The People’s Republic of China first law on Traditional Chinese Herbal Medicine came into force on the 1st of July 2017. This law encompasses industrial normalization by guaranteeing the quality and safety of herbs in cultivation, collection, storage and processing. Producers of Traditional Chinese Medicine (hereinafter TCM) are not only targeting the Chinese market, but are also looking for access to the European market. With this new legislation in force in China, it is a good time to have a look at the current possibilities for market access of TCM on the European market. The name “TCM” would suggest the product could only be qualified as a medicinal product. However, other product qualifications are possible as well. In this post, it will be investigated how Chinese herbal remedies and products fit into the EU framework.
For market access, product qualification is vital. Qualification of TCM as medicinal products might seem obvious. However, western medicine is mostly focused on curing a certain disease or disorder, whereas TCM is focused on healing the body itself. Healing in short means the body should be strengthened to ‘treat itself’. Many of the traditional herbal remedies have healing properties, such as strengthening the immune system. As an alternative to medicinal products, other qualifications of TCM could be botanicals, so that they could be marketed as food supplements or as other foodstuffs. We previously reported on product qualification in this blog, explaining what legal tools have been developed for this purpose over time in case law. These criteria equally apply to TCM.
Simplified registration procedure for traditional herbal medicinal products
An example of a traditional herbal medicinal product we can mention sweet fennel, which is indicated for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. For this group of traditional herbal medicinal products, just like for TCM, a simplified registration regime can be found in the EU Medicinal Products Regulation. In short, the efficacy of the product containing the herb used in TCM’s can be substantiated with data on usage of the herb. This eliminates the need for costly clinical trails to prove the efficacy of the active ingredient(s) in the product. However, safety and quality of the TCM still need to be substantiated.
Eligibility for simplified registration procedure
To qualify as traditional herbal medicinal product, a number of cumulative criteria should be met, including the following.
- Evidence is available on medicinal use of the product during at least 30 years prior to application for EU market authorization, of which at least 15 years within the EU.
- Such evidence sufficiently demonstrates the product is not harmful in the specified conditions of use and the efficacy is plausible on the basis of longstanding use and experience.
- The product is intended and designed for use without the supervision of a medical practitioner and can only be administrated orally, externally and/or via inhalation.
The presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for the simplified registration referred to above. At least, this is the case as the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). TCM intended and designed to be prescribed by a medical practitioner can enter the EU market, but cannot benefit from the simplified registration procedure for traditional herbal medicinal products.
Currently the focus of healthcare is shifting from purely curing diseases to prevention thereof. TCM could play an interesting role in such paradigm shift. Although food business operators (hereinafter FBOs) cannot claim a foodstuff can cure a disease, such product can contribute to prevention of a disease. As such, FBOs can inform the public that consumption of a particular foodstuff can support the regular action of particular body functions. An example of a herbal remedy used in TCM and currently on the EU market is cinnamon tea; used in Chinese medicine to prevent and treat the common cold and upper-respiratory congestion. Obviously, the advantage of bringing a foodstuff (for instance, a food supplement) to the market as opposed to a medicinal product is that unless the foodstuff is a Novel Food, you do not need a prior authorization.
As long as a foodstuff has a history of safe use in the EU dating back prior to 1997, FBOs do not need prior approval for market introduction. If no such history of safe use can be established, both the current and new Novel Food Regulation prescribe that the FBO receives a Novel food authorization. A helpful tool for establishing a history of safe use is the novel foods catalogue, being a non-exhaustive list of products and ingredients and their regulatory status. Another source is Tea Herbal and infusions Europe (hereinafter THIE); the European association representing the interests of manufactures and traders of tea and herbal infusions as well as extracts thereof in the EU. THIE’s Compendium, which should be read in combination with THIE’s inventory list (also non-exhaustive), contains numerous herbs and aqueous extracts thereof, which are used in the EU. Other herbs might not be considered Novel Foods, as long as the FBO can prove a history of safe use in the EU prior to 1997. For instance, the history of safe use of Goji berries has been successfully substantiated.
Traditional foodstuffs from third countries
In previous blogs we already pointed to a new procedure to receive a Novel Food authorization as of 1 January 2018, relating to ‘traditional foods from third countries’. EFSA published a guidance document for FBOs wishing to bring traditional foods to the EU market, enabling them to use data from third counties instead of European data for the substantiation of the safety of the foodstuff. The procedure is a simplified procedure to obtain a Novel Food authorization for a foodstuff, which has been consumed in a third country for at least a period of 25 years. For sure, this is not an easy one, but we have high hopes that such data can be established for TCM being used in Asia. In the affirmative, the FBO can use these data to substantiate the safety of the product and receive a Novel Foods authorization via a 4 months short track procedure, enabling the FBO to market the foodstuff at stake in the EU.
Health claims for herbal products
The EU Claims Regulation provides the legal framework for health and nutrition claims to be used on foodstuffs. In previous blogs we elaborated how such claims can be used for botanicals, being herbs and extracts thereof. So far, no authorized claims for botanicals are available, but their use is nevertheless possible under certain circumstances. In sum, an on-hold claim can be used when the FBO clearly states the conditional character thereof (by stating the number of such on hold claim on this claims spreadsheet. Upon dispute, the FBO should furthermore be able to substantiate that the compound in the final product can have the claimed effect when consumed in reasonable amounts. TCM can take advantage of this current practice, thereby communicating the healing effect thereof, which basically comes down to a contribution to general health. It should be carefully checked though, if the claim for the herbal remedy at stake has not been rejected, as happened to four claims regarding caffeine.
EU market introduction of TCM could take place in various ways, depending on the qualification of the product at stake. Qualification as a regular foodstuff certainly ensures the quickest way to market, as no prior market approval is required. This will be different if the product qualifies as a Novel Food. However, as of 1 January 2018, a fast track authorization procedure will be available for traditional foods from third countries, from which TCM might benefit as well. TCM could furthermore use so-called botanical claims, in order to communicate the healing effects thereof. When the TCM qualifies as a medicinal product, the good news is that for traditional herbal medicinal products, a simplified registration procedure is available under the EU Medicinal Product Directive, provided that certain criteria are met. Registration takes place via the national competent authorities in each Member State, which in the Netherlands is the Medicines Evaluation Board (CBG).
If you like to add a new ingredient to – for example – a beverage or want to start selling ‘superberries’ or an exotic seed from Asia in the EU, you should always check whether the food is a so-called novel food. The producer, importer or any other person responsible for the placing of a product on the EU market is primarily responsible for compliance with the EU-legislation, including the Novel Foods Regulation.
According to this Regulation, novel foods require pre-market approval in the EU. But when is a food product actually a novel food? Based on a steady stream of questions, our firm has noticed clients struggle with this question. Good news: this guidance document, recently published by the European Commission brings some relief.
Novel Foods Regulation
Food products (including ingredients) that have not been used to a significant degree for human consumption within the EU prior to the entry into force of the Novel Foods Regulation on 15 May 1997, are, in general, considered novel foods and they should fall in one of the following categories:
- foods and food ingredients with a new or intentionally modified primary molecular structure;
- foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
- foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals (except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use);
- foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.
The Regulation does not apply to food additives, flavourings and extraction solvents used in the production of foodstuffs. Furthermore genetically modified organisms fall outside the scope of the Regulation since the Regulation on genetically modified food and feed that entered into force on 18 april 2004.
Human consumption to a significant degree
A food product is not a novel food within the meaning of the Regulation if it has been used for human consumption to a significant degree in the EU. What is a ‘significant degree’?
This is where the guidance document from the European Commission is helpful. It includes a decision tree and questionnaire to help you assess your product.
The facts to support that a food has already been used for human consumption to a significant degree within the European Union before 15 May 1997 should be based on robust, reliable information. Data must be taken from referenced sources and must relate to foods which have been legally on the Community market.
All available data and information should be taken into account in establishing whether the food product in question falls within the scope the Regulation. These could include for example, recipes, cookbooks, catalogues and sales data. Also (national) legislation regulating the food in question should be taken into account.
Food products commonly used and known in different EU Member States and in specific regions vary greatly. According to the EC guidance, an established history of food use to a significant degree in at least one EU Member State is sufficient to exclude the food from the scope of the Regulation. Obviously, the more a food has been used the easier it is to demonstrate ‘a significant degree’ of use.
Borderline products: Food/Drugs/Cosmetics
Products that have been used for their medicinal effects or as cosmetics are not considered novel foods. The food has to be used for the purpose of food, and not otherwise. Also, the classification of products as medicinal product or a food can differ across the EU because a food product can be classified as a medicinal product in one Member State and as food in another.
Use in food supplements
The Standing Committee on the Food Chain and Animal Health agreed in its meeting of 14 February 2005, that a use exclusively in food supplements before 15 May 1997 would not be considered as “human consumption to a significant degree”. Authorisation under the Regulation would be necessary if the food product has been exclusively used in food supplements.
Herbals considered as food
Significant use of a food product within Europe can be substantiated if the food product is listed on the ‘Inventory list of herbals considered as food’. This list has been drawn up by the European Herbal Infusions Association (EHIA), and is based on the habits, the traditions and/or the regulatory status of plants in different member states. EHIA’s list can be regarded as a compendium of the different histories of use all over Europe. This makes this list a useful resource because it helps to identify whether certain plant material has been used as food ingredient in Europe.
Novel Food Catalogue
In addition, the Novel Food Catalogue of the European Commission can be consulted. The Novel Food Catalogue is a non-exhaustive list of products of plant and animal origin and other substances subject to the Regulation. The list is a living document that is amended with novel foods earmarked by EU member states and the Commission in the Novel Food Working Group. The catalogue provides important guidance as to whether a product will require authorization under the Regulation. If a food product is not listed, this supports the conclusion that the product is not covered by the Regulation.
Useful documentation on Member State-level
Some EU countries have extensively documented which plants/herbs are considered safe and are allowed to be marketed as food. This documentation also gives insight into whether a food product is allowed and whether it is regarded as a novel food that is subject to the Regulation.
For example Belgium and Germany use detailed lists of allowed plants. The German list is helpful to determine whether a plant/herb is considered as food, drug or novel food.
Belgium has recently updated their indicative lists of plants, plant parts and substances and their novel food status. On the Belgian website you can also find a link to a convenient PDF-file named ‘Tools to prove that a food or food ingredient is not a novel food’.
In case of doubt, you may consider consulting the relevant competent authority for novel foods on the status of your food product. But you don’t want to spill the beans; always think it through before contacting authorities because they cannot un-know what you tell them about your product. An example of a review on the status of goji berries by UK’s Food Standards Agency can be found here.
Tools for the novel food toolbox
Are you familiar with similar lists such as the lists used in Belgium and Germany or other documents (preferable in English) that are helpful in the process of determining the status of a food product in the light of the Regulation or other convenient tools? Great! Your comment would be appreciated.
Best check before
Why do you have to check if the food product you are planning to sell on the EU market is a novel food? As mentioned in the beginning of this post, novel foods require pre-market approval. A non-compliant food product is illegal and liability-issues and/or fines might end up on your plate. Better check before you market, and use the tools mentioned in this post to help you find the answer.