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).
Traditionally milk comes from cows or other animals such as goats. However, in recent decades, a large number of alternatives to traditional milk were introduced to the market. From a consumer perspective, these alternatives are similar to “traditional milk” in terms of purpose of use. These alternative food products are produced using plant-based protein derived from soy, coconut or other sources. There is an ongoing debate in the US regarding whether or not these ‘alternative milks’ are to be considered ‘milk’ and can be sold as such. This debate could be the precursor to a much more encompassing debate on whether alternative sources for traditionally produced foods from animal origin can be named after the product they are meant to replace, or rather marketed to be the plant based alternative for. This post will elaborate on this discussion, and will discuss the relevant EU framework and prejudicial questions in the Tofutown case pending at the Court of Justice of the European Union (“ECJ”)
The dairy controversy
The dairy controversy has arisen as more and more plant-based food companies are marketing their products as ‘milk’ (“Alternatives”), be it as almond milk or soymilk, but nonetheless as ‘milk’. In the US, the traditional dairy industry (mostly cow milk) has tried to stop the use of the word ‘milk’ for Alternatives, because, its representatives are of the opinion that the term is misleading when used to describe what are in fact Alternatives. This plea did not go unheard and the milk lobby, in combination with a number of lawmakers in the American congress, presented the draft Dairy pride act. The Dairy pride act limits the use of the term ‘milk’, to milk produced from animals (including products such as ‘traditional’ butter). In reaction, the NGO Good Food Institute filed a report claiming that the arguments presented by the traditional dairy industry are invalid. This NGO is of the opinion that no consumer is misled as long as the name of the product ‘milk’ is combined with the alternative source for the milk production. If, and when, the Dairy pride act will enter into force is still unclear.
If you think a similar regulation would be inconceivable in the EU, think again. In fact, in the EU a number of products have a legal definition included in marketing standards. The purpose of these legal definitions is to protect consumers against misleading and to create a level playing field for food business operators (“FBO’s”). For products such as honey, chocolate, and olive oil such legislation exists, which regulates the production process and name under which the product can be sold. In addition to such marketing standards mostly laid down in EU Directives, regulating single products or production chains, there is a general Regulation on agricultural production. This Regulation includes marketing standards for certain agricultural products.
Regulation 1308/2013 establishes a common organization of the markets in agricultural products (hereinafter: CAP Regulation). This regulation lays down production rules for particular agricultural products such as, but not limited to, wheat, wine, and several meat products. The CAP Regulation also applies to milk and milk derived products, and contains the following definition of milk:
‘”Milk” means exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom.’
Apart from the product ‘milk’, Annex VII part 3 of the CAP Regulation reserves the following terms exclusively for milk products: whey, cream, butter, buttermilk etc. (the list contains 16 products traditionally produced using milk).
A strict interpretation of article 78.1 in combination with article 78.2 and Annex VII part III of the CAP Regulation would mean that the term ‘milk’ should only be used for milk products from animal origin. The norm does not contain an exception for plant-based alternatives. However, it is unclear whether milk can be used if it is combined with an explicit mention of the plant-based origin of the product such as soy. It can be argued that the Alternatives do not qualify as ‘milk’, and that, therefore, the Regulation does not apply to Alternatives. This precise issue is currently the subject of a the Tofutown case pending at the ECJ (C-442/16).
The Tofutown case
Tofu is made from soya beans. The German company TofuTown.com sells alternatives to butter and cheese from mammalian origin. The company markets their Tofucheese and Tofubutter as plant-based alternative to the traditional cheese and butter. Neither products contain any ‘milk’, and are marketed towards vegetarians and/or vegans who prefer plant-based alternatives for cheese and butter. The Verband Sozialer Wettbewerb (German Competition Authority) objected to the use of the words ‘butter’ and ‘cheese’ in the tofu products because, in their view, tofutown.com did not comply with the CAP Regulation as the products were not milk-based. The German court requested the answering of preliminary questions by the Court of Justice of the European Union on the interpretation of the above-mentioned rules regarding the product names. The following prejudicial questions were put forward:
- Can Article 78(2) of the CAP Regulation be interpreted as meaning that the definitions, designations and sales descriptions defined in its Annex VII need not satisfy the relevant requirements of this Annex if the relevant definitions, designations and sales descriptions are expanded upon by clarifying or descriptive additions (such as ‘tofubutter’ for a pure plant-based product)?
