23 Amendments of María SORNOSA MARTÍNEZ related to 2007/0064(COD)
Amendment 24 #
Proposal for a regulation
Recital 22
Recital 22
It is therefore appropriate for the Community to provide for procedures to set reference points for control action at concentrations of the residues for which scientific advice indicates that consumer exposure is negligible and laboratory analysis is technically feasible in order to facilitate intra-Community trade and imports, without undermining a high level of human-health protection in the Community. However, the setting of reference points for control action should in no way precondone the illegal use of non-authorised substances to treat food-producing animals. Therefore, any residues of those substances in food are in fact undesirable.
Amendment 25 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part and point (a)
Article 1 – paragraph 1 – introductory part and point (a)
1. TFor the purpose of ensuring food safety, this Regulation lays down rules and procedures in order to establish the following: (a) the maximum concentration of a residue of a pharmacologically active substance contained in a veterinary medicinal product or in a biocide product used in animal-rearing, which may be permitted in food of animal origin ("maximum residue limit");
Amendment 28 #
Proposal for a regulation
Article 1 – paragraph 1 – point (b)
Article 1 – paragraph 1 – point (b)
(b) the tolerance level of a residue of a pharmacologically active substance below which human exposure to that residue through food containing the substance is considered negligible, established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation ("reference points for action").
Amendment 34 #
Proposal for a regulation
Article 3
Article 3
Amendment 38 #
Proposal for a regulation
Article 5
Article 5
With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing species, the CommitteeAgency (bearing constantly in mind the need to provide a high level of public-health protection) shall, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider: (a) using maximum residue limits established for a pharmacologically active substance in a particular foodstuff or for another foodstuff derived from the same species, or in one or more species for other species. (b) using maximum residue limits established for a pharmacologically active substance in one or more species for other species, or (c) using maximum residue limits established for a pharmacologically active substance in a given foodstuff derived from one species for another foodstuff derived from other species.
Amendment 39 #
Proposal for a regulation
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. Once it has consulted the Agency, the Commission shall lay down rules on the use of a maximum residue limit relating to a given foodstuff in another foodstuff of the same species, or to one or more species in other species. Those rules shall specify how and in what circumstances the scientific data relating to residues in a given foodstuff or in one or more species may be used for the purpose of establishing a maximum residue limit in other foodstuffs or other species. The measures intended to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).
Amendment 43 #
Proposal for a regulation
Article 6 – paragraph 2 – point (b)
Article 6 – paragraph 2 – point (b)
(b) the risk of unintended toxicological, pharmacological or microbiological effects in human beings;
Amendment 46 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. If the metabolism and depletion of the substance cannot be assessed and the use of the substance is designed to promote animal health and welfarehealth, the scientific risk assessment may take into account monitoring data or exposure data.
Amendment 48 #
Proposal for a regulation
Article 7 – point (b)
Article 7 – point (b)
(b) other legitimate factors such as the technological aspects of food and animal- feed 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;
Amendment 53 #
Proposal for a regulation
Article 9 –- paragraph 1
Article 9 –- paragraph 1
1. For substances not intendThe Commission or Member States may forward to the Agency requests for an opinion on maximum residue limits for pharmacologically active substances in one of the following circumstances: (a) the substance in question is authorised for use in a veterinary medicinal products to be placed on the market in the Community and where no application for such in a third country and no application in respect of that substances has been masubmitted pursuant to Article 3, or (b) the substance in question is included in accordance with Article 3, the Commission or Member States may forward to the Agency requests for an opinion on maximum residue limits medicinal product intended to be used pursuant to Article 11 of Directive 2001/82/EC but no application in respect of that substance has been submitted pursuant to Article 3, or (c) the substance in question is included in a biocide product used in animal- rearing and a maximum residue limit must be established pursuant to Article 10(2)(ii)(b) of Directive 98/8/EC. 2. Articles 4 to 87 shall apply. The applications for an opinion which are referred to in paragraph 1 of this Article shall comply with the format and content requirements laid down by the Commission pursuant to Article 12(1).
Amendment 58 #
Proposal for a regulation
Article 10
Article 10
Where the Commission, the applicant underany person who has submitted an application for an opinion pursuant to 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, it may request the Agency to issue a new opinion on the substances in question. That request shall be accompanied by information explaining the issue to be addressed. Article 8(2) andto (4) or Article 9(2) and (3) respectively shall apply to the new opinion.
Amendment 61 #
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The Commission shall, in consultation with the Agency, adopt rules on the use of a maximum residue level of a particular foodstuff for another foodstuff of the same species, or of one or more species for other species as referred to in Article 5. Those rules shall specify how and under what circumstances scientific data on residues in a particular foodstuff or in a species or more species may be used for setting a maximum residue limit in other foodstuffs, or other species. Thos, pursuant to Article 5(1a), the measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance withpursuant to the regulatory procedure with scrutiny referred to in Article 20(3).
Amendment 64 #
Proposal for a regulation
Article 13 – paragraph 2 – point (c)
Article 13 – paragraph 2 – point (c)
(c) the absence of the need to establish a maximum residue limit;
Amendment 66 #
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 establishmentthe adoption by the Commission (if there are no objections from the Community) of a maximum residue limit 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.
Amendment 75 #
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13 a Accelerated procedure for an Agency opinion In specific cases where a veterinary medicinal product or a biocide product needs to be authorised as a matter of urgency for reasons relating to the protection of public health or of animal health or welfare, the Commission, any person who has requested an opinion pursuant to Article 3 or a Member State may ask the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit of a pharmacologically active substance contained in those products. The format and the content of the application shall be laid down by the Commission pursuant to the provisions of Article 12(1). Despite what is stated in Article 9(2) and in Article 8(2), the Agency shall ensure that the Committee is able to issue its opinion within 150 days following receipt of the application.
Amendment 77 #
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 Regulation 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 Regulation 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 is not in accordance with the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differencesthe adoption of a maximum residue limit without objections from the Community, and the adoption by the Commission of the Codex Alimentarius as referred to in Article 13(3).
Amendment 78 #
Proposal for a regulation
Article 14 - paragraph 1 a (new)
Article 14 - paragraph 1 a (new)
1a. Where the Agency has been asked for its opinion and the draft Regulation is not in accordance with that opinion, the Commission shall provide a detailed explanation of the reasons for the differences.
Amendment 80 #
Proposal for a regulation
Article 14 - paragraph 2 a (new)
Article 14 - paragraph 2 a (new)
2a. The Regulation referred to in paragraph 1 shall be adopted by the Commission in accordance with, and within 30 days after the end of, the regulatory procedure referred to in Article 20(2).
Amendment 81 #
Proposal for a regulation
Article 14 - paragraph 2 b (new)
Article 14 - paragraph 2 b (new)
2b. In the case of the accelerated procedure referred to in Article 13a, the Commission shall adopt the Regulation mentioned in paragraph 1 within 15 days of the conclusion of the regulatory procedure referred to in Article 20(2).
Amendment 82 #
Proposal for a regulation
Article 15
Article 15
Amendment 85 #
Proposal for a regulation
Article 16
Article 16
Amendment 93 #
Proposal for a regulation
Article 17 - paragraph 1 - subparagraph 3
Article 17 - paragraph 1 - subparagraph 3
The reference points for action shall be reviewed regularly in the light of technological and scientific progress.
Amendment 95 #
Proposal for a regulation
Article 18
Article 18