ANNEX IISupplementary provisions
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’