Food contact materials
IAS and NIAS: Intentionally and Non-Intentionally Added Substances
Food contact materials include food packaging (plastics, paper, board, cans, etc.) and food production equipment (tubes, conveyor belts, containers, gloves etc.). Since there is a potential risk that during its processing, storage, and distribution, some ingredients from those FCM may be transferred into food, the substances used in the formulation must undergo toxicological safety evaluations.
The general principles applicable to FCM are set out in Regulation (EC) No 1935/2004 stating that materials and articles in contact with food shall only be authorised if it is demonstrated that they do not present risks to human health.
For substances used in FCM, genotoxicity testing is always required, even if their migration leads to a low exposure. Beyond this, three threshold levels of human exposure, namely 1.5, 30 and 80 μg/kg bw per day, are proposed as triggers for the requirement of additional toxicity data, e.g.:
- 90-days subchronic toxicity study
- Reproductive toxicity study
- Developmental toxicity study
- Long-term toxicity and carcinogenicity study
- Toxicokinetic study, providing data on absorption, distribution, metabolism and excretion of the substance with consideration of the potential for accumulation in the human body
Non testing methods, such as (Q)SAR and read-across studies, can be pursued, being acceptable from a regulatory perspective.
We can support you in the safety assessment of FCMs with a range of solutions and services: