Commission Implementing Regulation (EU) 2022/698 of 3 May 2022 renewing the approval of the active substance bifenazate 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)

• CELEX: Implementing Regulation (EU) 2022/698
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance bifenazate, as specified in Annex I, is renewed subject to the conditions and restrictions laid down in that Annex.

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 July 2022.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Bifenazate

149877-41-8

736

isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

980 g/kg

Toluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material.

1 July 2022

30 June 2037

Only uses on non-edible crops in permanent greenhouses shall be authorised.

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 bifenazate, 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 protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

—

the risk to bees and bumble bees released for pollination in permanent greenhouses.

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

The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity.

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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 109 on bifenazate 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

‘ 152

Bifenazate

149877-41-8

736

isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

980 g/kg

Toluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material.

1 July 2022

30 June 2037

Only uses on non-edible crops in permanent greenhouses shall be authorised.

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 bifenazate, 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 protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

—

the risk to bees and bumble bees released for pollination in permanent greenhouses.

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

The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity.’

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