Q: Is there any progress in the regulatory discussions within MHLW?
A: There aren’t any official comments from MHLW about how to deal with the safety of cultivated food. However, I can at least share three news items regarding the progress.
(1) On 15 December 2023, a study group under the MHLW, officially called the Newly Developed Food Committee of the Food Sanitation Council, established under the Pharmaceutical Affairs and Food Sanitation Council, shared the experts' comments during the study sessions. This group will be transferred to CAA the following April. One of the largest consumer organizations’ comments on the discussions regarding cellular agriculture was also shared as reference material.
Important points of expert opinions exchanged at the meeting
※Matters below should not be seen as the official and final judgments from MHLW but are just a summary of expert comments invited to the study group. Their opinions can be updated by the proper information sharing from the industry, which JACA is trying to proceed with through a project called “PJ Safety.” (see Q&A part 3 of this article or “Selected activities of JACA to encourage the Japanese Government to build consensus on how to face the Cellular Agriculture Industry ― PJ Safety.” https://www.jaca.jp/about-jaca)
【Concerns raised during the meeting related to safety】
● Primary cell-based vs cell-line-based
▶️ They are considering differentiating the interpretation of having consumption history by the cell type (Primary cells, cell lines, etc.). They were also interested in the difference in epigenetic changes that occur by the cell type
▶️ Some say that the quality of cell lines is more stable – i.e. using cell lines is advantageous in terms of quality control. On the other hand, the following questions need to be addressed. For example, whether the cell line may secrete an unexpected bioactive substance, whether the cell line is judged to be a tumor cell, and if so, what the effect on the person who ate it. During the meeting, the comments on the FOOD SAFETY ASPECTS OF CELL-BASED FOOD published by FAO were also referred to
● Whether the culture process is considered to be within the scope of the Food Sanitation Law
● How to handle the safety of using genetically modified growth factors
● How to handle the safety of foods derived from genetically modified cells
● Confirmation of non-persistence of substances in culture
● The risk of contamination with virulence factors (Bacteria, viruses, prions, etc.)
● Possibility of risk assessment in combination with distribution and cooking type
● Examination of the necessity of animal safety studies
【Other concerns raised during the meeting】
● The need of discussion on import, food labeling, etc.
● Importance of consideration in cooperation with relevant ministries and agencies
● The need of proper explanations to consumers
● The urgency of taking the initiative to participate in international discussions
Summarized opinions submitted by the Japanese Consumers' Co-operative Union (JCCU)
● Ensure transparency about the technical and safety information
● Cooperate and clarify the division of roles among relevant ministries and agencies
● Careful arrangement of terms and definitions is essential for understanding consumers, not only about the nomenclature of the food itself but also about critical terms to express the manufacturing process, ingredients, etc.
● It would be easier to understand cultivated food based on the similarities and differences with existing foods, and whether the differences relate only to the manufacturing process or both the manufacturing process and the final product
● Typical areas of safety concerns need to be shared in public and discussed. The safety of different parts of each product needs to be examined on a case-by-case basis
● Some points of attention for manufacturing control were also raised in the comment
● Appropriate consideration should be given to product labeling rules from the viewpoint of ensuring consumers' choices based on transparency
● It is also necessary to provide consumers with information on the background and purpose of cell culture food development and research and how it would affect the consumer's day-to-day life.
*The author briefly translated and summarized the official material linked below. This article may contain potential mistranslation. Please check https://www.mhlw.go.jp/stf/newpage_36807.html for official information.
(2) The progress report for the first year of the 3-year research funded by MHLW is now available. From the report, we could understand the status of the discussion among the experts serving MHLW, though all the information is in Japanese. The research is called “Research on Food Hygiene Hazards and Risks by Pioneering Investigation of Cell Cultured Food Using Foodtech ― Development of Risk Profiles and Validation and Reduction using Model Cell Experimental Systems.” The report is also one of the reference materials used in the expert discussions mentioned in (1).
(3) On 11th December 2023, with the help of Mr. Norihiro Nakayama, The Executive Director of Japan’s Parliamentary Group for Cellular Agriculture, JACA succeeded in holding an opinion exchange session with relevant ministries. During the session, JACA member companies were able to share with the government the hurdles that the industry is having now. It was a remarkable opportunity for the ministries to understand other ministries’ state of discussion. Although the opinions exchanged among the attendees are confidential, JACA emphasized during the event that we would like the relevant ministries and agencies to accelerate the examination and establish a consultation system that allows companies to share their ideas on safety, including trade secrets, and get some form of endorsement from the government about the “safety” before selling it in the market. In addition, JACA requested ministries that information be continuously shared among ministries and agencies so that the steps taken after discussions on safety proceed smoothly.