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)
Date: 2004-04-16
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuffs legislation, human nutrition

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,

HAS ADOPTED THIS DIRECTIVE:

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/107/EEC of 21
the
December 1988 on the approximation of
Member States concerning food additives authorised for use in
foodstuffs intended for human consumption (1), and in particu-
lar Article 3(3)(a) thereof,

the laws of

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

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).

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

It is necessary to adopt specifications for the new addi-
tives 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.

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

techniques for additives as set out

Directive 96/77/EC should therefore be amended accord-
ingly.

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

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 Direc-
tive.

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.

This Directive is addressed to the Member States.

Article 5

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).

L 113/20

EN

Official Journal of the European Union

20.4.2004

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

ANNEX

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

‘E 407 CARRAGEENAN

Synonyms

Definition

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.)

Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of
Gigartinaceae, Solieriaceae, Hypneaeceae and Furcellariaceae,
the class
Rhodophyceae (red seaweeds). No organic precipitant shall be used other than
methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potas-
sium, 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

families of

EINECS

232-524-2

Description

Identification

Yellowish to colourless, coarse to fine powder which is practically odourless

A. Positive tests for galac-
anhydrogalac-

tose,
tose and for sulphate

for

Purity

Methanol, ethanol,
propane-2-ol content

Not more than 0,1 % singly or in combination

Viscosity of a 1,5 % solu-
tion at 75 °C

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 °C, four hours)

Sulphate

Ash

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

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

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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

20.4.2004

EN

Official Journal of the European Union

L 113/21

E 407a PROCESSED EUCHEUMA SEAWEED

Synonyms

Definition

PES (acronym for processed eucheuma seaweed)

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 magne-
sium 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 galac-
anhydrogalac-

tose,
tose and for sulphate

for

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 % solu-
tion at 75 °C

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 °C, four hours)

Sulphate

Ash

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

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

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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’

L 113/22

EN

Official Journal of the European Union

20.4.2004

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

Definition

Hydrogenated polydec-1-ene
Hydrogenated poly-alpha-olefin

Chemical formula

C10nH20n+2 where n = 3 — 6

Molecular weight

560 (average)

Assay

Description

Identification

A. Solubility

B. Burning

Purity

less than 98,5 % of hydrogenated poly-1-decene, having the following

Not
oligomer distribution:
C30: 13 — 37 %
C40: 35 — 70 %
C50: 9 — 25 %
C60: 1 — 7 %

Colourless, odourless, viscous liquid

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

Burns with a bright flame and a paraffin-like characteristic smell

Viscosity

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

Compounds with carbon
number less than 30

Readily carbonisable
substances

Not more than 1,5 %

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

Lead

Not more than 1 mg/kg

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

Definition

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

Diacetin

Glyceryl diacetate consists predominantly of a mixture of the 1,2- and 1,3-diace-
tates of glycerol, with minor amounts of the mono- and tri-esters

Glyceryl diacetate
1,2,3-propanetriol diacetate

C7H12O5

176,17

Not less than 94,0 %

Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour

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

Acidity

Arsenic

Lead

Not more than 0,02 %

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

Not more than 3 mg/kg

Not more than 5 mg/kg

20.4.2004

EN

Official Journal of the European Union

L 113/23

E 1519 BENZYL ALCOHOL

Synonyms

Definition

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

Phenylcarbinol
Phenylmethyl alcohol
Benzenemethanol
Alpha-hydroxytoluene

Benzyl alcohol
Phenylmethanol

C7H8O
108,14

Not less than 98,0 %

Colourless, clear liquid with a faint, aromatic odour

Soluble in water, ethanol and ether

B. Refractive index

C. Specific gravity

[n]D20:1,538 – 1,541

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

Aldehydes

Lead

Not more than 0,5

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

Not more than 5 mg/kg’