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DIRECTIVE 362L2645 |
EEC: Council
Directive on the approximation of the rules of the Member States concerning the
colouring matters authorized for use in foodstuffs intended for human
consumption
Amendments:
Amended by 365L0469 (OJ P 178 26.10.1965 p.2793) (SE SER1 I p.0082)
Amended by 367L0653 (OJ P 263 30.10.1967 p.4) (SE SER1 I p.0285)
Amended by 368L0419 (OJ L 309 24.12.1968 p.24) (SE SER1 I p.0597)
Amended by 370L0358 (OJ L 157 18.07.1970 p.36) (SE SER1 I p.0434)
Amended by 172B
Amended by 373D0101(01) (OJ L 002 01.01.1973 p.1)
Amended by 376L0399 (OJ L 108 26.04.1976 p.19)
Amended by 378L0144 (OJ L 044 15.02.1978 p.20)
Amended by 179H
Amended by 381L0020 (OJ L 043 14.02.1981 p.11)
Amended by 185I
Amended by 385L0007 (OJ L 002 03.01.1985 p.22)
Incorporated by 294A0103(52) (OJ L 001 03.01.1994 p.263)
See 394L0036 (OJ L 237 10.09.1994 p.13)
Amended by 395L0045 (OJ L 226 22.09.1995 p.1)
COUNCIL DIRECTIVE on the
approximation of the rules of the Member States concerning the colouring
matters authorised for use in foodstuffs intended for human consumption
THE COUNCIL OF THE EUROPEAN ECONOMIC
COMMUNITY,
Having regard to the Treaty establishing the European
Economic Community, and in particular Articles 100 and 227 (2) thereof;
Having regard to the proposal from the Commission;
Having regard to the Opinion of the European Parliament;
Having regard to the Opinion of the Economic and Social Committee;
Whereas all rules relating to the colouring matters which may be used in
foodstuffs intended for human consumption must give priority to the protection
of public health, but the protection of the consumer against falsification and
the needs of the economy must also be taken into consideration;
Whereas differences between national rules concerning these colouring matters
hinder the free movement of foodstuffs and may create conditions of unfair
competition, thereby directly affecting the establishment or functioning of the
common market;
Whereas the approximation of these rules is necessary for the free movement of
foodstuffs;
Whereas the harmonisation of such rules must involve, as a first stage, the
establishment of a single list of colouring matters whose use is authorised for
colouring foodstuffs and the laying down of criteria of purity which those
colouring matters must satisfy, while, during a second stage, the Council is to
take decisions on the harmonisation of the conditions governing the colouring
of foodstuffs;
Whereas, in order to take the economic needs of certain States into account, a
period should be set during which such Member States may, in respect of certain
colouring matters, retain their existing rules, it being understood that during
that period the Council may, in the light of any scientific research carried
out, take decisions as to the authorisation of such colouring matters;
HAS ADOPTED THIS DIRECTIVE:
Article 1
1.
Save
as otherwise provided in Article 2, 3, 4 or 13, Member States shall not
authorise the use for colouring foodstuffs intended for human consumption
(hereinafter called "foodstuffs") of any colouring matters other than
those listed in Annex I.
2.
The
use of such colouring matters for colouring foodstuffs shall not be subject to
any general prohibition.
3.
Where
the use in foodstuffs of one of the colouring matters listed in Annex I might
endanger human health, a Member State may, for a maximum period of one year,
suspend the authorisation to use that colouring matter in foodstuffs. It shall
inform the other Member States and the Commission of any such suspension within
one month. The Council shall, acting unanimously on a proposal from the
Commission and by directive, forthwith decide whether the list in Annex I
should be amended and, if so, to what extent. The Council may, if necessary,
extend the period set in the first sentence of this paragraph.
4.
The
provisions of this Directive shall also apply to imported products, whether or
not processed, intended for consumption within the Community.
Article 2
1.
For
a period of three years following notification of this Directive, Member States
may maintain the provisions of their existing national rules concerning the
colouring matters listed in Annex II
2.
Before
expiry of the period set in paragraph 1, the Council may, under Article 100 of
the Treaty, act on a proposal for a directive authorising the use of these
colouring matters. Authorisation may be granted only if, after scientific
investigation, these colouring matters are proved harmless to health and if
their use is necessary for economic reasons. Where the Council has not acted
within the period set in paragraph 1, Article 12 shall apply.
Article 3
This Directive shall not affect national rules concerning natural substances
which are used in the manufacture of certain foodstuffs because of their
aromatic, rapid or nutritive properties but which also have a subsidiary
colouring property, for example paprika, turmeric, saffron and sandal-wood in
particular.
Article 4
This
Directive shall not affect national rules concerning colouring matters
authorised:
a)
for
colouring the shells of hard boiled eggs, tobacco and manufactured tobacco;
b)
for
stamping meat, citrus fruit, cheese-rinds, the shells of eggs and other
external parts not usually consumed with the foodstuffs.
Article 5
This
Directive shall not affect national rules specifying which foodstuffs may be
coloured by means of the colouring matters listed in Annexes I and II or on
what conditions they may be so treated.
Article 6
The
Member States shall, for diluting or dissolving the colouring matters listed in
Annex I, authorise the use of the following products only:
Sodium
carbonate and sodium hydrogen carbonate
Sodium chloride
Sodium sulphate
Glucose
Lactose
Sucrose
Dextrins
Starches
Ethanol
Glycerol
Sorbitol
Edible oils and fats
Beeswax
Water.
Article 7
By way
of derogation from Articles 5 and 6, Member States may authorise the use of
pigment rubine and of burnt umber, whether or not mixed with paraffin wax or
with other harmless substances, only for colouring cheese-rinds.
Article 8
The
Member States shall take all measures necessary: - to ensure that the colouring
matters listed in Annex I, where these are used to colour foodstuffs, satisfy
the criteria, both general and specific, laid down in Annex III;
-
to
ensure that the products listed in Article 6, where these are used to dilute or
dissolve the colouring matters listed in Annex I, satisfy the general criteria
of purity laid down in Annex III, Section A (1) and (2) (b).
Article 9
1. The Member States shall take all measures necessary to
ensure that the colouring matters listed in Annex I are placed on the market
only if their packagings or containers bear:
(a) the name and address of the manufacturer or of the
seller established within the European Economic Community;
(b) the number of colouring matter or matters according to
the European Economic Community numbering system given in Annex I;
(c) the words "colouring matter for foodstuffs".
2. If the information required under paragraph 1 appears on
the packagings or containers and if the words required under paragraph 1 (c)
are given in two of the official languages of the Community, one of Germanic
and the other of Latin origin, Member States shall not refuse to allow the
importation of colouring matters listed in Annex I solely on the grounds that
they consider the labelling inadequate.
Article
10
This Directive shall apply to chewing gum in so far as the
latter contains any colouring matter.
Article
11
1.
The
Council, acting unanimously on a proposal from the Commission, may amend by
directive the criteria of purity laid down in Annex III if it becomes evident,
in particular in the light of scientific research, that this is necessary for
the protection of public health.
2.
After
consulting the Member States, the Commission shall establish by directive the
methods of analysis needed to verify that the criteria of purity laid down in
Annex III are satisfied.
Article
12
1. Member States shall, within a period
of one month following notification of this Directive, amend their rules in
accordance with the above provisions. The rules thus amended shall apply to
products placed on the market in Member States not later than two years after
that notification.
2. Where the last sentence of Article 2
(2) is applicable, the date of expiry of the period set in that Article shall
be substituted for the date of notification referred to in the preceding
paragraph.
Article
13
This Directive shall not affect the provisions of national
rules concerning products intended for exportation from the Community.
Article
14
This Directive shall also apply in the French overseas
departments.
Article
15
This Directive is addressed to the Member States.
Done at Brussels, 23 October 1962.
For the Council
The President
E. COLOMBO
ANNEX I
The colouring matters referred to in Article 1 of this Directive
are listed in the three sections below.
The chemical name given is usually that of the colouring
matter when combined with sodium. Except as provided in respect of No E 180,
pigment rubine, the use is authorised of the acid itself, of the colouring
matter combined with sodium, calcium, potassium and aluminium, whether these
combinations are mentioned or not, and of other combinations where stated.
Synthetic chemical products which are identical to the
natural colouring matters listed below are also authorised. >PIC FILE=
"T0050794">
>PIC FILE= "T0050795">
>PIC FILE= "T0050796">
>PIC FILE= "T0050797">
ANNEX II
>PIC FILE= "T0050798">
ANNEX III Criteria of Purity
A. GENERAL CRITERIA OF
PURITY
Unless otherwise provided in the specific criteria in
Section B the colouring matters referred to in Annex I are required to satisfy
the following criteria of purity, quantities and percentages being calculated
on the pure colour.
1. Inorganic impurities
(a) They should contain not more than 5 mg/kg of arsenic and
not more than 20 mg/kg of lead;
(b) They should contain not more than 100 mg/kg of the
following substances, taken separately : antimony, copper, chromium, zinc,
barium sulphate ; and not more than 200 mg/kg of these products taken together;
(c) They should not contain cadmium, mercury, selenium,
tellurium, thallium, uranium or chromates, or soluble combinations of barium in
detectable quantities.
2. Organic impurities
(a) They should not contain 2-naphthylamine, benzidine,
amino-4-diphenyl (or xenylamine) or their derivatives;
(b) They should not contain polycyclic aromatic
hydrocarbons;
(c) Synthetic organic colouring matters should contain not
more than 0 701 % of free aromatic amines;
(d) Synthetic organic colouring matters should contain not
more than 0 75 % of intermediate synthetic products other than free aromatic
amines;
(e) Synthetic organic colouring matter should contain not
more than 4 % of accessory colouring matters (isomers, homologues etc.);
(f) Sulphonated organic colouring matters should contain not
more than 0 72 % of substances extractable by diethyl ether.
B. SPECIFIC CRITERIA
OF PURITY
E 101 - Lactoflavin (Riboflavin)
Lumiflavin : Prepare ethanol-free chloroform as follows : Shake 20 ml of
chloroform with 20 ml of water gently but carefully for three minutes and allow
time to separate. Draw off the chloroform layer and repeat the operation twice
using 20 ml each time. Finally, filter the chloroform through dry filter paper,
shake the filtrate well for five minutes with 5 g of powdered anhydrous sodium
sulphate, leave the mixture to settle for two hours, then decant or filter the
clear chloroform. Shake 25 mg of riboflavin with 10 ml of ethanol-free
chloroform for five minutes, then filter : the colour of the filtrate should
not be more intense than that of an aqueous solution obtained by diluting 3 ml
of 0 71 N potassium dichromate to 1000 ml.
E 102 - Tartazine
Products insoluble in water : not more than 0 72 %
Accessory colourings : not more than 1 %
E 103 - Chrysoine S
Products insoluble in water : not more than 0 72 %
E 104 - Quinoline Yellow
Products insoluble in water : not more than 0 72 %
E 105 - Fast Yellow AB
Products insoluble in water : not more than 0 72 %
Accessory colourings : not more than 3 %
Unsulphonated aromatic amines and aniline : not more than 10 mg/kg
(a) Determination of 2-aminoazobenzene and 4-aminoazobenzene
: Dissolve 20 70 g of Fast Yellow AB in 400 ml of water and add 5 ml of N
sodium hydroxide. Shake in a separating funnel with four successive portions of
50 ml of chlorobenzene, for five minutes each time. Wash the combined
chlorobenzene extracts with successive amounts of 400 ml of 0 71 N sodium
hydroxide until the upper aqueous layer remains colourless. Filter the chlorobenzene
solution through a thickly-folded filter paper and measure the extinction (E1)
in a spectrophotometer against chlorobenzene contained in cells of suitable
thickness (d1) at 414 m¶.
Calculation: >PIC FILE= "T0050799">
Note: >PIC FILE= "T0050800">
The aminoazobenzene content can be determined only up to 90 %. It is possible
to separate the 2- and 4- compounds by the following method. Concentrate 100 ml
of chlorobenzene extract to about 20 ml by heating in a water bath in a current
of warm air. Pour the concentrated solution on a column of alumina (of
appropriate size). Elute with chlorobenzene. The first 100 ml of the
chlorobenzene eluate contains the 2-aminoazobenzene. The para compound of the
chlorobenzene is then eluted. Dilute the two solutions to 100 ml. Measure the
extinction of the ortho-compound at 414 m¶ (E2), and that of the para-compound
at 376 m¶ (E3). >PIC FILE= "T0050801">
(b) Determination of aniline : Shake 75 ml of the remaining
chlorobenzene extract with two successive portions of 50 ml of 0 75 N
hydrochloric acid, then with two successive portions of 25 ml of water.
Neutralise the combined aqueous extracts with a 30 % solution of sodium
hydroxide, then acidify with 10 ml of 0 75 N hydrochloric acid. Dissolve 1-2 g
of potassium bromide in this solution. After cooling in iced water, add about
20 drops of 0 71 N sodium nitrate and leave to settle for ten minutes. Remove
the excess nitrite by the addition of sulphamic acid. Pour the solution into
about 5 ml of a 3 % solution of R salt (disodium salt of 2-naphthol-3,
6-disulphonic acid) added to 10 ml of 2 N sodium hydroxide. Leave to settle for
fifteen minutes. Acidify the solution of the dyestuff with Congo Red TS
(indicator) until the latter turns blue, and filter. The aminoazobenzene
dyestuff will remain on the filter. Dilute the filtrate to 200 ml, then measure
the extinction at 490 m¶ or E4.
Calculation: >PIC FILE= "T0050802">
E 110 - Orange Yellow S, Sunset Yellow FCF
Products insoluble in water : not more than 0 72 %
E 111 - Orange GGN
Products insoluble in water : not more than 0 72 %
E 120 - Cochineal, carminic acid
Paper chromatography : with a solution of 2 g of trisodium citrate in 100 ml 5
% ammonium hydroxide, cochineal gives only a single stain in the alkaline zone.
E 122 - Azorubin, Carmoisine
Products insoluble in water : not more than 0 72 %
Accessory colourings : not more than 1 %
E 123 - Amaranth
Products insoluble in water : not more than 0 72 %
E 124 - Cochineal Red A, Ponceau 4 R
Products insoluble in water : not more than 0 72 %
E 125 - Scarlet GN
Products insoluble in water : not more than 0 72 %
E 126 - Ponceau 6 R
Products insoluble in water : not more than 0 72 %
Accessory colourings : not more than 3 %
E 131 - Patent Blue V
Products insoluble in water : not more than 0 75 %
Chromium (estimated as CR) : not more than 20 mg/kg
Accessory colourings : not more than 1 %
E 132 - Indigotin indigo carmine
Products insoluble in water : not more than 0 72 %
Accessory colourings : not more than 1 %
Isatinsulphonic acid : not more than 1 %
E 141 - Copper complexes of chlorophylls and chlorophyllins
A 1 % solution of copper chlorophyll complex in turpentine should not be turbid
and should not form a sediment.
Copper (free ionisable Cu) : not more than 200 mg/kg
E 151 - Brilliant Black BN, Black PN
Products insoluble in water : not more than 0 72 %
Accessory colourings : not more than 15 %. (The presence of accessory
colourings among which the diacetylised compound has been identified is
essential in order to obtain the precise shade.)
Intermediate products : not more than 1 %
E 152 - Black 7984
Products insoluble in water : not more than 0 72 %
Lead : not more than 10 mg/kg
Arsenic : not more than 2 mg/kg
E 153 - Carbo medicinalis vegetalis (charcoal)
Higher aromatic hydrocarbons : Extract 1 g of carbon black with 10 g of pure
cyclohexane for two hours. The extract should be colourless. It should have
little or no fluorescence in ultra-violet light ; on evaporation it should
leave no residue.
Tarry products : boil 2 g of carbon black with 20 ml of N sodium hydroxide,
then filter. The filtrate should be colourless.
E 160 (a) - Alpha-, Beta-, Gamma-Carotene
Chromatography : By absorption on alumina or silica gel, pure Beta-carotene
shows only one zone.
E 160 (b) - Bixin and Norbixin (Roucou, Annatto)
Chromatography:
(a) Annatto : Dissolve a sufficient quantity of Annatto in
benzene or dilute a benzene solution of Annatto to obtain a solution of the
same colour as a 1 % solution of potassium dichromate. Pour 3 ml of the
solution on the top of an alumina column ; elute slowly. Wash the column three
times with benzene. The bixin is very heavily absorbed on the surface of the
alumina and forms a brilliant orange-red zone (as distinct from crocetin
saffron). A very pale yellow zone usually moves very rapidly across the column,
even with crystallised pure bixin. The bixin cannot be eluted in benzene, light
petroleum, ether, chloroform, acetone, etharol or methanol. But the ethanol and
methanol cause the orange tint to turn into an orange yellow.
Carr-Price reaction : Remove the benzene from the column by washing three times
with chloroform previously dehydrated by means of potassium carbonate. After
elution of the last chloroform wash, add 5 ml of the Carr-Price reagent to the
top of the column. The bixin zone immediately turns to blue-green (as distinct
from crocetin).
(b) Bixin : Dissolve 1 to 2 mg of crystallised bixin in 20
ml of chloroform. Add 5 ml of this solution to the top of the prepared column.
Rinse the solution with chloroform previously dehydrated with sodium carbonate
and proceed as for (a) (Carr-Price reaction).
(c) Alkaline solutions of norbixin : Place 2 ml of an
aqueous solution of Annatto in a 50 ml separating funnel. Add sufficient 2 N
sulphuric acid to obtain a highly acid reaction. The norbixin will separate out
as a red precipitate. Add 50 ml of benzene, then shake vigorously. After
separation discard the aqueous layer and wash the benzene solution with 100 ml
of water until the solution is no longer acid. Centrifuge the solution (usually
emulsified) of norbixin in benzene for ten minutes at 2500 revolutions per
minute. Decant the clear norbixin solution and dehydrate by means of anhydrous
sodium sulphate. Pour 3-5 ml of this solution on the top of the alumina column.
Norbixin like bixin will form an orange-red zone on the surface of the alumina.
When eluted as in (a), it will behave like bixin and will also give the
Carr-Price reaction.
E 162 -
Beetroot red, betanin
Paper Chromatography : With butanol saturated with 2 N hydrochloric acid as a
solvent (ascending chromatography), betanin gives a single red spot with a
brownish trail and little migration.
E 171 -
Titanium dioxide
Substances soluble in hydrochloric acid : Suspend 5 g of titanium dioxide in
100 ml of 0 75 N hydrochloric acid and heat for thirty minutes in a water bath,
stirring from time to time. Filter in a Gooch crucible on the bottom of which
three layers have been placed, the first of coarse asbestos the second of
filter paper reduced to a pulp and the third of fine asbestos. Wash with three
successive portions of 0 75 N hydrochloric acid each of 10 ml. Evaporate the
filtrate to dryness in a platinum evaporating dish, then heat to a dull red
until the weight is constant. The weight of the residue should not exceed 0
70175 g.
Antimony : not more than 100 mg/kg
Zinc : not more than 50 mg/kg
Soluble barium compounds : not more than 5 mg/kg
E 172 -
Iron oxides and hydroxides
Selenium : not more than 1 mg/kg
Mercury : not more than 1 mg/kg
E 181 -
Burnt umber
Manganese oxides computed on the basis of Mn3O4 : not more than 8 %
Organic matters not completely burnt : Boil 2 g of burnt umber in 30 ml of a 20
% solution of potassium hydroxide, then filter. The filtrate should be
colourless.
End of the document