Commission Directive 2006/129/EC of 8 December 2006 amending and correcting Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners   (Text with EEA relevance)
Date: 2006-12-08
Institutions: European Commission
Subjects: food additive, food inspection, food standard, foodstuffs legislation, human nutrition

9.12.2006

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Official Journal of the European Union

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COMMISSION DIRECTIVE 2006/129/EC

of 8 December 2006

amending and correcting 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,

for individual heavy metals of interest. For reasons of
clarity the whole text concerning those substances
should be replaced.

Having regard to the Treaty
Community,

establishing the European

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

the laws of

After consulting the Scientific Committee on Food and the
European Food Safety Authority,

Whereas:

(1)

(2)

(3)

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
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).

additives mentioned

the

for

It is appropriate to withdraw the purity criteria for E 216
propyl p-hydroxybenzoate and E 217 sodium propyl
p-hydroxybenzoate which are no longer permitted for
use as food additives.

the

regarding

following

A number of language versions of Directive 96/77/EC
contain errors
substances:
E 307 alpha-tocopherol, E 315 erythorbic acid, E 415
xanthan gum. Those errors need to be corrected.
In
addition it is necessary to take into account the specifi-
cations 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).
the specific
purity criteria have been adapted to reflect the limits

In particular where appropriate,

(4)

(5)

(6)

The level of sulphated ash in the purity criteria for
E 472c citric acid esters of mono- and diglycerides of
fatty acids should be amended in order to cover partially
or wholly neutralised products.

It is necessary to ensure that E 559 aluminium silicate is
produced from raw kaolinitic clay which is free from
unacceptable dioxin contamination. The presence of
dioxin in the raw kaolinitic clay should therefore be
restricted to the lowest possible level.

It is necessary to adopt specifications for the new food
additives authorised through Directive 2006/52/EC of the
European Parliament and of the Council of 5 July 2006
amending Directive 95/2/EC on food additives other than
colours and sweeteners and Directive 94/35/EC on
in foodstuffs: E 319 tertiary-
sweeteners
butylhydroquinone (TBHQ), E 426 soybean hemicel-
lulose, E 462 ethyl cellulose, E 586 4-hexylresorcinol,
E 1204 pullulan and E 1452 starch aluminium octenyl
succinate.

for use

(7)

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

(8)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

(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

2004/45/EC (OJ L 113, 20.4.2004, p. 19).

(3) OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive

2006/52/EC (OJ L 204, 26.7.2006, p. 10).

Article 1

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

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Article 2

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 15 February 2008 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 be accompanied by such a
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.

This Directive shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 8 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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

ANNEX

1. The texts concerning E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate are deleted.

2. The text concerning E 307 alpha-tocopherol is replaced by the following:

‘E 307 ALPHA-TOCOPHEROL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

DL-α-Tocopherol

DL-5,7,8-Trimethyltocol
DL-2,5,7,8-Tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-
chromanol

233-466-0

C29H50O2

430,71

Content not less than 96 %

Slightly yellow to amber, nearly odourless, clear, viscous oil
which oxidizes and darkens on exposure to air or light

A. Solubility tests

Insoluble in water, freely soluble in ethanol, miscible in ether

B. Spectrophotometry

In absolute ethanol the maximum absorption is about 292 nm

Purity

Refractive index

nD

20 1,503 to 1,507

Specific absorption E1 %

1 cm in ethanol

E1 %

1 cm (292 nm) 72 to 76

Sulphated ash

Specific rotation

Lead

(0,01 g in 200 ml of absolute ethanol)

Not more than 0,1 %

[α]25

D0° ± 0,05° (1 in 10 solution in chloroform)

Not more than 2 mg/kg’

3. The text concerning E 315 erythorbic acid is replaced by the following:

‘E 315 ERYTHORBIC ACID

Synonyms

Definition

Isoascorbic acid

D-Araboascorbic acid

Chemical name

D-Erythro-hex-2-enoic acid γ-lactone

Isoascorbic acid

D-Isoascorbic acid

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Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

201-928-0

C6H8O6

176,13

Content not less than 98 % on the anhydrous basis

White to slightly yellow crystalline solid which darkens gradually
on exposure to light

