Definition of ‘Novel Food’
The first Novel Food regulation was introduced in 1997 by Regulation (EU) 258/97 with the aim of establishing a food safety mechanism to control newly developed, synthetic or genetically produced food. An updated version of the regulation came into force on 1st January 2018 (Regulation (EU) 2015/2283).
According to art. 3, ‘novel food’ is:
“any food that was not used for human consumption to a significant degree within the Union before 15 May 1997”.
If a food is considered novel, it must be authorised by the EU Commission and undergo a pre-market safety assessment by the European Food Safety Authority (EFSA), before it can be legally marketed in the EU.
The Novel Food Catalogue serves as a non-legally binding orientation on whether a product (of animal and plant origin, as well as other substances) will need an authorisation under the Novel Food Regulation. The Novel Food Catalogue reflects the opinion of the Member States.
Cannabis in the Novel Food regulation
Until the end of 2018, extracts of cannabidiol were considered novel only if the levels of cannabidiol were “higher than the CBD levels in the source Cannabis sativa L.”.
The Standing Committee already decided in December 1997 and the Commission confirmed to the European hemp industry in writing in the beginning of 1998 literally:
“it was decided that foods containing parts of the hemp plant do not fall under the scope of the regulations EC 258/97” and also “that hemp flowers … are considered to be food ingredients” (e. g. used for the production of beer-like beverages)”.
Obviously, hemp flowers and leaves being parts of the hemp plant, were not considered to be Novel Food.
However, in January 2019, Member States’ representatives updated the Catalogue entries for “Cannabis sativa L.” and “Cannabinoids”. These updates are demonstrably incorrect, based on logic and historical facts, as EIHA repeatedly explained to Member States and the European Commission.
- The new entry for “Cannabis sativa L.” does not mention hemp leaves and flowers. From this alone, it is obvious that the latest changes, which seem to be hastily written, concerning the entries in the Novel Food catalogue are not correct. Moreover, the traditionally produced hemp extracts are also missing, although extraction is considered as a traditional and conventional method of food processing.
- In the new entry for “Cannabinoids” extracts with a naturally occurring level of cannabinoids are now excluded, although they were mentioned in the previous entry formulation. Such products were already on the market and consumed before 1997 to a significant degree.
EIHA has already shared substantial evidences with the European Commission proving that hemp flowers, leaves and extracts have been consumed as food for centuries and that the so-called “low-THC” varieties, defined as industrial hemp, have always contained cannabidiol (CBD). Particularly in these industrial hemp varieties – including those that were already listed in the EU catalogue of varieties long before 1997 – the respective content of CBD in relation to THC is very high compared to “high-THC” cannabis varieties.
The position conveyed by EIHA has always been consistent and aligned to the following: Hemp leaves and flowers as well as such hemp extracts from industrial hemp, with the natural content of cannabinoids, (i.e. those that are not enriched with isolated CBD) are traditional foods and do not fall under the scope of the Novel Food Regulation.
This position is perfectly in line with the Novel Food Catalogue entries’ formulations in place until January 2019.
EIHA Novel Food Consortium
Because of the situation described above a legal and planning security for the European hemp industry and for the trade of CBD-related products can only be achieved by approval as Novel Food. EIHA intends to secure a fair market for its members who farm, process and trade with CBD related products – a constant, reliable and EU wide regulated common market status.
The main tasks for EIHA are to finally achieve a legal and planning security for the European hemp industry and its CBD market, including a level playing field for all European companies and global players, as well as to avoid free rider effects by entities that are not willing to contribute.
EIHA’s Board proposed to its members during the General Assembly of June 2019 to create a Novel Food Consortium, with the aim of submitting a joint Novel Food application and share the costs. EIHA estimates that an individual company registering a single product under Novel Food guidelines need to invest between €350,000 and €500,000. The EIHA Novel Food Consortium will have the advantage of reducing the costs per company to an affordable level. These fees will increase over time. The founding members will have a preferential partnership rate. Based on the latest assessment it is estimated that the consortium will invest up to €3,5 million for financing all relevant and unprecedented toxicological studies on CBD and THC.
The steps already taken by EIHA prior to the creation of the NF Consortium include:
- The hiring of a service provider (ChemSafe);
- The designation of a task force whose members were strictly appointed based on their expertise.
Why should companies join us?
By becoming a Regular Member of EIHA you automatically and mandatorily join the Consortium, as we need to combine our forces in order to offer a united solution to a common challenge facing the entire hemp industry. Being part of the Consortium means that following a positive outcome of the novel food application, your company’s products will be allowed to be marketed in the EU with an exclusivity on the study that will last 5 years.