# L_2023241EN.01014701.xml

| 29.9.2023 | EN | Official Journal of the European Union | L 241/147 |
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29.9.2023

EN

Official Journal of the European Union

L 241/147

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COMMISSION IMPLEMENTING DECISION (EU) 2023/2101

of 28 September 2023

postponing the expiry date of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 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) | Sulfuryl fluoride was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-types 8 and 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC. |
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(1)

Sulfuryl fluoride was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-types 8 and 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.

| (2) | On 28 June 2017, applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 (‘the applications’). |
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(2)

On 28 June 2017, applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 (‘the applications’).

| (3) | On 14 February 2018, the evaluating competent authority of Sweden informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications 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 14 February 2018, the evaluating competent authority of Sweden informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications 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. |
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(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. |
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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 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) | Pursuant to Commission Implementing Decision (EU) 2018/1479 (3), the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 has been postponed to 30 June 2021, which corresponded to the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 18 under Commission Directive 2009/84/EC (4), in order to allow sufficient time for the examination of the application. |
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(6)

Pursuant to Commission Implementing Decision (EU) 2018/1479 (3), the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 has been postponed to 30 June 2021, which corresponded to the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 18 under Commission Directive 2009/84/EC (4), in order to allow sufficient time for the examination of the application.

| (7) | Commission Implementing Decision (EU) 2021/713 (5) further postponed the expiry date of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 to 31 December 2023, in order to allow sufficient time for the examination of the applications. |
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(7)

Commission Implementing Decision (EU) 2021/713 (5) further postponed the expiry date of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 to 31 December 2023, in order to allow sufficient time for the examination of the applications.

| (8) | On 20 January 2023, the Agency received the recommendations from the evaluating competent authority for the renewal of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18. |
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(8)

On 20 January 2023, the Agency received the recommendations from the evaluating competent authority for the renewal of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18.

| (9) | 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 finalize the examination of the applications. Taking into account the time-limits for preparation and submission by the Agency of its opinions and for the Commission to decide whether to renew the approval of sulfuryl fluoride for use in biocidal products for product-types 8 and 18, the expiry date should be postponed to 31 December 2024. |
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(9)

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 finalize the examination of the applications. Taking into account the time-limits for preparation and submission by the Agency of its opinions and for the Commission to decide whether to renew the approval of sulfuryl fluoride for use in biocidal products for product-types 8 and 18, the expiry date should be postponed to 31 December 2024.

| (10) | After the further postponement of the expiry date of the approval, sulfuryl fluoride remains approved for use in biocidal products of product-types 8 and 18 subject to the conditions set out in Annex I to Directive 98/8/EC, |
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(10)

After the further postponement of the expiry date of the approval, sulfuryl fluoride remains approved for use in biocidal products of product-types 8 and 18 subject to the conditions set out in Annex I to Directive 98/8/EC,

HAS ADOPTED THIS DECISION:

Article 1

The expiry date of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 set out in Implementing Decision (EU) 2021/713 is postponed to 31 December 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, 28 September 2023.

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) 2018/1479 of 3 October 2018 postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 (OJ L 249, 4.10.2018, p. 16).

3

(4)  Commission Directive 2009/84/EC of 28 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto (OJ L 197, 29.7.2009, p. 67).

4

(5)  Commission Implementing Decision (EU) 2021/713 of 29 April 2021 postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 (OJ L 147, 30.4.2021, p. 21).

5

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