A. Melting range

About 164 °C to 172 °C with decomposition

B. Positive test
reaction

for ascorbic acid/colour

Purity

Loss on drying

Sulphated ash

Specific rotation

Oxalate

Lead

Not more than 0,4 % after drying under reduced pressure on
silica gel for 3 hours

Not more than 0,3 %

[α]25

D10 % (w/v) aqueous solution between – 16,5° to – 18,0°

To a solution of 1 g in 10 ml of water add 2 drops of glacial
acetic acid and 5 ml of 10 % calcium acetate solution. The
solution should remain clear

Not more than 2 mg/kg’

4. The following text concerning E 319 tertiary-butylhydroquinone (TBHQ) is inserted after E 316 sodium erythorbate:

‘E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)

Synonyms

Definition

TBHQ

Chemical names

Tert-butyl-1,4-benzenediol

2-(1,1-Dimethylethyl)-1,4-benzenediol

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

217-752-2

C10H14O2

166,22

Content not less than 99 % of C10H14O2

White crystalline solid having a characteristic odour

A. Solubility

Practically insoluble in water; soluble in ethanol

B. Melting point

Not less than 126,5 °C

C. Phenolics

Dissolve about 5 mg of the sample in 10 ml of methanol and
add 10,5 ml of dimethylamine solution (1 in 4). A red to pink
colour is produced

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Purity

Tertiary-Butyl-p-benzoquinone

Not more than 0,2 %

2,5-Di-tertiary-butyl hydroquinone

Not more than 0,2 %

Hydroxyquinone

Not more than 0,1 %

Toluene

Lead

Not more than 25 mg/kg

Not more than 2 mg/kg’

5. The text concerning E 415 xanthan gum is replaced by the following:

‘E 415 XANTHAN GUM

Definition

strains of Xanthomonas

Xanthan gum is a high molecular weight polysaccharide gum
produced by a pure-culture fermentation of a carbohydrate
campestris, purified by
with natural
recovery with ethanol or propan-2-ol, dried and milled.
It
contains D-glucose and D-mannose as the dominant hexose
units, along with D-glucuronic acid and pyruvic acid, and is
prepared as
Its
sodium, potassium or
solutions are neutral

calcium salt.

the

Molecular weight

Approximately 1 000 000

Einecs

Assay

Description

Identification

234-394-2

Yields, on dried basis, not less than 4,2 % and not more than
5 % of CO2 corresponding to between 91 % and 108 % of
xanthan gum

Cream-coloured powder

A. Solubility

Soluble in water. Insoluble in ethanol

Purity

Loss on drying

Total ash

Pyruvic acid

Nitrogen

Not more than 15 % (105 °C, 21/2hours)

Not more than 16 % on the anhydrous basis determined at
650 °C after drying at 105 °C for four hours

Not less than 1,5 %

Not more than 1,5 %

Ethanol and propan-2-ol

Not more than 500 mg/kg singly or in combination

Lead

Total plate count

Yeast and mould

E. coli

Salmonella spp.

Not more than 2 mg/kg

Not more than 5 000 colonies per gram

Not more than 300 colonies per gram

Absent in 5 g

Absent in 10 g

Xanthomonas campestris

Viable cells absent in 1 g’

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6. The following text concerning E 426 soybean hemicellulose is inserted after E 425(ii) konjac glucomannan:

‘E 426 SOYBEAN HEMICELLULOSE

Synonyms

Definition

Soybean hemicellulose is a refined water-soluble polysaccharide
obtained from natural
strain soybean fibre by hot water
extraction

Chemical names

Water soluble soybean polysaccharides

Assay

Description

Identification

Water soluble soybean fibre

Not less than 74 % carbohydrate

Free flowing spray-dried white powder

A. Solubility

Soluble in hot and cold water without gel formation

pH of 1 % solution

5,5 ± 1,5

B. Viscosity of 10 % solution

Not more than 200 mPa.s

Purity

Loss on drying

Not more than 7 % (105 °C, 4 h)

Protein

Total ash

Arsenic

Lead

Mercury

Cadmium

Not more than 14 %

Not more than 9,5 % (600 °C, 4 h)

Not more than 2 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Standard plate count

Not more than 3 000 colonies per gram

Yeast and mould

Not more than 100 colonies per gram

E. Coli

Negative in 10 g’

