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Document 32004L0045

    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)

    IO L 113, 20.4.2004, p. 19–23 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

    ⏵Foilsíodh an doiciméad seo in eagrán speisialta (CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO)

    Legal status of the document No longer in force, Date of end of validity: 08/10/2008

    ELI: http://data.europa.eu/eli/dir/2004/45/oj

    20.4.2004   

    EN

    Official Journal of the European Union

    L 113/19

    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 consumption (1), and in particular Article 3(3)(a) thereof,

    After consulting the Scientific Committee on Food,

    Whereas:

    (1)

    Commission Directive 96/77/EC (2) 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 sweeteners (3).

    (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:

    Article 1

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

    Article 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.

    Article 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.

    Article 4

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

    Article 5

    This Directive is addressed to the Member States.

    Done at Brussels, 16 April 2004.

    For the Commission

    David BYRNE

    Member of the Commission

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

    (3)  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).

    ANNEX

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

    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

    EINECS

    232-524-2

    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 content

    Not more than 0,1 % singly or in combination

    Viscosity of a 1,5 % solution at 75 oC

    Not less than 5 mPa.s

    Loss on drying

    Not more than 12 % (105 oC, four hours)

    Sulphate

    Not less than 15 % and not more than 40 % on the dried basis (as SO4)

    Ash

    Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC

    Acid-insoluble ash

    Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

    Acid-insoluble matter

    Not 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 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not 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 content

    Not more than 0,1 % singly or in combination

    Viscosity of a 1,5 % solution at 75 oC

    Not less than 5 mPa.s

    Loss on drying

    Not more than 12 % (105 oC, four hours)

    Sulphate

    Not less than 15 % and not more than 40 % on the dried basis (as SO4)

    Ash

    Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC

    Acid-insoluble ash

    Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

    Acid-insoluble matter

    Not 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 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 300 colonies per gram

    E. coli

    Negative in 5 g

    Salmonella spp.

    Negative in 10 g’

    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 formula

    C10nH20n+2 where n = 3 — 6

    Molecular weight

    560 (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

    Viscosity

    Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 °C

    Compounds with carbon number less than 30

    Not more than 1,5 %

    Readily carbonisable substances

    After 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

    Nickel

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg’

    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 formula

    C7H12O5

    Molecular weight

    176,17

    Assay

    Not 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 ash

    Not more than 0,02 %

    Acidity

    Not more than 0,4 % (as acetic acid)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    E 1519   BENZYL ALCOHOL

    Synonyms

    Phenylcarbinol

    Phenylmethyl alcohol

    Benzenemethanol

    Alpha-hydroxytoluene

    Definition

    Chemical names

    Benzyl alcohol

    Phenylmethanol

    Chemical formula

    C7H8O

    Molecular weight

    108,14

    Assay

    Not 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 range

    Not less than 95 % v/v distils between 202 and 208 °C

    Acid value

    Not more than 0,5

    Aldehydes

    Not more than 0,2 % v/v (as benzaldehyde)

    Lead

    Not more than 5 mg/kg’
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