THE LEGISLATION OF FOOD COLOURS IN EUROPE
Dr. Ulrike Arlt
The use of food colours is as old as the human civilisation.
Egyptian papyri dating 1500 BC indicate that natural colours such as turmeric,
saffron and paprika were added to foods in order to flavour them, and to make
them more appealing 1.
Food colours seem also to have played an important role in ancient Europe,
as can be concluded e.g. from one of the most beautiful paintings from the
Greek Island Thera, "Female gatherers of saffron" (-1500 BC).2
During the Middle Ages (5th-15th century), the economy in
the European countries was based on agriculture, and the peasants were accustomed
to producing their own food locally and/or trading within the village communities.
Under feudalism, foodstuffs were mainly regarded as means to survive. Aesthetic
aspects were not considered, at least not by the vast majority of the generally
very poor population.
This situation changed with urbanisation at the beginning
of the Modem Ages, when trade, especially the import of precious spices and
colours from climatically favoured countries, emerged. The new citizenship
began to open new markets and was at the same time the main customer for the
improved goods. One of the very first European food laws, the Law from Augsburg
(Germany, 1531) dates back to the early period of these times. Obviously,
it was driven by the wish to put unwelcome "competitors" of precious
food colours (spices) out of the running. Still based on medieval jurisdiction,
the punishment laid down was drastic: falsifiers of saffron were burnt!3
With the onset of the industrial revolution, thousands of
people began to move to the new centers of industrialisation. The nourishing
of these ancient peasants changed fundamentally; all of a sudden, they totally
depended on foods produced and sold by others. These new urban dwellers demanded
for perishable food at low cost.
Analytical chemistry was still in the process of development; on this basis,
and especially in the absence of legal or administrative obstacles, it is
not surprising that the adulteration of foods flourished. It was driven by
the keen competition among the growing amount of food producers and traders
in the growing cities. Especially heavy metals and other inorganic elements
turned out to be cheap and suitable to "restore" the colour of watered-down
milk and other adulterated foodstuffs. One of the first advocates for a public
regulation of foods, the scientist A.H. Hassel, summarised the
situation of the British consumer in the 19th century
". ..Thus, with potted meat, fish and sauces taken at breakfast he
would consume more or less Armenian bole, red lead, or even bisulphuret of
mercury. At dinner with his curry or cayenne he would run the chance of a
second dose of lead or mercury; with pickles, bottled fruit and vegetables
he would be nearly sure to have copper administrated to him; and while he
partook of bon-bons at dessert, there was no telling of the number of poisonous
pigments he might consume. Again his tea if mixed or green, he would certainly
not escape without the administration of a little Prussian Blue... .',4
Under these conditions, it is hardly surprising that food
poisonings were common. In 1851 e.g. about 200 people were
poisoned in England, 17 of them fatally directly as a result of eating adulterated lozenges5. The situation cried out for food regulations.
The first European food laws date back to the end of the
19th century. The first German food law from 1887 e.g. stipulates the absence
of dangerous minerals such as arsenic, copper, chromium, lead, mercury, zinc
and others in foods3. Although, in contrast to today, these
first laws followed the principle of a negative listing (substances not allowed
for use), they were already driven by the main principles of today's food
regulations all over the world, since all of these regulations follow the
same goal: the protection of the consumer from toxic substances and from fraud.
In the 20th century, the improvement of chemical analysis
and the development of trials to identify the toxic features of substances
added to foods lead to the replacement of the negative lists by lists of substances
allowed to be used for the production and the improvement of foods. This principle
is called a positive listing, and almost all recent legislation's are based
Positive listing implies that substances meant for
human consumption have been tested for their safety, and that they have to
meet specified purity criteria prior to their approval by the corresponding
AUTHORITIES AND SCIENTIFIC EXPERT COMMITTEES
In the European Union (EU; formerly European (Economic)
Community, E(E)C), the safety of food colours and other food additives is
nowadays evaluated by the Scientific Committee on Food (SCF), an advisory
expert committee of the European Commission, located in Brussels (Belgium).
