Last week, Japan officially launched a public consultation period for a Bill to regulate the emerging cannabis and CBD industry in the country. After passing the legislation in November 2023, the Japanese government has just published detailed proposals on the limits it intends to set for finished CBD products and hemp growers.
The proposals suggest that CBD will be approved for use in food, with strict limits on the amount of THC allowed, which means that the market is likely to be dominated by isolated products.
According to Dr. Yuji Masataka, the leading medical cannabis specialist in Japan, these strict thresholds “will make parallel imports of products difficult, which could keep the prices of CBD products high”, but could benefit the analysis of cannabis.
“Cannabis products are characterized by their diversity. The stricter standards of THC will homogenize the products, leading to the loss of the entourage effect.
“It is not certain that users who seek to preserve their health will continue to enjoy the same advantages after the revision of the law. On the other hand, companies that can meet these strict standards can find an opportunity to the expansion of the market”.
New thresholds
As part of the new proposals, for which interested parties have until June 13 or 29 to provide comments, the guidelines for “standard zero” have been presented. Two types of zero standards are currently considered, one for agricultural products and the other for finished products.
For the first, the Japanese government proposed limit agricultural products to 0.3% THCwhich corresponds to the limits established in other European markets.
If this proposal is “reasonable”, since it aligns with many international markets, the limits of THC levels in finished products will be much tighter.
In the preliminary assessment report 2 of the regulation, the proposed zero standard for CBD oils will be 10mg/kg or 0.001% (10ppm), increasing to 0.10mg/kg or 0.00001% (0.1ppm) for beverages, and to 1mg/kg or 0.0001% (1ppm) for “others”, which includes foods.
According to the annex of the proposals, these zero standards were obtained referring to the European standards of food safety and estimate the amount that a person of 50 kg would consume in one sitting.
Dr. Masataka questioned this methodology and suggested that another option would be to refer directly to standards in other countries.
This means that Japan would have a limit 1,000 times stricter than the European or American markets, a directive that could have significant consequences for the industry in the future.
In addition, he points out that no standard has been established for the raw material, a contradiction that risks causing confusion in companies.
“From the logic provided in the document, it is clear that the zero standards for products (oil, drinks, others) are designed to avoid any impact from a single catch. I am concerned that there are no specific standards for CBD raw materials “, he explained.
“It is common that CBD crystals or concentrated oils are imported for the domestic production of CBD oil and cosmetics. Since the zero standard is set as a ratio to the total weight, the amount of THC in concentrated raw materials will be relatively higher, even if it’s a very small amount.”
“Without mention of raw materials, the implicit zero standard for raw materials would be 1 ppm, which is extremely strict. There is an obvious contradiction in having a stricter zero standard for raw materials than for final products such as oil, which have a zero standard of 10 ppm”.
In addition, he said that these strict standards could be difficult for manufacturers to meet, and even more so for those responsible for testing the products, given the equipment needed to detect such low levels of THC, which means that costs could increase.
It is also likely that broad-spectrum products will be squeezed out of the market, resulting in “the elimination of various minor cannabinoids”, raising concerns about “increased processes and costs passed on to consumers”.
Since no standards have been established for pharmaceutical products, the project could still do soEpidyolexone of the only ones cannabis medicines to be legalized in Japan, a narcotic substance.
Dr. Masataka said, “Like using narcotics off-label It is not authorized, less than 1% of patients suffering from refractory epilepsy will be prescribed this medication.