Commission Implementing Decision (EU) 2024/1285 of 13 May 2024 postponing the expiry date of the approval of hexaflumuron for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-05-13
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, insecticide, market approval








L_202401285EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1285


15.5.2024







            COMMISSION IMPLEMENTING DECISION (EU) 2024/1285
of 13 May 2024
         
postponing the expiry date of the approval of hexaflumuron for use in biocidal products of product-type 18 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 14(5) thereof,


After consulting the Standing Committee on Biocidal Products,

Whereas:







(1)


Hexaflumuron was approved as an active substance for use in biocidal products of product-type 18 by Commission Implementing Regulation (EU) 2015/1982 (2) subject to the conditions set out in the Annex to that Regulation (‘the approval’).












(2)


On 23 September 2020, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of hexaflumuron for use in biocidal products of product-type 18 (‘the application’).












(3)


On 18 February 2021, the evaluating competent authority of Greece informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.












(4)


The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.












(5)


Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.












(6)


Commission Implementing Decision (EU) 2021/1299 (3) postponed the expiry date of the approval of hexaflumuron for use in biocidal products of product-type 18 to 30 September 2024, in order to allow sufficient time for the examination of the application.












(7)


On 2 May 2023 the evaluating competent authority informed the Commission that the evaluation is delayed due to the need of the evaluating competent authority to assess additional data on endocrine disruptor properties of the active substance. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the fourth quarter of 2024.












(8)


Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalise the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval, the expiry date should be postponed to 31 March 2027.












(9)


After the further postponement of the expiry date of the approval, hexaflumuron remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex to Implementing Regulation (EU) 2015/1982,





HAS ADOPTED THIS DECISION:



Article 1
The expiry date of the approval of hexaflumuron for use in biocidal products of product-type 18 set out in Implementing Regulation (EU) 2015/1982 is postponed to 31 March 2027.


Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




Done at Brussels, 13 May 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/2022-04-15


(2)  Commission Implementing Regulation (EU) 2015/1982 of 4 November 2015 approving hexaflumuron as an existing active substance for use in biocidal products for product-type 18 (OJ L 289, 5.11.2015, p. 13, ELI: http://data.europa.eu/eli/reg_impl/2015/1982/oj).

(3)  Commission Implementing Decision (EU) 2021/1299 of 4 August 2021 postponing the expiry date of approval of hexaflumuron for use in biocidal products of product-type 18 (OJ L 282, 5.8.2021, p. 36, ELI: http://data.europa.eu/eli/dec_impl/2021/1299/oj).


ELI: http://data.europa.eu/eli/dec_impl/2024/1285/oj
ISSN 1977-0677 (electronic edition)