# 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), Annex II

Extent: E+W+S+N.I.

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:
C6H7O2(OR1)(OR2)(OR3)
where R1, R2, R3 each may be one of the following:
H
CH2CHOHCH3
CH2CHO(CH2CHOHCH3)CH3
CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weight
From about 30 000 to 150 000 g/mol
Assay
The average number of hydroxypropoxy groups
(–OCH2CHOHCH3) 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: https://www.legislation.gov.uk/eur/2018/1461/annex/II (the official version)
Page: https://openlegislation.uk/eu-regulation-2018-1461/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.