Commission Regulation (EU) 2025/666 of 4 April 2025 amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of sodium carboxy methyl cellulose, cellulose gum (E 466) and the Annex to Commission Regulation (EU) No 231/2012 as regards specifications for cellulose (E 460), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose, cellulose gum (E 466), cross-linked sodium carboxy methyl cellulose, cross linked cellulose gum (E 468) and enzymatically hydrolysed carboxy methyl cellulose (E 469)

Regulation (EU) 2025/666 · Regulation · 8 articles

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 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

Article 2

Annex III to Regulation (EC) No 1333/2008 is amended in accordance with Annex II to this Regulation.

Article 3

The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex III to this Regulation.

Article 4

1. The food additives cellulose (E 460), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose, cellulose gum (E 466), cross-linked sodium carboxy methyl cellulose, cross linked cellulose gum (E 468) and enzymatically hydrolysed carboxy methyl cellulose (E 469) that have been lawfully placed on the market before 27 October 2025 may be added to food in accordance with Annexes II and III to Regulation (EC) No 1333/2008 until the exhaustion of stocks. 2. Foods, containing cellulose (E 460), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose, cellulose gum (E 466), cross-linked sodium carboxy methyl cellulose, cross linked cellulose gum (E 468) or enzymatically hydrolysed carboxy methyl cellulose (E 469) that have been lawfully placed on the market before 27 October 2025, may be placed on the market until their date of minimum durability or ‘use-by date’. 3. Foods belonging to food categories 13.1.5.1 ‘Dietary foods for infants for special medical purposes and special formulae for infants’ and 13.1.5.2 ‘Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC’ and containing sodium carboxy methyl cellulose, cellulose gum (E 466) in accordance with Annexes II and III to Regulation (EC) No 1333/2008, that have been lawfully placed on the market before 27 April 2027 may continue to be marketed until their date of minimum durability or ‘use-by date’.

Article 5

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . Articles 1 and 2 shall apply from 27 April 2027. Article 3 shall apply from 27 October 2025.

Supplementary provisions

ANNEX ISupplementary provisions

ANNEX I Part E of Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) in category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants), the entry concerning the food additive E 466 (Sodium carboxy methyl cellulose, Cellulose gum) is deleted; (2) in category 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC), the entry concerning the food additive E 466 (Sodium carboxy methyl cellulose, Cellulose gum) is deleted.

ANNEX IISupplementary provisions

ANNEX II In Section B of Part 5 of Annex III to Regulation (EC) No 1333/2008 the entry concerning the food additive E 466 (Sodium carboxy methyl cellulose, Cellulose gum) is deleted.