Laws enacted by the European Commission are binding to all
member countries of the EU, and have to be implemented into their national
laws within a given time frame. In non-EU member states, food additives are
regulated by the national authorities, which usually, but not in all cases,
try to harmonise them with the laws adopted in Brussels.
Another important expert committee, working on a global
basis, is JECFA (Joint WHO/FAO Expert Committee on Food Additives), the advisory
committee of the World Health Organisation (WHO) and the Food and Agriculture
According to the SCE's and JEFF A's toxicological evaluation,
an ADI (Acceptable Daily Intake) value, expressed in mg/kg body weight per
day, is allocated to the additive, or its use is not recommended.
EU FOOD ADDITIVE LEGISLATION
The first "Directive concerning the colouring matters
authored for use in foodstuffs6, was published in 1962. According
to this positive list, 36 food colours were allowed to be used. 20 of them
were natural colours, and 16 were artificial pigments not occurring in nature.
These colours had been considered as safe according to the toxicological data
However, this "horizontal" list did not specify
the levels of use, nor the foodstuffs in which the colourants were permitted
to be used. This information was laid down either in "vertical"
Directives for single foodstuffs, or still in the national regulations. Since
the member states could basically choose from the horizontal Directive those
colours, which were suitable for the use in the various foodstuffs, these
vertical laws caused a barrier of trade within the EU. In Germany e.g. quinoline
yellow was permitted for the colouration of puddings and desserts, while tartrazine
was not. In France, the situation was exactly opposite: Tartrazine was allowed
for the above purpose, and quinoline yellow was not.
In order to overcome this obstacle, the positive list of
food colours had to be combined with the determination of their application
in the different food categories.
Furthermore, the commercial production of foods and the
increasing international trade required the regulation of many other substances
necessary to cover storation and transportation of industrially "processed"
foods. Industrial processing includes e.g. cooking, freezing, stabilisation
and preservation of foods; these processes make it possible that foodstuffs
are available at any time of the year and at any place of the world.
The processing of foods requires adjusting of otherwise
lost aromas, colours and nutrients in order to maintain a healthy, attractive
and appetising food. Many other substances are needed to assure its stabilisation
and preservation, e.g. antioxidants, humectants and stabilisers.
In order to categorise this vast amount of auxiliary materials
and to regulate their use, the EU Council developed a Frame "Directive
concerning Food Additives Authored for Use in Foodstuffs (89/IO7/EEC)7,
adopted in 1989. The Directive identifies 24 categories of food additives,
among those colours, sweeteners, emulsifiers and others (Table I).
Categories of food additives according to Frame Directive 89/107/EEC
|Preservative||Flavour Enhancer||Anti-foaming agent|
|Emulsifier||Acid Regulator||Flour treatment agent|
|Emulsifying agent||anti-caking agent||firming agent|
|Gelling agent||Raising agent||Sequestrant|
|Enzyme||Bulking agent||Propelling and packaging gases|
The Frame Directive defines the term "food additives"
and distinguishes them from other substances present in or added to foods.
Within the meaning of the Directive, food additives are substances which
are usually not consumed as a food in itself - whether or not of nutritive
value -, and which are intentionally added for their technological purpose.
The Directive does not apply to:
Substances used in process, but which do not have any technological
|Nutrients||Minerals, trace elements or vitamins, unless
they are added for their technological purpose; e.g. vitamin E for its
function as an antioxidant or riboflavin (vitamin B2) for colouration
|Flavourings||Due to the high amount of flavouring substances
(~3000 as compared to ~30 colours), a positive listing of flavours turned
out to be difficult. Since the application of flavourings is mostly self-limited
and concentrations applied to foods are usually low, the exclusion of
flavourings from the positive listing of food additives seemed to be justified;
especially as a long history of safe use of these substances could be
assumed. The first Frame Directive laying down a community
procedure for flavouring substances was published by the EU Parliament
in 19968 and foresees a
positive regulation of flavours, based on adequate toxicological evaluation,
by the year 2000. Such an assessment might be based on an abridged toxicological
evaluation procedure, as it is recently practised by JECFA. This procedure
allows the evaluation of -200 flavouring substances per year9.