7. The following text concerning E 462 ethyl cellulose is inserted after E 461 methyl cellulose:

‘E 462 ETHYL CELLULOSE

Synonyms

Definition

Chemical names

Chemical formula

Cellulose ethyl ether

Ethyl cellulose is cellulose obtained directly from fibrous plant
material and partially etherified with ethyl groups

Ethyl ether of cellulose

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2) where R1 and R2 may be any of
following:
— H
— CH2CH3

the

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Assay

Description

Identification

A. Solubility

Content not less than 44 % and not more than 50 % of ethoxyl
groups (-OC2H5) on the dried basis (equivalent to not more than
2,6 ethoxyl groups per anhydroglucose unit)

Slightly hygroscopic, white to off white, odourless and tasteless
powder

Practically insoluble in water, in glycerol and in propane-1,2-diol
but soluble in varying proportions in certain organic solvents
depending upon the ethoxyl content. Ethyl cellulose containing
less than 46 to 48 % of ethoxyl groups is freely soluble in
in chloroform and in
tetrahydrofuran,
aromatic
cellulose
Ethyl
containing 46 to 48 % or more of ethoxyl groups is freely
soluble in ethanol, in methanol, in toluene, in chloroform and
in ethyl acetate

in methyl acetate,

ethanol mixtures.

hydrocarbon

B. Film forming test

Purity

Loss on drying

Sulphated ash

Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of
toluene ethanol. A clear, stable, slightly yellow solution is
formed. Pour a few ml of the solution onto a glass plate and
allow the solvent to evaporate. A thick, tough, continuous, clear
film remains. The film is flammable

Not more than 3 % (105 °C, 2 h)

Not more than 0,4 %

pH of a 1 % colloidal solution

Neutral to litmus

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg’

8. The text concerning E 472c citric acid esters of mono- and diglycerides of fatty acids is replaced by the following:

‘E 472c CITRIC ACID ESTERS OF MONO- AND DIGLYCYERIDES OF FATTY ACIDS

Synonyms

Citrem

Citric acid esters of mono- and diglycerides

Citroglycerides

Mono- and diglycerides of fatty acids esterified with citric acid

Esters of glycerol with citric acid and fatty acids occurring in
food oils and fats. They may contain small amounts of free
glycerol,
free citric acid and free glycerides.
They may be partially or wholly neutralised with sodium
hydroxide or with potassium hydroxide

free fatty acids,

Yellowish or light brown liquids to waxy solids or semi-solids

Definition

Description

Identification

A. Positive test for glycerol, for fatty acids

and for citric acid

B. Solubility

Insoluble in cold water

Dispersible in hot water

Soluble in oils and fats

In soluble in cold ethanol

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Purity

Acids other than citric and fatty acids

Not detectable

Free glycerol

Total glycerol

Total citric acid

Not more than 2 %

Not less than 8 % and not more than 33 %

Not less than 13 % and not more than 50 %

Sulphated ash (determined at 800 ± 25 °C) Non-neutralised products: not more than 0,5 %

Partially or wholly neutralised products: not more than 10 %

Lead

Free fatty acids

Not more than 2 mg/kg

Not more than 3 % estimated as oleic acid

Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be
present up to a maximum level of 6 % (expressed as sodium oleate).’

9. The text concerning E 559 aluminium silicate (kaolin) is replaced by the following:

‘E 559 ALUMINIUM SILICATE (KAOLIN)

Synonyms

Definition

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Kaolin, light or heavy

Aluminium silicate hydrous (kaolin) is a purified white plastic
clay composed of kaolinite, potassium aluminium silicate,
feldspar and quartz. Processing should not include calcination.
The raw kaolinitic clay used in the production of aluminium
silicate shall have a level of dioxin which does not make it
injurious to health or unfit for human consumption

215-286-4 (kaolinite)

Al2Si2O5(OH)4 (kaolinite)

264

Content not less than 90 % (sum of silica and alumina, after
ignition)

Silica (SiO2) Between 45 % and 55 %

Alumina (A12O3) Between 30 % and 39 %

Fine, white or greyish white, unctuous powder. Kaolin is made
up of loose aggregations of randomly oriented stacks of kaolinite
flakes or of individual hexagonal flakes.

A. Positive test for alumina and for silicate

B. X-ray diffraction

C.

