# 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) EU Regulation No 88/2014 · adopted 31 January 2014 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) ## Introductory text 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) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular Article 28(5) thereof, Whereas: (1) Categories 1, 2, 3, 4 and 5 of Annex I to Regulation (EU) No 528/2012 are well defined so as to allow certain presumptions as regards the properties of the substances falling therein. The inclusion in category 6 of that Annex requires the submission of a data package allowing a full risk assessment for the intended use. The procedure for amending one of those categories upon request in order to include therein active substances, or modifying the restrictions therein, should be transparent and equal for all applicants. It is therefore appropriate to further specify it. (2) The data required for inclusion of an active substance in Annex I to Regulation (EU) No 528/2012 should be sufficient to evidence that the substance does not give rise to concern within the meaning of Article 28(2) of Regulation (EU) No 528/2012. (3) In order to be consistent, the procedure for submission and validation of an application for inclusion of an active substance in Annex I to Regulation (EU) No 528/2012 should be identical to that for submission and validation of an application for approval of an active substance. However, where the former may require less data to be submitted, the evaluation procedure should be adapted accordingly. (4) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products referred to in Article 82(1) of Regulation (EU) No 528/2012, HAS ADOPTED THIS REGULATION: ## 1 Subject matter This Regulation lays down the procedures to be followed for the purpose of amending, at the request of an applicant, the Simplified Active Substance List under Regulation (EU) No 528/2012 in order to: (a)include active substances in category A or category B of the Simplified Active Substance List in accordance with Article 28(1) of that Regulation; or (b)make amendments of the relevant restrictions in those categories. ## 2 Data requirements for an application An application for an inclusion or an amendment referred to in Article 1 shall include the information specified in the Annex to this Regulation. ## 3 Submission and validation of applications 1. The procedure laid down in Article 7(1) and... the third subparagraph of Article 7(3)... of Regulation (EU) No 528/2012 shall apply for the submission of applications for inclusions or amendments referred to in Article 1 of this Regulation. 2. Where the application concerns category B of the Simplified Active Substance List under Regulation (EU) No 528/2012, the first and second subparagraphs of Article 7(3) and Article 7(4) and (5) of that Regulation shall apply for the validation of the application. ## 4 Evaluation of applications 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Decision on inclusion of an active substance in the Simplified Active Substance List Provided that there is evidence that an active substance does not give rise to concern within the meaning of Article 28(1) of Regulation (EU) No 528/2012, the Secretary of State may with the consent of the Scottish Ministers and the Welsh Ministers, issue a decision pursuant to that Article amending the Simplified Active Substance List under that Regulation in the sense referred to in Article 1 of this Regulation where the competent authority has submitted an opinion pursuant to: (a)Article 4 (1) of this Regulation; or (b)Article 8(4) of Regulation (EU) No 528/2012... (c)... ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature ... Done at Brussels, 31 January 2014. For the Commission The President José Manuel Barroso ## Annex: Data requirements for the inclusion of an active substance in the Simplified Active Substance List under Regulation (EU) No 528/2012 ### Section A: Data for inclusion in category A ## 1 An application for inclusion of an active substance in category A of the Simplified Active Substance List under Regulation (EU) No 528/2012 shall specify the relevant category, the identity of the substance and the intended uses of the products for which authorisation will be sought, and contain conclusive evidence to demonstrate the following: (a)that the substance complies with the description of the relevant category; and (b)that there is a robust consensus of expert opinion that the substance does not give rise to concern in accordance with Article 28(2) of that Regulation. The evidence referred to in point (b) shall include all relevant published literature data regarding the substance in question and all relevant data on the substance generated by the applicant. It may also include read-across from chemical analogues/homologues, (Q)SAR predictions, data from existing studies, in vitro studies, historical human data, or conclusions from other regulatory authorities or frameworks. ## 2 By way of derogation from paragraph 1(b), where there is no conclusive evidence of a robust consensus of expert of opinion regarding one or more endpoints, an application shall contain all additional data necessary to show that the substance does not give rise to concern in accordance with Article 28(2) of Regulation (EU) No 528/2012. ## B Data for inclusion in category B An application for inclusion of an active substance in category B of the Simplified Active Substance List under Regulation (EU) No 528/2012 shall contain the data referred to in Article 6 of that Regulation to allow a state-of-the-art risk assessment. --- Source: https://www.legislation.gov.uk/eur/2014/88 (the official version) Page: https://openlegislation.uk/eu-regulation-2014-88 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.