Scientific opinion on the assessment of the exposure of the population of the republic of Croatia to delta‐9‐tetrahydrocanabinol (δ9‐thc) from industrial hemp food on the market of the republic of Croatia
Year: 2025
Type: article
Abstract: Summary Delta‐9‐tetrahydrocannabinol (Δ9‐THC) is a naturally occurring psychoactive compound derived from the hemp plant Cannabis sativa. In 2015, EFSA established an acute reference dose (ARfD) of 1 μg/kg body weight (bw) for Δ9‐THC and assessed acute dietary exposure from milk and dairy products. In addition, following the European Commission Recommendation 2016/2115 on the monitoring of the presence of Δ9‐THC in food and the issuing of a new mandate, EFSA assessed the acute human exposure to Δ9‐THC. In recent years, the availability of various hemp‐based products has increased on the market, particularly in retail. Data on the Δ9‐THC concentration and other cannabinoids in hemp‐based food products on the Croatian market have never been collected in a comprehensive and structured manner. Therefore, the Croatian Agency for Agriculture and Food (HAPIH) in 2023 conducted a study with the aim of determining their presence. The establishment of maximum permitted levels of Δ9‐THC equivalents in hemp seeds and hemp‐derived products under Commission Regulation (EU) 2023/915 highlighted the need for additional knowledge on the levels of Δ9‐THC concentration in hemp‐based foods on the Croatian market. A total of 176 samples were collected from 12 food categories according to the FoodEx2 classification. Most analyzed samples were found in the categories “Legumes, nuts, oilseeds and spices” and “Sugars and related products, confectionery desserts and water‐based desserts”, followed by “Coffee, cocoa, tea and herbal infusions” and “Cereals and cereal‐based products”. From a total of 176 samples analyzed, Δ9‐THC was detected in concentrations below the limit of quantification (LOQ) in 138 samples (78.41%). In the food categories “Animal and vegetable fats and oils and their primary derivatives” and “Coffee, cocoa, tea and herbal infusions”, a significant number of samples showed quantifiable results. However, in most other categories, almost all results were below the LOQ value. Due to the large number of samples below the LOQ in certain food categories, the acute risk assessment was performed for two scenarios („hemp oil” and „tea”). Food consumption data were obtained from the National Dietary Survey conducted between 2019 and 2023 among a population aged 10 to 99 years. The survey included a representative sample of 1,913 participants, divided into four age groups: adolescents, adults, elderly, and the very elderly. Due to the limited data on consumption of hemp‐based products in the HAPIH database, proxy data based on “standard” food categories were used to calculate acute exposure. The food categories used for the exposure assessment are based on Level 2 of the FoodEx2 classification. The mean exposure and 95th percentile exposure (P95) were calculated on the bases of different concentration percentiles, and presented for the respective age groups. The mean exposure results for the “hemp oil” UB scenario showed that participants from age groups “young children, other children, adolescents and adults” exceeded the established ARfD of 1 μg/kg body weight/day at both the P50 (1.07 – 2.48) and P75 (1.30 – 3.01) concentrations of Δ9‐THC. Participants in the age groups “elderly and very elderly” exceeded the established ARfD of 1 μg/kg body weight/day at the P75 concentrations of Δ9‐THC (1.02 – 1.11). The P95 exposure results for the “hemp oil” UB scenario showed that participants from all age groups exceeded the established ARfD of 1 μg/kg body weight/day at the P50 (2.05 – 6.27 and P75 concentrations of Δ9‐THC (2.50 – 7.63). In the “hemp oil” scenario, an additional scenario was calculated in which all foods that deep‐fried were excluded, given that hemp oil is not expected to be used in the preparation of such foods. Since there were no significant changes regarding consumer health, these results are not presented in this opinion. In the “tea” scenario, the exposure assessment was calculated for two cases: the first assumes that 0.5% or 1.9% of Δ9‐THC from the dry material transfers into the infusion, and the second assumes a 60% transfer in the case of the addition of a fat component. The mean exposure results for the “tea” UB scenario, where the transfer of Δ9‐THC from the dry tea matter to the infusion was 0.5% and 1.9%, showed that only participants in the “young children” age group with 1,22 μg/kg body weight/day exceeded the established ARfD at the P75 concentration of Δ9‐THC in the case of a transfer 1.9%. The P95 exposure results for the “tea” UB scenario, where the transfer of Δ9‐THC from the dry tea matter to the infusion was 0.5% and 1.9%, showed that only participants in the “young children” age group exceeded the established ARfD of 1 μg/kg body weight/day at the P50 (1.32 μg/kg body weight/day) and P75 concentrations of Δ9‐THC (2.78 μg/kg body weight/day) when assuming a 1.9% transfer of Δ9‐THC from dry matter to infusion, as well as participants in the “other children” category at P75 concentrations of Δ9‐THC (1.54 μg/kg body weight/day). For the “tea” scenario, the results of the mean and P95 exposure also show that the participants in all age groups significantly exceeded the established ARfD of 1 μg/kg body weight/day at the P50 (4.27 – 18.30) and P75 concentrations of Δ9‐THC (9.01 – 38.67), whereby a 60% transfer of Δ9‐THC from the dry matter to the infusion was assumed due to the addition of a fat component. Ad hoc Expert Body for the adoption of this Scientific opinion recommended that the collection of data on the consumption of hemp foods and hemp containing foods should be continued in order to reduce the uncertainties associated with the use of “substitute” data in exposure assessment. Further research is also needed on the stability of Δ9‐THC, as well as its transformation during food processing, including cooking, and additional studies on the transfer of Δ9‐THC from dry tea material into the infusion. It is also recommended to continue sampling and analyzing hemp food products from the Croatian market, with special attention to samples from family farms and their web shops, where high levels of Δ9‐THC have been detected.
Source: Food Risk Assess Europe
Language: English
Subfield: Pharmacology (medical)
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: European Food Safety Authority
OpenAlex ID: W4417030784