29 Amendments of Pilar AYUSO related to 2014/0255(COD)
Amendment 81 #
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
c) the export to third countries of medicated feed and intermediate products. However, Articles 9, 15, 16 and 17the following articles shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries: - Article 9, except as provided for in Annex III, point 1, and - Articles 15, 16 and 17.
Amendment 91 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
b) ' intermediate productmedicated feed ' : a mixture of one or more veterinary medicinal products with one or more feed materials, intended to be used for the manufacture of medicated feed;
Amendment 92 #
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
Amendment 93 #
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
d) ' non-target feed ' : medicated feed which is not intended to contain a specific veterinary medicinal product;
Amendment 96 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
g) ' distributor ' : any feed business operator that supplies medicated feed, packaged and ready for use, to the animal holder or, in the case of non-food producing animals, to other distributors who are authorised to distribute veterinary medicinal products;
Amendment 98 #
Proposal for a regulation
Article 2 – paragraph 2 – point h
Article 2 – paragraph 2 – point h
h) ' mobile mixer ' : a feed business operator with a feed establishment consisting of a specifically equipped lorrymobile system for the manufacture of medicated feed, who travels in order to provide services to different animal holdings;
Amendment 100 #
Proposal for a regulation
Article 2 – paragraph 2 – point i
Article 2 – paragraph 2 – point i
i) ' on-farm mixer ' : a feed business operator manufacturing medicated feed on the farm of useintended exclusively for animals on his or her farm.
Amendment 106 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) 'intermediate productmedicated feed': a mixture of one or more veterinary medicinal products with one or more feedraw materials, intended to be used for the manufacture of medicated feed;
Amendment 115 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. Distributors who supply medicated feed solely for non-food producing animals, distributed in sealed bags on prescription and sent to the holders of the animals, shall be exempt from the requirements applying to feed business operators.
Amendment 118 #
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 123 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
The Commission shall be empowered to adopt delegatedimplementing acts in accordance with Article 19 concerning the establishment of specific carry-over limits for active substances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Amendment 129 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – introductory part
Article 7 – paragraph 2 – subparagraph 2 – introductory part
Where no specific carry-over limits have been set for an active substance, the followinga carry- over limits of 3% of the active substance in medicated feed to non-target feed shall apply:.
Amendment 134 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
Amendment 141 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point b
Article 7 – paragraph 2 – subparagraph 2 – point b
Amendment 145 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Medicated feed and intermediate products may 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/ECmobile mixers.
Amendment 149 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. In addition to Article 11(1), and Articles 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 150 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Where containers are used instead of packaging materiales, they shall be accompanied bya documents complying with paragraph 1.
Amendment 155 #
Proposal for a regulation
Article 10
Article 10
Amendment 156 #
Proposal for a regulation
Article 11
Article 11
Amendment 170 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
Amendment 177 #
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 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 185 #
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 active substance of the veterinary medicinal product calculated on the basis of the relevant parametersper kg of medicated feed.
Amendment 189 #
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Feed business operators supplying medicated feed to the holder of food- producing animals, or on-farm mixers of medicated feed for food-producing animals shall ensure that the quantities supplied or mixed do not exceed: the quantities required for treatment, which shall be determined in accordance with the conditions of use established in the authorisation to place on the market the veterinary medicinal products included in the prescription.
Amendment 192 #
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 196 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 196 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Medicated feed and intermediate products may 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/ECmobile mixers.
Amendment 207 #
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 218 #
Proposal for a regulation
Article 17
Article 17
Amendment 285 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1