CELEX: 32016R1814
Language: en
Date: 2016-10-13 00:00:00
Title: Commission Regulation (EU) 2016/1814 of 13 October 2016 amending the Annex to Regulation (EU) No 231/2012 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 as regards specifications for steviol glycosides (E 960) (Text with EEA relevance)

14.10.2016   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 278/37
            
         COMMISSION REGULATION (EU) 2016/1814
   of 13 October 2016
   amending the Annex to Regulation (EU) No 231/2012 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 as regards specifications for steviol glycosides (E 960)
   (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 Article 14 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)
            
            
               Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.
            
         
               (2)
            
            
               Those specifications 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.
            
         
               (3)
            
            
               On 13 November 2013 an application was submitted for the amendment of specifications concerning the food additive steviol glycosides (E 960). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
            
         
               (4)
            
            
               The current specifications stipulate that steviol glycosides (E 960) preparations contain not less than 95 % of ten named steviol glycosides: stevioside, rebaudiosides A, B, C, D, E and F, steviolbioside, rubusoside and dulcoside, on a dried basis. The specifications further define the preparations/final product consisting mainly (at least 75 %) of stevioside and/or rebaudioside A.
            
         
               (5)
            
            
               The applicant requests that rebaudioside M is added to the list of permitted steviol glycosides as an additional glycoside that may comprise the assay value of not less than 95 % (total steviol glycoside content). The applicant also requests that the minimum amount of 75 % of stevioside and/or rebaudioside A is deleted, i.e., to change the ‘Definition’ of steviol glycosides.
            
         
               (6)
            
            
               The applicant further requests to expand the lists of chemical names and molecular weights and CAS numbers to include, in addition to stevioside and rebaudioside A, the other nine steviol glycosides. Rebaudioside M should also be added to the listing of molecular formulas. To account for the greater sweetness potency of rebaudioside M, the ‘Description’ of steviol glycosides should be amended.
            
         
               (7)
            
            
               Since stevioside and rebaudioside A may not necessarily be the principal steviol glycosides, the stevioside and rebaudioside A criterion under the ‘Identification’ of steviol glycosides should be removed from the specifications.
            
         
               (8)
            
            
               According to information provided by the applicant, a production process has been developed which allows for the selective isolation of rebaudioside M resulting in the production of steviol glycosides preparations enriched in rebaudioside M specifically, at a range of concentrations (from 50 % up to nearly 100 %). According to the applicant, only leaves of the Stevia rebaudiana Bertoni plant comprise the starting material for the production of steviol glycoside extracts containing at least 50 % rebaudioside M. Its manufacturing process is similar to the general method of extracting steviol glycosides from the leaves of S. rebaudiana which has been previously reviewed by EFSA in 2010 (4).
            
         
               (9)
            
            
               In the new production process, the crushed stevia leaves are extracted with hot water and the resulting extract is subjected to isolation and purification (by use of ion-exchange chromatography). This initial stage is followed by additional purification steps, including further and repeated recrystallisation and separation steps. Through the manipulation of these purification steps (i.e. specific number of crystallisation steps, solvent concentration, as well as temperature and duration of the process) the manufacturer is able to selectively crystallise a preparation high in rebaudioside M. Also, the production process involves use of solvents (ethanol and methanol) that are currently recognised for use in the manufacture of steviol glycoside preparations.
            
         
               (10)
            
            
               That production process results in a preparation that contains 95 % of steviol glycosides with rebaudioside M representing more than 50 % of the finished product and the remainder comprising the following ten related steviol glycosides in any combination and ratio: stevioside, rebaudiosides A, B, C, D, E, F, dulcoside, steviolbioside and rubusoside. While extracts characterised by a ≥ 95 % content of rebaudioside M contain < 5 % of rebaudiosides D, A and B combined, extracts with a lower rebaudioside M content (approximately 50 %) may comprise close to 40 % rebaudioside D and 7 % rebaudioside A.
            
