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The Regulation of Colorants in the European Union

October 1, 2001

The European Commission has not, as yet, moved to harmonize the regulation of colorants used in food- contact plastics in the European Union. Thus, there is currently no Community-wide directive specifically dealing with these types of materials.

In short, manufacturers and distributors of colorants and colored plastics must review their products to determine if they meet the applicable purity specifications in the various Member States that have these standards; in addition, for products marketed in France, it must be determined that the colorant in question appears on the French positive list. As in most jurisdictions, manufacturers of finished articles must ensure that any colorants or pigments used in food-contact materials do not color the food they contact.

While there is no Community-wide positive list for colorants used in food-contact materials, colorants and materials containing colorants are covered by the EU's Framework Directive (Directive 89/109/EEC) for food-contact materials. Like all materials used in contact with food, colorants must meet the general safety requirement of the directive, i.e., they must be manufactured in accordance with good manufacturing practices and they must not transfer their constituents to foodstuffs in quantities that could endanger human health or bring about an unacceptable change in the composition of the food or its organoleptic characteristics.

The Monomers Directive (Directive 90/128/EEC) applies to materials consisting exclusively of plastics, and provides a positive list of permissible monomers for use in plastic food-contact materials. All monomers used in the production of food-contact plastics must be included on this list. The Monomers Directive also contains an initial list of substances that may be used as additives in the manufacture of plastic materials; these substances have been reviewed and considered safe by the EU Scientific Committee on Food (SCF), the body responsible for evaluating food-contact substances in the EU. Because the list of permitted additives is not yet complete, additives used in the production of food-contact plastics are not required to be included on the Monomers Directive positive list. Unlisted additives may still be used, provided that their use meets the general safety criteria and complies with any applicable specific legislation in force in the individual Member States.

As mentioned above, the Monomers Directive and its amendments are not intended, as yet, to apply to colorants used in plastic materials. The Practical Guide (Practical Guide No. 1, A Practical Guide for Users of EEC Directives on Materials and Articles Intended to Come into Contact with Foodstuffs), published by the European Commission, makes clear that colorants are not currently intended to be covered by the directive:

Future "possible" rules concerning, for example, catalysts, colorants, inks and adhesives will be considered later. At this stage, the Commission services are unable to specify whether the list will be extended to these products. Therefore any extrapolation of the list to these products is gratuitous. Moreover, the Commission Services can only add that the rules to be applied to these products will be examined only after the positive list for monomers and additives is officially adopted and that they are unable to specify any date.1

Member State Requirements Control

In the absence of any EU directive specifically addressing pigments or colorants, one must turn to the requirements of the individual Member States to assess whether each EU Member State explicitly permits the use of a specific colorant in plastic food-contact articles.

Four EU Member States have specific requirements for colorants permitted in food contact plastics, but only France has a specific positive list of permitted materials. France's "positive list" of permitted colorants is found in Circulaire No. 176 of December 1959, as amended. Colorants used in food-contact materials in France must either be listed on the Circulaire or they must be marketed on the basis of the principle of mutual recognition.2 In addition, these materials must also meet certain purity specifications.

Three Member States, Belgium, Germany, and The Netherlands, have purity requirements for colorants.3 In general, these requirements are related to the presence of antimony, arsenic, barium, cadmium, chromium and other heavy metals, as well as aromatic amines and some other specific organic compounds of concern. The specific requirements vary slightly country by country. In Germany, The Netherlands, and Belgium any colorant can be used provided that the material meets the purity requirements (and of course provided it does not raise any health, safety, or unacceptable organoleptic concerns).

In the remaining Member States that do not have specific requirements for colorants in packaging materials, it is necessary only that the material be safe for its intended use and not adversely affect the organoleptic properties of the food. It is generally, however, a prudent practice to ensure that the purity specifications set forth in Belgium, France, Germany or The Netherlands–or the Council of Europe Resolution AP(89)1 on colorants for plastics, discussed below–are met as a demonstration of the safety of the material.

