EU Authorities Continue Efforts to Develop Regulatory System for Active and Intelligent Packaging

The future regulation of active and intelligent packaging materials in the European Union (EU) continues to be a subject of great interest to both industry and regulatory officials. EU directives and some national laws in the Member States are considered to be an impediment to the marketing of many of these innovative packaging systems because their provisions, in many cases, would not permit the use of many of the systems being developed.

"Active" packaging materials are regarded as those materials that intentionally influence the conditions of the packaged food by releasing or absorbing substances. Examples of active packaging include oxygen scavengers or moisture absorbers, which may dramatically lengthen shelf-life or improve the quality of the food. "Intelligent" packaging materials provide information to consumers regarding the conditions of the food by indicating, for example, microbial spoilage or the time and temperature history of the packaged food.

Currently, there is no specific regulation of these materials at the Community level. As with all food-contact materials, the general safety provision of the Framework Directive (89/109/EEC) must be met, but there are no specific provisions in the Plastics Directive (2002/72/EEC) or other EU legislation specifically directed at active and intelligent packaging.

Nor is there is specific legislation at the Member State level. Some countries, however, have given approvals for active packaging materials on a case-by-case basis. Only The Netherlands takes the position that active packaging materials are prohibited under its national regulatory system; however, it is our understanding that the competent authorities in The Netherlands will soon propose new national legislation covering these materials.

The European Commission also intends to begin proposing legislation for active and intelligent packaging materials at the Community level. The Commission sponsored a research project in 1999 that was aimed at studying the existing regulatory systems in Europe and recommending changes to permit the safe use of active and intelligent packaging systems. This project, known as the Actipak Project, was completed last year; a report was issued that reviewed all the existing EU directives that may be affected and proposed what changes should be made.

It is our understanding that the Commission is considering the report and the changes it proposes to the existing directives. At present, the Commission has proposed certain changes to the Framework Directive that:

• make explicit that the Framework Directive applies to active and intelligent packaging,
• define active and intelligent packaging, and
• call for a specific directive to further define the requirements that these materials should meet.

The provisions that will be laid down in the specific directive are unclear but they may include a certification system by recognized laboratories for active packaging materials, directions for migration studies, and labeling requirements. A specific directive may also contain provisions for intelligent packaging such that these materials may be exempt from further regulation if they are separated from the food by a functional barrier. The EU, however, does not yet have established standards for determining the presence of a functional barrier.

At the present time, while these new legislative initiatives are being considered by the competent authorities, manufacturers and suppliers of active packaging materials may still market their products in the EU.

To lawfully market a product, the producer must first determine that it would be safe for its intended use. Special attention must be paid to any byproducts or impurities that may be created in the functioning of the "active" packaging. If the material is safe, and not covered in an area that is harmonized (e.g., regenerated cellulose or monomers for plastic materials), the material may be marketed in those Member States that do not have specific requirements for food-contact materials beyond the EU directives.

It may also be possible to market a product in Member States with additional legislation pertaining to food-contact materials, but this decision should be made on a case-by-case basis after careful consideration of the national regulatory environment in relation to the particular aspects of the product of interest.