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)
Commission Implementing Regulation (EU) 2023/574of 13 March 2023setting 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)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/EECOJ L 309, 24.11.2009, p. 1., and in particular Article 27(5) thereof,Whereas:(1)Article 27(1) of Regulation (EC) No 1107/2009 specifies that a co-formulant is not to be accepted for inclusion in a plant protection product where it has been established that its residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment, or its use, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, has a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment.(2)Pursuant to Article 27(2) of Regulation (EC) No 1107/2009, co-formulants which are not accepted for inclusion in plant protection products must be included in Annex III to Regulation (EC) No 1107/2009. A first list of unacceptable co-formulants has been established by Commission Regulation (EU) 2021/383Commission Regulation (EU) 2021/383 of 3 March 2021 amending Annex III to Regulation (EC) No 1107/2009 of the European Parliament and of the Council listing co-formulants which are not accepted for inclusion in plant protection products (OJ L 74, 4.3.2021, p. 7). amending Annex III to Regulation (EC) No 1107/2009 listing co-formulants which are not accepted for inclusion in plant protection products.(3)Annex III to Regulation (EC) No 1107/2009 may need to be updated in light of new technical and scientific knowledge. In order to ensure a predictable and uniform implementation of Article 27 of Regulation (EC) No 1107/2009, it is appropriate to set out precise rules for the identification of unacceptable co-formulants in those same products, which may then be listed in an updated version of that Annex III. For such purposes, this Regulation establishes a set of detailed criteria to determine whether a co-formulant might have harmful or unacceptable effects as provided for in Article 27(1) of Regulation (EC) No 1107/2009, which should ensure that co-formulants meet safety standards that are protective for human health and the environment.(4)Co-formulants are chemical substances which may be used for different purposes, including in plant protection products. Their manufacturing, placing on the market and uses are regulated under Regulation (EC) No 1907/2006 of the European Parliament and of the Council ("REACH")Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).. Co-formulants must be registered under that Regulation including when they are intended for use in plant protection products. They can be identified as substances of high concern in accordance with Article 59 of Regulation (EC) No 1907/2006 or be subject to restrictions in accordance with Title VIII of that Regulation.(5)A co-formulant should not be accepted for inclusion in plant protection products when it is or has to be classified as carcinogenic, mutagenic or toxic to reproduction, Categories 1A or 1B. To establish a harmonised hazard classification of co-formulants, Member States or manufacturers, importers or downstream users may submit proposals for harmonised classification in accordance with Article 37 of Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilRegulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1)..(6)A co-formulant should also not be accepted for inclusion in plant protection products where it is identified as substance of very high concern in accordance with Regulation (EC) No 1907/2006 for reasons other than its classification as carcinogenic, mutagenic or toxic to reproduction, Categories 1A or 1B.(7)Consequently, if the properties of co-formulants used in plant protection products give rise to concern that their use in plant protection products could lead to harmful effects on human or animal health, Member States should first take appropriate actions in accordance with those two Regulations as such hazard properties are also relevant for all other uses of the substances concerned, and thereafter propose the inclusion of the co-formulants into Annex III to Regulation (EC) No 1107/2009.(8)In addition, a co-formulant should not be accepted for inclusion in a plant protection product in cases where the co-formulant has been identified as a persistent organic pollutant under Regulation (EU) 2019/1021 of the European Parliament and of the CouncilRegulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45)..(9)Furthermore, if a co-formulant used in plant protection products has been identified as having endocrine-disrupting properties under Regulation (EU) No 528/2012 of the European Parliament and of the CouncilRegulation (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 (OJ L 167, 27.6.2012, p. 1)., has not been approved as active substance for use as preservative during storage, or any restrictions have been established in accordance with that Regulation which affect uses in plant protection products, its use in them should be considered unacceptable.(10)In the interest of efficiency, consistency and predictability, with regard to the specific restrictions as provided for in Annex XVII to Regulation (EC) No 1907/2006, it is appropriate to guarantee that such restrictions should also apply for all those substances susceptible to be used, or which are currently used, as co-formulants in plant protection products.(11)Lastly, in order to maintain coherence with the approval criteria for active substances, safeners and synergists, the criteria for the approval of active substances concerning human or animal health and the environment, as provided for in Annex II to Regulation (EC) No 1107/2009, insofar as not already covered by the other criteria for not accepting co-formulants, should also apply to co-formulants.(12)It is necessary and appropriate to lay down rules on the procedure to follow for the inclusion of co-formulants in Annex III to Regulation (EC) No 1107/2009. The information to be submitted by the Member States for such purposes should be specified. To ensure consistency in evaluation, a technical assessment should be performed by the European Food Safety Authority ("the Authority"), following a notification from a Member State and the submission of a pertinent report by the latter on the reasons why a co-formulant might meet the criteria as established in this Regulation, in cases where no action under other Union legislation has been initiated or completed by the notifying Member State. It is necessary to clarify that the Authority should be entitled to require relevant information from the other Member States and, where appropriate, from the European Chemicals Agency.(13)Pursuant to Article 27(3) of Regulation (EC) No 1107/2009, the Commission may review co-formulants at any time. In doing so, it may also take into account relevant information provided by the Member States. It is therefore deemed necessary to establish a procedure allowing Member States to notify the Commission about co-formulants already listed in Annex III to Regulation (EC) No 1107/2009 which may need to be deleted from that Annex or about any conditions established in that Annex for co-formulants which may need to be amended.(14)This Regulation does not affect the possibility for Member States to temporarily prohibit or restrict the application of a co-formulant within its territory on the basis of Article 81(2) of Regulation (EC) No 1107/2009 subject the conditions laid down in that Article.(15)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: