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Decision

Commission Implementing Decision (EU) 2018/1477 of 2 October 2018 on the terms and conditions of the authorisations of biocidal products containing ethyl butylacetylaminopropionate referred by Belgium in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2018) 6291) (Text with EEA relevance.)

CELEX
Implementing Decision (EU) 2018/1477
Date of document
Articles
4
Source
EUR-Lex
Article 1

This Decision applies to the biocidal products identified by the asset numbers BE-0012319-0000 and BE-0012317-0000 in the Register for Biocidal Products.

Article 2

When applying the application rate derived from the efficacy studies, the biocidal products referred to in Article 1 meet the condition laid down in Article 19(1)(b)(i) of Regulation (EU) No 528/2012 but not the condition laid down in Article 19(1)(b)(iii) of that Regulation for all intended uses.

As a consequence, the intended uses of the aerosol contested product and the intended use of the pump spray contested product for infants under 1 year of age may only be authorised in accordance with Article 19(5) of that Regulation.

The reference Member State shall update the product assessment report referred to in Article 30(3)(a) of Regulation (EU) No 528/2012 accordingly.

Article 3

When granting or amending product authorisations for the biocidal products referred to in Article 1 in accordance with Article 19(1) of Regulation (EU) No 528/2012 and, where relevant, Article 19(5) of that Regulation, Member States shall include the following condition:

‘Within two years of the publication by the European Chemicals Agency of Union guidance on how to generate efficacy data for insect repellents at the recommended application rates, the authorisation holder shall submit data to confirm the minimum effective application rate. Those data shall be submitted in the form of an application for a change of the authorisation in accordance with Commission Implementing Regulation (EU) No 354/2013’.

Article 4

This Decision is addressed to the Member States.

4 articles

Cite this act

Commission Implementing Decision (EU) 2018/1477 of 2 October 2018 on the terms and conditions of the authorisations of biocidal products containing ethyl butylacetylaminopropionate referred by Belgium in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2018) 6291) (Text with EEA relevance.) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32018D1477

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