Commission Implementing Regulation (EU) 2023/574 of 13 March 2023 setting out detailed rules for the identification of unacceptable co-formulants in plant protection products in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilText with EEA relevance.

32023R0574

Den Europæiske UnionForordning2023

European Union

§ Article 63

Article 63 of Regulation (EC) No 1107/2009 shall apply to the information and studies submitted.

Where Article 4(8) applies and where the notified co-formulant is registered in accordance with Title II of Regulation (EC) No 1907/2006, the notifying Member State or ECHA may, where appropriate, request information from the persons referred to in Article 36 of that Regulation.

Where Article 4(8) applies, the Authority shall allow for a period of 120 days after publication of the co-formulant report pursuant to Article 5 to submit comments on or data relevant to that report. It shall make the comments or data received publicly available without undue delay. The Authority may request ECHA to contribute to the call for data.

Article 7

Assessment by the Authority

Where Article 4(8) applies, the Authority shall, following a notification pursuant to Article 3(3), carry out an assessment in an independent, objective and transparent manner and in the light of current scientific and technical knowledge, to verify whether the co-formulant is to be considered as unacceptable for inclusion in a plant protection product.

The Authority shall issue the results of its work on the technical assessment carried out in accordance with paragraph 1 and update the co-formulant report within 12 months from the end of the period referred to in Article 6(4).

Upon request of the Authority, the notifying Member State shall provide scientific assistance in the preparation of the technical assessment and of the updated co-formulant report.

The Authority shall, where appropriate, organise a consultation of experts, including experts from the notifying Member State and, where relevant, the other Member States. In that case, the period provided in paragraph 2 shall be extended by 1 month.

The Authority shall consult the Member States and the Commission on its draft technical assessment and shall address any comments received prior to its adoption.

The Authority shall establish the format of the document reporting the results of its work, which shall include sections concerning the evaluation procedure and the properties of the co-formulant concerned.

Where necessary, the Authority’s document reporting the results of its work shall specify whether specific conditions of use should be set for the notified co-formulant in Annex III to Regulation (EC) No 1107/2009.

Article 8

Inclusion of the co-formulant in Annex III to Regulation (EC) No 1107/2009

When Article 4(3), first subparagraph, Article 4(4), Article 4(5), first subparagraph, Article 4(6) or Article 4(7), first subparagraph, applies, the Commission shall present a draft Regulation to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 within six months from the notification submitted by the Member State, taking into account the co-formulant report.

When Article 4(3), second subparagraph, applies, the Commission shall present a draft Regulation to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 within six months from the adoption of the relevant opinion of the Risk Assessment Committee of ECHA.

When Article 4(5), second subparagraph, applies, the Commission shall present a draft Regulation to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 within six months after the publication of the updated list including the notified co-formulant in accordance with Article 59(10) of Regulation (EC) No 1907/2006.

When Article 4(7), second subparagraph, applies, the Commission shall present a draft Regulation to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 within six months after the amendment of Annex XVII to Regulation (EC) No 1907/2006 has entered into force.

When Article 4(8) applies, the Commission shall present a draft Regulation to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 within six months of receiving from the Authority the document reporting the results of its work and the updated co-formulant report.

The Commission shall adopt a Regulation on the basis of Article 27(2) and, where required, Article 78(2) of Regulation (EC) No 1107/2009 providing that:

(a) a co-formulant is listed in Annex III to Regulation (EC) No 1107/2009, subject to conditions and restrictions, where appropriate;

(b) a co-formulant is not listed in Annex III to Regulation (EC) No 1107/2009; or

(d) the entry of a co-formulant is deleted from the list in Annex III to Regulation (EC) No 1107/2009.

Article 9

Amendments of national lists of unacceptable co-formulants

Without prejudice to Article 81(2), second subparagraph, of Regulation (EC) No 1107/2009, Member States that have adopted through national provisions lists of unacceptable co-formulants in plant protection products, shall amend those lists in accordance with any Regulation adopted under Article 8.

Article 10

Entry into force

This Regulation shall enter into force on the twentieth 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, 13 March 2023.

For the Commission

The President

Ursula von der Leyen

Annex

ANNEX

Criteria for identification of an unacceptable co-formulant

(1) The co-formulant is classified as mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(2) The co-formulant is classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(3) The co-formulant is classified as toxic for reproduction category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(4) The co-formulant is listed in Annexes I to V to Regulation (EU) 2019/1021.

(5) The co-formulant is included in the list referred to in Article 59(1) of Regulation (EC) No 1907/2006 (candidate list) due to its identification:

(a) as persistent, bioaccumulative and toxic in accordance with Article 57, point (d), of that Regulation;

(b) as very persistent and very bioaccumulative in accordance with Article 57, point (e), of that Regulation; or

(c) as a substance of very high concern in accordance with Article 57, point (f), of that Regulation due to endocrine disrupting properties.

(6) The co-formulant is identified as having endocrine-disrupting properties in accordance with Regulation (EU) No 528/2012.

(7) A decision has been adopted not to approve the co-formulant as an active substance for product-type 6 under Regulation (EU) No 528/2012.

(8) A decision has been adopted to approve the co-formulant as an active substance under Regulation (EU) No 528/2012 with restrictions which are relevant for uses as co-formulant in plant protection products.

(9) The use of a substance as a co-formulant in plant protection products is included in Annex XVII to Regulation (EC) No 1907/2006, as restricted for the use in plant protection products.

(10) The co-formulant does not fall under any of the points 1 to 9, but, having regard to realistic conditions of use and good plant protection practice, it does not comply with one of the criteria for the approval of active substances as provided for in Annex II to Regulation (EC) No 1107/2009, when used as a co-formulant in a plant protection product.

Metadata

Type: Forordning
År: 2023
Ikrafttrædelsesdato: 1. januar 1970