(Utkast) Kommisjonens gjennomføringsforordning om EU-godkjenning av bioocidproduktfamilien “Pal IPA Product Family”
(Draft) Commission Implementing Regulation granting a Union authorisation for the biocidal product family “Pal IPA Product Family”
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 19.10.2019
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) On 29 June 2016, Pal Hygiene Products Limited, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named “Pal IPA Product Family” of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of United Kingdom had agreed to evaluate the application. The application was recorded under the case number BC-DY025578-07 in the Register for Biocidal Products.
(2) “Pal IPA Product Family” contains propan-2-ol, 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 22 August 2018, 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 25 March 2019, the Agency submitted to the Commission an opinion, including the proposed terms and conditions of the authorisation, the draft summary of the biocidal product characteristics ('SPC') of “Pal IPA Product Family” 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 “Pal IPA Product Family” 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 proposed terms and conditions and the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.
(6) On 4 June 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 “Pal IPA Product Family”.
(8) In the opinion the Agency also recommends that a long-term storage test at ambient temperature for wipes in their commercial packaging be conducted by the authorisation holder as a condition in the authorisation. The Commission agrees with that recommendation and considers that the submission of this test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1)(d) of that Regulation on the basis of the existing data.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products
Klima- og miljødepartementet