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 · Extends to United Kingdom
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 productsf1, 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:
Annotations to the whole text
Footnotes
Contents
- 1Subject matter
- 2Data requirements for an application
- 3Submission and validation of applications
- 4Evaluation of applications
- 5Decision on inclusion of an active substance in the Simplified Active Substance List
- 6Article 6 Repealed
- Signature
- Annex: Data requirements for the inclusion of an active substance in the Simplified Active Substance List under Regulation (EU) No 528/2012
- Data for inclusion in category A
- 1An 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:
- 2Division 2
- BData for inclusion in category B
1Subject matter
This Regulation lays down the procedures to be followed for the purpose of amending, at the request of an applicant, F1the Simplified Active Substance List under Regulation (EU) No 528/2012 in order to:
- (a)
- (b)
make amendments of the relevant restrictions in those categories.
2Data 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.
3Submission and validation of applications
4Evaluation of applications
The F1... 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 F2opinion to the F3Secretary of State, the Scottish Ministers and the Welsh Ministers. Where the application concerns inclusion in F4category A of F5the Simplified Active Substance List under Regulation (EU) No 528/2012, F6the 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 F7category B of F8the Simplified Active Substance List under Regulation (EU) No 528/2012, F9the opinion shall be submitted within 365 days of validation of that application.
Prior to submitting its F10opinion to the F11Secretary of State, the Scottish Ministers and the Welsh Ministers,, the F12... competent authority shall give the applicant the opportunity to provide written comments on the F13opinion within 30 days. The F14... competent authority shall take due account of those comments when finalising its F15opinion.
Where it appears that additional information is necessary to F16provide the opinion, the F17... competent authority shall request that the applicant submit such information within a specified time limitF18.... 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.
An application concerning inclusion of an active substance in category A of F19the 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,
be considered as an application for inclusion in category B of the Simplified Active Substance List under that Regulation; and
be subject to validation pursuant to Article 3(2).
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5Decision on inclusion of an active substance in the Simplified Active Substance ListF8
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 F1Secretary of State may with the consent of the Scottish Ministers and the Welsh Ministers, issue a decision pursuant to that Article amending F2the Simplified Active Substance List under that Regulation in the sense referred to in Article 1 of this Regulation where the F3competent authority has submitted an opinion pursuant to:
6F1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signature
F1...
Done at Brussels, 31 January 2014.
For the Commission
The President
José Manuel Barroso
1An 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:F1F2
- (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.