19 Amendments of Carl SCHLYTER related to 2007/0064(COD)
Amendment 22 #
Proposal for a regulation
Recital 20
Recital 20
(20) The Community contributes in the context of the Codex Alimentarius to the development of international standards on maximum residue limits, while ensuring that the high level of human health protection adopted in the Community is not reduced. The Community should therefore take over without a further risk assessment those Codex maximum residue limits it has supported in the relevant Codex Alimentarius Commission meeting. Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced. , subject to a review of substances not authorised in the EU and of specific synergetic and cumulative effects of specific substances that may harm human health. Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced, without jeopardising the level of protection required for authorisation in the Community. The Commission must involve the European Parliament formally before agreement is reached.
Amendment 30 #
Proposal for a regulation
Article 1 — paragraph 1 — subparagraph 1 a (new)
Article 1 — paragraph 1 — subparagraph 1 a (new)
This includes, as appropriate, provisions on the use and placing on the market of pharmacologically active substances.
Amendment 37 #
Proposal for a regulation
Article 5
Article 5
Amendment 41 #
Proposal for a regulation
Article 6 — paragraph 1
Article 6 — paragraph 1
1. The scientific risk assessment shall consider the metabolism and depletion 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), paying particular attention to the synergetic and cumulative effects of different pharmacologically active substances and to effects on vulnerable categories of people. Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 12(1). The risk assessment should comply with the principles for assessing the safety of foodstuffs laid down in Regulation (EC) No 178/2002.
Amendment 47 #
Proposal for a regulation
Article 7 — point (b)
Article 7 — point (b)
(b) other legitimate factors such as the technological aspects of food production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products and the likelihood of misuse or illegal use; misuse includes the prophylactic use of veterinary medicinal products when diseases can be managed by making proportionate and reasonable changes to the conditions in which animals are kept;
Amendment 54 #
Proposal for a regulation
Article 9 — paragraph 1 — subparagraph 1
Article 9 — paragraph 1 — subparagraph 1
1. For substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made in accordance with Article 3, the Commission or, Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on maximum residue limits. Paragraph 3 suggests that third parties may also forward requests, although this possibility isOr. en Justification not included in paragraph 1. Systematic clarification.
Amendment 56 #
Proposal for a regulation
Article 9 — paragraph 3 a (new)
Article 9 — paragraph 3 a (new)
3a. Paragraphs 1 to 3 shall apply mutatis mutandis to authorised pharmacologically active substances for which the cost of the procedure for the establishment of residue limits is disproportionate in relation to the economic revenue from the substance on account of the limited distribution of the animal species or their minor economic significance (‘minor uses’). In the event of extrapolation between different animal species, a safety factor of at least 10 shall be applied when setting maximum residue limits. The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 20(3), establish more precise requirements for the application of this paragraph.
Amendment 59 #
Proposal for a regulation
Article 12 — paragraph 1 — introductory part
Article 12 — paragraph 1 — introductory part
1. In accordance with the regulatory procedure referred to in Article 20(2), tThe Commission shall, in consultation with the Agency, adopt the followingrules on:
Amendment 60 #
Proposal for a regulation
Article 12 — paragraph 1 — subparagraph 1 a (new)
Article 12 — paragraph 1 — subparagraph 1 a (new)
Decisions shall be made, in the case of point (a), in accordance with the regulatory procedure referred to in Article 21(2) and, in the case of point (b), in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
Amendment 69 #
Proposal for a regulation
Article 13 — paragraph 3
Article 13 — paragraph 3
3. A maximum residue limit shall be laid down where it appears necessary for the protection of human health pursuant to an opinion of the Agency in accordance with Articles 4, 9 or 10 or pursuant to a vote by the Community in favour of the establishment of a maximum residue limit. Maximum residue limits agreed by the Community for a pharmacologically active substance intended for use in a veterinary medicinal product in the Codex Alimentarius. In the latter case an additional assessment by the Agency is not required must be of equal value to the Community health protection provisions in force. An additional assessment by the Agency in the interests of health protection as regards at least the synergetic and cumulative effects of different pharmacologically active substances shall be required when the Agency or relevant Member State authorities have concerns as regards health protection.
Amendment 70 #
Proposal for a regulation
Article 13 — paragraph 3 a (new)
Article 13 — paragraph 3 a (new)
3a. Before the Commission agrees to maximum residue limits in the Codex Alimentarius, the procedure referred to in Article 21(3) shall apply. The Commission may approve the maximum residue limits in the Codex Alimentarius only if they guarantee an equal level of safety for human health as Community legislation. Article 13(e) of Regulation (EC) No 178/2002 must be taken into account.
Amendment 71 #
Proposal for a regulation
Article 13 — paragraph 4
Article 13 — paragraph 4
4. A provisional maximum residue limit may be established for a pharmacologically active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a hazard for humarisk to human health. The decision on risk must be based on thealth principles referred to in Article 6 and the rules laid down in Article 12. The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed fivthree years. That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow scientific studies in progress to be completed.
Amendment 79 #
Proposal for a regulation
Article 14 — paragraph 2
Article 14 — paragraph 2
2. The Regulation referred to in paragraph 1 shall be adopted by the Commission in accordance with, and within 390 days after the end of, the regulatory procedure with scrutiny referred to in Article 20(23).
Amendment 87 #
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Article 16a Use of unclassified substances Administering veterinary medicinal products that contain pharmacologically active substances not included in the Annex to food—producing animals shall be prohibited. Clinical trials authorised by the appropriate national authorities upon notification or approval pursuant to the relevant legislation shall be exempt, provided that the food from the animals used in such trials contains no residues harmful to human health.
Amendment 89 #
Proposal for a regulation
Article 17 — paragraph 1 — subparagraph 1 a (new)
Article 17 — paragraph 1 — subparagraph 1 a (new)
The principles of risk assessment pursuant to Articles 4 to 8 shall be applied in order to guarantee a high level of health protection.
Amendment 94 #
Proposal for a regulation
Article 17 — paragraph 1 — subparagraph 3 a (new)
Article 17 — paragraph 1 — subparagraph 3 a (new)
Foodstuffs of animal origin containing pharmacologically active substances for which no maximum residue limits have been set may not be placed on the market. This prohibition shall apply also where special detection limits are set in respect of such substances under other Community provisions and those detection limits are exceeded.
Amendment 102 #
Proposal for a regulation
Article 19 a (new)
Article 19 a (new)
Article 19a Placing on the market If the maximum residue limits or reference quantities established under this Regulation are exceeded, the product shall not be placed on the market as a foodstuff, transformed into foodstuffs or mixed with foodstuffs.
Amendment 104 #
Proposal for a regulation
Article 22
Article 22
Within [690] days after the entry into force of this Regulation, the Commission shall adopt, in accordance with the regulatory procedure referred to in Article 20(23), a Regulation containing the pharmacologically active substances and their classification regarding maximum residues limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.
Amendment 106 #
Proposal for a regulation
Article 23 — paragraph 1 — subparagraph 3 a (new)
Article 23 — paragraph 1 — subparagraph 3 a (new)
Commission Decisions 2002/657/EC and 2005/34/EC shall expire within three years of the entry into force of this Regulation. Any new regulations adopted shall comply with the risk assessment criteria of this Regulation.