# L_2021065EN.01005801.xml

| 25.2.2021 | EN | Official Journal of the European Union | L 65/58 |
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25.2.2021

EN

Official Journal of the European Union

L 65/58

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COMMISSION IMPLEMENTING DECISION (EU) 2021/333

of 24 February 2021

postponing the expiry date of approval of alphachloralose for use in biocidal products of product-type 14

(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 alphachloralose 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 14, 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 alphachloralose 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 14, 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) | The approval of alphachloralose for use in biocidal products of product-type 14 will expire on 30 June 2021. On 24 December 2019, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of alphachloralose. |
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(2)

The approval of alphachloralose for use in biocidal products of product-type 14 will expire on 30 June 2021. On 24 December 2019, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of alphachloralose.

| (3) | On 15 October 2020, the evaluating competent authority of Poland 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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(3)

On 15 October 2020, the evaluating competent authority of Poland 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. |
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(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 an 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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(5)

Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare an 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 alphachloralose for use in biocidal products of product-type 14 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 alphachloralose for use in biocidal products of product-type 14 for a period of time 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 31 December 2023. |
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(6)

Consequently, for reasons beyond the control of the applicant, the approval of alphachloralose for use in biocidal products of product-type 14 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 alphachloralose for use in biocidal products of product-type 14 for a period of time 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 31 December 2023.

| (7) | Except for the expiry date of approval, alphachloralose remains approved for use in biocidal products of product-type 14 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC, |
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(7)

Except for the expiry date of approval, alphachloralose remains approved for use in biocidal products of product-type 14 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 alphachloralose for use in biocidal products of product-type 14 is postponed to 31 December 2023.

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, 24 February 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

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