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.)

• CELEX: Regulation (EU) 2018/1461
• 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:

(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 II

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’