Special Focus
European Commission Releases New Draft of the Super Regulation for Food Contact Plastics
Jan 2005
Devon W. Hill
In a previous PackagingLaw.com article (see link below), we provided a detailed discussion of the provisions of a new European Union (EU) directive covering food-contact plastics. (We refer to that new legislation in our February article as the "Super Directive," but since the passage of the new Framework Regulation (published in the Official Journal of the European Union Nov. 13, 2004 and effective Dec. 3, 2004), the European Commission will now be permitted to promulgate these types of provisions as regulations, so the proposal is now being referred to as the "Super Regulation.")
The Super Regulation is intended to consolidate and repeal the existing EU directives covering the use of plastics in contact with food—most notably the current Plastics Directive (2002/72/EC) and the various directives on migration testing. The most important provisions of the Super Regulation were discussed in our early article—this report provides an update on the latest version of the Super Regulation which was released in November 2004.
The latest version of the Super Regulation (EMB 993/Rev. 6-3) takes into account many of the comments that were submitted to the Commission by various professional organizations and other interested parties. These views were then discussed in the Commission's Technical Working Group and with official representatives of the 25 EU Member States, which met with the Commission on November 3-5, 2004.
For the most part, the latest version of the draft Regulation is substantially similar to the version discussed in our earlier article. However, there are a few significant changes that should be pointed out. Of interest to many companies is the change to the language of the section of the regulation dealing with the appropriate level of analytical sensitivity to determine that a substance is separated from food by a functional barrier.
As discussed in our earlier article, the Super Regulation introduces the concept of a "functional barrier" into EU food contact law. This concept would permit the use of substances that are not listed on the positive lists contained in the regulation in food contact articles, provided they are separated from food by a functional barrier. More specifically, the regulation provides that a substance can be considered to be separated from food by a functional barrier if the substance is not detectable at the lowest concentration at which the substance could be measured with statistical certainty by a validated method of analysis. The lowest measurable concentration, however, cannot exceed 0.01 mg of the substance/kg food. Materials that are considered to be carcinogens, mutagens, or reproductive toxins are not eligible for use in food-contact articles by virtue of this exemption.
Certain professional organizations, including The Society of the Plastics Industry, Inc., argued that the 0.01 mg/kg level of sensitivity is more than adequate for confirming that a material will not be present at any level of concern, and that there should be no need to impose a limit lower than 0.01 mg/kg to determine that the substance will not migrate to food. In the latest draft of the Super Regulation, the Commission has removed the language concerning lowest validated method. The test now simply states that the substance must not be detectable at a level of 0.01 mg/kg.
In addition to this change, Version 6.3 makes clear that the proposed Regulation would only apply to multi-layer materials where the layer in direct contact with the food is plastic. A significant change in the new Regulation from the current Plastics Directive is that plastic layers in food contact articles with plastic and non-plastic layers will now be regulated. The change from the last draft makes clear that the food contact layer in multi-layer article must be plastic for the article to fall within the scope of the Super Regulation. Moreover, the application of the Regulation to multi-layer materials will be postponed and will not take effect until three years from the date the Regulation is published. The Commission has stated that it intends to finalize the requirements by the early part of 2005, but there is considerable industry opposition to the Super Regulation in its current form and it is not at all clear when the Super Regulation will be adopted.
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