New EU Regulation setting maximum levels of delta-9-tetrahydrocannabinol (Δ9 -THC) in hemp seeds and products

Last 12th August 2022,  it was published the Commission Regulation (EU) 2022/1393 amending Regulation (EC) No 1881/2006 as regards maximum levels of delta-9-tetrahydrocannabinol (Δ9-THC) in hemp seeds and products derived therefrom

Regulation (EC) No 1881/2006 sets maximum levels for certain contaminants in foodstuffs.

The European Food Safety Authority (EFSA) established in 2015, an acute reference dose (ARfD) of 1 μg Δ9-THC/kg body weight (bw). In order to obtain more data on the presence of Δ9-THC and other relevant non-psycho-active precursors in hemp derived foods and foods containing hemp or hemp-derived ingredients, Recommendation (EU) 2016/2115 was adopted.

On 7 January 2020, EFSA published a scientific report assessing acute human exposure to Δ9 -THC, taking into account the occurrence data generated through Recommendation (EU) 2016/2115. The ARfD of 1 μg/kg bw was exceeded in certain acute exposure estimates. Although the exposure estimates are expected to overestimate acute exposure to Δ9 -THC in the Union, the current exposure to Δ9-THC is a potential health concern.

Maximum levels should therefore be set in hemp seeds and hemp seed derived products to ensure a high level of human health protection. Since delta-9-tetrahydrocannabinolic acid (Δ9-THCA) can be converted into Δ9-THC through processing, the maximum levels should be set for the sum of Δ9-THC and Δ9-THCA, expressed in Δ9-THC equivalents. 

This Regulation shall enter into force 1st September 2022. This Regulation shall apply from 1 January 2023. Foodstuffs listed in the Annex, lawfully placed on the market before 1 January 2023, may remain on the market until their date of minimum durability or use-by date.

Our laboratories can support you to know more about the contents of THC and other cannabinoids in hemp seeds, hemp seed oil, and food. Mérieux NutriSciences provides a wide range of services (including testing) to food manufacturers for the Cannabinoids sector  and can help you to identify if the product is a food, novel food, drug or pharmaceutical and guarantee them to meet regulations and quality standards. Our laboratories are ISO17025 accredited (*).

(**) Click  here to see our complete Scopes of ISO17025 accreditations: Germany