Novel food applications
The safety of novel foods is assessed before they are allowed to be introduced to the consumers. The authorisation is granted to a specific operator on an application, which shall contain clarification of the safety of the product pursuant to the conditions approved in the Community.
Content of application and assessment process
The Commission has issued Recommendation 97/618/EC regarding the drafting of a novel food application. The assessment of safety focuses on the safety of edible products in human consumption. The first assessment of the safety of a novel food is conducted by one member state. The initial assessment of that member state is commented on by experts of the other member states. The responsible member state draws up the initial assessment report within 90 days after which the other member states have 60 days to comment on the report. If a reasoned objection is made against the application for placing on the market, the matter is referred to the Commission. The Commission shall consult the European Food Safety Authority EFSA. If no objections are made against the first assessment, the decision on authorisation/rejection is made by the responsible member state.
Finnish Food Safety Authority is the Finnish coordination
Novel food applications are submitted to the EU member state in which the product is to be first placed on the market. In Finland, the competent authority to which the applications are to be addressed is the Finnish Food Safety Authority Evira. The first assessment of the application is carried out by the Novel Food Board operating under the Ministry of Agriculture and Forestry. The Board members are experts in the fields of e.g. food science, nutrition, toxicology, molecular biology, medicine and microbiology.
The application should be drafted carefully and Evira should be contacted before the application is submitted. Applications that are deficient or do not contain all the required documents cannot be reviewed.
The processing of novel food applications is subject to a fee. By virtue of the Decree of the Ministry of Agriculture and Forestry on the fees chargeable by the Finnish Food Safety Authority (1161/2014) (in Finnish), Evira charges a fee of 2.550 € for the processing of the novel food application referred to in the Novel Food Regulation (EC) No 258/97. If the application is withdrawn or otherwise ceases to have effect before the procedure has been completed, Evira can charge a processing fee, which is half the amount that would otherwise have been charged. The Novel Food Board also charges a fee of 2.700 – 25.000 € based on the amount of work related to the processing of the novel food application, as stipulated in the Decree of the Ministry of Agriculture and Forestry on the fees chargeable by the Ministry (868/2012) (in Finnish) (position June 2015).