Current opportunities for TCM on the EU market
On the 1st of July 2017, the first law on Traditional Herbal Medicine (TCM) came into force in the People’s Republic of China. The law will bring quality and safety standards to TCM. For many years, TCM was the only treatment available in China while nowadays both TCM and Western medicine co-exist. However, the TCM market was unregulated concerning the quality, safety and efficacy of the plants used, and on how practitioners got their knowledge. The new law aims to raise the status of TCM and to prove its efficacy, e..g. local governments will be requested to launch TCM institutions in all medical centers, increase funding for its development, and widen the extent of TCM education. Also, companies will be investing in clinical trials and proving that their drugs have a similar efficacy as Western drugs.
a&r comments: The required standardization, guaranteeing the safety and quality of herbs in cultivation, collection, storage, and processing, might facilitate market entry of TCM in the EU. TCM products may be eligible for a simplified registration procedure where traditional use can be substantiated based on at least 30 years of traditional use of which at least 15 years in EU, under the premise that the quality and safety still needs to be substantiated.
Market opportunities for traditional foods under the new Novel Food Regulation
According to the new Novel Food Regulation (EU 2015/2293), which will enter into force at the beginning of next year (January 2018), two types of applications – for “typical” novel foods (article 10) and for traditional foods from third countries (article 14) are possible. In contrast to novel foods, traditional foods from third countries can be brought to the market following a relatively simple notification procedure (article 15). The notification for the placing on the market of a traditional food from a third country is sent to the Commission who forwards it to all the Member States and EFSA. Unless either a Member State or EFSA submit reasoned safety objections, the product is ready for commercialization within a few months. In case of reasoned objections, the notification can be transformed into an application (Article 16).
Apart from the procedure, the main difference between notification and authorization is that the assumption of safety of the traditional foodstuffs is basically derived from their history of safe use outside of the EU. If the safe consumption of the food can be demonstrated for at least 25 consecutive years (continued use), and if the product complies with all relevant EU food laws, the costly and time-consuming toxicity studies may be unnecessary. This opens great opportunities for food business operators such as processors of exotic fruits and vegetables or traditional foodstuffs from countries outside the EU. This procedure might also be suitable for new protein sources such as insects.
The challenge for applicants lies in providing sufficient evidence for the history of safe use of the traditional food. The EFSA guidance (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2016 #31164) covers the requirements for both notifications and applications.
The definition of traditional foods from a third country applies to any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, and includes
(ii) food consisting of, isolated from, or produced from microorganisms, fungi or algae;
(iv) food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:
- traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
- non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
(v) food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
(vi) food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae.
These foods must be derived from primary production as defined in point 17 of article 3 of regulation (EC) 178/2002.
The following categories listed in Article 3 of (EU) 2015/2283 do not qualify for the notification procedure:
(ii) Food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;
(iii) food consisting of, isolated from or produced from material of mineral origin;
(vii) food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
(viii) food consisting of engineered nanomaterials as defined in point (f) of this paragraph;
(ix) vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where:
- a production process not used for food production within the Union before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; or
- they contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;
(x) food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC.
In order to substantiate the history of safe use, data pertinent to the safety of the food must be identified. It is advised to follow the guidance on systematic reviews by EFSA to make sure that all relevant information is retrieved and presented appropriately. The search strategy, databases and other sources used incl. non-peer-reviewed literature should be documented and the limits of the research (language, publication dates etc.) should be indicated.
The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use, and its proposed conditions of use. The specifications of the traditional food and conditions of use must be provided.
The verification of the identity of traditional foods from third countries should be conducted using internationally recognized databases and methodologies.
Apart from the general requirements on the description of the manufacturing process (flow scheme, critical control points, quality systems and the like), the peculiarities of traditional food production must be taken into account as well. Handling of sources like propagation, growth and harvesting conditions for plants and fungi, or breeding and farming conditions for farmed animals, or hunting, catching and killing of wild living animals must be described, as well as post-harvest handling of the foods, e.g. transport, drying, storage conditions.
The presentation of the compositional data follows the same principles as for other novel foods. The typical composition should be analyzed in 5 independent batches.
The decision whether a traditional food from a third county may be considered safe depends on the quality of the information that demonstrate the continued use outside the EU. Such information may be derived from international or national organizations, governmental documentation, figures on cultivation/harvesting, and sales and trade. Further information might be obtained from cookbooks, recipes and anecdotal data. If possible, the traditional modalities of use (e.g. preparation type), extent of use and duration of the exposure should be characterized.
A comprehensive literature research may support the evidence.
The extent of use may be derived from information on the production volumes in a third country, the use of the food in a specific geographic area, the quantity of consumption and serving size, or food consumption data. It is important to differentiate e.g. between the intake of parts of a plant, preparations made out of it or extracts or oils.
Manufacturers of traditional foods have to provide information on the intended uses, use levels and target populations for their foods in the EU. Any precaution or restriction of use (e.g. pregnant or lactating women, young children) must be indicated.