Commission Implementing Regulation (EU) No 88/2014Show full title

Article 4 Evaluation of applications

1. The evaluating competent authority shall evaluate whether there is evidence that the substance does not give rise to concern in accordance with Article 28(2) of Regulation (EU) No 528/2012 and, where relevant, to which restrictions its use should be subject. It shall send an assessment report and the conclusions of its evaluation to the European Chemicals Agency set up under Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1) (‘the Agency’). Where the application concerns inclusion in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012, the assessment report and the conclusions shall be submitted within 180 days of the payment of the fees referred to in the third subparagraph of Article 7(3) of that Regulation. Where the application concerns inclusion in category 6 of Annex I to Regulation (EU) No 528/2012, the assessment report and the conclusions shall be submitted within 365 days of validation of that application.

Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.

2. Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall request that the applicant submit such information within a specified time limit, and shall inform the Agency accordingly. The periods referred to in paragraph 1 of this Article shall be suspended from the date of issue of that 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.

3. An application concerning inclusion of an active substance in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012, which, following a request for additional data pursuant to paragraph 2, complies fully with Article 6 of Regulation (EU) No 528/2012 shall, where the applicant so requests,

(a) be considered as an application for inclusion in category 6 of Annex I to that Regulation; and

(b) be subject to validation pursuant to Article 3(2).

4. The Agency shall, having regard to the conclusions of the evaluating competent authority, prepare and submit to the Commission the opinion referred to in Article 28 of Regulation (EU) No 528/2012 within 270 days of receipt of the conclusions of the evaluation in the case of an application for inclusion in category 6 of Annex I to Regulation (EU) No 528/2012, and within 180 days of that receipt in the case of an application for inclusion in category 1, 2, 3, 4 or 5 of Annex I to that Regulation.

(1)

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).