         
               (11)
            
            
               In its opinion (5) of 8 December 2015 the European Food Safety Authority (‘the Authority’) concluded that extending the current specifications to include rebaudiosides D and M as alternatives to rebaudioside A in the predominant components of steviol glycosides would not be of a safety concern. The Authority also concluded that provided that the total amount of steviol glycosides (stevioside; rebaudiosides A, B, C, D, E, F and M; steviolbioside; rubusoside and dulcoside) were greater than 95 %, which are all converted to steviol, and given that there was no evidence of absorption for intact glycosides at realistic use levels, the specific steviol glycosides (E 960) composition would not be of a safety concern. It was also considered that the ADI of 4 mg/kg bw/day (expressed as steviol equivalents) can also be applied where total steviol glycosides (stevioside; rebaudiosides A, B, C, D, E, F and M; steviolbioside; rubusoside and dulcoside) comprise more than 95 % of the material.
            
         
               (12)
            
            
               Taking into account the submitted application and the evaluation made by the Authority, it is appropriate to amend the specifications of the food additive E 960.
            
         
               (13)
            
            
               Regulation (EU) No 231/2012 should therefore be amended accordingly.
            
         
               (14)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Regulation (EU) No 231/2012 is amended in accordance with the Annex to this Regulation.
   Article 2
   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 Members States.
      Done at Brussels, 13 October 2016.
      
         
            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 Panel on Food Additives and Nutrient Sources (ANS); Scientific Opinion on safety of steviol glycosides for the proposed uses as a food additive. EFSA Journal 2010;8(4):1537. [85 pp.]. doi:10.2903/j.efsa.2010.1537
   
      (5)  EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to food), 2015. Scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive. EFSA Journal 2015;13(12):4316, 29 pp. doi:10.2903/j.efsa.2015.4316
   
      ANNEX
      In the Annex to Regulation (EU) No 231/2012, the entry for E 960 steviol glycosides is replaced by the following:
      
         
            ‘E 960 STEVIOL GLYCOSIDES
         
         
                     
                        Synonyms
                     
                  
                  
                      
                  
               
                     
                        Definition
                     
                  
                  
                     The manufacturing process comprises two main phases: the first involving water extraction of the leaves of the Stevia rebaudiana Bertoni plant and preliminary purification of the extract by employing ion exchange chromatography to yield a steviol glycoside primary extract, and the second involving recrystallisation of the steviol glycosides from methanol or aqueous ethanol resulting in a final product containing not less than 95 % of the below identified 11 related steviol glycosides, in any combination and ratio.
                     The additive may contain residues of ion-exchange resins used in the manufacturing process. Several other related steviol glycosides that may be generated as a result of the production process, but do not occur naturally in the Stevia rebaudiana plant have been identified in small amounts (0,10 to 0,37 % w/w).
                  
               
                     Chemical name
                  
                  
                     Steviolbioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid
                     Rubusoside: 13-β-D-glucopyranosyloxykaur-16-en-18-oic acid, β-D-glucopyranosyl ester
                     Dulcoside A: 13-[(2-O-α–L-rhamnopyranosyl-β–D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
                     Stevioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
                     Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D- glucopyranosyl ester
                     Rebaudioside B: 13-[(2-O-β–D-glucopyranosyl-3-O-β–D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid
                     Rebaudioside C: 13-[(2-O-α–L-rhamnopyranosyl-3-O-β–D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
                     Rebaudioside D: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester
                     Rebaudioside E: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester
                     Rebaudioside F: 13[(2-O-β-D-xylofurananosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
                     Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester
                  
               
                     Molecular formula
                  
                  
                     
                        Trivial name
                     
                  
                  
                     
                        Formula
                     
                  
                  
                     
                        Conversion factor
                     
                  
               
                     Steviol
                  
                  
                     C20 H30 O3
                     
                  
                  
