Commission Regulation (EU) 2023/447 of 1 March 2023 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 glucosylated steviol glycosides as sweetener (Text with EEA relevance)
Date: 2023-03-01
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, food safety, food substitute, foodstuff, human nutrition, labelling, market approval, sweetener








L_2023065EN.01001601.xml










2.3.2023   


EN


Official Journal of the European Union


L 65/16








            COMMISSION REGULATION (EU) 2023/447
of 1 March 2023
         
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 glucosylated steviol glycosides as sweetener
(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 10(3) and 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)


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 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)


In January 2019, an application was submitted for the authorisation of glucosylated steviol glycosides as a new food additive for use as a sweetener. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.












(5)


Glucosylated steviol glycosides are produced via enzymatic bioconversion using a cyclomaltodextrin glucanotransferase that catalyses the transfer of glucose from starch to mixtures enriched in one or more individual steviol glycosides from purified Stevia Rebaudiana leaf extracts. They consist of a mixture of glucosylated steviol glycosides, containing 1–20 additional glucose units bound to the parent steviol glycosides. They have an improved sweetness profile as compared to the other authorised sweeteners including steviol glycosides from Stevia (E 960a).












(6)


The European Food Safety Authority (‘the Authority’) evaluated the safety of glucosylated steviol glycosides and expressed its opinion on 15 December 2021 (4). The Authority considered that the metabolism of glucosylated steviol glycosides is sufficiently similar to the already authorised steviol glycosides, and thus the toxicological data previously assessed by the Authority for steviol glycosides (E 960a) were considered to support their safety as a food additive. The enzyme cyclomaltodextrin glucanotransferase (EC 2.4.1.19) derived from a non-genetically modified strain of Anoxybacillus caldiproteolyticus and intended to be used in the manufacture of modified steviol glycosides does not give rise to safety concerns under the intended conditions of use based on the data provided to the Authority (5). The Authority concluded that there is no safety concern for the use of glucosylated steviol glycosides as a food additive for the same proposed uses and use levels as steviol glycosides (E 960a–960c) used as sweeteners.












(7)


Therefore, it is appropriate to authorise the food additive ‘glucosylated steviol glycosides’ (E 960d) as a sweetener in the food categories where steviol glycosides (E 960a–960c) are currently authorised and at the same the maximum levels.












(8)


The specifications for the food additive glucosylated steviol glycosides should be included in Regulation (EU) No 231/2012 as it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.












(9)


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












(10)


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





HAS ADOPTED THIS REGULATION:



Article 1
The 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, 1 March 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(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 2022;20(2):7066.

(5)  
            EFSA Journal 2022;20(1):7004.




ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:






(a)


In Part B, 2. Sweeteners, the following entry is inserted after the entry for E 960c:






‘E 960d


Glucosylated steviol glycosides’;














(b)


In Part C, (5) Other additives that may be regulated combined, point (v) is replaced by the following:






‘(v)


E 960a – 960d: Steviol glycosides






E-number


Name




E 960a


Steviol glycosides from Stevia




E 960c


Enzymatically produced steviol glycosides




E 960d


Glucosylated steviol glycosides’;


















(c)


Part E is amended as follows:






(1)


In category 01.4 (Flavoured fermented milk products including heat-treated products), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


100


(1) (60)


only energy-reduced products or with no added sugar’;














(2)


In category 03 (Edible ices), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


only energy-reduced products or with no added sugar’;














(3)


In category 04.2.2 (Fruit and vegetables in vinegar, oil, or brine), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


100


(1) (60)


only sweet-sour preserves of fruit and vegetables’;














(4)


In category 04.2.4.1 (Fruit and vegetable preparations excluding compote), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


only energy-reduced’;














(5)


In category 04.2.5.1 (Extra jam and extra jelly as defined by Directive 2001/113/EC), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


only energy-reduced jams jellies and marmalades’;














(6)


In category 04.2.5.2 (Jam, jellies and marmalades and sweetened chestnut purée as defined by Directive 2001/113/EC), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


only energy-reduced jams jellies and marmalades’;














(7)


In category 04.2.5.3 (Other similar fruit or vegetable spreads), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


only energy-reduced fruit or vegetable spreads and dried-fruit-based sandwich spreads, energy-reduced or with no added sugar’;














(8)


In category 05.1 (Cocoa and Chocolate products as covered by Directive 2000/36/EC), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


270


(1) (60)


only energy-reduced or with no added sugars’;














(9)


In category 05.2 (Other confectionery including breath freshening microsweets), the entries for E 960a – 960c (Steviol glycosides) are replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


270


(1) (60)


only cocoa or dried fruit based, energy reduced or with no added sugar




 


E 960a – 960d


Steviol glycosides


330


(1) (60)


only cocoa, milk, dried fruit or fat based sandwich spreads, energy-reduced or with no added sugar




 


