Last week, Japan officially launched a public comment period for draft legislation set to regulate the country’s emerging cannabis and CBD industries.
After passing the legislation in November 2023, the Japanese government has now published detailed proposals on the limits it intends to set for both finished CBD products and hemp farmers.
The proposals suggest that CBD will be approved for use in foods, with strict limits on the amount of THC allowed, meaning the market is likely to be dominated by isolate-based products.
These strict thresholds, according to Dr Yuji Masataka, MD, Japan’s first specialist in medical cannabis, will ‘make parallel imports of products difficult, potentially keeping CBD product prices high’, but could benefit the inspection industry.
“Cannabis products are characterised by their diversity. Stricter THC standards will homogenise products, leading to the loss of the entourage effect.
“It is unclear if users seeking health maintenance will continue to receive the same benefits after the law revision. On the other hand, companies that can meet these strict standards may find it an opportunity for market expansion.”
New thresholds
Under the new proposals, for which interested parties have until June 13 or June 29 to offer feedback, guidelines for the ‘zero standards’ have been put forward.
Two types of zero standards are currently being considered, one for agricultural products and another for finished products.
For the former, the Japanese government has proposed to limit agricultural products to 0.3% THC, which matches limits in other markets across Europe.
While this proposal is ‘reasonable’, as it aligns with numerous international markets, the limits on THC levels in finished products will be far stricter.
In the Preliminary Evaluation Report 2 of the regulation, the proposed zero standard for CBD oils will be 10mg/kg or 0.001% (10ppm), falling to 0.10mg/kg or 0.00001% (0.1ppm) for beverages, and 1mg/kg or 0.0001% (1ppm) for ‘others’, which includes foods.
According to the appendix of the proposals, these zero standards were reached by referencing European food safety standards, and estimating the amount a 50kg person would consume at one time.
Dr Masataka has questioned this methodology, and has suggested that another option would have been to directly reference the standards in other countries.
This means that Japan would have a limit some 1,000 times stricter than European or American markets, a guideline that could have significant consequences for the industry moving forward.
READ MORE: The Future of CBD in Japan: How Legal Reforms Will Shape the Market – Business of Cannabis
Furthermore, he points out that no standards have been set for raw materials, a contradiction likely to lead to confusion for businesses.
“From the rationale provided in the document, it is clear that the zero standards for products (oil, beverages, others) are designed to prevent any impact from a single intake. I am concerned that there are no specified standards for CBD raw material,” he explained.
“It is common for CBD crystals or concentrated oils to be imported for domestic production of CBD oil and cosmetics. As the zero standard is set as a ratio to total weight, the amount of THC in concentrated raw materials will be relatively higher even if it’s a very small amount.
“With no mention of raw materials, the implied zero standard for raw materials would be 1ppm, which is extremely strict. There is a clear contradiction in having a stricter zero standard for raw materials than for final products like oil, which have a 10ppm zero standard.”
Furthermore, he pointed out that these strict standards could be difficult for manufacturers to adhere to, and even more difficult for those tasked with testing products given the equipment needed to detect such small levels of THC, meaning costs could rise.
It would also make it likely that broad spectrum products would be forced out of the market, resulting in the ‘elimination of various minor cannabinoids’, raising concerns about ‘increased processes and costs being passed on to consumers’.
As standards have also not been set for pharmaceutical products, the bill could also render Epidyolex, one of the only cannabis medicines to be legalised in Japan, a narcotic substance.
Dr Masataka said: “Since off-label use of narcotics is not permitted, fewer than 1% of patients with refractory epilepsy would be prescribed it.”
Dr Yuji Masataka, MD, is a graduate of the Faculty of Medicine, Kumamoto University. After meeting medical cannabis specialist Dr Jeffrey Hergenrather in California in 2016, he decided to become Japan’s first specialist in medical cannabis. In 2017, while working in the Department of Neurology at Kumamoto University, he, as Representative Director, established the nonprofit organisation Green Zone Japan, which aims to raise awareness about medical cannabis. Currently, he also holds the position of Vice Chairman at the Japanese Society of Clinical Cannabinoid Research.
Dr Masataka also will act as a Key Opinion Leader for Astrasana Japan Co. Ltd., providing support to create a progressive and inclusive landscape in Japan, where CBD products are not only widely accepted but also celebrated for their potential health benefits and recognised as a valuable market opportunity.
