摘要：Food contact materials (FCMs) are used to make food contact articles (FCAs) that come into contact with food and beverages during, e.g., processing, storing, packaging, or consumption. FCMs/FCAs can cause chemical contamination of food when migration of their chemical constituents (known as food contact chemicals, FCCs) occurs. Some FCCs are known to be hazardous. However, the total extent of exposure to FCCs, as well as their health and environmental effects, remain unknown, because information on chemical structures, use patterns, migration potential, and health effects of FCCs is often absent or scattered across multiple sources. Therefore, we initiated a research project to systematically collect, analyze, and publicly share information on FCCs. As a first step, we compiled a database of intentionally added food contact chemicals (FCCdb), presented here. The FCCdb lists 12′285 substances that could possibly be used worldwide to make FCMs/FCAs, identified based on 67 FCC lists from publicly available sources, such as regulatory lists and industry inventories. We further explored FCCdb chemicals’ hazards using several authoritative sources of hazard information, including (i) classifications for health and environmental hazards under the globally harmonized system for classification and labeling of chemicals (GHS), (ii) the identification of chemicals of concern due to endocrine disruption or persistence related hazards, and (iii) the inclusion on selected EU- or US-relevant regulatory lists of hazardous chemicals. This analysis prioritized 608 hazardous FCCs for further assessment and substitution in FCMs/FCAs. Evaluation based on non-authoritative, predictive hazard data (e.g., by in silico modeling or literature analysis) highlighted an additional 1411 FCCdb substances that could thus present similar levels of concern, but have not been officially classified so far. Lastly, for over a quarter of all FCCdb chemicals no hazard information could be found in the sources consulted, revealing a significant data gap and research need.
关键词：Food contact material ; Intentionally added substance (IAS) ; Health hazard ; Environmental hazard ; Endocrine disruption ; Persistence ; Substitution ; Carc2 Carcinogenicity Category 2 hazard classification ; CAS Chemical Abstracts Service ; CFR Code of Federal Regulation ; CFSAN Center for Food Safety and Applied Nutrition ; C&L Classification and Labeling ; CMR carcinogenic; mutagenic; toxic to reproduction ; CPDat Chemical and Products Database (a database maintained by the US EPA) ; CompTox computational toxicology ; CoRAP Community Rolling Action Plan ; DSSTox Distributed Structure-Searchable Toxicity (a database maintained by the US EPA) ; DTXSID Substance Identifier used in the DSSTox database ; EC European Commission ; ECHA European Chemicals Agency ; EDC endocrine disrupting chemical ; EFSA European Food Safety Authority ; ENVH environmental hazard ; EPA Environmental Protection Agency ; EU European Union ; FACET Flavours; Additives; and food Contact materials Exposure Task ; FCA food contact article ; FCC food contact chemical ; FCCdb database of intentionally added Food Contact Chemicals ; FCM food contact material ; FCN food contact substance notification ; FCS food contact substance ; FDA Food and Drug Administration ; GHS Globally Harmonized System for classification and labeling of chemicals ; HH health hazard ; IAS intentionally added substance ; IER ion-exchange resin ; JRC Joint Research Centre ; Muta2 Mutagenicity Category 2 hazard classification ; NIAS non-intentionally added substance ; NZIoC New Zealand Inventory of Chemicals ; OECD Organization for Economic Cooperation and Development ; PBT; persistent bioaccumulative; toxic ; PMT persistent; mobile; toxic ; PFAS per- and polyfluoroalkyl substance ; POP persistent organic pollutant ; REACH Registration; Evaluation; Authorization and Restriction of Chemicals ; Repr2 Reproductive Toxicity Category 2 hazard classification ; SIN Substitute It Now ; SVHC substance of very high concern ; TEDX The Endocrine Disruption Exchange ; ToxVal Toxicity Values (a database maintained by the US EPA) ; TSCA Toxic Substances Control Act ; UNEP United Nation’s Environment Programme ; vPvB very persistent; very accumulative ; vPvM very persistent; very mobile
