cover the manufacturing, nalytical or transport activities assigned by the subcontracting party, and all the technical provisions taken in relation thereto. All the provisions contained in the contract, including any proposed technical modifications or other provisions, shall comply with the provisions of this Regulation.

Amendment    73

Proposal for a regulation

Annex 2 – point 2

Text proposed by the Commission

Amendment

2. The daily dose of the veterinary medicinal product shall be incorporated in a quantity of medicated feed that ensures the uptake of the daily dose by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration.

2. The daily dose of the veterinary medicinal product shall be incorporated in accordance with the prescription.

Amendment    74

Proposal for a regulation

Annex 3 – introductory part

Text proposed by the Commission

Amendment

The label of medicated feed and intermediary products shall include the following particulars:

The label of medicated feed and intermediary products shall include, in accordance with the requirements of this Annex and of Regulation (EC) No 767/2009, the following particulars, in a simple, clear and easily understandable manner for the end users:

Amendment    75

Proposal for a regulation

Annex 3 – point 1

Text proposed by the Commission

Amendment

(1) the expression ‘Medicated feed’ or ‘Intermediate product for medicated feed’ supplemented by the expression ‘complete’ or ‘complementary’, as appropriate, and the target species;

(1) the expression ‘Medicated feed’ or ‘Intermediate product for medicated feed’ supplemented by the expression ‘complete’ or ‘complete dietetic’ or ‘complementary’ or ‘complementary dietetic’, as appropriate, and the target species;

Justification

It may be appropriate to modify the nutritional content of the diet to complement the medicated feed. This is particularly important for the treatment of chronic conditions in pets. In this case, it should be possible to provide information on the label in relation to nutritional content as well as medicinal content.

Amendment    76

Proposal for a regulation

Annex 3 – point 2

Text proposed by the Commission

Amendment

(2) the name or business name and the address of the feed business operator responsible for the labelling;

deleted

Amendment    77

Proposal for a regulation

Annex 3 – point 3

Text proposed by the Commission

Amendment

(3) the approval number of the person responsible for the labelling in accordance with Article 12;

(3) the approval number of the person responsible for the labelling and of the manufacturer if different from the person responsible for labelling, in accordance with Article 12;

Amendment    78

Proposal for a regulation

Annex 3 – point 4

Text proposed by the Commission

Amendment

(4) the batch reference number of the medicated feed or intermediate product;

deleted

Amendment    79

Proposal for a regulation

Annex 3 – point 5

Text proposed by the Commission

Amendment

(5) the net quantity of medicated feed expressed in units of mass in the case of solid feed, and in units of mass or volume in the case of liquid feed;

deleted

Amendment    80

Proposal for a regulation

Annex 3 – point 6

Text proposed by the Commission

Amendment

(6) the veterinary medicinal products with name, active substance, strength, added amount, marketing authorisation holder and marketing authorisation number, preceded by the heading ‘medication’;

(6) the veterinary medicinal products with name, active substance, added amount of active substance, preceded by the heading ‘medication’;

Justification

The reason for mentioning on the label the amount of the veterinary medicinal substance and its strength is to allow the user to calculate the amount of active substance. It is therefore much more useful to provide directly the amount of active substance. The indication of the authorisation holder and authorisation number is superfluous for the user. For the sake of legibility of the label, these particulars should not be required.

Amendment    81

Proposal for a regulation

Annex 3 – point 7

Text proposed by the Commission

Amendment

(7) therapeutic indications of the veterinary medicinal products, any contra-indications and adverse events in so far as these particulars are necessary for the use;

(7) any contra-indications and adverse events in so far as these particulars are necessary for the use;

Justification

Therapeutic indications are superfluous since the medicated feed shall be used in accordance with the prescription where the animals and the disease to be treated are already mentioned.

Amendment    82

Proposal for a regulation

Annex 3 – point 9

Text proposed by the Commission

Amendment

(9) a recommendation to read the package leaflet of the veterinary medicinal products, including a hyperlink where it can be found, a warning that the product is only for the treatment of animals, as well as another warning that the product must be kept out of the sight and reach of children;

(9) a recommendation to read the package leaflet of the veterinary medicinal products, including a hyperlink where it can be found, a warning that the product is only for the treatment of animals, a warning that the product must be kept out of the sight and reach of children, as well as another warning that persons in the proximity of animals treated with medicated feed may be contaminated.

Amendment    83

Proposal for a regulation

Annex 3 – point 10

Text proposed by the Commission

Amendment

(10) the list of feed additives, preceded by the heading 'additives', contained in medicated feed for food-producing animals in accordance with Chapter I of Annex VI to Regulation (EC) No 767/2009 or in case of medicated feed for non-food producing animals in accordance with Chapter I of Annex VII to that Regulation and, if applicable, the labelling requirements laid down in the respective feed additive authorisation act;

deleted

Amendment    84

Proposal for a regulation

Annex 3 – point 11

Text proposed by the Commission

Amendment

(11) the name(s) of the feed materials as listed in the Catalogue referred to in Article 24(1) of Regulation (EC) No 767/2009 or in the register referred to in Article 24(6) of that Regulation. Where several feed materials are used for the manufacture, they shall be listed in accordance with the provisions laid down in Article 17(1)(e) and (2) of Regulation (EC) No 767/2009;

