09:00 - 12:00 GMT
FCM Regulations in Mercosur and migration testing
There will be discussion of the most recent amendments to GMC Res 39/19 (including GMC Res 62/19 and GMC Res 11/20), which includes the positive list of additives allowed for use in plastic materials and polymeric coatings for food contact.
And this session will also discuss the updates to GMC Res 02/12 including GMC Res 19/21 (on the positive list of monomers and starting substances for plastic FCMs), GMC Res 56/92 and GMC Res 20/21 (on the general safety requirements for plastic FCMs), GMC Res 46/06 and GMC Res 16/20 (on metallic FCMs) and GMC Res 40/15 and GMC Res 21/21 (on the general safety requirements for paper FCMs).
The implementation process of GMC resolutions at a national level (in the Mercosur member states) will also be clarified.
Additionally, FCM regulations in Colombia, Bolivia, Ecuador, Mexico and Chile will be looked at, and any corresponding FCM compliance requirements.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- how Mercosur regulations (resolutions) apply to the FCMs you are interested in, including those for plastics, cellulose-based FCMs, regenerated cellulose FCMs, elastomeric FCMs, metallic FCMs;
- the current regulations in Colombia, Bolivia, Ecuador, Mexico and Chile;
- substances already cleared in the current Mercosur resolutions;
- the restrictions for certain key listed FCM substances, with respect to their specific migration limits (SMLs);
- carrying out a worst-case calculation (WCC) in cases where experimental or theoretical (modelling) migration data is missing;
- migration testing conditions to be applied, with case study examples;
- the analytical challenges in identifying non-intentionally added substances (Nias) that migrate into food under intended conditions of use;
- key steps when considering the risk assessment of FCM substances migrating into food;
- the steps in a new FCM substance petition to Anvisa (Brazil) or CONAL (Argentina); and
- how to demonstrate compliance of materials and articles intended for use in food contact applications on these markets, and the importance of place in the supply chain.