Novel Foods Approval
In the European Union (EU) if a product (e.g. a botanical) is intended to be used for food purposes, as a nutraceutical, food ingredient, oral cosmeceutical, or dietary supplement and without medical claims (health claims can be acceptable), then the preferred route is to seek approval through the Novel Foods Directive, Novel Foods Regulation (EC) No 2015/2283.
Consequently, many companies seeking regulatory approval for nutraceuticals food ingredients and supplements are now obtaining approval through this route. There are three main ways to do this:
1. Novel Foods Approval - Not Novel Letter
This is the simplest and most straightforward way of obtaining marketing authorisation for a food in the EU (Note: In some cases, this can be quite an involved process that needs careful thought and planning.). An executive summary can be prepared by Dr. John Wilkinson Consultancy and submitted to the competent authority via a technical dossier. This often involves history of use searches. Should your product be considered "not novel", then you will be issued with a "not novel" letter and you are free to market your product across the EU member states.
2. Novel Foods Approval - Substantial Equivalence applications
Under substantial equivalence:
This category was withdrawn from January 2018. Although substantial equivalence arguments to support "not novel" food decisions and also to assess whether a particular ingredient may require the submission of a novel food dossier or not. Please contact us for further information with regard to substantial equivalence and it use in novel food approvals.
Previously, If the product was shown to be substantially equivalent to existing products on the market, then novel foods approval could be obtained by a simplified procedure rather than a full application.
This had many advantages such as reduced costs and in general, faster evaluation and approval times. Substantial equivalence was based on the composition of the product, intake and a safety profile similar to an existing product.
Each application had unique qualities that had to be carefully considered in order for an application to be successful. Data from the scientific literature or from competitor products could be used to support the application thereby reducing the costs substantially compared to a full application where full safety data generated by the applicant is needed (exceptions do exist, however, see below).
For a recent example of a Dr John Wilkinson, substantial equivalence application on behalf of one of our clients:
3. Novel Foods Approval - Full Applications
These are the most time consuming and costly in terms of seeking novel foods approval under the novel food directive. A full application has to include such data as the definition of the botanical / food, production and manufacturing procedures, analytical and safety data. The costs of the safety data alone has prevented many companies from seeking approval through this route. However, it is possible to circumvent some or all of the safety data (toxicology, clinical trials) with rigorous "history of use data" from the country of origin or other areas of the world where the product has been sold.
For a recent example of a Dr John Wilkinson full application on behalf of one of our clients see:
Dr John Wilkinson's consultancy has experience in all the above areas and can help you decide which route is most suitable with regard to the product and the budget available. We can write and submit the applications on your behalf and also generate analytical, safety (including history of use) data, if needed.
We can also help you develop and get approval for any health claims that you want associated with the product.
4. Traditional foods and Novel Foods Approval
Under a change in the novel foods approval process in the EU, the costs and speed to approval for “traditional foods” such as exotic fruits, vegetables and traditionally used juices will now, in principle, be greatly reduced since the change came into force in January 2018.
We were one of the first regulatory consultants to obtain novel foods approval for an exotic fruit in the EU in 2010. In fact our dossier submission was used as a template to draft the new directive and Dr Wilkinson was a consultant to EFSA on this issue in the early days of development of the “Traditional Foods” category and continues to advise companies on approval of exotic fruits, vegetables and juices.
Dr Wilkinson also continues to give lectures, interviews and to publish papers and articles on this topic – see “publications” section under “about” on this site and also the above links.
One of the key aspects for obtaining novel foods approval for a new (to the EU) fruit or vegetable is to demonstrate 25 years of use from the country of origin or to show that the fruits has been on sale in the EU prior to 1997 and to demonstrate GMP and GACP (Good manufacturing and Good Agricultural and Collection Practices) including developing and setting realisable novel food specifications for the product / ingredient.
We have extensive experience in these areas and are experts in collecting “traditional use” information both for meeting the requirements of a novel food and also for herbal medicine approval (traditional herbal registrations THR’s ) under the THMPD (Traditional Herbal Medicinal Products Directive) in the EU.
5. Union List of Novel Foods
We help companies check that they meet the requirements for a potential Novel Food to appear on the Union List. This replaces the old system which was mainly due to substantial equivalence, we help companies with compliance in meeting the specifications on the Union List of Novel Foods.
Please contact us on the form below for more details.
Other services we offer:
Compliance issues with Novel foods
6. Novel food or not?
Are you unsure if your product is a novel food – please fill out the submission form and we will provide a free initial assessment. This service is strictly confidential.
8. Union list updates
Are you selling or want to sell a product that you believe is the same as an “approved” novel food in the EU but not sure if you are in compliance or have the correct documents with EU food law? Submit a request and we will check you data within 48 hours for compliance. This is a fee paying service.
9. Expert opinion letter on “not novel food” status
If you believe that your product is “not novel” we can assess this and if we agree, we can in many circumstances, as experts provide a signed legal document confirming its status as “not novel” without the need of assessment by a regulatory department in the EU. This is a fee paying service.
10. Innovative ways of obtaining novel foods in approval in the EU or obtaining "not novel" food status.
We are exploring innovative ways in which we can help our clients get regulatory approval within the novel foods directive but without the need of extensive and costly toxicological and human clinical trials or a significant history of use within the EU by for example reviewing the status of a natural product as a herbal medicine, food additive, supplement or novel food.
This will be of particular interest to companies that manufacture or supply exotic foods and medicinal foods that have a safe history of use in the country of origin such as China India, Japan, Africa countries, and South America and now want to sell these products in the EU.
Finally, it could be that a company's product / ingredient may not need novel foods approval in the EU. We have helped hundreds of companies obtain "not novel" food status in the EU thereby saving hundreds of thousands of pounds and lengthy negotiations with the EU regulators.
Please get in touch via the following form so we can help you with any of the above issues.