33 Amendments of Annie SCHREIJER-PIERIK related to 2014/0255(COD)
Amendment 49 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treated. The prescription can only be given by a veterinarian after examination of the animal and when a diagnosis is made, or if the veterinarian has personal knowledge of the condition of the animal. A written or electronic prescription is always required when the medicine is dispensed by anyone other than the veterinarian. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 56 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to ensure a particularly prudent userudent use, by which is meant appropriate use of medicines according to prescription, of medicated feed for food-producing and non-food producing animals and therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record- keeping by the animal holder should be provided for.
Amendment 65 #
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription which has been issued after examination of the animals to be treatedand when a diagnosis is made, or if the veterinarian has personal knowledge of the condition of the animal. A written or electronic prescription is always required when the medicine is dispensed by anyone other than the veterinarian. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 68 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to ensure a particularly prudent use, by which is meant appropriate use of medicines according to prescription, of medicated feed for food- producing and non-food producing animals and therefore provide the basis for the assurance of a high level of protection of public health, specific conditions concerning the use and the validity of the prescription, compliance with the withdrawal period and record- keeping by the animal holder should be provided for.
Amendment 76 #
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 animal. Prophylactic use of antibiotics should in particular not be allowed.
Amendment 78 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) the manufacture, storage and transport of medicated feed and intermediate products intended for pets, non-food producing animals and food-producing animals;
Amendment 79 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) the placing on the market, including import, and use of medicated feed and intermediate products intended for pets, non-food producing animals and food- producing animals;
Amendment 82 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as of 1 January 2006 should be strictly adhered to and properly enforced.
Amendment 86 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) the manufacture, storage and transport of medicated feed and intermediate products intended for both non-food and food-producing animals;
Amendment 88 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) the placing on the market, including import, and use of medicated feed and intermediate products intended for both non-food and food-producing animals;
Amendment 93 #
Proposal for a regulation
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) the definitions of 'feed additive', 'antimicrobials', 'antibiotic' and 'daily ration' as laid down in Article 2(2) of Regulation (EC) No 1831/2003;
Amendment 95 #
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 other distributors and directly to the animal holder;
Amendment 97 #
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 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 111 #
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 other distributors and directly to the animal holder;
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 2 – point i d (new)
Article 2 – paragraph 2 – point i d (new)
(id) 'cross-contamination': a contamination resulting from a carry-over or from the transfer in feed of any unintended substance;
Amendment 121 #
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 126 #
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 131 #
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 137 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
(a) for antimicrobial active substances, 12% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non- target feed;
Amendment 142 #
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, 34% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non- target feed.
Amendment 159 #
Proposal for a regulation
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
Amendment 174 #
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 and after having knowledge of the feeding systems the possibilities of mixing and other relevant farm specificities. 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 183 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
(a) for antimicrobial active substances, 12% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non- target feed;
Amendment 187 #
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, 34% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non- target feed.
Amendment 197 #
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 the quantities required for a duration mentioned in the summary of the product characteristics, unless specifically licensed otherwise under COM(2014) 556 final, 2014/0255 (COD).
Amendment 200 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1a. Before a repeated prescription, it is necessary for the veterinarian to do a sensitivity check and to evaluate if the treatment can be stopped or needs to be continued or changed.
Amendment 218 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The personveterinarian or another professional person qualified to do so in accordance with applicable national law 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. (N.B. horizontal amendment to replace relevant wording throughout the proposal)
Amendment 233 #
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 and after having knowledge of the feeding systems, the possibilities of mixing and other relevant farm specificities. 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 243 #
Proposal for a regulation
Article 16 – title
Article 16 – title
Use in food-producing and non-food producing animals
Amendment 258 #
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 or the quantities required for a duration mentioned in the summary of the product characteristics, unless otherwise specifically authorised under Regulation (EU) 2015/... (Veterinary Medicinal Products).
Amendment 263 #
Proposal for a regulation
Article 16 – paragraph 1 c (new)
Article 16 – paragraph 1 c (new)
1c. Before a repeated prescription, it is necessary for the veterinarian to do a sensitivity check and to evaluate if the treatment can be stopped or needs to be continued or changed.
Amendment 268 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Medicated feed containing antimicrobialbiotic veterinary medicinal products shall not be used to prevent diseases in food-producing animals or to enhance their performance.
Amendment 272 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Medicated feed containing antimicrobialbiotic veterinary medicinal products shall not be used tofor prevent diseases in food-producingive treatment (prophylaxis). Prophylaxis with antimals or to enhance their performanceicrobials shall never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions.