Document ID: 32022R1037
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>30.6.2022&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 173/52</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2022/1037
of 29 June 2022
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 glycolipids as a preservative in beverages
(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&#160;1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>The Annex to Commission Regulation (EU) No&#160;231/2012&#160;<a>(<span>3</span>)</a> lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No&#160;1333/2008.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>The Union list of food additives and the specifications for food additives may be updated in accordance with the common procedure referred to in Article&#160;3(1) of Regulation (EC) No&#160;1331/2008, either on the initiative of the Commission or following an application from a Member State or an interested party.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In December 2019, an application was submitted to the Commission for the authorisation of use of glycolipids as a preservative in flavoured drinks, some other products falling under the category 14.1 &#8216;non-alcoholic beverages&#8217; and alcohol free beer and malt beverages.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The European Food Safety Authority (&#8216;the Authority&#8217;) evaluated the safety of the proposed use of glycolipids as a food additive. In the Authority&#8217;s opinion&#160;<a>(<span>4</span>)</a> adopted on 4&#160;May 2021, an acceptable daily intake (&#8216;ADI&#8217;) of 10 mg/kg bw per day was established. The Authority noted that the highest estimate of exposure of 3,1&#160;mg/kg bw per day, in toddlers, is within the established ADI and concluded that the exposure to glycolipids does not raise a safety concern at the uses and use levels proposed by the applicant.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>Glycolipids are produced by fungus<span>Dacryopinax spathularia</span> in a fermentation process. Glycolipids, when used as a preservative, prolong the shelf life of beverages by protecting them against deterioration caused by micro-organisms and inhibit the growth of pathogenic micro-organisms. Glycolipids are active against yeast, moulds and gram-positive bacteria and can serve as an alternative to other preservatives currently authorised in beverages.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>It is therefore appropriate to authorise the use of glycolipids as a preservative in the beverages covered by the application and to assign E 246 as the E-number to that additive.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The specifications for glycolipids (E 246) should be included in the Annex to Regulation (EU) No&#160;231/2012 as this additive is included in the Union list of food additives laid down in Annex II to Regulation (EC) No&#160;1333/2008 for the first time.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(9)</p></td><td><p>Regulations (EC) No&#160;1333/2008 and (EU) No&#160;231/2012 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(10)</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, 29 June 2022.
For the Commission
The President
Ursula VON DER LEYEN
( 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 2021;19(6):6609
ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
<table><col/><col/><tbody><tr><td><p>(a)</p></td><td><p>in Part B, point 3 &#8216;Additives other than colours and sweeteners&#8217;, the following new entry is inserted after the entry for food additive E 243:</p><table><col/><col/><tbody><tr><td><p>&#8216;E 246</p></td><td><p>Glycolipids&#8217;</p></td></tr></tbody></table></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(b)</p></td><td><p>Part E is amended as follows:</p><table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>in Category 14.1.4 (Flavoured drinks), the entry for E 246 (Glycolipids) is inserted after the entry for E 242:</p><table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>&#8216;E 246</p></td><td><p>Glycolipids</p></td><td><p>50</p></td><td><p>&#160;</p></td><td><p>excluding dairy based drinks&#8217;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>in Category 14.1.5.2 (Other), the entry for E 246 (Glycolipids) is inserted after the entry for E 242:</p><table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>&#8216;E 246</p></td><td><p>Glycolipids</p></td><td><p>20</p></td><td><p>(93)</p></td><td><p>only liquid tea concentrates and liquid fruit and herbal infusion concentrates&#8217;</p></td></tr></tbody></table></td></tr></tbody></table><table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>in Category 14.2.1 (Beer and malt beverages), the entry for E 246 (Glycolipids) is inserted after the entry for E 220 &#8211; 228:</p><table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#160;</p></td><td><p>&#8216;E 246</p></td><td><p>Glycolipids</p></td><td><p>50</p></td><td><p>&#160;</p></td><td><p>only alcohol free beer and malt beverages&#8217;</p></td></tr></tbody></table></td></tr></tbody></table></td></tr></tbody></table>
ANNEX II
In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for food additive E 243:
<table><col/><col/><tbody><tr><td><p>&#8216;<span>E 246 glycolipids</span></p></td></tr><tr><td><p><span>Synonyms</span></p></td><td><p>&#160;</p></td></tr><tr><td><p><span>Definition</span></p></td><td><p>The naturally occurring glycolipids are obtained by a fermentation process using the wild type strain MUCL 53181 of the fungus<span>Dacryopinax spathularia</span> (edible sweet osmanthus ear mushroom). Glucose is used as a carbon source. The solvent-free downstream process includes filtration and microfiltration to remove microbial cells, precipitation and washing with buffered water to purify. The product is pasteurized and spray-dried. The production process does not chemically modify the glycolipids or change their innate composition.</p></td></tr><tr><td><p>CAS number</p></td><td><p>2205009-17-0</p></td></tr><tr><td><p>Chemical name</p></td><td><p>Glycolipids from<span>Dacryopinax spathularia</span></p></td></tr><tr><td><p>Assay</p></td><td><p>Not less than 93&#160;% total glycolipid content on the dried basis.</p></td></tr><tr><td><p><span>Description</span></p></td><td><p>Beige to light brown powder, weak characteristic odour</p></td></tr><tr><td><p><span>Identification</span></p></td><td><p>&#160;</p></td></tr><tr><td><p>Solubility</p></td><td><p>Complies (10 g/l in water)</p></td></tr><tr><td><p>pH</p></td><td><p>Between 5,0 and&#160;7,0 (10 g/l in water)</p></td></tr><tr><td><p>Turbidity</p></td><td><p>Not more than 28 NTU (10 g/l in water)</p></td></tr><tr><td><p><span>Purity</span></p></td><td><p>&#160;</p></td></tr><tr><td><p>Water content</p></td><td><p>Not more than 5&#160;% (Karl Fischer Method)</p></td></tr><tr><td><p>Protein</p></td><td><p>Not more than 3&#160;% (factor N x 6,25)</p></td></tr><tr><td><p>Fat</p></td><td><p>Not more than 2&#160;% (gravimetric)</p></td></tr><tr><td><p>Sodium</p></td><td><p>Not more than 3,3&#160;%</p></td></tr><tr><td><p>Arsenic</p></td><td><p>Not more than 1 mg/kg</p></td></tr><tr><td><p>Lead</p></td><td><p>Not more than 0,7&#160;mg/kg</p></td></tr><tr><td><p>Cadmium</p></td><td><p>Not more than 0,1&#160;mg/kg</p></td></tr><tr><td><p>Mercury</p></td><td><p>Not more than 0,1&#160;mg/kg</p></td></tr><tr><td><p>Nickel</p></td><td><p>Not more than 2 mg/kg</p></td></tr><tr><td><p><span>Microbiological criteria</span></p></td><td><p>&#160;</p></td></tr><tr><td><p>Total aerobic count</p></td><td><p>Not more than 100 colonies per gram</p></td></tr><tr><td><p>Yeast and moulds</p></td><td><p>Not more than 10 colonies per gram</p></td></tr><tr><td><p>Coliforms</p></td><td><p>Not more than 3 MPN per gram</p></td></tr><tr><td><p><span>Salmonella</span> spp.</p></td><td><p>Absent in&#160;25 g&#8217;</p></td></tr></tbody></table>