1978L0663 — EN — 29.02.1992 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 25July 1978
laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for
use in foodstuffs
(78/663/EEC)
(OJ L 223, 14.8.1978, p. 7)
Amended by:
OfficialJournal
No page date
►M1 CouncilDirective 82/504/EEC of 12 Jul y 1982 L 230 35 5.8.1982
►M2 Commission Directive 90/612/EEC of 26 October 1990 L 326 58 24.11.1990
►M3 Commission Directive 92/4/EEC of 10 February 1992 L 55 96 29.2.1992
Corrected by:
►C1 Corrigendum, OJ L 296, 21.10.1978, p. 50 (78/663)
►C2 Corrigendum, OJ L 91, 10.4.1979, p. 7 (78/663)
1978L0663 — EN — 29.02.1992 — 001.001 — 2
▼B
COUNCIL DIRECTIVE
of 25July 1978
laying down specific criteria of purity for emulsifiers, stabilizers,
thickeners and gelling agents for use in foodstuffs
(78/663/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,
Having regard to CouncilDirective 74/329/EEC of 18 June 1974 on the
approximation of the laws of the Member States relating to emulsifiers,stabilizers, thickeners and gelling agents for use in foodstuffs (
1), as last
amended by Directive 78/612/EEC (2), and in particular Article 7 (1)
thereof,
Having regard to the proposalfrom the Commission,Whereas under Article 6 of Directive 74/329/EEC emulsifiers, stabi-
lizers, thickeners and gelling agents must satisfy specific criteria ofpurity established in accordance with Article 7 (1) of that Directive,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The specific criteria of purity referred to in Article 6 (1) (b) of Directive
74/329/EEC are given in the Annex to this Directive.
▼M1
Article 2
As regards the substances referred to in the Annex under E 477,
Member States may, until31 December 1984, authorize for use infoodstuffs a product containing not more than 4 % dimer and trimer ofpropane-1,2-diol.
▼
B
Article 3
Member States shall bring into force the laws, regulations and adminis-
trative provisions necessary to comply with this Directive not later than18 months after the notification of this Directive. They shall forthwithinform the Commission thereof.
Article 4
This Directive is addressed to the Member States.
(1) OJ No L 189, 12. 7. 1974, p. 1.
(2) OJ No L 197, 22. 7. 1978, p. 22.
1978L0663 — EN — 29.02.1992 — 001.001 — 3
▼B
ANNEX
SPECIFIC CRITERIA OF PURITY FOR EMULSIFIERS, STABILIZERS,
THICKENERS AND GELLING AGENTS FOR USE IN FOODSTUFFS
General observations
(a) Where interpretation of the criteria set out below requires the definition of
certain technical details, reference should be made to the methods of analysisestablished pursuant to Article 7 (2) of Directive 74/329/EEC.
(b) Unless otherwise stated, the quantities and percentages shall be calculated in
terms of weight of the product as such.
(c) The specific criteria of purity applicable to substances E 322, E 339 (i), (ii)
and (iii), E 340 (i), (ii) and (iii) and E 341 (i) and (ii) are laid down byCouncil Directive 78/664/EEC of 25 July 1978 laying down specific criteriaof purity for antioxidants which may be used in foodstuffs intended forhuman consumption (
1). The regime applicable to hydrolysed lecithins is set
out in the same Directive.
E 341 — (iii) Tricalcium orthophosphate
Chemical description — tricalcium diorthophosphate; Ca3(PO4)2,
— hydroxyapatite; Ca5(PO4)3OH.
Appearance Impalpable white powder.
Content Not less than 90 % expressed as Ca3(PO4)2after calcination at
8 0 0±2 5 °C to constant weight.
Volatile matter Not more than 10 % determined by calcination at 800 ± 25 °C
to constant weight.
Fluoride Not more than 50 mg/kg expressed as fluorine.
E 400 — Alginic acidChemical description Linear glycuronoglycan consisting mainly of beta (1-4) linked
D-mannuronic and alpha (1-4) linked L-guluronic acid units inpyranose ring form. Hydrophilic colloidal carbohydrateextracted by the use of dilute alkali from various species ofbrown seaweeds.
Description Nearly odourless, tasteless, white to yellowish fibrous powder.
Content Yields, on a volatile matter-free basis, not less than 20 % and
not more than 23 % of carbon dioxide corresponding to not lessthan 91.0 % and not more than 104.5 % of alginic acid (equiva-lent weight 200).
Ash Not more than 4 % on a volatile matter-free basis determined at
600 °C after drying at 105 °C for four hours.
▼
M1
▼B
Volatile matter Not more than 15 % determined by drying at 105 °C for four
hours.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)►
M1Not more than 2 %. ◄
(1) OJ No L 223, 14. 8. 1978, p. 30.
1978L0663 — EN — 29.02.1992 — 001.001 — 4
▼B
E 401 — Sodium alginate
Chemical name Sodium salt of alginic acid.
Description Nearly odourless, tasteless white to yellowish fibrous or gran-
ular powder.
Content Yields, on a volatile matter-free basis, not less than 18 % and
not more than 21 % of carbon dioxide corresponding to not lessthan 90.8 % and not more than 106.0 % of sodium alginate(equivalent weight 222).
Ash Not less than 18.0 % and not more than 27.0 % on a volatile
matter-free basis determined at 600 °C after drying at 105 °C
for four hours.
▼
M1
▼B
Volatile matter Not more than 15 % determined by drying at 105 °C for four
hours.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)►
M1Not more than 2 %. ◄
E 402 — Potassium alginate
Chemical name Potassium salt of alginic acid.
Description Nearly odourless, tasteless white to yellowish fibrous or gran-
ular powder.
Content Yields, on a volatile matter-free basis, not less than 16.5 % and
not more than 19.5 % of carbon dioxide corresponding to notless than 89.2 % and not more than 105.5 % of potassiumalginate (equivalent weight 238).
Ash Not less than 23 % and not more than 32 % on a volatile
matter-free basis determined at 600 °C after drying at 105 °C
for four hours.
