The European Commission has finally harmonized the maximum levels of Delta-9-THC found in some hemp based foods. The publication of the forecast, officially approved on 14.2.22 (subsequently contained in reg. (EU) 2022/1393 of the following 11 August 2022).
Hemp in food, the EU amendment
The EU Commission he amended - following a positive opinion of the Standing Committee for Plants, Animals, Food and Feed (PAFF) - Regulation (EC) 1881/2006 with regard to the maximum levels of delta-9-tetrahydrocannabinol (Delta-9-THC ) in hemp seeds and derived products.
The maximum levels established will be directly applicable in all Member States, starting from the twenty-first day following the publication of the regulation in the Official Journal, for dry foods derived from seeds and hemp seed oil.
A transitional period, during which the use and sale of existing stocks legitimately placed on the market before the application of the regulation will be allowed, will allow economic operators to prepare for the new rules.
The Delta-9-THC thresholds
The quantity of Delta-9-THC tolerated in food is as follows:
- for dry products (flour, proteins, seeds, snack), 3 mg / kg,
- for hemp seed oil, 7,5 mg / kg.
Legislation establishes that a product is not compliant only if, beyond any reasonable doubt, there is a quantity higher than the maximum permitted level, plus the corresponding measurement uncertainty, the acceptable level of which, however, is not defined.
The Italian discipline
Law 242/2016, 'Provisions for the promotion of hemp cultivation and agro-industrial chain'laid the foundations for the rebirth of this supply chain in Italy. However, the succession of misunderstandings and disinformation, in Europe (1) as in Italy (2) - by GIFT regularly investigated - has actually hindered the development of this sector.
A circular of the MiPAAF of 22.5.2018 (3) had tried to introduce clarifications on inflorescences, ornamental purpose and import of seeds. Specifying, with regard to the inflorescences of hemp, that these, although not expressly mentioned by law n. 242 of 2016 fall within the field of crops intended for horticulture, provided that these products derive from one of the accepted varieties, registered in the common catalog of varieties of agricultural plant species. If the overall THC content does not exceed the levels established by the legislation, and as long as the product does not contain substances harmful to health.
The use of inflorescences for food purposes, however, it remained subject to a legislative vacuum, which the ministry's circular could not fill due to a clear lack of competence.
The Ministry of Health, with decree 4.11.19 published in the Official Journal 15.1.20, had defined the THC thresholds allowed on hemp-based foods produced in Italy. Providing, for hemp seeds (including shredded, chopped, ground other than flour) and for supplements containing foods derived from hemp, the threshold of 2 mg / kg, for hemp seed oils of 5 mg / kg. Without providing anything for the inflorescences for food use.
Application implications
In Italy, the products that were legally marketed pursuant to decree 4.11.19, may continue to be marketed even after the end of the transitional period:
- in the case of dry products (flour, proteins, seeds, snack), and for hemp seed oil, as the Italian tolerance threshold was lower than that set by the European legislator,
- for other products, in the absence of harmonization, decree 4.11.19 continues to apply. Provided, of course, the food does not fall within the scope of the legislation novel food. The same applies to hemp inflorescences, for which a shared interpretation at European level continues to be lacking.
The fragmentation of the market domestic, in this important sector, has therefore been reduced, but not completely eliminated by the new regulation. Due to its small scope, which includes only dry products (flour, proteins, seeds, snack) and hemp seed oil, and due to the absence of a forecast relating to measurement uncertainty.
Dario Dongo and Giulia Torre
Footnotes to the story
(1) Dario Dongo, Hemp and CBD, the great chaos. GIFTS (Great Italian Food Trade). one https://www.greatitalianfoodtrade.it/etichette/canapa-e-cbd-il-grande-caos
(2) Dario Dongo. Industrial hemp, the bluff of the United Sections of Cassation. GIFTS (Great Italian Food Trade). one https://www.greatitalianfoodtrade.it/consum-attori/canapa-industriale-il-bluff-delle-sezioni-unite-di-cassazione
(3) Dario Dongo. Cannabis Sativa, MipAAF clarifications. GIFTS (Great Italian Food Trade). one https://www.greatitalianfoodtrade.it/mercati/canapa-sativa-chiarimenti-mipaaf