The general criteria for the use of food additives are laid down in Annex II of the Directive:
Food additives can be approved only provided that they are
meant to preserve the nutritional value of a food, to enhance its keeping
quality, or to provide aids in the manufacture. It is understood that the
use is limited to the lowest level of use necessary to achieve the desired
effect, and the applicant is obliged to demonstrate the reasonable technological
He has also to prove that the purpose cannot be achieved
by other means, which are technologically and economically practicable. Furthermore,
the over-all principle of consumer protection -food additives should present
no hazard to the health of the consumer, nor should they mislead him -is laid
down in the Annex.
The Frame Directive demands for the elaboration of specific
Directives regulating the particular categories of food additives. These should
combine a horizontal listing for " additives the use of which is authored
to the exclusion of all others", with a vertical legislation, defined
as " a list of foodstuffs, to which those additives may be added rod,
where appropriate, a limit on the technological purpose of their use".
In the meantime, these amending Directives have been adopted
and implemented into the national laws of the
member states. These are the Directives for:
Colours 10, Sweeteners 11 and "Miscellaneous"
Additives12, the latter including all other food additive categories
listed in Table 1.
THE RECENT EU FOOD COLOUR DIRECTIVE
The recent Colour Directive 94/36/EC on colours for use
in foodstuffs was adopted in 1994. As the first Colour Directive from 1962,
which it replaces, the recent Directive includes the regulation of natural
and artificial colours, which are listed according to the European (E-) numbering
system: In Europe, to the evaluated food additives (whether or not authored
for use) an E number has been allocated, by which they are characterised and
The E numbers for colour additives range from E 100 (curcumin)
to E 180 (lithorubine BK). Since a pigment derived from extraction may be
differently specified as the same pigment derived from chemical synthesis,
it may be characterised by a differentiated E number: beta- carotene extracts
e.g. are listed under E 160ai (mixed carotenes), and synthetic beta-carotene
under E 160aii (beta-carotene).
Within the meaning of the Directive, food additive colours
are defined as:
"Substances which add or restore colour in a food,
and include natural sources which are normally not consumed as a foodstuff
as such and not normally used as a characteristic ingredient in food".
Thereby, the Colour Directive excludes colouring foodstuffs
and food ingredients, which may be used in the preparation of a final food,
from the food additive regulation.
The colour of a French "ratatouille", an Italian
tomato soup or other tomato-based foods e.g. is mainly derived from the content
of lycopene, the predominant carotenoid pigment present in tomatoes. As long
as tomatoes or tomato concentrate -both common foodstuffs as such -are used
for the preparation of such a meal, lycopene, although listed as an authorised
food colour (E 160d) in the Colour Directive, is not regarded as a food colour
additive within the meaning of the Directive.
The same applies for natural pigments
-whether or not authored as permitted food colours -in other foodstuffs, e.g.
in cherries, beetroots, carrots, spinach or fruit juices, and for food ingredients,
e.g. red pepper or curry "characteristically" colouring a hot Mexican
meal or an Indian curry dish, as well as the almost black sauce derived from
the ink of squids, which forms part of some special Mediterranean
According to the Colour Directive, the legal situation
of such pigments changes, when they are selectively extracted -relative to
the nutritive or aromatic constituents -from the original source material,
and (in line with Frame Directive 89/107 /EEC) intentionally added
to foods for the purpose of their colouration.
The selective extraction e.g. of the food
colour curcumin (E 100) is obtained, if not only celluloses, waxes and vegetable
lipids are removed from curcuma roots, but also the volatile oily compounds
(such as camp her, xanthorrizol and tumerol) characteristic for the taste
and the flavour of the source material14.
