Towards a Strict Positive List for Additives Used in Food-Contact Plastics: Companies Should Start Reviewing their Product Formulations

Date: Jun 03, 2002

The European Commission recently confirmed its intention to complete the positive list for additives used in food-contact plastics by 1 January 2005. This decision will have wide ranging effects since the remaining national list of additives in place in the Member States will no longer be available to establish a suitable basis for the use of food-contact additives in the EU, therefore requiring companies to petition for the listing of those remaining additives in the so-called Monomers Directive 90/128/EEC. 

The Monomers Directive is the relevant legal document pertaining to plastic materials used in contact with food. The Directive is the most comprehensive of those that have been adopted by the Commission pursuant to the Framework Directive 89/109/EEC on food-contact materials. The Monomers Directive has been amended six times, and it currently sets forth a complete list of monomers that can be used to form food-contact polymers; only those monomers that appear on the Directive can be used in the EU to form plastics in contact with food. For the moment, this proscription only applies to materials consisting exclusively of plastics. The Monomers Directive does not apply to multi-layer materials where one of the layers is a non-plastic, or to any other article that is not entirely plastic. 

Beginning with the third amendment to the Directive, the Commission developed a list of additives that can be used in the formation of food-contact plastics. At the present time, the additives list is incomplete. If an additive is listed on the Directive, it can be used throughout the EU in the formulation of food-contact plastics. If an additive is not on the list, however, it can still be used provided that it has a positive status in the national laws of the Member States where it is intended to be marketed or used. For those Member States that do not have additional laws on food-contact materials beyond the Framework Directive and the Monomers Directive, an additive can be used in a plastic materials provided that the material does not cause a health or safety concern in the food contacting the plastic material.  In those countries with national positive lists, the additive must be listed or the product must be marketed in that country on the basis of the principle of mutual recognition. The principle of mutual recognition allows for the legal importation and sale in one Member State of products that are lawfully marketed in another Member State even if the products do not comply with the specific regulatory requirements of the country of import. 

This regulatory strategy for establishing the status of food-contact plastics will change with the completion of the Monomers Directive's positive list of additives, as announced by the Commission. Indeed, once the list is closed, no plastic additives will be permitted in contact with food unless they appear on the list or if they are part of a non-plastic material. Thus, if products are being marketed today on the basis that they appear on the positive list of a Member State, for example, these additives will need to be petitioned to the Scientific Committee on Food for inclusion in the Monomers Directive in order to ensure their continued use for food-contact applications. 

In addition to the additives currently listed in the Monomers Directive, the Commission indicated its intention that the scope of the positive list be extended to cover the use of colorants, adhesives, and polymeric additives. With respect to the later, the European Commission already issued a draft Discussion Note (EMB/755 Rev.1) to serve as the basis for developing a new policy leading to the adoption of a positive list of polymeric additives in 2005. 

The EU final positive list of plastic additives may still be a few years ahead. However, considering the time required to prepare and submit an additive petition in the EU and to get it reviewed, approved, and eventually listed in an amendment to the Monomers Directive, companies could start reviewing the status of the substances they use as additives to initiate the relevant actions in time.

For further information, please contact Devon W. Hill at hill@khlaw.com .