Commission Implementing Decision (EU) 2021/1286 of 2 August 2021 postponing the expiry date of approval of dinotefuran for use in biocidal products of product-type 18 (Text with EEA relevance)
Date: 2021-08-02
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: chemical product, insecticide, market approval, plant health control








L_2021279EN.01003901.xml










3.8.2021   


EN


Official Journal of the European Union


L 279/39








            COMMISSION IMPLEMENTING DECISION (EU) 2021/1286
of 2 August 2021
         
postponing the expiry date of approval of dinotefuran for use in biocidal products of product-type 18
(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)


The active substance dinotefuran was approved as an active substance for use in biocidal products of product-type 18 (2).












(2)


The approval of dinotefuran for use in biocidal products of product-type 18 will expire on 31 May 2022. On 11 November 2020, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of dinotefuran.












(3)


On 25 March 2021, the evaluating competent authority of Belgium 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 Regulation (EU) No 528/2012, 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, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In such case, 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)


Consequently, for reasons beyond the control of the applicant, the approval of dinotefuran for use in biocidal products of product-type 18 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of dinotefuran for use in biocidal products of product-type 18 for a period sufficient to enable the examination of the application. Considering the time limits for the evaluation by the evaluating competent authority and for the preparation and submission of the opinion by the Agency, it is appropriate to postpone the expiry date of approval to 30 November 2024.












(7)


Except for the expiry date of approval, dinotefuran remains approved for use in biocidal products of product-type 18 subject to the specifications and conditions set out in Implementing Regulation (EU) 2015/416,





HAS ADOPTED THIS DECISION:



Article 1
The expiry date of approval of dinotefuran for use in biocidal products of product-type 18 is postponed to 30 November 2024.


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, 2 August 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  Commission Implementing Regulation (EU) 2015/416 of 12 March 2015 approving dinotefuran as an active substance for use in biocidal products for product-type 18 (OJ L 68, 13.3.2015, p. 30).