If no information is found after consulting the information listed in the section Establishment of Novel Food Status, the producer, importer r any other person responsible for the placing of a product in the corresponding EU market, shall provide the competent authorities with the information necessary to justify that the product does not fall under the scope of Regulation (EC) No 258/97, as the food operator has the primary responsibility for ensuring compliance with current food safety laws.

As sometimes it is difficult to demonstrate human consumption to a significant degree prior to 15 May 1997, the Commission together with the Member States prepared a Guidance and Information Document for food operators and national authorities on how to demonstrate «Human consumption to a significant degree». The purpose of this document is to assist both the competent authorities and the stakeholders to understand it better, to apply it correctly and in a uniform manner, and to offer tools to help determine whether or not the product falls within the scope of the regulation.

This document is also available in English: «Human Consumption to a Significant Degree » Information and Guidance Document.