Commission Implementing Regulation (EU) 2018/1264

law://eu/reg/2018/1264@2026-11-12

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 20(1) thereof,Whereas:

(1)Commission Directive 2006/41/EC^note included pethoxamid 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 pethoxamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.

(4)An application for the renewal of the approval of pethoxamid 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 31 August 2016.

(7)The Authority communicated the renewal assessment report to the applicant and to the 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 30 August 2017 the Authority communicated to the Commission its conclusion^note on whether pethoxamid 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 pethoxamid to the Standing Committee on Plants, Animals, Food and Feed on 6 October 2017.

(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 the active substance pethoxamid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(11)It is therefore appropriate to renew the approval of pethoxamid.

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

(13)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. It is, in particular, appropriate to require further confirmatory information.

(14)Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15)Commission Implementing Regulation (EU) 2018/84^note extended the expiry date of pethoxamid to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 December 2018.

(16)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 pethoxamid 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 December 2018.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions
PethoxamidCAS No 106700-29-2CIPAC No 665	2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide	≥ 940 g/kgImpurities:Toluene: max 3 g/kg.	1 December 2018	30 November 2033	PART AUse shall be limited to one application every two years in the same field at a maximum dose of 1200 g active substance per hectare.PART BFor 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 pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms and earthworms;the risk to consumers from residues in the succeeding crops or in case of crop failure.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council, in particular as carcinogen category 2;2. the effect of water treatment processes on the nature of residues present in drinking water;3. the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605^note amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.

Annex II

(1)in Part A, entry 122 on pethoxamid is deleted;

(2)in Part B, the following entry is added:^note^note^noteNoCommon Name, Identification NumbersIUPAC NamePurity^noteDate of approvalExpiration of approvalSpecific provisions‘127PethoxamidCAS No 106700-29-2CIPAC No 6652-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide≥ 940 g/kgImpurities:Toluene: max 3 g/kg.1 December 201830 November 2033PART AUse shall be limited to one application every two years in the same field at a maximum dose of 1200 g active substance per hectare.PART BFor 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 pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.In their overall assessment Member States shall pay particular attention to:

1.the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council^note, in particular as carcinogen category 2;

2.the effect of water treatment processes on the nature of residues present in drinking water;

3.the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.

—the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;

—the risk to aquatic organisms and earthworms;

—the risk to consumers from residues in the succeeding crops or in case of crop failure.

Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605^note amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.’

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

Commission Implementing Regulation (EU) 2018/1264

Commission Implementing Regulation (EU) 2018/1264

Article 1Renewal of the approval of the active substance#

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

Article 3Entry into force and date of application#

Annex I

Annex II

Connections

History · 2 versions

Key facts

Article 1Renewal of the approval of the active substance#

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

Article 3Entry into force and date of application#

Annex I

Annex II