In the European Union (EU) if 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 258/97. This was introduced initially for the safety determination of GMO’s but in the past five years or so has now broadened to review the safety of other novel foods which have not been on sale prior to 1997 in the EU (http://www.acnfp.gov.uk/assess/ ).
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 straight forward way of obtaining marketing authorisation for a food in the EU. An executive summary is prepared by Herbal Sciences and submitted to the competent authority. 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 25 member states.
2. Novel Foods Approval - Substantial Equivalence applications
If the product can be shown to be substantially equivalent to existing products on the market, then novel foods approval can be obtained by a simplified procedure rather than a full application. This has many advantages such as reduced costs and in general, faster evaluation and approval times. Substantial equivalence is based on the composition of the product, intake and a safety profile similar to an existing product. Each application has unique qualities that have to be carefully considered in order for an application to be successful. Data from the scientific literature or from competitor products can 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 Herbal Sciences substantial equivalence application on behalf of one of our clients see: http://www.acnfp.gov.uk/assess/simproc/astaxanthinextract
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 Herbal Sciences full application on behalf of one of our clients see:
http://www.acnfp.gov.uk/assess/fullapplics/baobab
Herbal Sciences International 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. See our Nutrition and Health Claims page for more information
Please contact Dr Wilkinson in the first instance to discuss your requirements:
Direct Line: +44 (0) 1376 320 354; +44 (0)794169 6409.
If you are based in the USA you can call us at local rates on our Washington DC number: 1 (202) 657-6409 (UK times only - approx 5 hours ahead of Washington DC time).
E mail: info@herbalsciencesinternational.com with the subject heading: Novel Foods Approval
Innovative ways of obtaining novel foods in approval in the EU
We have developed 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. Our recent success with the African fruit "Baobab" is an example of this new approach pioneered by Herbal Sciences International Ltd. This is a landmark case and paves the way for rural growers and producers to get approval in the EU at a fraction of the cost: i.e., only tens of thousands of euro's rather than typically 5 - 6 million euro's.
This will be of 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.
For more information and in the strictest confidence contact Dr Wilkinson on +44 (0) 794 169 6409
or via e mail: info@herbalsciencesinternational.com
