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Document 32023R0447
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)
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)
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)
C/2023/1353
OJ L 65, 2.3.2023, p. 16–27
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Modifies | 32008R1333 | Addition | annex II part B point 2 Text | 22/03/2023 | |
Modifies | 32008R1333 | Replacement | annex II part C point 5 point (v) | 22/03/2023 | |
Modifies | 32008R1333 | Replacement | annex II part E Text | 22/03/2023 | |
Modifies | 32012R0231 | Addition | annex Text | 22/03/2023 |
Relation | Act | Comment | Subdivision concerned | From | To |
---|---|---|---|---|---|
Corrected by | 32023R0447R(01) | (FR) | |||
Corrected by | 32023R0447R(02) | (FR) |
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:
|
(b) |
In Part C, (5) Other additives that may be regulated combined, point (v) is replaced by the following:
|
(c) |
Part E is amended as follows:
|
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. |
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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) |
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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. |
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Description |
White to light yellow powder, approximately between 100 and 200 times sweeter than sucrose (at 5 % sucrose equivalency). |
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Identification |
|||
Solubility |
Soluble in water |
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pH |
Between 4,5 and 7,0 (1 in 100 solution) |
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Purity |
|||
Total ash |
Not more than 1 % |
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Loss on drying |
Not more than 6 % (105 °C, 2 h) |
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Residual solvent |
Not more than 200 mg/kg methanol Not more than 3 000 mg/kg ethanol |
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Arsenic |
Not more than 0,015 mg/kg |
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Lead |
Not more than 0,1 mg/kg |
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Cadmium |
Not more than 0,1 mg/kg |
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Mercury |
Not more than 0,1 mg/kg |
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Microbiological criteria |
|||
Total (aerobic) plate count |
Not more than 1 000 CFU/g |
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Yeast and moulds |
Not more than 200 CFU/g |
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E. coli |
Negative in 1 g |
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Salmonella |
Negative in 25 g’. |