Date: Mar 01, 2007
The European Commission has decided that if an additive for plastics (antioxidants, slip control agents and the like) is not included on one of two lists by Dec. 31, 2007, it will not be permitted for use in the European Union beginning in 2008.
Unfortunately, unless an additive is already on an EU positive list or the subject of a petition for inclusion on the list and currently on the market in a Member State, it may be too late.
As reported in my Jan. 2006, column, the European Commission's Plastics Directive (2002/72/EC) contains a list of additives (in Annex III) that are permitted for use in the manufacture of plastic food contact materials and articles throughout the EU. Currently, this list is "incomplete" because it does not yet fully harmonize the laws of the EU Member States.
In 2004, the Plastics Directive was amended (2004/19/EC) to require this incomplete list to eventually be made "complete."
The amendment also permits the Commission to establish a "provisional list" of additives that may continue to be used beyond the date chosen by the Commission, pending their addition to the positive list. (These would likely be additives under consideration for inclusion on the positive list, but for which review had not yet been completed by the time of the lists closing.)
But here is the rub. To be included on the provisional list of additives (if not on the incomplete list already), a substance must be (1) on the market in an EU Member State as of Dec. 31, 2006, and (2) the subject of a petition that has been filed with the European Food Safety Agency (EFSA) no later than Dec. 31, 2006.
This means that if you filed a petition for use of a new additive in 2006, but did not market that product somewhere in the EU in 2006, it will not be included on the provisional list.
It also means that if you have an additive on the market in the EU based on a clearance by a Member State, but it is not the subject of a petition filed by the end of last year, it will not be added to the provisional list, and (unless you can file a petition and have the substance added to the Annex III positive list before the end of the year) it will be prohibited from use in the EU beginning in 2008.
It's not clear how many additives used in Europe are in this pickle. However, given the limited number of additives already included on the Annex III positive list and the relatively small number of petitions that were filed by the end of 2006, it is expected that the Commission's action will come as quite a surprise to some plastics manufacturers and product marketers.
Industry representatives, along with Keller and Heckman, are working on remedying the situation. Let me know if you would like to add your voice to the protests.
Used with permission. Copyright FOOD & DRUG PACKAGING, March, 2007.
For further information about this article, please contact George G. Misko at 202-434-4170 or by email at firstname.lastname@example.org.