                     1,00
                  
               
                     Steviolbioside
                  
                  
                     C32 H50 O13
                     
                  
                  
                     0,50
                  
               
                     Rubusoside
                  
                  
                     C32 H50 O13
                     
                  
                  
                     0,50
                  
               
                     Dulcoside A
                  
                  
                     C38 H60 O17
                     
                  
                  
                     0,40
                  
               
                     Stevioside
                  
                  
                     C38 H60 O18
                     
                  
                  
                     0,40
                  
               
                     Rebaudioside A
                  
                  
                     C44 H70 O23
                     
                  
                  
                     0,33
                  
               
                     Rebaudioside B
                  
                  
                     C38 H60 O18
                     
                  
                  
                     0,40
                  
               
                     Rebaudioside C
                  
                  
                     C44 H70 O22
                     
                  
                  
                     0,34
                  
               
                     Rebaudioside D
                  
                  
                     C50 H80 O28
                     
                  
                  
                     0,29
                  
               
                     Rebaudioside E
                  
                  
                     C44 H70 O23
                     
                  
                  
                     0,33
                  
               
                     Rebaudioside F
                  
                  
                     C43 H68 O22
                     
                  
                  
                     0,34
                  
               
                     Rebaudioside M
                  
                  
                     C56 H90 O33
                     
                  
                  
                     0,25
                  
               
                     Molecular weight and CAS No
                  
                  
                     
                        Trivial name
                     
                  
                  
                     
                        CAS Number
                     
                  
                  
                     
                        Molecular weight (g/mol)
                  
               
                     Steviol
                  
                  
                      
                  
                  
                     318,46
                  
               
                     Steviolbioside
                  
                  
                     41093-60-1
                  
                  
                     642,73
                  
               
                     Rubusoside
                  
                  
                     64849-39-4
                  
                  
                     642,73
                  
               
                     Dulcoside A
                  
                  
                     64432-06-0
                  
                  
                     788,87
                  
               
                     Stevioside
                  
                  
                     57817-89-7
                  
                  
                     804,88
                  
               
                     Rebaudioside A
                  
                  
                     58543-16-1
                  
                  
                     967,01
                  
               
                     Rebaudioside B
                  
                  
                     58543-17-2
                  
                  
                     804,88
                  
               
                     Rebaudioside C
                  
                  
                     63550-99-2
                  
                  
                     951,02
                  
               
                     Rebaudioside D
                  
                  
                     63279-13-0
                  
                  
                     1 129,15 
                  
               
                     Rebaudioside E
                  
                  
                     63279-14-1
                  
                  
                     967,01
                  
               
                     Rebaudioside F
                  
                  
                     438045-89-7
                  
                  
                     936,99
                  
               
                     Rebaudioside M
                  
                  
                     1220616-44-3
                  
                  
                     1 291,30 
                  
               
                     Assay
                  
                  
                     Not less than 95 % steviolbioside, rubusoside, dulcoside A, stevioside, rebaudiosides A, B, C, D, E, F and M on the dried basis, in any combination and ratio.
                  
               
                     
                        Description
                     
                  
                  
                     White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5 % sucrose equivalency).
                  
               
                     
                        Identification
                     
                  
               
                     Solubility
                  
                  
                     Freely soluble to slightly soluble in water
                  
               
                     pH
                  
                  
                     Between 4,5 and 7,0 (1 in 100 solution)
                  
               
                     
                        Purity
                     
                  
               
                     Total ash
                  
                  
                     Not more than 1 %
                  
               
                     Loss on drying
                  
                  
                     Not more than 6 % (105 °C, 2h)
                  
               
                     Residual solvents
                  
                  
                     Not more than 200 mg/kg methanol
                     Not more than 5 000  mg/kg ethanol
                  
               
                     Arsenic
                  
                  
                     Not more than 1 mg/kg
                  
               
                     Lead
                  
                  
                     Not more than 1 mg/kg’