ANNEX IISupplementary provisions
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’