Novel foods can enter the EU market through two different procedures: an application or notification procedure. The application procedure is used when a novel food enters the EU food market for the first time. The notification procedure is only for traditional foods from third countries.
Novel food applications and notifications are sent to the European Commission in electronic form via the electronic submission system found on the Commission's website. The Commission will check their appropriateness and then, if necessary, send them to EFSA for evaluation. Summaries of the relevant novel food applications and notifications sent to the Commission can be found on the Commission's website.
The Commission has adopted an implementing regulation
- on the information required by the applications; and
- on the notification of traditional foods from third countries
EFSA webinar: Scientific considerations to be taken into account in the preparation of a novel food application
Application procedure
The application procedure is used when a novel food is placed on the EU food market for the first time. The novel food authorisation shall be granted on application by the operator, which shall include an explanation of the safety of the product in accordance with the Commission Implementing Regulation.
EFSA has prepared a guide on the information required for an application for a novel food. This information includes:
- identification of the novel food
- production process
- composition data
- history of consumption of the novel food
- proposed uses and levels of use
- information on absorption, distribution, metabolism and excretion
- nutrition information
- toxicity information
- allergenicity
Processing of a novel food application
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Receipt of application and safety assessment request
- The novel food application is sent to the EU Commission via an electronic system. The European Commission requests the opinion of the European Food Safety Authority (EFSA) no later than one month after verifying the appropriateness of the application.
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Safety Assessment and Statement
- EFSA shall check the adequacy of the information submitted to it and, if necessary, request additional information from the applicant. EFSA then assessed the safety of the novel food on the basis of the information provided in the application.
- EFSA shall deliver an opinion within nine months of the date of receipt of the appropriate application by the Commission.
- EFSA publishes completed safety assessments on its website (at the bottom of the page).
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Decision on approval or rejection
- The European Commission will take a decision within seven months of EFSA's opinion.
Notification procedure for traditional foods from third countries
The facilitated notification procedure can be used if you want to place on the market a novel food that has been in traditional and safe use in a non-EU country for at least 25 years by a significant proportion of the population.
As with applications for novel foods, notifications must include a statement that the food is safe. This is done by showing that the food has traditionally been used by a significant proportion of the population.
As with other novel foods, traditional foods from a third country can only be placed on the European Union market after the Commission has processed the notification, adopted an implementing act allowing the placing on the market of the traditional food and after the Union list has been updated.
After receiving the notification, the EU Commission will assess the suitability of the notification and the necessary information. The Commission will then forward the notification to the Member States and EFSA. Within four months, Member States or EFSA may submit duly substantiated safety objections to the placing on the market of the traditional food in question to the Commission.
EFSA has prepared a guide on what information is needed to make a notification and this information includes:
- description of traditional food
- production process
- composition
- information on history of consumption from third countries
- user experience for at least 25 years
Processing of a traditional food declaration from third countries
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Receiving the notification and forwarding it
- The notification is sent to the European Commission via an electronic submission system. The EU Commission will forward the notification to the Member States and EFSA no later than one month after the suitability check.
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Consideration of safety and objections
- Member States and EFSA have four months to review the information contained in the notification and, where appropriate, to raise duly substantiated safety objections to the placing on the market of the traditional food in question.
- If no objections are raised, the food shall be added to the Union list. If objections are raised, the applicant may submit an application for the authorisation of a traditional food.
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Application for approval of traditional foods from third countries
- This application is not a conventional novel food application, but a response to objections raised by one or more authorities during the review.
- The application will be sent to the European Commission, which will forward it to EFSA for an opinion. EFSA will issue its opinion within six months. If necessary, EFSA may request additional information from the applicant, but in this case the processing time is extended.
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Decision on approval or rejection
- No later than three months after EFSA's opinion, the EU Commission will decide whether to approve or reject the novel food application (note that the decision on the novel food application will take seven months).
- The Commission may, if necessary, request additional information from the applicant and, if necessary, extend the processing time.