In addition, in every Member State, as in most jurisdictions around the world, it is important to ensure that colored packaging materials do not impart any visible color to the food.

Council of Europe Criteria

In addition to the legislation at the Member State level, the Council of Europe (CoE) Resolution on the use of colorants for food-contact plastics also identifies purity criteria (see "Council of Europe resolution AP(89)1 on the Use of Colorants in Plastic Materials Coming into Contact with Food"). The CoE is a supranational political body consisting of over 43 European Countries. The CoE addresses these food- contact issues through a committee of experts on food-contact materials established under the Partial Agreement in the Social and Public Health Field.4 Within this group, the CoE has established nine ad hoc committees dealing with specific types of food-contact materials, incluing colorants.

While resolutions and guidances passed by the CoE do not have the force of law in the Member States, they are intended to be the basis of future Community-wide directives, and can lend support to a determination that a specific material is safe for use in contact with food. The purity specifications set forth in CoE Resolution AP(89)1 are often viewed by customers as a valuable guide to establishing the safety of materials for use in food-contact applications throughout Europe.

The recommendations set forth in CoE Resolution AP(89)1 are as follows:

  • Colored plastic food-contact materials should not, by reason of their coloration, pose a risk to human health or bring about a deterioration in the organoleptic characteristics or an unacceptable change in the nature, substance, or quality of contacted food.
  • Colorants should be sufficiently integrated into the plastic articles so as to preclude any visible migration of the colorants into contacted food.
  • Colorants should comply with the following limits on heavy metals content. These limits are identical to those set forth in The Netherlands.
  • Colorants should meet the following limits on unsulfonated aromatic amines and sulfonated aromatic amines extractable polychlorinated biphenyls (PCBs).
  • The use of inorganic cadmium pigments should be restricted to those applications in which their special technological advantages cannot be met by alternative products.
  • With respect to carbon black, the use of this colorant should comply with any national requirements for food grade material and the toluene extractable fraction of the carbon black should in any case not exceed 0.15%.

Thus, until such time as the European Commission decides to take up the harmonization of colorants used in food-contact plastics, manufacturers and distributors should review their products to determine if they meet the applicable purity specifications, that the colorants do not transfer to the food, and, in France, whether these materials appear on the French positive list.

FOOTNOTES

1The latest version of the Practical Guide for Users of EEC Directives, updated through Sept. 4, 1998, does not address the issue of colorants under the Directive, merely noting that the matter will be addressed in an accompanying (but as of yet unavailable) memorandum. In the absence of the memorandum, industry continues to rely on the Practical Guide No. 1 for guidance on the use of colorants in the EU.

2The principle of mutual recognition allows for the legal importation and sale in one Member State of products that are legally marketed in another Member State even if the products do not comply with the specific regulatory requirements of the country of import. As interpreted by the European Court of Justice, this means that Member States should allow products that are eligible for mutual recognition to freely circulate within their territory unless they are able to demonstrate, following an appropriate authorization procedure, that the product presents a danger to public health. For a fuller discussion of this issue see "The Article 30 Solution: An Alternative to Market Food-Contact Material in the European Union" by Jean- Philippe Montfort, Food and Drug Journal (1996).

3In Germany, these requirements are only in the form of recommendations and are not legally binding. The Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (BgVV) provides guidance on the use of food-contact materials. BgVV Recommendation IX, titled "Farbmittel zum Einfärben von Kunststoffen und anderen Polymeren für Bedarfsgegenstände" ("Colorants and Pigments for Plastic and other Polymers for use in Food-Contact Applications"), provides guidance on the safety of colorants in plastic food-contact materials. However, we believe it prudent that materials manufacturers meet these limitations to demonstrate the safety of their product.

4Partial agreements are used within the CoE when a group of Member States wishes to engage in issues that not all of the member countries wish to join. A partial agreement only binds those states that join the agreement. With regard to the work on food-contact materials, the members of the agreement include all of the Member States of the European Community, except Greece, as well as Cyprus, Norway, Slovenia, and Switzerland.