▼
M1
▼B
Volatile matter Not more than 15 % determined by drying at 105 °C for four
hours.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)►
M1Not more than 2 %. ◄
E 403 — Ammonium alginate
Chemical name Ammonium salt of alginic acid.
Description White to yellowish fibrous or granular powder.
Content Yields, on a volatile matter-free basis, not less than 18 % and
not more than 21 % of carbon dioxide corresponding to not lessthan 88.7 % and not more than 103.6 % of ammonium alginate(equivalent weight 217).
Ash Not more than 4% on a volatile matter-free basis determined at
600 °C after drying at 105 °C for four hours
▼
M1
▼B
Volatile matter Not more than 15% determined by drying at 105 °C for four
hours.
1978L0663 — EN — 29.02.1992 — 001.001 — 5
▼B
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)►
M1Not more than 2 %. ◄
E 404 — Calcium alginate
Chemical name Calcium salt of alginic acid.
Description Nearly odourless, tasteless white to yellowish fibrous or gran-
ular powder.
Content Yields, on a volatile matter-free basis, not less than 18 % and
not more than 21 % of carbon dioxide corresponding to not lessthan 89.6 % and not more than 104.5 % of calcium alginate(equivalent weight 219).
Ash Not less than 15 % and not more than 24 % on a volatile
matter-free basis determined at 600 °C after drying at 105 °C
for four hours.
▼
M1
▼B
Volatile matter Not more than 15 % determined by drying at 105 °C for four
hours.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)►
M1Not more than 2 %. ◄
E 405— Propane-1,2-diol alginate
Chemical description Propane-1.2-diolester of al ginic acid; varies in composition
according to its degree of esterification and the percentage offree and neutralized carboxyl groups in the molecule.
Description Nearly odourless and tasteless, white to yellowish fibrous or
granular powder.
Content Yields, on a volatile matter-free basis, not less than 16 % and
not more than 20 % of carbon dioxide.
Ash Not more than 10 % on a volatile matter-free basis determined
at 600 °C after drying at 105 °C for four hours.
Total propane-1,2-diol content Not less than 15 % and not more than 36 %.
Free propane-1,2-diol content Not more than 12 %.
▼
M1
▼B
Volatile matter Not more than 20 % determined by drying at 105 °C for four
hours.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)►
M1Not more than 2 %. ◄
E 406 — Agar
Chemical description A hydrophilic colloidal polygalactoside, about 90 % of the
galactose molecules being of the D-form and 10 % of theL-form. On about every tenth D-galactopyranose unit one of thehydroxylgroups is esterified with sul phuric acid which isneutralized by calcium, magnesium, potassium or sodium. It isextracted from certain marine algae of the families Gelidiaceae
andSphaerococcaceae and related red algae of the class Rhodo-
phyceae .
Description It occurs as white to pale yellow powder, fibres or flakes and is
either odourless, or has a slight characteristic odour and a muci-laginous taste.
1978L0663 — EN — 29.02.1992 — 001.001 — 6
▼B
Ash Not more than 6.5 % determined at 550 °C on a volatile
matter-free basis.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)Not more than 0.5 % determined at 550 °C on a volatile
matter-free basis.
Gelatin and other proteins Dissolve about 1 g of agar in 100 ml of boiling water and allow
to coolto about 50 °C. To 5 mlof the sol ution add 5 mlof
trinitrophenol solution (1 g of anhydrous trinitrophenol/100 mlof hot water). No turbidity appears within 10 minutes.
Insoluble matter (in hot water) Not more than 1 %.
Volatile matter Not more than 20 % determined by drying at 105 °C for five
hours.
Starch and dextrins Boil100 mg of agar in 100 mlof water. Cooland add a few
drops of iodine solution (14 g I
2in a solution of 36 g KI in
100 mlH2O, add three drops of HCL and dilute to 1 000 ml).
No blue or red colour is produced.
Water absorption Place 5 g of agar in a 100 ml graduated cylinder, fill to the
mark with water, mix and allow to stand at about 25 °C for 24
hours. Pour the contents of the cylinder through moistened glasswool, allowing the water to drain into a second 100 ml grad-uated cylinder. Not more than 75 ml of water is obtained.
E 407 — CarrageenanChemical description Carrageenan is obtained by aqueous extraction of seaweeds of
Gigartinaceae, Solieriaceae, Hypneaceae andFurcellariaceae ,
families of the class Rhodophyceae (red seaweeds). No organic
precipitants shall be used other than methanol, ethanol andisopropanol. Carrageenan consists chiefly of the potassium,sodium, magnesium and calcium salts of polysaccharidesulphate esters which, on hydrolysis, yield galactose and 3.6-anhydrogalactose. Carrageenan shall not be hydrolysed or other-wise chemically degraded.
Description Yellowish to colourless, coarse to fine powder which is practi-
cally odourless and has a mucilaginous taste.
Volatile matter Not more than 12 % determined by drying at 105 °C for four
hours.
Sulphate Not less than 15 % and not more than 40 % on a volatile
matter-free basis, expressed as SO
4.
▼M2
Acid-insoluble ash (insoluble in10 % w/v hydrochloric acid)Not more tha n 1 % dry matter.
Acid-insoluble matter (insoluble in
1 % v/v sulphuric acid)Not more tha n 2 % dry matter.
▼
B
Ash Not less than 15 % and not more than 40 % determined at
550 °C on a volatile matter-free basis.
Methanol, ethanol, isopropanol
contentNot more tha n 1 % singly or in combination.
Viscosityof a 1.5 % solution at
75 °CNot less than five centipoises.
E 410 — Locust bean gum
Chemical description Consists mainly of a high molecular weight hydrocolloidal poly-
saccharide, composed of galactopyranose and mannopyranoseunits combined through glycosidic linkages, which may bedescribed chemically as galactomannan.
Description Locust bean gum is the ground endosperm of the seeds of the
carob tree, Cerationia siliqua (L.) Taub. (Fam. Leguminosae ). It
is a white to yellowish-white, nearly odourless powder.
