ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 236 on kieselgur (Diatomaceous earth) 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 ‘143 Kieselgur (Diatomaceous earth) CAS No 6 1790-53-2 CIPAC No 647 No IUPAC name exists for kieselgur Other synonyms: Diatomaceous earth, Diatomite 1 000 g/kg Minimum content of amorphous silica of 800 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: Crystalline silica with particle size below 10 μm – maximum of 1 g/kg 1 February 2021 31 January 2036 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 kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate. Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate.’ ( 1 ) Further details on the identity and the specification of the active substance are provided in the renewal report.