Some natural colours and colour extracts, however, may still
not be characterised by their colouring properties alone, but may have further,
either physiological (e.g. riboflavin = vitamin B2) or flavouring (many spices
such as paprika and turmeric) properties. Their classification with respect
to food legislation is not always easy; especially since the pre-marketing
approval requirements depend on the classification of the substance. The EU
Colour Directive tries to resolve this issue by excluding those pigments from
the food additive legislation which are explicitly used for their aromatic,
sapid or nutritive purpose, and when their colouring effect in the special
food is only a secondary one.
In line with the requirements of Frame Directive 89/197/EEC
the Colour Directive combines the horizontal listing of permitted food colours
(Annex I) with the regulation of their applications and limits in the different
Annexes II and ill define foodstuffs, which may not contain
colours at all (among others milk, fruit juices, coffee, wine and foods for
infants and young children), and foodstuffs to which only certain permitted
colours may be added (e.g. butter, which may exclusively be co loured with
carotenes). The Annexes N and V specify the food categories and limits for
the permitted food colours. They have been divided into
three groups (Table 2):
A. Colours permitted for use in all food categories at quantum
satis15, except those laid down in Annexes
II and III. These are:
|E number||Food colour|
|E 101||(i) Riboflavin
|E 140||Chlorophylls and Chlorophyllins|
|E 141||Copper complexes of
Chlorophylls and Chlorophyllins
|E 150a||Plain caramel|
|E 150b||Caustic sulphite caramel|
|E 150d||Sulphite ammonia caramel|
|E 153||Vegetable carbon|
|E 160c||Paprika extract, Capsanthin, Capsorubin|
|E 162||Beetroot Red,, Betanin|
|E 170||Calcium carbonate|
|E 171||Titanium dioxide|
|E 172||Iron oxides and hydroxides|
B. Colours allowed up to a maximum level in a specified
number of foodstuffs:
|E number||Food colour|
|E 104||Quinoline Yellow|
|E 110||Sunset Yellow FCF, Orange Yellow S|
|E 120||Cochineal, Carminic acid, Carmines|
|E 122||Azorubine, Carmoisine|
|E 124||Ponceau 4R., Cochineal Red A|
|E 131||Patent Blue V|
|E 132||Indigotine, Indigo carmine|
|E 133||Brilliant Blue FCF|
|E 142||Green S|
|E 151||Brilliant Black BN, Black PN|
|E 155||Brown HT|
|E 160c||Beta-8'-carotenal (C30)|
|E 160f||Ethyl ester of beta-apo.-8'-carotenoic
C. Colours very restricted in their use and allowed for
certain foodstuffs, only:
|E number||Food colour|
|E 180||Lithorubine BK|
|E 160b||Annatto, Bixin, Norbixin|
In comparison with the first Colour Directive from 1962,
seven artificial colours, namely Chrysoine S, Fast Yellow AB, Orange GGN,
Scarlet GN, Ponceau 6R, Anthroquinone Blue and Black 7984, and one natural
colour, Orchil, have been deleted from the positive list. This deletion and
the classification of food colours in the recent Colour Directive was based
on the SCF's ongoing evaluation of new toxicological data available.
In general, the approval of a food colour requires toxicological
data including long-term studies and information on the absorption and pharmacokinetics
of the substance, which allows the allocation of an ADI value to it. These
requirements are laid down in a Guideline on the "Presentation of an
Application for Assessment of a Food Additive prior to its Authorisation",
edited in 1989 by the European Commission.
However, the SCF evaluation made a couple of exemptions
from this extended toxicological testing for natural colour extracts, to which
no formal ADI value could be allocated (ADI "acceptable"), provided
that their intake as a food colour would not result in an ingestion substantially
differing from the amounts likely to be ingested from the normal consumption
of the foods in which they occur.
The SCF has nevertheless insisted on several
occasions that colours from natural materials, even if they are derived from
foods, cannot be held to be safer a priori than synthetic materials;
nor could synthetic equivalents of substances present in food automatically
be given the same evaluation as the food from which it derived. What is important
to the SCF is the technical nature of the colour, the condition of its
isolation and processing, its purity and the quantities absorbed
PURITY CRITERIA / SPECIFICATIONS
The specifications for the approved food
additives are separately regulated by the EU Commission and laid down in the
so-called "Specification-Directives" for colours, sweeteners and
"miscellaneous" additives. The specifications for food colours are
laid down in Commission Directive 95/45/EC17. They usually
include the definition of the original source material of natural extracts
and the solvents allowed to be used in the extraction procedure, the identification
and the minimum content of the colouring material (measured by absorption),
and the limits for residual solvents and heavy metals.
EU FOOD ADDITIVE AUTHORISATION PROCEDURES
Basically, the European food additive laws are enforced
in a CO decision procedure involving three European key institutions: the
Commission, the Parliament and the Council.
A company who wishes to market a new food colour has to
approach the European Commission, represented by 20 members nominated by the
governments of the EU member states, as the initiator of the legislation.
The applicant can do so using two ways:
Either the company seeks authorisation from a member state,
which will then approach the Commission. A national authorisation is given
for two years; within this time frame, the Commission is obliged to either
seek for the Councils approval of the colour on a European level, or to refuse
its use. In the latter case, the national authorisation is cancelled. Alternatively,
the company may directly submit his request to the Commission. In this case,
there is no time limit for the Commission's decision. Although this approach
may take longer, the applicant does not risk a rejection of the national approval
for his product, which would render a second application more difficult.
After consulting the SCF, the Commission forwards his regulatory
proposal to the European Parliament, consisting of 626 members directly elected
by the European population, for its opinion. The Commission proposal
and the Parliament's opinion have to be approved by the European Council,
the decision-making body of the EU. The Council consists of one representative
from each member state (15), usually the Ministers (therefore also called
the "Council of Ministers"). The approved regulatory decision has
then to be implemented into the appropriate law by the Commission.
Since all three institutions have to come to an agreement
on the application, the approval of a new food colour is a long-lasting procedure,
taking at least two years, but usually longer.
In order to speed up the decision-making on matters of more
technical relevance, e.g. as laid down in the Specification Directives, the
power of implementing changes has been delegated to the European Commission
directly, without having to pass through the Parliament and the Council.
Applications for a change of the specifications of an already
approved food colour, such as the use of different source material or changes
in the manufacturing process resulting in a different impurity profile, have
to be adopted by the Commission in accordance with the Standing Committee
on Foodstuffs, a permanent delegation of representatives from all member states.
Depending on the envisaged change of the specifications and provided that
they do not result in a different toxicological profile which might require
a different classification of the colour in the Colour Directive, such changes
within the Specification Directive may be adopted within six to nine months.
The EU Colour Directive does not distinguish between "natural"
or "artificial" colours, and neither of these terms may or has to
be used on the label of a finished foodstuff. The reason for this is mainly
based on the SCF's view that the claim "natural", due to the higher
perception of "natural" material by the majority of the European
consumer, might result in the misinterpretation that such
products are a priori safe18. Furthermore, such a
labelling requirement would result in an unjustified competitive disadvantage
to artificial colour manufacturers, since the safety of all food colours,
irrespective of their origin, has been investigated prior to their marketing
On the other hand, the EU Labelling Directive19
demands for the declaration of all food additives present in foods. They have
to be declared by the name of the category of food additives (e.g. colour
or antioxidant), followed by either the full name of the additive or by its E number (e.g. riboflavin or E 101).
In order to ensure that the purchaser is sufficiently informed
about the product, the Labelling Directive furthermore demands that all products
are labelled in the national language of the appropriate member state.
THE GLOBAL HARMONISATION OF FOOD COLOURS
The global trade requires harmonisation of food regulations
on a world-wide basis in order to abolish barriers of trade and to ensure
that the economical and nutritional demands of all nations are considered.
Since the beginning of the 60s of our
century, JECFA has played an important role in the development of international
standards for food additives, not only by its toxicological assessments, which
are continuously published by WHO in a "Technical Report Series",
but furthermore by elaborating appropriate purity criteria, which are laid
down in the two volumes of the "Compendium of Food Additive Specifications"
and their supplements20. These specifications
are not legally binding but very often serve as a guiding principle, especially
in countries where no own scientific expert committees have been established.