1978L0663 — EN — 29.02.1992 — 001.001 — 7
▼B
Galactomannan content Not less than 75 %.
Insoluble matter (in 0.4 N
sulphuric acid)Not more tha n 4 % after digestion for six hours.
Ash Not more than 1.2 % determined at 800 °C.
Volatile matter Not more than 14 % determined by drying to constant weight at
102 to 105 °C (three to five hours).
Protein (N × 6.25) Not more than 7 %.
E 412 — Guar gumChemical description Consists mainly of a high molecular weight hydrocolloidal poly-
saccharide composed of galactopyranose and mannopyranoseunits combined through glycosidic linkages, which may bedescribed chemically as galactomannan.
Description Guar gum is the ground endosperm of the seeds of the guar
plant,Cyamopsis tetragonolobus (L.) Taub. (Fam. Legumi-
nosae ). It is a white to yellowish-white, nearly odourless
powder.
Galactomannan content Not less than 75 %.
Insoluble matter (in 0.4 N
sulphuric acid)Not more tha n 4 % after digestion for six hours.
Ash Not more than 1.5 % determined at 800 °C.
Volatile matter Not more than 14 % determined by drying to constant weight at
102 to 105 °C (three to five hours).
Protein (N × 6.25) Not more than 7 %.
E 413 — TragacanthChemical description Consists mainly of high molecular weight polysaccharides
composed of galacto-arabans and acidic polysaccharidescontaining galacturonic acid groups.
Description Tragacanth is a dried gummy exudate obtained from Astragalus
gummifer Labillardiere , or other Asiatic species of Astra-
galus (Fam.Leguminosae ).
Unground tragacanth occurs as flattened, lamellated, frequently
curved fragments or straight or spirally twisted linear piecesfrom 0.5 to 2.5 mm in thickness. It is white to pale yellow incolour. It is odourless and has an insipid, mucilaginous taste.
Powdered tragacanth is white to yellowish-white in colour.
Viscosityof a 1 % solution at
25 °CNot less than 250 centipoises.
Ash Not more than 3.5 % determined at 550 °C.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)Not more than 0.5 % determined at 550 °C.
Karaya gum Boil1 g with 20 mlof water untila mucil age is formed. Add
5 mlof hydrochl oric acid and again boilthe mixture for fiveminutes. No permanent pink or red colour develops.
E 414 — AcaciaChemical description Consists mainly of high molecular weight polysaccharides and
their calcium, potassium and magnesium salts, which on hydrol-ysis yield arabinose, galactose, rhamnose and glucuronic acid. Itis obtained as a dried gummy exudate from the stems andbranches of Acacia senegal (L) Willd. or of related species of
Acacia (Fam.Leguminosae ).
Description Unground acacia occurs as white, yellowish-white or pale
pinkish spheroidaltears of varying sizes or in angul ar fragments.It is also available commercially in the form of white oryellowish-white flakes, granules or powder.
1978L0663 — EN — 29.02.1992 — 001.001 — 8
▼B
Ash Not more tha n 4 % determined at 550 °C.
Acid-insoluble ash (insoluble in
approximately3 N hy drochloricacid)Not more than 0.5 % determined at 550 °C.
Insoluble matter (in approximately
3 N hydrochloric acid)Not more than 1 %.
Volatile matter Not more than 15 % determined by drying at 105 °C for five
hours.
Starch or dextrin Boil a 1 in 50 solution of the gum and cool. To 5 ml add one
drop of iodine solution (14 g of iodine in a solution of 36 g ofpotassium iodide in 100 mlof water, add three drops of hydro-chloric acid and dilute to 1 000 ml). No bluish or reddish colouris produced.
Tannin T o1 0m lo fa1i n5 0s o l ution add about 0.1 mlof ferric
chloride solution (9 g FeCl
3,6 H2O made up to 100 mlwith
water). No blackish colouration or blackish precipitate isformed.
▼
M1
E 415— Xanthan gum
Chemical description Xanthan gum is a high molecular weight polysaccharide gum
produced by pure-culture fermentation of a carbohydrate withXanthomonas campestris , purified by recovery with ethanolor
isopropanol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronicacid and pyruvic acid, and is prepared as the sodium, potassiumor calcium salt. Its solutions are neutral.
Description Cream-coloured powder.
Content Xanthan gum yields, on a volatile matter-free basis, not less than
4.2 % and not more than 5.0 % of carbon dioxide.
Volatile matter Not more than 15 % determined by drying at 105 °C for 2 1/2
hours.
Ash Not more than 16% on a volatile-matter-free basis determined at
600 °C after drying at 105 °C for four hours.
Pyruvic acid Not less than 1.5 %.
Nitrogen Not more than 1.5 %.
Isopropanol Not more than 750 mg/kg.
Microbiological criteria Viable cells of Xanthomonas campestris shall be absent.
▼
B
E 420 — (i) Sorbitol
Chemical name D-sorbitol.
Description White hygroscopic crystalline powder, flakes or granules,
having a sweet taste.
Content Sorbitol contains not less than 98 % of glycitols and not less
than 91 % of D-sorbitol, on a dry-matter basis in each case.Glycitols are compounds with the structural formula CH
2OH
(CHOH)nCH2OH where ‘n' is an integer. That part of the
product which is not D-sorbitol is composed mainly of mannitol,together with small quantities of other glycitols, where n ≤4,
and minor quantities of hydrogenated oligosaccharides.
Water Not more tha n 1 % (KarlFischer).
Reducing sugars Not more than 0.3 % on a dryweight basis, expressed as
dextrose.
1978L0663 — EN — 29.02.1992 — 001.001 — 9
▼B
Total sugars Not more than 1 % on a dryweight basis, expressed as dextrose.
Sulphated ash Not more than 0.1 % at 800 ± 25 °C on a dryweight basis.
Sulphate Not more than 0.01 % on a dryweight basis, expressed as SO4.
