Notice - Notification of WTO Members: Commission Implementing Regulation (EU) 2021/363 of 26 February 2021 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 as a feed additive for all animal species
WTO code |
G/SPS/N/EU/463 |
Date notice |
09/03/2021 |
Notice type |
Regular |
Title |
Commission Implementing Regulation (EU) 2021/363 of 26 February 2021 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 as a feed additive for all animal species |
Summary |
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. In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159. That application was accompanied by the particulars and documents required under Article 7 of Regulation (EC) No 1831/2003. The application concerns the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 as a feed additive for all animal species, to be classified in the additive category "technological additives". The European Food Safety Authority ("the Authority") concluded in its opinion of 1 July 2020 that, under the proposed conditions of use, the preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is not toxic by inhalation and the respiratory exposure is likely to be low but a risk of sensitisation via the respiratory route could not be excluded. The additive is non-irritant to skin and eyes and is not considered a as a dermal 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 also concluded that the preparation concerned has the capability to degrade fumonisins in fermenting feed (with a fumonisin content within the limits operating in the Union) but only in silages, not in other fermenting feeds. 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. The assessment of the preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 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 preparation should be authorised.
|
Product |
Preparation of a kind use in animal nutrition (HS Code: 2309) |
Country |
European Union |
File attach:
NEU463.pdf
Orther Notice: