Regulation (EC) No. 258/97 concerning novel foods and novel food ingredients was enacted into European Law in response to the imminent arrival of GM-based food products. The legislation required all food products that had no significant history of consumption in Europe before 1997 to undergo a safety assessment prior to being marketed. Although the European Commission also published a guidance document, there is still a great deal of uncertainty for the applicant regarding the level of detail necessary to ensure a smooth approval process for their own product.
 
The usual route to securing novel food approval requires safety testing and/or consumer exposure data. Herbal Sciences International Limited has pioneered an alternative way of seeking novel food approval. Instead of conducting traditional safety testing, we have employed the traditional history of use outside Europe combined with phytochemical studies to demonstrate the safety of a novel food. This route has been used to obtain authorization for Baobab dried fruit pulp. For applicants wishing to market exotic fruit and vegetables, the proposed legislation changes may make the novel food approval process significantly easier. The European Commission is planning to accept evidence of the traditional history of use instead of a safety dossier to approve these types of food products. In this article, we detail the methods used for obtaining novel foods approval in the EU in general, their applicability to nutraceuticals and also newer approval methods that will substantially reduce the costs for producers and manufacturers of getting regulatory approval in the EU.
 
Background and Developments
The European Union response to the impending release of genetically modified foodstuffs onto the marketplace in the 1990s was regulation (EC) No. 258/97 concerning novel foods and novel food ingredients. Whether or not a foodstuff or food ingredient was subject to this legislation was entirely dependent upon its history of consumption within the European Union.¹ If there was a significant history of consumption before this legislation came into force on 15 May 1997, then the food product did not fall under the scope of this directive. Conversely, if there was no history of consumption in Europe, then regulation (EC) No. 258/97 was applicable and the food product would need to undergo a safety evaluation by the European Community before authorization to market would be granted.²
 
Currently, the novel food regulation does not apply to food additives, flavourings or extraction solvents used in the production of foodstuffs. During the past 11 years since this regulation came into force, there has also been a significant change to the scope of the novel food regulation. Any novel food products that contain or are derived from genetically modified material are no longer subject to the novel food regulations.
 
Novel Food Applications
According to the novel food legislation, (EC) No. 258/97, the safety evaluation of any foodstuff or food ingredient involves the submission of a safety dossier to the European Community. This dossier should demonstrate to the assessors that the novel product is safe for consumers. The type of information necessary is dependent upon whether the food product requires a full application or qualifies for a substantial equivalence application. Generally, a full novel food application is more detailed in terms of the level of information needed to compile the safety dossier compared with a substantial equivalence application. However, this is only a generalized statement because each novel food application has its own unique characteristics. When a novel food qualifies for a substantial equivalence application, safety studies are not required because the assessment for the novel food product is based on the history of safe use and/or the safety evaluation of the food counterpart. 
 
The novel food regulations state that the actual evaluation process for a full application should take place in two stages.² First, the applicant submits its dossier to the regulatory authority, which has 90 days to produce an initial opinion. This initial opinion is distributed to the other EU members who have 60 days to produce their own assessment of the dossier. A unanimous or majority opinion in favour of the dossier is sufficient for an authorization to be granted. In practice, the framework described above is rarely achieved. The main reason for this difference boils down to the fact that the EU members are entitled to ask for more data or clarification on any issues relating to the applicant's dossier. When this happens, the 'clock' stops until the applicant has satisfactorily resolved these issues. 
 
The European Community has published a guidance document, 97/618/EC, to help applicants plan their safety dossiers.³ As genetically modified-type food products are no longer regulated under the novel food legislation, there are basically three categories of novel food stuff or food ingredients — pure chemicals or simple mixtures, complex novel foods and foods produced using a novel process. The novel food regulation is essentially a safety evaluation for a food product. Whereas other factors such as product specification are important, the applicant needs to demonstrate to the European Community that its novel food product will be safe by using extensive data on previous exposure limits from dietary and nutrition statistics and/or do safety studies.
 
In this instance, the guidance document, 97/618/EC, is not particular helpful in deciding how much detail is necessary to demonstrate safety.³ Clearly, safety studies are a significant expenditure for any applicant marketing a novel food product. An equally important issue is that the EU members may request further data to support the safety of the novel food product that can slow down the evaluation process significantly. The applicant needs to judge this issue carefully.
 
History of Use and the Safety of Novel Foods
There is a new and potentially very important development that may provide an alternative to "normal toxicity and safety studies" to support novel food approvals. In certain circumstances, such as exotic fruits and vegetables that have no history of use in Europe, there may be sufficient data available from the traditional history of use for a particular novel food outside Europe to be used for evidence of safety with conventional toxicity studies. This information should be combined with an extensive review of the botany and phytochemistry of the novel food product. By identifying the phytochemicals and potential contaminants, the applicant can argue for safety on the basis of these individual components in the novel food product. Including a discussion on the level of these phytochemicals at the anticipated intake levels for consumers provides the EU member authorities with sufficient information to be able to make a safety assessment.
 
Herbal Sciences International Ltd, together with one of its clients, Phytotrade Africa, has pioneered this new approach for the novel foods approval of Baobab dried fruit pulp.⁴ Baobab is extensively consumed across Southern Africa without ill effects. A review of the phytochemistry of Baobab enabled us to identify the major phytochemicals and potential contaminants in the dried fruit pulp. By quantifying these phytochemicals, we were able to make a strong argument to support the safety of Baobab dried fruit pulp as a novel food ingredient. To date, Baobab dried fruit pulp has been given a positive opinion by the Food Standards Agency in the UK, and we are currently awaiting a final decision from the remaining EU member states. If this groundbreaking approach is agreed by the rest of the EU member states, it will result in substantial savings, in terms of the costs of getting novel food approvals for producers — that is, going from an average cost of  €3 million down to €100,000 or less per application!
 
For conventional novel food approvals, since 1997, the European Community has given 29 authorizations for novel food products via the full application procedure.⁵ Phytostanol and phytosterol esters have the highest number of authorizations — with 9 in total — and the average time taken for a full novel food application to be authorized is 894 days.
 
Substantial Equivalence of Novel Foods
For substantial equivalence applications, the type of information required is slightly different. The guidance document, 97/618/EC, for novel foods actually provides very little help.³ Essentially, the reader is simply informed that the assessment is a dynamic and analytical process in which the novel food is compared with its counterpart food product. Recently, the UK Advisory Committee for Novel Food and Processes released their own guidance document because they were receiving numerous requests from applicants requesting advice.⁶ According to this document, the substantial equivalence application is only suitable for food products derived from animals, plants, micro-organisms, fungi or algae.
 
Typically, the applicant will need to use one counterpart food product as the means of demonstrating substantial equivalence of the novel food product. At a more detailed level, the applicant needs to provide data that show that the novel food product is substantially equivalent to the food counterpart in five key areas: composition; nutritional value; metabolism; intended use; and level of undesirable substances. According to the latest statistics obtained from the European Community, there have been a total of 174 substantial equivalence notifications for novel food approval.⁷ Phytostanol and phytosterol esters have the highest number of substantial equivalence notifications with 86, followed by noni juice and argan oil, which have 46 and 18 notifications, respectively. The average time taken for a notification to be issued for a substantial equivalence application is just under 3 months. An example of a recent substantial equivalence application in the public domain was based on the equivalence of an astaxanthin-rich dried algae compared with a supercritical carbon dioxide extract of the algae. On behalf of the manufacturer, Valensa (formerly US Nutra), based in Florida, USA, Herbal Sciences International Ltd managed to obtain a substantial equivalence novel foods approval for them in 2004 (see www.acnfp.gov.uk/assess/simproc/astaxanthinextract).
 
