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Commission Directive 2004/45/EC of 16 April 2004 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)

EU Directive 2004/45 · Adopted 16 April 2004 · Extends to United Kingdom

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Commission Directive 2004/45/EC

of 16 April 2004

amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners

(Text with EEA relevance)

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 authorised for use in foodstuffs intended for human consumptionf1, and in particular Article 3(3)(a) thereof,

After consulting the Scientific Committee on Food,

Whereas:

(1)

Commission Directive 96/77/ECf2 of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners sets out the purity criteria for the additives mentioned in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweetenersf3.

(2)

The Scientific Committee on Food concluded in its opinion of 5 March 2003 that the presence of low molecular weight carrageenan should be kept to a minimum. Consequently, the relevant criterion of the existing purity criteria for E 407 Carrageenan and E 407a (Processed Eucheuma Seaweed) set out in Directive 96/77/EC needs to be adapted.

(3)

It is necessary to adopt specifications for the new additives authorised through Directive 2003/114/EC of the European Parliament and of the Council of 22 December 2003 amending Directive 95/2/EC on food additives other than colours and sweeteners: E 907 Hydrogenated poly-1-decene, E 1517 Glyceryl diacetate and E 1519 Benzyl alcohol.

(4)

It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(5)

Directive 96/77/EC should therefore be amended accordingly.

(6)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Annotations to the whole text

Footnotes

f1

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).

f2

OJ L 339, 30.12.1996, p. 1. Directive as last amended by Directive 2003/95/EC (OJ L 283, 31.10.2003, p. 71).

f3

OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive 2003/114/EC (OJ L 24, 29.1.2003, p. 58).

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4
  5. 5Article 5
  6. Signature
  7. Annex Annex

1

The Annex to Directive 96/77/EC is amended in accordance with the Annex to this Directive.

2

1.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 April 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.

Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

3

Products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted.

4

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

5

This Directive is addressed to the Member States.

Signature

Done at Brussels, 16 April 2004.

For the Commission

David Byrne

Member of the Commission

The Annex to Directive 96/77/EC is amended as follows:

  1. 1..

    The texts concerning E 407 Carrageenan and E 407a Processed Eucheuma Seaweed are replaced by the following:

    ‘E 407

    CARRAGEENAN

    Synonyms

    Products of commerce are sold under different names such as:

    Irish moss gelose

    Eucheuman (from Eucheuma spp.)

    Iridophycan (from Iridaea spp.)

    Hypnean (from Hypnea spp.)

    Furcellaran or Danish agar (from Furcellaria fastigiata)

    Carrageenan (from Chondrus and Gigartina spp.)

    Definition Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaeceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
    EINECS232-524-2
    Description Yellowish to colourless, coarse to fine powder which is practically odourless
    Identification

    A.

    Positive tests for galactose, for anhydrogalactose and for sulphate

    Purity
    Methanol, ethanol, propane-2-ol contentNot more than 0,1 % singly or in combination
    Viscosity of a 1,5 % solution at 75 oCNot less than 5 mPa.s
    Loss on dryingNot more than 12 % (105 oC, four hours)
    SulphateNot less than 15 % and not more than 40 % on the dried basis (as SO4)
    AshNot less than 15 % and not more than 40 % determined on the dried basis at 550 oC
    Acid-insoluble ashNot more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
    Acid-insoluble matterNot more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
    Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)Not more than 5 %
    ArsenicNot more than 3 mg/kg
    LeadNot more than 5 mg/kg
    MercuryNot more than 1 mg/kg
    CadmiumNot more than 1 mg/kg
    Total plate countNot more than 5 000 colonies per gram
    Yeast and mouldsNot more than 300 colonies per gram
    E. coli Negative in 5 g
    Salmonella spp.Negative in 10 g

    E 407a

    PROCESSED EUCHEUMA SEAWEED

    Synonyms PES (acronym for processed eucheuma seaweed)
    Definition Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
    Description Tan to yellowish, coarse to fine powder which is practically odourless
    Identification

    A.

    Positive tests for galactose, for anhydrogalactose and for sulphate

    B.

