Knowledge Center: Announcement

Draft EFSA restriction on Bisphenols

New Draft regulation for a restriction on bisphenol A and other bisphenols in food contact materials

The EC published its draft regulation to prohibit the use of bisphenol A (BPA) and other bisphenols and their derivatives with harmonized classification for specific hazardous properties in certain materials and articles intended to come into contact with food.

The substance 4,4′-isopropylidenediphenol (CAS number 80-05-7) (FCM 151),
commonly known as bisphenol A (BPA), is used in the manufacture of certain food
contact materials and articles. Primarily it is used in the manufacture of epoxy resins
that form the basis of varnishes and coatings including those applied to the internal
and external surfaces of metal food packaging, such as cans, tins and jar lids, as well
as in certain types of plastic including polycarbonate and polysulfide food storage and
processing equipment. Due to its diverse chemical properties, BPA may also be used
in other materials such as printing inks, adhesives, ion-exchange resins and rubbers
that form part of finished food contact articles. BPA can migrate into food from the
material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.

In 2015, the use of BPA was already prohibited in food contact articles intended to come in contact with food for infants and your children. Based on the updated opinion of EFSA on BPA in 2023, BPA from dietary exposure is now considered as a health concern for all population groups.

In order to minimize its presence and migration into food and subsequent consumers’ dietary exposure as far as possible, its use in the manufacture of any food contact materials and articles in which it may be used, including plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins and rubbers should be prohibited. Regulation (EU) No 10/2011 should be amended to remove BPA from the list of substances authorized for the use in the manufacture of plastic food contact materials and articles.

It is recognized that the prohibition of bisphenols will consequently result in business operators needing to identify substances, in particular other bisphenols and their derivatives, to replace BPA in the food contact materials and articles where it is currently used, particularly for food contact varnishes and coatings, in order to continue to adequately meet the needs of the food supply chain and ensure food safety. A transition period of 18 months and for some specific material and articles a period of 36 months is proposed.

Monitoring by business operators and reporting to Member States for the unintentional presence of BPA in recycled paper and board food contact materials and articles should be established at Union level.

Mandatory monitoring and reporting to Member States should also be carried out for
food contact materials and articles for which a derogation from the prohibition of the
use of BPA in their manufacture is granted, namely for the synthesis of BADGE for
heavy-duty varnishes and coatings and for polysulfide resins for use in filtration
membranes.

Triskelion will keep you up-to-date on the finalization of this regulation.
We can be of assistance with implementing this new regulation once into force, the mandatory monitoring, and evaluating your food contact material for a declaration of compliance.

Please contact our Business Development Manager Steven Verheul for any questions or assistance. tel: +31 6 5000 7631