EFSA and CBD – what does a safe daily intake of 2 mg mean

In February 2026, the European Food Safety Authority (EFSA) issued an opinion that fundamentally affected the entire CBD industry in Europe. The Panel on Nutrition, Novel Foods and Food Allergens (NDA) set a provisional safe daily intake of cannabidiol (CBD) at 0.0275 mg per kilogram of body weight per day – for an adult weighing 70 kg, this is approximately 2 mg of CBD daily.

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This figure is surprisingly low for most consumers, manufacturers, and experts alike. A typical starting CBD oil dose has traditionally ranged around 10–25 mg daily, and many regular users take significantly more. What exactly did EFSA decide, how did it arrive at this limit, and what does it mean in practice for Czech consumers?

What Exactly Did EFSA Decide

Context of the Decision

EFSA has been addressing CBD safety as a novel food since 2019. In June 2022, it issued its first opinion, which identified serious data gaps – particularly regarding potential effects of CBD on the liver, endocrine, nervous, and reproductive systems.

In February 2026, EFSA updated this opinion and for the first time set a specific numerical limit: a provisional safe daily intake. The key word is "provisional" – the limit may be revised once missing data becomes available.

How EFSA Arrived at the 2 mg Figure

The NDA Panel used a standard toxicological method in three steps:

1. Identification of the toxicological reference point: The Panel analyzed subchronic studies conducted according to good laboratory practice (GLP) principles and, through dose-response modeling, determined the level at which first adverse effects begin to appear.

2. Application of an uncertainty factor of 400: An uncertainty factor of 400 was applied to the toxicological reference point – substantially higher than the standard 100 typical in toxicology. This factor includes:

3. Interspecies differences (converting from animal models to humans): factor 10
4. Interindividual variability (differences between individuals): factor 10

5. An additional factor of 4 accounting for the lack of chronic toxicity data and remaining data gaps

6. Resulting provisional safe intake: 0.0275 mg/kg of body weight/day, or approximately 2 mg for an adult weighing 70 kg.

What the Limit Applies to – and What It Doesn't

The provisional safe daily intake applies exclusively to:
- Food supplements in the novel food format
- CBD with at least 98 % purity
- Products without nanoparticles
- Products where the manufacturing process is considered safe and genotoxicity is excluded

The Panel also stated that CBD safety cannot be determined for:
- People under 25 years of age
- Pregnant and nursing women
- People taking CBD concurrently with medicines (risk of drug interactions)

Remaining Data Gaps

EFSA confirmed that the data gaps identified in 2022 remain unfilled. The most pressing questions persist in the areas of:
- Hepatotoxicity (liver damage from long-term use)
- Effects on the endocrine system and hormonal balance
- Long-term effects on the nervous system
- Impacts on the reproductive system

It is precisely these unresolved questions that explain why the limit is labeled "provisional" and why the uncertainty factor was set so high.

What It Means for Consumers

Practical Impact on Dosing

For better orientation: a typical 10% CBD oil in a 10 ml bottle contains a total of 1,000 mg of CBD. A single drop of such oil corresponds to approximately 5 mg of CBD – or 2.5 times the provisional safe daily intake according to EFSA.

In practice, virtually no commonly available CBD product meets the EFSA limit at standard dosing. Even the lowest concentration at the lowest dose falls at or above the limit.

Is There Cause for Alarm?

No – and understanding this context is crucial. The provisional safe daily intake does not mean that doses above 2 mg are provably harmful. It means that EFSA, based on available data and with a high uncertainty factor, cannot guarantee the long-term safety of higher doses within food legislation.

In clinical studies, CBD is administered at doses of 150–1,500 mg daily – for example, in epilepsy treatment through the registered medicinal product Epidiolex, which is dosed at 5–20 mg/kg of body weight daily, equaling several hundred milligrams – and all under direct medical supervision.

Context is key: EFSA assesses CBD as a food, not as a medicine. Food and dietary supplements are held to far stricter safety standards than medicines, where higher risk is acceptable in exchange for demonstrated therapeutic benefit.

EFSA vs. FSA UK: 2 mg vs. 10 mg

One of the most striking aspects of the current situation is the significant difference between the European and UK approaches to the safe daily intake of CBD.