deleted

Amendment    85

Proposal for a regulation

Annex 3 – point 12

Text proposed by the Commission

Amendment

(12) the analytical constituents of medicated feed for food-producing animals in accordance with Chapter II of Annex VI to Regulation (EC) No 767/2009 or in accordance with Chapter II of Annex VII to that Regulation in case of medicated feed for non-food producing animals;

deleted

Amendment    86

Proposal for a regulation

Annex 3 – point 13

Text proposed by the Commission

Amendment

(13) in case of medicated feed for non-food producing animals, a free telephone number or other appropriate means of communication in order to allow the purchaser to obtain, in addition to the mandatory particulars, information on the feed additives contained in the medicated feed or on the feed materials contained in the medicated feed where they are designated by category as provided for in Article 17(2)(c) of Regulation (EC) No 767/2009;

deleted

Amendment    87

Proposal for a regulation

Annex 3 – point 14

Text proposed by the Commission

Amendment

(14) the moisture content if it exceeds 14 %;

deleted

Amendment    88

Proposal for a regulation

Annex 3 – point 15

Text proposed by the Commission

Amendment

(15) the instructions for use, in accordance with the veterinary prescription and with the summary of product characteristics referred to in Article 14 of Directive 2001/82/EC;

(15) the instructions for use, in accordance with the summary of product characteristics referred to in Article 14 of Directive 2001/82/EC, or with the veterinary prescription, if available at the time of manufacture.

Amendment    89

Proposal for a regulation

Annex III – point 16 a (new)

Text proposed by the Commission

Amendment

 

(16a) information that inappropriate disposal of medicated feed poses serious threats to the environment and may contribute to antimicrobial resistance, and information on where and how to appropriately dispose of unused material.

Justification

Information on where and how to appropriately dispose of unused material can be provided by a hyperlink.

Amendment    90

Proposal for a regulation

Annex 4 – point 1

Active substance per kg of medicated feed

Tolerance

> 500 mg

± 10%

> 10 mg and ≤ 500 mg

± 20%

> 0,5 mg and ≤ 10 mg

± 30%

0,5 mg

± 40%

 

Amendment

1. The tolerances laid down in this point shall include technical deviations

Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an active substance indicated on the label, the following tolerances shall apply:

Active substance per kg of medicated feed

Tolerance

> 500 mg

± 20 %

> 100 mg and ≤ 500 mg

± 25 %

> 10 mg and ≤ 100 mg

± 30 %

10 mg

± 35%

Amendment    91

Proposal for a regulation

Annex 4 – point 2

Text proposed by the Commission

Amendment

2. For the labelling particulars referred to in points 10 and 12 of Annex III to this Regulation, the tolerances laid down in Annex IV to Regulation (EC) No 767/2009 shall apply, as appropriate.

deleted

Justification

Respecting tolerances by taking account of both technical and analytical deviations does not appear to be applicable in practice, since none of the analytical methods have been validated. Consequently, only the technical deviations should be considered and a single tolerance limit of +/- 10% imposed, regardless of the content and the active substance in question.

Amendment    92

Proposal for a regulation

Annex V – point 1

Text proposed by the Commission

Amendment

1. Surname, forename, address and professional membership number of the person allowed to prescribe a veterinary medicinal product.

1. Surname, forename, address and professional membership number of the veterinarian or another professional person qualified to prescribe a veterinary medicinal product in accordance with applicable national law.

Amendment    93

Proposal for a regulation

Annex V – point 2

Text proposed by the Commission

Amendment

2. Issue date and signature or electronic identification of the person allowed to prescribe a veterinary medicinal product.

2. Issue date and signature or electronic identification of the veterinarian or another professional person qualified to prescribe a veterinary medicinal product in accordance with applicable national law.

(1)

Not yet published in the Official Journal.


EXPLANATORY STATEMENT

1. Introduction

Medicated feed is an efficient and economic tool for treating groups of animals. The manufacturing standards applied in its production guarantee that the medicine is distributed in a homogeneous and stable manner in the feed. In this way, each animal has access to the same quantity of medicine and in the correct quantities for the treatment to be effective. Moreover, it helps to avoid handling animals individually and to cause them distress. Medicated feed is therefore important for livestock farmers. It is also used for pets, although less frequently and above all for the treatment of chronic conditions.

It is important to underline that medicated feed is only one of various therapeutic alternatives for the oral administration of veterinary medicines to groups of animals. Others exist such as soluble medicines (mixing drinking water with veterinary medicines) or ‘top dressing’, whereby the farmer manually sprinkles veterinary medicinal products onto feed.

Medicated feed, in addition to the specific rules contained in the proposal under consideration, is subject to general legislation on feed hygiene and labelling as well as the rules on placing on the market and use of feed and feed additives.

One should also mention that the Commission has recently proposed a new regulation on veterinary medicinal products (hereafter known as the ‘VMP proposal’). It is that proposal which sets out the basic rules for veterinary medicinal products, some of which are used for the manufacture of medicated feed. It is therefore in the context of that regulation that issues related to the proper use of veterinary medicines must be resolved. It follows that the medicated feed proposal has to be scrutinised in parallel with the VMP proposal.

2. The Commission Proposal

The draft regulation on medicated feed updates the current EU legislation in this field set out in Directive 90/167/EEC. That directive contains a number of lacunae which are well explained in the explanatory statement of the Commission proposal and will not be repeated here. For instance, it does not address the issue of carry-over between batches or impose specific labelling requirements for medicated feed. Furthermore, many discrepancies have emerged in the way Directive 90/167/EEC has been implemented and applied on the ground in the Member States.

3. The Position of the Rapporteur

The rapporteur considers that it is important to update Directive 90/167/EEC and that replacing it with a regulation is appropriate given that it is widely agreed that at present the differences among Member States in regulating medicated feed have become too wide.

The rapporteur insists that the existence of a separate legislative proposal for medicated feed must not lead to any discrimination of medicated feed vis-à-vis any other form of oral administration of veterinary medicines to animals. Unfortunately, at present the Commission proposal does discriminate against the use of medicated feed, since it contains specific provisions that are stricter than the VMP proposal. Some examples of that are provided below or in the amendments proposed.

Such discrimination is hard to understand, given that medicated feed is produced according to high manufacturing standards. For instance, the homogeneous distribution of veterinary products in the feed is guaranteed, meaning that animals consume roughly the same amount of medication per unit of feed. A similar standard of homogeneous distribution cannot be produced by manual mixing. Medicated feed is therefore very useful for farmers and its production and use should not be obstructed.

Specific Issues

Definitions

•  The rapporteur feels that it is important to define ‘antimicrobials’ and ‘antibiotics’ in EU legislation. She considers that those definitions should naturally be placed in the VMP proposal, as Mrs Paulsen has suggested in her relevant draft opinion. ‘Antibiotics’ is a more useful term to employ in certain articles than ‘antimicrobial’ since the significant public health problem caused by ‘antimicrobial resistance’ is mainly related to the excessive use of antibiotics for fighting infections.

•  The proposal contains an unclear definition of ‘non-target feed’ and the rapporteur has therefore proposed alternative wording.

•  The rapporteur also proposes more rigorous definitions of ‘mobile mixer’ and ‘on-farm mixer’.

Anticipated Production

Anticipated production is a useful tool for medicated feed manufacturers, allowing them to structure and plan production, in a way that reduces carry-over, since they can switch less often from producing one type of medicated feed to another. The rapporteur thinks that the advantages of anticipated production should be extended to so-called ‘minor species’ (fish, rabbits, sheep and goats for instance), in order to facilitate treatment of these species, which suffer from a lack of availability of veterinary medicines catered to them.

Carry-Over

The Commission proposes to establish a general 1% carry-over limit for all active substances containing antimicrobials, until such time as specific limits are set for each active substance individually. However it does not provide convincing evidence that fixing such a limit would achieve concrete results in terms of fighting against antimicrobial resistance, which is an important public health issue. What seems more certain is that imposing a 1% limit would impose such stringent production standards that they would threaten the economic viability of medicated feed manufacturers. The rapporteur therefore considers that a 3% general limit for all active substances is more appropriate until specific limits - established by the European Feed and Safety Authority (EFSA) and based on scientific evidence - are fixed for each active substance, exactly as the text of the proposal foresees.

Use in Food-Producing Animals (Article 16)

The Commission proposal sets limits for the quantities of medicated feed that suppliers are allowed to provide to farmers (one month’s supply or 2 weeks for antimicrobials). The rapporteur believes that setting time limits of this type in an EU regulation is inappropriate. It should the responsibility of the person issuing the prescription to determine the quantities and time needed for a treatment. Manufacturers of medicated feed must simply respect the prescription. Treatment times are normally defined in the summary of product characteristics (SPC) of the veterinary medicinal product, providing the necessary guidance to veterinarians who are responsible for establishing the length of the treatment.

Article 16 proposes to ban the use of medicated feed containing antimicrobials to prevent diseases. The rapporteur broadly supports this approach since the use of antibiotics cannot be a substitute for high standards in animal husbandry. However, in clearly defined exceptional cases preventive use of antibiotics might be allowed, under the guidance of the veterinarian.

In any case, the VMP proposal does not ban preventive use of antibiotics. As things stand, therefore, antibiotics could be used to prevent diseases via other forms of oral administration of veterinary medicines but not through medicated feed. The rapporteur proposes an amendment requiring that the issue of preventive use of antibiotics be regulated in the VMP proposal, where it would be valid for all forms of administration of medicines to groups of animals.

Annexes

In annex IV, the rapporteur proposes changes to the permitted tolerances of deviations from the amount of an active substance indicated on the label, in order to adapt them to the proportions used in the manufacture of medicated feed.


OPINION of the Committee on the Environment, Public Health and Food Safety (18.6.2015)

for the Committee on Agriculture and Rural Development

on the proposal for a regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC

(COM(2014)0556 – C8‑0143/2014 – 2014/0255(COD))

Rapporteur: Norbert Lins

SHORT JUSTIFICATION

The differences in the transposition of Directive 90/167/EEC throughout the Member States has led the European Commission to put forward a proposal for a Regulation on Medicated Feed, medicated feed being one of the most effective ways of administering veterinary medicines to animals.

In its impact assessment the Commission has identified four main problems in the transposition of Directive 90/167/EEC: residues of veterinary medicinal products (VMP) in non-target feed, imprecise dosage of VMP, barriers to expand the production and intra EU trade of medicated feed and impossible market access of medicated feed for pets.

With its current proposal the Commission intends therefore to harmonise the production standards of medicated feed in the EU, whilst ensuring the appropriate level of safety. In addition, the scope of the Regulation applies to both food producing animals and non-food animals.

It is in the interest of all humans that our animals - food or non-food producing ones - are in good health. Farmers, veterinarians, merchants, consumers or private owners should apply high standards reaching good animal welfare and health. This presupposes also that in case of illness there are adequate VMPs available for all species. Animal welfare, food safety and human health are extremely closely interconnected.

