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European Pharmacopoeia - CJEU - Regulation

Hemp Flower Cultivation

Industrial hemp (Cannabis sativa L.) is an ancient crop with applications in textiles, construction, food and CBD extraction. THC threshold regulation determines its economic viability.

Scientific Classification: Chemotypes

The European Pharmacopoeia (Ph. Eur. 11.5), in its monograph Cannabis Flos (3028) of July 2024, officially classifies cannabis into three chemotypes according to their cannabinoid profile:

THC-dominant

THC: Minimum 5%

CBD: Maximum 1%

Psychoactive recreational or medicinal cannabis

Intermediate THC/CBD

THC: Minimum 1%

CBD: Variable

Significant proportions of both

CBD-dominant

THC: Maximum 1%

CBD: Minimum 5%

CBD-rich industrial hemp

Key: The European Pharmacopoeia establishes 1% THC as the maximum threshold for the CBD-dominant chemotype, scientifically recognizing that this level does not produce psychoactive effects.

The Problem: Arbitrary 0.2% Threshold

The 0.2% THC limit in force in Spain has no scientific basis. Its origin dates back to administrative decisions in the 1970s, not to studies on psychoactivity or safety.

1
Lack of profitability:The restrictive threshold limits cultivable varieties and reduces the value of the crop.
2
Legal uncertainty:Farmers can be criminalized for natural variations in THC content.
3
Competitive disadvantage:Other European countries have already adopted higher thresholds, attracting investment and talent.

European Legal Framework

Kanavape Judgment (CJEU C-663/18)

On November 19, 2020, the EU Court of Justice established a fundamental precedent:

"CBD extracted from the cannabis plant does not constitute a narcotic drug within the meaning of the 1961 Single Convention on Narcotic Drugs."
  • CBD is not a narcotic drug according to international conventions
  • Legally produced CBD products can circulate freely in the EU
  • States may not prohibit marketing without scientific justification
  • Article 34 TFEU protects free movement of hemp products

German Precedent (October 2024)

The German government officially confirmed the legality of hemp flowers with less than 0.3% THC, setting an important precedent for Europe:

  • Elimination of the "abuse clause" that restricted trade
  • Authorization of hemp cultivation in indoor installations
  • Recognition of flowers as an integral part of industrial hemp
  • Compatibility confirmed with the Single Convention 1961

The Solution: 1% THC Threshold

The global regulatory trend points towards 1% THC as a scientifically sound and economically viable threshold:

Scientific basis

  • European Pharmacopoeia (Cannabis Flos 3028)
  • German Pharmacopoeia DAB 2020
  • United Nations ST/NAR/40 Manual
  • Confirmation INTCF Spanish

Countries with 1% or more

  • Switzerland: 1%
  • Czech Republic: 1%
  • Italy: 0.6% (case law)
  • Colombia: 1%

Benefits of the 1% threshold

+200%

Cultivable varieties

100%

Legal certainty

0

Psychoactivity

Supports regulatory change

AECANI is actively working for Spain to adopt the 1% THC threshold, in line with scientific evidence and the European trend.