# L_2020143EN.01000601.xml

| 6.5.2020 | EN | Official Journal of the European Union | L 143/6 |
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6.5.2020

EN

Official Journal of the European Union

L 143/6

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/617

of 5 May 2020

renewing the approval of the active substance metalaxyl-M, and restricting the use of seeds treated with plant protection products containing it, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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/EEC (1), and in particular Article 20(1) and 49(2) thereof,

Whereas:

| (1) | Commission Directive 2002/64/EC (2) included metalaxyl-M as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2002/64/EC (2) included metalaxyl-M as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (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 (4). |
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(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 (4).

| (3) | The approval of the active substance metalaxyl-M, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2020. |
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(3)

The approval of the active substance metalaxyl-M, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 June 2020.

| (4) | An application for the renewal of the inclusion of metalaxyl-M in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article. |
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(4)

An application for the renewal of the inclusion of metalaxyl-M in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State. |
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(5)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. 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 November 2013. |
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(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 November 2013.

| (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. |
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(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 January 2015, the Authority communicated to the Commission its conclusion (6) on whether metalaxyl-M can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft review report for metalaxyl-M to the Standing Committee on Plants, Animals, Food and Feed on 14 July 2015 and a revised version on 16 July 2019. |
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(8)

On 30 January 2015, the Authority communicated to the Commission its conclusion (6) on whether metalaxyl-M can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft review report for metalaxyl-M to the Standing Committee on Plants, Animals, Food and Feed on 14 July 2015 and a revised version on 16 July 2019.

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

The applicant was given the opportunity to submit comments on the draft review report.

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

It has been established with respect to one or more representative uses of at least one plant protection product containing metalaxyl-M 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 metalaxyl-M. |
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(11)

It is therefore appropriate to renew the approval of metalaxyl-M.

| (12) | 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. |
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(12)

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.

| (13) | Risks for birds and mammals from consumption of treated seeds have been identified by the Authority. Taking into consideration those risks, the use of seeds treated with plant protection products containing metalaxyl-M should be restricted. It is therefore appropriate that seeds treated with plant protection products containing metalaxyl-M should only be sown in greenhouses. |
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(13)

Risks for birds and mammals from consumption of treated seeds have been identified by the Authority. Taking into consideration those risks, the use of seeds treated with plant protection products containing metalaxyl-M should be restricted. It is therefore appropriate that seeds treated with plant protection products containing metalaxyl-M should only be sown in greenhouses.

| (14) | The Commission considers that metalaxyl-M does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, and in accordance with the guidance for the identification of endocrine disruptors (7). |
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(14)

The Commission considers that metalaxyl-M does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, and in accordance with the guidance for the identification of endocrine disruptors (7).

| (15) | The risk assessment for the renewal of the approval of metalaxyl-M is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing metalaxyl-M may be authorised. It is therefore appropriate not to maintain the restriction to uses as a fungicide. |
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(15)

The risk assessment for the renewal of the approval of metalaxyl-M is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing metalaxyl-M may be authorised. It is therefore appropriate not to maintain the restriction to uses as a fungicide.

| (16) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(16)

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

| (17) | The restriction to the use of treated seeds should apply as of 1 June 2021 in order to allow for a sufficient period of transition. |
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(17)

The restriction to the use of treated seeds should apply as of 1 June 2021 in order to allow for a sufficient period of transition.

| (18) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(18)

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 1

Renewal of the approval of the active substance

The approval of the active substance metalaxyl-M is renewed as set out in Annex I.

Article 2

Amendments 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 3

Restriction to the use of treated seeds

Seeds treated with plant protection products containing metalaxyl-M shall only be sown in greenhouses.

Article 4

Entry 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.

Official Journal of the European Union

It shall apply from 1 June 2020.

However, Article 3 shall apply as of 1 June 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 May 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Directive 2002/64/EC of 15 July 2002 amending Council Directive 91/414/EEC to include cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen as active substances (OJ L 189, 18.7.2002, p. 27).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

5

(6)  EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance metalaxyl-M. EFSA Journal 2015;13(3):3999, 105 pp. doi:10.2903/j.efsa.2015.3999.

6

EFSA Journal

(7)  Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311, 135 pp. https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5311

7

EFSA Journal

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Metalaxyl-M | methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate | ≥ 920 g/kg | 1 June 2020 | 31 May 2035 | When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised. |
| CAS No 70630-17-0 (R)
  CIPAC No 580 | | The following impurities are of toxicological concern and must not exceed the following levels in the technical material: | 2,6-dimethylphenylamine:
  max. content 0,5 g/kg |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Metalaxyl-M

methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate

≥ 920 g/kg

1 June 2020

31 May 2035

When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised.

CAS No 70630-17-0 (R)

CIPAC No 580

The following impurities are of toxicological concern and must not exceed the following levels in the technical material:

2,6-dimethylphenylamine:

max. content 0,5 g/kg

| | 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:
  max. content 1 g/kg |
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4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:

max. content 1 g/kg

| | 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester:
  max. content 0,18 g/kg |
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2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester:

max. content 0,18 g/kg

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, 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 specification of the technical material as commercially manufactured; |
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—

the specification of the technical material as commercially manufactured;

| — | the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; |
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—

the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;

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

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

| — | the protection of non-target arthropods, birds and mammals. |
| --- | --- |

—

the protection of non-target arthropods, birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (2) by 26 May 2022.

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(1)  Further details on the identity and the specification of the active substance are provided in the review report.

(2)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

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ANNEX II

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

| (1) | in Part A, entry 37 on metalaxyl-M is deleted; |
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(1)

in Part A, entry 37 on metalaxyl-M is deleted;

| (2) | in Part B, the following entry is added:











  No | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘140 | Metalaxyl-M | methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate | ≥ 920 g/kg | 1 June 2020 | 31 May 2035 | When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised. |
| | CAS No 70630-17-0 (R)
  CIPAC No 580 | | The following impurities are of toxicological concern and must not exceed the following levels in the technical material: | 2,6-dimethylphenylamine:
  max. content 0,5 g/kg |

(2)

in Part B, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘140

Metalaxyl-M

methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate

≥ 920 g/kg

1 June 2020

31 May 2035

When used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised.

CAS No 70630-17-0 (R)

CIPAC No 580

The following impurities are of toxicological concern and must not exceed the following levels in the technical material:

2,6-dimethylphenylamine:

max. content 0,5 g/kg

| | 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:
  max. content 1 g/kg |
| --- | --- |

4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:

max. content 1 g/kg

| | 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester:
  max. content 0,18 g/kg |
| --- | --- |

2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester:

max. content 0,18 g/kg

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, 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 specification of the technical material as commercially manufactured; |
| --- | --- |

—

the specification of the technical material as commercially manufactured;

| — | the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; |
| --- | --- |

—

the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;

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

—

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

| — | the protection of non-target arthropods, birds and mammals. |
| --- | --- |

—

the protection of non-target arthropods, birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 by 26 May 2022.

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(1)  Further details on the identity and the specification of the active substance are provided in the review report.’

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