Food Contact Material

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.

The safety assessment focuses on the risks related to the dietary exposure to chemicals due to:

  • the migration of the active and/or intelligent substance(s)
  • the migration of their degradation and/or reaction products
  • their toxicological properties

Applications shall be submitted in accordance with Regulation (EC) No 450/2009, where the applicant should provide all available data relevant to the evaluation conducted by EFSA.

The amount of toxicity data needed should be related to the expected human exposure level, in accordance with the principle that the higher the exposure, the greater the amount of data required.

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.