There are three different ways for oral administration of medicines to animals. The oral administration of medicines, which have been added by the animal holders themselves to the feed or to the drinking water, is not regulated by this proposal. Only medicated feed into which the medicine is incorporated by either the holders themselves or by another approved manufacturer is in the scope of the present regulation proposed by the Commission.

The rapporteur welcomes the proposal for a Regulation on Medicated Feed. A harmonisation of the rules on manufacture, the placing on the market and the use of medicated feed will benefit the creation of a genuine single market. This will trigger more competition as well as innovation and will raise the availability of veterinary medicines, in particular for minor species.

The rapporteur welcomes that the Regulation considers both food and non-food producing animals in its scope. Large groups of animals and pets suffering from chronic diseases are the main target of medicated feed.

For the rapporteur a strong coherence between the Regulation on Medicated Feed and the new proposal for a Regulation on Veterinary Medicinal Products is vital. Due to the various cross-references a coordinated process was followed. In this regard clear definitions on antimicrobials and the different forms of treatment (curative, control and preventive) were introduced in the draft opinion.

For the rapporteur another main detail is the prudent, based on scientific research use of antimicrobials as active substance in medicated feed. The use of antimicrobials needs to be reduced and the fight against antimicrobial resistance (AMR) needs to be intensified. Therefore common efforts and good cooperation between the human and the animal health sectors are indispensable.

In this logic, the prophylactic use of medicated feed containing antimicrobials should not be allowed. Furthermore, in connection with the carry-over limits, special attention should be paid to antimicrobials. EFSA should be in charge of setting specific and general limits on carry-over for active substances via a scientific risk assessment.

A key actor in the application of medicated feed is the veterinarian. Medicated feed can only be administered after an examination, diagnosis and prescription by a veterinarian. The rapporteur underlines the central and strong role of the veterinarian.

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 take into account the following amendments:

Amendment    1

Proposal for a regulation

Citation 5 a (new)

Text proposed by the Commission

Amendment

 

Having regard to the European Parliament resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance(P8_TA(2015)0197),

Amendment    2

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) Livestock production occupies a very important place in the agriculture of the Union. The rules concerning medicated feed have significant influence on the keeping and on the rearing of animals, including non-food producing animals, and on the production of products of animal origin.

(2) Livestock production, animal health and welfare, occupy a very important place in the agriculture of the Union. The rules concerning medicated feed have significant influence on the keeping and on the rearing of animals, including non-food producing animals, and on the production of products of animal origin.

Amendment    3

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

 

(3a) Prevention of disease is better than cure. Medicinal treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.

Amendment    4

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) As a type of feed, medicated feed falls within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council6, of Regulation (EC) No 767/2009 of the European Parliament and of the Council7, of Regulation (EC) No 1831/2003 of the European Parliament and of the Council8 and of Directive 2002/32/EC of the European Parliament and of the Council9. Specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment, personnel, manufacture quality control, storage and transport, record-keeping, complaints and product recalls, the application of procedures based on the hazard analysis and critical control points (HACCP) principles and labelling.

(6) As a type of feed, medicated feed falls within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council6, of Regulation (EC) No 767/2009 of the European Parliament and of the Council7, of Regulation (EC) No 1831/2003 of the European Parliament and of the Council8 and of Directive 2002/32/EC of the European Parliament and of the Council9. Specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment, personnel, manufacture quality control, animal welfare, storage and transport, record-keeping, complaints and product recalls, the application of procedures based on the hazard analysis and critical control points (HACCP) principles and labelling.

__________________

__________________

6 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

6 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).

7 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (OJ L 229, 1.9.2009, p. 1).

7 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed (OJ L 229, 1.9.2009, p. 1).

8 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

8 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).

9 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).

9 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).

Amendment    5

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals.

(9) Medicated feed should be manufactured only with authorised veterinary medicinal products and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be foreseen to ensure a safe and efficient treatment of the animals. The inclusion rates set should as a matter of principle be geared to a farm’s average needs. To take account of the specific features of the small-scale farming sector, and in particular to enable small or remote farms to optimise livestock care, it should be permissible to retain established control systems provided it is ensured that the prescription, production and use of medicated feed take place under the instructions and supervision of a veterinarian, or another professional person qualified to do so in accordance with applicable national law, and are subject to an external process control.

Amendment    6

Proposal for a regulation

Recital 12

 

Text proposed by the Commission

Amendment

(12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of "carry-over" is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed, while the term "cross-contamination" is to be considered as a contamination resulting from a carry-over or from the transfer in feed of any unintended substance. Carry-over of active substances contained in medicated feed to non-target feed should be avoided or kept as low as possible. In order to protect animal health, human health and the environment, maximum levels of carry-over for active substances contained in medicated feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority and taking into account the application of good manufacturing practice and the ALARA (As Low As Reasonably Achievable) principle. General limits should be set out in this Regulation, taking into account the unavoidable carry-over and the risk caused by the active substances concerned.

(12) Carry-over may occur during production, processing, storage and transport of feed where the same production and processing equipment, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of "carry-over" is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed. Carry-over of active substances contained in medicated feed to non-target feed should be avoided or strictly kept as low as possible. In order to protect animal health, human health and the environment, maximum limits for levels of carry-over for active substances contained in non-target feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority and taking into account the application of good manufacturing practice and the ALARA (As Low As Reasonably Achievable) principle. General limits should be set out in this Regulation, taking into account the unavoidable carry-over and the risk caused by the active substances concerned.

