Other notifications


Chemicals in Non-Harmonised Materials

In the EU it is only possible to submit Technical Dossiers to EFSA for new food contact substances if they have application in materials for which harmonised legislation exists. For new food contact substances in non-harmonised materials it is necessary to show that the food contact substance is safe according to the national legislation of one European member state and then apply the Principle of Mutual recognition to market the substance in all the other member states. The easiest way of achieving this is to notify the food contact substance in a member state that has national legislation covering the intended use. Pira recommends that:

  • Papermaking chemicals are notified to either the German and Dutch national authorities.
  • Can coating chemicals are notified to the German national authority.
  • Colorants are notified to the French national authority.

The Technical Dossiers that need to be submitted to these regulators are harmonised with EFSA requirements in Germany and the Netherlands, and very closely aligned in the case of the French requirement s for colorants.

Other Unlisted Chemicals

In the EU, a threshold of no regulatory concern does not exist at present. However, Directive 2007/19/EC specifies a no detectable migration value of 0.01 mg/kg for unlisted substances migrating from layers behind the food contact layer in multilayer food packaging. Below this threshold level the substances would not have to be positively listed in EU regulations. Extrapolation of this approach to other food contact situations has led to a number of customers requesting migration testing of specific substances to show no migration as a means of satisfying the requirements of the Framework Regulation (EC) no 1935/204. This approach has been successfully applied by Pira International to show the safety of chemicals from printing inks, adhesives and non intentional added substances such as the reaction and degradation products of listed substances.

Contacts:

Ian Cooper
email: ian.cooper@pira-international.com
Tel: +44 1372 80 2182

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