ANNEX IISupplementary provisions
ANNEX II The Annex to Regulation (EU) No 231/2012 is amended as follows: (1) the entry for food additive E 422 Glycerol is replaced by the following: ‘ E 422 GLYCEROL Synonyms Glycerin; Glycerine Definition Glycerol is obtained only from vegetable oils and fats, either directly or from the crude glycerol obtained as a by-product of biodiesel production and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. Einecs 200-289-5 Chemical name 1,2,3-propanetriol; Glycerol; Trihydroxypropane Chemical formula C 3 H 8 O 3 Molecular weight 92,10 Assay Content not less than 98 % of glycerol on the anhydrous basis Description Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable Identification Specific gravity (25 °C/25 °C) Not less than 1,257 Refractive index [n] D 20 between 1,471 and 1,474 Purity Water content Not more than 5 % (Karl Fischer method) Sulphated ash Not more than 0,01 % determined at 800 ± 25 °C Butanetriols Not more than 0,2 % Acrolein Not more than 3 mg/kg Fatty acids and esters Not more than 0,1 % calculated as butyric acid Chlorinated compounds Not more than 30 mg/kg (as chlorine) 3-Monochloropropane-1,2-diol (3- MCPD) Not more than 0,1 mg/kg Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg’ (2) the entry for food additive E 475 Polyglycerol esters of fatty acids is replaced by the following: ‘ E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS Synonyms Polyglycerol fatty acid esters; Polyglycerin esters of fatty acid esters Definition Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol. The polyglycerol is produced from glycerol complying with the specifications for E 422. Einecs Chemical name Chemical formula Molecular weight Assay Content of total fatty acid ester not less than 90 % Description Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids Identification Test for glycerol Passes test Test for polyglycerols Passes test Test for fatty acids Passes test Solubility The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils Purity Sulphated ash Not more than 0,5 % (800 ± 25 °C) Acids other than fatty acids Less than 1 % Free fatty acids Not more than 6 % estimated as oleic acid Total glycerol and polyglycerol Not less than 18 % and not more than 60 % Free glycerol and polyglycerol Not more than 7 % Arsenic Not more than 0,1 mg/kg Lead Not more than 0,3 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD Not more than 2,5 mg/kg Glycidyl fatty acid esters, expressed as glycidol Not more than 10 mg/kg. This applies from 20 July 2023 until 20 January 2024. Not more than 5 mg/kg. This applies from 20 January 2024. Erucic acid Not more than 2 % Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). ’; (3) the entry for food additive E 476 Polyglycerol polyricinoleate is replaced by the following: ‘ E 476 POLYGLYCEROL POLYRICINOLEATE Synonyms Glycerol esters of condensed castor oil fatty acids; Polyglycerol esters of polycondensed fatty acids from castor oil; Polyglycerol esters of interesterified ricinoleic acid; PGPR Definition Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids. Castor oil used for the production of polyglycerol polyricinoleate is free of ricin. The polyglycerol is produced from glycerol complying with the specifications for E 422. Einecs Chemical name Chemical formula Molecular weight Assay Description Clear, highly viscous liquid Identification Solubility Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons Test for glycerol Passes test Test for polyglycerols Passes test Test for ricinoleic acid Passes test Refractive index [n] D 65 between 1,4630 and 1,4665 Purity Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol Hydroxyl value Not less than 80 and not more than 100 Acid value Not more than 6 Arsenic Not more than 0,1 mg/kg Lead Not more than 0,1 mg/kg Mercury Not more than 0,1 mg/kg Cadmium Not more than 0,1 mg/kg Sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD) Not more than 2,5 mg/kg Glycidyl fatty acid esters (expressed as glycidol) Not more than 1 mg/kg’