Substances in Non-Harmonized 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 harmonized legislation exists. For new food contact substances in non-harmonized 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. Smithers 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 harmonized 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

Substances that are not positively listed in Regulation (EU) No 10/2011 may be used provided they are used behind a functional barrier that reduces their migration into food to less than 0.01 mg/kg. However, unlisted substances that are mutagenic, carcinogenic or toxic to reproduction are not allowed.

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