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TITLE-VI: EVALUATION
CHAPTER-1: Dossier evaluation
ARTICLE 41: Compliance check of registrations
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ARTICLE 41: Compliance check of registrations
1. The Agency may examine any registration in order to verify any of the following:
(a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;
(b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;
(c) that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;
(d) that any explanation(s) submitted in accordance with Article 11(3) or Article 19(2) have an objective basis.
2. The list of dossiers being checked for compliance by the Agency shall be made available to Member States competent authorities.
3. On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51.
4. The registrant shall submit the information required to the Agency by the deadline set.
5. To ensure that registration dossiers comply with this Regulation, the Agency shall select a percentage of those dossiers, no lower than 5 % of the total received by the Agency for each tonnage band, for compliance checking. The Agency shall give priority, but not exclusively, to dossiers meeting at least one of the following criteria:
(a) the dossier contains information in Article 10(a)(iv), (vi) and/or (vii) submitted separately as per Article 11(3); or
(b) the dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or
(c) the dossier is for a substance listed in the Community rolling action plan referred to in Article 44(2).
6. Any third party may electronically submit information to the Agency relating to substances that appear on the list referred to in Article 28(4). The Agency shall consider this information together with the information submitted according to Article 124 when checking and selecting dossiers.
7. The Commission may, after consulting with the Agency, take a decision to vary the percentage of dossiers selected and amend or include further criteria in paragraph 5 in accordance with the procedure referred to in Article 133(4).
Referred by:
ARTICLE 22: Further duties of registrants
ARTICLE 42: Check of information submitted and follow-up to dossier evaluation
ARTICLE 50: Registrants' and downstream users' rights
ARTICLE 51: Adoption of decisions under dossier evaluation
ARTICLE VI: INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ARTICLE VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE [66]
ARTICLE IX: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE [68]
ARTICLE X: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE [70]