29 Amendments of Paolo DE CASTRO related to 2014/0255(COD)
Amendment 51 #
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. In order to protect animal health, human health and the environment, maximum levels of carry- over forfor traces of active substances contained in medicatedin 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. GeneralIn the interim, general maximum limits should be set out in this Regulation according to a basic approach, taking into account the unavoidable carry- over and the risk caused by the active substances concerned.
Amendment 90 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) the placing on the market, including import from third countries, and use of medicated feed and intermediate products;
Amendment 96 #
Proposal for a regulation
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) the definitions of 'food-producing animal', 'non-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;
Amendment 142 #
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 Ithe requirements of Regulation (EC) No 183/2005 and Regulation (EC) No 767/2009 and additional requirements established in Annex I and III to this Regulation.
Amendment 154 #
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
(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; this includes, in particular, provisions relating to possible interactions between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed;
Amendment 157 #
Proposal for a regulation
Article 5 – paragraph 2 – point c
Article 5 – paragraph 2 – point c
Amendment 168 #
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 avoidminimise carry-over.
Amendment 174 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerning the establishment of specific carry-overmaximum limits for traces of active substances in non-target feed.
Amendment 177 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1 a (new)
Article 7 – paragraph 2 – subparagraph 1 a (new)
(1a) Carry-over limits for each specific substance shall be determined by the Commission on the basis of a scientific risk assessment carried out by the European Food Safety Authority (EFSA).
Amendment 199 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. In addition to Articles 11(1), Articles 1211(4), 12, 14, 15(b), 15(d), 15(e), 15(f), 17(1)(a), 17(1)(d), 17(1)(e), 17(1)(f), 17(2) and 147(3) of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products shallould comply with Annex III to this Regulation.
Amendment 203 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. PIn addition to the tolerances listed in Annex IV to Regulation (EC) No 767/2009, the permitted tolerances for discrepancies between the labelled compositional valuesactive 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 230 #
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 237 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
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 and the quantity of medicated feed calculated on the basis of the relevant parameters. The daily dose of the veterinary medicinal product shall be incorporated in a quantity of 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.
Amendment 278 #
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
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 fivthree years after the date of administration of medicated feed, including when the animal is slaughtered during the five-year period.
Amendment 282 #
Proposal for a regulation
Article 17 – title
Article 17 – title
Collection systems of unused or expired products
Amendment 287 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicated feed and intermediate products that are expired or in case the anim. The collected material shoulder has received a bigger quantity of medicated feed than he actually uses for the treatment referred to in the veterinary prescrip be disposed of in accordance with existing regulations.
Amendment 297 #
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 avoidminimise 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 311 #
Proposal for a regulation
Annex 3 – point 2
Annex 3 – point 2
Amendment 313 #
Proposal for a regulation
Annex 3 – point 3
Annex 3 – point 3
(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 314 #
Proposal for a regulation
Annex 3 – point 4
Annex 3 – point 4
Amendment 315 #
Proposal for a regulation
Annex 3 – point 5
Annex 3 – point 5
Amendment 316 #
Proposal for a regulation
Annex 3 – point 6
Annex 3 – point 6
(6) the veterinary medicinal products with name, active substance, strength, added amount, marketing authorisation holder and marketing authorisation number of the active substance, preceded by the heading ‘medication’;
Amendment 320 #
Proposal for a regulation
Annex 3 – point 7
Annex 3 – point 7
(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;
Amendment 322 #
Proposal for a regulation
Annex 3 – point 10
Annex 3 – point 10
Amendment 323 #
Proposal for a regulation
Annex 3 – point 11
Annex 3 – point 11
Amendment 324 #
Proposal for a regulation
Annex 3 – point 12
Annex 3 – point 12
Amendment 325 #
Proposal for a regulation
Annex 3 – point 13
Annex 3 – point 13
Amendment 326 #
Proposal for a regulation
Annex 3 – point 14
Annex 3 – point 14
Amendment 345 #
Proposal for a regulation
Annex 4 – point 2
Annex 4 – point 2