ANNEX IIISupplementary provisions

ANNEX III The Annex to Regulation (EU) No 231/2012 is amended as follows: (1) the entry for ‘E 460 (i) Microcrystalline cellulose, cellulose gel’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-34-6’; (b) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 7 % (105 °C, 3 hours) Water soluble matter Not more than 0,24 % Sulphated ash Not more than 0,5 % (800 ± 25 °C) Starch Not detectable To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced Carboxyl groups Not more than 1 % Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’; (2) the entry for ‘E 460 (ii) powdered cellulose’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-34-6’; (b) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 7 % (105 °C, 3 hours) Water soluble matter Not more than 1,0 % Sulphated ash Not more than 0,3 % (800 ± 25 °C) Starch Not detectable To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced Arsenic Not more than 0,1 mg/kg Lead Not more than 0,3 mg/kg Mercury Not more than 0,2 mg/kg Cadmium Not more than 0,1 mg/kg’; (3) the entry for ‘E 461 methyl cellulose’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-67-5’; (b) the specification ‘Einecs’ is replaced by the following: ‘Einecs 618-391-7’; (c) the specification ‘Identification’ is replaced by the following: ‘ Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid pH Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)’; (d) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 10 % (105 °C, 3 hours) Sulphated ash Not more than 1,5 % (800 ± 25 °C) Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’; (4) the entry for ‘E 462 ethyl cellulose’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-57-3’; (b) the specification ‘Einecs’ is replaced by the following: ‘Einecs 618-384-9’; (c) the specification ‘pH’ is replaced by the following: ‘pH Neutral to litmus (1 % colloidal dispersion)’; (d) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 3 % (105 °C, 2 hours) Sulphated ash Not more than 0,4 % Arsenic Not more than 0,5 mg/kg Lead Not more than 0,5 mg/kg Mercury Not more than 0,5 mg/kg Cadmium Not more than 0,5 mg/kg’; (5) the entry for ‘E 463 hydroxypropyl cellulose’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-64-2’; (b) the specification ‘Einecs’ is replaced by the following: ‘Einecs 618-388-0’; (c) the specification ‘Identification’ is replaced by the following: ‘ Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Soluble in ethanol. Insoluble in ether Gas chromatography Determine the substituents by gas chromotography pH Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)’; (d) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 10 % (105 °C, 3 hours) Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C Propylene chlorohydrins Not more than 0,1 mg/kg Arsenic Not more than 0,5 mg/kg Lead Not more than 0,5 mg/kg Mercury Not more than 0,5 mg/kg Cadmium Not more than 0,5 mg/kg’; (6) the entry for ‘E 463a low-substituted hydroxypropyl cellulose (L-HPC)’ is amended as follows: (a) the specification ‘Einecs number’ is replaced by the following: ‘Einecs 618-388-0’; (b) the specification ‘pH’ is replaced by the following: ‘pH Not less than 5,0 and not more than 7,5 (1 % colloidal dispersion)’; (c) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 5,0 % (105 °C, 1 hour) Residue on ignition Not more than 0,8 % determined at 800 °C ± 25 °C Propylene chlorohydrins Not more than 0,1 mg/kg (on an anhydrous basis) (gas chromatography–mass spectrometry (GC–MS)) Arsenic Not more than 0,5 mg/kg Lead Not more than 0,5 mg/kg Mercury Not more than 0,5 mg/kg Cadmium Not more than 0,15 mg/kg’; (7) the entry for ‘E 464 hydroxypropyl methyl cellulose’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-65-3’, (b) the specification ‘Einecs’ is replaced by the following: ‘Einecs 618-389-6’; (c) the specification ‘Identification’ is replaced by the following: ‘ Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Insoluble in ethanol Gas chromatography Determine the substituents by gas chromatography pH Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)’; (d) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 10 % (105 °C, 3 hours) Sulphated ash Not more than 1,5 % for products with viscosities of 50 mPa.s or above Not more than 3 % for products with viscosities below 50 mPa.s Propylene chlorohydrins Not more than 0,1 mg/kg Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’; (8) the entry for ‘E 465 ethyl methyl cellulose’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-59-5. The CAS number 9004-69-7 has also been assigned to ethyl methyl cellulose’; (b) the specification ‘Identification’ is replaced by the following: ‘ Identification Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal dispersion. Soluble in ethanol. Insoluble in ether pH Not less than 5,0 and not more than 8,0 (1 % colloidal dispersion)’; (c) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight) Sulphated ash Not more than 0,6 % Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’; (9) the entry for ‘E 466 sodium carboxy methyl cellulose, cellulose gum’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 9004-32-4’; (b) the specification ‘Einecs’ is replaced by the following: ‘Einecs 618-378-6’; (c) the specification ‘Identification’ is replaced by the following: ‘ Identification Solubility Yields a viscous colloidal dispersion in water. Insoluble in ethanol Foam test A 0,1 % dispersion of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers) Precipitate formation To 5 ml of a 0,5 % dispersion of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth) Colour reaction Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear dispersion is produced, and use the dispersion for the following test: To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface pH Not less than 5,0 and not more than 8,5 (1 % colloidal dispersion)’; (d) the specification ‘Purity’ is replaced by the following: ‘ Purity Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH 2 COOH) per anhydroglucose unit Loss on drying Not more than 12 % (105 °C to constant weight) Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg Total glycolate Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis Sodium Not more than 12,4 % on the anhydrous basis’; (10) the entry for ‘E 468 cross-linked sodium carboxymethyl cellulose, cross-linked cellulose gum’ is amended as follows: (a) the following specification is inserted after the ‘Definition’: ‘CAS number 74811-65-7’; (b) the specification ‘Einecs’ is replaced by the following: ‘Einecs 629-739-2’; (c) the specification ‘pH’ is replaced by the following: ‘pH Not less than 5,0 and not more than 7,0 (1 % dispersion)’; (d) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 6 % (105 °C, 3 hours) Water soluble matter Not more than 10 % Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit Sodium content Not more than 12,4 % on anhydrous basis Arsenic Not more than 0,2 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’; (11) the entry for ‘E 469 enzymatically hydrolysed carboxymethylcellulose, enzymatically hydrolysed cellulose gum’ is amended as follows: (a) the specification ‘Identification’ is replaced by the following: ‘ Identification Solubility Soluble in water, insoluble in ethanol Foam test Vigorously shake a 0,1 % dispersion of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums Precipitate formation To 5 ml of a 0,5 % dispersion of the sample, add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum Colour reaction Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear dispersion is produced. Dilute 1 ml of the dispersion with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface Viscosity (60 % solids) Not less than 2 500 kgm– 1s– 1 at 25 °C corresponding to an average molecule weight of 5 000 Da pH Not less than 6,0 and not more than 8,5 (1 % colloidal dispersion)’; (b) the specification ‘Purity’ is replaced by the following: ‘ Purity Loss on drying Not more than 12 % (105 °C to constant weight) Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis Sodium chloride and sodium glycolate Not more than 0,5 % singly or in combination Residual enzyme activity Passes test. No change in viscosity of test dispersion occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’

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