Chapter III, Article 6 · Commission Delegated Regulation (EU) 2024/369

Contents

Article 6Consultation of the applicant and opinion#

1.The Committee for Risk Assessment shall provide an opinion on the risks to human health arising from the uses of the starting substance, composition or organic cementitious constituent covered by the application for on the basis of Implementing Decision (EU) 2024/365.The Committee for Risk Assessment shall prepare a draft opinion taking into account any information submitted by interested parties within 10 months from the publication of the application or within 13 months from that publication in the case of a joint opinion in accordance with the below.The draft opinion may be a joint draft opinion covering several applications in the following cases:

(a)where they cover the same starting substance, composition or organic cementitious constituent;

(b)where they cover the same non-intentionally added species;

(c)where they are based on similar toxicological information;

(d)where they raise similar considerations, in particular in case of absence of adverse effect identified;

(e)in any other duly justified case.

2.ECHA shall send the draft opinion of the Committee for Risk Assessment to the applicant without undue delay. ECHA shall at the same time inform the applicant of the right to comment within 30 days.

3.The Committee for Risk Assessment shall finalise its opinion taking into account the comments from the applicant on the draft opinion, if any.

4.ECHA shall forward the opinion of the Committee for Risk Assessment to the applicant and the Commission without undue delay.

5.The Commission shall without undue delay, taking into account the opinion of the Committee for Risk Assessment, decide on the application in accordance with Article 11(4) of the Directive.