EFSA’s experts recommend refining the safety assessment of substances used in food contact materials, including the introduction of a more comprehensive approach to estimate consumer exposure, particularly for infants and toddlers. In the future, EFSA intends to update the Guidance on data requirements for the evaluation of these substances.
“This opinion reflects both advances in science and our experience over the last decade in applying existing EU guidelines,” said Dr Laurence Castle, a member of EFSA’s expert Panel on Food Contact Materials (CEF) and chair of the working group that developed the opinion.
Dr Castle stated that the scientific opinion “presents recent scientific developments that impact on the estimation of consumer exposure to substances migrating from food contact materials, the tiered approach to their safety assessment, toxicological data requirements and consideration of the migration of non-intentionally added substances (NIAS)”.
The next step in this process is for the European Commission to discuss with authorities in Member States the implications of these refinements for risk management. The Commission will then advise EFSA on the necessary levels of protection for consumers. EFSA will use the Commission’s advice to develop Guidance on data requirements for applications for the safety assessment of substances in food contact materials.
Among the opinion’s findings and key proposals are:
- Identification and evaluation of all substances that migrate should focus more on the finished materials and articles, including the manufacturing process used, rather than concentrating on the substances used.
- To better estimate consumer exposure EFSA’s experts propose setting four default food categories driven by infants’ and toddlers’ food consumption, that are approximately 9, 5, 3 and 1.2 times higher than the current default for consumption (i.e. 17 grams/kilogram of body weight per day). Using these default categories would give a higher level of protection for consumers, particularly for infants and toddlers.
- The amount of toxicity data needed should be related to the expected human exposure. The CEF Panel proposes three threshold levels of human exposure, namely 1.5, 30 and 80 micrograms/kilogram of body weight per day, as triggers for the requirement for additional toxicity data. This applies in principle to all migrating substances, i.e. both intentionally and non-intentionally added substances (including oligomers).
- Genotoxicity testing for substances used in food contact materials should be mandatory even if their migration into food leads to a low exposure. Alternative methods to animal testing could have increased importance for the safety assessment of NIAS.
The CEF Panel experts considered stakeholder feedback from a public consultation whilst finalising their opinion and refined some aspects. They included an additional food consumption category and clarified how to combine information on food consumption with information on migration of chemicals into food, to estimate consumer exposure. They also clarified the need to take account of other sources of exposure to these substances and introduced an additional tier in the toxicological data requirements.
The opinion and a technical report on the public consultation are available below:
- Scientific opinion: Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials
- Technical report: Public consultation on draft scientific opinion on "recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials"
- Food contact materials include a wide variety of materials such as plastics, paper, ceramic, metals and ink used in food packaging, food containers and other articles that come into contact with food. For an overview of the current submission process and data requirements for safety assessment of EU regulated food contact materials such as plastics, recycling plastic processes, active and intelligent materials see Food contact material applications: overview and workflow
- As a general principle, a tiered approach guides the design of toxicological testing strategies, i.e. the greater the exposure through migration, the more toxicological data are required. Additional data or information may be requested if the data submitted are equivocal or warrant further investigation.
- Migration is the transfer of chemicals or particles from food contact materials into the food itself. The rate of migration under the intended conditions of use is a critical factor in assessing the potential risks of exposure to these substances.
- Non-intentionally added substances (NIAS) in food contact materials may also migrate into food. Examples of NIAS include impurities of the substance, and reaction and degradation products present, for example, as a result of the manufacture and the use of the substance and of the resulting food contact materials.
- As risk assessor EFSA provides independent scientific advice on potential threats in the food chain. The European Commission as risk manager uses this advice as a basis for making decisions to address these issues.