UK FSA: 10 mg Daily

The UK Food Standards Agency (FSA) set the recommended maximum daily CBD intake at 10 mg in October 2023 – five times the European limit. The FSA reached this figure in collaboration with the Committee on Toxicity (COT) and the Advisory Committee on Novel Foods and Processes.

The FSA specified an acceptable daily intake (ADI) of 0.15 mg/kg per day, compared to 0.0275 mg/kg at EFSA.

Why Such a Difference?

The key difference does not lie in different scientific data, but in the approach to regulatory uncertainty. EFSA applied an additional factor of 4 due to missing chronic toxicity data, bringing the total uncertainty factor to 400. The FSA chose a less conservative interpretation and accepted a lower factor.

Both institutions nonetheless agree that there is no acute safety risk from consuming higher CBD doses. The FSA explicitly states: "There is no acute safety concern from consumption of more than 10 mg CBD per day. However, above this level and over time, there is evidence of some adverse effects on the liver and thyroid gland."

The difference between 2 mg and 10 mg is thus not a scientific dispute – it is a difference in regulatory philosophy when dealing with scientific uncertainty.

Novel Food Status: Where We Are and Where We're Heading

What Is Novel Food

Novel Food is any food that has not been consumed in significant quantities in the EU before 15 May 1997. CBD extracts and isolates fall into this category as of 2019, when the European Commission confirmed their registration in the novel food catalogue.

In practice, this means that CBD products sold as food or dietary supplements require authorization – that is, individual approval based on safety assessment by EFSA. Without this approval, they operate in a regulatory gray zone.

Current Status of the Authorization Process

• More than 200 applications for CBD authorization as a novel food have been submitted to the European Commission
• 17 applications are currently in the risk assessment phase at EFSA
• As of March 2026, no CBD application has been approved as a novel food in the EU
• The establishment of a provisional safe intake in February 2026 is concrete progress, but the authorization process is far from complete

Industry Response: EIHA Position

The European Industrial Hemp Association (EIHA), which represents the interests of the European hemp industry, responded to the EFSA decision with cautious optimism. The industry welcomed EFSA's setting of a numerical limit – without it, the authorization process could not proceed. At the same time, it expressed concern about the conservatism of the 2 mg figure and called for rapid closure of data gaps that would allow the limit to be revised upward.

Requirements for Applications from 2026

According to current regulatory requirements, all applications for CBD authorization as a novel food must:
- Be based on rigorous dose-response profiles
- Contain comprehensive analysis of impurities and byproducts
- Present data on long-term effects (chronic toxicity studies)
- Strictly exclude data extrapolation to children, young adults (under 25), pregnant and nursing women, and people taking medicines

How EFSA's Decision Affects Products on the Market

Impact on Manufacturers

Setting a 2 mg/day limit creates an unprecedented challenge for CBD product manufacturers in the EU across several fronts:

1. Product Reformulation: Complying with the limit of 2 mg would require extremely low-concentration formulations or drastically reduced dosing recommendations that are in sharp contrast with current practice.

2. Labeling: Labels will need to reflect the new limit. The recommended daily dose must not exceed 2 mg of CBD, which is in stark contrast with currently stated dosing regimens.

3. Economic Viability: A product with a maximum of 2 mg of CBD per daily dose will be difficult to market in a market where consumers are accustomed to substantially higher doses.

4. Expansion of a Dual Market: There is a realistic risk of further widening the gap between the regulated market (approved novel food) and the unregulated market (products sold outside food legislation) – with the second segment being considerably larger.

Impact on Czech Consumers

For the Czech consumer, several specific findings apply:

• CBD oils are legally available in the Czech Republic as hemp products – not as an approved novel food under EU law
• Czech regulation is based primarily on THC content limits (up to 1%), not the EFSA limit for CBD
• If you use CBD for specific purposes, consult appropriate dosing with your doctor – individual assessment is always more valuable than a general regulatory limit
• Always choose products with a verifiable laboratory certificate (COA); our article on how to select a quality CBD oil offers practical guidance

The Future of CBD in the European Union

Three Possible Scenarios for 2026 and Beyond

Optimistic Scenario: EFSA receives required chronic toxicity data from ongoing studies, closes identified data gaps, and revises the limit upward – potentially closer to the UK limit of 10 mg. In parallel, first CBD products receive authorization as a novel food.

Realistic Scenario: The authorization process continues slowly. The industry invests in required studies, whose completion and evaluation will take 2–3 years. In the meantime, CBD will continue to be sold in a regulatory gray zone as a hemp product – outside the framework of approved novel food.

Pessimistic Scenario: Data gaps cannot be closed in the foreseeable future. The 2 mg limit becomes a de facto binding standard, the CBD industry in the EU shrinks significantly, and innovation and consumer markets shift to the United Kingdom and other countries outside European novel food regulation.

The Role of Other Cannabinoids

EFSA's decision applies exclusively to CBD. Other cannabinoids – such as CBG, CBN, or THCV – have not yet been assessed by EFSA in the context of novel food safety, with the exception of Delta-8-THC, which EFSA evaluated as equipotent to Delta-9-THC.

With the expansion of commercial use of other cannabinoids, regulatory attention is naturally expected to expand to them as well – and experiences with CBD will significantly influence how quickly and strictly EFSA approaches them.

FAQ – Frequently Asked Questions

Does the 2 mg Limit Mean That Higher CBD Doses Are Dangerous?

No. The 2 mg limit is a provisional safe daily intake established with a high uncertainty factor (400) due to missing long-term data – it is not a toxicity threshold. There is no evidence of acute risk at higher doses. In clinical studies and epilepsy treatment, CBD is administered in the hundreds of milligrams per day.

Why Is the UK Limit Five Times Higher Than the European One?

The UK FSA used a lower uncertainty factor because it took a more pragmatic approach to interpreting available data. Both institutions work from a similar scientific foundation; they differ in regulatory philosophy – specifically in how much weight to give to unresolved data gaps.

Does the EFSA Limit Apply to CBD Oils Sold in the Czech Republic?

Formally, the EFSA limit applies to CBD as a novel food (dietary supplement). In the Czech Republic, CBD products are sold primarily as hemp products regulated by THC content (up to 1%). However, with gradual harmonization of Czech regulations with European law, it is likely that this limit will increasingly apply in practice.

Can I Continue Using CBD Oil?

EFSA's decision does not change the legal availability of CBD products on the Czech market. If you are already using CBD oil, there is no reason for sudden change. Consult your dosing with your doctor – especially if you take any medications whose metabolism occurs through the liver enzyme CYP450, where interaction with CBD is proven. Always choose products with an available laboratory certificate.

When Will CBD Be Approved as a Novel Food in the EU?

As of March 2026, no CBD application has been approved. Setting the provisional safe intake is an important milestone, but full approval requires closing data gaps through new studies. A realistic estimate is at least 2–3 years from meeting all data requirements.

How Will EFSA's Decision Affect CBD Product Prices?

In the short term, likely minimally – most CBD products available in the EU are not currently sold as approved novel food. In the long term, if the limit becomes binding, manufacturers will be forced to switch to much lower concentrations, which will affect both prices and consumer perception of product efficacy.

This article is informational in nature and does not constitute legal or medical advice. CBD regulation in the EU and Czech Republic is evolving dynamically. Information is current as of the publication date (March 2026). Before using CBD products, consult your doctor, especially if you take medications, are pregnant or nursing, are under 25, or suffer from health conditions. CBD products are not medicines and are not intended to diagnose, treat, or prevent any disease.

Sources

1. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA). "Update of the statement on safety of cannabidiol as a novel food." EFSA Journal, 2026. efsa.onlinelibrary.wiley.com
2. EFSA. "Provisional safe level for cannabidiol as a novel food." Press release, February 2026. efsa.europa.eu
3. Food Standards Agency (UK). "Food Standards Agency and Food Standards Scotland update consumer advice for CBD." food.gov.uk
4. Food Safety. "EU Sets Provisional Safe Level for CBD as Novel Food." February 2026. food-safety.com
5. EIHA. "Press Release: EFSA provisional safe CBD level." February 2026. eiha.org
6. Nutrition Insight. "EU sets first provisional safety limit for CBD under novel food regulation." nutritioninsight.com
7. Citeline / HBW Insight. "EFSA Restarts CBD Novel Food Process With 2mg Per Day Provisional Intake Level." insights.citeline.com
8. Business of Cannabis. "Clinical Evidence vs. Food Law: Europe's CBD Dilemma." businessofcannabis.com
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10. Cannashield. "EFSA CBD Safe Intake Level For Hemp Products." cannashield.io