EFSA Sets Provisional Safety Level for CBD – Why Helsama Welcomes a Clearer Regulatory Framework

On 9 February 2026, the European Food Safety Authority (EFSA) published a new scientific statement on cannabidiol (CBD) under the EU Novel Food regulation.

After several years of regulatory uncertainty, the authority has now established a provisional safety level for CBD in food supplements.

But what does this actually mean – and what does it not mean?

What Has EFSA Established?

EFSA's expert panel (NDA) has set a provisional safety level of:

0.0275 mg CBD per kg body weight per day

For an adult weighing 70 kg, this corresponds to approximately 2 mg CBD per day.

It is important to understand that this level:

• Is provisional
• Is based on available scientific data
• May be adjusted as more research is published

EFSA emphasises that knowledge gaps remain, particularly regarding long-term effects.

Does This Apply to All Foods?

No.

The provisional safety level applies only to food supplement formulations in ongoing Novel Food assessments.

This means that:

• It does not apply generally to all foods
• It is not a general "approval" of CBD in food
• It does not replace the requirement for an individual Novel Food application

In the EU, food supplements are a specific category of food with their own rules.

Is CBD Now Approved in the EU?

No.

EFSA's statement is a scientific risk assessment, not a market authorisation.

For a CBD product to be legally sold as a food supplement in the EU, the following is required:

• An approved Novel Food application
• A decision by the European Commission
• That the product meets established specifications and conditions

The fact that a product contains less than approximately 2 mg CBD per day does not automatically mean it may be sold.

Our CBD Isolate and the Novel Food Process

The CBD isolate we use is covered by a validated and submitted Novel Food application under Regulation (EU) 2015/2283.

This means that:

• Safety documentation has been submitted in accordance with EU requirements
• The raw material is undergoing regulatory review within the EU
• The product is specified according to established purity and quality criteria

We only work with suppliers who follow the EU regulatory process and can provide complete technical and toxicological documentation.

It is important to distinguish between an ongoing regulatory review and a final market authorisation. We follow the process carefully and continuously adapt to applicable legislation.

Helsama's View

We see this as a sign that the EU's regulatory process is moving forward. Clarity is essential for long-term quality, consumer safety, and a serious hemp industry.

We follow developments closely and always prioritise:

• Transparency
• Scientific foundation
• Responsible product development

When new decisions are made, we will update our customers and partners.

Read the news on EFSA's website →