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 ‘28 Aqueous extract from the germinated seeds of sweet Lupinus albus CAS No: Not available for the extract BLAD protein: 1219521-95-5 CIPAC No: Not allocated Not applicable The minimum purity is not relevant for the extract. BLAD protein content: 195 – 210 g/kg. The following relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured were identified: Total quinolizidine alkaloids (QA): ( lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrohombifoline, multiflorine, sparteine ) Maximum content: provisionally set at 0,05 g/kg 27 April 2021 27 April 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 review report on aqueous extract from the germinated seeds of sweet Lupinus albus , 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 necessary labelling instructions concerning the measures to address foaming and stability of dilutions of the formulation. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; and 2. in particular on the maximum content of the quinolizidine alkaloids ( lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrohombifoline, multiflorine, sparteine ). The applicant shall submit the information referred in points 1 and 2 by 27 October 2021.’ ( 1 ) Further details on identity and specification of active substance are provided in the review report.