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Cannabis Chemotypes: The 1% of the Pharmacopoeia

The European Pharmacopoeia (Ph. Eur. 11.5) officially classifies cannabis by chemotype. The CBD-dominant chemotype is defined by a threshold of up to 1% of THC.

2024-12-14
3 minutos de lectura
The European Pharmacopoeia is the official reference standard for medicines in the EU. In its most recent edition (11.5), it establishes a fundamental scientific classification of cannabis based on its chemical composition or "chemotypes". This standard officially recognizes the 1% THC threshold for CBD-rich varieties.
Book of the European Pharmacopoeia and botany

The European Pharmacopoeia defines the quality and safety standards for cannabis products in the Union.

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Pharmacological Standard

The European Pharmacopoeia does not use the 0.2% threshold. To define what is a CBD-dominated plant, it uses the scientific threshold of 1% of THC.

The 3 Official Chemotypes

According to the monograph Ph. Eur. 3028, cannabis is divided into

Chemotype I

THC-Dominant

High THC, low or no CBD. This is narcotic or traditional medicinal cannabis.

Chemotype II

Intermediate

Balanced presence of THC and CBD (ratio close to 1:1).

Chemotype III

CBD-Dominant

CBD predominates over THC. Limit: Maximum 1% THC.

Why is this definition important?

This classification is the legal and scientific basis for

  1. Quality Control: Allows laboratories to certify products with European standards
  2. Legal Certainty: Unlinks CBD (fiber/industrial) chemotype from narcotic cannabis
  3. Harmonization: This is the criterion to be followed by all Member States for the pharmaceutical and wellness industry
Molecular diagram of cannabinoids

Chemical differentiation between CBD and THC is the key to proportional and fair regulation.

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Harmonization Opportunity

While the European Pharmacopoeia recognizes 1% for the CBD chemotype, the Spanish administrative framework currently applies 0.2% as an operational criterion. This difference raises opportunities for harmonization based on scientific criteria.

Towards a Real Standard

AECANI advocates harmonization of the industrial sector with the criteria of the European Pharmacopoeia. If 1% is safe for medicines, it is also safe for the agricultural and industrial sector

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There is an opportunity for harmonization between the industrial sector and the European Pharmacopoeia criteria, which defines the CBD-dominant chemotype as non-narcotic.


📚 References

  1. European Pharmacopoeia (Ph. Eur.) 11.5 - Monograph 3028 "Cannabis Flower"
  2. EDQM - European Directorate for the Quality of Medicines & HealthCare
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