Amendment    7

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) Medicated feed should be marketed in sealed containers for safety reasons and to protect user’s interest.

(14) Medicated feed should be marketed in specially labelled sealed containers for safety reasons and to protect the user’s interest.

Amendment    8

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.

(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid written or electronic veterinary prescription issued, for a limited period of time, by a veterinarian or another professional person qualified to do so in accordance with applicable national law after examination and diagnosis of the animals to be treated. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.

Amendment    9

Proposal for a regulation

Recital 18

 

Text proposed by the Commission

Amendment

(18) In order to ensure a particularly prudent use of medicated feed for food-producing animals and therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-keeping by the animal holder should be provided for.

(18) In order to ensure a particularly prudent use of medicated feed for animals and therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record-keeping by the animal holder should be provided for.

Justification

A prudent use of medicated feed is vital for all animals, not only for food-producing ones.

Amendment    10

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. Preventive use or use to enhance the performance of food-producing animals should in particular not be allowed.

(19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials. Prophylactic use of antibiotics should in particular not be allowed.

Amendment    11

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

 

(19a) In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as of 1 January 2006 should be strictly adhered to and properly enforced.

Amendment    12

Proposal for a regulation

Recital 19 b (new)

Text proposed by the Commission

Amendment

 

(19b) The One Health concept, endorsed by the World Health Organisation (WHO), recognises that human health, animal health and ecosystems are interconnected and it is therefore essential for both animal and human health to ensure prudent use of antimicrobial medicines in food-producing animals.

Amendment    13

Proposal for a regulation

Recital 19 c (new)

Text proposed by the Commission

Amendment

 

(19c) The WHO has identified food products of animal origin as the main potential route of contamination for transmission of resistant bacteria and resistant genes from food-producing animals to humans.

Amendment    14

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) A system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal, human health or the environment.

(20) A system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal, human health or the environment. Collection points should keep records on the return of unconsumed medicated feed containing antimicrobial veterinary medicinal products.

Amendment    15

Proposal for a regulation

Article 1

Text proposed by the Commission

Amendment

This Regulation shall apply to:

1. This Regulation shall apply to

(a) the manufacture, storage and transport of medicated feed and intermediate products;

the manufacture, storage, transport, placing on the market, including import and export to third countries, and use of medicated feed and intermediate products for both food-producing and non-food producing animals. However, the following articles shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries:

(b) the placing on the market, including import, and use of medicated feed and intermediate products;

 

(c) the export to third countries of medicated feed and intermediate products. However, Articles 9, 15, 16 and 17 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.

- Article 9, except as provided for in Annex III, point 1, and

 

- Articles 15, 16 and 17.

 

2. This Regulation shall not apply to finished veterinary medicinal products to be orally administered that have been approved for use via feed or drinking water.

Amendment    16

Proposal for a regulation

Article 2 – paragraph 1 – point c

 

Text proposed by the Commission

Amendment

(c) the definitions of 'food-producing animal', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;

(c) the definitions of 'food-producing animal', 'non-food producing animals', 'feed materials', 'compound feed', 'complementary feed', 'mineral feed', labelling', 'label', 'minimum storage life' and 'batch' as laid down in Article 3(2) of Regulation (EC) No 767/2009;

Justification

Medicated feed and intermediate products are also used for non-food producing animals (such as fur and pet animals) so it is important to clarify that, in both the scope of the regulation and the definitions that apply.

Amendment    17

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ' intermediate product ' : a mixture of one or more veterinary medicinal products with one or more feeds, intended to be used for the manufacture of medicated feed;

(b) ' intermediate medicated feed ' : a mixture of one or more veterinary medicinal products with one or more feed materials, intended to be used for the manufacture of medicated feed;

Justification

To tighten up the definition and avoid possible confusion in practice. The term ‘intermediate medicated feed’ is more appropriate than ‘product’, since it concerns a feed rather than a medicinal product.

Amendment    18

Proposal for a regulation

Article 2 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) 'distributor': any feed business operator that supplies medicated feed, packaged and ready for use, to the animal holder;

(g) 'distributor': any feed business operator that supplies medicated feed, packaged and ready for use, to other distributors and directly to the animal holder;

Amendment    19

Proposal for a regulation

Article 2 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) ' mobile mixer ': a feed business operator with a feed establishment consisting of a specifically equipped lorry for the manufacture of medicated feed;

(h) ' mobile mixer ': a feed business operator with a feed establishment consisting of a specifically equipped mobile system for the manufacture of medicated feed, who travels in order to provide services to different animal holdings.

Amendment    20

Proposal for a regulation

Article 2 – paragraph 2 – point i

Text proposed by the Commission

Amendment

(i) ' on-farm mixer ': a feed business operator manufacturing medicated feed on the farm of use.

(i) ' on-farm mixer ': a feed business operator manufacturing medicated feed intended exclusively for animals on his or her farm.

Amendment    21

Proposal for a regulation

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

 

Text proposed by the Commission

Amendment

 

(ia) 'antimicrobials': a general term for any compound with a direct action on micro-organisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials/antibiotics, anti-virals, anti-fungals and antiprotozoals;

Justification

Though the term antimicrobial is used throughout the proposal there is no reference to a definition. The introduced definitions were adopted by HMA (Heads of Medicines Agencies) in October 2012.

