Food System

Hemp in food, EU adopts maximum THC limits

March 15, 2022

The European Commission has finally harmonized the maximum levels of Delta-9-THC found in some hemp foods. Publication of the forecast, officially approved on 14.2.22 (later contained in the reg. (EU) 2022/1393 of the following August 11, 2022).

Hemp in food, the EU amendment

The EU Commission has amended-following a positive opinion from the Standing Committee on Plants, Animals, Food and Feed (PAFF)-Regulation (EC) 1881/2006 with regard to maximum levels of delta-9-tetrahydrocannabinol (Delta-9-THC) in hemp seed and hemp products.

The maximum levels set will be directly applicable in all member states, as of the twenty-first day after publication of the regulation in the Official Journal, for dry foods derived from hemp seeds and hemp seed oil.

A transitional period, during which the use and sale of stocks already existing and legitimately placed on the market prior to the implementation of the regulation will be allowed, will allow economic operators to prepare for the new rules.

The thresholds of Delta-9-THC

The amount of Delta-9-THC tolerated in food is as follows:

– For dry products (flour, protein, seeds, snacks), 3 mg/kg,

– For hemp seed oil, 7.5 mg/kg.

The legislation states that a product is noncompliant only if, beyond reasonable doubt, there is a quantity present that exceeds the maximum allowable level, plus the corresponding measurement uncertainty, the acceptable level of which is not defined, however.

The Italian discipline

Law 242/2016, ‘Provisions for the promotion of the cultivation and agro-industrial chain of hemp‘ laid the foundation for the revival of this chain in Italy. However, the succession of misunderstandings and misinformation, in Europe (1) as well as in Italy (2)-by GIFT punctually investigated-has actually hindered the development of this sector.

A MiPAAF circular dated 5/22/2018 (3) had tried to introduce clarifications on inflorescences, ornamental purpose and seed import. Specifying, with regard to hemp inflorescences, that these, while not specifically mentioned in Law No. 242 of 2016 fall within the scope of crops intended for floriculture, provided that such products are derived from one of the permitted varieties listed in the Common Catalogue of Varieties of Agricultural Plant Species. If the total THC content does not exceed the levels set by regulations, and provided that the product does not contain substances harmful to health.

However, the use of inflorescences for food purposes remained subject to a legislative vacuum, which the ministry circular could not fill due to a clear lack of competence.

The Ministry of Health, by decree 4.11.19 published in the Official Gazette 15.1.20, had defined the THC thresholds allowed on hemp foods produced in Italy. Providing, for hemp seeds (including crushed, chopped, ground other than flour) and supplements containing hemp-derived foods, a threshold of 2 mg/kg, for hemp seed oils 5 mg/kg. Without providing anything for inflorescences for food use.

Application implications

In Italy, products that were legally marketed under Decree 4.11.19 can continue to be marketed following the conclusion of the transitional period:

– if they are dry products (flour, protein, seeds, snacks), and for hemp seed oil, as the Italian tolerance threshold was lower than that set by the European legislature,

– For additional products, in the absence of harmonization, Decree 4.11.19 continues to apply. Provided, it is understood, that the food does not fall under the scope of novel food regulations. The same is true for hemp inflorescences, for which there continues to be a lack of shared interpretation at the European level.

The fragmentation of the internal market, in this important area, has thus been reduced, but not completely eliminated by the new regulation. Because of its small scope, which includes only dry products (flour, protein, seeds, snacks) and hemp seed oil, and because of the absence of a prediction regarding measurement uncertainty.

Dario Dongo and Giulia Torre