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)

• CELEX: Regulation (EU) 2025/666
• Articles: 8

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.

Schedules & Appendices

ANNEX I

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 II

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 III

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’