Interest in CBD as an ingredient in pet products is growing in Europe. How can manufacturers navigate the still inconsistent regulatory environment?
What is CBD?
CBD, a cannabidiol, is a trending ingredient in the pharmaceutical, cosmetic and food industries. Unlike THC, this phytocannabinoid is non-psychoactive, and is studied for its effects on epilepsy and other movement disorders, anxiety, cognition, pain, and even skin conditions like eczema. Given the plethora of effects, it is not surprising that CBD is gaining more interest even from the pet industry, veterinarians and pet owners.
An emerging ingredient
In Europe and the US, an oral solution of CBD is approved as a medicine, an anti-epileptic, for treatment of epilepsy associated with Lennox–Gastaut syndrome in children or Dravet syndrome, a severe myoclonic epilepsy of infancy (SMEI). Although at this moment there are no regulatory approved medicines for companion animals using cannabinoids derived from the medical cannabis plant in Europe, it seems like this will change soon.
Currently, a company CannPal is developing a drug candidate, CPAT-01, as a pain and inflammatory control for dogs, containing cannabidiol and tetrahydrocannabinol. It will be submitted for market authorisation as the first cannabinoid veterinary medicinal product (VMP) for companion animals in Europe.
Regulations still unclear
The CBD market is growing but, as the sales of CBD products increase, the industry is often confronted with conflicting EU regulations. CBD oil can be considered to be legal in most European countries, with different limits of THC prescribed by law – from the highest limit in Switzerland being 1%, to a strict 0% of THC allowed in Estonia, Finland, France, Ireland and Norway. However, legality of CBD is not a simple issue, especially in Belgium and Slovakia where it can be regarded as illegal.
CBD is usually sold in the form of supplements, oils or foods and these are not allowed to be marketed by using health claims, as there are no health claims relating to hemp or CBD that are authorised for use under Regulation (EC) No 1924/2006. Nonetheless, assertions of calming effect, pain reduction and insomnia treatment can be found all over the media.
Classified as a novel food
To further complicate the matter, the European Food Safety Authority (EFSA) recently reclassified CBD as a Novel Food, defined as food ‘that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force’. According to EFSA, this means that ‘before it may be placed on the market in the EU as a food or food ingredient, a safety assessment under the Novel Food Regulation is required’.
Thus, manufacturers in the pet industry wanting to use CBD products would be wise to apply for novel food authorisation to their member state authorities and enlist the help of hemp/CBD legality experts to navigate through the jungle of inconsistencies with more success.