Bregt Raus January 18 2023 Why the European Union's harmonisation of THC limits in hemp seeds puts pressure on Belgian food laws ALTIUS | Healthcare & Life Sciences - Belgium Bregt Raus Healthcare & Life Sciences IntroductionBackgroundBelgian cannabis food lawCommentIntroductionHemp seeds – which have been eaten in the European Union for a long time – may contain trace amounts of tetrahydrocannabinol (THC) as this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonise the maximum levels for THC in hemp seeds throughout the European Union through the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022, which has been in effect since 1 January 2023, amends the annex to the EU Contaminants Regulation(1) to this effect. This EU harmonisation puts pressure on conservative national food laws, such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.BackgroundHemp seeds have a history of consumption in the European Union – they are thus not a novel food – and are praised for their nutritional value. The seeds come from the cannabis sativa plant. They are commonly referred to as "hemp seeds" rather than "cannabis seeds" to signal that they originate from a cannabis plant with very low levels of THC – the principal psychoactive constituent of cannabis. The seeds may contain trace amounts of THC because THC is a natural constituent of the plant.The EU regulator was concerned that exposure to traces of THC could pose a health concern and considered it appropriate to harmonise the maximum levels thereof throughout the European Union. Commission Regulation 2022/1393 amended the annex to the EU Contaminants Regulation by adding maximum levels of THC in hemp seeds and products derived therefrom.Belgian cannabis food lawProducts that are linked to the cannabis plant often face controversy as "cannabis" can be a loaded term. It can refer to both the cannabis sativa plant or a psychoactive drug commonly known as "marijuana". National regulators struggle with this conceptual confusion, which has resulted in laws that may be considered to be overly conservative. The current regulation of hemp seeds in Belgium is a good example of this.Under the Belgian Royal Decree of 31 August 2021, it is prohibited to produce and place on the market foods that contain parts of the cannabis plant. The Belgian federal government has explicitly stated that hemp products with low THC levels, such as hemp seeds, fall under this broad prohibition.A company that wishes to market hemp seeds in Belgium has to request a derogation from the federal authorities on the basis of a toxicological and analytical dossier. If a derogation is granted, it applies to only one batch. If companies fail to obtain a derogation, their products will be removed from the market.CommentBelgium's strict prior approval process for hemp seeds is questionable from an EU law perspective. By harmonising THC limits within the food contaminants framework, the European Commission has sent an implicit but clear signal that hemp seeds are just like other foods. THC levels – like other contaminants – should be within the defined limits, and compliance with such limits is monitored through sampling and official controls (under the new rules for official controls in the food contaminants space, which also apply since 1 January 2023).(2)Belgian law, however, applies the opposite logic: hemp seeds are a prohibited food and are subject to prior authorisation. This setup makes it costly and difficult to market hemp seeds in Belgium, arguably in contravention of the EU legislature's intent to put an end to the internal market fragmentation. EU law, however, has primacy over national law. If the Belgian Royal Decree remains unchanged, it can be challenged on this basis.For further information on this topic please contact Bregt Raus at ALTIUS by telephone (+32 2 426 1414) or email ([email protected]). The ALTIUS website can be accessed at www.altius.com.Endnotes(1) EU Regulation No. 1881/2006 of 19 December 2006.(2) See Commission Delegated Regulation (EU) 2022/931 of 23 March 2022 and Commission Implementing Regulation (EU) 2022/932 of 9 June 2022.