Amendment    22

Proposal for a regulation

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

 

Text proposed by the Commission

Amendment

 

(ib) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;

Justification

In order to clarify the term "preventive use", a precise distinction between the different forms of treatment was added. The introduced definition was adopted by EPRUMA (European Platform for the Responsible Use of Medicines in Animals) in May 2013.

Amendment    23

Proposal for a regulation

Article 2 – paragraph 2 – point i c (new)

 

Text proposed by the Commission

Amendment

 

(ic) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;

Justification

In order to clarify the term "preventive use", a precise distinction between the different forms of treatment was added. The introduced definition was adopted by EPRUMA (European Platform for the Responsible Use of Medicines in Animals) in May 2013.

Amendment    24

Proposal for a regulation

Article 2 – paragraph 2 – point i d (new)

 

Text proposed by the Commission

Amendment

 

(id) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection.

Justification

In order to clarify the term "preventive use", a precise distinction between the different forms of treatment was added. The introduced definition was adopted by EPRUMA (European Platform for the Responsible Use of Medicines in Animals) in May 2013.

Amendment    25

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: ' HACCP ' ) system as provided for in Regulation (EC) No 183/2005.

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall put in place, implement and maintain a permanent written procedure or procedures based on the hazard analysis and critical control points (hereinafter: ' HACCP ' ) system as provided for in Regulation (EC) No 183/2005. Established control systems for on-farm mixers may be retained, provided it is ensured that the principles of the HACCP are complied with.

Justification

In implementing Regulation (EC) No 183/2005, primary feed producers already comply with the principles of the HACCP in the records they keep. It should remain possible to use these records.

Amendment    26

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid carry-over.

1. Feed business operators manufacturing, storing, transporting and placing on the market medicated feed and intermediate products shall apply measures in accordance with Article 3 and 4 to avoid carry-over in accordance with the ALARA principle, in order to avoid risk for animal health, human health or the environment.

Amendment    27

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

Substance-specific carry-over limits shall be set on the basis of a scientific risk assessement conducted by the European Food Safety Authority (EFSA).

Amendment    28

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Where no specific carry-over limits have been set for an active substance, the following carry-over limits shall apply:

Where no specific carry-over limits have been set for an active substance, the following general carry-over limits shall apply:

Amendment    29

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

 

The Commission shall be empowered to adopt delegated acts in accordance with Article 19 in order to adapt the general carry over limits set out in points (a) and (b) of this paragraph to scientific developments on basis of a scientific risk assessment conducted by EFSA.

Amendment    30

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 2 b (new)

Text proposed by the Commission

Amendment

 

Non-target feed, where carry-over limits have been exceeded, may not be placed on the market or fed to animals.

Amendment    31

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued. This provision shall not apply to on-farm mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with Articles 10 or 11 of Directive 2001/82/EC.

Medicated feed and intermediate products may be manufactured and stored before the prescription referred to in Article 15 is issued. This provision shall not apply to mobile mixers or in case of manufacture of medicated feed or intermediate products from veterinary medicinal products in accordance with Articles 10 or 11 of Directive 2001/82/EC. This ban shall not apply to outermost regions as part of Member States.

Amendment    32

Proposal for a regulation

Article 9 – paragraph 1

Text proposed by the Commission

Amendment

1. In addition to Article 11(1), Articles 12 and 14 of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products shall comply with Annex III to this Regulation.

1. In addition to Article 11(1) and Articles 12, 14, 15 and 17 of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products shall comply with Annex III to this Regulation.

Justification

Many of the requirements laid down in Annex III to this proposal are already established in Articles 15 and 17 of Regulation (EC) No 767/2009. We are proposing that this article should include a reference to the provisions in that regulation that relate to the labelling and circulation of feed.

Amendment    33

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. Where containers are used instead of packaging material, they shall be accompanied by documents complying with paragraph 1.

2. Where containers are used instead of packages, they shall be accompanied a document complying with paragraph 1.

Justification

We are proposing that all labelling information should be included in a single document (in a manner similar to that specified in Regulation (EC) No 767/2009). If the reference to various documents is maintained, it would make it difficult for the competent authorities to check compliance with labelling rules, and could also make it difficult to monitor the traceability of medicated feed.

Amendment    34

Proposal for a regulation

Article 10

Text proposed by the Commission

Amendment

Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.

Medicated feed and intermediate products shall be placed on the market only in properly labelled and sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused.

Amendment    35

Proposal for a regulation

Article 12

Text proposed by the Commission

Amendment

Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority.

Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent public authority. Where on-farm mixers include medicinal products solely for use on their own farms, they shall notify their activity to the competent authority.

Justification

On-farm mixers are already registered with the authorities. An additional approval procedure goes against the principle of administrative simplification and cost saving for businesses.

Amendment    36

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription and to the conditions laid down in paragraphs 2 to 6.

1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription, issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law, and to the conditions laid down in paragraphs 2 to 6.

Amendment    37

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The person issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance.

2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The veterinarian or another professional person qualified to do so in accordance with applicable national law issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance.

Amendment    38

Proposal for a regulation

Article 15 – paragraph 5

Text proposed by the Commission

Amendment

5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.

