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).
Do bugs have a place on your dinner plate other than the fly that lands on it or the caterpillar that accidently ended up in your dish, as it happened to live in the cauliflower you prepared for dinner? If you live in Europe you are likely to answer this question with ‘no’ and you might even have a slightly disgusted look on your face right now…
FAO and European Commission on insects
In other parts of the world certain insects are part of people’s diet and are sometimes even considered as a delicate and exclusive bite. The call to expand the consumption of edible insects worldwide recently became louder. According to the UN Food and Agricultural Organization (FAO), insects can potentially help solving the increasing demand for animal protein. In 2013 FAO published the report ‘Edible insects’ and in May 2014 the first international conference ‘Insects for food and feed‘ was organized in the Netherlands in collaboration between Wageningen University and FAO. This video provides a summary of the conference. Furthermore, Wageningen University announced the launch of the first scientific journal focussing on this topic in 2015. On 27 November 2013 the Director General for Health and Consumers mentioned edible insects as an interesting alternative source of protein in her speech:
‘Looking to the future, feeding a growing world population will inevitably increase pressure on already limited resources – land, oceans, water and energy. The development of alternative sources of protein will no doubt grow in importance and significance to meet the future protein demand. Such sources include cultured meat, seaweed, beans, fungi and, of course, insects. The greater use of insects is an interesting alternative both for human consumption and animal feed, given the prospect of high protein yields with low environmental impacts.’
Are edible insects Novel Foods?
During the abovementioned conference it became clear that there was an urgent need to develop legislation on edible insects to give the food and feed industry clear guidance on the requirements they have to meet. This discussion paper provides a look at the regulatory frameworks influencing insects as food and feed at international, regional and national levels. This paper, however, is not exhaustive. The European Commission has asked EFSA to deliver a scientific opinion on the risks of insect consumption, but this opinion is expected in 2015 at the earliest. Another question is whether insects should be considered Novel Foods covered by EC Regulation 258/97. According to this Regulation, Novel Foods require pre-market approval in the EU (Do you want to read more about Novel Foods? Check this, this and this post). At this moment the European Commission has not explicitly decided on whether insects should be considered Novel Foods or not. Until a clear position and a harmonization of the novel food status of insects at European level have been adopted, some Member States decide to apply their own ‘rules’ for the placing on the market of insects intended for human consumption.
In Belgium the placing on the market of the species included in the table below is tolerated, provided that the requirements of food legislation are met, especially and among others the application of good hygiene practices, traceability, compulsory notification, labelling and organisation of a self-checking system based on the HACCP principles. This tolerance does not apply to food ingredients isolated from insects, such as protein isolates.
Also France and the United Kingdom seem to tolerate the sale of edible insects in their countries. If you have any additional information from your country or region to include in this post, you are cordially invited to share this with us through firstname.lastname@example.org.
On 15 October 2014 the Dutch Office for Risk Assessment & Research (in Dutch ‘Bureau Risicobeoordeling & onderzoeksprogrammering‘, herinafter: ‘BuRO’) published their advisory report to the Inspector-General of the Netherlands Food and Consumer Product Safety Authority (in Dutch: ‘NVWA’) and the Dutch Ministers of Health Welfare and Sport and Agriculture. According to this report the following insects are currently produced and sold in the Netherlands.
The NVWA asked to assess the chemical, microbiological and parasitological risks of consuming heat-treated and non-heat-treated insects. The risk assessment was limited to the three species mentioned in table 1 above. BuRO recommends the Ministers to treat those insects as foods in the meaning of the General Food Law (Regulation 178/2002) that are required to comply with the hygiene regulations (Regulations 852/2004 and 853/2004) and all other food-related legislation. Those insects are not treated as Novel Foods in the Netherlands.
With regards to food safety, BuRO recommends the NVWA to use the following minimum requirements for rearing facilities:
- Products introduced to the market must have been heated to reduce microbiological risks. The hygiene criteria for processing of raw materials in meat preparations should be used.
- Food safety criteria for insect products:
– Salmonella: absent in 10 grams;
– L. monocytogenes: <100 CFU/g;
– B. cereus, C. perfringens, S. aureus and Campylobacter spp: criteria stated in the Decree on Preparation of Foodstuffs.
- Shelf life of 52 weeks must be demonstrated.
In the Netherlands, the Laboratory of Entomology from Wageningen University is involved in research on edible insects. Scientists Arnold van Huis and Marcel Dicke and cooking instructor Henk van Gurp even published a cookbook: the Insect Cookbook. Click here, here and here for video’s from these scientists on eating insects. More and more supermarkets in the Netherlands sell edible insects. Online it is possible to order various kinds of edible insects from around the world, which are not included in the lists above. NVWA does not seem to focus on enforcement in this area as long as food safety is not at stake.
A slaughterhouse for insects?
The question has been raised whether Regulations regarding to slaughtering animals are also applicable to the killing of insects for consumption. Regulation 1099/2009 on the protection of animals at the time of killing covers the killing of animals bred or kept for the production of food, wool, skin, fur or other products as well as the killing of animals for the purpose of depopulation and for related operations. So far, the Regulation seems to apply to the killing of insects. However, the Regulation defines ‘animals’ as ‘any vertebrate animal, excluding reptiles and amphibians’. Insects are invertebrates, which have an exoskeleton and don’t have a spinal column. This means that insects are outside the scope of this Regulation.
Novel Food or not, despite the lack of (legal) guidance and certainty regarding the regulatory status of insects on EU level, it is clear that the attitude towards the use of insects for food and feed is positive. Therefore, some Member States take action to allow the marketing of insects as food in their country until a clear position has been reached at European level. When EFSA publishes their report and the European Commission takes its position regarding the use of insects for food and feed, you will read it here or get informed through Twitter: @FoodHealthLegal.
On 24 September 2014 our firm organizes a seminar addressing the developments in Functional and Medical Foods. Where? Next door to our office in Pakhuis de Zwijger.
The Institute of Medicine has designated functional food as “any food or food ingredient that provides a health benefit beyond its nutritional benefit”. Functional foods comprise food supplements, probiotics and other foods having a beneficial effect on human health, which is often advertised by health or nutrition claims as using those claims in connection with this type of foods is very attractive from a marketing point of view.
Functional foods are just one step away from medical foods, catering for particular nutritional needs that regular foods do not supply. Contrary to functional foods, medical foods are highly regulated. Furthermore, both types of food are subject to specific legislation regarding health and nutrition claims as well as regarding food information to be provided to consumers.
The regulatory requirements for health and nutrition claims offer a chance and a challenge. Also, as of 13 December 2014, all food business operators have to comply with very strict, new information requirements on the basis of the Regulation on Food Information to Consumers. To what extent does this regulation help the final consumer to make healthy choices and how does this impact the entrepeneur? Our seminar will address these issues and provides practical guidance on solutions. Speakers are: Bernd Mussler (Innovation Project Manager at DSM), Ruud Albers (CEO at Nutrileads) and us (Karin Verzijden and Sofie van der Meulen).
A few spots left!
We still have a few spots left! Attendance is free and you are welcome to bring along your colleagues. More info? Check the invitation on our website. For registration, please send an e-mail to email@example.com with your name, the names of colleagues you would like to register and contact information. Questions? Contact our office manager Marjon Kuijs at firstname.lastname@example.org or +31 (0) 88 650 6500.
Looking forward to see you there!
Missed our seminar? Download our slides!
Early this week the Academy of European Law’s Annual Conference on Food Law took place on 5 and 6 May in Trier and offered a unique opportunity to receive an analysis of recent legislation, case law and ongoing policy developments in the field of food law (for an overview of the full programme, click here).
Key topics that were discussed during the conference:
- New EU rules on articles treated with biocidal products
- The Commission’s proposals on animal cloning and novel food
- Recent case law of the CJEU
- The legislative package for healthier animals and plants for a safer food chain: smarter rules for safer food
- The harmonisation of food standards and food safety measures within the framework of the World Trade Organisation
My talk discussed the Commission’s proposals on animal cloning and novel food. Novel foods are all foods that were not used for human consumption to a significant degree within the EU prior to 15 May 1997. An example is juice of an exotic fruit: noni juice. Currently novel foods are covered by Regulations 258/97 and 1852/2001. Novel foods, including food from cloned animals, are subject to pre-market approval, but obtaining market access under the current regime is a lengthy process that can take up 3 to 6 years. Therefore, between 2008 and 2011, a new proposal for a Novel Foods Regulation was published, but this proposal has never been adopted as concilliation failed in March 2011. One of the sensitive issues was food from cloned animals. In order to find a solution for this issue, the latest proposal for a Regulation on Novel Foods no longer covers such food.
Food from animal clones and animal cloning are now covered in two separate proposals:
These proposals will result in:
- A temporary ban on the imports of animal clones and a prohibition to place food from animal clones on the market
- A temporary ban on the use of cloning technique in the EU for farm animals
Download my slides and…
Do you want to learn more about the proposals? You can download my slides here! See you at the next ERA Annual Conference on European Food Law?