Contents
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 additivesnote, 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 flavouringsnote, and in particular Article 7(5) thereof,Whereas:
(1)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.
(2)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.
(3)Commission Regulation (EU) No 231/2012note lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.
(4)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.
(5)On 25 January 2018, an application was submitted for the authorisation of the use of oat lecithin as a food additive in the food category 5.1 ‘Cocoa and Chocolate products as covered by Directive 2000/36/EC’ of the European Parliament and of the Councilnote in Part E of Annex II to Regulation (EC) No 1333/2008, at a maximum level of 20000 mg/kg. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(6)The European Food Safety Authority (‘the Authority’) evaluated the safety of oat lecithin as a food additive and, in its opinionnote of 10 December 2019, it concluded that there is no safety concern for oat lecithin to be used as a food additive for the proposed use and use levels.
(7)Oat lecithin is a fractionated oat oil, which acts as an emulsifier and facilitates the manufacturing of cocoa and chocolate products by reducing the viscosity and yield value of chocolate products. This allows molten chocolate to be pumped easily during processing. Furthermore, oat lecithin prevents fat bloom, a greyish haze, from developing on the surface of products during storage.
(8)It is therefore appropriate to authorise the use of oat lecithin as an emulsifier in the food category ‘cocoa and chocolate products as covered by Directive 2000/36/EC’, at the maximum use level of 20000 mg/kg, and to assign E 322a as E-number to that additive.
(9)The specifications for oat lecithin (E 322a) should be included in Regulation (EU) No 231/2012, as 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.
(10)Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly.
(11)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
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.
Annex I
(1)in Part B, point 3 ‘Additives other than colours and sweeteners’, the following new entry is inserted after the entry for food additive E 322:E 322a | Oat lecithin
(2)in Part E, in food category 5.1 ‘Cocoa and Chocolate products as covered by Directive 2000/36/EC’, the following new entry for ‘Oat lecithin’ is inserted after the entry for E 322:| E 322a | Oat lecithin | 20000 | | |
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
Annex II
In the Annex to Regulation (EU) No 231/2012, the following entry is inserted after the entry for food additive E 322:
E 322a OAT LECITHINSynonyms | Fractionated oat oilDefinition | Oat lecithin is a fractionated oat oil rich in polar lipids, mainly galactolipids. Oat lecithin is produced from food grade oat kernels that are sieved and extracted using ethanol at an elevated temperature to produce a crude lipid extract. This crude extract undergoes multistage evaporation and filtration, yielding crude oat oil, which is separated, evaporated and filtered to produce oat lecithin.Only ethanol may be used in the extraction as extraction solvent.Einecs | 281-672-4Assay | Not less than 30 % of polar lipids insoluble in acetoneDescription | Yellowish-brown viscous liquidIdentification |Choline | Not more than 2 g/100 gPhosphorous | Not less than 0,5 %Polar lipids | Not less than 35 % w/wNeutral lipids | 55–65 % w/wSaturated | 17–20 % w/wMonounsaturated | 38–42 % w/wPolyunsaturated | 38–42 % w/wPurity |Loss of drying | Not more than 2 %Toluene-insoluble matter | Not more than 1 % w/wAcid value | Not more than 30 mg KOH/gPeroxide value | less than 10 meq O2/kg fatSolvent residues | Ethanol: not more than 300 mg/kgArsenic | Not more than 0,1 mg/kgLead | Not more than 0,05 mg/kgMercury | Not more than 0,02 mg/kgCadmium | Not more than 0,05 mg/kgMicrobiological criteria |Aerobic plate count | Not more than 1000 CFU/gYeast | Not more than 100 CFU/gMoulds | Not more than 100 CFU/gEnterobacteriaceae | Not more than 10 CFU/gAerobic spores | Not more than 1 CFU/gOther |Gluten | Not more than 20 mg/kg
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.