Commission Implementing Regulation (EU) 2021/81 of 27 January 2021 approving the basic substance Allium cepa L. bulb extract 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 the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/81
• Articles: 5

Article 1 Approval of a basic substance

The substance Allium cepa L. bulb extract as specified in Annex I is approved as a basic substance subject to the conditions as 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

Specific provisions

Allium cepa L. bulb extract

CAS No: not allocated

CIPAC No: not allocated

Not applicable

The onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus Allii Cepae

17.2.2021

Allium cepa L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium cepa L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof.

( 1 )   Further details on identity, specification and manner of use of the basic substance are provided in the review report.

ANNEX II

ANNEX II

In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Specific provisions

‘23

Allium cepa L. bulb extract

CAS No: not allocated

CIPAC No: not allocated

Not applicable

The onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus Allii Cepae

17.2.2021

Allium cepa L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium cepa L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof.’

( 1 )   Further details on identity, specification and manner of use of basic substance are provided in the review report.