Brussels, Belgium
March 14, 2022
All Member States will have to follow common values, driving consistency across the EU and creating a stable and more attractive market for investors.
Following a positive opinion of the Standing Committee for Foodstuffs, the Commission amended Regulation (EC) No 1881/2006 as regards the maximum levels of delta-9-tetrahydrocannabinol (Delta-9-THC) in hemp seeds and products derived therefrom.
These values will be applicable for dry food derived from seeds and hemp seed oil and will be mandatory for all Member States. This initiative finally puts an end to the internal market fragmentation and will most likely give a further boost to the investment in the sector. The rules will be directly applicable in all Member States 20 days following the publication of the regulation and its annexes on the Official Journal. To enable economic operators to prepare for the new rules, the regulation will provide as well for a transitional period before the maximum levels apply allowing for already existing stock to be used and sold.
The maximum 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 Standing Committee did not fix in writing a measurement uncertainty. 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 praxis 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 - 50%.
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 evaluation of the test results must be carried out by adding the corresponding measurement uncertainty in order to verify the marketability of the respective product.
EIHA asked for higher values, but endorsed and supported the EU Commission's proposals on maximum levels for THC in food on the condition of a clear and official regulation on measurement uncertainties.
EIHA is disappointed that the official measurement uncertainty for THC has not been fixed. This continues to lead to ambiguity and uncertainty in the market. Now every FBO must constantly explain and defend the measurement uncertainty to the authorities
EIHA already asked the commission for an official statement, included in the document publishing the maximum levels for THC in food, regarding the measurement uncertainty in the range of 40-50% and the concept of non-compliance only if the test result is beyond reasonable doubt above the maximum level.
De facto, taking into account the stated measurement uncertainty of the laboratories, the hemp foodstuffs mentioned containing between 4,2 – 4,5 mg/kg for dry products and between 10,50 - 11,25 mg/kg for oil will be marketable.
“This long-awaited piece of legislation is a significant win for our industry and the EIHA has been a strong advocate for this change for almost ten years. EIHA also contributed with sound scientific facts to the stakeholder consultation of the European Commission in 2020. These EU-wide maximum levels will greatly help our members and all food business operators wishing to work with hemp seed derived products, such as hemp seed oil” says Daniel Kruse, EIHA President.
Until now, Member States would fix their own maximum THC level in seed products or follow the outdated and unnecessarily strict 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. “Piece by piece, we are achieving a true single hemp market for Europe” adds Lorenza Romanese, EIHA Managing Director, “We will continue in this direction and do our best to make life easier for hemp farmers and processors”.
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