in force 2020-04-28 MODIFIED+341 −55§
Amended by Regulation (EU) 2020/507 32020R0507
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates added to the text: 2023-12-31, 2027-12-31
Paragraph 5 changes the compliance-check selection rule from a single flat threshold of at least 5% of dossiers received per tonnage band to a split scheme: at least 20% of dossiers for registrations in tonnage bands of 100 tonnes or more per year must be selected until 31 December 2023, and at least 20% of dossiers for registrations in tonnage bands below 100 tonnes per year must be selected until 31 December 2027.
The introductory wording of paragraph 5 is also reworded from describing the Agency ensuring compliance to describing the Agency checking compliance, and the priority criteria list is now introduced as applying when selecting dossiers for compliance checking, with the criteria themselves left unchanged.
Cited: Art. 41, v1 · Art. 41, v2
text before / after
02006R1907-20200227 → 02006R1907-20200428
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 check compliance of registration dossiers comply with this Regulation, the Agency shall select select, until 31 December 2023, a percentage of those dossiers, dossiers no lower than 5 20 % of the total received by the Agency for each registrations in tonnage band, bands of 100 tonnes or more per year.
The Agency shall, until 31 December 2027, also select a percentage no lower than 20 % of the total received by the Agency for registrations in tonnage bands of less than 100 tonnes per year.
When selecting dossiers for compliance checking. The 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).