Commission Implementing Regulation (EU) 2021/421 of 9 March 2021 concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species (Text with EEA relevance)

• Published date: 10 March 2021
• Date of Signature: 09 March 2021
• Official Gazette Publication: Official Journal of the European Union, L 083, 10 March 2021

10.3.2021 EN Official Journal of the European Union L 83/21

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/421

of 9 March 2021

concerning the authorisation of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of a tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category ‘sensory additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 4 October 2019 (2) and 1 July 2020 (3) that, under the proposed conditions of use the tincture derived from Artemisia vulgaris L. (mugwort tincture) does not have adverse effects on animal health, consumer health or the environment. The Authority indicated that no conclusions can be drawn on the additive’s potential to be a dermal/eye irritant or a skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(5) The Authority also concluded, that Artemisia vulgaris L. and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6) The assessment of tincture derived from Artemisia vulgaris L. (mugwort tincture) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised.

(7) Restrictions and conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

(8) The fact that tincture derived from Artemisia vulgaris L. (mugwort tincture) is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed which is administered via water.

(9) The measures provided for in this Regulation are in accordance

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