Commission Directive 2009/10/EC of 13 February 2009 amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Date: 2009-02-13
Institutions: European Commission
Subjects: codification of EU law, consumer protection, food additive, food chemistry, foodstuffs legislation, human nutrition

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Official Journal of the European Union

14.2.2009

COMMISSION DIRECTIVE 2009/10/EC

of 13 February 2009

amending Directive 2008/84/EC laying down specific purity criteria on food additives other than
colours and sweeteners

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

opinion, the existing specifications for E234 nisin should
be amended in order to adapt the definition and the
purity criteria set out for that additive.

Having regard to the Treaty
Community,

establishing the European

to

regard

Council Directive

Having
of
21 December 1988 on the approximation of the laws of the
Member States concerning food additives authorised for use in
intended for human consumption (1),
foodstuffs
and in
particular Article 3(3)(a) thereof,

89/107/EEC

After consulting the Scientific Committee on Food (SCF) and
the European Food Safety Authority (EFSA),

Whereas:

(1)

(2)

than colours and sweeteners (2)

Commission Directive 2008/84/EC of 27 August 2008
laying down specific purity criteria on food additives
the
other
purity criteria for the additives mentioned in European
Parliament and Council Directive 95/2/EC of 20 February
1995 on food additives other
and
sweeteners (3).

than colours

sets out

The European Food Safety Authority (hereinafter EFSA)
concluded in its opinion of 20 October 2006 (4) that
nisin produced through a modified production process
using a sugar-based medium is equivalent with respect to
health protection to the one produced by the original
that
milk-based medium process. On the basis of

(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 253, 20.9.2008, p. 1.
(3) OJ L 61, 18.3.1995, p. 1.
(4) http://www.efsa.europa.eu/en/science/afc/afc_opinions/ej314b_

nisin.html

(3)

(4)

(5)

the request of

Formaldehyde is used as a preservative during the manu­
facture of alginic acid, alginate salts and esters of alginic
acid. It has been reported that residual formaldehyde, up
in the final gelling
to 50 mg/kg, may be present
additives. At
the Commission, EFSA
assessed the safety in use of formaldehyde as a preser­
vative during the manufacture and preparation of food
additives (5). EFSA in its opinion of 30 November 2006
concluded that
to gelling
additives containing residual formaldehyde at the level
of 50 mg/kg of additive would be of no safety concern.
Therefore the existing purity criteria for E400 alginic
acid, E401 sodium alginate, E402 potassium alginate,
E403 ammonium alginate, E404 calcium alginate, and
E405 propane-1,2-diol alginate should be amended in
such a way that the maximum level of formaldehyde is
set at 50 mg/kg.

estimated exposure

the

Formaldehyde is not currently used in the processing of
seaweeds for the production of E407 carrageenan and
E407a processed eucheuma seaweed. However,
it may
be naturally occurring in marine algae and be conse­
quently present as an impurity in the finished product.
It is therefore appropriate to fix a maximum level of
adventitious presence of the above substance in those
food additives.

Guar gum is authorised as a food additive for use in
foodstuffs by Directive 95/2/EC. In particular, it is used
as thickener, emulsifier, and stabiliser. A request to use a
partially depolymerised guar gum as a food additive,
produced from native guar gum by one of the three
treatment,
manufacturing processes consisting of heat
acid hydrolysis or alkaline oxidation, was submitted to
the Commission. EFSA assessed the safety in use of

(5) Opinion of

flavourings,
the Scientific Panel on food additives,
processing aids and materials in contact with food (AFC) on a
request from the Commission related to use of formaldehyde as a
preservative during the manufacture and preparation of
food
additives; Question No EFSA Q-2005-032.
http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178620766610.htm

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in its opinion of 4 July 2007 (1),
that additive and,
estimated that partially depolymerised guar gum has
been shown to be very similar to native guar gum
with respect to the composition of the final product. It
also concluded that partially depolymerised guar gum is
of no safety concern for its use as thickener, emulsifier or
stabiliser. However,
in the same opinion, EFSA recom­
mended that the specifications for E412 guar gum should
be adjusted to take into account the increased level of
salts and the possible presence of undesirable by-
products
from the manufacturing
process. On the basis of the recommendations issued
by EFSA,
the specifications of guar gum should be
amended.

that may result

is necessary to adopt

It
for E504(i)
magnesium carbonate authorised as a food additive for
use in foodstuffs through Directive 95/2/EC.