Chloride Not more than 0.005 % on a dryweight basis, expressed as Cl.
Nickel Not more than 2 mg/kg, expressed as Ni.
E 420 — (ii) Sorbitol syrupDescription Clear, colourless and sweet-tasting aqueous solution of sorbitol
and hydrogenated oligosaccharides. That part of the productwhich is not D-sorbitolis composed mainl y of hydrogenatedoligosaccharides formed by the hydrogenation of glucose syrupused as raw material(in which case the syrup is non-crystal -lizing) or mannitol. Minor quantities of glycitols where n ≤4
may be present. Glycitols are compounds with the structuralformula CH
2OH (CHOH)nCH2OH, where ‘n' is an integer.
Content Not less than 69 % total solids and not less than 50 % of
D-sorbitol.
Reducing sugars Not more than 0.3 % on a dryweight basis, expressed as
dextrose.
Sulphated ash Not more than 0.1 % on a dryweight basis (after ignition at
8 0 0±2 5 °C).
Sulphate Not more than 0.01 % on a dryweight basis, expressed as SO4.
Chloride Not more than 0.005 % on a dryweight basis, expressed as Cl.
Nickel Not more than 2 mg/kg, expressed as Ni.
E 421 — MannitolChemical name D-mannitol.
Description White crystalline solid which is odourless and has a sweet taste.
Content Not less than 98 % of D-mannitol (C
6H14O6) on a volatile
matter-free basis.
Melting range 165 to 169 °C.
Specific rotation
[α]D25Not less than + 23.0 °and not more than + 24.3 °.
Volatile matter Not more than 0.3 % determined by drying at 105 °C for four
hours.
Reducing sugars Not more than 0.05 %, expressed as dextrose.
Sulphate Not more than 0.01 %, expressed as SO4.
Chloride Not more than 0.007 %, expressed as Cl.
Ash Not more than 0.1 % determined at 800 ± 25 °C.
Nickel Not more than 2 mg/kg, expressed as Ni.
E 422 — GlycerolDescription Clear, colourless hygroscopic syrupy liquid with a sweet taste
accompanied by a sensation of heat to the tongue.
Content Not less than 98 % of glycerol (C
3H8O3).
Specific gravity(25/25 °C) Not less than 1.257.
Refractive index
[n]D201.471 to 1.474.
1978L0663 — EN — 29.02.1992 — 001.001 — 10
▼B
Acrolein, glucose and ammonium
compoundsHeat a mixture of 5 mlof gl yceroland 5 mlof potassium
hydroxide solution (1 in 10) at 60 °C for five minutes. It neither
becomes yellow nor emits an odour of ammonia.
Butanetriols Not more than 0.2 %.
Chlorinated compounds (expressed
as Cl)Not more than 0.003 %.
Fattyacids and esters Not more than 0.1 % calculated as butyric acid.
Sulphated ash Not more than 0.01 % determined at 800 ± 25 °C.
E 440 (a) — PectinChemical description Pectin consists mainly of the partial methyl esters of polygalac-
turonic acid and their sodium, potassium, calcium andammonium salts.
Pectin is obtained by aqueous extraction of appropriate edible
plant material, usually citrus fruits or apples. No organic precipi-tants shall be used other than methanol, ethanol and isopropanol.
Description White, light yellow, light grey or light brown powder.
Galacturonic acid Not less than 65 % calculated on an ash and volatile matter-free
basis after washing with acid and alcohol.
▼
C2
Volatile matter Not more than 12 % determined by drying at 105 °C for two
hours.
▼B
Acid-insoluble ash (insoluble inapproximately3 N hy drochloricacid)Not more than 1 %.
Free methanol, ethanol and
isopropanol contentNot more than 1 %, singly or in combination, on a volatile
matter-free basis.
Sulphur dioxide residue Not more than 50 mg/kg on a volatile matter-free basis.
Nitrogen content Not more than 0.5 % determined after washing with acid and
alcohol (kjeldahl).
E 440 (b) — Amidated pectinChemical description Amidated pectin consists mainl y of the partialmethylesters and
amides of polygalacturonic acid and their ammonium, sodium,potassium and calcium salts. It is obtained by aqueous extractionof appropriate edible plant material, usually citrus fruits orapples and treatment with ammonia under alkaline conditions.No organic precipitants shall be used other than methanol,ethanoland isopropanol .
Description White, light yellow, light grey or light brown powder.
Degree of amidation Not more than 25 % of totalcarboxylgroups.
Galacturonic acid Not less than 65 % calculated on an ash and volatile matter-free
basis determined after washing with acid and alcohol.
▼
C2
Volatile matter Not more than 12 % determined by drying at 105 °C for two
hours.
▼B
Acid-insoluble ash (insoluble inapproximately3 N hy drochloricacid)Not more than 1 %.
Free methanol, ethanol and
isopropanol contentNot more than 1 %, singly or in combination, on a volatile
matter-free basis.
Sulphur dioxide residue Not more than 50 mg/kg on a volatile matter-free basis.
Nitrogen content Not more than 2.5 % after washing with acid and alcohol
(kjeldahl).
1978L0663 — EN — 29.02.1992 — 001.001 — 11
▼B
E 450 (a) — (i) Disodium dihydrogen diphosphate
Description White powder or grains.
Content Not less than 95.0 % of Na2H2P2O7.
Content in P2O5 Not less than 63.0 % and not more than 64.0 %.
Volatile matter Not more than 0.5 % determined by drying at 105 °C for four
hours.
pH of 1 % solution Not less than 3.7 and not more than 4.4.
Water insoluble matter Not more than 0.6 %.
Fluoride Not more than 10 mg/kg expressed as fluorine.
E 450 (a) — (ii) Trisodium diphosphateDescription White powder or grains. Occurs anhydrous or as a monohydrate.
Content Not less than 95.0 % of Na
3HP2O7or of Na3HP2O7,H2O.
Content in P2O5 Not less than 57.5 % and not more than 58.5 % for the anhy-
drous salt. Not less than 53.6 % and not more than 54.6 % forthe monohydrate.
p Ho fa1% solution Not less than 6.7 and not more than 7.3.
Volatile matter Not more than 0.5 % determined by drying at 105 °C for four
hours.
Water insoluble matter Not more than 0.2 %.
Fluoride Not more than 10 mg/kg expressed as fluorine.
E 450 (a) — (iii) Tetrasodium diphosphateDescription White, crystalline or granular powder. Occurs anhydrous or as a
decahydrate.
Content Not less than 95.0 % of Na
4P2O7or of Na4P2O7, 10H2O.
Content in P2O5 Not less than 52.5 % and not more than 54.0 % for the anhy-
drous salt.
Not less than 31.5 % and not more than 32.5 % for the decahy-
drate.
Loss on ignition Not more than 0.5 % for the anhydrous salt, not less than 38 %
and not more than 42 % for the decahydrate, in both casesdetermined after drying at 105 °C for four hours, followed by
ignition at 550 °C for 30 minutes.
p Ho fa1% solution Not less than 9.9 and not more than 10.7.
Water insoluble matter Not more than 0.2 %.
Fluoride Not more than 10 mg/kg expressed as fluorine.
E 450 (a) — (iv) Tetrapotassium diphosphateDescription Colourless crystals or white, very hygroscopic powder.
Content Not less than 95.0 % of K
4P2O7.
Content in P2O5 Not less than 42.0 % and not more than 43.7 %.
Loss on ignition Not more than 2 % after drying at 105 °C for four hours
followed by ignition at 550 °C for 30 minutes.
1978L0663 — EN — 29.02.1992 — 001.001 — 12
▼B
p Ho fa1% solution Not less than 10.0 and not more than 10.7.
Water insoluble matter Not more than 0.2 %.
Fluoride (expressed as F) Not more than 10 mg/kg.
E 450 (b) — (i) Pentasodium triphosphateDescription White, slightly hygroscopic granules or powder. Occurs anhy-
drous or as a hexahydrate.
Content Not less than 85.0 % of Na
5P3O10or of Na5P3O10·6H2O, the
remainder being principally other sodium phosphates(E 450).
Content in P2O5 Not less than 56.0 % and not more than 58.0 % for the anhy-
drous salt.
Not less than 43.0 % and not more than 45.0 % for the hexahy-
drate.
Loss on ignition Not more than 0.5 % for the anhydrous salt and not more than
23.5 % for the hexahydrate, in both cases determined afterdrying at 105 °C for four hours followed by ignition at 550 °C
for 30 minutes.
p Ho fa1% solution Not less than 9.3 and not more than 10.1.
Water insoluble matter Not more than 0.2 %.
Fluoride (expressed as F) Not more than 10 mg/kg.
E 450 (b) — (ii) Pentapotassium triphosphateDescription White, very hygroscopic powder.
Content Not less than 85.0 % of K
5P3O10, the remainder being princi-
pally other potassium phosphates (E 450).
Content in P2O5 Not less than 46.5 % and not more than 48.0 %.
Loss on ignition Not more than 0.5 % calculated on the P2O5content after drying
at 105 °C for four hours, followed by ignition at 550 °C for 30
minutes.
p Ho fa1% solution Not less than 9.3 and not more than 10.1.
Water insoluble matter Not more than 2 %.
Fluoride (expressed as F) Not more than 10 mg/kg.
E 450 (c) — (i) Sodium polyphosphatesChemical description Heterogeneous mixtures of sodium salts of linear condensed
polyphosphoric acids of general formula H
(n+2)PnO(3n+1)where ‘n'
is not less than 2.
Description Fine white powders or crystals or colourless glassy platelets.
Content in P2O5 Not less than 59.5 % and not more than 70.0 %, calculated on
the ignited basis.
Loss on ignition Not more than 0.5 % after drying at 105 °C for four hours
followed by ignition at 550 °C for 30 minutes.
p Ho fa1% solution Not less than 3.6 and not more than 9.0.
Water insoluble matter Not more than 0.2 %.
Fluoride Not more than 10 mg/kg expressed as fluorine.
Cyclic phosphates Not more than 8 %.
E 450 (c) — (ii) Potassium polyphosphatesChemical description Heterogeneous mixtures of potassium salts of linear condensed
polyphosphoric acids of general formula H
(n+2)PnO(3n+1)where ‘n'
is not less than 2.
1978L0663 — EN — 29.02.1992 — 001.001 — 13
▼B
Description Fine white powders or crystals or colourless glassy platelets.
Content in P2O5 Not less than 53.5 % and not more than 61.5 %, calculated on
the ignited basis.
Loss on ignition Not more than 2 % after drying at 105 °C for four hours
followed by ignition at 550 °C for 30 minutes.
p Ho fa1% solution Not more than 7.8 (1).
Water insoluble matter Not more than 0.2 % (1).
Fluoride Not more than 10 mg/kg expressed as fluorine.
Cyclic phosphates Not more than 8 %.
►M1 E 460 — (i) ◄Microcrystalline cellulose
Chemical description Microcrystalline cellulose is purified partially depolymerized
cellulose prepared by acid hydrolysis of alpha-cellulose obtaineddirectly from fibrous plant material. It has a molecular weight ofabout 36 000.
Description A fine white or almost white odourless powder.
Volatile matter Not more than 5 % determined by drying to constant weight at
105 °C.
pH Shake about 5 g with 40 mlof carbon dioxide-free water for 20
minutes and centrifuge. The pH of the supernatant liquid isbetween 5.5 and 7.
Sulphated ash Not more than 0.1 % determined at 800 ± 25 °C.
Water soluble substances Not more than 0.16 %.
Diethyl ether extractable matter Not more than 200 mg/kg.
Chloride Not more than 350 mg/kg expressed as Cl.
Sulphate Not more than 600 mg/kg expressed as SO
4.
▼M1
E 460 — (ii) Powdered cellulose
Chemical description Powdered cellulose is purified mechanically disintegrated cellu-
lose prepared by processing alpha-cellulose obtained directlyfrom fibrous plant material. It has a molecular weight of1 . 6×1 0
5or greater.
Description A white, odourless powder.
Content Not less than 92 % (C12H20O10)n.
Volatile matter Not more than 7 % determined by drying at 105 °C for three
hours.
pH Shake about 5 g with 40 mlof carbon-dioxide-free water for 20
minutes and centrifuge. The pH of the supernatant liquid isbetween 5.0 and 7.5.
Sulphated ash Not more than 0.3 % determined at 800 ± 25 °C.
Water-soluble substances Not more than 1 %.
▼
B
E 461 — Methylcellulose
Chemical description Methylcellulose is cellulose obtained directly from fibrous plant
material and partially etherified with methyl groups.
Description Slightly hygroscopic white or slightly yellowish or greyisho-
dourless and tasteless, granular or fibrous powder.
1978L0663 — EN — 29.02.1992 — 001.001 — 14
▼B
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C6H7O2(OR1) (OR2) (OR3) where
R1,R2,R3each may be
—H ,—C H
3,o r
—C H2CH2OH.
Molecular weight From about 20 000 to 380 000.
Content of substituted groups Not less than 25 % and not more than 33 % of methoxyl
groups (-OCH3). Not more than 5 % of hydroxyethoxylgroups
(-OCH2CH2OH).
Volatile matter Not more than 10 % determined by drying to constant weight at
105 °C.
Sulphated ash Not more than 1.5 % determined at 800 ± 25 °C.
p Ho fa1% solution Not less than 5 and not more than 8.
E 463 — HydroxypropylcelluloseChemical description Hydroxypropylcellulose is cellulose obtained directly from
fibrous plant material and partially etherified with hydroxy-propylgroups.
Description Slightly hygroscopic white or slightly yellowish or greyish
odourless and tasteless, granular or fibrous powder.
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR1) (OR2) (OR3) where
R1,R2,R3each may be any one of the following:
—H ,—C H
2CHOHCH3,
—C H2CHO (CH2CHOHCH3)C H3,
—C H2CHO [CH2CHO (CH2CHOHCH3)C H3]C H3.
Molecular weight From about 30 000 to 1 000 000.
Content of substituted groups Not more than 80.5 % of hydroxypropoxylgroups
(-OCH2CHOHCH3) on a volatile matter-free basis, equivalent to
not more than 4.6 hydroxypropylgroups per anhydrogl ucoseunit.
p Ho fa1% solution Not less than 5.0 and not more than 8.0.
Volatile matter Not more than 10 % determined by drying to constant weight at
105 °C.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
E 464 — HydroxypropylmethylcelluloseChemical description Hydroxypropylmethylcellulose is cellulose obtained directly
from fibrous plant material and partially etherified with methylgroups and containing a small degree of hydroxypropyl substitu-tion.
Description Slightly hygroscopic white or slightly yellowish or greyish
odourless and tasteless, granular or fibrous powder.
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR1) (OR2) (OR3) where
R1,R2and R3each may be any one of the following:
—H ,—C H
3,
—C H2CHOHCH3,
1978L0663 — EN — 29.02.1992 — 001.001 — 15
▼B
—C H2CHO (CH2CHOHCH3)C H3,
—C H2CHO [CH2CHO (CH2CHOHCH3)CH3]C H3.
Molecular weight From about 13 000 to 200 000.
Content of substituted groups Not less than 19 % and not more than 30 % of methoxyl
groups (-OCH3) and not less than 3 % and not more than 12 %
hydroxypropoxylgroups (-OCH2CHOHCH3) on a volatile
matter-free basis.
p Ho fa1% solution Not less than 5.0 and not more than 8.0.
Volatile matter Not more than 10 % determined by drying to constant weight at
105 °C.
Sulphated ash Not more than 1.5 % for products with viscosities greater than
50 cP and not more than 3.0 % for products with viscosities of50 cP or less, determined at 800 ± 25 °C.
E 465— EthylmethylcelluloseChemical description Ethylmethylcellulose is cellulose obtained directly from fibrous
plant material and partially etherified with methyl and ethylgroups.
Description Slightly hygroscopic white or slightly yellowish or greyish
odourless and tasteless, granular or fibrous powder.
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR1) (OR2) (OR3) where
R1,R2and R3each may be any one of the following:
—H ,—C H
3,
—C H2CH3.
Molecular weight From about 30 000 to 40 000.
Content of substituted groups Not less than 14.5 % and not more than 19.0 % of ethoxyl
groups (-OC2H5) and not less than 3.5 % and not more than
6.5% of methoxylgroups (-OCH3) on a volatile matter-free
basis.
Volatile matter Fibrous form: not more than 15 %. Powdered form: not more
than 10 %. determined by drying to constant weight at 105 °C
in each case.
Sulphated ash Not more than 0.6 % determined at 800 ± 25 °C.
p Ho fa1% solution Not less than 5 and not more than 8.
E 466 — CarboxymethylcelluloseChemical description Carboxymethylcellulose is the partial sodium salt of a carboxy-
methyl ether of cellulose, the cellulose being obtained directlyfrom fibrous plant material.
Description Slightly hygroscopic white or slightly yellowish or greyish
odourless and tasteless, granular or fibrous powder.
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR1) (OR2) (OR3) where
R1,R2and R3each may be any one of the following:
—H ,—C H
2COONa,
—C H2COOH.
Molecular weight ►M2Higher than approximately 17 000 (degree of polymeri-
zation approximately 100). ◄
Content Not less than 99.5 % of carboxymethylcellulose calculated on a
volatile matter-free basis.
1978L0663 — EN — 29.02.1992 — 001.001 — 16
▼B
Sodium chloride and sodium
glycolateNot more than 0.5 % total, and not more than 0.4 % of sodium
glycolate.
Degree of substitution Not less than 0.2 and not more than 1.0 carboxymethyl groups
(-CH2COOH) per anhydroglucose unit.
