Safety

※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/JACA/en/key-players/)

【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

• 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.