About ten years ago, the EU has started with the harmonization of the legislation on food contact materials. Harmonization means that for a specific food contact material the EU fixes specific requirements which evaluation allows to consider it as generally “in compliance” on all EU territory. Different national EU countries could also provides specific requirement for a data material: these are named Additional National Legislation.

The harmonization is a process constantly in evolution but currently the FCM that provide an EU harmonized legislation are the following:

* REGENERATED CELLULOSE FILM
* CERAMICS
* PLASTICS
* ELASTOMERS AND RUBBERS
* COATINGS AND ADHESIVES

Legislation can be distinguished in two kinds:

- DIRECTIVES which should be implemented in the national legislation, before becoming in effect.
- REGULATIONS which will be in force immediately and may not be implemented in the national legislation.

The “hinge” Regulation about FCM is the framework Regulation (EC) 1935/2004.

This apply to all FCM and can be reassumed with the Article 3 of said Regulation:

“Materials and articles designed to contact food substances, directly or indirectly, must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or a deterioration in the organoleptic properties.