News \ Legislation - N°66 reality indeed included in List 1 “Dangerous plants bidiol (CBD), it is a Novel Food. This active that are not allowed for use in or as foos-d ingredient is not contained in the parts of the tuffs” of the Annex to the amended Royal plant authorized to be used in food supple- Decree of 29 August 1997. This provision ments (seeds and fi bres), since it is found in also applies to hemp varieties that contain the resin. If a food supplement puts forward THC (tetrahydrocannabinol) levels that do its CBD levels, it is considered to be enriched not exceed 0.2%. and therefore a Novel Food. Thus, France For its part, on 30 October 2018 Italy noti- refuses this type of statement. To sum up, fied the EC (2018/546/I) of its intention to the DGCCRF accepts the products based on issue a decree aimed at setting maximum hemp seed oil, but not on cannabis-derived thresholds of tetrahydrocannabinol (THC) in oleoresin. foods. The draft text defines: - “hemp for An exception to the prohibition may never- food use”: plant of Cannabis sativa L. theless be requested. The assessment is - “food derived from hemp”: part or deriva- made on a case-by-case basis, taking into tives of hemp parts which have registered account the THC levels of each batch and significant food consumption under the other product characteristics, based on ana- Novel Food regulation lysis reports for each batch that demonstrate - THC: concentration yielding from the sum the absence of a toxic substance in the pro- of concentrations of the substance “∆9-THC ducts. ((-) trans-∆9-THC)” and the non-active acid The authorization may therefore be valid for a precursor “∆9-THCA-A (9-tetrahydrocanna- batch of products, the batch numbers being binolic acid A)”. specifi ed on the derogations. These latter are 043 Annex I lists the authorized foods derived issued by the French Public Health and allow from hemp: seeds, flour and oils obtained placing the products legally on the market. from the seeds. Annex II sets the following maximum limits: 2 mg/kg for hemp seeds, ◗What about the United States? flour from seeds; 5 mg/kg for oil from hemp seeds; 2 mg/kg for food supplements contai- In the United States, the Food and Drug ning foods derived from hemp. Administration seems to want to “soften” In France, the potential authorization of its position regarding hemp and can- Cannabis sativa L. was recently discussed nabis. FDA Commissioner Scott Gottlieb during a DGCCRF/Synadiet meeting For the signed the Agriculture Improvement Act authorities, cannabis is listed as a psycho- on 20 December. One of its effects is that tropic plant, and so is THC. In fact, both are it changes, at federal level, the framework prohibited. But there is a legal way, that of for the production and marketing of hemp Hemp under the Decree of 2 August 1990, provided that the plant and its derivatives which specifi es in Article 1 that “the cultiva- contain less than 0.3% per dry weight of tion, import, export and the industrial and THC. As a result, hemp is no longer consi- commercial use ( bres and seeds) of Can- dered an illegal substance by the federal nabis sativa L. varieties meeting the following authorities (the plant has been removed criteria are allowed: the delta-9-tetrahydro- from the Controlled Substances Act). Hulled cannabinol level of these varieties should not hemp seeds, the proteins and oil extracted exceed 0.20%”. The subtlety is that it is the from seeds are recognized as safe - GRAS plant - not the fi nished product - that must status. contain less than 0.2% THC. If THC is found On the other hand, any claims made by a in the fi nished product, the authorities shall food product containing CBD, and even consider the product as non-compliant. The more so if containing THC, must be sub- DGCCRF authorizes the registration of food mitted to the FDA for authorization prior to supplements containing hemp oil obtained being launched - a process identical to that from seeds by cold pressing. As for canna- of a medicine. ■ News on Functional & Health Ingredients \ N°66 \ January - February - March 2019 \ ■