Italy adopts decree setting maximum THC levels in supplements

The decree​​ updates November 2018’s notification to the European Commission (EC) to set maximum THC levels not only in supplements but foodstuffs containing Cannabis sativa L.​ derivates.

“The decree gives legal certainty to the use of some hemp derivatives such as oil from seeds, seeds and hemp flour,”​ explains Luca Bucchini, managing director of Hylobates Consulting,

“It also clearly permits the use of such food ingredients in food supplements, even if the formal aim of the decree is to set maximum THC limits in such foods, in the absence of EU maximum limits for THC in foods and in these foods particularly. ​

“It also establishes an official analytical method (the one recommended by the EC). It will mean that such hemp derivatives can be used with more certainty, and that robust analytical protocols can be set up,” ​he adds.

“Importantly the decree allows the addition of other hemp derivatives with minimal effort, should those recognised as not novel.”​

The decree, published on 15 January, in the Ministry’s official journal, also sets out the maximum level of tetrahydrocannabinol (THC) allowed in seeds and seed flour (2mg/kg) and oil obtained from seeds (5mg/kg).

EFSA warning ​

Earlier this month​​, The European Food Safety Authority (EFSA) warned of consequences to the heart and cardiovascular system as a result of consuming large amounts of hemp products that included supplements, teas and energy drinks.

Writing in the Authority’s official journal, the report​​​ outlines the complications that can occur with the excessive consumption of the psychoactive compound Delta‐9‐tetrahydrocannabinol (Δ9‐THC).

EFSA concluded that the acute reference dose (ARfD) of one μg/kg bw was exceeded in the adult high consumers of hemp and hemp‐containing products considered in this assessment. (Both upper bound (UB) and lower bound (LB)scenario).

“Further research is needed in order to obtain sensitive, validated (this including interlaboratory validation) and Δ9‐THC specific methods to be translated to reliable official methods,”​ the report recommended.

“Member states should be encouraged to collect and submit to EFSA more occurrence data (based on selective methods) for Δ9‐THC in food and especially of animal origin, including dairy products, eggs and meat of animals fed with hemp and hemp‐derived products.”​ ​

Legal status of hemp and CBD oils​ ​

Depending on how the product is manufactured, current requirements state hemp oils and CBD oils may need authorisation under the Novel Food Regulation (EU) 2015/2283, before they can be legally placed on the EU market.

Generally speaking, hemp oil obtained by cold-pressing the seeds or other parts of the hemp plant does not require pre-market authorisation.

If, however, the natural CBD content of hemp oil is selectively increased using certain forms of extraction or purification techniques, then a novel food authorisation may be required.

So far, no health claims relating to hemp or CBD are authorised for use under Regulation (EC) No 1924/2006.

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The event wants to bring together the science, business and regulation governing CBD to look at how businesses can unlock this important market opportunity. For more details, check out our advanced programmed, and view confirmed speakers, visit the CBD Global Summit website​​.