COMMI SSION REGUL ATION (EU) 2021/1156 
of 13 July 2021
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 steviol glycosides (E 960) and 
rebaudioside M produced via enzyme modif ication of steviol glycosides from Stevia 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng 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) and 14 thereof,
Havi ng regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008
establishing a common author isation 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) The Annex to Commission Regulation (EU) No 231/2012 (3)lays down specifi cations for food additives listed in 
Annex es II and III to Regulation (EC) No 1333/2008.
(3) The Union list of food additives and the specifications for food additives 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 follo wing an application from a Member State or an inter ested party.
(4) In Febr uary 2018, an application was submitted to the Commission for the amendment of the specifi cations 
concer ning the food additive steviol glycosides (E 960). The Commission made the application available to the 
Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(5) The current specifi cations stipulate that stevi ol glycosides (E 960) are to contain not less than 95 % of eleven named 
stevi ol glycosides: stevioside, rubusoside, dulcoside A, steviolbioside and rebaudiosides A, B, C, D, E, F and M, on a 
dried basis, in any combination and ratio. The manufa ctur ing process of this food additive comprises two main 
phases, the first involving water extraction from the leav es of the Stevia rebaudiana Bertoni plant and preliminar y 
purification of the extract, and the second involving recr ystallisation of the steviol glycosides.
(6) The applicant request ed an amendment of the specifications of stevia glycosides (E 960) to include a new method for 
the production of rebaudioside M. Rebaudioside M is a minor glycoside present at very low levels (< 1%) in the stevia 
leaf, whic h has a taste profile that is more reflective of sucrose when compar ed to the major glycosides (i.e. stevioside 
and rebaudioside A).
(7) The new process involves the biocon version of purified stevia leaf extract (≥95% steviol glycosides) through a 
multistep enzymatic process with enzymes prepared at the first stage of the process. The resulting rebaudioside M 
undergoes a series of purification and isolation steps to produce the final rebaudioside M (≥ 95%).
(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 specificat ions 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).EN Offi cial Jour nal of the European Union 14.7.2021                                                                                                                                         L 249/87  (8) The European Food Safety Author ity (‘the Author ity’) evaluated the safety of the proposed amendment of the 
specifications of the food additive steviol glycosides (E 960) and adop ted its opinion on 24 Septembe r 2019 (4). The 
Authority considered that the enzymatic step process applied for the production of rebaudioside M may result in 
imp urities, different from those that may be present in stevi ol glycosides (E 960) obtained from wate r extraction of 
the leav es of the Stevia rebaud iana followed by recr ystallisation. Theref ore, the Author ity considered that separate 
specifications for rebaudioside M produced with this process are needed. Further more, it concluded that the existing 
Acceptable Daily Intake (ADI) of 4 mg/kg bw per day can also be applied to rebaudioside M produced via enzyme 
modifi cation of stevi ol glycosides. The Auth ority considered that exposure to rebaudioside M (expressed as steviol 
equivalent) will not be higher than the exposure to steviol glycosides (E 960) if replaced by rebaudioside M 
produced via the enzymatic step process. The Author ity also concluded that rebaudioside M produced by enzyme 
modifi cation of steviol glycosides, using UDP -glucosyltransfe rase and sucrose synthase enzymes produced by the 
genetically modified yeasts K. phaffii UGT -a and K. phaffii UGT -b, would not be of safety concer n for the same 
proposed uses and at the same use levels as steviol glycosides (E 960).
(9) Theref ore, it is appropr iate to author ise the use of rebaudioside M produced via the enzymatic step process as a 
sweet ener in the food catego ries where steviol glycosides (E 960) are currently author ised.
