24 Amendments of Nicola CAPUTO related to 2014/0255(COD)
Amendment 28 #
Proposal for a regulation
Recital 4
Recital 4
(4) Experience with the application of Directive 90/167/EEC has shown that further measures 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 medicated feed under clearly defined conditions.
Amendment 47 #
Proposal for a regulation
Recital 6
Recital 6
(6) As a type 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 59 #
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 allowed.
Amendment 74 #
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, the conditions under which medicated feed may be used to treat non-food producing animals and of the amendment to the Annexes to this Regulation. Those Annexes concern provisions on feed business operators obligations related to 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 79 #
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 useanimals. Use of antibiotics to enhance the performance of food-producing animals should in particularwas already banned in 2006. In addition, routine preventive use of medicated feed containing antimicrobials should not be allowed.
Amendment 103 #
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) 'medicated feed': a mixfeed resulting from the manufacture of one or more veterinary medicinal products authorised for this purpose or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing;
Amendment 107 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) 'intermediate product': amedicated feed': feed resulting from the mixture of one or more veterinary medicinal products authorised for this use with one or more feeds, intended to be used for the manufacture of medicated feed;
Amendment 124 #
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 128 #
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 (sub-clinically) infected;
Amendment 133 #
Proposal for a regulation
Article 2 – paragraph 2 – point i g (new)
Article 2 – paragraph 2 – point i g (new)
(ig) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 164 #
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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Amendment 175 #
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 184 #
Proposal for a regulation
Article 15 – paragraph 5 – subparagraph 1 a (new)
Article 15 – paragraph 5 – subparagraph 1 a (new)
Veterinarians qualified to prescribe medicated feed in accordance with applicable national law shall not retail medicated feed.
Amendment 214 #
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Article 16a Use in non-food producing 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 non-food producing animals. Such conditions shall be based on scientific evidence and shall define the species of non-food producing animals as well as the specific health conditions which may be treated with medicated feed.
Amendment 223 #
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 226 #
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 228 #
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 229 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for individual animals or a group of 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 238 #
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 calculated on the basis of the relevant parameters 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 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 254 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 264 #
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 performance.
Amendment 283 #
Proposal for a regulation
Article 17 – title
Article 17 – title
Collection systems of unused or expired products
Amendment 288 #
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 308 #
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.