# L_2021282EN.01003601.xml

| 5.8.2021 | EN | Official Journal of the European Union | L 282/36 |
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5.8.2021

EN

Official Journal of the European Union

L 282/36

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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

(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 hexaflumuron was approved as an active substance for use in biocidal products of product-type 18 (2). |
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(1)

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

| (2) | The approval of hexaflumuron for use in biocidal products of product-type 18 will expire on 31 March 2022. 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. |
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(2)

The approval of hexaflumuron for use in biocidal products of product-type 18 will expire on 31 March 2022. 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.

| (3) | As hexaflumuron meets the criteria for being a persistent, bioaccumulative and toxic substance (PBT substance), and a very persistent and very bioaccumulative substance (vPvB substance) according to Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3), it meets the exclusion criteria set out in Article 5(1), point (e), of Regulation (EU) No 528/2012. |
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(3)

As hexaflumuron meets the criteria for being a persistent, bioaccumulative and toxic substance (PBT substance), and a very persistent and very bioaccumulative substance (vPvB substance) according to Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3), it meets the exclusion criteria set out in Article 5(1), point (e), of Regulation (EU) No 528/2012.

| (4) | 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 Regulation (EU) No 528/2012, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation. |
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(4)

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 Regulation (EU) No 528/2012, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

| (5) | 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. |
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(5)

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.

| (6) | 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. |
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(6)

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.

| (7) | Consequently, for reasons beyond the control of the applicant, the approval of hexaflumuron 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 hexaflumuron for use in biocidal products of product-type 18 for a period of time sufficient to enable the examination of the application. |
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(7)

Consequently, for reasons beyond the control of the applicant, the approval of hexaflumuron 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 hexaflumuron for use in biocidal products of product-type 18 for a period of time sufficient to enable the examination of the application.

| (8) | Considering the time-limits for the evaluation by the evaluating competent authority, for the preparation and submission of the opinion by the Agency and the period of time necessary to decide if at least one of the conditions in Article 5(2), first subparagraph, of Regulation (EU) No 528/2012 is fulfilled and whether the approval of hexaflumuron may therefore be renewed, it is appropriate to postpone the expiry date of approval to 30 September 2024. |
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(8)

Considering the time-limits for the evaluation by the evaluating competent authority, for the preparation and submission of the opinion by the Agency and the period of time necessary to decide if at least one of the conditions in Article 5(2), first subparagraph, of Regulation (EU) No 528/2012 is fulfilled and whether the approval of hexaflumuron may therefore be renewed, it is appropriate to postpone the expiry date of approval to 30 September 2024.

| (9) | Except for the expiry date of approval, hexaflumuron remains approved for use in biocidal products of product-type 18 subject to the specifications and conditions set out in Implementing Regulation (EU) 2015/1982, |
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(9)

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

HAS ADOPTED THIS DECISION

Article 1

The expiry date of approval of hexaflumuron for use in biocidal products of product-type 18 is postponed to 30 September 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, 4 August 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

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(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).

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(3)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

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