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Commission Implementing Regulation (EU) 2016/1802Show full title
Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
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Commission Implementing Regulation (EU) 2016/1802
of 11 October 2016
amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(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 17(7) thereof,
Whereas:
(1) In Commission Implementing Regulation (EU) No 414/2013(2) it is necessary to clarify that an individual product covered under a biocidal product family authorisation is also eligible as a related reference product with a view to obtain an authorisation for a same product.
(2) References to applications for registration are now obsolete as this procedure is no longer applicable since the repeal of Directive 98/8/EC of the European Parliament and of the Council(3) and should therefore be deleted.
(3) To respond to the needs of economic operators, in particular small and medium-sized enterprises, Article 3 of Implementing Regulation (EU) No 414/2013 should provide for the possibility to apply for national authorisation of same products in cases where the related reference product has been authorised by Union authorisation or is the subject of an application for such an authorisation.
(4) It is necessary to clearly identify and to further specify the procedure for the submission of applications for authorisation of a same product and for acceptance of such applications where the related reference product has been authorised under the simplified authorisation procedure set out in Article 26 of Regulation (EU) No 528/2012 or is the subject of an application for such an authorisation.
(5) In order to bring further predictability, guidelines on the details related to the handling of the applications covered by Implementing Regulation (EU) No 414/2013 should be developed by the European Chemicals Agency (‘the Agency’) and regularly updated on the basis of experience and scientific or technical progress.
(6) To make the text clearer and unambiguous, the wording of Articles 5 and 6 should be amended.
(7) Implementing Regulation (EU) No 414/2013 should therefore be amended accordingly.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:
(2)
Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).
(3)
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
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