Commission Implementing Regulation (EU) 2025/119 of 24 January 2025 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus

• CELEX: Implementing Regulation (EU) 2025/119
• Articles: 3

Article 1 Amendment to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In Part D of the Annex, row 28, aqueous extract from the germinated seeds of sweet Lupinus albus , is amended as follows:

(1)

the column ‘Purity’ is replaced by the following:

‘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, tetrahydrorhombifoline, multiflorine, sparteine )

Maximum content: set at 0,05 g/kg.

Level of lupanine , as a marker compound: set at 0,035 g/kg.’;

(2)

the column ‘Specific provisions’ is replaced by the following:

‘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.’.