31 Amendments of Michel DANTIN related to 2014/0255(COD)
Amendment 102 #
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) 'medicated feed': a mixture of one or more veterinary medicinal products or one intermediate products with one or more feeds which is ready to be directly fed to animals without further processing, owing to the properties brought by the medicinal part of the mixture for treating or preventing disease and owing to the properties brought by the feed part of the mixture for providing nutrition;
Amendment 110 #
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) 'medicated feed business operator': any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under their control, including brokers and livestock farmers using medicated feed intended for the animals in their possession;
Amendment 135 #
Proposal for a regulation
Article 2 – paragraph 2 – point i h (new)
Article 2 – paragraph 2 – point i h (new)
(ih) 'medicated feed manufacturer': any medicated feed business operator that manufactures medicated feed;
Amendment 137 #
Proposal for a regulation
Article 2 – paragraph 2 – point i i (new)
Article 2 – paragraph 2 – point i i (new)
(ii) 'broker': any person active in the buying or selling of medicated feed (excluding the distribution of medicated feed), which operations do not involve the physical handling thereof but rather the trading thereof, independently and in the name of a physical or legal person;
Amendment 141 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
Amendment 145 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. A Member State may impose restrictions for prohibiting or regulating the use of mobile mixers in its territory.
Amendment 148 #
Proposal for a regulation
Article 3 – paragraph 1 c (new)
Article 3 – paragraph 1 c (new)
1c. By way of derogation from paragraph 1, the provisions of Chapter II shall not apply to livestock farmers who only use medicated feed for their own animals.
Amendment 162 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. FMedicated feed business operators manufacturing medicated feed shall ensure the homogeneous incorporation of the veterinary medicinal product or the intermediate product into the feed. Medicated feed business operators manufacturing intermediate products shall ensure the homogeneous incorporation of the veterinary medicinal product into the feed.
Amendment 191 #
Proposal for a regulation
Article 7 – paragraph 2 b (new)
Article 7 – paragraph 2 b (new)
2b. The Commission shall be empowered to adopt implementing acts for establishing criteria in respect of: - the definition of the batch, pursuant to this Article; - the analytical methods that must be employed by medicated feed business operators; - the sampling methods and analytical methods that must be employed by medicated feed business operators and the competent authorities in order to check that the specific carry-over limits have been complied with. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Amendment 193 #
Proposal for a regulation
Article 7 – paragraph 2 c (new)
Article 7 – paragraph 2 c (new)
2c. A detailed schedule listing, in order of priority, the different active substances for which specific carry-over limits must be adopted shall be established by way of an implementing act. The agencies (EFSA and EMA) shall be consulted as the list is being compiled. 24 months from the date of entry into force of this Regulation, the Commission shall submit a report to the European Parliament and to the Council, indicating the specific carry-over limits adopted.
Amendment 207 #
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article 11a Trading with non-EU countries Imports, from non-EU countries, of food- producing animals which have been administered medicated feed containing antimicrobial veterinary medicinal products in order to prevent disease shall be prohibited. Similarly, imports of foodstuffs derived from those animals shall be prohibited.
Amendment 209 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
Amendment 240 #
Proposal for a regulation
Article 15 – paragraph 6 a (new)
Article 15 – paragraph 6 a (new)
6a. The prescribing party shall be required, in accordance with Article 5(2)(d), to satisfy himself that the medicated feed and the feed commonly used to feed treated animals do not contain, as active substances, the same coccidiostat.
Amendment 242 #
Proposal for a regulation
Article 15 – paragraph 6 b (new)
Article 15 – paragraph 6 b (new)
Amendment 246 #
Proposal for a regulation
Article 16 – title
Article 16 – title
Use in food-producing animals
Amendment 250 #
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. FMedicated 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:
Amendment 270 #
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 280 #
Proposal for a regulation
Article 16 – paragraph 4 a (new)
Article 16 – paragraph 4 a (new)
4a. Packaged medicated feed to be fed to food-producing animals must be stored separately. Silos that once contained medicated feed must be emptied before being loaded with other types of feed, and cleaned regularly.
Amendment 292 #
Proposal for a regulation
Annex 1 – section 2 – point 1 – paragraph 1
Annex 1 – section 2 – point 1 – paragraph 1
1. Feed business operators shall have sufficient staff possessing the skills and qualifications necessary for the manufacture of the products concerned. All the staff shall be informed clearly in writing of their duties, responsibilities and powers, especially when any change is made, in such a way as to obtain the desired product qualityA qualified person responsible for the manufacture of medicated feed and intermediate products and a qualified person responsible for quality control shall be delegated. They must be independent from one another.
