Activities of James NICHOLSON related to 2014/0255(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC PDF (981 KB) DOC (651 KB)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC
Amendments (22)
Amendment 39 #
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 45 #
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, but appropriate derogations should be provided for in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent excessive burden for the feed business operators.
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 53 #
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 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 64 #
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 allThe use of antimicrobials in medicated feed to enhance the performance of animals should never be allowed. The use of antimicrobials 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 knowled. ge 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 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 101 #
Proposal for a regulation
Article 2 – paragraph 2 – point i a (new)
Article 2 – paragraph 2 – point i a (new)
(ia) 'antimicrobials': an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans.
Amendment 117 #
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 avoid carry-overor minimise carry-over in accordance with the ALARA principle.
Amendment 124 #
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 active substances in non-target feed on the basis of a scientific risk assessment by the European Food Safety Authority (EFSA).
Amendment 130 #
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 in non- target feed, a general maximum limit of 3% of the active substance in the last batch of medicated feed or intermediate product produced shall apply:.
Amendment 132 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
Amendment 139 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point b
Article 7 – paragraph 2 – subparagraph 2 – point b
Amendment 154 #
Proposal for a regulation
Article 10
Article 10
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 in so far as the application of that requirement is not necessary to protect human or animal health or consumer interests and would represent excessive burden for the feed business operators.
Amendment 173 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The prescription shall be valid for a maximum period of six months for non- food producing animals and three weeks for food-producing animalsonly for the period determined by the person who issued the prescription.
Amendment 182 #
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 group of animals under the care of the person who issued the prescription and only for athe 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 188 #
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 provided for in the prescription.
Amendment 190 #
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 193 #
Proposal for a regulation
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – 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 209 #
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. The use of antimicrobials 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.
Amendment 233 #
Proposal for a regulation
Annex I – section 3 – point 2
Annex I – section 3 – point 2
2. Technical or organisational measures shall be taken to avoid or minimise, any cross- contamination and errors, to carry out checks in the course of manufacture and to ensure effective tracing of the products used for the manufacture of medicated feed and intermediate products.