Following the mandate set out in Regulation (EC) Nº 450/2009 of May 29th 2009 on active and intelligent materials and articles intended to come into contact with food, the  European Food Safety Authority (EFSA) has published the Guidelines on submission of a dossier for safety evaluation. Industry may submit their applications within 18 months from publication of these Guidelines.

Regulation (EC) n° 450/2009 on active and intelligent materials and articles intended to come into contact with food lays out an authorisation process for the use of new active or intelligent substances in food contact materials. The legislation foresees that manufacturers requesting such an authorisation must first submit an application for the assessment of the safety of the relevant substances to European Food Safety Authority (EFSA).

As requested by Regulation the EFSA has published guidelines for industry on how to submit applications for the safety assessment of active and intelligent substances in materials which are intended to come into contact with food.

In general terms, active food contact materials absorb or release substances in order to preserve or improve the condition of packaged food or extend its shelf life. Intelligent food contact materials monitor the condition of packaged food or the surrounding environment, providing information on the freshness of the food. 

The Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food, specify which aspects EFSA will take into account when assessing the safety of active or intelligent substances - for example, their toxicological properties and the extent to which they, or their breakdown products, may transfer into foods.

The document also sets out the types of data that EFSA needs to conduct its safety assessments such as information on the physical or chemical characteristics of the relevant substances, how they are manufactured and their intended uses.

A community list of authorised substances, that can be used to manufacture an active or intelligent component of active and/or intelligent materials and articles, will be established after EFSA has performed a risk assessment and has issued an opinion on each substance. In some cases, restrictions may be proposed by the EFSA on a group of substances especially when the active or intelligent function implies interactions between different substances.

The guidelines were adopted by EFSA’s expert panel on food contact materials, the CEF Panel, on July 21st following a public consultation.