- Is Annex VII, Part III, point 1, to the CAP Regulation to be interpreted as meaning that the expression ‘milk’ is exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom, or may the expression ‘milk’ — where necessary with the addition of explanatory terms such as ‘soya-milk’ — also be used in the marketing of plant-based (vegan) products?
- Is Annex VII, Part III, point 2, to the CAP Regulation, in conjunction with Article 78, to be interpreted as meaning that the descriptions listed in detail in point 2(a), such as, in particular, ‘whey’, ‘cream’, ‘butter’, ‘buttermilk’, ‘cheese’, ‘yoghurt’ or the term ‘cream’ etc., are reserved exclusively for milk products, or can pure plant-based/vegan products, which are produced without (animal) milk, also fall within the scope of Annex VII, Part III, point 2, to the CAP Regulation?
One of the core principles of food law, besides safety, is the principle that foodstuffs shall not mislead consumers. This ‘misleading argument’ is the main argument used by the dairy lobby in the US to justify the restriction of the use of the term ‘milk’ solely for milk from cows or other animals. We share the view of the Good food institute that the names would be misleading is not acceptable. No consumer is misled when buying an alternative plant based product such as ‘soy milk’, because the products are clearly marketed as alternative and the origin is mentioned in the product name and on the front of the pack, as well as in the legal name. However, we are of the opinion that labeling of these Alternatives should never be similar to traditional milk products, or carry pictures of cows or other animals that provide milk.
Precursor to bigger debate on plant-based alternatives
Milk is not the only product definition under scrutiny; the discussion is already spreading to meat products. Traditional food producers feel the heat from competitors producing Alternatives for their products. These Alternatives are not only suitable for vegetarians and vegans, but also for the mainstream consumer who could be concerned with the environmental impact of meat or perhaps is lactose intolerant. The Alternatives are plenty and range from the use of soy to algae or even insects to replace the traditional product. Many Alternatives have not only animal welfare in mind, but also sustainability.
In the Netherlands the Vegetarian Butcher made headlines, because he used terms reserved for meat products for his vegetarian alternatives. Instead of waiting for a court to rule on the matter, the vegetarian butcher chose to change his terms slightly to avoid being penalized for using the wrong terms. To give an example, “gehakt” (mincemeat) became “gehacked”, which, in Dutch sounds the same, but formally has a different definition. The Vegetarian Butcher also published a statement on YouTube to clarify why he changed the product names. Perhaps this could be the solution for producers of alternatives for traditional animal derived products, in case the ruling of the CJEU is in favor of the traditional producers. Another idea would be to introduce the term ‘malk’ (‘a’ is derived from plant); ‘milk’ or milk products produced using plant-based sources.
A debate is ongoing in the US regarding the definition of milk and whether plant-based alternatives can use the term ‘milk’ to describe their products. In the EU, the definition is already part of a Regulation, which forbids the use of the term ‘milk’ in other products than milk of animal origin. The Tofutown case will hopefully clarify if producers of Alternatives will be able to use terms such as milk, which are traditionally linked to products from animal origin, if the producer mentions the source of the milk together with the term ‘milk’. We have seen this debate is not limited to ‘milk’, but also includes other products for which non-animal alternatives are available and marketing standards such as the CAP Regulation apply to. We will keep you posted on developments in the debate on definitions of Alternatives. Please do not hesitate to share your view on this topic with us!