Project co-financed by:

Description of the project:

Research in the field of public health and food represent a long-term investment in the health of the population and support the integration of measures for the prevention of disease across populations. This research proposal is using the holistic approach to ensure the safe use of hemp in food, especially in food supplements. Food business operators are, only by amending the Regulation governing the conditions for authorization of cultivation of cannabis and poppies, allowed using species Cannabis sativa, where the content of tetrahydrocannabinol (THC) not exceeding 0.2% of the dry matter of the plants, for the production of conventional foods and food supplements. Foods containing or made entirely of various components of hemp may still contain trace amounts of THC, and more than sixty other cannabinoids, some of them are also biologically active eg. cannabidiol (CBD), cannabinol (CBN). Their content in the final product can be substantially increased by the procedures of poor agricultural and manufacturing practices (contamination at harvest and storage) and the concentration steps or extraction. The proposed research project will achieve our research goals:

• to describe the availability of hemp in conventional foods, food supplements and other products that are intended to be consumed, on the Slovenian market;
• to use an appropriate analytical technique and method to determine the content of biologically active cannabinoids THC, CBD and CBN and other cannabinoids relevant in a representative sample of food products;
• to develop the model to calculate exposure of the Slovenian population of biologically active cannabinoids through food;
• to assess the risk to health due to the exposure of hemp in food in the Slovenian market for various population groups;
• to prepare a synthesis of the most effective approaches for the safe use of industrial hemp in food, based on a systematic review of the evidence and the results of our project.

Work will be organized in following work packages:

• WP 1: The availability of food and other products containing hemp;
• WP 2: The levels of cannabinoids in food and other products of hemp;
• WP 3: Risk assessment of food and other products containing hemp;
• WP 4: Evidence base proposals for amendments to the relevant legislation.

We will use a unique national database and software tools - "CLAS" and "P3 Professional", which will monitor and determine the frequency, incidence and availability of conventional foods, food supplements and other products with hemp. Based on the review of available food products, we will prepare a sampling plan for at least 60 products with hemp, which are intended to be eaten. To analyze the content of cannabinoids: tetrahydrocannabinol

(THC), cannabidiol (CBD) and cannabinol (CBN) and some other cannabinoids relevant to each product group, we will use already existing analytical methods based on liquid chromatography with tandem mass spectrometry (LC / MS / MS). The basic statistical analyses will show the distribution of the content of biologically active cannabinoids from hemp in food and other products in the Slovenian market, which has not yet been done.

The risk assessment procedures will evaluate the safety of hemp in food of all population groups. We follow the European Food Safety Authority guidance for the safety assessment of botanicals. Based on the identified levels of THC, CBD, CBN and other cannabinoids of hemp we will produce an dietary exposure assessment. We will use deterministic approach with the the average or the highest detected levels of individual cannabinoids in the investigated food categories and average intake of these food categories. In the case of food supplements and other products, we will the recommended daily dosage. We will assess different scenarios of intake for the general population, adults, adolescents and children.

The risk will be identified by comparing the calculated exposure scenarios to the reference (safe) doses. For THC that already exists and for other cannabinoids we have yet to be determined on the basis of the critical dose of literature. With the risk assessment we will show if there is a likelihood of health risks with the normal diet and the current use of industrial hemp in food.

Representative national data and risk assessment will be complemented by a systematic review of measures to ensure the safety of hemp use in the European Union and other countries. Proposals for measures will be adapted to the objectives of the Resolution of the National Programme on Nutrition and Physical Activity for Health 2015-2025, particularly in terms of ensuring safe and healthy food, with an emphasis on locally-sustainable supply and self-sufficiency.

Evidence based recommendations from this project will be communicated within the Slovenian government, the European Food Safety Authority, stakeholders (including food industry), civil society and non-governmental organizations. The strategy targeted dissemination of information will raise public awareness about the benefits and potential risks of the use of hemp in food.

The results of the research project will be useful for the food business operators to plan, reformulate and develop existing or new food products. It will also be useful to complement the good agricultural and manufacturing practices for hemp, and will have a major impact on the work of official controls and thus to ensure safe food products to the Slovenian market.