Commission Implementing Regulation (EU) 2020/229 of 19 February 2020 concerning the authorisation of L-tryptophan as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/229of 19 February 2020concerning the authorisation of L-tryptophan 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 applications were submitted for the authorisation of L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176. These applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation (EC).(3)The applications concern the authorisation of L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176 as a feed additive for all animal species, to be classified in the additive category "nutritional additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinions of 22 January 2019EFSA Journal 2019;17(2):5601., 2 April 2019EFSA Journal 2019;17(5):5694., 3 April 2019EFSA Journal 2019;17(5):5695. and of 16 May 2019EFSA Journal 2019;17(6):5729. that, under the proposed conditions of use, L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176 does not have an adverse effect on the health of non-ruminant animal, consumer safety or the environment. To be safe for ruminants, the L-tryptophan should be protected against degradation in the rumen. The Authority stated a risk for the users of the additive upon inhalation due to the endotoxin levels of the L-tryptophan produced by Escherichia coli KCCM 80152 and Escherichia coli CGMCC 7.248. 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 considered L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176 an efficacious source of the essential amino acid tryptophan for non-ruminant animals; for the supplemental L- tryptophan to be fully efficacious in ruminants, it should be protected against degradation in the rumen. 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.(5)The assessment of L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176 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.(6)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: