Italy serves notice of plans to set maximum THC levels in supplements

By Will Chu

- Last updated on GMT

Italy’s Ministry of Health has notified the European Commission (EC) of its intention to set maximum levels of THC (tetrahydrocannabinol) in food supplements.

The regulation​ contains provisions concerning the definition of maximum levels of THC in food with limits specifically defined for supplements containing foods derived from cannabis.

Additional details of the Ministry’s intentions extend towards foods derived from hemp such as seeds, flour and oil obtained from the seeds.

“Based on the precautionary principle, the limits are defined as the sum of the active substance (A9-THC, A9-tetrahydrocanabinol) and the non-active acid precursor (A9-THCA-A, delta-9-tetrahydrocannabinolic acid A),”​ the notification read.

“In specific situations this can lead to the formation of the active substance. The regulation also clarifies the relationship between hemp and food use.” 

A good source of protein

The regulation, which does not mention specific levels of THC, is of particular reference to operators in the food sector and to Authorities, who apply relevant legislation on food hygiene and controls. 

Additionally, the regulation also provides clarifications to Authorities and operators on what cannabis-derived foodstuffs can be produced and placed on the market at national level.

Clarification on a national level aims to clear up the confusion surrounding the main cannabinoid THC (Δ9-tetrahydrocannabinol) and its precursors, which can act as narcotics.

What the Ministry of Health want to make clear is the conditions in which the hemp seeds can be used, which contain virtually no cannabinoids.

A good source of protein, the seeds of industrial hemp plants have proved useful in human nutrition with the seed’s oil rich in omega-3 and omega-6 fatty acids.

The seed can be used to make protein powder as well as bread and cereals. Likewise, the oil is used in dietary supplements and for margarine, salad dressing and cosmetics.

Legal status of hemp oils 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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