Novel Food is defined "as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation (EC) No 258/97 on novel food came into force". As of 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods is applicable. It repeals and replaces Regulation (EC) No 258/97and Regulation (EC) No 1852/2001, which were in force until 31 December 2017.
The underlying principles underpinning Novel Food in the European Union are that Novel Foods must be:
- Safe for consumers
- Properly labelled, so as not to mislead consumers
- If Novel Food is intended to replace another food, it must not differ in a way that the consumption of the Novel Food would be nutritionally disadvantageous for the consumer
Pre-market authorization of Novel Foods based on an evaluation in line with the above principles is necessary, and hence it has to be approved by the European Commission and EFSA before entering the market.
Therefore, Novel foods can vary in many ways and come from anywhere.
Novel Foods categorization
In light of the Novel Food Regulation, Novel Foods are already present in Europe, such as insects, and can be classified in the following categories:
- food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;
- food consisting of, isolated from or produced from microorganisms, fungi or algae;
- food consisting of, isolated from or produced from material of mineral origin;
- food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:
- traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
- non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
- food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
- food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
- food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
- food consisting of engineered nanomaterials;
- vitamins, minerals and other substances used in accordance with Directive no. 2002/46/EC, Regulation (EC) no. 1925/2006 or Regulation (EU) no. 609/2013, where:
- a production process not used for food production within the Union before 15 May 1997 has been applied; or
- they contain or consist of engineered nanomaterials;
- food exclusively used in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive no. 2002/46/EC.
- oil rich in omega-3 fatty acids from krill as a new source of food
- edible insects
- plant sterols as a new substance
- nanotechnology as a new way of producing food
How to get Novel Foods approved in Europe?
The European Food Safety Authority (EFSA) is in charge (and can be missioned by the European Commission) to conduct the risk assessment which is based on dossiers submitted by applicants. All products falling into this regulation have to go through a complete protocol (including application process) to demonstrate the food safety and nutritional relevance of the product or ingredient(s). The following steps are required to get the authorization:
- Preliminary assessment to determine if the product is considered a novel food or not, including technical dossier in Support.
- Consultation process according to Regulation (EU) 2018/456
- Traditional foods from third countries process according to Regulation (EU) 2015/2283
- Evaluation and Experimental plan design according to EFSA requirements
- Nutritional information: nutritional characterization and contaminants
- Composition data: physico-chemical and nanomaterials characterization
- ADME & Pre-clinical test evaluations
- Toxicological information: genotoxicity tests
- Clinical studies
- Dossier preparation and submission
- Answers to possible EFSA requests
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Our large capabilities (in vitro, in vivo, and clinical) allow us to address new EFSA requirements (such as nanocharacterization for novel food already approved). Additionally, to ensure successful launch on the market we can support you in the following:
- Sensory/Consumer studies
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- Packaging services
- Regulatory consulting
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