Hemp Products (e.g. CBD) in Food and Supplements
If you plan to sell hemp/CBD oil as a supplement or in a general food, you must consider that some forms of hemp-derived products cannot be sold as food or food supplements in the EU.
What are hemp oils and CBD oils?
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.
Is it legal to grow hemp in Ireland?
Yes, under license from the Department of Health and facilitated by the Health Products Regulatory Authority, certain varieties of hemp can be grown in Ireland.
What are cannabinoids?
The hemp plant naturally contains more than 100 cannabinoids, the most prominent being cannabidiol (CBD) and tetrahydrocannabinol (THC).
Why are some hemp/CBD oils considered to be novel foods?
The purification or concentration of select components of the hemp plant including the use of certain extraction methods involving solvents, like supercritical CO2 or ethanol, in the production of hemp-derived foods or ingredients may bring them within the scope of the novel food Regulation. The reason for this is that when purifying or concentrating select components of the hemp plant, other more undesirable and possibly toxic substances could also be concentrated and therefore pose a new safety risk to consumers that must be assessed.
A novel food is a food or food ingredient that was not available on the EU market to a significant degree before 15 May 1997.
A novel food must be authorised before it can be placed on the EU market. To check the novel food status of a hemp-derived product you intend to place on the Irish market, contact the Food Safety Authority of Ireland (FSAI) at [email protected].
Novel Food Status of Hemp (Cannabis sativa) and hemp-derived cannabinoids
The current novel food status of hemp or derived products such as CBD can be viewed in the Novel Food Catalogue on the Commission website
The novel food catalogue is an informal, non-legally binding record of discussions at EU level about the novel food status of various foods or ingredients.
Why do I see CBD oil extracts regularly on sale?
The FSAI is working with our inspectors to identify unauthorised novel foods on the Irish market. As we become aware of such products on the market we contact the relevant food business operators.
How do I apply for a novel food authorisation?
Information on novel foods and how to submit an application for authorisation is available on the Novel Food Section of the European Commission website.
Do the transition measures set out in Article 35.2 of the novel food Regulation (EU) 2015/2283 apply to hemp/CBD products?
No. Those transition measures apply only to products “lawfully placed on the market by 1 January 2018”. Hemp/CBD products produced using non-aqueous extraction methods such as CO2 or ethanol extraction have always been considered to fall within the scope of the novel food Regulation.
Are there any authorised health claims for hemp oils or CBD oils?
No health claims for hemp or CBD have been authorised for use under Regulation (EC) No 1924/2006 (see our section on Nutrition and Health Claims).
A health claim is any claim that states, suggests or implies that a relationship exists between a person’s health and a food category, a food or one of its constituents.
Can medicinal claims be made about hemp oils or CBD oils?
You cannot make a medicinal claim about food. Claims such as ‘treats seizures’, ‘cures cancer’, ‘lowers anxiety’ or ‘anti-inflammatory’ must not be made verbally, on the label of a food or on associated marketing material such as websites, social media, leaflets, etc.
Medicinal products fall within the remit of the Health Products Regulatory Authority (HPRA) and must be authorised prior to being placed in the Irish market (see HPRA’s Guide to Definition of a Human Medicine).
What is THC and how is it regulated?
The cannabis plant contains a range of cannabinoids – some of which are psychoactive (affect the mind). Tetrahydrocannabinol (THC) is psychoactive and is considered a narcotic.
In Ireland, THC is controlled under the Misuse of Drugs Acts 1977.
Unlike some residues and contaminants, there is no tolerance level set for THC in food under EU or Irish food law. General Food Law (Regulation (EU) No 178/2002) simply requires all food placed on the market to be safe.
Are there levels of THC that would be considered unsafe in food?
The European Food Safety Authority (EFSA) derived an acute reference dose of 0.001 mg/kg body weight (1 µg/kg body weight) for THC in 2015.
Taking a 70 kg person as an example, this acute reference dose means that the consumption of less than 0.07 mg (70 µg) of THC is unlikely to cause an adverse effect.