28 Amendments of Marco ZULLO related to 2014/0255(COD)
Amendment 45 #
Proposal for a regulation
Recital 6
Recital 6
(6) As a types of feed, medicated feed and intermediate products 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 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 53 #
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 toin 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 forimits for trace levels of 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 78 #
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-producantimicrobials ing animals. Preventive use or use to enhance the performance of food-producing animals should in particular not be allowed. The Commission should encourage innovation in the development of nutritional solutions to preserve animals' welfare and thereby contribute to reduce the need for veterinary treatment, in particular via antimicrobials.
Amendment 89 #
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 95 #
Proposal for a regulation
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) the definitions of 'food-producing animal' and '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;
Amendment 104 #
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) 'medicated feed': a mixtureresult of the manufacturing of one or more veterinary medicinal products or intermediate products authorised for this purpose with one or more feeds which is ready to be directly fed to animals without further processing;
Amendment 122 #
Proposal for a regulation
Article 2 – paragraph 2 – point i e (new)
Article 2 – paragraph 2 – point i e (new)
(ie) '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;
Amendment 127 #
Proposal for a regulation
Article 2 – paragraph 2 – point i f (new)
Article 2 – paragraph 2 – point i f (new)
(if) '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 infected;
Amendment 155 #
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 regarding interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed;
Amendment 156 #
Proposal for a regulation
Article 5 – paragraph 2 – point c
Article 5 – paragraph 2 – point c
Amendment 163 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
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 mixanufacturing technology (mixing, spraying, etc.). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Amendment 167 #
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 173 #
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 trace levels of active substances in non-target feed.
Amendment 186 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point b
Article 7 – paragraph 2 – subparagraph 2 – point b
(b) for the other active substances, 3%1% of the authorised maximum content of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non- target feed for withdrawal feed and for 'continuous food-producing animals' feed.
Amendment 200 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. In addition to Article 11(1), Articles 121(4), 12, 14, 15 and 147 of Regulation (EC) No 767/2009, the labelling of medicated feed and intermediate products shall comply with Annex III to this Regulation.
Amendment 204 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. Permitted tolerances for discrepancies between the labelled compositional values ofand amount of active substances in 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 221 #
Proposal for a regulation
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
Amendment 236 #
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 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
Amendment 257 #
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 weeken days in case of medicated feed containing antimicrobial veterinary medicinal products, unless differently provided for in the prescription in accordance with the summary of product characteristics (SPC).
Amendment 271 #
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-producing animals or to enhance their performancefor prophylaxis. Metaphylaxis is allowed to minimize the spread of an infection within a group of animals where the presence of an infectious agent has been confirmed.
Amendment 301 #
Proposal for a regulation
Annex 1 – section 6 – point 2 – point i
Annex 1 – section 6 – point 2 – point i
(i) for the distributor who supplies to the animal holder information on the person who has issued the prescription, including at least his name and address.
Amendment 307 #
Proposal for a regulation
Annex 2 – point 2
Annex 2 – point 2
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 raccordance with the prescription.
Amendment 310 #
Proposal for a regulation
Annex 3 – point 1
Annex 3 – point 1
(1) the expression 'Medicated feed' or 'Intermediate product for medicated feed' supplemented by the expression 'complete' or 'complementary', as appropriate, and the target species;
Amendment 312 #
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 318 #
Proposal for a regulation
Annex 3 – point 6
Annex 3 – point 6
(6) the veterinary medicinal products with name, active substance, strength, and its added amount, strength, marketing authorisation holder and marketing authorisation number, preceded by the heading ‘medication';
Amendment 319 #
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 333 #
Proposal for a regulation
Annex 4 – point 1 – paragraph 1
Annex 4 – point 1 – paragraph 1
1. The tolerances laid down in this point shall include technical and analytical deviations.
Amendment 339 #
Proposal for a regulation
Annex 4 – point 1 – paragraph 2
Annex 4 – point 1 – paragraph 2
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: