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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.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- 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.