(10) Taking into account the ongoing process for the amendment of the International Number ing System for food 
additives of the Codex Alimentar ius, it is appropr iate to include the new food additive as ‘E 960c enzymatically 
produced steviol glycosides ’ in Part B of Annex II to Regulation (EC) No 1333/2008 for labelling purposes. In the 
inter est of clarity and coherence, the currently author ised food additive ‘steviol glycosides (E 960)’ should be 
renamed to ‘steviol glycosides from Stevia (E 960a)’ . As those food additives may be regulated combined, a new 
group for stevi ol glycosides, including both of them, should be inser ted in Part C of Annex II to Regulation (EC) 
No 1333/2008, and all entr ies for stevi ol glycosides (E 960) in Part E of Annex II to that Regulation should be 
replaced according ly, while maintaining the currently applicable uses and maximum level for author ised uses and 
use levels.
(11) The specifications for rebaudioside M produced via enzyme modific ation of steviol glycosides from Stevia should be 
included in Regulation (EU) No 231/2012 in parallel with the inclusion of ‘E 960c enzymatically produced stevi ol 
glycosides’ in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008.
(12) Regulations (EC) No 1333/2008 and (EU) No 231/2012 should theref ore be amended according ly.
(13) In order to allow economic operat ors to adapt to the new rules, it is appropr iate to provide for a transitional period 
during which the food additive ‘steviol glycosides from Stevia (E 960a)’ and foods containing it may continue to be 
mark eted as ‘steviol glycosides (E 960)’.
(14) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
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.
(4)EFSA Jour nal 2019;17(10):5867, 19 pp.EN Offi cial Jour nal of the European Union L 249/88                                                                                                                                         14.7.2021  Article 3
The food additive ‘steviol glycosides ’ (E 960) and foods containing it, which are labelled or placed on the mark et up 
to 18 months after the entr y into force of this Regulation and which compl y with the requirements of this Regulation, 
may be market ed until the stoc ks are exhausted.
Article 4
This Regulation shall enter into force on the twentieth day followi ng 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, 13 July 2021
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 14.7.2021                                                                                                                                         L 249/89  ANNEX I 
Annex II to Regulation (EC) No 1333/2008 is amended as follows :
(a) Part B2 is amended as follows:
(1) The entr y for E 960 (Steviol glycosides) is replaced by the follo wing:
‘E 960a Stevi ol glycosides from Stevia’
(2) The followi ng entr y is inser ted after the entr y for E 960a:
‘E 960c Enzymatically produced steviol glycosides’
(b) In point (5) of Part C, the follo wing new point (v) is inser ted after point (u) for E 626–635: Ribonucleotides:
‘(v) E 960a – 960c: Steviol glycosides
E-number Name
E 960a Steviol glycosides from Stevia
E 960c Enzymatically produced stevi ol glycosides ’
(c) Part E is amended as follows:
(1) In Categor y 01.4 (Flavoured fermented milk products including heat-treated products), the entr y for E 960 
(Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 100 (1) 
(60)only energy-reduced products or with no 
added sugar ’
(2) In Categor y 03 (Edible ices), the entr y for E 960 (Steviol glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)only energy-reduced products or with no 
added sugar ’
(3) In Categor y 04.2.2 (Fruit and veget ables in vinegar , oil, or brine), the entr y for E 960 (Steviol glycosides) is 
replaced by the following:
‘E 960a – 
960cSteviol glycosides 100 (1) 
(60)only sweet-sour preser ves of fruit and 
vegetables’
(4) In Categor y 04.2.4.1 (Fruit and vegetable preparations excl uding compo te), the entr y for E 960 (Steviol 
glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)only energy-reduced’EN Offi cial Jour nal of the European Union L 249/90                                                                                                                                         14.7.2021  (5) In Categor y 04.2.5.1 (Extra jam and extra jelly as defined by Directive 2001/113/EC), the entr y for E 960 (Steviol 
glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)only energy-reduced jams jellies and 
mar malades ’
(6) In Categor y 04.2.5.2 (Jam, jellies and mar malades and sweet ened chestnut purée as defined by Directive 
2001/113/EC), the entr y for E 960 (Steviol glycosides) is replaced by the follo wing:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)only energy-reduced jams jellies and 
mar malades ’
(7) In Categor y 04.2.5.3 (Other similar fruit or vege table spreads), the entr y for E 960 (Steviol glycosides) is replaced 
by the followi ng:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)only energy-reduced fruit or vegetable spreads 
and dried-fr uit-based sandwich spreads, 
energy-reduced or with no added sugar’
(8) In Categor y 05.1 (Cocoa and Chocolat e products as covered by Directive 2000/36/EC), the entr y for E 960 
(Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 270 (1) 
(60)only energy-reduced or with no added sugars’
(9) In Categor y 05.2 (Other confecti oner y including breath freshening microsweets), the entr ies for E 960 (Steviol 
glycosides) are replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 270 (1) 
(60)only cocoa or dried fruit based, energy reduced 
or with no added sugar
E 960a – 
960cSteviol glycosides 330 (1) 
(60)only cocoa, milk, dried fruit or fat based 
sandwich spreads, energy-reduced or with no 
added sugar
E 960a – 
960cSteviol glycosides 350 (1) 
(60)only confectioner y with no added sugars
only energy-reduced hard confectioner y 
(candies and lollies)
only energy-reduced soft confecti oner y 
(chewy candies, fruit gums and foam suga r 
products/marshmallows)
only energy-reduced liquor ice
only energy-reduced nougat
only energy-reduced marzipanEN Offi cial Jour nal of the European Union 14.7.2021                                                                                                                                         L 249/91  E 960a – 
960cSteviol glycosides 2 000 (1) 
(60)only breath-freshening micro-sweets, energy- 
reduced or with no added suga rs
E 960a – 
960cSteviol glycosides 670 (1) 
(60)only strong ly flavoured freshening throat 
pastilles, energy-reduced or with no added 
sugars’
(10) In Categor y 05.3 (Chewing gum), the entr y for E 960 (Steviol glycosides) is replaced by the follo wing:
‘E 960a – 
960cSteviol glycosides 3300 (1) 
(60)only with no added sugar’
(11) In Categor y 05.4 (Decorations, coatings and fillings, excep t fruit-based fillings covered by cate gory 4.2.4) the 
entr ies for E 960 (Steviol glycosides) are replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 330 (1) 
(60)only confectionary with no added sugar
E 960a – 
960cSteviol glycosides 270 (1) 
(60)only cocoa or dried fruit based, energy reduced 
or with no added sugar’
(12) In Categor y 06.3 (Cereals and cereal products), the entr y for E 960 (Steviol glycosides) is replaced by the 
followi ng:
‘E 960a – 
960cSteviol glycosides 330 (1) 
(60)only breakf ast cereals with a fibre conte nt of 
more than 15 %, and containing at least 20 % 
bran, energy reduced or with no added sugar ’
(13) In Categor y 07.2 (Fine baker y wares), the entr y for E 960 (Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 330 (1) 
(60)only essoblate n — wafer paper ’
(14) In Categor y 09.2 (Processed fish and fisher y products including molluscs and crustaceans), the entr y for E 960 
(Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)only sweet-sour preser ves and semi preser ves 
of fish and mar inades of fish, crustaceans and 
molluscs ’EN Offi cial Jour nal of the European Union L 249/92                                                                                                                                         14.7.2021  (15) In Categor y 11.4.1 (Table-top sweet eners in liquid form), the entr y for E 960 (Stevi ol glycosides) is replaced by the 
