# L_2023015EN.01001501.xml

| 17.1.2023 | EN | Official Journal of the European Union | L 15/15 |
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17.1.2023

EN

Official Journal of the European Union

L 15/15

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/116

of 16 January 2023

amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance oxamyl

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 17, first paragraph, thereof,

Whereas:

| (1) | Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009. |
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(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

| (2) | Commission Implementing Regulation (EU) 2021/2068 (3) extended the approval period of the active substance oxamyl until 31 January 2023. |
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(2)

Commission Implementing Regulation (EU) 2021/2068 (3) extended the approval period of the active substance oxamyl until 31 January 2023.

| (3) | An application for the renewal of the approval of the active substance oxamyl was submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4). |
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(3)

An application for the renewal of the approval of the active substance oxamyl was submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

| (4) | Although the European Food Safety Authority’s conclusion (5) on the evaluation of the active substance oxamyl is available and the Commission has initiated discussions at the Standing Committee on Plants, Animals, Food and Feed, it still appears that the approval is likely to expire before a decision has been taken on renewal. Therefore, and as this delay is for reasons beyond the control of the applicant, it is necessary to extend its approval for a limited period of time to enable the completion of the assessment required in order to take a decision on the application for a renewal of its approval. |
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(4)

Although the European Food Safety Authority’s conclusion (5) on the evaluation of the active substance oxamyl is available and the Commission has initiated discussions at the Standing Committee on Plants, Animals, Food and Feed, it still appears that the approval is likely to expire before a decision has been taken on renewal. Therefore, and as this delay is for reasons beyond the control of the applicant, it is necessary to extend its approval for a limited period of time to enable the completion of the assessment required in order to take a decision on the application for a renewal of its approval.

| (5) | In case the Commission is to adopt a Regulation providing that the approval of oxamyl is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards the case where the Commission is to adopt a Regulation providing for the renewal of the approval of oxamyl, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date. |
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(5)

In case the Commission is to adopt a Regulation providing that the approval of oxamyl is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards the case where the Commission is to adopt a Regulation providing for the renewal of the approval of oxamyl, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

| (6) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(6)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (7) | Taking into account that the current approval of oxamyl expires on 31 January 2023, this Regulation should enter into force as soon as possible. |
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(7)

Taking into account that the current approval of oxamyl expires on 31 January 2023, this Regulation should enter into force as soon as possible.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, in the sixth column, ‘Expiration of approval’, of entry 116, Oxamyl, the date is replaced by ‘31 October 2023’.

Article 2

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 309, 24.11.2009, p. 1.

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(2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

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(3)  Commission Implementing Regulation (EU) 2021/2068 of 25 November 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (OJ L 421, 26.11.2021, p. 25).

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(4)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

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Although Implementing Regulation (EU) No 844/2012 was repealed by Implementing Regulation (EU) 2020/1740 (OJ L 392, 23.11.2020, p. 20), the provisions concerning the renewal of the approval of active substances laid down in Implementing Regulation (EU) No 844/2012 continue to apply in accordance with Article 17 of Implementing Regulation (EU) 2020/1740.

(5)  EFSA (European Food Safety Authority), 2022. Conclusion on the peer review of the pesticide risk assessment of the active substance oxamyl. EFSA Journal 2022;20(5):7296. https://doi.org/10.2903/j.efsa.2022.7296.

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