Article 1
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Commission Regulation (EU) 2025/652 of 2 April 2025 amending Regulation (EC) No 1333/2008 of the European Parliament and the Council and Commission Regulation (EU) No 231/2012 as regards the use of Steviol glycosides produced by fermentation using Yarrowia lipolytica
Commission Regulation (EU) 2025/652 of 2 April 2025 amending Regulation (EC) No 1333/2008 of the European Parliament and the Council and Commission Regulation (EU) No 231/2012 as regards the use of Steviol glycosides produced by fermentation using Yarrowia lipolytica
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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 .
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I Annex II to Regulation (EC) No 1333/2008 is amended as follows: (a) in point 2 (Sweeteners) of Part B, the following entry is inserted after the entry for E 960a: ‘E 960b Steviol glycosides from fermentation’ (b) in point (5) (Other additives that may be regulated combined) of Part C, point (v) is replaced by the following: ‘(v) E 960a – 960d: Steviol glycosides E-number Name E 960a Steviol glycosides from stevia E 960b Steviol glycosides from fermentation E 960c Enzymatically produced steviol glycosides E 960d Glucosylated steviol glycosides’
ANNEX IISupplementary provisions
ANNEX II In the Annex to Regulation (EU) No 231/2012 the following entry is inserted after the entry for food additive E 960a: ‘ E 960B(I) REBAUDIOSIDE M FROM FERMENTATION PRODUCED BY YARROWIA LIPOLYTICA Synonyms Definition Rebaudioside M from fermentation produced by Yarrowia lipolytica consist of a mixture of steviol glycosides composed of rebaudioside M as the main componant, with some rebaudioside D, and smaller amounts of rebaudioside A and rebaudioside B. The manufacturing process comprises two main phases. The first phase involves fermentation of a simple sugar source by a non-toxigenic non-pathogenic strain of Yarrowia lipolytica that has been genetically modified with heterologous genes to overexpress genes which are involved in the synthesis of steviol glycosides to result in the strain VRM (CBS 147477). Removal of biomass by solid-liquid separation and heat treatment is followed by concentration of the steviol glycosides. The second phase involves purification by employing ion exchange chromatography, followed by cristallisation of the steviol glycosides from ethanol, resulting in a final product containing not less than 95 % of rebaudiosides M, D, A and B. Viable cells and DNA of Yarrowia lipolytica VRM shall not be detected in the food additive. Chemical name 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 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 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 Rebaudioside A C 44 H 70 O 23 0,33 Rebaudioside B C 38 H 60 O 18 0,40 Rebaudioside D C 50 H 80 O 28 0,29 Rebaudioside M C 56 H 90 O 33 0,25 Molecular weight and CAS No Trivial name CAS Number Molecular weight (g/mol) Rebaudioside A 58543-16-1 967,01 Rebaudioside B 58543-17-2 804,88 Rebaudioside D 63279-13-0 1 129,15 Rebaudioside M 1220616-44-3 1 291,30 Assay Not less than 95 % of rebaudioside M, rebaudioside D, rebaudioside A and rebaudioside B, on the dried basis. Particle size Not more than 0,5 % of particles of less than 300 nm (by STEM method) Description White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5 % sucrose equivalency). Identification Solubility 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 ethanol Kaurenoic acid Not more than 0,3 mg/kg (measured by liquid chromatography-mass spectrometry detection) Arsenic Not more than 0,01 mg/kg Lead Not more than 0,01 mg/kg Cadmium Not more than 0,01 mg/kg Mercury Not more than 0,05 mg/kg Microbiological criteria Total (aerobic) plate count Not more than 1 000 CFU/g Yeast and moulds Not more than 100 CFU/g Escherichia coli Negative in 1 g Salmonella spp. Negative in 25 g Residual protein Not more than 20 mg/kg’
Other acts of the same type
Commission Regulation (EU) 2019/800 of 17 May 2019 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the extension of the use of carminic acid, carmine (E 120) in certain meat products traditional in French Overseas Territories (Text with EEA relevance.)Commission Regulation (EU) 2019/801 of 17 May 2019 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of mono- and diglycerides of fatty acids (E 471) on certain fresh fruits (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/802 of 17 May 2019 correcting the Greek language version of Implementing Regulation (EU) 2018/775 laying down rules for the application of Article 26(3) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, as regards the rules for indicating the country of origin or place of provenance of the primary ingredient of a food (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/803 of 17 May 2019 concerning the technical requirements regarding the content of quality reports on European statistics on natural gas and electricity prices pursuant to Regulation (EU) 2016/1952 of the European Parliament and of the Council (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/804 of 17 May 2019 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species and repealing Regulations (EC) No 1750/2006 and (EC) No 634/2007 (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/805 of 17 May 2019 concerning the authorisation of a preparation of muramidase produced by Trichoderma reesei DSM 32338 as a feed additive for chickens for fattening and minor poultry species for fattening (holder of authorisation DSM Nutritional Products Ltd, represented in EU by DSM Nutritional Products Sp. Z o.o) (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/822 of 17 May 2019 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2019/823 of 17 May 2019 concerning the classification of certain goods in the Combined NomenclatureCouncil Regulation (EU) 2019/952 of 17 May 2019 on the allocation of fishing opportunities under the Protocol on the implementation of the Fisheries Partnership Agreement between the European Community and the Republic of Cape Verde (2019-2024)Commission Delegated Regulation (EU) 2019/1974 of 17 May 2019 supplementing Regulation (EU) No 1295/2013 of the European Parliament and of the Council by establishing additional qualitative and quantitative performance indicatorsCommisson Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility (Text with EEA relevance.)Commission Implementing Regulation (EU) 2019/773 of 16 May 2019 on the technical specification for interoperability relating to the operation and traffic management subsystem of the rail system within the European Union and repealing Decision (Text with EEA relevance.)
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