EFSA is changing its mind with regard to the safety of CBD food products following review of recent animal and human studies. The studies are about toxicity, the interaction of multiple drugs when taken with CBD medicinal, and the relation between CBD and endocrine alterations.
Let’s introduce the key concepts, the background of the theme and dive into it.
What is CBD and why is EFSA reassessing its safety?
Cannabidiol (CBD) is a non-psychoactive compound derived from Cannabis Sativa, and it is widely used in wellness products such as oils, gummies, and supplements. While it doesn’t cause a “high” like THC, its popularity has rapidly grown, particularly in the food supplement industry.
In the European Union, however, CBD is classified as a novel food. That means a pre-market authorization is required, including a rigorous scientific safety evaluation by the European Food Safety Authority (EFSA). In 2022, EFSA identified significant data gaps that prevented a conclusive opinion on the safety of CBD. In 2025, EFSA released an updated scientific statement, which also opened for public consultation, a standard EU mechanism that invites stakeholders to comment on draft assessments.
What is the updated EFSA statement about?
Despite the expansion of scientific literature, many safety concerns persist. EFSA reviewed recent animal and human studies; however, most were limited by poor study design, short exposure durations, or confounding factors, such as co-medication.
Key findings include:
- Liver toxicity: A confirmed concern, with consistent effects in animal studies and enzyme elevations in human trials, especially when CBD is taken with other drugs.
- Reproductive and developmental toxicity: Further evidence from animal models supports this risk, including potential impacts on offspring and fetal exposure.
- Endocrine disruption: Alterations in thyroid and adrenal markers have been observed.
- Drug interactions: CBD interferes with liver enzymes critical for metabolizing other compounds, heightening risks in polypharmacy contexts.
EFSA has now proposed a provisional safe intake level of 0.0275 mg/kg body weight/day (equivalent to 2 mg/day for a 70 kg adult). This applies only to formulations of CBD with purity >95%, no nanoparticles, and confirmed absence of genotoxicity.
Consequently, EFSA states that safety cannot be established for:
- Individuals under 25 years old,
- Pregnant or breastfeeding women,
- Consumers taking medication.
What comes next for the CBD market in Europe?
As of October 2025, no orally consumed CBD product is authorized as a novel food in the EU.
EFSA’s careful stance can be seen in the updated statement; this latter clarifies that further high-quality data are needed, particularly in healthy populations.
However, EFSA’s updated draft is currently open for public consultation, allowing stakeholders (including companies, researchers, and consumers) to submit scientific comments or evidence that could help refine the final statement. This is a unique opportunity to engage in the regulatory process and address key concerns directly with EFSA.
The deadline to submit comments is today, October 14 2025.
Feedback can be submitted via EFSA’s official website.
If you or your organization holds new safety data on CBD, mostly on liver toxicity, reproductive endpoints, or pharmacokinetic interactions, now is the best time to act.
Submitting evidence during the public consultation may influence EFSA’s final conclusions and future authorization pathways.
