# L_2021279EN.01004101.xml

| 3.8.2021 | EN | Official Journal of the European Union | L 279/41 |
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3.8.2021

EN

Official Journal of the European Union

L 279/41

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COMMISSION IMPLEMENTING DECISION (EU) 2021/1287

of 2 August 2021

postponing the expiry date of approval of indoxacarb 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 indoxacarb was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products of product-type 18, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive. |
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(1)

The active substance indoxacarb was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products of product-type 18, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

| (2) | On 26 June 2018, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of indoxacarb for use in biocidal products of product-type 18. |
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(2)

On 26 June 2018, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of indoxacarb for use in biocidal products of product-type 18.

| (3) | On 12 November 2018, the evaluating competent authority of France 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. |
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(3)

On 12 November 2018, the evaluating competent authority of France 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) | As the competent authority is carrying out a full evaluation of the application, in accordance with Article 14(3) of Regulation (EU) No 528/2012, 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 within 270 days of receipt of the recommendation from the evaluating competent authority. |
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(4)

As the competent authority is carrying out a full evaluation of the application, in accordance with Article 14(3) of Regulation (EU) No 528/2012, 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 within 270 days of receipt of the recommendation from the evaluating competent authority.

| (5) | Pursuant to Implementing Decision (EU) 2019/1030 (3), the expiry date of approval of indoxacarb for use in biocidal products of product-type 18 has been postponed to 30 June 2022 in order to allow sufficient time for the examination of the application. However, the evaluating competent authority has not yet finalised the examination and has not yet submitted its assessment report and the conclusions of its evaluation to the Agency. |
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(5)

Pursuant to Implementing Decision (EU) 2019/1030 (3), the expiry date of approval of indoxacarb for use in biocidal products of product-type 18 has been postponed to 30 June 2022 in order to allow sufficient time for the examination of the application. However, the evaluating competent authority has not yet finalised the examination and has not yet submitted its assessment report and the conclusions of its evaluation to the Agency.

| (6) | On 29 October 2020, the evaluating competent authority has requested the applicant to submit additional information to carry out the evaluation in accordance with Article 8(2) of Regulation (EU) No 528/2012 and has set the deadline of 30 September 2022 for submitting this information. |
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(6)

On 29 October 2020, the evaluating competent authority has requested the applicant to submit additional information to carry out the evaluation in accordance with Article 8(2) of Regulation (EU) No 528/2012 and has set the deadline of 30 September 2022 for submitting this information.

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

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

| (8) | Considering the time necessary for the completion of 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 June 2024. |
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(8)

Considering the time necessary for the completion of 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 June 2024.

| (9) | Except for the expiry date of approval, indoxacarb remains approved for use in biocidal products of product-type 18 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC, |
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(9)

Except for the expiry date of approval, indoxacarb remains approved for use in biocidal products of product-type 18 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC,

HAS ADOPTED THIS DECISION:

Article 1

The expiry date of approval of indoxacarb for use in biocidal products of product-type 18 is postponed to 30 June 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

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

1

(2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

2

(3)  Commission Implementing Decision (EU) 2019/1030 of 21 June 2019 postponing the expiry date of approval of indoxacarb for use in biocidal products of product-type 18 (OJ L 167, 24.6.2019, p. 32).

3

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