Bisphenol A in food contact materials
Ban in France / New scientific opinion by the European Food Safety Authority and evaluation by the European Chemicals Agency
Bisphenol A – a substance used predominantly in the manufacture of food contact materials, such as reusable plastic dishes and plates or the inner coating of food cans – has come under fire due to its potentially harmful impact on health, including its effect on the reproductive organs. Following sustained criticism, a European directive back in 2011 banned the use of the substance as a monomer in the manufacture of plastic infant feeding bottles. Now the legitimacy of using bisphenol A in the manufacture of food contact materials as a whole is at stake.
The replacement of bisphenol A with other substances is currently still a matter of considerable uncertainty, however. A number of various plastic alternatives are available, yet these substances have been subjected to far less toxicological testing – if any – than bisphenol A. There is thus a danger that a substitute for bisphenol A would replace a relatively minor and intensively studied risk with other completely unforeseeable ones. In a few years or even decades, for instance, any substitute substance used may turn out to have considerably more damaging effects than bisphenol A and any damage then occurring could not be undone.
French ban on use in force
Since 1 January 2015, a ban has been in force in France on the use of bisphenol A in “packaging, containers or utensils” intended for direct contact with food. It is thus no longer permitted for food contact materials and packaging containing bisphenol A to be marketed in France. As a result, companies with Europe-wide operations now face the challenge of ensuring that their supply chain organization and their purchasing and inventory planning conform in an effective and economically viable way to the various different legal provisions, on the one hand, in France and, on the other hand, to those in the rest of the EU. This brings with it a not insignificant impairment of intra-Community trade. Companies find themselves forced to choose either manufacturing their products (or having them manufactured) in line with various specifications and a variety of criteria for the relevant countries, or switching their entire production line for food contact materials over to alternative substances.
New scientific opinion by the European Food Safety Authority (EFSA)
The recent publication on 21 January 2015 of the latest opinion on bisphenol A by the EFSA should now sharpen the focus on the uncertainties surrounding bisphenol A substitution, which we mentioned in the introduction above. In its opinion, the EFSA concludes that with the current exposure of consumers to bisphenol A, the substance does not represent a health risk for any age group (including unborn children, infants, toddlers and adolescents). Dietary exposure or aggregate exposure from a variety of sources (diet, dust, cosmetics and thermal paper) was said to be considerably below the safe upper limit (“Tolerable Daily Intake”, TDI). With this reassessment, the EFSA has taken the opportunity to considerably reduce the TDI value compared to its previous assessment (4 µg/kg body weight per day instead of 50 µg/kg body weight previously), yet the highest estimates for dietary and aggregate exposure were reported to be three to five times below the new TDI value.
Evaluation by the European Chemicals Agency (ECHA)
As well as the EFSA, the European Chemicals Agency (ECHA) is also investigating bisphenol A. The currently on-going ECHA substance evaluation aims to examine whether any additional regulatory measures (such as restrictions, authorization obligations) are necessary. At the same time, France has also forwarded a proposal to the ECHA for a change in the harmonized classification and labelling of bisphenol A, aimed at securing a harmonized classification as toxic for reproduction category 1B (instead of category 2 as previously). The ECHA Risk Assessment Committee already approved the proposal on 14 March 2014. It thus seems likely that the change in classification of bisphenol A and its higher rating as potentially toxic for reproduction will be implemented.
Ban on bisphenol A in other EU Member States?
Ultimately, in the light of the recent ban in France, the latest EFSA opinion and the evaluation by the ECHA, the close monitoring of further developments relating to bisphenol A is advisable as it cannot be ruled out that the French ban might be followed by the implementation of corresponding prohibitions in other individual EU Member States. It is still conceivable that a reaction to the French ban could result in an EU-wide prohibition of the use of bisphenol A in similar items, just as the unilateral initiatives by Denmark and France in 2010 paved the way for the European ban on bisphenol A in plastic infant feeding bottles implemented by Directive 2011/8/EU dated 28 January 2011.
If you are affected by this issue or if you have any questions, please contact Bärbel Milsch.
Practice Group: Distribution & Franchise Systems, E-Commerce