The European Industrial Hemp Association (EIHA) is welcoming the EU’s maximum levels of delta-9-tetrahydrocannabinol (Delta-9-THC) in hemp seeds and derivatives.
The levels have been set at 3.0 mg/kg for dry products (flour, proteins, seeds, snacks) and 7.5 mg/kg for hemp seed oil.
The initiative is geared to end internal market fragmentation and boost investment in the sector. The values are applicable to dry food derived from seeds and hemp seed oil.
“There was a real necessity from the sector to have a harmonized approach toward THC residues in the EU. Until now, all member states were doing basically what they wanted,” Lorenza Romanese, managing director, European Industrial Hemp Association (EIHA) tells FoodIngredientsFirst.
“As a consequence, it was very difficult for a fixed-base operator (FBO) to prepare different products for different member states. Take the example of Italy. Italy voluntarily adopted 2 mg/kg for the dry food and 5 mg/kg for the oil. Now it will have to amend these restrictive values and adopt the EU ones,” explains Romanese.
Phasing in new regulatory practice
The regulation will provide for a transitional period before the maximum levels apply to allow existing stock to be used and sold.
For around a decade, EIHA has been an advocate of this legislation and provided evidence to the stakeholder consultation of the European Commission in 2020.
Until now, member states would fix their own maximum THC level in seed products or follow the outdated and acute reference dose (ARfD) of 1 mg/kg/bw of Delta-9-THC derived from a 2015 EFSA recommendation.
Inconsistencies among the 27 member states have put operators in a very difficult situation and often impeded a smooth trade or blocked it altogether.
Belgium, for example, used 10 mg THC/kg in hemp seed oil, 5 mg for seed and seed flour, 0.04 mg for soft drinks and 0.2 mg for other food and drink.
Romanese elaborates: “As you can imagine, different values in different member states affected the operators that needed to prepare different products according to the country where they were shipping.”
The limits are still quite low compared to the US, Canada or Switzerland. “But with the uncertainty measurement taken into account we are approaching their values which is good,” explains Romanese.
According to the EIHA, the European Food Safety Authority (EFSA) is still using values that are too strict. EIHA is advocating for a higher value such as 7mg/kg, used in Switzerland and has launched a human trial to achieve this goal.
Driving testing consistency
All member states will have to follow common values, driving consistency across the EU and creating a stable market for investors. The legislation clearly states that a product is non-compliant only if it is beyond reasonable doubt above the maximum level plus the corresponding measurement uncertainty.
The decision followed a positive opinion of the standing committee for foodstuffs. The committee did not fix a “measurement uncertainty” in writing. Measurement uncertainty is defined as a parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.
In accredited laboratories doing analysis for official controls have to comply with the rules on how to determine their expanded measurement uncertainty. Laboratories are obliged to report their results with the measurement uncertainty, which can range from 40 to 50%.
“Piece by piece, we are achieving a true single hemp market for Europe,” adds Romanese.
“We will continue in this direction and do our best to make life easier for hemp farmers and processors.”
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