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EU’s new THC limits for hemp-based products will ‘level the playing field’ for food producers

19 Apr 2022

The EU’s introduction of maximum permitted THC levels in hemp-based food products means a “level playing field” which should drive new product innovation and marketplace development, Asa Waldstein, principal of the Supplementary Advisory Group told Ingredients Network.

The new EU-wide levels were recently introduced in an amendment of European Commission’s Regulation (EC) No 1881/2006, and mean that the maximum levels of delta-9-tetrahydrocannabinol (Delta-9-THC) are now capped at 3 mg/kg for dry hemp seed products – including flour, proteins, seeds and snacks – and 7.5 mg/kg for hemp seed oil.

Before the rules were enacted, companies developing and marketing hemp food products faced a “patchwork” of regulations across 27 EU member states which was “challenging to navigate,” said Waldstein, who is also executive chair of the American Herbal Products Association (AHPA) cannabis committee.

The European Industrial Hemp Association’s (EIHA) managing director, Lorenza Romanese, added that the EU’s piecemeal legislative framework previously meant uncertainty for the food and nutrition sector, as well as “misleading [or] wrong interpretation by authorities on the limits of THC in food”.

Previous inconsistencies in THC levels ‘hindered or blocked trade’

Fixed-base operators (FBOs) “needed to trade products with different limits depending on the country where they intended to place their products. For example, Italy adopted even stricter rules when it comes to THC limits in food,” Romanese – whose organisation provided evidence for the EC’s stakeholder consultation on the matter in 2020 – told Ingredients network.

Italy had previously voluntarily adopted a 2 mg/kg limit for dry food and 5 mg/kg for oil.

Some countries, meanwhile, followed the older acute reference dose (ARfD) of 1 mg/kg of body weight of Delta-9-THC, derived from a 2015 European Food Safety Authority (EFSA) recommendation. Other countries had higher levels for some instances, such as Belgium, which used a 10 mg/kg THC limit in hemp seed oil, 5 mg/kg for seed and flour, but 0.04 mg for soft drinks and 0.2 mg for other food and drink.

The inconsistencies have often hindered or blocked trade of food hemp products.

New THC limits to bring harmony, clarity & more product innovation

The new European limits across all member states remove many of these confounding complexities, Waldstein said, adding that the newly level playing field “should initiate new products innovation and marketplace development”.

Romanese said that the new harmony and clarity afforded to the food sector for hemp-based products will also likely see an increase in trading.

The regulation still allows for a transition period before maximum THC levels apply to allow existing stock to be used and sold.

Even after the transition period, maximum THC levels will be calculated using a “measurement of uncertainty” granting a 40% to 50% leeway on guided THC levels in hemp seed-derived products, Romanese pointed out.

Applying this measure, upper Delta-9-THC limits are acceptable at between 4.2 to 4.5 mg/kg in dry products, and 10.50 to 11.25 mg/kg in oils.

Lower than the U.S., Canada and Switzerland

Despite welcoming the move, EIHA had sought a higher limit – as much as 20 mg/kg for hemp seed oil.

The new EU levels still fall below those of Canada, Switzerland and in the U.S., where a recent Department of Agriculture (USDA) ruling set THC concentration in hemp at no more than 0.3% on a dry-weight basis.

Still, Waldstein highlighted barriers in the U.S. hemp market, specifically for the hemp cannabinoid sector.

“Although these rules do not impact the hemp cannabinoid product market, the continued opportunity for cannabinoids in cosmetic and ingestible products is worth mentioning,” he said.

“In the U.S., we've seen the hemp cannabinoid product market hindered by the [U.S. Food and Drug Administration’s] unfavourable position on CBD, and I look forward to seeing regulations soften in the UK, thus creating more market opportunities.”