In accordance with Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, the European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) evaluates the safety of certain substances prior to their authorisation for use in food contact materials (FCM) plastics. The current guidelines on this risk assessment process and the corresponding data requirements from applicants date back to the Scientific Committee on Food (SCF) guidelines from 2001. In the light of new developments in science and regulation, along with the experience gained since 2001 from the safety evaluation of hundreds of substances, it is appropriate to revisit the scientific underpinnings of the SCF guidelines published back in 2001 with a view to possibly updating them.
This Opinion is an outcome of a self-tasking activity by the CEF Panel. It describes the recent developments in the risk assessment of chemicals in food and explores their potential impact on EFSA evaluation of FCM substances. The draft of this opinion was published for a 3-month public consultation and was then modified in the light of the scientific comments received. EFSA technical report on that consultation process lists the comments received and provides a response to those comments, and it has been published as an accompanying document to this final, adopted Opinion. This Opinion will provide the European Commission (EC) with the scientific basis for a discussion among risk managers on possible implications for risk management. It is intended that, in turn, the EC will provide feedback for EFSA to prepare updated guidelines for data requirements for the safety assessment of a substance to be used in FCM.
One major area revisited is the estimation of consumer exposure. For most substances used in FCM, human exposure data were not readily available in the past. For this reason, the SCF used the assumption that a person may consume daily up to 1 kg of food in contact with 6 dm² of the relevant FCM. Now that EFSA’s Comprehensive European Food Consumption Database is available, based on the 95th percentile value for the highest European Union (EU) country and using the default water consumption figures set by the World Health Organization (WHO) for infants, four food group categories could be set. For category 1, FCM intended for contact with water and foodstuffs such as reconstituted infant milk formula, the age group with the highest consumption is ‘Infants’, with a consumption figure of 150 g/kg body weight (bw) per day. For category 2, in which contact with category 1 is excluded, but contact with milk, milk products and other non-alcoholic drinks is intended, then the age group with the highest consumption is ‘Toddlers’, with a value of 80 g/kg bw per day. For category 3, in which contact with food categories 1 and 2 are excluded but contact is with foods specifically intended for infants and toddlers, the age group with the highest consumption is ‘Toddlers’, with a value of 50 g/kg bw per day. For category 4, in which the FCM is intended for contact with foods other than those covered by categories 1, 2 and 3, the age group with the highest consumption is ‘Toddlers’, with a value of 20 g/kg bw per day. The food consumption values for these four categories are approximately 9, 5, 3 and 1.2 times higher than the current SCF default model, i.e. 17 g/kg bw per day (1 kg food consumed by an adult weighting 60 kg bw), and so using them would afford a higher level of protection, especially for infants and toddlers. Under certain conditions, special exposure scenarios might be used if consumption were lower.
Regarding the identification and evaluation of all substances that migrate, experience gained over the years has shown that more focus is needed on the finished materials and articles, including the manufacturing process used. Substances used in the manufacture of plastic materials or articles may contain impurities originating from their manufacturing. Moreover, during manufacturing and use, reaction and degradation products can be formed, of which oligomers can be the dominant class. These substances have become known as non-intentionally added substances (NIAS) and are referred to as such in Commission regulations. Whether their presence is intentional or not, it is necessary to evaluate the safety of all migrating substances and not just of the starting substances – for example the monomers or additives alone – and the guidelines should be updated to account more fully for this more comprehensive approach. This change towards the finished FCM and its use calls for an adjustment of the present system of listing substances in order to render transparent what has been evaluated.
