HEADLINES FROM EFSA’s STATEMENT ON THE “SAFETY OF CANNABIDIOL AS A NOVEL FOOD: DATA GAPS AND UNCERTAINTIES” (PUBLISHED ON 7TH JUNE 2022)
In our view the “Plain Language Summary” published by EFSA does not provide enough detail for those involved in the industry and the full Statement will prove too detailed for many. Therefore, this document is a “Headline Overview” to assist market participants to understand the most significant developments in the EFSA position in respect of ingestible CBD.
Please note that the content herein does not represent our opinions, but our summation of the opinion expressed by the EFSA Panel on Nutrition, Novel Food and Food Allergens (NDA).
- The kinetic behaviour of CBD in humans following long-term exposure is not fully understood and the possibility that the long-term accumulation observed in rats could also occur in humans is of concern and represents a data gap.
- There is clear evidence for liver toxicity of CBD, demonstrated by liver hypertrophy in laboratory animals and increases in liver enzymes in experimental animals and in human studies. No NOAEL can be derived from these studies. Therefore, studies are necessary both in humans and in experimental animals that enable the identification of a point of departure (i.e., NOAEL).
DRUG-DRUG INTERACTION (DDI)
- Most studies have focused on interactions between CBD and neurological drugs used to treat epilepsy, and data on potential interactions with other drugs are lacking.
- It should be noted that interaction between other drugs and CBD, because of common metabolic pathways, would also impact on the kinetics of CBD.
- Both animal and human data show that CBD has extensive effects on liver function. The extent to which these liver effects might modify the metabolism of drugs is not known, and it is an important data gap, especially given the wide range of CYP enzymes with which CBD interacts and the possibility of enzymes induction. Additionally, the CBD concentrations at which these interactions manifest is not clear.
- Evidence suggests that CBD may affect gastrointestinal function by triggering diarrhoea in humans. There is a lack of studies specifically designed to investigate this diarrhoea-inducing effect during acute and longer-term exposure to CBD in healthy human population groups.
- Furthermore, there is a lack of understanding the mechanism by which CBD may exert this diarrhoea-triggering effect.
- Evidence suggests that oral exposure to CBD affects the endocrine system. An important knowledge gap in animal studies on the potential endocrine effects of exposure to CBD, in particular in females.
- Furthermore, given the effects on IL10 expression, other aspects of immune function should be examined.
- In order to assess the presence of a fraction of small particles in CBD as a NOVEL FOOD, experimental data are needed according to EFSA’s “Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles” (EFSA Scientific Committee, 2021b).
- If the manufacturing or formulation of the NOVEL FOOD foresees the use of nanotechnology resulting in the production of a nanomaterial or a nanoformulated form, the EFSA “Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health” applies (EFSA Scientific Committee, 2021a).
- In particular, any reduction of the particle size, modification of the surface chemistry of CBD particles or processes promoting the formation of nanoemulsions to achieve a better water solubility and/or improved absorption, trigger the need for an assessment according to the above-mentioned guidance (EFSA Scientific Committee, 2021a).
- The Panel identified data gaps regarding the potential genotoxicity of CBD for all three genetic endpoints (gene mutation, structural and numerical chromosomal alterations), which should be assessed based on the characteristics of the Novel Food.