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Applications for the inclusion of additives

The ongoing harmonisation within the EU has led to the following amendments relating to applications for the inclusion of additives used in the production of plastics that come into contact with foodstuffs.

Up to now, on the European level, additives were specified in an “incomplete list” in Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs. In addition to the substances in this list, further substances regulated on the national level may also be used. There are plans to change this incomplete list into a positive list. A corresponding timetable was announced in Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72/EC (Official Journal No. L 71 of 10 March 2004, p. 8). According to this timetable, the European Commission will establish by 31 December 2007 at the latest the date on which the incomplete list of additives will become a positive list.

As a transitional solution the European Commission will establish a “provisional list” at the latest by that date containing the additives which may continued to be used in accordance with the conditions laid down on the national level until their evaluation by the European Food Safety Authority (EFSA). The precondition for inclusion in the provisional list is that the substances have been authorised in at least one Member State by 31 December 2006 and that data required for evaluation by EFSA have also been submitted by that date. The European Commission also considers the substances listed in the BfR recommendations as having been authorised in a Member State. New additives may always be added to the EU lists following an evaluation by EFSA.

After 31 December 2006 the Member States may no longer authorise any additives that  have not been evaluated by EFSA. Hence, BfR will only accept applications for substances of this kind up to 15 January 2006. After that date applications for inclusion in the Recommendations for Plastics will only be accepted for polymer production aids and for aids to polymerisation. A comprehensive definition of these terms can be found in the “Practical Guide”:  http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/practical_guide_en.pdf.

After publication of the provisional list any additives not contained in this list will be deleted from the Recommendations. As soon as a EU positive list for additives is available, the relevant parts of the Recommendations for Plastics will be completely withdrawn.

There are no changes to recommendations concerning materials other than those covered by Directive 2002/72/EC (silicons, dispersions, hard paraffins and microcrystalline waxes, rubber, paper and board).

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