(Utkast) Kommisjonens gjennomføringsforordning EU-godkjenning av biocidproduktfamilien “HYPRED‘s octanoic acid based products”
(Draft) Commission Implementing Regulation granting a Union authorisation for the biocidal product family “HYPRED‘s octanoic acid based products”
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 19.2.2020
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) On 25 August 2015, HYPRED SAS, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named “HYPRED‘s octanoic acid based products” of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under the case number BC-LR019297-17 in the Register for Biocidal Products.
(2) “HYPRED‘s octanoic acid based products” contains octanoic acid, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.
(3) On 19 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency ('the Agency').
(4) On 11 July 2019, the Agency submitted to the Commission an opinion , including the draft summary of the biocidal product characteristics ('SPC') of “HYPRED‘s octanoic acid based products” and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.
(5) The opinion concludes that “HYPRED‘s octanoic acid based products” is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.
(6) On 25 July 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.
(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for “HYPRED‘s octanoic acid based products”.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
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