5. The prescribed medicated feed may be used only for animals examined by the veterinarian or another professional person qualified to do so in accordance with applicable national law who issued the prescription and only for a diagnosed disease. The veterinarian or another professional person qualified to do so in accordance with applicable national law who issued the prescription shall verify, based on the knowledge of the feeding systems in use, the possibilities of mixing and other relevant farm specificities, that this medication is justified for the target animals on veterinary grounds.

 

Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.

Amendment    39

Proposal for a regulation

Article 16 – title

Text proposed by the Commission

Amendment

Use in food-producing animals

Use in food-producing and non-food producing animals

Amendment    40

Proposal for a regulation

Article 16 – paragraph 1 – introductory words

Text proposed by the Commission

Amendment

1. Feed business operators supplying medicated feed to the holder of food-producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed:

1. Feed business operators supplying medicated feed to the holders of food-producing and non-food producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed:

Amendment    41

Proposal for a regulation

Article 16 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the quantities required for one month's treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products.

(b) the quantities required for one month's treatment or one week in the case of medicated feed containing antimicrobial veterinary medicinal products, unless the summary of product characteristics of the prescribed antimicrobial veterinary medicinal product establishes a treatment period of a duration longer than one week.

Amendment    42

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. Member States shall ensure that holders of food-producing animals apply the preventive measures listed in Annex Va before resorting to the use of medicated feed containing antimicrobials for metaphylaxis.

(This amendment is linked to the amendment introducing a new Annex Va.)

Justification

Clear conditions should be set with regard to metaphylaxis.

Amendment    43

Proposal for a regulation

Article 16 – paragraph 2

 

Text proposed by the Commission

Amendment

2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food-producing animals or to enhance their performance.

2. Medicated feed containing antibiotic veterinary medicinal products shall not be used for preventive treatment (prophylaxis). Prophylaxis with antimicrobials shall never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions.

Amendment    44

Proposal for a regulation

Article 16 – paragraph 4

Text proposed by the Commission

Amendment

4. Feed business operators feeding food-producing animals with medicated feed shall keep records in accordance with Article 69 of Directive 2001/82/EC. Those records shall be kept for five years after the date of administration of medicated feed, including when the animal is slaughtered during the five-year period.

4. Feed business operators feeding food-producing animals with medicated feed shall keep records in accordance with Article 69 of Directive 2001/82/EC. Those records shall be kept for five years after the date of administration of medicated feed, including when the animal is slaughtered during the five-year period. Member States shall ensure that the data in those records is collected and transferred to the Union database on veterinary medicinal products (referring to Articles 51 and 54 in the proposal for a Regulation on veterinary medicinal products (2014/0257 (COD)).

Amendment    45

Proposal for a regulation

Article 17

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription.

Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the animal holder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescription. Member States shall ensure that manufacturers of medicated feed and farmers are informed where to find these collections systems and how to get their unused leftovers of medicated feed to these collection points. Member States shall ensure that operators of collection points keep records of the medicated feed collected. Those records shall be kept for five years after collection.

Justification

It is important to know how much medicated feed is returned.

Amendment    46

Proposal for a regulation

Annex I – section 3 – point 2

Text proposed by the Commission

Amendment

2. Technical or organisational measures shall be taken to avoid any cross-contamination and errors, to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products.

2. Technical or organisational measures shall be taken to avoid or strictly minimise any carry-over and errors, to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products.

Amendment    47

Proposal for a regulation

Annex I – section 3 – point 4

Text proposed by the Commission

Amendment

4. The products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoid any cross-contamination.

4. The products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoid or strictly minimise any carry-over.

Amendment    48

Proposal for a regulation

Annex I – section 6 – point 2 – point i

Text proposed by the Commission

Amendment

(i) information on the person who has issued the prescription, including at least his name and address.

(i) information on the veterinarian or another professional person qualified to do so in accordance with applicable national law who has issued the prescription, including at least his name and address.

Amendment    49

Proposal for a regulation

Annex II – point 1

Text proposed by the Commission

Amendment

1. Mobile mixers or on-farm mixers shall only use veterinary medicinal products at inclusion rates above 2 kg/t of feed.

1. Mobile mixers or on-farm mixers shall only use veterinary medicinal products at inclusion rates above 2 kg/t of feed. By way of derogation, smaller inclusion rates may be specified in the veterinary prescription:

 

- to adjust the quantity of medicated feed produced to the size of the herd;

 

- if the prescription, production and use take place under the supervision of the veterinarian, or another professional person qualified to do so in accordance with applicable national law, monitoring the herd; and

 

- if the farmer and the veterinarian, or another professional person qualified to do so in accordance with applicable national law, monitoring the herd are subject to an external process control.

Amendment    50

Proposal for a regulation

Annex III – paragraph 1 – point 16 a (new)

Text proposed by the Commission

Amendment

 

(16a) information that inappropriate disposal of medicated feed poses serious threats to the environment and may contribute to antimicrobial resistance. Information on where and how to appropriately dispose of unused material.

Justification

Information on where and how to appropriately dispose of unused material can be provided by a hyperlink.

Amendment    51

Proposal for a regulation

Annex III – paragraph 1 – point 16 b (new)

Text proposed by the Commission

Amendment

 

(16b) for medicated feed containing antibiotics: the request to use antibiotics only as a last resort and in a most prudent and responsible manner.

Amendment    52

Proposal for a regulation

Annex IV – point 1 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of 10% shall apply. For the other active substances, the following tolerances shall apply:

Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of 3% shall apply. For the other active substances, the following tolerances shall apply:

Justification

Given the potency of antimicrobial active substances, a tolerance of 10% is far too high.

