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)
Date: 2015-04-24
Institutions: European Commission
Subjects: food safety, foodstuff, market approval, sweetener




L_2015107EN.01001701.xml










25.4.2015   


EN


Official Journal of the European Union


L 107/17








            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.












(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
            





(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.




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 ’


 


 













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-Aminoisocaproic 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’