Article 1
Open ↗Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Source
Commission Regulation (EU) 2018/1461 of 28 September 2018 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 Low-substituted hydroxypropyl cellulose (L-HPC) in food supplements (Text with EEA relevance.)
Commission Regulation (EU) 2018/1461 of 28 September 2018 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 Low-substituted hydroxypropyl cellulose (L-HPC) in food supplements (Text with EEA relevance.)
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
Open ↗The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3
Open ↗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
Open ↗ANNEX I Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry E 463a for Low-substituted hydroxypropyl cellulose (L-HPC) is inserted after the entry for E 463 Hydroxypropyl cellulose: ‘E 463a Low-substituted hydroxypropyl cellulose (L-HPC)’ (2) in Part E, in food category 17.1 ‘Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms’, the following new entry for Low-substituted hydroxypropyl cellulose (L-HPC) is inserted after the entry for E 459 Beta-cyclodextrin: ‘E 463a Low-substituted hydroxypropyl cellulose (L-HPC) 20 000 only food supplements in tablet form’
ANNEX IISupplementary provisions
Open ↗ANNEX II In the Annex to Regulation (EU) No 231/2012 the following entry for E 463a (Low-substituted hydroxypropyl cellulose (L-HPC)) is inserted after the entry for E 463 (Hydroxypropyl cellulose): ‘ E 463a LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (L-HPC) Synonyms Cellulose hydroxypropyl ether, low substituted Definition L-HPC is a low-substituted poly (hydroxypropyl) ether of cellulose. L-HPC is manufactured by partial etherification of the anhydroglucose units of pure cellulose (wood pulp) with propylene oxide/hydroxypropyl groups. The resulting product is then purified, dried and milled to yield low-substituted hydroxypropyl cellulose. L-HPC contains not less than 5,0 % and not more than 16,0 % of hydroxypropoxy groups, calculated on the dried basis. L-HPC differs from hydroxypropyl cellulose (E 463) with respect to the degree of molar substitution with hydroxypropoxy groups of the glucose ring unit (0,2 for L-HPC vs 3,5 for E 463) of the cellulose backbone. IUPAC name Cellulose, 2-hydroxypropyl ether (low substituted) CAS number 9004-64-2 Einecs number Chemical name Hydroxypropyl ether of cellulose, low-substituted Chemical formula The polymers contain substituted anhydroglucose units with the following general formula: C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 ) where R 1 , R 2 , R 3 each may be one of the following: — H — CH 2 CHOHCH 3 — CH 2 CHO(CH 2 CHOHCH 3 )CH 3 — CH 2 CHO[CH 2 CHO(CH 2 CHOHCH 3 )CH 3 ]CH 3 Molecular weight From about 30 000 to 150 000 g/mol Assay The average number of hydroxypropoxy groups (–OCH 2 CHOHCH 3 ) corresponds to 0,2 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis Particle size by laser diffraction method — Not less than 45 μm (not more than 1 % in weight of particles of less than 45 μm) and not more than 65 μm by size-exclusion chromatography (SEC) — Average (D50) particle size between 47,3 μm and 50,3 μm; D90 value (90 % below given value) between 126,2 μm and 138 μm Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder Identification Passes test Solubility Insoluble in water; swelling in water. It dissolves in a solution of 10 % sodium hydroxide producing a viscous solution. Assay Determination of the degree of molar substitution by gas chromatography pH Not less than 5,0 and not more than 7,5 (1 % colloidal suspension) 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 2 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 0,5 mg/kg Cadmium Not more than 0,15 mg/kg’
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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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