In order to furthermore regulate the use of these
evaluated additives, in 1962 WHO and F AO created an international commission,
the Codex Alimentarius21, which is composed of authorities,
food industry associations and consumer groups from all over the world.
Within the Codex organisation, the Codex Committee for Food
Additives and Contaminants is responsible for working out recommendations
for the application of food additives, the General Standard for
Food Additives. Once a year, the committee meets, usually in Den Haag
(The Hague/The Netherlands), in order to discuss the draft recommendations
and to incorporate the regulations and legislative proposals from all members.
The final standard for food colours, developed according to the prescribed
eight step procedure for elaboration's of Codex measures22,
is likely to be adopted in 1999. In the light of the World Trade Organisations
General Agreement on Tariffs and Trade (GATT) the Codex Standard, although
not legally binding, influences food colour regulations all over the world.
European Food Colour Legislation
Dr. Ulrike Arlt NATCOL
|1||Handbook of U.S. Colorants
for Foods, Drugs and Cosmetics, D.M Marmion (Ed.), Wiley-Interscience
publication, New York (1984).
|2|| Die Wandmalereien yon Thera,
Ch. Doumas, Metamorphosis Verlag GmbH, Miinchen (1996).
|3||Roche Food Colour Legislation
Report, G. Huschke (1993).
|4||Pure Food and Pure Food Legislation,
AJ. Amos (Ed), Butterworths, London
|5||Development in Food Colours,
J. Walford (Ed.), Elsevier Applied Science
Publishers, Lonon/New York (1984).
|6||EC Council Directive of 11
|7||EC Council Directive from
21 December 1988.
|8||EU Parliament and Council
Directive 299/96 of 23 November, 1996.
|9||I.C. Munro et al., Correlation
of structural class with no-observed-efIect levels, Fd. Chem Toxicol.
34, p. 829 (1996).
|10||European Parliament and Council
Directive 94/36/EC from 30 June, 1994.
|11|| European Parliament and
Council Directive 94/35/EC from 30 June, 1994.
|12||European Parliament and Council
Directive on Food Additives others than Colours and Sweeteners 95/2/EC
from 20 February, 1995.
|13||Feed additives indirectly
adding colour to a food are also exempt from the Colour Directive, if
they form part of the "characteristic" ingredients of a foodstuff.
In Europe e.g. egg yolks are usually indirectly coloured by feeding the
hens with carotenoids such as canthaxanthin or beta-apo-carotenoic acid
ester, an esterified derivative of beta-carotene. Such egg yolks are used
in the manufacture of most kinds of noodles in Europe, thereby adding
the characteristic colour to them.
|14||F.-K. Marcus & H.-P.
Hansen, Fiirbende Lebensmittelextrakte, Food Technologie Magazin 3 (July
|15||Quantum satis (lat, ''as
much as suffices"). Within the meaning of the Directive, the quantum
satis use of a food colour shall be in accordance with Good Manufacturing
Practice (GMP) at levels not higher than necessary to achieve the intended
purpose and provided that the use does not mislead the consumer.
|16||Report of the Scientific
Committee for Food on Colouring matters, Opinion expressed 10 December
1987, CS/COL/89 -Final.
|17||Commission Directive 95/45/EC
of 26 July 1995 laying down Specific Purity Criteria concerning Colours
for Use in Foodstuffs.
|18||Report of the Scientific
Committee for Food on Colouring matters of 10 December 1987
|19||Council Directive 79/112/EEC
of 18 December 1978 on the Approximation of the Laws of the Member States
relating to the Labelling, Presentation and Advertising of
|20||F AO Food and Nutrition Paper
52, volume 1 and 2, edited by F AO in 1992, plus various addenda.
lat: "food code".
|22|| Codex Alimentarius
Commission Procedure Manual, Eighth Edition, issued by the Secretariat
of JECF A in Rome (1993).