The Future for Novel Foods
In January 2008, the European Commission published its proposal regulation that will replace the current novel food regulation.⁸ No date has been given as to when this will come into force, but there are significant differences between this proposed legislation and the current legislation. The applicant will submit its novel food application directly to the European Food Safety Agency who will do the necessary assessment. The applicant will also be required to inform the authorities when any new information that affects the safety of the novel food product becomes available. The most interesting change relates to novel foods that have a history of safe use in a third country. Instead of submitting a safety dossier, the applicant is required to send details concerning the traditional use of the novel food product. Provided that there are no objections, the novel food will then be notified in a similar fashion to a substantial equivalence application.
 
Conclusions
The regulation (EC) No. 258/97 concerning novel foods and novel food ingredients has been in force for almost 11 years. During this time, 29 novel food products have received authorization via the full application procedure and 174 novel food products have been notified via the substantial equivalence procedure. In many ways, the novel food procedure can be an uncertain process for applicants who need to submit a full application and it is wise to get an expert to help with the submission process. Not only are sufficient data of suitable quality needed to obtain approval, powerful "proof of persuasion" arguments are also required to support the dossier.
 
With regards to exotic fruits, vegetables and herbs, a more novel route was highlighted using the history of use of a novel food outside of the EU, with Baobab dried fruit pulp as an example of new groundbreaking approvals in the future. However, this route is clearly not suitable for all applications and is more applicable for exotic fruits, herbs and vegetables. However, when the proposed novel food legislation becomes law, the route for novel food approval will be easier for these exotic food products than under the current legislation.
 
References
1. DG SANCO (2008), "Food and Feed Safety Law, Novel Foods, Introduction," accessed from http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm in April 2008.
2. European Community (15 May 1997), "Regulation (EC) No. 258/97 Concerning Novel Foods and Novel Food Ingredients," accessed from http://europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31997R0258&model=guichett in April 2008.
3. European Community (29 July 1997), "Commission Recommendation 97/618/EC Concerning the Scientific Aspects and the Presentation of Information Necessary to Support Applications for the Placing on the Market of Novel Foods and Novel Food Ingredients and the Preparation of Initial Assessment Reports Under the Regulation (EC) No. 258/97 of the European Parliament and of the Council," accessed from http://europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31997H0618&model=guichett in April 2008.
4. ACNFP (2006), "Advisory Committee for Novel Food and Processes, Novel Food Assessments, Baobab Dried Fruit Pulp," submitted and written by Herbal Sciences International Ltd on behalf of Phytotrade Africa (www.food.gov.uk/multimedia/pdfs/baobabapplicationfinal.pdf).
5. DG SANCO (2007), "Food and Feed Safety Law, Novel Foods, Authorizations," accessed from http://ec.europa.eu/food/food/biotechnology/novelfood/authorisations_en.htm in April 2008. Note: The complete report commissioned and undertaken by Herbal Sciences International Ltd can be obtained by contacting the company directly.
6. Advisory Committee for Novel Food and Processes, "Novel Food Assessments, Guidelines for the Presentation of Data to Demonstrate Substantial Equivalence, accessed from www.food.gov.uk/multimedia/pdfs/seguidelines.pdf in April 2008.
7. DG SANCO (2008), "Food and Feed Safety Law, Novel Foods, List of Notifications, accessed from http://ec.europa.eu/food/food/biotechnology/novelfood/notifications_en.htm in April 2008.
8. DG SANCO (2008), "Food and Feed Safety Law, Novel Foods, Review of Regulation (EC) 258/97," accessed from http://ec.europa.eu/food/food/biotechnology/novelfood/initiatives_en.htm in April 2008.
 
More information
Dr John A. Wilkinson, BSc, PhD, DIC, MRSC, CChem, Director, and Dr Mathew Hall, Senior Scientist. Herbal Sciences International Ltd is a UK-based international consulting company specializing in the regulatory approval of novel foods, supplements and botanicals in the European Union (EU) and in the United States of America (USA).

Contact
Dr John Wilkinson
Herbal Sciences International Ltd
The Seed Bed Centre
Langston Road
Loughton, Essex IG10 3TQ, UK.
Tel. +44 1376 320 354
info@herbalsciencesinternational.com
www.herbalsciencesinternational.com