Delta-9-tetrahydrocannabinol (THC) is the psychoactive ingredient of the hemp plant, which contains very small amounts of THC. While demand for hemp is growing rapidly across Europe, guidelines for hemp seed and products derived from them are incongruous and governed by a patchwork of national regulations. This has caused confusion and hampered growth.
Member States have set their own maximum THC levels in seed products or were forced to comply with the outdated and unnecessarily strict ‘acute reference dose’ (ARfD) of one mg/kg of Delta-9-THC, derived from a 2015 EFSA recommendation.
EIHA Managing Director, Lorenza Romanese, says that inconsistencies among member states have put operators in a very difficult situation and often impeded smooth trade or blocked it altogether.
“Piece by piece, we are achieving a true single hemp market for Europe. We will continue in this direction and do our best to make life easier for hemp farmers and processors.”
The European Industrial Hemp Association (EIHA) has been calling for harmonised legislation to guarantee consumer safety and expansion of the hemp food industry and described the legislation as “a major milestone on the journey to a single hemp market for Europe”.
“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.
Nevertheless, the association expressed disappointment that the Standing Committee failed to fix a measurement uncertainty for THC, which was a condition for its support and endorsement. The EIHA had also asked for higher THC values.
Measurement uncertainty is a parameter that characterises the dispersion of values that could be attributed to the measurand. The regulations state that laboratories are obliged to report their results with measurement uncertainty, which can range from 40-50%.
The EIHA asserts that this will “lead to ambiguity and uncertainty in the market” and has requested an official statement to clarify the caveat.
Guidance on the new regulations will be released in the Commission amended Regulation (EC) 1881/2006. Rules are mandatory for all EU member states 20 days following publication in the Official Journal, although a transitional period will be included to allow existing stock to be used or sold.
Maximum levels have been set at 2,0 mg/kg for dry products (flour, proteins, seeds, and snacks) and 7,5 mg/kg for hemp seed oil. Values apply to dry food derived from seeds and hemp seed oil.
This means that hemp food products containing between 4,2 - 4,5 mg/kg for dry products and between 10,50 - 11,25 mg/kg for oil will be classified as suitable for the market.
The legislation states that a product is non-compliant if THC levels are above the maximum level “beyond reasonable doubt” plus the corresponding measurement uncertainty.
It stipulates that 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.