‘Novel Food’ is defined as food that has “not been consumed to a significant degree by humans in the EU before 15 May 1997”. A 'Novel Food' can be a newly developed, innovative food, a food produced using new technologies and production processes, as well as a food which is or has been traditionally eaten outside of the EU. For the consumer, Novel Foods in the EU should: be safe, not mislead, not be nutritionally disadvantageous.
Novel Foods must have an authorisation before they are allowed on the EU market. As of 1 January 2018, Regulation (EU) 2015/2283 on novel foods is applicable. That Regulation has both an Application Procedure and (for traditional foods from a third country) a Notification Procedure.
A Novel Food can be placed on the European Union market only after the Commission has processed an application for the authorisation of a novel food. Traditional foods from a third country can be placed in the European Union market only after the Commission has processed a notification.
The comparator system in the USA is called "GRAS", an acronym for "Generally Recognized As Safe". Whereas the regulatory requirements differ from the EU, the science is quite similar. The USA GRAS inventory contains over 1000 entries.
The UK has Regulation 2015/2283 as "retained law": the Regulation is the same, while the evaluation is done by the UK FSA Advisory Committee on Novel Foods and Processes (ACNFP).
Detailed information can be found:
- European Commission (EC) - what is Novel Food
- EC Request for a novel food authorisation
- Novel Food Regulation (EU) 2015/2283)
- EU Novel Food Catalogue and Consultation process on novel food status
- EU Summary of applications and notifications
- EFSA overview of running evaluations
- EU Union list of novel foods
- EC: List of authorisations under the former Novel Food Regulation (258/97)
- EC: Consultations on novel food status (under Implementing Regulation 2018/456)
- Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications
- European Food Safety Authority (EFSA)
- Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283
- Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283
- Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/22831 (Revision 1)
- 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)
What do I offer
- Anticipating the outcome of the evaluation of a dossier by EFSA (based on 9 years of practical experience).
- Actual building a dossier for an application or for a notification (Novel Food or GRAS).
- Smart thinking of designing a strategy for an application or for a notification.
- Checking the status of a (novel) food under Implementing Regulation (EU) 2018/456.
- Collaboration in (EU) projects as an SME.
Expertise with the topic
- 2021 -> now: Member UK FSA Advisory Committee on Novel Foods and Processes (ACNFP)
- Nine years member of EFSA NDA Panel Member (2006-2015).
- Nine years member of EFSA working group on Novel Foods (2006-2015).
- Three years chair of EFSA working group on Novel Foods (2012-2015).
- Dozens of EFSA Scientific Opinions during the years 2006-2015.
- Publications on Novel Foods: scientific publications, EFSA Guidances.
Some key publications in the area
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), Turck D, Bresson J-L,Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle H, Naska A,Neuhäuser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjödin A, Stern M, Tomé D, Vinceti M, Willatts P,Engel K-H, Marchelli R, Pöting A, Poulsen M, Salminen S, Schlatter J, Arcella D, Gelbmann W, de Sesmaisons-Lecarré A, Verhagen H and van Loveren H, 2016. Revision 1: EFSA Journal 2021;19(3):6555, 27 doi:10.2903/j.efsa.2021.6555
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), Turck D, Bresson J-L,Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle H, Naska A,Neuhäuser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjödin A, Stern M, Tomé D, Vinceti M, Willatts P,Engel K-H, Marchelli R, Pöting A, Poulsen M, Schlatter J, Gelbmann W, de Sesmaisons-Lecarré A, Verhagen H and van Loveren H, 2016. Revision 1: EFSA Journal 2021; 19( 3):6557, 21 pp. doi: 10.2903/j.efsa.2021.6557
- Kumar H., Salminen S., Verhagen H., Rowland I., Heimbach J., Banares S., Young T., Nomoto K., and Lalonde M. (2015). Novel probiotics and prebiotics: road to the market. Current Opinion in Biotechnology: 32:99–103
- Sprong C., van den Bosch R., Iburg S., de Moes K., Paans E., Sutherland Borja S., van der Velde H., van Kranen H., van Loveren L., van der Meulen B. & Verhagen H. (2014). Grey Area Novel Foods: An Investigation into Criteria with Clear Boundaries. European Journal of Nutrition & Food Safety 4(4): 342-363.
- Verhagen H., te Boekhorst J., Kamps L., van Lieshout M.J., Ploeger H., Verreth D., Salminen S., and van Loveren H. (2009). Novel Foods: an explorative study into their grey area. British Journal of Nutrition 101: 1270-1277.