EU Deadline Approaches For Listing And Allowed Use of Plastics Additives

Date: Jan 01, 2006

Additives for plastics for food packaging and other food-contact applications are required to be on the European Union's (EU) positive list by Dec. 31, 2007, per the second amendment to the EU "Plastics Directive" (Commission Directive 2004/19/EC, amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs). Barring another extension by the EU prior to this time, additives not on the list by that date-or at least the subject of a pending petition for inclusion filed before the end of 2006-will be prohibited from use in plastic packaging.

Accordingly, companies that make or use additives in the production of plastics (these are substances such as antioxidants, stabilizers, adjuvants and production aids) that are marketed for food-contact use in the EU should take action now to ensure that additives of importance to them are included on the list prior to the deadline.

The only exceptions are for additives that are the subject of complete petitions which have been submitted to the European Food Safety Authority (EFSA) no later than Dec. 31, 2006. This latter provision is intended to ensure the uninterrupted use of additives that currently are not listed until such time as EFSA has an opportunity to complete its review process.

Now and later

At present, additives for plastics are included in Annex III to the Plastics Directive. This list is considered to be "incomplete," in that additives that are included on the list are expressly authorized for use in the production of food-contact plastics throughout the EU, while unlisted additives may still be used in the manufacture of food-contact plastics in the EU, provided that their use is demonstrated to be safe and meets any relevant national requirements.

This situation will change, however, at the end of 2007. At that point, only additives that appear on the Directive's positive list, and additives that are included on a "provisional list," will be permitted. The "provisional list" will consist of additives that are the subject of a valid petition filed before the end of 2006. Once EFSA completes its review of all the substances on the "provisional list," the resulting additives list containing all approved additives will be deemed to be "complete" and exclusive.

Although there have been several proposed deadlines for "completion" of the additives list in the past, this time it looks like the authorities are serious, and the bell is about to toll.

Like the current situation for monomers, additional additives may be added to the positive list after the date the positive list becomes complete; however, the new additives will not be permitted for use in food-contact plastics until they complete the petitioning, review and listing process.

Petitions filed with EFSA to support the safe use of new additives in food contact plastics must, in most cases, include migration test data, as well as toxicology data. This being the case, to meet the December 2006 filing deadline, companies interested in filing petitions to support positive listings for the additives they produce or use need to begin developing and assembling the necessary data without delay.

Used with permission. Copyright FOOD & DRUG PACKAGING, January, 2006.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.