BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) 2021/567 approved aqueous extract from the germinated seeds of sweet Lupinus albus as a low-risk active substance in accordance with Regulation (EC) No 1107/2009. That approval was made subject to certain conditions, in particular the submission of confirmatory information by the applicant as regards 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. In particular, that confirmatory information concerned the maximum content of the quinolizidine alkaloids (lupanine, 13α-OHlupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13αtigloyloxylupanine, α-isolupanine, tetrahydrorhombifoline, multiflorine, sparteine). 

(2) In accordance with that requirement, the applicant submitted an updated dossier in October 2021, which was evaluated by the rapporteur Member State, the Netherlands, in the form of a revised draft assessment report. 

(3) On 9 December 2022, the Netherlands circulated the revised draft assessment report to the other Member States, the applicant and the European Food Safety Authority (‘the Authority’) for comments. On 22 September 2023, the Authority, added its scientific views on the specific points raised during the commenting. On 5 December 2023, the Authority published a technical report summarising the outcome of the consultation process for aqueous extract from the germinated seeds of sweet Lupinus albus. 

(4) In its review report for aqueous extract from the germinated seeds of sweet Lupinus albus of 23 May 20244 , the Commission considered the need to remove the indication that the specification of the technical material is provisional, as stablished in Annex I to Implementing Regulation (EU) 2021/567. 

(5) Furthermore, based on the confirmatory information received, the maximum content of the quinolizidine alkaloids (lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrorhombifoline, multiflorine, sparteine) should be maintained at a level of 0.05 g/kg. Additionally, based on the outcome of the assessment, the Commission considers that lupanine is to be set as a marker of those quinolizidine alkaloids, and the maximum content of this compound is considered to be set at a level of 0.035 g/kg. 

(6) The Commission invited the applicant to submit its comments on the review report and the Commission carefully examined them. 

(7) In order to ensure a high level of protection for consumers, it is appropriate to establish a maximum level for the relevant impurities in the technical specification of the active substance. The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. 

(8) Member States should be allowed sufficient time to amend or withdraw authorisations for plant protection products containing aqueous extract from the germinated seeds of sweet Lupinus albus which do not comply with the specification of the technical material as commercially manufactured. 

(9) For plant protection products containing aqueous extract from the germinated seeds of sweet Lupinus albus, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should expire, at the latest, 15 months after the entry into force of this Regulation. 

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,