Amendment    53

Proposal for a regulation

Annex V – point 1

Text proposed by the Commission

Amendment

1. Surname, forename, address and professional membership number of the person allowed to prescribe a veterinary medicinal product.

1. Surname, forename, address and professional membership number of the veterinarian or another professional person qualified to prescribe a veterinary medicinal product in accordance with applicable national law.

Amendment    54

Proposal for a regulation

Annex V – point 2

Text proposed by the Commission

Amendment

2. Issue date and signature or electronic identification of the person allowed to prescribe a veterinary medicinal product.

2. Issue date and signature or electronic identification of the veterinarian or another professional person qualified to prescribe a veterinary medicinal product in accordance with applicable national law.

Amendment    55

Proposal for a regulation

Annex V a (new)

Text proposed by the Commission

Amendment

 

Annex Va

 

Preventive measures

 

Preventive measures to be used before resorting to antimicrobial treatment of entire groups (metaphylaxis):

 

- using good healthy breeding stock that grows naturally, with suitable genetic diversity

 

- conditions that respect the behavioural needs of the species, including social interactions/ hierarchies

 

- stocking densities that do not increase risk of disease transmission

 

- isolation of sick animals away from the rest of the group

 

- (for chickens and smaller animals) subdivision of flocks into smaller, physically separated groups

 

- Implementation of existing animal welfare rules pursuant to Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23),

 

Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33), Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28).

Justification

These preventative measures include regularly checking the welfare of individual animals, which would not be possible in many mass rearing operations for chickens for example.

PROCEDURE

Title

Manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC

References

COM(2014)0556 – C8-0143/2014 – 2014/0255(COD)

Committee responsible

       Date announced in plenary

AGRI

20.10.2014

 

 

 

Opinion by

       Date announced in plenary

ENVI

20.10.2014

Rapporteur

       Date appointed

Norbert Lins

13.11.2014

Discussed in committee

31.3.2015

 

 

 

Date adopted

17.6.2015

 

 

 

Result of final vote

+:

–:

0:

51

3

3

Members present for the final vote

Marco Affronte, Zoltán Balczó, Lynn Boylan, Nessa Childers, Alberto Cirio, Birgit Collin-Langen, Mireille D’Ornano, Miriam Dalli, Seb Dance, Angélique Delahaye, Stefan Eck, Bas Eickhout, Eleonora Evi, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Jens Gieseke, Julie Girling, Sylvie Goddyn, Matthias Groote, Françoise Grossetête, Anneli Jäätteenmäki, Jean-François Jalkh, Benedek Jávor, Karin Kadenbach, Kateřina Konečná, Giovanni La Via, Peter Liese, Norbert Lins, Susanne Melior, Miroslav Mikolášik, Massimo Paolucci, Gilles Pargneaux, Piernicola Pedicini, Pavel Poc, Marcus Pretzell, Frédérique Ries, Annie Schreijer-Pierik, Davor Škrlec, Renate Sommer, Dubravka Šuica, Tibor Szanyi, Jadwiga Wiśniewska, Damiano Zoffoli

Substitutes present for the final vote

Nikos Androulakis, Renata Briano, Nicola Caputo, Marijana Petir, Sirpa Pietikäinen, Gabriele Preuß, Bart Staes, Tom Vandenkendelaere

Substitutes under Rule 200(2) present for the final vote

José Inácio Faria, Fredrick Federley, Anthea McIntyre, James Nicholson, Jens Nilsson


PROCEDURE – COMMITTEE RESPONSIBLE

Title

Manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC

References

COM(2014)0556 – C8-0143/2014 – 2014/0255(COD)

Date submitted to Parliament

10.9.2014

 

 

 

Committee responsible

       Date announced in plenary

AGRI

20.10.2014

 

 

 

Committees asked for opinions

       Date announced in plenary

ENVI

20.10.2014

IMCO

20.10.2014

 

 

Not delivering opinions

       Date of decision

IMCO

3.12.2014

 

 

 

Rapporteurs

       Date appointed

Clara Eugenia Aguilera García

4.12.2014

 

 

 

Legal basis disputed

       Date of JURI opinion

JURI

13.7.2015

 

 

 

Date adopted

15.3.2016

 

 

 

Result of final vote

+:

–:

0:

40

3

0

Members present for the final vote

John Stuart Agnew, Clara Eugenia Aguilera García, Eric Andrieu, Paul Brannen, Daniel Buda, Nicola Caputo, Matt Carthy, Michel Dantin, Albert Deß, Diane Dodds, Herbert Dorfmann, Norbert Erdős, Edouard Ferrand, Luke Ming Flanagan, Beata Gosiewska, Martin Häusling, Esther Herranz García, Jan Huitema, Peter Jahr, Elisabeth Köstinger, Zbigniew Kuźmiuk, Philippe Loiseau, Mairead McGuinness, Ulrike Müller, James Nicholson, Maria Noichl, Marijana Petir, Laurenţiu Rebega, Bronis Ropė, Jordi Sebastià, Jasenko Selimovic, Lidia Senra Rodríguez, Czesław Adam Siekierski, Marc Tarabella

Substitutes present for the final vote

Pilar Ayuso, Franc Bogovič, Rosa D’Amato, Jørn Dohrmann, Peter Eriksson, Julie Girling, Ivan Jakovčić, Karin Kadenbach, Sofia Ribeiro, Tibor Szanyi

Date tabled

5.4.2016

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