Notice - Notification of WTO Members: Commission Implementing Regulation (EU) 2020/2116 of 16 December 2020 concerning the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids and its extension of use to other finfish, and repealing Regulation (EC) No 244/2007
| WTO code |
G/SPS/N/EU/456 |
| Date notice |
12/01/2021 |
| Notice type |
Regular |
| Title |
Commission Implementing Regulation (EU) 2020/2116 of 16 December 2020 concerning the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids and its extension of use to other finfish, and repealing Regulation (EC) No 244/2007 |
| Summary |
L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 was authorised for 10 years as a feed additive for salmonids by Commission Regulation (EC) No 244/2007. In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids. The application included a request to change the strain designation to Escherichia coli NITE SD 00268 and was accompanied by the particulars and documents required under Article 14 of that Regulation. In addition, in accordance with Article 7 of that Regulation, the application requested an extension of use to other finfish. The application was accompanied by the particulars and documents required under Article 7 of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its opinion of 18 March 2020 that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE SD 00268, when supplemented at levels appropriate to the requirements of the target species, does not have an adverse effect on animal health, consumer health or the environment. The Authority also concluded that while the additive in question is not a skin irritant, it was not possible to conclude on the potential for the additive to be toxic if inhaled, an irritant to eyes 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. The Authority also concluded that the additive is an efficacious source of the amino acid histidine for fish species. The Authority does not consider that there is a need for specific requirements of post- market monitoring. It also verified the reports 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 L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE SD 00268 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation. As a consequence of the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 244/2007 should be repealed.
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| Product |
HS Code 2309 - Preparation of a kind used in animal nutrition
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| Country |
European Union |
File attach:
NEU456.pdf
Orther Notice: