Implementing regulation 2014/88 - Specification of a procedure for the amendment of Annex I to Regulation 528/2012 concerning the making available on the market and use of biocidal products - Main contents
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official title
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| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2014/88 |
| CELEX number i | 32014R0088 |
| Document | 31-01-2014 |
|---|---|
| Publication in Official Journal | 01-02-2014; OJ L 32 p. 3-5 |
| Effect | 21-02-2014; Entry into force Date pub. +20 See Art 6 |
| End of validity | 31-12-9999 |
1.2.2014 |
EN |
Official Journal of the European Union |
L 32/3 |
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 (1), 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:
Article 1
Subject matter
This Regulation lays down the procedures to be followed for the purpose of amending, at the request of an applicant, Annex I to Regulation (EU) No 528/2012 in order to:
(a) |
include active substances in category 1, 2, 3, 4, 5 or 6 of that Annex in accordance with Article 28(1) of that Regulation; or |
(b) |
make amendments of the relevant restrictions in those categories. |
Article 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.
Article 3
Submission and validation of applications
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1.The procedure laid down in Article 7(1) and (2), the third subparagraph of Article 7(3), and Article 7(6) 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 6 of Annex I to 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.
Article 4
Evaluation of applications
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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...
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