Global Food Contact Materials Regulations

This module will look at Mercosur regulations that directly impact FCMs. These are known as resolutions. Before taking an in-depth look at the regulations, the session will look at how Mercosur (Grupo Mercado Común del Sur (GMC)) defines FCMs under GMC Resolution 03/92. 

There will be discussion of the most recent amendment to Mercosur Resolution 39/19, which includes the positive list of additives allowed to be used in plastic materials and polymeric coatings for food contact. 

And this session will also discuss the updates to GMC Resolution 02/12 (positive list of monomers and starting substances for food contact plastic), GMC Resolution 56/92 (general safety requirements for food contact plastics), GMC Resolution 46/06 (food contact metals) and GMC Resolution 40/15 (general safety requirements for food contact paper). 

The implementation process of GMC resolutions at a national level (Mercosur member states) will also be clarified.

FCM regulations in Colombia, Bolivia, Ecuador, Mexico and Chile will also be looked at, and any corresponding FCM compliance requirements discussed. 

During this module, you will learn about:

• 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
• what substances have already been cleared in the current Mercosur resolutions
• what the restrictions are 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
• what migration testing conditions are to be applied, with case study examples
• what the analytical challenges are during the identification of non-intentionally added substances (Nias) that migrate into food under intended conditions of use
• what the key steps are when considering the risk assessment of FCM substances migrating into food
• what the steps are for a new FCM substance petition to Anvisa (Brazil) or CONAL (Argentina); and,
• demonstrating compliance with food contact applications in the above-mentioned markets.

Cristina Garcia

Project Manager, Knoell Iberia S.L.

This module will look at the regulations that exist currently on recycled plastic materials intended for use in food contact applications in the following key markets: the EU, UK (after Brexit), Switzerland, US, Mercosur, Japan, South Korea and India.

A particular focus will be given to the new EU regulation on recycled plastic FMCs i.e., Regulation (EU) No 2022/1616, which fully replaced the previous Regulation (EC) No 282/2008. 

As per the new EU regulation, new terms such as suitable and novel recycling technologies will be introduced and the associated regulatory requirements will be discussed in direct connection with an EU authorization on the recycling processes. 

The registration forms for recycling installations, recycling facilities, recycling companies, recycling schemes and novel recycling technologies will be presented and discussed, as well as the Union Register created by the European Commission until 18 July 2023 will be presented.  

During this module, you will learn about:

• the new requirements for recycled plastics intended for use in the EU in food contact applications, considering Regulation (EU) No 2022/1616;
• the requirements that apply for recycled plastic materials intended for use in food contact applications in the US; the US FDA Guidance for industry: use of recycled plastics in food packaging will be presented and discussed;
• the acceptance criteria for recycled polyethylene terephthalate (PET) resin intended for use in food contact applications in India and the guidelines for the recycling process;
• the requirements of Mercosur GMC Resolutions 25/99 and 30/07 on PCR-PET intended for use in food contact applications in Mercosur;
• the restrictions/requirements that apply to post-consumer recycled (PCR) plastics intended for use in FCMs in Japan will be presented;
• the tests (e.g., challenge tests, migration tests) to be considered, with case study examples;
• the analytical challenges in identifying non-intentionally added substances (Nias) that migrate from PCR plastics into food, considering the intended conditions of use;
• key steps for obtaining authorisation on the recycling technology/process in the EU and US; and,
• how to demonstrate compliance of recycled plastic materials intended for use in food contact applications in the above mentioned markets.

Cristina Garcia

Project Manager, Knoell Iberia S.L.