Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (Codified version) (Text with EEA relevance)
| Coming into Force | 08 July 2008 |
| End of Effective Date | 30 November 2012 |
| Celex Number | 32008L0060 |
| ELI | http://data.europa.eu/eli/dir/2008/60/oj |
| Published date | 18 June 2008 |
| Date | 17 June 2008 |
| Official Gazette Publication | Official Journal of the European Union, L 158, 18 June 2008 |
| 18.6.2008 | EN | Official Journal of the European Union | L 158/17 |
COMMISSION DIRECTIVE 2008/60/EC
of 17 June 2008
laying down specific purity criteria concerning sweeteners for use in foodstuffs
(Text with EEA relevance)
(Codified version)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
Whereas:
| (1) | Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (2) has been substantially amended several times (3). In the interest of clarity and rationality the said Directive should be codified. |
| (2) | It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (4). |
| (3) | It is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). |
| (4) | Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria. |
| (5) | The measures provided for in this Directive are in line with the opinion of the Standing Committee on the Food Chain and Animal Health. |
| (6) | This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.
Article 2
Directive 95/31/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 17 June 2008.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
(2) OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6).
(3) See Annex II, Part A.
(4) OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, p. 10).
ANNEX I
| E 420 (i) — SORBITOL | |||
| Synonyms | D-glucitol, D-sorbitol | ||
| Definition | |||
| Chemical name | D-glucitol | ||
| Einecs | 200-061-5 | ||
| Chemical formula | C6H14O6 | ||
| Relative molecular mass | 182,17 | ||
| Assay | Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer | ||
| Description | White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste | ||
| Identification | |||
| Very soluble in water, slightly soluble in ethanol | ||
| 88 to 102 °C | ||
| To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C | ||
| Purity | |||
| Water content | Not more than 1 % (Karl Fischer method) | ||
| Sulphated ash | Not more than 0,1 % expressed on dry weight basis | ||
| Reducing sugars | Not more than 0,3 % expressed as glucose on dry weight basis | ||
| Total sugars | Not more than 1 % expressed as glucose on dry weight basis | ||
| Chlorides | Not more than 50 mg/kg expressed on dry weight basis | ||
| Sulphates | Not more than 100 mg/kg expressed on dry weight basis | ||
| Nickel | Not more than 2 mg/kg expressed on dry weight basis | ||
| Arsenic | Not more than 3 mg/kg expressed on dry weight basis | ||
| Lead | Not more than 1 mg/kg expressed on dry weight basis | ||
| Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis | ||
| E 420 (ii) — SORBITOL SYRUP | |||
| Synonyms | D-glucitol syrup | ||
| Definition | |||
| Chemical name | Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides. The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer | ||
| Einecs | 270-337-8 | ||
| Assay | Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis | ||
| Description | Clear colourless and sweet-tasting aqueous solution | ||
| Identification | |||
| Miscible with water, with glycerol, and with propane-1,2-diol | ||
| To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C | ||
| Purity | |||
| Water content | Not more than 31 % (Karl Fischer method) | ||
| Sulphated ash | Not more than 0,1 % expressed on dry weight basis | ||
| Reducing sugars | Not more than 0,3 % expressed as glucose on dry weight basis | ||
| Chlorides | Not more than 50 mg/kg expressed on dry weight basis | ||
| Sulphates | Not more than 100 mg/kg expressed on dry weight basis | ||
| Nickel | Not more than 2 mg/kg expressed on dry weight basis | ||
| Arsenic | Not more than 3 mg/kg expressed on dry weight basis | ||
| Lead | Not more than 1 mg/kg expressed on dry weight basis | ||
| Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis | ||
| E 421 — MANNITOL | |||
| (I) MANNITOL | |||
| Synonyms | D-mannitol | ||
| Definition | Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose | ||
| Chemical name | D-mannitol | ||
| Einecs | 200-711-8 | ||
| Chemical formula | C6H14O6 | ||
| Molecular weight | 182,2 | ||
| Assay | Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis | ||
| Description | White, odourless, crystalline powder | ||
| Identification | |||
| Soluble in water, very slightly soluble in ethanol, practically insoluble in ether | ||
| Between 164 and 169 °C | ||
| Passes test | ||
| [α] 20 D: + 23 ° to + 25 ° (borate solution) | ||
| Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH | ||
| Purity | |||
| Loss on drying | Not more than 0,3 % (105 °C, four hours) | ||
| Reducing sugars | Not more than 0,3 % (as glucose) | ||
| Total sugars | Not more than 1 % (as glucose) | ||
| Sulphated ash | Not more than 0,1 % | ||
| Chlorides | Not more than 70 mg/kg | ||
| Sulphate | Not more than 100 mg/kg | ||
| Nickel | Not more than 2 mg/kg | ||
| Lead | Not more than 1 mg/kg | ||
| (II) MANNITOL MANUFACTURED BY FERMENTATION | |||
| Synonyms | D-mannitol | ||
| Definition | Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii | ||
| Chemical name | D-mannitol | ||
| Einecs | 200-711-8 | ||
| Chemical formula | C6H14O6 | ||
| Molecular weight | 182,2 | ||
| Assay | Not less than 99 % on the dried basis | ||
| Description | White, odourless crystalline powder | ||
| Identification | |||
| Soluble in water, very slightly soluble in ethanol, practically insoluble in ether | ||
| Between 164 and 169 °C | ||
| Passes test | ||
| [α] 20 D: + 23 ° to + 25 ° (borate solution) | ||
| Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH | ||
| Purity | |||
| Arabitol | Not more than 0,3 % | ||
| Loss on drying | Not more than 0,3 % (105 °C, four hours) | ||
| Reducing sugars | Not more than 0,3 % (as glucose) | ||
| Total sugars | Not more than 1 % (as glucose) | ||
| Sulphated ash | Not more than 0,1 % | ||
| Chlorides | Not more than 70 mg/kg | ||
| Sulp | |||
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