Notice - Notification of WTO Members: Commission Implementing Regulation (EU) 2020/2117 of 16 December 2020 concerning the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 with the new name 'selenised yeast Saccharomyces cerevisiae CNCM I-3399' as a feed additive for all animal species, and repealing Regulation (EC) No 900/2009
| WTO code |
G/SPS/N/EU/457 |
| Date notice |
12/01/2021 |
| Notice type |
Regular |
| Title |
Commission Implementing Regulation (EU) 2020/2117 of 16 December 2020 concerning the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 with the new name 'selenised yeast Saccharomyces cerevisiae CNCM I-3399' as a feed additive for all animal species, and repealing Regulation (EC) No 900/2009 |
| Summary |
Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 900/2009. In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 as feed additive for all animal species in the additive category 'nutritional additives'. The application was accompanied by the particulars and documents required under Article 14 of Regulation (EC) No 1831/2003. It results from the opinion of the European Food Safety Authority ('the Authority') of 7 May 2020 that, under the proposed conditions of use, selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 does not have an adverse effect on animal health, consumer safety or the environment. The Authority also concluded that the additive is a potential dermal and respiratory sensitizer. 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 proof of the efficacy of the additive, on which the initial authorisation was based, withstands in a renewal procedure. Finally, the Authority recommended changing the denomination of the additive. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of this additive should be renewed. As a consequence of the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 as feed additive, Regulation (EC) No 900/2009 should be repealed. Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
|
| Product |
HS Code 2309 - Preparation of a kind used in animal nutrition |
| Country |
European Union |
File attach:
NEU457.pdf
Orther Notice: