Commission Implementing Regulation (EU) 2020/1090 of 24 July 2020 concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/1090of 24 July 2020concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive for all animal species(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionOJ L 268, 18.10.2003, p. 29., and in particular Article 9(2) thereof,Whereas:(1)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.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003 three applications were submitted for the authorisation of L-histidine monohydrochloride monohydrate. The applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.(3)The applications concern the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 as a feed additive for all animal species, to be classified in the additive category "nutritional additives". L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 and Corynebacterium glutamicum KCCM 80179 are also applied for the additive category "sensory additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinions of 2 July 2019EFSA Journal 2019; 17(7):5783.,EFSA Journal 2019; 17(7):5784.,EFSA Journal 2019; 17(8):5785. that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179, when supplemented at levels appropriate to the requirements of the target species, does not have an adverse effect on animal health, consumer safety or the environment. This conclusion covers also the use of L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 or Corynebacterium glutamicum KCCM 80179 as sensory additive at the intended use level. With respect to the safety of the user of the additive, the Authority stated only a mild irritation risk to the eyes for L-histidine monohydrochloride monohydrate produced by Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179. For L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE BP-02526, the Authority stated a risk by inhalation. Therefore, appropriate protective measures should be taken for this additive to prevent adverse effects on human health, in particular as regards the users of the additive. Further, the Authority concluded that L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 is an efficacious source of the essential amino acid L-histidine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. Moreover, the Authority concluded that L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 or Corynebacterium glutamicum KCCM 80179 is efficacious as feed flavouring compound.(5)The Authority does not consider that there is a need for specific requirements of post-market monitoring. It 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.(6)Restrictions and conditions should be provided for to allow for a better control for those additives when used as flavourings. For these additives used as flavourings recommended contents should be indicated on the label. Where such contents are exceeded, certain information should be indicated on the label of premixtures. The use of L-histidine monohydrochloride monohydrate as a flavouring compound is not authorised in water for drinking. The fact that L-histidine monohydrochloride monohydrate is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.(7)The assessment of that substance 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 substance should be authorised as specified in the Annex to this Regulation.(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: