21 Amendments of Julie GIRLING related to 2014/0255(COD)
Amendment 47 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines.
Amendment 52 #
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 limits for levels of carry- over for active substances contained in medicatednon-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, a general maximum 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 58 #
Proposal for a regulation
Recital 14
Recital 14
(14) Medicated feed should be marketed in sealed containers for safety reasons and to protect user's interest. However, appropriate derogations should be provided for where the application of this requirement is not necessary to protect human or animal health or consumer interests, and would represent an excessive administrative and technical burden.
Amendment 63 #
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. However, the possibility to manufacture medicated feed before a prescription is presented to the manufacturer should not be excluded.
Amendment 67 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines.
Amendment 71 #
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 usetake measures to reduce the overall use of antimicrobials, specifically antibiotics, in food-producing animals. The use of antimicrobials in medicated feed to enhance the performance of food- producing animals should in particular not be allbe prohibited. The use of antimicrobials, specifically antibiotics, in medicated feed before a disease is diagnosed or clinical signs are present should only be allowed in very exceptional circumstances and under prescription on the basis of the epidemiological and clinical knowledge of the person who issued the prescription. It should never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions.
Amendment 115 #
Proposal for a regulation
Article 2 – paragraph 2 – point i a (new)
Article 2 – paragraph 2 – point i a (new)
(ia) 'antimicrobial': an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans. Antimicrobials are inclusive of anti-bacterials, anti-virals, anti-fungals and antiprotozoals;
Amendment 118 #
Proposal for a regulation
Article 2 – paragraph 2 – point i b (new)
Article 2 – paragraph 2 – point i b (new)
Amendment 172 #
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-over limits for specific active substances in case of risk for animal or human health or for the environment on the basis of risk assessments conducted by EFSA.
Amendment 179 #
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 following carry- over limits shall apply: shall be set at 3% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non-target feed.
Amendment 181 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
Amendment 185 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point b
Article 7 – paragraph 2 – subparagraph 2 – point b
Amendment 205 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Medicated feed and intermediate products shall be placed on the market only in sealed packages or containers. Packages or containers shall be sealed in such a way that, when the package or container is opened, the seal is damaged and cannot be reused. Appropriate derogations should be provided for those instances where the application of this requirement is not necessary to protect human or animal health or consumer interests, and would represent an excessive administrative and technical burden.
Amendment 216 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The prescription shall contain the information set out in Annex Vrticle 110 of Regulation EU 2015/... (Veterinary Medicinal Products). The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The person 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.
Amendment 222 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
Amendment 227 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for animals examined byunder the care of 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 248 #
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 prescribed by the person issuing the prescription.
Amendment 252 #
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 253 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 265 #
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 inenhance the performance of food- producing animals or to enhance their performance. . Medicated feed containing antimicrobial veterinary medicinal products, specifically antibiotics, may be permitted in exceptional cases before a disease is diagnosed or clinical signs are present under prescription on the basis of the epidemiological and clinical knowledge of the person who issued the prescription.
Amendment 328 #
Proposal for a regulation
Annex 3 – point 15
Annex 3 – point 15
(15) the instructions for use in line with the veterinary prescription and the summary of the product characteristics referred to in Article 14 of Directive 2001/82/EC and the veterinary prescription if available at the time of manufacture;