The Legislation of Food Colours in Europe
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. 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”Anchor (-1500 BC).
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!
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 situationAnchor of the British consumer in the 19th century as follows:
“…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… .”
Under these conditions, it is hardly surprising that food poisonings were common. In 1851 about 200 people were poisoned in England, 17 of them fatally directly as a result of eating adulterated lozenges. 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 stipulates the absence of dangerous minerals such as arsenic, copper, chromium, lead, mercury, zinc and others in foods. 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 on it.
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.
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 Organisation (FAD). 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 foodstuffs, was published in 1962. According to this positive list, 36 food colours were allowed to be used. Twenty 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 available. 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 1).
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 effect on the finished foodstuff.
- 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 purposes.
- 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 1968> 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 year.
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 need. 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 specified. 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 dishes.
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 material.
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 foodstuffs. 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 coloured 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 satis, 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 150c Ammonia caramel
E 150d Sulphite ammonia caramel
E 153 Vegetable carbon
E 160a Carotenes
E 160c Paprika extract, Capsanthin, Capsorubin
E 162 Beetroot Red,, Betanin
E 163 Anthocyanins
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 100 Curcumin
E 102 Tartrazine
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 129 AlluraRedAC
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 160d Lycopene
E 160c Beta-8′-carotenal (C30)
E 160f Ethyl ester of beta-apo.-8′-carotenoic acid (C30)
E 161b Lutein
C. Colours very restricted in their use and allowed for certain foodstuffs, only:
E number Food colour
E 123 Amaranth
E 127 Erythrosine
E 128 Red2G
E 154 BrownFK
E 161g Canthaxanthin
E 173 Aluminium
E 174 Silver
E 175 Gold
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 tAnchorhat 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 approval. 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. SincAnchore 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 spAnchorecifications 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 foAnchorr 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 measures, 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