ABSTRACT
Food contact materials (FCMs) are materials and articles intended to be placed in direct or indirect contact with foodstuffs, or which can reasonably be expected to come into contact with food under normal or foreseeable conditions of use. Substances intentionally used to manufacture FCMs, as well as non-intentionally added substances resulting from impurities, by-products and/or degradation products, can migrate from FMCs into food and, consequently, are taken up by humans. To protect consumers' health, EU legislation requires that FCMs must be sufficiently inert to prevent substances from being transferred into the food in quantities that could endanger human health. At the German Federal Institute for Risk Assessment (BfR), Unit 74 'Safety of Food Contact Materials' deals with the risk assessment of FCMs and provides recommendations on the use of substances for the production of FCMs for which no specific European measures exist yet (e.g. silicone, rubber, paper and board). The BfR 'Recommendations on Food Contact Materials' are not legally binding; however, they represent the current state of the scientific and technical knowledge for the conditions under which these materials meet the requirements for consumer safety. As part of the EU-FORA programme, the fellow was involved in the risk assessment tasks and projects undertaken by Unit 74, which include: (i) the scientific evaluation of analytical and toxicological data from dossiers for adding new substances to the database 'BfR Recommendations on Food Contact Materials'; (ii) the hazard assessment of cyclic volatile methylsiloxanes (cVMS) migrating from silicone FCMs into foodstuff; and (iii) in vitro metabolic stability study of cyclic methylsiloxanes in the presence of S9 fraction, performed in the BfR laboratories. Moreover, the EU-FORA fellowship was a great opportunity for the fellow to build a strong network of food safety experts and to be part of an international community of risk assessment professionals.
ABSTRACT
Thousands of intentionally added substances can be used in printing inks and adhesives applied to plastic food packaging. Some of them can be transferred to foodstuffs through a phenomenon called migration, arising concerns on the potential adverse health effects derived from the exposure to chemicals that have not yet been assessed for their risks to humans. The large number of the substances concerned and the lack of prioritisation strategies hamper the work of control authorities, since it is not clear which substances should be monitored as first priority. In this study, a hazard prioritisation strategy is proposed. An inventory listing more than 6,000 substances used in inks and adhesives applied to plastic food packaging was compiled and filtered using several exclusion criteria aimed to set apart those substances for which there is no apparent need for further evaluation or because fall into one of the exclusion categories of the Threshold of Toxicological Concern (TTC) approach. Additionally, substances with a molecular weight >1,000 Da were removed. Approximately 2,300 substances were retained, for which a comprehensive hazard profiling was conducted based on the general scheme for the application of the TTC approach. First, structural alerts for genotoxic and non-genotoxic carcinogenicity were investigated. If a substance was neither genotoxic nor belonging to the chemical classes of organophosphates and carbamates, the Cramer classification was used. Furthermore, the substances were searched for their presence in three so-called 'Substances of Concern' lists and RASFF notifications. Groups of high, medium and low priority substances were established, resulting in 1,660 substances classified as high and medium priority. A panel of five experts evaluated these substances with respect to their relevance for further risk evaluations. By applying this hazard prioritisation strategy, 696 substances were identified as 'Very High Priority Substances' (VHPS) for which further assessments should be performed.
