Chapter III, Article 4 · Commission Delegated Regulation (EU) 2024/369

Contents

Article 4Accordance check#

1.ECHA shall assess whether the application from an applicant complies with the following:

(a)it provides the information which is necessary and sufficient to be in accordance with Article 3(7);

(b)it falls within the scope of Article 11(5) of Directive (EU) 2020/2184 and complies with Article 3(3) to (6).

2.Where the application does not fulfil the criterion of Article 4(1), point (a), ECHA shall notify the reasons to the applicant. The applicant shall bring its application into accordance within six months of the date of receipt of the reasons from ECHA.Where the application does not fulfil the criterion of Article 4(1), point (b), ECHA shall notify this conclusion to the applicant. The applicant shall provide its comment within one month of the date of receipt of the reasons from ECHA.

3.Where the application does not comply with the requirements set out in Article 4(1), the procedure shall be terminated and ECHA shall notify it to the applicant.

4.ECHA shall inform the applicant of the accordance of its application without undue delay, indicating the date of completion of the accordance check.

5.Passing the accordance check is without prejudice to the opinion of the Committee for Risk Assessment in accordance with Article 6.

6.Where an application for review of an existing entry limited to the indication of the adoption of a harmonised classification and labelling under Section 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament andof the Council^note or the inclusion of a substance in the Candidate List established under Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council^note, ECHA may address that application directly to the Commission upon completion of the accordance check. In such case, Articles 5 and 6 of this Regulation shall not apply.

7.Where an application under Article 3(9) for which no updated information is available, ECHA may address that application directly to the Commission upon completion of the accordance check. In such case, Article 6 shall not apply.

8.Where applications to which Annex VI, Section 1, point 3 of Commission Implementing Decision (EU) 2024/365 may apply, ECHA may address the corresponding parts of that application directly to the Committee for Risk Assessment. In such case, Article 5 shall not apply.

9.Where an application is submitted to ECHA to review an entry from one of the positive lists referred to in Article 1 of Commission Implementing Decision (EU) 2024/367^note, that entry shall remain valid after its expiry date until the Commission decides on the application to review that entry provided that the application is submitted to ECHA no later than 18 months prior to the expiry date.