Commission Implementing Regulation (EU) 2017/1531

law://eu/reg/2017/1531@2026-11-13

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/EEC^note and in particular Article 24 in conjunction with Article 20(1) thereof,Whereas:

(1)Commission Directive 2003/23/EC^note included imazamox as an active substance in Annex I to Council Directive 91/414/EEC^note.

(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 540/2011^note.

(3)The approval of the active substance imazamox, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2018.

(4)An application for the renewal of the approval of imazamox was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012^note within the time period provided for in that Article.

(5)The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 13 April 2015.

(7)The Authority communicated the renewal assessment report to the applicant and to the other Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)On 15 March 2016 the Authority communicated to the Commission its conclusion^note on whether imazamox can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for imazamox to the Standing Committee on Plants, Animals, Food and Feed on 11 July 2016.

(9)The applicant was given the opportunity to submit comments on the draft renewal report.

(10)It has been established with respect to one or more representative uses of at least one plant protection product containing imazamox that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of imazamox.

(11)The risk assessment for the renewal of the approval of imazamox is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing imazamox may be authorised. It is therefore appropriate to remove the restriction to use only as a herbicide.

(12)The Commission, however, considers that imazamox is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Imazamox is 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 in fresh water and sediment is higher than 120 days and the long term no-observed effect concentration for aquatic plants is 0,0045 mg/l. Imazamox therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(13)It is therefore appropriate to renew the approval of imazamox as a candidate for substitution.

(14)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, it is, however, necessary to include certain conditions and restrictions.

(15)The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(16)Commission Implementing Regulation (EU) 2017/841^note extended the approval period of imazamox to 31 July 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation should apply from 1 November 2017.

(17)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 as a candidate for substitution#

The approval of the active substance imazamox, as a candidate for substitution, is renewed as set out in Annex I.

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 3Entry 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 November 2017.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
imazamoxCAS No 114311-32-9CIPAC No 619	2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]-5-methoxymethylnicotinic acid	≥ 950 g/kgThe impurity cyanide ion (CN^–) shall not exceed 5 mg/kg in the technical material.	1 November 2017	31 October 2024	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 imazamox, 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 protection of consumers;the protection of aquatic plants and of non-target terrestrial plants;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of authorisation shall include risk mitigation measures and monitoring programs shall be initiated to verify potential groundwater contamination from imazamox and metabolites CL 312622 and CL 354825 in vulnerable zones, where appropriate.

Annex II

(1)in Part A, entry 41 on imazamox is deleted;

(2)in Part E, the following entry is added:^noteNumberCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘8imazamoxCAS No 114311-32-9CIPAC No 6192-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]-5-methoxymethylnicotinic acid≥ 950 g/kgThe impurity cyanide ion (CN^–) shall not exceed 5 mg/kg in the technical material.1 November 201731 October 2024For 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 imazamox, 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 protection of consumers;

—the protection of aquatic plants and of non-target terrestrial plants;

—the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures and monitoring programs shall be initiated to verify potential groundwater contamination from imazamox and metabolites CL 312622 and CL 354825 in vulnerable zones, where appropriate.’

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

Commission Implementing Regulation (EU) 2017/1531

Commission Implementing Regulation (EU) 2017/1531

Article 1Renewal of the approval of the active substance as a candidate for substitution#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II

Key facts

Connections

History · 2 versions

Article 1Renewal of the approval of the active substance as a candidate for substitution#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force and date of application#

Annex I

Annex II