IR absorption

Purity

Characteristic peaks at 7,18/3,58/2,38/1,78 Å

Peaks at 3 700 and 3 620 cm–1

Loss on ignition

Between 10 and 14 % (1 000 °C, constant weight)

Water soluble matter

Not more than 0,3 %

Acid soluble matter

Iron

Potassium oxide (K2O)

Carbon

Arsenic

Not more than 2 %

Not more than 5 %

Not more than 5 %

Not more than 0,5 %

Not more than 3 mg/kg

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Lead

Mercury

Not more than 5 mg/kg

Not more than 1 mg/kg’

10. The following text concerning E 586 4-hexylresorcinol is inserted after E 578 calcium gluconate:

‘E 586 4-HEXYLRESORCINOL

Synonyms

Definition

4-Hexyl-1,3-benzenediol

Hexylresorcinol

Chemical names

4-Hexylresorcinol

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Nitric acid test

C. Bromine test

205-257-4

C12H18O2

197,24

Not less than 98,0 % on the dried basis

White powder

Freely soluble in ether and acetone; very slightly soluble in water

To 1 ml of a saturated solution of the sample, add 1 ml of nitric
acid. A light red colour appears

To 1 ml of saturated solution of
bromine
TS. A yellow,
producing a yellow solution

the sample, add 1 ml of
dissolves

precipitate

flocculent

D. Melting range

62 to 67 °C

Purity

Acidity

Sulphated ash

Not more than 0,05 %

Not more than 0,1 %

Resorcinol and other phenols

Shake about 1 g of the sample with 50 ml of water for a few
minutes, filter, and to the filtrate add 3 drops of ferric chloride
TS. No red or blue colour is produced

Nickel

Lead

Mercury

Not more than 2 mg/kg

Not more than 2 mg/kg

Not more than 3 mg/kg’

11. The following text concerning E 1204 pullulan is inserted after E 1200 polydextrose:

‘E 1204 PULLULAN

Definition

Linear, neutral glucan consisting mainly of maltotriose units
connected by -1,6 glycosidic bonds. It is produced by fermen-
tation from a food grade hydrolysed starch using a non-toxin
producing strain of Aureobasidium pullulans. After completion of
the fermentation, the fungal cells are removed by microfiltration,
the filtrate is heat-sterilised and pigments and other impurities
are removed by adsorption and ion exchange chromatography

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Einecs

Chemical formula

232-945-1

(C6H10O5)x

Assay

Description

Identification

Not less than 90 % of glucan on the dried basis

White to off-white odourless powder

A. Solubility

Soluble in water, practically insoluble in ethanol.

B. pH of 10 % solution

5,0 to 7,0

C. Precipitation with polyethylene glycol

600

Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous
solution of pullulan. A white precipitate is formed

D. Depolymerisation with pullulanase

Purity

Loss on drying

Prepare two test tubes each with 10 ml of a 10 % pullulan
solution. Add 0,1 ml pullulanase solution having activity 10
units/g to one test tube, and 0,1 ml water to the other. After
the
incubation at about 25 °C for 20 min,

the viscosity of

pullulanase-treated solution is visibly lower than that of
untreated solution

the

Not more than 6 % (90 °C, pressure not more than 50 mm Hg,
6 h)

Mono-, di- and oligosaccharides

Not more than 10 % expressed as glucose

Viscosity

Lead

100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C)

Not more than 1 mg/kg

Yeast and moulds

Not more than 100 colonies per gram

Coliforms

Salmonella

Absent in 25 g

Absent in 25 g’

12. The following text concerning E 1452 starch aluminium octenyl succinate is inserted after E 1451 acetylated oxidised

starch:

‘E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE

SAOS

Starch aluminium octenyl succinate is starch esterified with octe-
nylsuccinic anhydride and treated with aluminium sulphate

White or nearly white powder or granules or (if pregelatinised)
flakes, amorphous powder or coarse particles

Synonyms

Definition

Description

Identification

A. If not pregelatinised: by miscroscopic

observation

B.

Iodine staining positive (dark blue to
light red colour)

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Purity

(all values expressed on an anhydrous basis
except for loss on drying)

Loss on drying

Not more than 21 %

Octenylsuccinyl groups

Not more than 3 %

Octenylsuccinic acid residue

Not more than 0,3 %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for the other modified starches unless
otherwise specified

Arsenic

Lead

Mercury

Aluminium

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Not more than 0,3 %’