(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 CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534. These applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3)

The applications concern the authorisation of L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 26 February 2019 (2), 28 January 2020 (3), 18 March 2020 (4) and 25 May 2020 (5) that, under the proposed conditions of use, L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 does not have an adverse effect on the health of non-ruminant animals, 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 CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 and could not exclude a potential of L-tryptophan produced by Escherichia coli CGMCC 11 674 or Escherichia coli CGMCC 7.267 to be an irritant to skin and eyes or to be 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.

(5)

The Authority considered L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 an efficacious source of the essential amino acid tryptophan for non-ruminant animals; for the supplemental L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 to be fully efficacious in ruminants, it should be protected against degradation in the rumen. In its opinions, the Authority raised concerns about potential nutritional imbalances for amino acids, when they are administered via water for drinking. However, the Authority did not propose a maximum content for the supplementation with L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 as amino acid via water for drinking. 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)

The assessment of L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 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.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,