    Solubility

    		Forms cloudy viscous suspensions in water. Insoluble in ethanol
    Purity
    Methanol, ethanol, propane-2-ol contentNot more than 0,1 % singly or in combination
    Viscosity of a 1,5 % solution at 75 oCNot less than 5 mPa.s
    Loss on dryingNot more than 12 % (105 oC, four hours)
    SulphateNot less than 15 % and not more than 40 % on the dried basis (as SO4)
    AshNot less than 15 % and not more than 40 % determined on the dried basis at 550 oC
    Acid-insoluble ashNot more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
    Acid-insoluble matterNot less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
    Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)Not more than 5 %
    ArsenicNot more than 3 mg/kg
    LeadNot more than 5 mg/kg
    MercuryNot more than 1 mg/kg
    CadmiumNot more than 1 mg/kg
    Total plate countNot more than 5 000 colonies per gram
    Yeast and mouldsNot more than 300 colonies per gram
    E. coli Negative in 5 g
    Salmonella spp.Negative in 10 g

    ’

  2. 2..

    The following text concerning E 907 Hydrogenated poly-1-decene is inserted after E 905 Microcrystalline wax:

    ‘E 907

    HYDROGENATED POLY-1-DECENE

    Synonyms

    Hydrogenated polydec-1-ene

    Hydrogenated poly-alpha-olefin

    Definition
    Chemical formulaC10nH20n+2 where n = 3 — 6
    Molecular weight560 (average)
    Assay

    Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:

    C30: 13 — 37 %

    C40: 35 — 70 %

    C50: 9 — 25 %

    C60: 1 — 7 %

    Description Colourless, odourless, viscous liquid
    Identification

    A.

    Solubility

    		Insoluble in water; slightly soluble in ethanol; soluble in toluene

    B.

    Burning

    		Burns with a bright flame and a paraffin-like characteristic smell
    Purity
    ViscosityBetween 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 °C
    Compounds with carbon number less than 30Not more than 1,5 %
    Readily carbonisable substancesAfter 10 minutes shaking in a boiling water bath, a tube of sulfuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour
    NickelNot more than 1 mg/kg
    LeadNot more than 1 mg/kg

    ’

  3. 3..

    The following text concerning E 1517 Glyceryl diacetate and E 1519 Benzyl alcohol is added:

    ‘E 1517

    GLYCERYL DIACETATE

    Synonyms Diacetin
    Definition Glyceryl diacetate consists predominantly of a mixture of the 1,2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters
    Chemical names

    Glyceryl diacetate

    1,2,3-propanetriol diacetate

    Chemical formulaC7H12O5
    Molecular weight176,17
    AssayNot less than 94,0 %
    Description Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour
    Identification

    A.

    Solubility

    		Soluble in water. Miscible with ethanol

    B.

    Positive tests for glycerol and acetate

    C.

    Specific gravity

    		d20 20: 1,175 — 1,195

    D.

    Boiling range

    		Between 259 and 261 °C
    Purity
    Total ashNot more than 0,02 %
    AcidityNot more than 0,4 % (as acetic acid)
    ArsenicNot more than 3 mg/kg
    LeadNot more than 5 mg/kg

    E 1519

    BENZYL ALCOHOL

    Synonyms

    Phenylcarbinol

    Phenylmethyl alcohol

    Benzenemethanol

    Alpha-hydroxytoluene

    Definition
    Chemical names

    Benzyl alcohol

    Phenylmethanol

    Chemical formulaC7H8O
    Molecular weight108,14
    AssayNot less than 98,0 %
    Description Colourless, clear liquid with a faint, aromatic odour
    Identification

    A.

    Solubility

    		Soluble in water, ethanol and ether

    B.

    Refractive index

    		[n]D 20:1,538 – 1,541

    C.

    Specific gravity

    		d25 25: 1,042 — 1,047

    D.

    Positive test for peroxides

    Purity
    Distillation rangeNot less than 95 % v/v distils between 202 and 208 °C
    Acid valueNot more than 0,5
    AldehydesNot more than 0,2 % v/v (as benzaldehyde)
    LeadNot more than 5 mg/kg

    ’