Global Food Contact Materials Regulations

This session will look at the steps that should be taken to assess the risk of FCM-substances that migrate into food, under foreseeable conditions of use. 

We will look at the differences between the intentionally and non intentionally added substances (IAS and Nias). Then examine when a given IAS or Nias can be self-risk assessed, and when industry should consider, for an IAS, an application to a competent authority.

• which countries/regions, in the above mentioned markets allow self-risk assessments for an IAS and/or Nias migrating into food from a FCM;
• when there is no need for a (self) risk assessment of migrating substances into food from FCM;
• what to do when it is not possible to carry out a self-risk assessment, and when a risk assessment must be provided as part of a petitioning process for including a new FCM-substance on a given positive list in a given key market;
• what type of information (for example physico-chemical, (eco) toxicological) is needed to carry out the (self) risk assessment of an IAS or Nias migrating into food;
• when read-across can be used in the (self) risk assessment of an IAS and Nias migrating into food from an FCM;
• when a threshold of toxicological concern (TTC) approach can be used in the (self) risk assessment of an IAS or Nias migrating into food; and
• when and which specific (quantitative) structure-activity relationship (Qsar) tools can be used in the (self) risk assessment of an IAS or Nias migrating into food from a FCM.

Dr Alastair Mak, PhD

Toxicologist, Environmental and Human Toxicology, Knoell USA