Camilla Conto: “The CBD public consultation allows us to confirm or challenge EFSA’s methodology”

The European Food Safety Authority (EFSA) opened a public consultation on September 9th on updating the safety declaration for cannabidiol (CBD) as a novel food. The preliminary opinion proposes a maximum daily intake of 2 mg for a 70 kg adult. To better understand EFSA's rationale, CannaReporter® spoke with Camilla Conto, director of the Food Unit at the consultancy ChemSafe.

The European Food Safety Authority (EFSA) is considering including cannabidiol (CBD) in the novel foods catalogue and has issued a preliminary opinion, now subject to public consultation. The preliminary opinion defines a value that EFSA describes as "extremely cautious," proposing a maximum intake of 2 mg per day for a 70 kg adult, as the scientific literature continues to present data gaps. 

To better understand EFSA's rationale, CannaReporter® spoke with Camilla Conto, director of the Food Unit at the consulting firm ChemSafe. Camilla has a background in Chemistry and Pharmaceutical Technology and completed a second degree in Food Safety in London. Upon returning to Italy, she created and consolidated ChemSafe's Food Business Unit, which she currently leads. The expert explained that, in risk assessments, uncertainty factors (UF, of Uncertainty Factor) are used to address data gaps. In the case of CBD, EFSA applied three multipliers: 10 × for differences between species, 10 × for variability between individuals, 2 × to extrapolate from subchronic to chronic studies and 2 × additional due to the identified uncertainties. "The UF of 400 is high because there is still little evidence of safety," explains Camilla. "If new toxicological studies or long-term clinical trials emerge, this factor may be reduced and the dose adjusted."

When asked which data are most urgent, Camilla highlights three areas: Reproductive and developmental toxicity – EFSA emphasizes that the proposed dose does not apply to pregnant or lactating women or those under 25, as specific studies and clinical trials in healthy adults are lacking – the few available studies involved patients medicated with pharmaceutical doses of CBD, making it difficult to extrapolate results to healthy consumers; and chronic exposure and immunotoxicity. Furthermore, there is almost no research on the effects of prolonged use and on the immune system, which explains part of the uncertainty.

When asked whether the lack of data justifies the high uncertainty factor, Camilla confirms that it does: "EFSA used the best available method, but recognizes that there are uncertainties. The public consultation is an opportunity for scientists, companies, and consumers to contribute real information." In this sense, Camilla Conto emphasizes that companies can share unpublished toxicological or clinical data, while consumers can share their user experiences that help contextualize the safety of CBD. "Each comment can influence the final value defined by EFSA, either increasing or decreasing it," she emphasizes.

Finally, Camilla notes that the complex regulatory history of CBD—associated with medications and supplements—led to a particularly cautious approach. However, this doesn't mean the process is closed. Public consultation is a democratic instrument: the more data is made available, the more robust the final decision will be.

The questions CannaReporter® asked Camilla Conto

From what we've gathered, the authors [of the EFSA opinion] state in the updated assessment that there are significant data gaps. Do you consider this to limit the establishment of a realistic and safe daily dose of CBD?
Safety or uncertainty factors (SF/UF) are tools used by regulators to conduct risk assessments and establish safe levels when data gaps exist, as is the case here. The uncertainty factor of 400 is relatively high compared to more common values ​​such as 100 or 200. This can be seen as a limitation, as you mention, since additional toxicological or clinical data could reduce the factor and allow for a higher acceptable dose. In this case, the high UF is justified by the gaps identified by EFSA in the literature review, but it is applied to the animal study data presented by the proponents.

You mention that there's a factor of 400 in the estimates. Is this because we also lack clear data on this? What additional studies or data would be most useful to reinforce the scientific validity of this assessment? Aren't companies that submit CBD as a Novel Food required to conduct this type of toxicological assessment?
Applying an uncertainty factor (UF) is standard practice when risk assessments are based on animal data. In this case, EFSA considered the animal studies submitted by the proponents and derived a safe dose. The high UF was justified in the opinion as follows: a default factor of 100 (10 for interspecies variability and 10 for within-species variability), an additional factor of 2 for extrapolation from subchronic to chronic exposure, and another factor of 2 to reflect the overall uncertainty associated with the gaps identified in the literature. Well-designed human studies would naturally provide important additional evidence to reduce these uncertainties. Among the gaps, one of the most critical concerns is reproductive toxicity, highlighting the need for more data in this area. EFSA also restricted the target population to adults 25 years of age or older, excluding pregnant or lactating women. Standard animal studies cover these areas.

Last but not least, we have an alternative interpretation: what justifies the 400 factor and the conservative estimates is, in fact, a lack of data, in the spirit of public health protection. How do you see the role of public consultation in this, given that CBD is widely consumed in Europe and data are effectively nonexistent?
An uncertainty factor of 400 is presented as the most appropriate choice based on the evidence considered by EFSA. It can also be argued that CBD has not been evaluated as a standard "novel food," likely due to its complex regulatory history and associations beyond dietary use, which led to a more cautious approach. Regarding the public consultation, it allows scientists to provide evidence that may support a higher or lower safe dose, or confirm or challenge EFSA's methodology. Citizens can also contribute by sharing their experiences with CBD, which can serve as a means of gathering general information. EFSA should then consider, discuss, and, where appropriate, incorporate this input.

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Antonio João Costa

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I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.

I can be contacted by email at joao.costa@cannareporter.eu

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