Document ID: 32018R1461
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>1.10.2018&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 245/1</p></td></tr></tbody></table>
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( 1 ) , and in particular Articles 10(3) and 14 thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings ( 2 ) , and in particular Article 7(5) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>Only food additives included in the Union list in Annex II to Regulation (EC) No 1333/2008 may be placed on the market as such and used in foods under the conditions of use specified therein.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Regulation (EU) No 231/2012&#160;<a>(<span>3</span>)</a> lays down specifications for food additives listed in Annexes II and&#160;III to Regulation (EC) No 1333/2008.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>The Union list and the specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>On 21&#160;October 2016 an application was submitted for the authorisation of the use of low-substituted hydroxypropyl cellulose (L-HPC) as a food additive in food supplements in tablet form falling under the food category&#160;17.1 &#8216;Food supplements supplied in a solid form&#8217; in Part E of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>The European Food Safety Authority evaluated the safety of L-HPC as a food additive and in its opinion&#160;<a>(<span>4</span>)</a> of 20&#160;January 2018 concluded that there was no safety concern from the proposed use in food supplements in solid form (tablet), at a maximum use level of 20&#160;000 mg/kg and a typical use level of 10&#160;000 mg/kg.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Low-substituted hydroxypropyl cellulose (L-HPC) is water insoluble cellulose that facilitates the manufacturing of solid food supplements in tablet form due to its good compressibility and binding properties.&#160;Being insoluble in water, it absorbs water while increasing in volume. The increased volume makes the tablet disintegrating rapidly providing a fast release of the nutrients in the stomach.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>It is therefore appropriate to include low-substituted hydroxypropyl cellulose (L-HPC) in the Union list of food additives and to assign E 463a as E-number to that additive to enable its authorisation as a glazing agent in food supplements in solid form (tablet) at a maximum use level of 20&#160;000 mg/kg.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>The specifications for low-substituted hydroxypropyl cellulose (L-HPC) (E 463a) should be included in Regulation (EU) No 231/2012 when it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</p></td><td><p>Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(11)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
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 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 September 2018.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 354, 31.12.2008, p. 16 .
( 2 ) OJ L 354, 31.12.2008, p. 1 .
( 3 ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( OJ L 83, 22.3.2012, p. 1 ).
( 4 ) EFSA Journal 2018;16(1):5062.
ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Part B, point 3 &#8216;Additives other than colours and sweeteners&#8217;, the following new entry E 463a for Low-substituted hydroxypropyl cellulose (L-HPC) is inserted after the entry for E 463 Hydroxypropyl cellulose:</p><table><col/><col/><tbody><tr><td><p>&#8216;E 463a</p></td><td><p>Low-substituted hydroxypropyl cellulose (L-HPC)&#8217;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Part E, in food category 17.1 &#8216;Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms&#8217;, the following new entry for Low-substituted hydroxypropyl cellulose (L-HPC) is inserted after the entry for E 459 Beta-cyclodextrin:</p><table><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>&#8216;E 463a</p></td><td><p>Low-substituted hydroxypropyl cellulose (L-HPC)</p></td><td><p>20&#160;000</p></td><td><p>&#160;</p></td><td><p>only food supplements in tablet form&#8217;</p></td><td><p>&#160;</p></td></tr></tbody></table></td></tr></tbody></table>
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):
<table><col/><col/><tbody><tr><td><p>&#8216;<span>E 463a LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (L-HPC)</span></p></td></tr><tr><td><p><span>Synonyms</span></p></td><td><p>Cellulose hydroxypropyl ether, low substituted</p></td></tr><tr><td><p><span>Definition</span></p></td><td><p>L-HPC is a low-substituted poly (hydroxypropyl) ether of cellulose.</p><p>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.</p><p>L-HPC contains not less than 5,0 % and not more than 16,0 % of hydroxypropoxy groups, calculated on the dried basis.</p><p>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.</p></td></tr><tr><td><p>IUPAC name</p></td><td><p>Cellulose, 2-hydroxypropyl ether (low substituted)</p></td></tr><tr><td><p>CAS number</p></td><td><p>9004-64-2</p></td></tr><tr><td><p>Einecs number</p></td><td><p>&#160;</p></td></tr><tr><td><p>Chemical name</p></td><td><p>Hydroxypropyl ether of cellulose, low-substituted</p></td></tr><tr><td><p>Chemical formula</p></td><td><p>The polymers contain substituted anhydroglucose units with the following general formula:</p><p>C<span>6</span>H<span>7</span>O<span>2</span>(OR<span>1</span>)(OR<span>2</span>)(OR<span>3</span>)</p><p>where R<span>1</span>, R<span>2</span>, R<span>3</span> each may be one of the following:</p><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>H</p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>CH<span>2</span>CHOHCH<span>3</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>CH<span>2</span>CHO(CH<span>2</span>CHOHCH<span>3</span>)CH<span>3</span></p></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>&#8212;</p></td><td><p>CH<span>2</span>CHO[CH<span>2</span>CHO(CH<span>2</span>CHOHCH<span>3</span>)CH<span>3</span>]CH<span>3</span></p></td></tr></tbody></table></td></tr><tr><td><p>Molecular weight</p></td><td><p>From about 30&#160;000  to 150&#160;000  g/mol</p></td></tr><tr><td><p>Assay</p></td><td><p>The average number of hydroxypropoxy groups</p><p>(&#8211;OCH<span>2</span>CHOHCH<span>3</span>) corresponds to 0,2 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis</p></td></tr><tr><td><p>Particle size</p></td><td><p>by laser diffraction method &#8212; Not less than 45 &#956;m (not more than 1 % in weight of particles of less than 45 &#956;m) and not more than 65 &#956;m</p><p>by size-exclusion chromatography (SEC) &#8212; Average (D50) particle size between 47,3&#160;&#956;m and 50,3 &#956;m; D90 value (90 % below given value) between 126,2 &#956;m and 138&#160;&#956;m</p></td></tr><tr><td><p><span>Description</span></p></td><td><p>Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder</p></td></tr><tr><td><p><span>Identification</span></p></td><td><p>Passes test</p></td></tr><tr><td><p>Solubility</p></td><td><p>Insoluble in water; swelling in water. It dissolves in a solution of 10 % sodium hydroxide producing a viscous solution.</p></td></tr><tr><td><p>Assay</p></td><td><p>Determination of the degree of molar substitution by gas chromatography</p></td></tr><tr><td><p>pH</p></td><td><p>Not less than 5,0 and not more than 7,5 (1 % colloidal suspension)</p></td></tr><tr><td><p><span>Purity</span></p></td><td><p>&#160;</p></td></tr><tr><td><p>Loss on drying</p></td><td><p>Not more than 5,0 % (105 &#176;C, 1 hour)</p></td></tr><tr><td><p>Residue on ignition</p></td><td><p>Not more than 0,8 % determined at 800 &#176;C &#177; 25 &#176;C</p></td></tr><tr><td><p>Propylene chlorohydrins</p></td><td><p>Not more than 0,1 mg/kg (on an anhydrous basis) (gas chromatography&#8211;mass spectrometry (GC&#8211;MS))</p></td></tr><tr><td><p>Arsenic</p></td><td><p>Not more than 2 mg/kg</p></td></tr><tr><td><p>Lead</p></td><td><p>Not more than 1 mg/kg</p></td></tr><tr><td><p>Mercury</p></td><td><p>Not more than 0,5 mg/kg</p></td></tr><tr><td><p>Cadmium</p></td><td><p>Not more than 0,15 mg/kg&#8217;</p></td></tr></tbody></table>