Thông báo - Thông báo của các nước thành viên: Commission Implementing Regulation (EU) 2020/2120 of 16 December 2020 amending Implementing Regulation (EU) 2016/1964 as regards the authorisation of a preparation of montmorillonite-illite as feed additive for all animal species.
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||Commission Implementing Regulation (EU) 2020/2120 of 16 December 2020 amending Implementing Regulation (EU) 2016/1964 as regards the authorisation of a preparation of montmorillonite-illite as feed additive for all animal species.
The use of a preparation of montmorillonite-illite as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) 2016/1964. In accordance with Article 13 of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority ('the Authority') to issue an opinion on whether the authorisation of a preparation of montmorillonite-illite as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, considering a modification of the terms of that authorisation. The modification relates to the current authorisation for the use of the additive as anticaking agent in complementary feedingstuffs. The request was accompanied by the relevant supporting data. The Authority concluded in its opinions of 30 October 2014, 10 September 2015 and 20 March 2020 that the proposed modification to the terms of authorisation of the preparation of montmorillonite-illite does not modify the previous conclusions that the additive does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that dust generated during normal handling of the additive has the potential to expose the whole of the respiratory tract of users to harmful substances (crystalline silica) for which no safe levels of exposure have been identified and that in the absence of data on the effects on skin and eyes, must be considered as irritant to skin and eyes and as a potential 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 has also concluded that the additive is efficacious as an anti-caking agent. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of the proposed modification to the authorisation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Implementing Regulation (EU) 2016/1964 should therefore be amended accordingly.
||HS Code 2309 - Preparation of a kind used in animal nutrition
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