COMMISSION REGULATION (EU) 2015/649
of 24 April 2015
amending Annex II to Regulation (EC) No 1333/2008 of the European
Parliament and of the
Council and the Annex to Commission Regulation (EU) No 231/2012 as
regards the use of
L-leucine as a carrier for table-top sweeteners in tablets
(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 1333/2008 of the European Parliament
and of the Council of 16 December 2008
on food additives (
1
)， and in particular Articles 10(3)， 14 and 30(5) thereof，
Having regard to Regulation (EC) No 1331/2008 of the European Parliament
and of the Council of 16 December 2008
establishing a common authorisation procedure for food additives， food
enzymes and food flavourings (
2
)， and in
particular Article 7(5) thereof，
Whereas:
(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.