Sodium Not more than 9.7 % on a volatile matter-free basis.
Volatile matter Not more than 12 % determined by drying to constant weight at
105 °C.
p Ho fa1% solution Not less than 6 and not more than 8.5.
E 470 — Sodium, potassium and calcium salts of fatty acidsChemical description Sodium, potassium and calcium salts of fatty acids occurring in
food oils and fats, these salts being obtained either from ediblefats or from distilled food fatty acids.
Description White or creamy white light powders, flakes, or semi-solids.
Unsaponifiable matter Not more than 2 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Total glycerol (combined and free) Not more than 10 %.
Free alkali Not more than 0.1 % expressed as NaOH.
Matter insoluble in alcohol Not more than 0.2 % (sodium and potassium salts only).
Volatile matter Not more than 3 %.
Content of sodium, or potassium,
or calciumSodium
Not less than 9.0 % and not more than 14.0 % expressed as
Na
2O.
PotassiumNot less than 13.0 % and not more than 21.5 % expressed as
K
2O.
CalciumNot less than 8.5 % and not more than 13.0 % expressed as
CaO.
E 471 — Mono- and diglycerides of fatty acidsChemical description Mono- and diglycerides of fatty acids consist of mixtures of
glycerol mono-, di- and tri-esters of fatty acids occurring in foodfats. They may contain small amounts of free fatty acids andglycerol.
Description The product varies from a pale yellow to pale brown oily liquid
to a white or slightly off-white hard waxy solid. The solids maybe in the form of flakes, powders or small beads.
Mono- and di-ester content Not less than 70 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 7 %.
Total glycerol Not less than 16 % and not more than 33 %.
Polyglycerols Not more than 4 % diglycerol and not more than 1 % higher
polyglycerols both based on total glycerol content.
Water Not more tha n 2 % (KarlFischer).
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
Note: These criteria are based on the product without E 470.
E 472 (a) — Acetic acid esters of mono- and diglycerides of fatty acidsChemical description Esters of glycerol with acetic acid and fatty acids occurring in
food fats. They may contain small amounts of free glycerol, freefatty acids, free acetic acid and free glycerides.
1978L0663 — EN — 29.02.1992 — 001.001 — 17
▼B
Description Clear, mobile liquids to solids, from white to pale yellow in
colour.
Total acetic acid content Not less than 9 % and not more than 32 %.
Free fattyacids (and acetic acid) Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 2 %.
Total glycerol Not less than 14 % and not more than 31 %.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
E 472 (b) — Lactic acid esters of mono- and diglycerides of fatty acidsChemical description Esters of glycerol with lactic acid and fatty acids occurring in
food fats. They may contain small amounts of free glycerol, freefatty acids, free lactic acid and free glycerides.
Description Soft to hard waxy solids.
Total lactic acid content Not less than 13 % and not more than 45 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 2 %.
Total glycerol Not less than 13 % and not more than 30 %.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
Note: These criteria are based on the product without E 470.
E 472 (c) — Citric acid esters of mono- and diglycerides of food fatty acidsChemical description Esters of glycerol with citric acid and fatty acids occurring in
food oils and fats. They may contain small amounts of freeglycerol, free fatty acids, free citric acid and free glycerides.They may be partially or wholly neutralized with sodiumhydroxide or with potassium hydroxide.
Description Yellowish or light brown liquids to waxy solids or semi-solids.
Total citric acid content Not less than 13 % and not more than 50 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 2 %.
Total glycerol Not less than 11 % and not more than 29 %.
Sulphated ash Not more than 0.5 % for the non-neutralized products and not
more than 10.0 % for the partially or wholly neutralized prod-ucts determined at 800 ± 25 °C.
p Ho fa1% solution Not less than 3 and not more than 7.3.
E 472 (d) — Tartaric acid esters of mono- and diglycerides of food fatty acidsChemical description Esters of glycerol with tartaric acid (E 334) and fatty acids
occurring in food fats. They may contain small amounts of freeglycerol, free fatty acids, free tartaric acid and free glycerides.
Description Sticky viscous yellowish liquids to hard yellow waxes.
Total tartaric acid content Not less than 15 % and not more than 50 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 2 %.
Total glycerol Not less than 12 % and not more than 29 %.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
E 472 (e) — Mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids
1978L0663 —EN — 29.02.1992 — 001.001 — 18
▼B
Chemical description Esters of gl ycerolwith mono- and diacetyltartaric acids
(obtained from E 334 tartaric acid) and fatty acids occurring infood fats. They may contain small amounts of free glycerol, freefatty acids, free tartaric and acetic acids and their combinations,and free glycerides.
Description Sticky viscous liquids through a fat-like consistency to yellow
waxes which hydrolyse in moist air to liberate acetic acid.
Total tartaric acid content Not less than 10 % and not more than 40 %.
Total acetic acid content Not less than 8 % and not more than 32 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 2 %.
Total glycerol Not less than 11 % and not more than 28 %.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
E 472 (f) — Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acidsChemical description Esters of glycerol with acetic and tartaric (E 334) acids and fatty
acids occurring in food fats. They may contain small amounts offree glycerol, free fatty acids, free acetic and tartaric acids, andfree glycerides.
Description Clear mobile liquids to solids, from white to pale yellow in
colour.
Total acetic acid Not less than 10 % and not more than 20 %.
Total tartaric acid Not less than 20 % and not more than 40 %.
Free acetic acid Not less than 5.5 % and not more than 8.5 %.
Free tartaric acid Not more than 1 %.
Free fattyacids Not more tha n 3 % estimated as oleic acid.
Free glycerol Not more than 2 %.
Total glycerol Not less than 12 % and not more than 27 %.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
E — 473 Sucrose esters of fatty acidsChemical description Essentially the mono- and di-esters of sucrose with fatty acids
occurring in food fats. They may be prepared from sucrose andthe methyland ethylesters of food fatty acids or by extractionfrom sucroglycerides. ►
M3No organic solvent other than
dimethylsulphoxide, dimethylformamide, ethyl acetate, isopro-panol, isobutanol and methylethylketon may be used in theirpreparation. ◄
Description Soft solids, stiff gels or white to greyish-white powders.
Total sucrose fattyacid ester
contentNot less than 80 %.
Total glyceride content Not more than 20 %.
Free sucrose content Not more than 5 %.
Free fattyacid content Not more tha n 3 % estimated as oleic acid.
Sulphated ash Not more tha n 2 % determined at 800 ± 25 °C.
▼
M2
Dimethylsulphoxide content Not more than 2 mg/kg.
▼B
Dimethylformamide content Not more than 1 mg/kg.
1978L0663 — EN — 29.02.1992 — 001.001 — 19
▼B
Methanol content Not more than 10 mg/kg.
▼M2
Isobutanol content Not more than 10 mg/kg.
▼M3
Methylethylketon content Not more than 10 mg/kg.
Total ethyl acetate and isopro-
panol contentNot more than 350 mg/kg singly or in combination.
Note: These criteria are based on the product without E 470.
E 474 — SucroglyceridesChemical description Sucroglycerides are produced by reacting sucrose with an edible
fat or oil to produce a mixture of essentially mono- and di-estersof sucrose and fatty acids together with residualmono-, di- andtri-glycerides from that fat or oil. ►
M1No organic solvents
shall be used in their preparation other than cyclohexane, dime-thylformamide, ethyl acetate, isobutano land isopropanol. ◄
Description Soft solid masses, stiff gels or white to off-white powders.
Total sucrose fattyacid ester
contentNot less than 40 % and not more than 60 %.
Total glyceride content Not less than 40 % and not more than 60 %.
Free sucrose content Not more than 5 %.
Free fattyacid content Not more tha n 3 % estimated as oleic acid.
Sulphated ash Not more tha n 2 % determined at 800 ± 25 °C.
Dimethylformamide content Not more than 1 mg/kg.
Methanol content Not more than 10 mg/kg.
Total ethyl acetate and isopro-
panol contentNot more than 350 mg/kg singly or in combination.
▼
M1
Total cyclohexane and isobutanolcontentNot more than 10 mg/kg singly or in combination.
▼
B
Note: These criteria are based on the product without E 470.
E 475— Polyglycerol esters of non-polymerized fatty acidsChemical description Polyglycerol esters of fatty acids are produced by the esterifica-
tion of polyglycerol with food fats or with fatty acids occurringin food fats. The polyglycerol moiety is predominantly di-, tri-and tetra-glycerol and contains not more than 10 % of polygly-cerols equal to or higher than heptaglycerol.
Description Yellow or light brown liquids or semi-solids.
Total fattyacid ester content Not less than 90 %.
Free fattyacids Not more tha n 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 %.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
Note: These criteria are based on the product without E 470.
E 477 — Propane-1,2-diol esters of fatty acidsChemical description Consists chiefly of mixtures of propane-1,2-diol mono- and
di-esters of fatty acids occurring in food fats. The alcoholmoiety is exclusively propane-1,2-diol together with dimer andtraces of trimer. Organic acids other than food fatty acids areabsent.
1978L0663 — EN — 29.02.1992 — 001.001 — 20
▼B
Description Waxy white flakes, beads or solids.
Total fattyacid ester content Not less than 85 %.
Free propane-1,2-diol Not more than 5 %.
Dimer and trimer of propane-1,2-
diol►M1Not more than 0.5 %. ◄
Free fattyacids Not more tha n 6 % estimated as oleic acid.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
Total propane-1,2 Not less than 11 % and not more than 31 %.
Note: These criteria are based on the product without E 470.
E 481 — Sodium stearoyl-2-lactylateChemical description A mixture of the sodium salts of stearoyl lactylic acids and
minor amounts of sodium salts of other related acids, manufac-tured by the reaction of stearic acid and lactic acid. Other foodfatty acids may also be present, free or esterified, due to theirpresence in the stearic acid used.
Description Cream coloured powder or brittle solid with a characteristic
odour.
Sodium content Not less than 2.5 % and not more than 5 %.
Ester value Not less than 90 and not more than 190 mg KOH/g.
Total lactic acid (free and
combined)Not less than 15 % and not more than 40 %.
Acid value Not less than 60 and not more than 130 mg KOH/g.
E 482 — Calcium stearoyl-2-lactylateChemical description A mixture of calcium salts of stearoyl lactylic acids with minor
amounts of calcium salts of other related acids, manufactured bythe reaction of stearic acid and lactic acid. Other food fatty acidsmay also be present, free or esterified due to their presence inthe stearic acid used.
Description White or slightly yellowish powder or brittle solid with a char-
acteristic odour.
Calcium content Not less than 1.0 % and not more than 5.2 %.
Ester value Not less than 125 and not more than 190 mg KOH/g.
Total lactic acid (free and
combined)Not less than 15 % and not more than 40 %.
Acid value Not less than 50 and not more than 130 mg KOH/g.
E 483 — Stearyl tartrateChemical description Stearyltartrate is produced by the esterification of tartaric acid
(E 334) with stearyl alcohol. It consists chiefly of the di-esterwith minor amounts of mono-ester, tartaric acid and stearylalcohol. Other esters may also be present due to the presence inthe stearyl alcohol used of alcohols derived from food fattyacids other than stearic acid.
Description Cream coloured unctuous solid (at 25 °C).
Total ester content Not less than 90 %.
Total tartaric acid content Not less than 18 % and not more than 35 %.
Unsaponifiable matter Not less than 77 % and not more than 83 %.
Melting range 67 to 77 °C.
Ester value Not less than 163 and not more than 180 mg KOH/g.
1978L0663 — EN — 29.02.1992 — 001.001 — 21
▼B
Iodine value Not more than 4 (Wijs).
Acid value Not more than 6 mg KOH/g.
Sulphated ash Not more than 0.5 % determined at 800 ± 25 °C.
(1) A specialmethod of anal ysis is required to determine this.