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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)

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)

Regulation (EU) 2023/440 · Regulation · 5 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

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

Article 2

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

Article 3

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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

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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 IISupplementary provisions

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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 %’

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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