Commission Implementing Regulation (EU) 2016/146 of 4 February 2016 renewing the approval of the active substance lambda-cyhalothrin, as a candidate for substitution, 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 Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2016/146
• Articles: 5

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

The approval of the active substance lambda-cyhalothrin, as a candidate for substitution, 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 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 .

It shall apply from 1 April 2016.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Lambda-Cyhalothrin

CAS No 91465-08-6

CIPAC No 463

A 1:1 mixture of:

(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate

900 g/kg

1 April 2016

31 March 2023

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 lambda-cyhalothrin, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the:

(a)

protection of operators, workers and bystanders;

(b)

metabolites potentially formed in processed commodities;

(c)

risk to aquatic organisms, mammals and non-target arthropods.

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

The applicants shall submit confirmatory information as regards:

1.

a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010);

2.

toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)).

The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018.

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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 12 on lambda-cyhalothrin is deleted;

(2)

in Part E, the following entry is added:

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘5

Lambda-Cyhalothrin

CAS No 91465-08-6

CIPAC No 463

A 1:1 mixture of:

(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate

900 g/kg

1 April 2016

31 March 2023

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 lambda-cyhalothrin, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the:

(a)

protection of operators, workers and bystanders;

(b)

metabolites potentially formed in processed commodities;

(c)

risk to aquatic organisms, mammals and non-target arthropods.

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

The applicants shall submit confirmatory information as regards:

1.

a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010);

2.

toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)).

The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018.’

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