E 960a – 960d


Steviol glycosides


350


(1) (60)


only confectionery with no added sugars
only energy-reduced hard confectionery (candies and lollies)
only energy-reduced soft confectionery (chewy candies, fruit gums and foam sugar products/marshmallows)
only energy-reduced liquorice
only energy-reduced nougat
only energy-reduced marzipan




 


E 960a – 960d


Steviol glycosides


2 000 


(1) (60)


only breath-freshening micro-sweets, energy-reduced or with no added sugars




 


E 960a – 960d


Steviol glycosides


670


(1) (60)


only strongly flavoured freshening throat pastilles, energy-reduced or with no added sugars’;














(10)


In category 05.3 (Chewing gum), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


3300


(1) (60)


only with no added sugar’;














(11)


In category 05.4 (Decorations, coatings and fillings, except fruit-based fillings covered by category 4.2.4), the entries for E 960a – 960c (Steviol glycosides) are replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


330


(1) (60)


only confectionary with no added sugar




 


E 960a – 960d


Steviol glycosides


270


(1) (60)


only cocoa or dried fruit based, energy reduced or with no added sugar’;














(12)


In category 06.3 (Breakfast cereals), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


330


(1) (60)


only breakfast cereals with a fibre content of more than 15 %, and containing at least 20 % bran, energy reduced or with no added sugar’;














(13)


In category 07.2 (Fine bakery wares), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


330


(1) (60)


only essoblaten – wafer paper’;














(14)


In category 09.2 (Processed fish and fishery products including molluscs and crustaceans), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


only sweet-sour preserves and semi preserves of fish and marinades of fish, crustaceans and molluscs’;














(15)


In category 11.4.1 (Table-top sweeteners in liquid form), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides



quantum satis



(1) (60)’;


 














(16)


In category 11.4.2 (Table-top sweeteners in powder form), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides



quantum satis



(1) (60)’;


 














(17)


In category 11.4.3 (Table-top sweeteners in tablets), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides



quantum satis



(1) (60)’;


 














(18)


In category 12.4 (Mustard), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


120


(1) (60)’;


 














(19)


In category 12.5 (Soups and broths), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


40


(1) (60)


only energy-reduced soups’;














(20)


In category 12.6 (Sauces), the entries for E 960a – 960c (Steviol glycosides) are replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


120


(1) (60)


except soy-bean sauce (fermented and non-fermented)




 


E 960a – 960d


Steviol glycosides


175


(1) (60)


Only soy-bean sauce (fermented and non-fermented)’;














(21)


In category 13.2 (Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


330


(1) (60)’;


 














(22)


In category 13.3 (Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


270


(1) (60)’;


 














(23)


In category 14.1.3 (Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


100


(1) (60)


only energy-reduced or with no added sugar’;














(24)


In category 14.1.4 (Flavoured drinks), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


80


(1) (60)


only energy-reduced or with no added sugar’;














(25)


In category 14.1.5.2 (Other), the entries for E 960a – 960c (Steviol glycosides) are replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


30


(1) (60) (93)


only coffee, tea and herbal infusion beverages, energy-reduced or with no added sugars




 


E 960a – 960d


Steviol glycosides


30


(1) (60) (93)


only flavoured instant coffee and instant cappuccino products, energy-reduced or with no added sugars




 


E 960a – 960d


Steviol glycosides


20


(1) (60) (93)


only malt-based and chocolate/cappuccino flavoured drinks, energy-reduced or with no added sugars’;














(26)


In category 14.2.1 (Beer and malt beverages), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


70


(1) (60)


only alcohol-free beer or with an alcohol content not exceeding 1,2 % vol.; ‘Bière de table/Tafelbier/Table beer’ (original wort content less than 6 %) except for ‘Obergäriges Einfachbier’; beers with a minimum acidity of 30 milli-equivalents expressed as NaOH; Brown beers of the ‘oud bruin’ type’;














(27)


In category 14.2.8 (Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


150


(1)(60)’;


 














(28)


In category 15.1 (Potato-, cereal-, flour- or starch-based snacks), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


20


(1) (60)’;


 














(29)


In category 15.2 (Processed nuts), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


20


(1) (60)’;


 














(30)


In category 16 (Desserts excluding products covered in categories 1, 3 and 4), the entry for E 960a – 960c (Steviol glycosides) is replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


100


(1) (60)


only energy-reduced or with no added sugar’;














(31)


In category 17.1 (Food supplements supplied in a solid form, excluding food supplements for infants and young children), the entries for E 960a – 960c (Steviol glycosides) are replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


670


(1) (60)


 




 


E 960a – 960d


Steviol glycosides


1800


(1) (60)


only food supplements in chewable form’;














(32)


In category 17.2 (Food supplements supplied in a liquid form, excluding food supplements for infants and young children), the entries for E 960a – 960c (Steviol glycosides) are replaced by the following:










 


‘E 960a – 960d


Steviol glycosides


200


(1) (60)


 




 


E 960a – 960d


Steviol glycosides


1800


(1) (60)


only food supplements in syrup form’.

















