ANNEX IISupplementary provisions
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 ‘50 Bacillus subtilis RTI477 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 subtilis RTI477, 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 sensitisers, 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 .’.