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Cannabis as an ingredient in food or supplements (Ireland)

The Department of Health issues the licences for the cultivation of hemp in Ireland. The Health Products Regulatory Authority (HPRA) processes the applications received for such licences, on behalf of the Department of Health. The applications are assessed against what is legally permitted under the current Misuse of Drugs Laws. When hemp-derived products are placed on the market as ‘food’ in line with the General Food Law (EU Regulation 178/2002), numerous other regulations pertaining to the EU food legislation may apply, and are enforced by the Food Safety Authority of Ireland. The flowers/buds of the Cannabis plant fall outside the definition of food as they are considered narcotic drugs in line with the UN Single Convention on Narcotic Drugs 1961. Therefore the marketing of cannabis flowers or buds on their own as food in the EU is not permitted. While hemp seeds do not naturally produce or contain cannabinoids including cannabidiol (CBD), there may be varying levels of cannabinoids found in fibres and stalks of the hemp plant. Ireland does not consider CBD derived from legally-cultivated hemp by cold pressing as a novel food. This means cold-pressed CBD from legally-cultivated hemp can be sold as food in Ireland without requiring a novel food authorisation, subject to compliance with all other applicable food legislation. However, where cannabis-derived CBD products have been refined by purification, concentration, etc., they are considered novel foods that must be authorised in accordance with EU Regulation 2015/2283 prior to marketing. The rationale for this position is not related to the legal use of authorised extraction solvents, but is due to the potential safety threats posed by the higher concentration of desirable components and possible co-purified undesirable components, where they do not have a significant history of consumption prior to 1997. This general position has been agreed by all EU Member States as expressed in the entry for “Cannabinoids” in the EU Novel Food Catalogue The addition of synthetic or concentrated forms of plant-derived CBD to a hemp seed-derived food in order to boost the levels of CBD also makes that final food a novel food which must be authorised in accordance with EU Regulation 2015/2283 before it can be placed on the EU market. A number of products with names such as hemp oil, hemp seed oil, CBD oil or CBD hemp oil are available on the Irish market. These products come from the hemp plant (Cannabis sativa). They are usually, but not always, marketed as food supplements in liquid or capsule form. The Food Safety Authority of Ireland makes regular surveys of the marketplace and recalls products due to the presence of unsafe levels of Tetrahydfrocannabinol (THC) in excess of the European Food Safety Authority (EFSA) acute reference dose of 0.001 mg/kg boy weight (1 µg/kg body weight). Finally, the appearance of cannabis-infused edibles, such as jelly sweets, chocolates, cookies, and confectionery, is a relatively new trend in Ireland. Any such product infused with Tetrahydfrocannabinol (THC) must not contain levels in excess of the EFSA acute reference dose and the FSAI is monitoring their sale in the marketplace.

This is general information rather than legal advice and is current as of 30 May 2024. We recommend you contact a specialised food lawyer for legal advice for your particular circumstances to support commercial decisions which could impact your product or business.


RAYMOND O'ROURKE

Ireland
RAYMOND O'ROURKE