27 Amendments of Sylvie GODDYN related to 2014/0255(COD)
Amendment 18 #
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the import, manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (Text with EEA relevance)
Amendment 19 #
Proposal for a regulation
Title
Title
Proposal for a REGULATIONDIRECTIVE 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 (Text with EEA relevance)
Amendment 26 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
Amendment 38 #
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 levels of carry- over for active substances contained in medicated 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. General limits should be set out in this RegulationDirective, taking into account the unavoidable carry-over and the risk caused by the active substances concerned.
Amendment 57 #
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. PIn particular, preventive use or use to enhance the performance of food- producing animals should in particular not be allowed. not be allowed and the necessary measures should be taken to prevent the import of any live animals, carcases, meat, and prepared meals and dishes based on meat which have been treated for such purposes.
Amendment 76 #
Proposal for a regulation
Recital 24
Recital 24
(24) Since the Union is conducting negotiations with a partner whose practices are far removed from the Union's objectives, the objective of this RegulationDirective, namely ensuring a high level of protection of human and animal health, providing adequate information for users and strengthening the effective functioning of the internal market, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, ionly. In accordance with the principle of subsidiarproportionality as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation, this Directive does not go beyond what is necessary in order to achieve that objective,.
Amendment 77 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
This RegulationDirective shall apply to:
Amendment 111 #
Proposal for a regulation
Chapter 2 – title
Chapter 2 – title
Manufacture, storage, transport, import and placing on the market
Amendment 113 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
Feed business operators established in the Union or in third countries trading with Union Member States shall manufacture, store, transport and place on the market medicated feed and intermediate products in compliance with Annex I. Live animals, carcases, meat and prepared meals and dishes based on meat shall not be imported unless the provisions of this Directive are strictly complied with.
Amendment 122 #
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 concerningsubmit proposals to the European Parliament for the establishment of specific carry-over limits for active substances.
Amendment 157 #
Proposal for a regulation
Article 11 – title
Article 11 – title
Intra -Union trade and trade with third countries
Amendment 158 #
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
Amendment 163 #
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 persoveterinarian 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 172 #
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-in the case of medicated feed not containing antimicrobials, and three weeks for food- producing animals and antimicrobial- containing feed prescribed for non-food- producing animals.
Amendment 176 #
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 persoveterinarian who issued the prescription and only for a diagnosed disease. The persoveterinarian 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 220 #
Proposal for a regulation
Article 18
Article 18
The Commission shall be empowered to adopt delegated acts in accordance with Article 19 concerningsubmit amendments to Annexes I to V, to the European Parliament in order to take into account technical progress and scientific developments.
Amendment 221 #
Proposal for a regulation
Article 19 – title
Article 19 – title
Amendment 222 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this ArticleMember States shall adopt and publish, by ... [one year after entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate to the Commission the text of those provisions. They shall apply those provisions from … [two years after the entry into force of this Directive]. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Amendment 224 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The delegation of power referred to in Articles 7 and 18 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this RegulationMember States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Amendment 230 #
Proposal for a regulation
Article 23
Article 23
This RegulationDirective shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Amendment 231 #
Proposal for a regulation
Annex I – section 1 – point 5
Annex I – section 1 – point 5
5. Drainage facilities shall be adequate for the purpose intended; they shall be designed and constructed to avoid the risk of contamination of feed and of the environment; in particular, they shall prevent water contamination by antimicrobials, especially antibiotics and anti-parasites or substances classifiable as endocrine disruptors in animals and humans.
Amendment 232 #
Proposal for a regulation
Annex I – section 1 – point 6 a (new)
Annex I – section 1 – point 6 a (new)
6a. Feed used as the basis for medicated feed shall not be derived from genetically modified organisms.
Amendment 237 #
Proposal for a regulation
Annex I – section 6 – point 2 – point i
Annex I – section 6 – point 2 – point i
(i) information on the persoveterinarian who has issued the prescription, including at least his name and address.
Amendment 242 #
Proposal for a regulation
Annex III – paragraph 1 – point 4
Annex III – paragraph 1 – point 4
4. the batch reference number of the medicated feed or intermediate product and the country of manufacture;
Amendment 243 #
Proposal for a regulation
Annex III – paragraph 1 – point 9
Annex III – paragraph 1 – point 9
9. a recommendation to read the package leaflet of the veterinary medicinal products, including a hyperlink where it can be found, a warning that the product is only for the treatment of animals and, a warning that the product must be kept out of the sight and reach of children, and a warning concerning authorisation to administer the product to organically farmed animals in accordance with the regulations and directives in force and with any special conditions of use;
Amendment 249 #
Proposal for a regulation
Annex V – point 1
Annex V – point 1
1. Surname, forename, address and professional membership number of the person allowed to prescribe a veterinary medicinal productveterinarian.
Amendment 250 #
Proposal for a regulation
Annex V – point 2
Annex V – point 2
2. Issue date and signature or electronic identification of the person allowed to prescribe a veterinary medicinal productveterinarian.