Novel foods

Background

‘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. 

 

Detailed information can be found:

- European Commission (EC)

- European Food Safety Authority (EFSA)

- Novel Food Regulation (EU) 2015/2283)

- Administrative guidance for the preparation of applications on novel foods 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.

- 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

- 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.