Commission Implementing Regulation (EU) 2021/567 of 6 April 2021 approving the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/567
• Articles: 5

Article 1 Approval of the active substance

The active substance aqueous extract from the germinated seeds of sweet Lupinus albus , as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

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

Article 3 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 I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

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, 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.

ANNEX II

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.