24 Amendments of Elisabeth KÖSTINGER related to 2014/0255(COD)
Amendment 33 #
Proposal for a regulation
Recital 9
Recital 9
(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 and are subject to an external process control.
Amendment 48 #
Proposal for a regulation
Recital 9
Recital 9
(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 and are subject to an external process control.
Amendment 60 #
Proposal for a regulation
Recital 16
Recital 16
(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. 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 116 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
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.
Amendment 139 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
Feed business operators shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I. the requirements of Annex I. This shall not apply to agricultural establishments which feed on-farm-manufactured medicated feed to their own animals pursuant to Article 16.
Amendment 146 #
Proposal for a regulation
Article 3 – paragraph 1 b (new)
Article 3 – paragraph 1 b (new)
1b. Care should be taken to ensure that the medicated feed handling requirements imposed by the Regulation and secondary legislation on feed business operators, in particular on-farm mixers, are feasible and practical.
Amendment 148 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
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, where these are not fed directly to livestock, shall comply with Annex III to this Regulation.
Amendment 150 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 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.
Amendment 161 #
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 authority. Where on-farm mixers include medicinal products solely for use on their own farms, they shall notify their activity to the competent authority.
Amendment 167 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The prescription shall contain the information set out in Annex Vrticle 110 of the Regulation of the European Parliament and the Council on veterinary medicinal products1 a . 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. __________________ 1a Commission proposal COM(2014)558 final
Amendment 171 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
Amendment 183 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for the group of animals examininspected 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.
Amendment 194 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 198 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
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 must be notified to the competent authority. This provision shall not apply to on-farm mixers or 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.
Amendment 201 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
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, where these are not fed directly to livestock, shall comply with Annex III to this Regulation.
Amendment 206 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used routinely to prevent diseases in food- producing animals or to enhance their performance. It shall only be used in limited and precise circumstances prescribed by the veterinarian.
Amendment 210 #
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 authority. This shall not apply to agricultural establishments which feed on-farm-manufactured medicated feed to their own animals.
Amendment 217 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The prescription shall contain the information set out in Annex V, based on Article 110 of the Regulation on Veterinary Medicinal Products1 a . 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. __________________ 1a Commission Proposal COM (2014)558 final
Amendment 225 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The prescription shall be valid for a maximum period of six months for non- food producing animals and three weekmonths for food-producing animals.
Amendment 234 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for groups of 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.
Amendment 241 #
Proposal for a regulation
Annex II – point 1
Annex II – point 1
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 monitoring the herd; and - if the farmer and the veterinarian monitoring the herd are subject to an external process control.
Amendment 255 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
(b) the quantities required for one month's treatment or two weeks in case of medicated feed containing antimicrobial veterinary medicinal products.
Amendment 275 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used to prevent diseases in food-producingdomestic or farm animals or to enhance their performance.
Amendment 306 #
Proposal for a regulation
Annex 2
Annex 2