followi ng:
‘E 960a – 
960cSteviol glycosides quantum 
satis(1) 
(60)’
(16) In Categor y 11.4.2 (Table-top sweet eners in powder form), the entr y for E 960 (Stevi ol glycosides) is replaced by 
the followi ng:
‘E 960a – 
960cSteviol glycosides quan -
tum 
satis(1) 
(60)’
(17) In Categor y 11.4.3 (Table-top sweet eners in tablets), the entr y for E 960 (Steviol glycosides) is replaced by the 
followi ng:
‘E 960a – 
960cSteviol glycosides quantum 
satis(1) 
(60)’
(18) In Categor y 12.4 (Mustard), the entr y for E 960 (Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 120 (1) 
(60)’
(19) In Categor y 12.5 (Soups and broths) the entr y for E 960 (Steviol glycosides) is replaced by the follo wing:
‘E 960a – 
960cSteviol glycosides 40 (1) 
(60)only energy-reduced soups’
(20) In Categor y 12.6 (Sauces), the entr ies for E 960 (Steviol glycosides) are replaced by the following:
‘E 960a – 
960cSteviol glycosides 120 (1) 
(60)excep t soy-bean sauce (fermented and non- 
fermente d)
E 960a – 
960cSteviol glycosides 175 (1) 
(60)Only soy-bean sauce (fermented and non- 
fermente d)’EN Offi cial Jour nal of the European Union 14.7.2021                                                                                                                                         L 249/93  (21) In Categor y 13.2 (Dietar y foods for special medical purposes defined in Directive 1999/21/EC (excluding 
products from food categor y 13.1.5)), the entr y for E 960 (Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 330 (1) 
(60)’
(22) In Categor y 13.3 (Dietar y foods for weight control diets intended to replace total daily food intake or an 
individual meal (the whole or part of the tota l daily diet), the entr y for E 960 (Steviol glycosides) is replaced by 
the followi ng:
‘E 960a – 
960cSteviol glycosides 270 (1) 
(60)’
(23) In Categor y 14.1.3 (Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar 
products), (i) the entr y for E 960 (Steviol glycosides) is replaced by the follo wing:
‘E 960a – 
960cSteviol glycosides 100 (1) 
(60)only energy-reduced or with no added sugar ’
(24) In Categor y 14.1.4 (Flav oured drinks) , the entr y for E 960 (Steviol glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 80 (1) 
(60)only energy-reduced or with no added sugar ’
(25) In Categor y 14.1.5.2 (Other), the entr ies for E 960 (Stevi ol glycosides) are replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 30 (1) 
(60) 
(93)only coffee, tea and herbal infusion 
beverages, energy-reduced or with no added 
sugars
E 960a – 
960cSteviol glycosides 30 (1) 
(60) 
(93)only flavour ed instant coffe e and instant 
cappuccino products, energy-reduced or 
with no added sugars
E 960a – 
960cSteviol glycosides 20 (1) 
(60) 
(93)only malt-based and chocolate/cappuccino 
flavoured drinks, energy-reduced or with no 
added sugars’EN Offi cial Jour nal of the European Union L 249/94                                                                                                                                         14.7.2021  (26) In Categor y 14.2.1 (Beer and malt beverages), the entr y for E 960 (Steviol glycosides) is replaced by the following:
‘E 960a – 
960cSteviol glycosides 70 (1) 
(60)only alcohol-free beer or with an alcohol 
content not excee ding 1,2 % vol.; ‘Bière de 
table/T afelbier/T able beer ’ (original wor t 
content less than 6 %) excep t for 
‘Obergär iges Einf achbier ’; beers with a 
minimum acidity of 30 milli-equivalents 
expressed as NaOH; Brown beers of the ‘oud 
bruin’ type ’
(27) In Categor y 14.2.8 (Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and 
spirits with less than 15 % of alcohol), the entr y for E 960 (Steviol glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 150 (1) 
(60)’
(28) In Categor y 15.1 (Potato-, cereal-, flour - or starc h-based snac ks), the entr y for E 960 (Stevi ol glycosides) is 
replaced by the following:
‘E 960a – 
960cSteviol glycosides 20 (1) 
(60)’
(29) In Categor y 15.2 (Processed nuts), the entr y for E 960 (Stevi ol glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 20 (1) 
(60)’
