EU approves water extract of germinated seeds of sweet white lupin with low-risk active substance
By: Date: 2021-04-14 Categories: newsguide Tags: ,
   On April 6, 2021, the European Union issued Regulation (EU) 2021/567, approving the low-risk active substance sweet white lupin germinated seed water extract (Aqueous extract from the germinated seeds of sweet Lupinus albus). This regulation shall take effect on the twentieth day from the date of issuance.

   European Union Regulation (EU) No 540/2011 Annex Part D adds a corresponding entry, the number is 28. The specific approval information is as follows:

Common name

Identification number

Purity

Approval date

Approval expires

Sub-rules

Water extract of germinated seeds of sweet white lupine

CAS number:Not applicable to extracts

BLAD protein:1219521-95-5

CIPAC number:unassigned

The minimum purity has nothing to do with the extract.

BLAD protein content:195–210g/kg

The maximum content of total quinolazine alkaloids (QA) is temporarily set to 0.05g/kg

2021.4.27

2036.4.27

To implement the uniform principle of Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report should be taken into consideration, especially Annex I and II.

In the overall assessment, member states should pay special attention to the necessary label instructions, involving measures to address the foaming and dilution stability of the formulation.

Applicants should submit confirming information about the following to the committee, member states, and administration:

1. Whether the technical specifications (based on commercial scale production) and toxic batches during the production of the original drug meet the confirmed technical specifications;

2, especially the maximum content of quinolazine alkaloids.

Applicants should submit the above information before October 27, 2021.