EIHA’S NOVEL FOOD CONSORTIUM
On the 1st January 2018 the EU Regulation 2015/2283 on novel foods came into force, providing a definition for novel foods or novel food ingredients. According to Article 3 of the Novel Food (NF) Regulation, NF is a food that had not been consumed to a significant degree by humans in the EU before 15 May 1997 – as a consequence, if a food is considered novel it must undergo a pre-market safety assessment and authorisation before it can be legally marketed in the EU. This procedure, under Article 10 of the NF regulation is expensive and could take up to 2 years. In January 2019, the EU Member States and the European Commission published a new version of the catalogue concerning hemp and cannabinoids and this stated that hemp seeds and its derived products are not novel food; however, they applied this definition to flowers, leaves and hemp extracts, which since then have been left in a ‘grey zone.’
EIHA’s position is that hemp leaves, flowers and extracts from the plant material cannot be considered novel foods, as there is substantial evidence that these have been consumed by humans for centuries. It is also clear that parts of the plant contain a naturally occurring level of cannabinoids. EIHA believes that the NF definition should only be applied to CBD isolates, products enriched with cannabinoids above the naturally occurring level and genetically modified plants. EIHA will robustly defend this position.
With regards to all products containing a level of cannabinoids higher than the naturally occurring level, in June 2019 EIHA launched a proposal to its members to create a ‘Novel Food Consortium’ with the aim of submitting a joint Novel Food application (managed by the EIHA task force). This proposal was voted and approved in November 2019 at the General Assembly. On that basis, EIHA hired a server provider (ChemSafe), who conducted and delivered a feasibility study. This study provides preliminary results and a ‘roadmap’ as to the way forward. As a next step, ChemSafe will undertake a toxicological study for four different products (isolated, gold, regular and raw), hence covering the whole range of cannabinoids. These products were chosen by the EIHA’s Novel Food Task Force and will be submitted to RM for amendments shortly.
Just to reiterate, for all products containing low concentration of cannabinoids (naturally occurring level), EIHA will continue to argue with Authorities that is traditional food (hemp leaves, flowers and extracts); this policy is managed by EIHA Secretariat in Brussels.
By becoming a Regular Member of EIHA you automatically and mandatorily join the Consortium; as we need to combine our forces if we are to offer a united solution to a problem that affects us all. As part of the Consortium your company will benefit from the positive outcome that we hope to achieve with EFSA. Specifically, the success of the consortium’s application will mean that the commercialization of your products will be permitted in the near future; with a five-year exclusivity as a participant regarding the studies.
RM’s automatically receive updates from the Secretariat on the evolution of the “naturally occurring level” dossier.
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