3 Amendments of Daciana Octavia SÂRBU related to 2009/0076(COD)
Amendment 147 #
Council position
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency accordingly. Where such additional information includes animal testing, the applicant shall be advised by experts from the Agency or competent authorities regarding suitable alternative methods and testing strategies to replace, reduce or refine the use of vertebrate animals. As specified in the second subparagraph of Article 6(2), the evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or 10(1). The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.
Amendment 188 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
4. The Commission shall adopt the measures designed to set the criteriaand publish transparent criteria and guidance for defining what constitutes adequate justification to adapt the data required under paragraph 1 on the grounds referred to in paragraph 2(a), also in accordance with the objective that testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.
Amendment 191 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1
2. If, when the dossiers are evaluated, it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the Agency thereof. Where such additional information includes animal testing, the applicant shall be advised by experts from the Agency or competent authorities regarding suitable alternative methods and testing strategies to replace, reduce or refine the use of vertebrate animals.