Commission Implementing Regulation (EU) 2019/151 of 30 January 2019 renewing the approval of the active substance Clonostachys rosea strain J1446 as a low-risk active substance 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) 2019/151
• Articles: 5

Article 1 Renewal of the approval of active substance

The approval of the active substance Clonostachys rosea strain J1446, as specified in Annex I, is renewed subject to the conditions 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 April 2019.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Clonostachys rosea strain J1446

Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

Not applicable

Not applicable

Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

1 April 2019

31 March 2034

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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

—

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

—

the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012  ( 2 ) .

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

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

( 2 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

ANNEX II

ANNEX II

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

(1)

in Part A, entry 98 on Gliocladium catenulatum strain J1446 is deleted;

(2)

in Part D, the following entry is added:

‘15

Clonostachys rosea strain J1446

Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212

Not applicable

Not applicable

Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA.

1 April 2019

31 March 2034

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 Clonostachys rosea strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern;

—

the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

—

the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012  ( *1 ) .

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

( *1 )   https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf’