Guidelines for Hemp in the EU and a new THC risk assessment

Guidelines for Hemp in the EU and a new THC risk assessment

The European hemp sector has grown at an impressive rate in the past few decades, mainly driven by small and medium-sized enterprises operating in the food and food supplement market.

Hemp flower extract and hempseed products contain important phytochemicals that can contribute to a balanced and healthy lifestyle. However, a small amount of tetrahydrocannabinol (∆9-THC) remains even after the most careful cleaning process, it being a natural component of hemp. Maintaining a safe level of this contaminant is necessary to ensure the health of European consumers.

The European Union has established a threshold of 0.001 mg/kg per body weight, well below those of other countries such as Canada (0.014 mg/kg bw), Switzerland (0.007 mg/kg bw) and New Zealand (0.006 mg/kg bw).

On 22 September 2020, Polish Member of the European Parliament (MEP), Robert Biedron of the Group of the Progressive Alliance of Socialists and Democrats, tabled a written parliamentary question to the European Commission. MEP Biedron asked the Commission “why the guidelines used in the EU differ so significantly from those of other countries” and is “the Commission is planning to review the threshold and ask the European Food Safety Authority to conduct a new risk assessment?”

On 25 November, Health and Food Safety Commissioner Stella Kyriakides responded on behalf of the European Commission. In her answer she stated that “in 2015, the European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain (CONTAM Panel) delivered a scientific opinion for human health related to the presence of tetrahydrocannabinol (THC) in food”. She added that “as part of the assessment, the CONTAM Panel reviewed the available evidence from studies on toxicity in experimental animals and adverse effects in humans” and that “the risk assessments established by other authorities were not reviewed in detail as part of the CONTAM Panel assessment”.

Commissioner Kyriakides clarified that “the observed central nervous system effects such as mood alteration and sedation, as well as increases in heart rate, noted at low Δ -9-THC levels, were considered relevant for the risk assessment” and “since these effects were observed within a short time after intake, the CONTAM Panel concluded that it was appropriate to establish an acute reference dose (ARfD)”. In closing, the Commissioner declared that “the CONTAM Panel concluded that an ARfD of 1 μg Δ -9-THC/kg body weight was appropriate, taking into account the lowest-observed adverse-effect level and an uncertainty factor” and “in case new relevant toxicity studies would become available, the Commission would ask EFSA to assess these studies and to update if necessary its risk assessment, including the ARfD”.

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