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.
25.4.2015 EN Official Journal of the European Union L 107/17
(
1
) OJ L 354, 31.12.2008, p. 16.
(
2
) OJ L 354, 31.12.2008, p. 1.
(
3
) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to
Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
(
4
) EFSA Journal (2008) 870, 1-46. (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,
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Article 2
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 April 2015.
For the Commission
The President
Jean-Claude JUNCKER
L 107/18 EN Official Journal of the European Union 25.4.2015 ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) In Part B, in Section 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the
entry for food additive E 640:
‘E 641 L-leucine’
(2) In part E, in food category 11.4.3 ‘Table-top sweeteners in tablets’, the following new entry is inserted after the entry
for food additive E 640:
‘E 641 L-leucine 50 000’
25.4.2015 EN Official Journal of the European Union L 107/19 ANNEX II
In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for E 640:
‘E 641 L-LEUCINE
Synonyms 2-Aminoisobutylacetic acid; L-2-Amino-4-methylvaleric acid; alpha-Ami-
noisocaproic acid; (S)-2-Amino-4-methylpentanoic acid; L-Leu
Definition
Einecs 200-522-0
CAS number 61-90-5
Chemical name L-Leucine; L-2-Amino-4-methylpentanoic acid
Chemical formula C6H13NO2
Molecular Weight 131,17
Assay Content not less than 98,5 % and not more than 101,0 % on the
anhydrous basis
Description White or almost white crystalline powder or shiny flakes
Identification
Solubility Soluble in water, acetic acid, dilute HCl and alkaline hydroxides and
carbonates; slightly soluble in ethanol
Specific rotation [α]D
20 between + 14,5° and + 16,5°
(4 % solution (anhydrous basis) in 6N HCl)
Purity
Loss on drying Not more than 0,5 % (100 °C – 105 °C)
Sulphated Ash Not more than 0,1 %
Chlorides Not more than 200 mg/kg
Sulphates Not more than 300 mg/kg
Ammonium Not more than 200 mg/kg
Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg’
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.
25.4.2015 EN Official Journal of the European Union L 107/17
(
1
) OJ L 354, 31.12.2008, p. 16.
(
2
) OJ L 354, 31.12.2008, p. 1.
(
3
) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to
Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
(
4
) EFSA Journal (2008) 870, 1-46. (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,
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Article 2
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 April 2015.
For the Commission
The President
Jean-Claude JUNCKER
L 107/18 EN Official Journal of the European Union 25.4.2015 ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(1) In Part B, in Section 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the
entry for food additive E 640:
‘E 641 L-leucine’
(2) In part E, in food category 11.4.3 ‘Table-top sweeteners in tablets’, the following new entry is inserted after the entry
for food additive E 640:
‘E 641 L-leucine 50 000’
25.4.2015 EN Official Journal of the European Union L 107/19 ANNEX II
In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for E 640:
‘E 641 L-LEUCINE
Synonyms 2-Aminoisobutylacetic acid; L-2-Amino-4-methylvaleric acid; alpha-Ami-
noisocaproic acid; (S)-2-Amino-4-methylpentanoic acid; L-Leu
Definition
Einecs 200-522-0
CAS number 61-90-5
Chemical name L-Leucine; L-2-Amino-4-methylpentanoic acid
Chemical formula C6H13NO2
Molecular Weight 131,17
Assay Content not less than 98,5 % and not more than 101,0 % on the
anhydrous basis
Description White or almost white crystalline powder or shiny flakes
Identification
Solubility Soluble in water, acetic acid, dilute HCl and alkaline hydroxides and
carbonates; slightly soluble in ethanol
Specific rotation [α]D
20 between + 14,5° and + 16,5°
(4 % solution (anhydrous basis) in 6N HCl)
Purity
Loss on drying Not more than 0,5 % (100 °C – 105 °C)
Sulphated Ash Not more than 0,1 %
Chlorides Not more than 200 mg/kg
Sulphates Not more than 300 mg/kg
Ammonium Not more than 200 mg/kg
Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg’
