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 Council (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/574
• Articles: 11

Article 1 Subject matter

This Implementing Regulation lays down detailed rules and criteria for the identification of co-formulants that are not to be accepted for inclusion in plant protection products (‘unacceptable co-formulants’).

It applies to applications for authorisation of plant protection products, including for their amendment or renewal, submitted on or after 3 April 2023.

Article 2 Criteria for the identification of unacceptable co-formulants

The criteria for the identification of co-formulants which are considered unacceptable for inclusion in a plant protection product are set out in the Annex.

Article 3 Assessment and notification of co-formulants

1.   When assessing applications for authorisation of plant protection products, Member States shall verify whether co-formulants contained in plant protection products could be considered an unacceptable co-formulant based on the criteria set out in the Annex.

2.   For the purposes of the verification provided for in paragraph 1, Member State shall carry out an independent, objective and transparent assessment, in the light of current scientific and technical knowledge, on the basis of the information submitted in an application dossier for the authorisation of a plant protection product in accordance with Regulation (EC) No 1107/2009 and including, where appropriate, the information submitted in accordance with Title II of Regulation (EC) No 1907/2006.

3.   Following the verification provided for in paragraph 1, the Member State shall notify the other Member States, the Commission and the Authority where it considers that:

(a)

the co-formulant used or meant to be used in a plant protection product could meet one or more of the criteria set out in the Annex to this Regulation and therefore be an unacceptable co-formulant;

(b)

in the light of new scientific and technical knowledge, the entry of a co-formulant in the list of Annex III to Regulation (EC) No 1107/2009 should be amended; or

(c)

in the light of new scientific and technical knowledge, the entry of a co-formulant in the list of Annex III to Regulation (EC) No 1107/2009 should be deleted.

Article 4 Content of the co-formulant report

1.   A notification pursuant to Article 3(3) shall be accompanied by a co-formulant report.

2.   The co-formulant report shall contain:

(a)

the chemical identity of the co-formulant:

(1)

for a substance as specified in Section 2 of Annex VI to Regulation (EC) No 1907/2006;

(2)

for a preparation as specified for mixtures in Article 18(3) to Regulation (EC) No 1272/2008;

(b)

the criteria set out in the Annex which the notifying Member State considers to be met;

(c)

where appropriate, any specific conditions of use to be set for the co-formulant in Annex III to Regulation (EC) No 1107/2009.

3.   Where a co-formulant meets one or more of the criteria set out in points 1 to 3 of the Annex to this Regulation, and it is listed in Annex VI to Regulation (EC) No 1272/2008, the co-formulant report shall include a reference to the relevant entry in Annex VI to Regulation (EC) No 1272/2008 (i.e. the index number or CAS number).

Where a co-formulant is not included in the list in Annex VI to Regulation (EC) No 1272/2008, but the notifying Member State considers that it should be classified for the hazard classes referred to in points 1 to 3 of the Annex to this Regulation, the co-formulant report shall include a reference to the proposal for harmonised classification and labelling that the Member State or a manufacturer, importer or downstream user has submitted pursuant to Article 37 of Regulation (EC) No 1272/2008 to the European Chemicals Agency (‘ECHA’).

4.   Where a co-formulant meets the criterion set out in point 4 of the Annex to this Regulation, the co-formulant report shall include a reference to the relevant entry in Annexes I to V to Regulation (EU) 2019/1021.

5.   Where a co-formulant meets one or more of the criteria set out in point 5 of the Annex to this Regulation, and it is included in the list referred to in Article 59(1) of Regulation (EC) No 1907/2006, the co-formulant report shall include a reference to the relevant entry in that list.

Where a co-formulant is not included in the list referred to in Article 59(1) of Regulation (EC) No 1907/2006, but the notifying Member State considers that it should be identified as referred to in point 5 of the Annex to this Regulation, the co-formulant report shall include a reference to the dossier submitted as referred to in Annex XV to Regulation (EC) No 1907/2006.

6.   Where a co-formulant meets one or more of the criteria set out in points 6 to 8 of the Annex to this Regulation, the co-formulant report shall include a reference to the opinion adopted in accordance with Article 8(4) of Regulation (EU) No 528/2012.

7.   Where a co-formulant is included in Annex XVII to Regulation (EC) No 1907/2006 and the restriction is relevant for the use in plant protection products, the co-formulant report shall include a reference to the relevant entry in Annex XVII to Regulation (EC) No 1907/2006.

Where the use of a co-formulant is not included in Annex XVII to Regulation (EC) No 1907/2006, but the notifying Member State considers that it poses a risk to human health or the environment which is not adequately controlled and which needs to be addressed in accordance with Article 69(1) or (4) of Regulation (EC) No 1907/2006, the co-formulant report shall include a reference to the dossier referred to in Annex XV of Regulation (EC) No 1907/2006 and submitted to ECHA in accordance with Article 69 of Regulation (EC) No 1907/2006.

8.   Where the notifying Member State considers that the notified substance meets the criterion set out in point 10 of the Annex, the co-formulant report shall include the conclusions of the assessment carried out pursuant to Article 3(2).

9.   In cases where the co-formulant report includes information that is confidential in accordance with Article 63 of Regulation (EC) No 1107/2009 or the relevant provisions on confidentiality of the regulations referred to in paragraphs 2 to 8, the notifying Member States shall submit a confidential and a non-confidential version of the co-formulant report.

Article 5 Publication

The Commission shall, without undue delay, make the co-formulant report available to the public in an electronic format.

Article 6 Call for information

1.   Where Article 4(8) applies, the Authority shall request all Member States to report whether they have authorised any plant protection products containing the notified co-formulant.

2.   Where Article 4(8) applies, the notifying Member State – supported by the other Member States when necessary – shall require the holders of authorisations of plant protection products containing the notified co-formulant to submit to the Authority all information and studies on the notified co-formulant available to them.

The holders of such authorisations shall submit the information and studies by the end of the period set out in paragraph 4.

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

3.   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.

4.   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

1.   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.

2.   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.

3.   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.

4.   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.

5.   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.

6.   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

1.   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.

2.   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.

3.   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.

4.   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.

5.   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.

6.   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

(c)

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

Schedules & Appendices

ANNEX Criteria for identification of an unacceptable co-formulant

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.