Cannabidiol (CBD) and THC Impurities
- annolim
- 6 days ago
- 4 min read
What the New SCCS Opinion Means for Industry
The European regulatory landscape for cannabidiol (CBD) has shifted again — and this time, the most significant update comes not from EFSA or agricultural policymakers, but from the EU’s Scientific Committee on Consumer Safety (SCCS).
In November 2025, the SCCS released a preliminary opinion setting explicit safety thresholds for CBD in cosmetic products and maximum acceptable levels of Δ9-THC impurities in CBD ingredients.
This opinion sits alongside existing rules governing THC levels in hemp-derived foods and EFSA’s continued refusal to approve CBD as a novel food due to unresolved safety data gaps. Together, these developments form the most coherent picture to date of how the EU expects industry to manage CBD and its related impurities across product categories.
A First for Cosmetics: What the SCCS Opinion Says
The SCCS preliminary opinion — SCCS/1676/25 — is the first EU-level document to define practical, numeric limits for CBD in cosmetic formulations.
Read it here:
SCCS Preliminary Opinion on CBD (Nov 2025)
Key conclusions:
CBD is considered safe at concentrations up to 0.19% in dermal and oral cosmetic products.
Δ9-THC impurities should not exceed 0.00025% (w/w), equivalent to 2.5 mg/kg in CBD raw materials.
The opinion does not cover inhalation routes, such as sprays or aerosolised products.
The opinion is preliminary and open for stakeholder consultation — but historically, SCCS final opinions rarely diverge significantly from preliminary versions.
For cosmetic formulators, this is a regulatory milestone: for the first time, the EU provides clarity on what it considers a safe exposure level for topical and oral cosmetics containing CBD.
How This Fits With EFSA’s Stance on CBD in Foods
While SCCS took a pragmatic step forward for cosmetics, the European Food Safety Authority (EFSA) remains cautious. EFSA's official position on CBD as a novel food (2022 statement, still in effect) is that CBD cannot be declared safe under the proposed conditions of use submitted in applications.
EFSA opinion:
EFSA Statement on CBD as a Novel Food (2022)
EFSA emphasised multiple data gaps, including:
Potential liver effects
Endocrine and reproductive impacts
Drug–drug interactions
Insufficient human exposure data
This has led to numerous “clock-stopped” applications and a de facto freeze on authorisation of CBD-containing foods and supplements. Companies placing such products on the market without novel-food approval face significant enforcement risk in many member states.
THC Limits in Foods: Separate Rules Still Apply
Beyond CBD, EU law separately regulates Δ9-THC (and Δ9-THCA expressed as THC equivalents) in certain hemp-derived food categories.
The controlling legislation is:
Commission Regulation (EU) 2023/915 —
Maximum Levels for Certain Contaminants in Food
This regulation harmonises maximum THC levels across the EU for hemp seeds and products derived from hemp seeds, moving Europe away from the old patchwork of national limits.
Manufacturers of oils, seeds, flours, and snacks must ensure their products remain below these thresholds — which are expressed in mg/kg and include the sum of Δ9-THC + Δ9-THCA.
Why the SCCS Opinion Matters So Much
For the cosmetics sector, the SCCS opinion is the clearest guidance the EU has issued to date.
It provides:
A quantifiable CBD limit (0.19%)
A strict impurity limit for Δ9-THC (2.5 mg/kg)
A reinforced requirement for full analytical characterisation
A reminder that inhalation products may pose unique risks
It also signals that EU regulators are now distinguishing more clearly between product categories — cosmetics vs foods vs vaping products — rather than treating CBD as one regulatory block.
What Companies Should Do Now
1. Update cosmetic product specifications
Reformulate products where necessary to comply with the 0.19% CBD limit.
Ensure raw materials meet the 2.5 mg/kg THC impurity ceiling.
Maintain complete batch-specific COAs and validated analytical methods.
2. For foods and supplements: treat CBD as a novel food
You still require EU authorisation before placing CBD foods on the market.
Build or update your toxicological and human exposure datasets.
Prepare for EFSA requests on liver endpoints, reproductive toxicity, and interactions.
3. Strengthen your cannabinoid testing program
Regulators now expect:
Quantification of CBD, CBDA, Δ9-THC, Δ9-THCA
Reporting of THC equivalents
Accredited, validated methods with appropriate LOQs
Stability data demonstrating no THC increases over shelf-life
4. Review labelling and marketing claims
Avoid health or therapeutic claims (cosmetics cannot imply physiological effects).
For foods, keep claims fully compliant with the Nutrition & Health Claims Regulation.
Conclusion
The new SCCS preliminary opinion marks a major step toward regulatory clarity for CBD-containing cosmetics in the EU. With defined limits for CBD and THC impurities, cosmetic businesses now have concrete parameters for safe formulation. However, the broader landscape remains complex: CBD in foods is still blocked pending novel-food approval, and THC contaminant limits continue to apply across hemp-derived foods.
For responsible operators, 2025 is the year to strengthen testing, update specifications, and align product portfolios with EU expectations. The message from regulators is consistent: CBD is welcome on the EU market — but only within clearly defined, scientifically supported boundaries.
© 2025 THB. All rights reserved.
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