53 Amendments of Stefan ECK related to 2014/0255(COD)
Amendment 22 #
Proposal for a regulation
Recital 2
Recital 2
(2) Livestock production, animal health and welfare, occupiesy 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 27 #
Proposal for a regulation
Recital 4
Recital 4
(4) Experience with the application of Directive 90/167/EEC has shown that further measuPet animals should be excluded from the general scope of this Regulation. However, theres should be taken to strengthen the effective functioning of the Internal Market and to explicitly give and improve the possibility to treat non-food producing animals by mediche possibility to adopt clearly defined conditions under which medicated feed may be used to treat pet animals as a delegated feedact.
Amendment 29 #
Proposal for a regulation
Recital 6
Recital 6
(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). 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). 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 37 #
Proposal for a regulation
Recital 12
Recital 12
(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. Iprohibited 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.
Amendment 42 #
Proposal for a regulation
Recital 2
Recital 2
(2) Livestock production, animal health and welfare occupiesy 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 43 #
Proposal for a regulation
Recital 13
Recital 13
(13) Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed. Similarly, limits for the dDeviations of the labelled content of medicated feed from the actual content should be establishprohibited.
Amendment 46 #
Proposal for a regulation
Recital 6
Recital 6
(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, animal welfare, 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 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). 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).
Amendment 50 #
Proposal for a regulation
Recital 17
Recital 17
(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.
Amendment 50 #
Proposal for a regulation
Recital 12
Recital 12
(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. Iprohibited 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.
Amendment 55 #
Proposal for a regulation
Recital 18
Recital 18
(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, including animal 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 55 #
Proposal for a regulation
Recital 13
Recital 13
(13) Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed. Similarly, limits for the dDeviations of the labelled content of medicated feed from the actual content should be establishprohibited.
Amendment 62 #
Proposal for a regulation
Recital 17
Recital 17
(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.
Amendment 66 #
Proposal for a regulation
Recital 19
Recital 19
(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 allowbe prohibited.
Amendment 67 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) The One Health concept, endorsed by the World Health Organisation, 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 69 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) 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 69 #
Proposal for a regulation
Recital 18
Recital 18
(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 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 75 #
Proposal for a regulation
Recital 21
Recital 21
(21) In order to comply with the objective of this Regulation and to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the establishment of specific carry-over limits and of the amendment to the Annexes to this Regulation. Those Annexes concern provisions on feed business operators obligations related to animal health and welfare, the manufacture, storage, transport and placing on the market of medicated feed and intermediate products, the incorporation of the veterinary medicinal product into feed, the labelling particulars for medicated feed and intermediate products, the permitted tolerances for the compositional labelling of medicated feed or intermediate products and the specimen form to be used for the veterinary prescription. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 80 #
Proposal for a regulation
Recital 19
Recital 19
(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 allowbe prohibited.
Amendment 82 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
This Regulation shall not apply to pet animals unless a delegated act is adopted in accordance with Articles 16a and 19.
Amendment 120 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
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 avoidprevent carry-over.
Amendment 121 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
Amendment 127 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2
Article 7 – paragraph 2 – subparagraph 2
Amendment 133 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
Amendment 140 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point b
Article 7 – paragraph 2 – subparagraph 2 – point b
Amendment 146 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Medicated feed and intermediate products may not 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.
Amendment 152 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Permitted tolerances for dDiscrepancies 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 IVwon't be permitted.
Amendment 160 #
Proposal for a regulation
Article 12
Article 12
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.
Amendment 165 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
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 personveterinary agent 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 165 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
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 avoidprevent carry-over.
Amendment 170 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
Amendment 178 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for animals examined by the personveterinary agent who issued the prescription and only for a diagnosed disease. The personveterinary agent 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.
Amendment 178 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph -2
Article 7 – paragraph 2 – subparagraph -2
Amendment 195 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Medicated feed and intermediate products may not 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.
Amendment 202 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Permitted tolerances for dDiscrepancies 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 IVshall not be permitted.
Amendment 203 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. MSince there is a direct link between good animal husbandry and a responsible use of veterinary medicines, medicated feed containing antimicrobial veterinary medicinal products shall notever be used to prevent diseases in food-producing animals or to enhance their performance.
Amendment 211 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
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.
Amendment 215 #
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Article 16a Use in pet animals The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific conditions in which medicated feed may be used to treat pet animals.
Amendment 215 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
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 persoveterinarian 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 225 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The delegation of power referred to in Articles 7, 16a and 18 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 227 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The delegation of powers referred to in Articles 7, 16a and 18 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 229 #
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. A delegated act adopted pursuant to Articles 7, 16a and 18 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
Amendment 231 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for animals examined by the persoveterinarian who issued the prescription and only for a diagnosed disease. The persoveterinarian 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.
Amendment 234 #
Proposal for a regulation
Annex I – section 3 – point 2
Annex I – section 3 – point 2
2. Technical or organisational measures shall be taken to avoidprevent 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 235 #
Proposal for a regulation
Annex I – section 3 – point 3
Annex I – section 3 – point 3
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 monitornot be permitted, and appropriate measures to minimiseprevent this presence shall be taken.
Amendment 236 #
Proposal for a regulation
Annex I – section 3 – point 4
Annex I – section 3 – point 4
4. The products used for the manufacture and unprocessed feed shall be stored separately from medicated feed and intermediate products in order to avoidprevent any cross-contamination.
Amendment 239 #
Proposal for a regulation
Annex I – section 6 – point 2 – point i
Annex I – section 6 – point 2 – point i
(i) information on the personveterinary agent who has issued the prescription, including at least his name and address.
Amendment 240 #
Proposal for a regulation
Annex I – section 6 – point 2 – subparagraph 2
Annex I – section 6 – point 2 – subparagraph 2
Apart from the documents that are permanent in nature, the documents shall be kept for threesix years in the register after their date of issuance.
Amendment 247 #
Proposal for a regulation
Annex IV – heading 1
Annex IV – heading 1
Amendment 274 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. MSince there is a direct link between good animal husbandry and a responsible use of veterinary medicines, medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food-producing animals or to enhance their performance.
Amendment 296 #
Proposal for a regulation
Annex 1 – section 3 – point 2
Annex 1 – section 3 – point 2
2. Technical or organisational measures shall be taken to avoidprevent 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 298 #
Proposal for a regulation
Annex 1 – section 3 – point 3
Annex 1 – section 3 – point 3
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 monitornot be permitted, and appropriate measures to minimiseavoid this presence shall be taken.
Amendment 300 #
Proposal for a regulation
Annex 1 – section 6 – point 2 – point i
Annex 1 – section 6 – point 2 – point i
(i) information on the persoveterinarian who has issued the prescription, including at least his name and address.
Amendment 332 #
Proposal for a regulation
Annex 4
Annex 4