Commission Implementing Regulation (EU) 2025/109 of 22 January 2025 approving the active substance Bacillus velezensis strain RTI301 as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) No 540/2011

• CELEX: Implementing Regulation (EU) 2025/109
• Articles: 5

Article 1 Approval of the active substance

The active substance Bacillus velezensis strain RTI301, as specified in Annex I, is approved 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

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Bacillus velezensis RTI301

Not applicable

No relevant impurities

12 February 2025

12 February 2040

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 Bacillus velezensis RTI301, 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 protection of operators and workers, taking into account that microorganisms per se are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

—

the strict maintenance by the producer of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65  ( 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 )   Organisation for Economic Cooperation and Development (OECD): https://doi.org/10.1787/9789264221642-en

ANNEX II

ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘51

Bacillus velezensis RTI301

Not applicable

No relevant impurities

12 February 2025

12 February 2040

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 Bacillus velezensis RTI301, 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 protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use;

—

the strict maintenance by the producer of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65  ( 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 )   Organisation for Economic Cooperation and Development (OECD): https://doi.org/10.1787/9789264221642-en

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