Novel food applications: regulations and guidance
EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA’s guidance is updated regularly so applicants should check they are using the latest version before applying.
Novel foods
Regulatory framework
- Regulation 2017/2469 on administrative and scientific requirements for novel foods applications
- Regulation (EU) 2020/1824 amending Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries
- Regulation 2017/2470 on establishing the Union list of novel foods
- Regulation 2015/2283 on novel foods
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283 (update 29 November 2022)
- Administrative guidance for the processing of applications for regulated products (update 2021)
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update January 2024)
Applicable to applications submitted until 26 March 2021
- Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation EU 2015/2283
- Administrative guidance for the processing of applications for regulated products
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products
Scientific guidance
Applicable to applications submitted as of 27 March 2021
- Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1) (update 2021)
- Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation EU 2015/2283 (Revision 1) (update 2021)
Applicable to applications submitted until 26 March 2021
- Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation EU 2015/2283
- Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation EU 2015/2283
See also
- Nutrition applications: frequently asked questions
- Authorisation: European Commission’s Directorate-General for Health and Food Safety
- For submission of consultation requests (Article 4 of Regulation (EU) 2015/2283): list of competent…
- Video: Update of sectoral and administrative Guidance Documents to address the Transparency Regulat…