European Legislation
The following is the most pertinent European legislation relating to the use of plasticisers in food contact applications:
Food contact materials are defined as all products that are brought into contact with food. Examples of food contact materials are knives and forks, plates, cling film and all other food packaging, work surfaces and machinery used in food production.
The goal of the legislation in the field of food contact materials is to keep food safe and wholesome by preventing any transfer of the constituents of food contact materials to food in such a way as to damage the foodstuff or present a health risk to the public.
At the present time, the European Union and European national governments share the competence for regulating materials that come into contact with food. Although Europe-wide legislation does exist, there are still certain circumstances where national legislation applies. It is hoped eventually to move towards a clearer legislative situation, which will enable the full functioning of a single market in these products and provide assurance to consumers across Europe that the quality and safety of their food is protected to the highest degree.
Currently, European legislation is based on a three-tiered structure:
- A regulation concerns all materials which are intended to come into contact with foodstuffs: all types of packaging, bottles (plastic and glass), cutlery, domestic appliances (e. g. coffee makers) and even adhesives and inks for printing labels.
- Specific legislation sets rules for groups of products (e. g. plastics, regenerated cellulose film, ceramics)
- Further legislation deals with individual substances (e. g. Vinyl Chloride monomer)
Legislation relating to the use of plasticisers in food contact materials
The use of plasticisers in plastic products intended to come into contact with food are regulated at a European level by the following pieces of legislation. Given the regulatory situation, other legislation may regulate the use of plasticisers in food contact materials at a national level.
The Regulation, which entered into force at the end of 2004, replaced the previous Directive 89/109/EEC. The new Regulation seeks to provide the basis for increased harmonization of rules and repeats many of the principles and provisions of the old Directive (which set out the general principles of EU food contact legislation). It also introduces traceability obligations for food contact materials throughout their supply chain as well as new rules for "active and intelligent packaging systems".
Food contact materials are defined as materials and articles which in their finished state are either:
- intended to be brought into contact with food
- are already in contact with food and were intended for that purpose or
- can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use
The Regulation sets out a number of general principles for all food contact materials. These principles include:
- Materials and articles must not under normal or foreseeable conditions of use
- Endanger human health;
- Bring about an unacceptable change in the composition of the food;
- Bring about deterioration in the organoleptic characteristics thereof.
- The labelling, advertising and presentation of a material or article shall not mislead the consumers.
The Regulation also sets out a number of special requirements for active and intelligent materials and articles (e. g. packaging that, for example, changes colour if the product goes off or exceeds its use-by date).
The Plastics Directive is a specific Directive dealing with materials and articles made of plastic that are intended to come into contact with foodstuffs.
The Plastics Directive sets out the following general guidelines for the migration of the constituents of plastic articles to foodstuffs:
- Plastic articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area
- A limit is set at 60 milligrams of constituent per kilogram of foodstuff,
- where articles are containers with a capacity of between 500 millilitres and 10 litres
- where articles are to be filled and it is impractical to measure the surface area
- where the articles are caps and similar devices for sealing
In addition to general migration limits, the Plastics Directive sets out a positive list detailing the monomers and starting substances that are allowed to be used in food contact materials and sets specific migration limits for these substances in some cases. Further restrictions by Member States on the use of these substances are not allowed.
Additives to plastics are covered by an indicative list of additives regulated at an EU level. The nature of this list means that those additives, such as plasticisers, that are not on the list are still regulated at a national level.
Future Developments
The European Commission wishes to transform its indicative list of additives into a "positive" list (i. e. only substances on this list would be allowed in food contact materials across the EU). As a first step towards this, the EU Member States agreed to an amendment to the Plastics Directive in order to establish a cut off date of 31 December 2006 for data on additives to be submitted to the European Food Safety Authority for inclusion in the positive list. The Commission will decide before the end of 2007 when the positive list should come into effect. The amendment was published in the Official Journal of the European Community in March 2004.
A number of phthalates, including DINP, DEHP, DBP, DIDP and BBP, are currently being assessed by the Scientific Panel on Food Contact Materials of the European Food Safety Authority for their inclusion on the EU indicative list of plastic additives contained within the Plastics Directive. The opinions of the EFSA on recommended Tolerable Daily Intake levels for each of the five phthalates are likely to be adopted and published in the summer of 2005.
The Directive, which is a specific Directive dealing with regenerated cellulose film (RCF) that is intended to come into contact with foodstuffs, sets out migration limits to foodstuffs from the constituents of cellulose film and the coatings of cellulose film (up to a level of 50mg/dm2). A positive list sets out those substances approved for use in the EU and their migration limits in both cellulose film and its coatings.
In the Annex of the Directive there is a list of plasticisers that are permitted for use in regenerated cellulose film throughout the EU. In some cases the Annex lays down specific migration limits for each individual plasticiser.
Future Developments
An amendment to the RCF Directive was agreed to by EU Member States on 12 December 2003 in order to permit the use of all plastic coatings for regenerated cellulose film above 50mg/dm2, where they fulfill the conditions of the Plastics legislation. The amendment also removed DBP and BBP from the positive list of additives for use in plastic coated RCF, as they are no longer used in this application. The amendment was published in the Official Journal of the European Community on January 30 2004
Further Information
Additional legislative documents that you may find useful are described and referenced on the European Commission Food Contact Materials Resource Centre website.
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