Food Contact Materials – European Commission Tightens Bisphenol A Limits

Currently a prohibition on the use of BPA in the manufacture of polycarbonate infant feeding bottles is in place in the EU on the basis of the precautionary principle.  The new Regulation extends this ban by also prohibiting the use of BPA to manufacture infant cups as well as the migration of BPA from coated materials containing food intended for infants and children 0–3 year olds.
Based on an updated review of exposure data carried out by the European Food Safety Authority (EFSA), the new Regulation lowers the regulatory limit (specific migration limit or ‘SML’) for BPA and extends this restriction to coating materials, which are used to line food and drink cans.  A specific migration limit of 0,05 mg of BPA per kg of food (mg/kg) has been set for the migration into or onto food of BPA from varnishes or coatings applied to materials and articles. In addition, the new Regulation provides that no migration of BPA is permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.

The new Regulation will apply from 6 September 2018.  As from that date, business operators will have to ensure, among other, that varnished or coated materials and articles are in compliance with the new rules and are accompanied by a written declaration of compliance containing:

• details on the business operator issuing the declaration of compliance;
• details on the business operator which manufactures or imports the coated material or article;
• details on the varnished or coated material or article itself;
• confirmation that the varnish or coating applied meets applicable restrictions; and
• specifications on the use of the coated material or article (e.g., the type of food with which it is intended to be in contact, the time and temperature of treatment and storage in contact with food, the highest food contact surface area to volume ratio for which compliance has been verified).

At the present time, no total ban on the use of BPA applies as there is insufficient information on replacement substances and more assessment would need to be carried out on their safety and effectiveness before BPA could be fully replaced.  At the same time, the European Commission has mandated EFSA to undertake a full re-evaluation of BPA again on the basis of the results of anticipated new studies and scientific data to address the remaining uncertainties. This work is due to start in spring 2018.  Upon completion,  the Commission will decide what if any further action is necessary to protect consumers as regards BPA in food contact materials.

Authored by Jacqueline Mailly.