Amendment 293 #
Proposal for a regulation
Annex 1 – section 2 – point 1 – paragraph 2
Annex 1 – section 2 – point 1 – paragraph 2
Amendment 294 #
Proposal for a regulation
Annex 1 – section 2 – point 2
Annex 1 – section 2 – point 2
2. An organisation chart setting out the qualifications and responsibilities of the supervisory staff shall be drawn up and made available to the competent authorities in case of an inspectionThe manufacturer shall provide training on the specific risks associated with the medicated feed and veterinary medicinal products to all staff called upon to work in the manufacturing areas or control laboratories (technical staff, including maintenance and cleaning), and to any other person whose work could have an impact on the quality of the products. Newly recruited members of staff shall receive training that is commensurate with the tasks assigned to them. Their ongoing training shall be guaranteed, and its practical effectiveness periodically assessed. Training programmes shall be made available and approved, depending on the circumstances, either by the qualified person responsible for the manufacture operations, or by the qualified person responsible for the quality control operations. The records of the training sessions shall be retained.
Amendment 295 #
Proposal for a regulation
Annex 1 – section 2 – point 2 a (new)
Annex 1 – section 2 – point 2 a (new)
2a. Any person entering a manufacturing area must wear protective equipment that is appropriate for the operations performed therein. Operators must ensure that their hands do not come into direct contact with unprotected products or with any machinery that has come into contact with the products.
Amendment 299 #
Proposal for a regulation
Annex 1 – section 4 – point 1
Annex 1 – section 4 – point 1
1. Feed business operators shall, as part of a quality control system, have access to a laboratory with adequate staff anThe quality control plan shall lay down rules concerning manufacturing sequences or incompatibilities between certain manufacturing operations. This plan shall also define, if appropriate, the manufacturing operations that need to be carried out using dedicated equipment.
Amendment 302 #
Proposal for a regulation
Annex 1 – section 7 – title
Annex 1 – section 7 – title
PHARMACOVIGILANCE, COMPLAINTS AND PRODUCT RECALL
Amendment 303 #
Proposal for a regulation
Annex 1 – section 7 – point 1
Annex 1 – section 7 – point 1
1. FMedicated feed business operators placing medicated feed and intermediate products on the market shall implement a system for registering and processing complaints.
Amendment 304 #
Proposal for a regulation
Annex 1 – section 7 – point 2 a (new)
Annex 1 – section 7 – point 2 a (new)
2a. Medicated feed business operators, with the exception of holders of animals, shall report, to the competent authority and to the holder of the marketing authorisation of the veterinary medicinal product included in the composition of the medicated feed, any suspected adverse reactions to the medicated feed. The appropriate information collected from these reports shall be entered in the veterinary pharmacovigilance system described under Title VII of Directive 2001/82/EC.
Amendment 305 #
Proposal for a regulation
Annex 1 – section 7 a (new)
Annex 1 – section 7 a (new)
Section 7a OPERATIONS CARRIED OUT BY THIRD PARTIES Any subcontracted activity shall fall under an appropriately defined, agreed upon and monitored contract so as to avoid any misunderstandings that could lead to work or products of an insufficient quality. A written contract shall be drawn up between the subcontracting party and the subcontractor in order to clearly establish each party's obligations. The contract shall clearly set out the ways in which the qualified people responsible for manufacture, transport and quality control operations shall fulfil their responsibilities. A written contract shall cover the manufacturing and/or analytical and/or transport activities assigned by the subcontracting party, and all the technical provisions taken in relation thereto. All the provisions contained in the contract, including any proposed technical modifications or other provisions, must comply with the provisions of this Regulation.
Amendment 335 #
Proposal for a regulation
Annex 4 – point 1 – paragraph 1
Annex 4 – point 1 – paragraph 1
1. The tolerances laid down in this point shall include technical and analytical deviations.
Amendment 337 #
Proposal for a regulation
Annex 4 – point 1 – paragraph 2
Annex 4 – point 1 – paragraph 2
Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of ± 10% shall apply. For the other active substances, the following tolerances shall apply:
Amendment 341 #
Proposal for a regulation
Annex 4 – point 1 – paragraph 2 – table
Annex 4 – point 1 – paragraph 2 – table
Amendment 344 #
Proposal for a regulation
Annex 4 – point 2
Annex 4 – point 2