# Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance), Article 4: Evaluation of applications

Extent: E+W+S+N.I.

1. The ... 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 opinion to the Secretary of State, the Scottish Ministers and the Welsh Ministers. Where the application concerns inclusion in category A of the Simplified Active Substance List under Regulation (EU) No 528/2012, the opinion 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 B of the Simplified Active Substance List under Regulation (EU) No 528/2012, the opinion shall be submitted within 365 days of validation of that application.
Prior to submitting its opinion to the Secretary of State, the Scottish Ministers and the Welsh Ministers,, the ... competent authority shall give the applicant the opportunity to provide written comments on the opinion within 30 days. The ... competent authority shall take due account of those comments when finalising its opinion.
2. Where it appears that additional information is necessary to provide the opinion, the ... competent authority shall request that the applicant submit such information within a specified time limit.... 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 A of the Simplified Active Substance List under 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 B of the Simplified Active Substance List under that Regulation; and
(b) be subject to validation pursuant to Article 3(2).
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/eur/2014/88/article/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-88/article-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.