Contents
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/EECnote, and in particular Article 20(1) in conjunction with Article 24(1) thereof,Whereas:
(1)Commission Directive 2006/74/ECnote included metconazole as an active substance in Annex I to Council Directive 91/414/EECnote.
(2)Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011note.
(3)The approval of the active substance metconazole, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 March 2025.
(4)An application for the renewal of the approval of the active substance metconazole was submitted to Belgium, the rapporteur Member State, and the United Kingdom, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012note and within the time period provided for in that Article.
(5)The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.
(6)The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 26 February 2018. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of metconazole.
(7)The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.
(8)On 12 July 2019, the Authority requested additional information from the applicant on the endocrine disrupting properties of metconazole pursuant to Article 13(3a), first subparagraph, of Implementing Regulation (EU) No 844/2012. The applicant submitted information to allow the Authority to conclude the assessment as regards whether the scientific criteria for the determination of endocrine disrupting properties set out in point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation (EU) 2018/605note, are met.
(9)In April 2022, the rapporteur Member State made an updated draft renewal assessment report available to the Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur Member State considered the additional information regarding the criteria to identify endocrine disrupting properties and proposed renewing the approval of metconazole.
(10)On 11 July 2023, the Authority communicated to the Commission its conclusionnote which indicated metconazole can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(11)The Commission presented a renewal report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 11 and 12 December 2023 and on 30 and 31 January 2024 respectively.
(12)The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.
(13)It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance metconazole that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(14)The risk assessment for the renewal of the approval of the active substance metconazole is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing metconazole may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide and plant growth regulator.
(15)The Commission, however, considers that metconazole is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Metconazole is considered a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life of metconazole is higher than 40 days in fresh water and higher than 120 days in fresh water sediment, that the substance is classified as toxic for reproduction (category 2) pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Councilnote and that the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Therefore, it fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.
(16)It is therefore appropriate to renew the approval of metconazole as a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009.
(17)In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to provide for certain conditions and restrictions.
(18)In the light of the potential concern for an increasing prevalence of azole-resistant strains in A. fumigatus and taking into account the precautionary principle, it is in particular appropriate to restrict the use of products containing metconazole to professional users only.
(19)Furthermore, it is appropriate to require further confirmatory information on the assessment of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water. In addition, to increase confidence in this decision, information should be requested to confirm the appropriate toxicological reference values applicable to certain metabolites and the residue definition for risk assessment.
(20)Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(21)Commission Implementing Regulation (EU) 2015/408note listed metconazole as a candidate for substitution. In the light of the renewal of approval of metconazole as a candidate for substitution and the corresponding move of that substance to Part E of the Annex to Implementing Regulation (EU) No 540/2011, the entry for metconazole should be deleted from the Annex to Implementing Regulation (EU) 2015/408.
(22)Commission Implementing Regulation (EU) 2023/689note extended the approval period of metconazole to 15 March 2025 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.
(23)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 1Renewal of the approval of the active substance#
The approval of the active substance metconazole, as specified in Annex I to this Regulation, is renewed, subject to the conditions laid down in that Annex.
Article 2Amendments to Implementing Regulation (EU) No 540/2011#
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3Amendment to Implementing Regulation (EU) 2015/408#
The entry for metconazole is deleted from the Annex to Implementing Regulation (EU) 2015/408.
Article 4Entry into force and date of application#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 September 2024.
Annex I
| Common Name, Identification Numbers | IUPAC Name | Puritynote | Date of approval | Expiration of approval | Specific provisions |
|---|---|---|---|---|---|
| metconazoleCAS No: 125116-23-6 (unstated stereochemistry)CIPAC No: 706 | (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | ≥ 940 g/kg (sum of cis- and trans-isomers), with cis-metconazole (CL 354801) level not less than 800 g/kg and not more than 950 g/kgThe following impurities shall not exceed the following levels in the technical material:toluene: 2 g/kgethylcyclohexane: 2 g/kg | 1 September 2024 | 31 August 2031 | Use shall be limited to professional users.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on metconazole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the consumer exposure assessment with regards to residues that may be present in the primary crops and succeeding crops grown in rotation;the protection of operators and bystanders/residents;the protection of aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1. the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;2. the general toxicity profile of the metabolites M11 and M21 should be further investigated in order to confirm the appropriate toxicological reference values applicable to them. Moreover, confirmation of the presence of M11 and M21 and their ratio among the monohydroxylated metconazole compounds in crops, in order to confirm the residue definition for risk assessment.The applicant shall submit the confirmatory information referred to in point 1 by 15 July 2026 and in point 2 by 15 July 2026 to the Commission, Member States and the Authority. |
Annex II
(1)in Part A, entry 134 on metconazole is deleted;
(2)in Part E, the following entry is added:noteNoCommon Name, Identification NumbersIUPAC NamePuritynoteDate of approvalExpiration of approvalSpecific provisions‘15metconazoleCAS No: 125116-23-6 (unstated stereochemistry)CIPAC No: 706(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol≥ 940 g/kg (sum of cis- and trans-isomers), with cis-metconazole (CL 354801) level not less than 800 g/kg and not more than 950 g/kgThe following impurities shall not exceed the following levels in the technical material:
1.the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;
2.the general toxicity profile of the metabolites M11 and M21 should be further investigated in order to confirm the appropriate toxicological reference values applicable to them. Moreover, confirmation of the presence of M11 and M21 and their ratio among the monohydroxylated metconazole compounds in crops, in order to confirm the residue definition for risk assessment.
—toluene: 2 g/kg
—the consumer exposure assessment with regards to residues that may be present in the primary crops and succeeding crops grown in rotation;
—ethylcyclohexane: 2 g/kg
—the protection of operators and bystanders/residents;
—the protection of aquatic organisms.
1 September 202431 August 2031Use shall be limited to professional users.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on metconazole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:The applicant shall submit the confirmatory information referred to in point 1 by 15 July 2026 and in point 2 by 15 July 2026 to the Commission, Member States and the Authority.’
The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:
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