EFSA warns THC levels of hemp-containing supplements exceed safety limit – NutraIngredients.com

Writing in the Authority’s official journal, the report​ identifies the complications that can occur with the excessive consumption of the psychoactive compound Delta‐9‐tetrahydrocannabinol (Δ9‐THC).

“The data used to assess acute exposure to Total‐Δ9‐THC was finally composed of 588 samples (covering 13 hemp and hemp‐derived products),” ​the report states.

“Acute dietary exposure was assessed at the upper bound (UB) and lower bound (LB) for Total‐Δ9‐THC for consumers only of hemp and hemp‐derived dietary supplements’ (n = 26, at the UB P50 = 1,115, up to P75 = 19,800 micrograms (μg) Total‐Δ9‐THC/kg).”

“For this scenario on ‘Dietary supplements’: 26 samples were available and acute exposure was estimated up to the P75 occurrence level.

At this percentile, for high consumers the exposure to Total‐Δ9‐THC varied between 1.5 and 9.9 (UB) μg/kg bw in adults.

Sample quality

Discussing its methodology, the report acknowledges that within the ‘dietary supplements’ category and the 26 samples available, nine were reported as ‘dietary supplements’ with no further specification of the classification with a median concentration of 7,260 μg/kg.

Two samples were reported as ‘vitamin supplements’ and had a Total Δ9‐THC content of 280 and 26,300 μg/kg;

In addition, eight samples were reported as ‘protein and amino acids supplements’ with a median content of 2,145 μg/kg, whilst seven were identified as ‘Plant extract formula’ with a median of 897 μg/kg (with a max as high as 1,230,000 μg/kg).

While an acute exposure assessment to the supplements was performed; the report’s authors add the high heterogeneity of this category and the relatively high number of samples not further specified, meant results “should be interpreted with caution since high uncertainty is associated with the occurrence levels and therefore with the results of the exposure assessment”.

Derived from the hemp plant Cannabis sativa​, Δ9‐THC generally occurs at low concentrations. In the European Union (EU), hemp varieties cultivated and used for feed must be listed in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’.

According to Regulation (EU) No 1307/20131, the maximum content of THC in these varieties is limited to 0.2 % (w/w). However, THC is currently not regulated under any EU regulation for use in food.

Report conclusions

In concluding its findings, EFSA adds that its acute reference dose (ARfD) of one μg/kg bw was exceeded in the adult high consumers of most of the hemp and hemp‐containing products considered in this assessment, both under the LB and UB scenario.

“Further research is needed in order to obtain sensitive, validated (this including interlaboratory validation) and Δ9‐THC specific methods to be translated to reliable official methods,”​ the report recommends.

“Member states should be encouraged to collect and submit to EFSA more occurrence data (based on selective methods) for Δ9‐THC in food and especially of animal origin, including dairy products, eggs and meat of animals fed with hemp and hemp‐derived products.”

The report adds that consumption data on real consumers of hemp and hemp‐containing products are needed to refine the exposure assessment.

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