ANNEX II
In the Annex to Regulation (EU) No 231/2012 the following entry is inserted after the entry for food additive E 960c(iv):

‘E 960d   GLUCOSYLATED STEVIOL GLYCOSIDES










Synonyms



 





Definition



Mixture of larger glycosides of steviol derived by glucosylation of steviol glycosides extracted from leaves of Stevia rebaudiana Bertoni plant. The mixture is composed of glucosylated steviol glycosides and residual parent steviol glycosides from Stevia leaf. Glucosylated steviol glycosides are produced by treating the steviol glycosides, extracted from Stevia leaf, and starch suitable for human consumption with Cyclomaltodextrin glucanotransferase (EC 2.4.1.19) derived from a non-GMO strain of Anoxybacillus caldiproteolyticus St-88. The enzyme transfers glucose units from the starch to the steviol glycosides. The resulting material is heated and treated with activated carbon to remove the enzyme, then passed through adsorption/desorption resin to remove residual hydrolysed starch (dextrin), followed by purification and preparation of the final product using processes that may include decolourisation, concentration and spray drying.




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
And their glucosylated derivatives (1-20 added glucose units)




Molecular formula



Trivial name




Formula




Conversion factor





 


n-Glucosylated Steviolbioside


C(32+n*6)H(50+n*10)O(13+n*5)



 




n-Glucosylated Rubusoside


C(32+n*6)H(50+n*10)O(13+n*5)



 




n-Glucosylated Dulcoside A


C(38+n*6)H(60+n*10)O(17+n*5)



 




n-Glucosylated Stevioside


C(38+n*6)H(60+n*10)O(18+n*5)



 




n-Glucosylated Rebaudioside A


C(44+n*6)H(70+n*10)O(23+n*5)



 




n-Glucosylated Rebaudioside B


C(38+n*6)H(60+n*10)O(18+n*5)



 




n-Glucosylated Rebaudioside C


C(44+n*6)H(70+n*10)O(22+n*5)



 




n-Glucosylated Rebaudioside D


C(50+n*6)H(80+n*10)O(28+n*5)



 




n-Glucosylated Rebaudioside E


C(44+n*6)H(70+n*10)O(23+n*5)



 




n-Glucosylated Rebaudioside F


C(43+n*6)H(68+n*10)O(22+n*5)



 




n-Glucosylated Rebaudioside M


C(56+n*6)H(90+n*10)O(33+n*5)



 




n: number of glucose units enzymatically added to the parent steviol glycoside (n = 1-20)
Typical conversion factor for glucosylated steviol glycosides mixtures = 0,20 (on the dried, dextrin-free, basis)




 


Steviol


C20H30O3



1,00 




 


Steviolbioside


C32H50O13



0,50 




Rubusoside


C32H50O13



0,50 




Dulcoside A


C38H60O17



0,40 




Stevioside


C38H60O18



0,40 




Rebaudioside A


C44H70O23



0,33 




Rebaudioside B


C38H60O18



0,40 




Rebaudioside C


C44H70O22



0,34 




Rebaudioside D


C50H80O28



0,29 




Rebaudioside E


C44H70O23



0,33 




Rebaudioside F


C43H68O22



0,34 




Rebaudioside M


C56H90O33



0,25 




Molecular weight and CAS No



Trivial name




CAS Number




Molecular weight (g/mol)





n-Glucosylated Steviolbioside


Not available


642,73+n*162,15




n-Glucosylated Rubusoside


Not available


642,73+n*162,15




n-Glucosylated Dulcoside A


Not available


788,87+n*162,15




n-Glucosylated Stevioside


Not available


804,88+n*162,15




n-Glucosylated Rebaudioside A


Not available


967,01+n*162,15




n-Glucosylated Rebaudioside B


Not available


804,88+n*162,15




n-Glucosylated Rebaudioside C


Not available


951,02+n*162,15




n-Glucosylated Rebaudioside D


Not available


1129,15+n*162,15




n-Glucosylated Rebaudioside E


Not available


967,01+n*162,15




n-Glucosylated Rebaudioside F


Not available


936,99+n*162,15




n-Glucosylated Rebaudioside M


Not available


1291,30+n*162,15




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 % of total steviol glycosides, comprised of above mentioned steviol glycosides along with their glucosylated derivatives (1-20 added glucose units), on the dried, dextrin-free, basis.





Description



White to light yellow powder, approximately between 100 and 200 times sweeter than sucrose (at 5 % sucrose equivalency).





Identification





Solubility


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, 2 h)




Residual solvent


Not more than 200 mg/kg methanol
Not more than 3 000  mg/kg ethanol




Arsenic


Not more than 0,015 mg/kg




Lead


Not more than 0,1 mg/kg




Cadmium


Not more than 0,1 mg/kg




Mercury


Not more than 0,1 mg/kg




Microbiological criteria




Total (aerobic) plate count


Not more than 1 000  CFU/g




Yeast and moulds


Not more than 200 CFU/g





E. coli



Negative in 1 g





Salmonella



Negative in 25 g’.