Vietnam Sanitary and Phytosanitary Notification Authority and Enquiry Point

Mã WTO	G/SPS/N/EU/562
Ngày thông báo	26/04/2022
Loại thông báo	Bình thường
Tiêu đề	Commission Implementing Regulation (EU) 2022/653 concerning the authorisation of a preparation of the leaves extract of Melissa officinalis L. as a feed additive for all animal species
Tóm tắt	The leaves extract of Melissa officinalis L. was authorized without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of a preparation of the leaves extract of Melissa officinalis L. for all animal species. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant requested the preparation of the leaves extract of Melissa officinalis L. to be authorized also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use in water for drinking. Therefore, the use of the preparation of the leaves extract of Melissa officinalis L. in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinions of 28 January 2020 and 29 September 2021 that, under the proposed conditions of use, the preparation of the leaves extract of Melissa officinalis L. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that the exposure of users to dusts from the additive is not of concern. However, no data was provided on irritant properties for eyes or skin, thus no conclusion could be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory 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. The Authority concluded, that the preparation of the leaves extract of Melissa officinalis L. is recognized to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. 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.
Sản phẩm	Preparation of a kind used in animal nutrition (HS code: 2309)
Quốc gia	European Union

Tệp đính kèm:
NEU562.pdf

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