New Regulations in Japan – What it means and how to stay Compliant

The Japanese Government has again blessed us with new regulations on the CBD and Cannabinoid industry. Their regulations are not clear when it comes to which product is considered what category, but we do know that their THC limits have diminished. Now the question is this 10 PPM D9 THC + 0.877 D9 THCA or is it 1 PPM? We will investigate further and give some insider information from what our clients heard directly from Japan’s Ministry of Health, Labour and Welfare.

Understanding the Laws

As previously stated, the laws are not clear on which products fall into which categories. But we do have some strong evidence that persuaded us and our clients that some raw materials may fall into one of the below sections.

10 PPM Fats and Oils

This section defines the product as any material that has Fats or Oils within its composition. The tricky part is what do they define as a Fat or Oil? Well, technically speaking distillates are oils. If we take it quite literally then we could say that all Distillates fall into this section. Unfortunately, we have not received information on the legal side of things when it comes to this definition. We have received word that having a COA that is tested down to 10 PPM on D9 THC and D9 THCA with the accompanying paperwork showing that some form of FAT OR OIL is in the mixture would be acceptable.

Voluntate-Catalog-In-Japan-7

1PPM Laws and Products

Coming Soon.

0.1 PPM Laws and Products

Coming Soon

Safe Material Storage

One of the most overlooked aspects of being in this industry is how to store your raw materials. There are a few important factors to keep in mind and listed below.

Temperature and Oxygen

Temperature can directly impact the stability of most cannabinoids. When given time, warmer conditions, and oxygen; CBN can degrade into a quinone known as Cannabinol Quinone or HU-345.

Similarly, CBD can be significantly impacted. According to a study by Ema Kosovic, David Sykora, and Martin Kuchar from Switzerland (click here to see the study) they tested CBD oil and CBD isolate under different conditions. They mention that CBD can degrade first into D9 THC then into CBN. In their test they added different variables to see how each impacted the degradation process. Here are a few charts from their experiment:

Source

Source

This was their take on the results:

The main conclusion that may be derived is that the exposure to light alone for the given time period does not lead to significant changes in the CBD content, but in combination with other factors, such as the solvent used, increased temperature, and presence of oxygen, light may accelerate the degradation process.

Prolonged Moisture and Light

While we learned that Light has less impact, we are captivated by the fact that light exposure in combination of other variables such as oxygen, time, temp etc have increased results. We can conclude that keeping your materials in a dry, dark and cool place is the most ideal way to store any cannabinoid.

Safe Material Use & Mitigate Risk of Conversions

Warming and Cooling

While normally not an issue to heat basic cannabinoids, it is imperative that all firms within Japan take a great deal of care due to the low threshold for THC. This means keeping the jars and containers under Argon or Nitrogen and keeping the heat as low as possible to use the product. Further, the cannabinoids should not be heated for long periods of time.

The study “Effect of temperature in the degradation of cannabinoids: From a brief residence in the gas chromatography inlet port to a longer period in thermal treatments” explains and shows data based on certain criteria of heating CBD. We know that the only way to work with CBD is to heat it up, but consider lowering your temperature. The study shows:

Additionally, considering the degradation rate as a way of comparison with the initial concentration of CBD, the amount of this cannabinoid remains nearly constant after 2 min of thermal treatment. However, after 60 min, the degradation of CBD is over 80% (Figure 3B). This last point must be taken under consideration when cannabinoids are thermally processed in the pharmaceutical or food industry.

While the study focuses on high temperature handling, it is important to remember that the new Japanese law has a VERY low threshold for THC. The next figure does show higher temperature readings but we can see there is already a sizeable degradation starting at 250c. As a result of heating we generate D9 THC and CBN.

Source: https://www.frontiersin.org/files/Articles/1038729/fchem-10-1038729-HTML-r1/image_m/fchem-10-1038729-g001.jpg

Short-Term Moisture, Oxygen, and Light

Moisture, Oxygen, and Light can further cause unwanted conversions and changes to your cannabinoids. Keeping all materials under Argon or Nitrogen will help mitigate the oxygen problem, but make sure you are mixing in a climate controlled environment to keep moisture as low as possible. Light is okay as long as its not excessive.

Stable vs Unstable Cannabinoids – Not Clear

While Stable cannabinoids are less likely to convert, it is very possible to have minor unintended conversions. Following the guidelines above for all cannabinoids will give you the best chance at preserving the state of your cannabinoids. Unstable Cannabinoids should be a concern as they can easily change over. These include any Acidic cannabinoids and Acetates. They both can convert back to their base cannabinoid which is fine if that base cannabinoid is legal. Hedge your bets and stay safe.

The Risks of the Cheapest Options

COA Manipulation or False Representation

This occurrence is far to prevalent in todays market. There are a lot of distributors and brokers that will give you a Third Party Lab Test (Certificate of Analysis) that states inflated numbers, redacted data, or was tested in a different batch. These small discrepancies have caused massive issues for firms in Japan. From monetary loss of purchase due to retest proving its very different product or non-compliant to some Japanese Business Owners getting arrested.

Here is how you can find the most accurate information and help mitigate your risk.

  1. Cheapest Option may not be the best option. Yes it is great to find the best deal, but when there is more at stake then just cost, it would be wise to vet your potential supplier further.
  2. Check the dates on the lab test. Ask them for newer tests if the current one is older than 6 months.
  3. Ask to compare batch testing for quality assurance. With this information you can quickly figure out if this one company is only testing once through multiple batches or if they indeed have a history of compliance testing. See archived COA’s can help you understand the level of quality they can produce.
  4. Perfect COA’s Do Exist, but the numbers should change slightly. A perfect COA doesn’t mean 100% reporting cannabinoids. It means it checks all the boxes of Legality / Compliance, Potency expectable levels, No residual solvents, No Heavy Metals, No Microbials.
  5. Ask around to your colleagues in the industry. Does this company have a good reputation?
  6. Retest their materials. A quick disclaimer: All tests will be slightly different. Different labs or even same labs will not give the exact same results. What you are looking for is compliance and to make sure the potency is very close to the original COA. Also, be aware of false positives. While most 3rd Party Testing facilities do a great job, it is possible to get a contamination of the sample. Most reputable labs will retest to make sure.
Repeatable Process of Manufacturing

Repeatable Process of Manufacturing means does your supplier have a process they can repeat and get the same results every time. History of good product is key to differentiating and protecting your Japanese business. Bona Voluntate has a history of delivering compliant materials with good testing. We work openly and honestly to make sure the final decision is your best decision. We welcome visits and we are open to meetings at any time. Without our clients, we would not exist.

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About Author

Jon Bona

Jon Bona

Jon Bona has been serving as the Director of Operations at Bona Voluntate since 2021. With a strong commitment to advancing the cannabis industry, Jon specializes in developing and promoting high-quality cannabis-derived products and extracts.

Jon’s career in the cannabis sector began over a decade ago, where he focused on optimizing operations and ensuring sustainable practices. His expertise has been crucial in educating consumers about the benefits of cannabis, and he is dedicated to providing safe, effective, and reliable products.

In addition to his role at Bona Voluntate, Jon is actively engaged in the cannabis community. He regularly contributes articles on the latest research, trends, and practical tips for consumers. His insights are a blend of professional experience and a genuine passion for the industry.

For more information, visit Bona Voluntate and Voluntate Shop.

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