ANNEX IISupplementary provisions
ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Common Name, Identification Numbers IUPAC Name Purity ( *1 ) Date of approval Expiration of approval Specific provisions ‘84 Terpenoid blend QRD 460 CIPAC No: 982 Terpenoid blend QRD 460 is a blend of three components: — α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene; — p -cymene: 1-isopropyl-4-methylbenzene; — d -limonene: ( R )-4-isopropenyl-1-methylcyclohexene. The nominal concentration of each component in the active substance as manufactured should be as follows: — α-terpinene: 59,7 %; — p -cymene: 22,4 %; — d -limonene: 17,9 %. Each component should have a minimum purity as follows: — α-terpinene: 89 %; — p -cymene: 97 %; — d -limonene: 93 %. 10 August 2015 10 August 2025 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 terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the stability of formulations on storage; (b) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (d) the protection of surface water and aquatic organisms; (e) the protection of bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material; (2) the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.’ ( *1 ) Further details on identity and specification of active substance are provided in the review report.