(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

(2)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives that are listed in Annexes II and III to Regulation (EC) No 1333/2008.

(3)

Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

(4)

On 9 September 2010 an application for authorisation of the use of L-leucine as a carrier (tableting aid) for table-top sweeteners in tablets was submitted by Germany where such use was authorised. That application has been made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5)

There is a technological function and need for the use of L-leucine in table-top sweeteners in tablets. L-leucine is homogeneously mixed with sweeteners before pressing tablets from the mixture and it aids tableting by ensuring that the tablets do not remain stuck to the pressing tools.

(6)

The European Food Safety Authority (‘the Authority’) evaluated the safety of amino acids and related substances when used as flavouring substances and expressed its opinion on 29 November 2007 (4). The Authority concluded that the human exposure to amino acids through food is in orders of magnitude higher than the anticipated levels of exposure from their use as flavouring substances and that nine of the substances, including L-leucine, were not of safety concern at their estimated levels of intake as flavouring substances.

(7)

It was demonstrated in the application that even a high consumption of sweetener tablets would not exceed 4 % of the intake quantity recommended for L-leucine.

(8)

Therefore, it is appropriate to authorise the use of L-leucine as a carrier for table-top sweeteners in tablets as specified in Annex I to this Regulation and to assign E 641 as an E-number to that food additive.

(9)

The specifications for L-leucine should be included in Regulation (EU) No 231/2012 when it is included in the Union lists in Annex II to Regulation (EC) No 1333/2008 for the first time. In this regard it is appropriate to take into account the purity criteria of the European Pharmacopoeia for L-leucine.

(10)

Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.

(11)

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