Date: 2023-03-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2023/548 of 6 March 2023 not granting a Union authorisation for the biocidal product family ‘UL Hydrogen Peroxide Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2023) 1372) (Only the Dutch text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2023/548, dated 6 March 2023, addresses the application by Unilever Europe BV for Union authorisation of the biocidal product family "UL Hydrogen Peroxide Family 1." The decision, based on an assessment by the European Chemicals Agency (ECHA), concludes that authorisation is not granted due to unacceptable risks identified for users and the environment. The decision was made in accordance with Regulation EU No 528/2012.
Key Points / Main Content:
* **Application Details:**
* Unilever Europe BV applied for Union authorisation on 27 January 2017, for the biocidal product family "UL Hydrogen Peroxide Family 1" (product-type 2).
* Germany's competent authority agreed to evaluate the application.
* **Assessment and Opinion:**
* ECHA's opinion, submitted on 5 July 2022, concluded that the product family did not meet the conditions laid down in Article 19(1), points (b)(iii), (b)(iv) and (d) of Regulation (EU) No 528/2012.
* An unacceptable risk was identified for professional and non-professional users due to secondary inhalation exposure.
* Unacceptable environmental risks for sediment and soil compartments were identified, due to the presence of PEG-2 hydrogenated tallow amine.
* Data gaps existed regarding the physical and chemical properties of the products.
* **Decision:**
* A Union authorisation is not granted to Unilever Europe BV for the biocidal product family "UL Hydrogen Peroxide Family 1."
Impact Analysis:
* **Unilever Europe BV:**
* *Impact:* The application for Union authorisation for "UL Hydrogen Peroxide Family 1" has been rejected.
* *Action Required:* Cease making available on the market and use of the biocidal product family "UL Hydrogen Peroxide Family 1".
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision EU 2023/548: A decision by the European Commission regarding the non-authorization of the biocidal product family UL Hydrogen Peroxide Family 1.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Parliament: One of the legislative branches of the European Union.
Council of the European Union: A legislative body of the European Union where ministers from each member state meet to discuss, amend, and adopt laws, and coordinate policies.
UL Hydrogen Peroxide Family 1: A biocidal product family for which Unilever Europe BV applied for Union authorization, but was not granted.
Unilever Europe BV: The applicant company for Union authorization of the biocidal product family UL Hydrogen Peroxide Family 1.
European Chemicals Agency: An agency of the European Union that manages the registration, evaluation, authorisation and restriction of chemicals.
10.3.2023 EN Official Journal of the European Union L 73/17
COMMISSION IMPLEMENTING DECISION (EU) 2023/548
of 6 March 2023
not granting a Union authorisation for the biocidal product family ‘UL Hydrogen Peroxide Family 1’
in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(notified under document C(2023) 1372)
(Only the Dutch text is authentic)
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 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 44(5), first subparagraph,
thereof,
Whereas:
(1) On 27 January 2017, Unilever Europe BV submitted to the European Chemicals Agency (‘the Agency’) an application
in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product
family named ‘UL Hydrogen Peroxide Family 1’ of product-type 2, as described in Annex V to that Regulation,
providing written confirmation that the competent authority of Germany had agreed to evaluate the application.
The application was recorded under case number BC-MS029571-20 in the Register for Biocidal Products.
(2) ‘UL Hydrogen Peroxide Family 1’ contains hydrogen peroxide 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 for product-type 2.
(3) On 20 December 2021, 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 Agency.
(4) On 25 October 2021, the evaluating competent authority gave Unilever Europe BV the opportunity to provide
written comments on the assessment report and the conclusions of the evaluation, in accordance with
Article 44(1), second subparagraph, of Regulation (EU) No 528/2012. On 23 November 2021, Unilever Europe BV
sent its comments to the evaluating competent authority. During the Agency’s opinion-forming process on that
assessment report, the report was updated by the evaluating competent authority, and on 13 May 2022, Unilever
Europe BV was given the opportunity to provide comments on the updated assessment report and the draft opinion
of the Agency before the final opinion was adopted by the Biocidal Products Committee of the Agency on 15 June
2022. No comments were provided by Unilever Europe BV on that occasion.
(5) On 5 July 2022, the Agency submitted to the Commission its opinion(2) on ‘UL Hydrogen Peroxide Family 1’ in
accordance with Article 44(3) of Regulation (EU) No 528/2012.
(6) The opinion concludes that ‘UL Hydrogen Peroxide Family 1’ is a biocidal product family within the meaning of
Article 3(1), point (s), of Regulation (EU) No 528/2012, but that it does not meet the conditions laid down in
Article 19(1), points (b)(iii), (b)(iv) and (d), of that Regulation.
(1) OJ L 167, 27.6.2012, p. 1.
(2) ECHA opinion on the Union authorisation of the biocidal product family ‘UL Hydrogen Peroxide Family 1’, ECHA/BPC/344/2022,
adopted on 15 June 2022, https://echa.europa.eu/bpc-opinions-on-union-authorisation.L 73/18 EN Official Journal of the European Union 10.3.2023
(7) According to the opinion of the Agency, an unacceptable risk was identified for professional and non-professional
users from secondary inhalation exposure, and measures to mitigate the identified risk are not available or
applicable. Unacceptable environmental risks for the compartments sediment and soil were also identified, due to
the presence in the products of the substance of concern PEG-2 hydrogenated tallow amine. The opinion of the
Agency also indicated that data gaps were identified for certain endpoints, and it was not possible to conclude on
the physical and chemical properties of the products and whether they could be deemed acceptable for the
purposes of the appropriate use and transport of the product.
(8) The Commission concurs with the opinion of the Agency and considers it therefore appropriate not to grant a Union
authorisation for ‘UL Hydrogen Peroxide Family 1’.
(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
A Union authorisation is not granted to Unilever Europe BV for the making available on the market and use of the biocidal
product family ‘UL Hydrogen Peroxide Family 1’.
Article 2
This Decision is addressed to Unilever Europe BV, Weena 455, 3013AL Rotterdam, Netherlands.
Done at Luxembourg, 6 March 2023.
For the Commission
The President
Ursula VON DER LEYEN