CBD Oils and Hemp Oils - Legal Status
Are you planning to sell CBD oil? Did you know some forms of this oil are not allowed to be sold as food or food supplements in the EU?
If the CBD oil is extracted using particular extraction methods, like using solvents or supercritical CO2 extraction, you cannot sell it in the EU (unlike CBD oil extracted simply by pressing e.g. cold pressing). It is important that you know how the CBD oil has been extracted.
These types of oils need authorisation from the EU. If you want to sell these products you must apply for novel food authorisation. You can do this on the European Commission website.
You should be aware that this is not a quick process and authorisation may not be granted.
What is a novel food?
A novel food is a food or food ingredient that was not available on the EU market to a significant degree prior to May 15, 1997.
Why are some CBD/hemp oils considered to be novel foods?
Generally speaking, hemp oil obtained by cold-pressing the seeds or other parts of the hemp plant does not require authorisation. This is because hemp oil was consumed in the EU to a significant degree before 1997 (see entry for Cannabis sativa L in the EU Novel Food Catalogue).
If, however, the CBD/hemp oil is subjected to certain forms of extraction or purification techniques, then a novel food authorisation may be required, as there may be an accompanying increase in undesirable constituents. A typical example is hemp oil subjected to supercritical CO2 extraction.
But I see CBD oil extract for sale everywhere and can easily get it from suppliers? How can it be illegal?
These products have been placed on the market without authorisation and are not permitted for sale. As we become aware of such products their status on the market is addressed.
Why is it NOT OK to sell CBD oil that has been extracted using particular techniques?
When using particular techniques to purify or concentrate a desirable constituent in a food, like CBD, undesirable substances that may be harmful to consumers’ health could also be enriched. Extracts obtained using these techniques must be assessed for safety before they are authorised for sale.
How do I apply for 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 CBD products produced by non-aqueous extraction?
No. That transition measure applies only to products “lawfully placed on the market by 1 January 2018”. 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 and therefore were not “lawfully placed on the market by 1 January 2018”.
What are hemp oils and CBD oils?
A number of products with names such as hemp oil, hemp seed oil, cannabidiol oil, CBD oil or CBD hemp oil recently entered the Irish market. These products are derived from the hemp plant (Cannabis sativa). They are typically marketed as food supplements (or dietary supplements) in liquid or capsule form.
Oil is obtained from the hemp plant by cold-pressing the seeds or other parts of the hemp plant. This oil naturally contains low levels of cannabidiol (CBD), a non-psychoactive compound. CBD can also be chemically extracted from hemp to produce products with a higher CBD content.
Are there any authorised health claims for hemp oils or CBD oils?
A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. No health claims relating to hemp or CBD are authorised for use under Regulation (EC) No 1924/2006 (see FSAI’s Information on Nutrition and Health Claims).
Can medicinal claims be made about hemp oils or CBD oils?
Medicinal claims are those which attribute to food the property of preventing, treating or curing a human disease. It is not permitted to make a medicinal claim about food. Therefore claims such as ‘treats seizures’, ‘cures cancer’, ‘lowers anxiety’ or ‘anti-inflammatory’ must not be made on the label of a food, verbally or on associated marketing material such as websites, social media, leaflets, etc.
Products that either contain a medicinal substance or make a medicinal claim are considered to be medicinal products. 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).
Who authorises CBD for medicinal use in Ireland?
The HPRA is the competent authority for authorising medicinal products in Ireland. Its role is to ensure that only products that are safe, effective and of an appropriate quality based on clinical and scientific data can be authorised and supplied as medicines in Ireland (see HPRA’s report: Cannabis for Medical Use - A Scientific Review). At present there are no authorised medicines in Ireland that contain CBD as the only active ingredient. Accordingly, CBD products currently being sold for consumer use are not approved for the prevention or treatment of medical conditions or symptoms associated with such conditions.
Is it legal to grow hemp?
Yes, under licence from the Department of Health, certain varieties of the hemp plant (Cannabis sativa) are legally grown for a range of uses including for food and feed. The varieties of hemp permitted to be grown in Europe are those listed in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and for which the tetrahydrocannabinol (THC) content does not exceed 0.2% (Regulation (EU) No 1307/2013).
What is THC?
The cannabis plant contains a range of cannabinoids – some of which are psychoactive (affect the mind) and some not. Tetrahydrocannabinol (THC) or, more precisely, delta-9-tetrahydrocannabinol (Δ9-THC), is a psychoactive constituent of the hemp plant. As THC can cause symptoms associated with psychosis, products that contain THC are subject to strict controls under the Misuse of Drugs Acts 1977 to 2016.
At EU level, the presence of Δ9-THC, its precursors and other cannabinoids in food from hemp and in food from animals fed using hemp-derived feed is being monitored as part of official controls under Commission Recommendation (EU) 2016/2115.
Can THC be used in food?
Article 2(g) of Regulation (EU) No 178/2002 states that food shall not include: “narcotic or psychotropic substances within the meaning of theUnited Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971“
THC is listed as one of these narcotic or psychoactive substances.
The safety of THC in foodstuffs has been addressed by a 2015 European Food Safety Authority (EFSA) opinion which concluded an acute reference dose for Delta-9 Tetrahydrocannabinol (THC) at 1µg/kg body weight. This means that consuming food containing THC at greater than 1µg/kg body weight in one sitting or in a day may have adverse effects.
Last reviewed: 23/9/2019