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Risk assessment of packaging materials
C Munro1, J J Hlywka, E M Kennepohl
1Cantox Health Sciences International, Mississauga, Ontario, Canada. imunro@cantox.com
Food Additives and Contaminants
|April 19, 2002
Summary
The US Food and Drug Administration (FDA) uses a threshold of regulation to efficiently assess food packaging safety. This method protects public health by regulating negligible migration of packaging substances into food.
Area of Science:
- Food Science
- Toxicology
- Regulatory Science
Background:
- Human exposure to packaging materials occurs via migration of components into food.
- Evaluating packaging materials presents challenges due to low exposure levels and incomplete toxicological data.
Purpose of the Study:
- To describe the US Food and Drug Administration's (FDA) efficient process for evaluating food packaging materials.
- To introduce the 'threshold of regulation' concept for assessing negligible migration.
Main Methods:
- The FDA developed a process to determine when migration of packaging substances into food is too trivial to require regulation as a food additive.
- The threshold of regulation was established at 1.5 microg/person/day, based on carcinogenic potency data.
Main Results:
- Substances below the threshold, lacking structural alerts, and not known as carcinogens or potent toxins, are exempted from food additive regulation.
- This approach ensures public health protection, even if a substance is later found to be a carcinogen.
Conclusions:
- The FDA's threshold of regulation provides an efficient and protective model for evaluating the majority of food packaging materials.
- This risk assessment strategy balances regulatory efficiency with public health safety.