Activities of Avril DOYLE related to 2007/0064(COD)
Plenary speeches (4)
Explanations of vote
Establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (debate)
Establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (debate)
Establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (A6-0190/2008, Avril Doyle) (vote)
Reports (2)
REPORT Recommendation for second reading on the Council common position for adopting a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Regulation (EEC) No 2377/90 and amending Directie 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council PDF (142 KB) DOC (72 KB)
REPORT Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90 PDF (370 KB) DOC (422 KB)
Amendments (14)
Amendment 29 #
Proposal for a regulation
Article 1 — paragraph 1 — point (b a) (new)
Article 1 — paragraph 1 — point (b a) (new)
(ba) the maximum concentration of a residue of a pharmacologically active substance below which environmental exposure to that residue is considered negligible.
Amendment 33 #
Proposal for a regulation
Article 3 — paragraph 1
Article 3 — paragraph 1
Any pharmacologically active substance intended for use in veterinary medicinal products for administration to food— producing animals shall be subject to an opinion of the European Medicines Agency ("the Agency") on the maximum residue limit, and maximum environmental concentration formulated by the Committee for Medicinal Products for Veterinary Use ( ‘the Committee’).
Amendment 36 #
Proposal for a regulation
Article 4 — paragraph 2
Article 4 — paragraph 2
2. The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare and environmental safety are not negatively affected by the lack of availability of appropriate veterinary medicinal products.
Amendment 40 #
Proposal for a regulation
Article 6 — paragraph 1
Article 6 — paragraph 1
1. The scientific risk assessment shall consider the metabolism and depletion and excretion of pharmacologically active substances in relevant animal species and the type of residues, and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI). Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 12(1). The scientific risk assessment shall also consider the impact of any residues of the active substance in terms of safety of the environment.
Amendment 44 #
Proposal for a regulation
Article 6 — paragraph 2 — point (c a) (new)
Article 6 — paragraph 2 — point (c a) (new)
(ca) the type and amount of residue considered not to present a safety concern for the environment.
Amendment 45 #
Proposal for a regulation
Article 6 — paragraph 3
Article 6 — paragraph 3
3. If the metabolism and depletion and excretion of the substance cannot be assessed and the use of the substance is designed to promote animal health and welfare, the scientific risk assessment may take into account monitoring data or exposure data.
Amendment 50 #
Proposal for a regulation
Article 7 — point (d a) (new)
Article 7 — point (d a) (new)
(da) whether or not the predicted environmental concentrations are acceptable for the protection of the environment and, where appropriate, any conditions or restrictions for the use of the substance concerned.
Amendment 51 #
Proposal for a regulation
Article 8 — paragraph 2
Article 8 — paragraph 2
2. The Agency shall ensure that the opinion of the Committee is given within 210 days following the receipt of a valid application for a new substance in accordance with Article 3 and paragraph 1 of this Article. This time limit shall be suspended when the Agency requests the submission of supplementary information on the given substance within a specific time period, and until such time as the supplementary information requested has been provided.
Amendment 52 #
Proposal for a regulation
Article 8 — paragraph 2 a (new)
Article 8 — paragraph 2 a (new)
2a. The following shall apply in respect of pharmacologically active substances which are authorised for use in veterinary medicinal products on the date of entry into force of this Regulation: (a) After consulting the Agency, the Commission shall publish a timetable for the consideration of these substances, including time limits for submission of the information referred to under Article 8(1). The persons responsible for marketing the veterinary medicinal product concerned shall ensure that all relevant information is submitted to the Commission. The competent authorities of the Member States shall bring any other relevant information to the attention of the Commission. (b) After verifying within 30 days that the information is submitted in the correct form, the Commission shall forthwith submit the information for examination to the Agency, which shall deliver its opinion within a period of 120 days. This time limit shall be suspended when the Agency requests the submission of supplementary information on the given substance within a specified time period.
Amendment 57 #
Proposal for a regulation
Article 10 — paragraph 1
Article 10 — paragraph 1
Where the Commission, the applicant under Article 3, or a Member State under Article 9, as a result of new information, considers that a review of an opinion is necessary in order to protect human or animal health or the safety of the environment, it may request the Agency to issue a new opinion on the substances in question.
Amendment 62 #
Proposal for a regulation
Article 13 — paragraph 1
Article 13 — paragraph 1
1. The Commission shall classify the pharmacologically active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Articles 4, 9 or 10 and on the safe environmental concentration in accordance with Articles 4 and 10.
Amendment 63 #
Proposal for a regulation
Article 13 — paragraph 2 — introductory part
Article 13 — paragraph 2 — introductory part
2. The classification for safety of foodstuffs shall include a list of pharmacologically active substances and the therapeutic classes to which they belong. The classification shall also entail the establishment, in relation to each such substance, of one of the following:
Amendment 74 #
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Amendment 76 #
Proposal for a regulation
Article 14 — paragraph 1
Article 14 — paragraph 1
1. For the purpose of the classification provided for in Article 13, the Commission shall prepare a draft Regulations within 30 days after receipt of the Agency's opinion referred to in Articles 4, 9(1) or 10. The Commission shall also prepare a draft Regulations within 30 days after receipt of the result of a vote by the Community in favour of the establishment of a maximum residue limit in the Codex Alimentarius as referred to in Article 13(3). Where the draft Regulation iss are not in accordance with the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences.