Commission Regulation (EU) 2023/440 of 28 February 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 carbomer in food supplements (Text with EEA relevance)

• CELEX: Regulation (EU) 2023/440
• Articles: 5

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.

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 .

Schedules & Appendices

ANNEX I

ANNEX I

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(a)

in Part B, point 3 ‘Additives other than colours and sweeteners’, the following entry is inserted after the entry for food additive E 1209:

‘E 1210

Carbomer’

(b)

Part E is amended as follows:

(1)

in food category 17.1 ‘Food supplements supplied in a solid form, excluding food supplements for infants and young children’, the following entry is inserted after the entry for food additive E 1209:

‘E 1210

Carbomer

200 000 ’

(2)

in food category 17.2 ‘Food supplements supplied in a liquid form, excluding food supplements for infants and young children’, the following entry is inserted after the entry for food additive E 969:

‘E 1210

Carbomer

30 000 ’

ANNEX II

ANNEX II

In the Annex to Regulation (EU) No 231/2012 the following entry is inserted after the entry for E 1209:

‘

E 1210 CARBOMER

Synonyms

carbomer, carboxypolymethylene; carbomer homopolymer

Definition

High-molecular mass polymers obtained by polymerisation of acrylic acid and crosslinking with allyl pentaerythritol. The polymers are synthesised in ethyl acetate using a peroxide to initiate free-radical polymerisation.

CAS No

9007-20-9 (primary CAS), 9003-01-4 (secondary CAS)

Chemical name

Carbomer homopolymer, allyl pentaerythritol cross-linked

Chemical formula

-(CH 2 -CH)

m

-( XM )

p

COOH

m: number of monomer units; XM: crosslinker, p: number of crosslinker units, with m >> p

Weight average molecular weight

Assay

Carboxylic acid content not less than 56 % and not more than 68 % (on dried substance)

Description

White or almost white, fluffy, hygroscopic powder or granules

Identification

Attenuated total reflective infra-red spectroscopy

Proton nuclear magnetic resonance spectroscopy

Characteristic of the compound

Viscosity (Brookfield viscosimetry, 20 rpm) 25 °C

Type B

Type A

Type A

29 400 -39 400 mPa.s

4 000 -11 000 mPa.s

Physical form

powder

powder

granules

Pass through 40 mesh, % 425 μm

-

-

95 min

Pass through 100 mesh, % 150 μm

-

-

10 max

Solubility

Insoluble in water. Water-swellable and forms hydrogels in aqueous dispersions.

Purity

Residual monomers

Acrylic acid not more than 100 mg/kg

Residual crosslinker

tri and tetra-allyl pentaerythritol not more than 1 000  mg/kg

Residual solvant

Ethyl acetate not more than 0,5 % w/w

2-ethylhexanol

not more than 100 mg/kg

2-ethylhexylacetate

not more than 100 mg/kg

Lower molecular weight fraction < 1 000 Da

Not more than 0,75 % w/w

Loss on drying

Not more than 2 %

Sulphated ashes

Not more than 2,5 %’