(30) In Categor y 16 (Desser ts excluding products covered in categor ies 1, 3 and 4), the entr y for E 960 (Steviol 
glycosides) is replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 100 (1) 
(60)only energy-reduced or with no added sugar ’
(31) In Categor y 17.1 (Food supplements supplied in a solid form, excl uding food supplements for infants and young 
children), the entr ies for E 960 (Stevi ol glycosides) are replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 670 (1) 
(60)
E 960a – 
960cSteviol glycosides 1800 (1) 
(60)only food supplements in chewable form’EN Offi cial Jour nal of the European Union 14.7.2021                                                                                                                                         L 249/95  (32) In Categor y 17.2 (Food supplements supplied in a liquid form, excl uding food supplements for infants and young 
children), the entr ies for E 960 (Stevi ol glycosides) are replaced by the followi ng:
‘E 960a – 
960cSteviol glycosides 200 (1) 
(60)
E 960a – 
960cSteviol glycosides 1800 (1) 
(60)only food supplements in syrup form’EN Offi cial Jour nal of the European Union L 249/96                                                                                                                                         14.7.2021  ANNEX II 
The Annex to Regulation (EU) No 231/2012 is amended as follows:
(1) In the entr y for E 960 Steviol glycosides, the heading is replaced by the follo wing:
‘E 960a STEVIOL GLYCOSIDES FROM STEVIA ’
(2) The followi ng new entr y is inser ted after the entr y for E 960:
‘E 960c(i) REBA UDIOSIDE M PRODUCED VIA ENZYME MODIFIC ATION OF STEVIOL GLYCOSIDES 
FROM STEVIA
Synon yms
Def inition Rebaudioside M is a stevi ol glycoside compo sed predominantly of rebaudioside M with 
minor amounts of other steviol glycosides such as rebaudioside A, rebaudioside B, 
rebaudioside D, rebaudioside I, and stevioside.
Rebaudioside M is obtained via enzymatic bioconversion of purified steviol glycoside leaf 
extracts (95% steviol glycosides) of the Stevia rebaudiana Bertoni plant using UDP - 
glucosyltransf erase and sucrose synthase enzymes produced by the genetically modified 
yeasts K. phaff i (formerly kno wn as Pichia pastor is) UGT -a and K. phaff i UGT -b that facilitate 
the transfer of glucose from sucrose and UDP -glucose to steviol glycosides via glycosidic 
bonds.
After removal of the enzymes by solid-liquid separation and heat treatment, the purification 
involves concentration of the rebaudioside M by resin adsor ption, followed by 
recr ystallisation of rebaudioside M resulting in a final product containing not less than 95 % 
of rebaudioside M. Viable cells of the yeasts K. phaffii UGT -a and K. phaffii UGT -b or their 
DNA shall not be detected in the food additive.
Chemical name Rebaudioside M: 13-[(2-O-β-D-g lucop yranosyl-3-O-β-D-g lucop yranosyl-β-D- 
glucop yranosyl)o xy]kaur -16-en-18-oic acid, 2-O-β-D-g lucop yranosyl-3-O-β-D- 
glucop yranosyl-β-D-g lucop yranosyl ester
Molecular formula Trivial name Formula Conv ersion factor
Rebaudioside M C56 H90 O33 0,25
Molecular weight and 
CAS NoTrivial name CAS Number Molecular weight (g/mol)
Rebaudioside M 1220616-44-3 1,291.29
Assa y Not less than 95 % rebaudioside M on the dried basis.
Descr iption Whit e to light yellow powder , appro ximat ely between 200 and 350 times sweet er than 
sucrose (at 5 % sucrose equivalency).
Identif ication
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 solvent Not more than 5 000 mg/kg ethanolEN Offi cial Jour nal of the European Union 14.7.2021                                                                                                                                         L 249/97  Arsenic Not more than  0,015 mg/kg
Lead Not more than 0,2 mg/kg
Cadmium Not more than 0,015 mg/kg
Mercur y Not more than 0,07 mg/kg
Residual protein Not more than 5 mg/kg
Particle size Not less than 74 μm [using a mesh #200 sieve with a particle size limit of 74 μm] ’EN Offi cial Jour nal of the European Union L 249/98                                                                                                                                         14.7.2021