specifications

On the basis of data provided by the European Lime
Association,
it appears that the manufacturing of lime
products from available raw materials does not permit
them to comply with the existing purity criteria set for
E526 calcium hydroxide and E529 calcium oxide, as
regards the level of magnesium and alkali salts. Taking
that magnesium salts are of no safety
into account
concern and the specifications as set out in the Codex
Alimentarius as drafted by the Joint FAO/WHO Expert
Committee on Food Additives (hereafter JECFA),
is
appropriate to adjust
the levels of magnesium and
for E526 calcium hydroxide and E529
alkali
calcium oxide to the lowest achievable values, which
remain lower or equal to the levels set by JECFA.

salts

it

In addition, it is necessary to take into account the speci­
fications as set out in the Codex Alimentarius drafted
by JECFA with regard to the level of
lead for E526
calcium hydroxide and E529 calcium oxide. However,
due to the natural high background of lead contained
in the raw material
(calcium carbonate) extracted in
some Member States, and from which those additives
are derived, it appears difficult to align the level of lead
contained in those food additives with the upper limit of
lead set by JECFA. Therefore the current level of lead
should be reduced to the lowest achievable threshold.

it also indicated that the
this food additive. However,
presence of
lead should be restricted to the lowest
possible level. Taking into account the revised specifi­
cations for beeswax as set out in the Codex Alimentarius
is appropriate to amend the
as drafted by JECFA,
existing purity criteria for E901 beeswax in order to
lower the maximum permitted level of lead.

it

(10) Highly refined waxes deriving from synthetic hydro­
carbon feedstock (synthetic waxes) and from petroleum
based feedstock were jointly evaluated by the Scientific
Committee on Food (hereinafter SCF) (3) and an opinion
on mineral and synthetic hydrocarbons was issued on
22 September 1995. The SCF considered that sufficient
data had been provided to allocate a full group ADI
(acceptable daily intake), covering both types of waxes,
i.e. waxes deriving from petroleum based or synthetic
hydrocarbon feed stocks. When purity criteria for E905
microcrystalline wax were established,
the synthetic
hydrocarbon waxes were omitted and not included in
the
it
therefore necessary to amend the purity criteria for
E905 microcrystalline wax in order to also cover waxes
derived from synthetic hydrocarbon feedstocks.

The Commission

specifications.

considers

(11)

(12)

E230 (biphenyl) and E233 (thiabendazole) are no longer
permitted as food additives in the EU legislation. These
substances have been removed respectively by Directive
2003/114/EC and Directive 98/72/EC. Consequently, the
to Directive 2008/84/EC should be updated
Annex I
accordingly and the specifications to E230 and E233
should be withdrawn.

It is necessary to take into account the specifications and
analytical techniques for additives as set out in the Codex
Alimentarius drafted by the JECFA. In particular where
appropriate,
the specific purity criteria need to be
adapted to reflect the limits for individual heavy metals
of interest.

(13) Directive 2008/84/EC should therefore be amended

accordingly.

E 901 beeswax is authorised as a food additive in
Directive
of
27 November 2007 (2) confirmed the safety in use of

95/2/EC.

opinion

EFSA

its

in

(14)

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

in this Directive are in
Standing
the

opinion

the

of

(6)

(7)

(8)

(9)

(1) Opinion of

the Scientific Panel on food additives,
flavourings,
processing aids and materials in contact with food on a request
from the Commission related to an application on the use of
partially depolymerised guar gum as a food additive; Question No
EFSA-Q-2006-122.
http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178638739757.htm

(2) Beeswax (E 901) as a glazing agent and as carrier for flavours;
flavourings,
in contact with food (AFC);

the Panel on food additives,

Scientific Opinion of
processing aids
and materials
Question No EFSA-Q-2006-021.
http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178672652158.htm

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Annex I to Directive 2008/84/EC is amended in accordance
with the Annex to this Directive.

(3) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_37.pdf

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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 13 February 2010 at
the latest. They shall
forthwith communicate to the Commission the text of those
provisions.

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
its publication in the Official Journal of the European Union.

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 13 February 2009.

For the Commission

Androulla VASSILIOU
Member of the Commission

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ANNEX

The Annex I to Directive 2008/84/EC is amended as follows:

1. The text concerning E 234 nisin is replaced by the following:

‘E 234 NISIN

Definition

Nisin consists of several closely related polypeptides produced during the
fermentation of a milk or sugar medium by certain natural strains of
Lactococcus lactis subsp.lactis

Einecs

215-807-5

Chemical formula

C143H230N42O37S7

Molecular weight

3 354,12

Assay

Nisin concentrate contains not less than 900 units per mg in a mixture
of non-fat milk proteins or fermented solids and a minimum sodium
chloride content of 50 %

Description

White powder

Purity

Loss on drying

Not more than 3 % when dried to constant weight at 102 °C to 103 °C

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg’

2. The text concerning E 400 alginic acid is replaced by the following:

‘E 400 ALGINIC ACID

Definition

glycuronoglycan

consisting mainly
linked
Linear
D-mannuronic and α-(1-4)
linked L-guluronic acid units in pyranose
ring form. Hydrophilic colloidal carbohydrate extracted by the use of
dilute alkali from natural strains of various species of brown seaweeds
(Phaeophyceae)

of

β-(1-4)

Einecs

Chemical formula

232-680-1

(C6H8O6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Description

Alginic acid yields, on the anhydrous basis, not less than 20 % and not
more than 23 % of carbon dioxide (CO2), equivalent to not less than
91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculated
on equivalent weight basis of 200)

Alginic acid occurs in filamentous, grainy, granular and powdered forms.
It is a white to yellowish brown and nearly odourless

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Identification

A. Solubility

B. Calcium chloride precipitation

test

C. Ammonium sulphate precipi­

tation test

D. Colour reaction

Purity

Insoluble in water and organic solvents, slowly soluble in solutions of
sodium carbonate, sodium hydroxide and trisodium phosphate

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution,
add one fifth of its volume of a 2,5 % solution of calcium chloride. A
voluminous, gelatinous precipitate is formed. This test distinguishes
alginic acid from acacia gum, sodium carboxymethyl cellulose, carbox­
ymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean
gum, methyl cellulose and tragacanth gum

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution,
add one half of
its volume of a saturated solution of ammonium
sulphate. No precipitate is formed. This test distinguishes alginic acid
from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified
pectin, gelatin, locust bean gum, methyl cellulose and starch

Dissolve as completely as possible 0,01 g of the sample by shaking with
0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate
solution. Within 5 minutes, a cherry-red colour develops that finally
becomes deep purple

pH of a 3 % suspension

Between 2,0 and 3,5

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Sulphated ash

Not more than 8 % on the anhydrous basis

Sodium hydroxide (1 M solution)

Not more than 2 % on the anhydrous basis insoluble matter

Formaldehyde

Not more than 50 mg/kg

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Salmonella spp.

Absent in 5 g

Absent in 10 g’

3. The text concerning E 401 sodium alginate is replaced by the following:

‘E 401 SODIUM ALGINATE

Definition

Chemical name

Sodium salt of alginic acid

Chemical formula

(C6H7NaO6)n

Molecular weight

10 000-600 000 (typical average)

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Assay

Yields, on the anhydrous basis, not less than 18 % and not more than
21 % of carbon dioxide corresponding to not less than 90,8 % and not
more than 106,0 % of sodium alginate (calculated on equivalent weight
basis of 222)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification

Positive test for sodium and
alginic acid

Purity

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Salmonella spp.

Absent in 5 g

Absent in 10 g’

4. The text concerning E 402 potassium alginate is replaced by the following:

‘E 402 POTASSIUM ALGINATE

Definition

Chemical name

Potassium salt of alginic acid

Chemical formula

(C6H7KO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 16,5 % and not more than
19,5 % of carbon dioxide corresponding to not less than 89,2 % and not
more than 105,5 % of potassium alginate (calculated on an equivalent
weight basis of 238)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification

Positive test for potassium and for
alginic acid

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Purity

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

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 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g’

5. The text concerning E 403 ammonium alginate is replaced by the following:

‘E 403 AMMONIUM ALGINATE

Definition

Chemical name

Ammonium salt of alginic acid

Chemical formula

(C6H11NO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 18 % and not more than
21 % of carbon dioxide corresponding to not less than 88,7 % and not
more than 103,6 % ammonium alginate (calculated on an equivalent
weight basis of 217)

Description

White to yellowish fibrous or granular powder

Identification

Positive test for ammonium and
alginic acid

Purity

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Sulphated ash

Not more than 7 % on the dried basis

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

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Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Salmonella spp.

Absent in 5 g

Absent in 10 g’

6. The text concerning E 404 calcium alginate is replaced by the following:

‘E 404 CALCIUM ALGINATE

Synonyms

Calcium salt of alginate

Definition

Chemical name

Calcium salt of alginic acid

Chemical formula

(C6H7Ca1/2O6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 18 % and not more than
21 % carbon dioxide corresponding to not less than 89,6 % and not
more than 104,5 % of calcium alginate (calculated on an equivalent
weight basis of 219)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification

Positive test for calcium and
alginic acid

Purity

Loss on drying

Not more than 15,0 % (105 °C, 4 hours)

Formaldehyde

Not more than 50 mg/kg

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

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Yeast and moulds

Not more than 500 colonies per gram

E. coli

Salmonella spp.

Absent in 5 g

Absent in 10 g’

7. The text concerning E 405 propane-1,2-diol alginate is replaced by the following:

‘E 405 PROPANE-1,2-DIOL ALGINATE

Synonyms

Hydroxypropyl alginate

1,2-propanediol ester of alginic acid

Propylene glycol alginate

Definition

Chemical name

Propane-1,2-diol ester of alginic acid; varies in composition according to
its degree of esterification and the percentage of free and neutralised
carboxyl groups in the molecule

Chemical formula

(C9H14O7)n (esterified)

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 16 % and not more than
20 % of CO2 of carbon dioxide

Description

Nearly odourless, white to yellowish brown fibrous or granular powder

Identification

Positive test for 1,2-propanediol
and alginic acid after hydrolysis

Purity

Loss on drying

Not more than 20 % (105 °C, 4 hours)

Total propane-1,2-diol content

Not less than 15 % and not more than 45 %

Free propane-1,2-diol content

Not more than 15 %

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

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E. coli

Salmonella spp.

Absent in 5 g

Absent in 10 g’

8. The text concerning E 407 carrageenan is 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.)

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. Carra­
geenan 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. Formaldehyde may be
present as an adventitious impurity up to a maximum level of 5 mg/kg

Definition

Einecs

232-524-2

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

Description

Identification

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 °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

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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

Not more than 5 %

(Molecular weight fraction below
50 kDa)

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 2 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

Salmonella spp.

Absent in 5 g

Absent in 10 g’

9. The text concerning E 407a processed eucheuma seaweed is replaced by the following:

‘E 407a PROCESSED EUCHEUMA SEAWEED

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 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. Formaldehyde may be present as an adventitious
impurity up to a maximum level of 5 mg/kg.

Tan to yellowish, coarse to fine powder which is practically odourless

Synonyms

Definition

Description

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 °C

Not less than 5 mPa.s

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Loss on drying

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

Sulphate

Ash

Acid-insoluble ash

Acid-insoluble matter

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

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

Not less than 8 % and not more than 15 % on the dried basis (insoluble
in 1 % v/v sulphuric acid)

Low molecular weight carrageenan

Not more than 5 %

(Molecular weight fraction below
50 kDa)

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 2 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

Salmonella spp.

Absent in 5 g

Absent in 10 g’

10. The text concerning E 412 guar gum is replaced by the following:

‘E 412 GUAR GUM

Synonyms

Definition

Gum cyamopsis

Guar flour

(L.) Taub.

tetragonolobur

Guar gum is the ground endosperm of the seeds of natural strains of the
guar plant, Cyamopsis
(family Leguminosae).
Consists mainly of a high molecular weight hydrocolloidal polysaccharide
composed of galactopyranose and mannopyranose units combined
through glycosidic linkages, which may be described chemically as a
galactomannan. The gum may be partially hydrolysed by either heat
treatment, mild acid or alkaline oxidative treatment
for viscosity
adjustment.

Einecs

232-536-0

Molecular weight

Consists mainly of a high molecular weight hydrocolloidal polysaccharide
(50 000-8 000 000)

Assay

Description

Identification

Galactomannan content not less than 75 %

A white to yellowish-white, nearly odourless powder

A. Positive tests for galactose and

for mannose

B. Solubility

Soluble in cold water

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Purity

Loss on drying

Not more than 15 % (105 °C, 5 hours)

Ash

Not more than 5,5 % determined at 800 °C

Acid-insoluble matter

Not more than 7 %

Protein (N × 6,25)

Not more than 10 %

Starch

Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution (no blue colour is produced)

Organic peroxides

Not more than 0,7 meq active oxygen/kg sample

Furfural

Lead

Arsenic

Mercury

Cadmium

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg’

11. After the entry E 503(ii), the following text concerning E 504(i) is added:

‘E 504(i) MAGNESIUM CARBONATE

Synonyms

Definition

Hydromagnesite

Magnesium carbonate is a basic hydrated or a monohydrated magnesium
carbonate or a mixture of the two

Chemical name

Magnesium carbonate

Chemical formula

MgCO3.nH2O

Einecs

Assay

208-915-9

Not less than 24 % and not more than 26,4 % of Mg

Description

Odourless, light, white friable masses or as a bulky white powder

Identification

A. Solubility

Practically insoluble both in water or ethanol

B. Positive tests

for magnesium

and for carbonate

Purity

Acid insoluble matter

Not more than 0,05 %

Water soluble matter

Not more than 1 %

Calcium

Not more than 0,4 %

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Arsenic

Lead

Mercury

Not more than 4 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg’

12. The text concerning E 526 calcium hydroxide is replaced by the following:

‘E 526 CALCIUM HYDROXIDE

Synonyms

Definition

Slaked lime, hydrated lime

Chemical name

Calcium hydroxide

215-137-3

Ca(OH)2

74,09

Content not less than 92 %

White powder

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for alkali and for

calcium

B. Solubility

Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

Purity

Acid insoluble ash

Not more than 1,0 %

Magnesium and alkali salts

Not more than 2,7 %

Barium

Fluoride

Arsenic

Lead

Not more than 300 mg/kg

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 6 mg/kg’

13. The text concerning E 529 calcium oxide is replaced by the following:

‘E 529 CALCIUM OXIDE

Synonyms

Burnt lime

Definition

Chemical name

Calcium oxide

Einecs

215-138-9

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CaO

56,08

Content not less than 95 % on the ignited basis

Odourless, hard, white or greyish white masses of granules, or white to
greyish powder

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for alkali and for

calcium

B. Heat

on
moistening the sample in water

generated

is

C. Solubility

Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

Purity

Loss on ignition

Not more than 10 % (ca. 800 °C to constant weight)

Acid insoluble matter

Not more than 1 %

Barium

Not more than 300 mg/kg

Magnesium and alkali salts

Not more than 3,6 %

Fluoride

Arsenic

Lead

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 7 mg/kg’

14. The text concerning E 901 beeswax is replaced by the following:

‘E 901 BEESWAX

Synonyms

White wax, yellow wax

Definition

the
Yellow beeswax is the wax obtained by melting the walls of
honeycomb made by the honey bee, Apis mellifera L., with hot water
and removing foreign matter

White beeswax is obtained by bleaching yellow beeswax

Einecs

232-383-7 (beeswax)

Description

Identification

Yellowish white (white form) or yellowish to greyish brown (yellow
form) pieces or plates with a fine-grained and non-crystalline fracture,
having an agreeable, honey-like odour

A. Melting range

Between 62 °C and 65 °C

B. Specific gravity

About 0,96

C. Solubility

Insoluble in water

Sparingly soluble in alcohol

Very soluble in chloroform and ether

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Purity

Acid value

Not less than 17 and not more than 24

Saponification value

87-104

Peroxide value

Not more than 5

Glycerol and other polyols

Not more than 0,5 % (as glycerol)

Ceresin, paraffins and certain other
waxes

Absent

Fats, Japan wax, rosin and soaps

Absent

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg’

15. The text concerning E 905 microcrystalline wax is replaced by the following:

‘E 905 MICROCRYSTALLINE WAX

Synonyms

Definition

Petroleum wax, hydrocarbon wax, Fischer-Tropsch wax, synthetic wax,
synthetic paraffin

Refined mixtures of
petroleum or synthetic feedstocks

solid,

saturated hydrocarbons, obtained from

Description

White to amber, odourless wax

Identification

A. Solubility

Insoluble in water, very slightly soluble in ethanol

B. Refractive Index

nD

100 1,434-1,448

Alternative: nD

120 1,426-1,440

Purity

Molecular weight

Average not less than 500

Viscosity

Not less than 1,1 × 10-5 m2 s-1 at 100 °C

Alternative: Not less than 0,8 × 10-5 m2 s-1 at 120 °C, if solid at 100 °C

Residue on ignition

Not more than 0,1 wt %

Carbon number at 5 % distillation
point

Not more than 5 % of molecules with carbon number less than 25

Colour

Sulphur

Arsenic

Passes test

Not more than 0,4 wt %

Not more than 3 mg/kg

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Lead

Not more than 3 mg/kg

Polycyclic aromatic compounds

The polycyclic aromatic hydrocarbons, obtained by extraction with
dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:

Nm

280-289

290-299

300-359

360-400

Maximum absorbance per
cm path length

0,15

0,12

0,08

0,02

Alternative, if solid at 100 °C

PAC method as per 21 CFR& 175.250;

Absorbency at 290 nm in decahydronaphthalene at 88 °C: Not exceeding
0,01’

16. The text concerning E 230 and E 233 is deleted.