Japan: New food regulations to enter into force in coming months
A number of regulatory changes are coming to Japan in 2025, all geared towards enhancing consumer health and transparency. Key updates include the evolution of the Foods with Function Claims system, stricter compliance and clarity in nutrition claims and nutrient labelling, and the finalisation of the Food Contact Materials Positive List. These changes promise to elevate the standards of health and safety in the food industry, ensuring that consumers can trust the products they enjoy.
Pre-market approval of foods with function claims
Japan has been a dynamic and innovative market for food supplements, driven by consumer health preferences and rapid market growth. However, ten years since the self-substantiated functional food notification system was established, the Japanese government is updating the rules to enhance compliance and transparency, thus aiming to improve consumer protection and trust.
The Foods with Function Claims (FFC) system, launched on April 1, 2015, allows businesses to label products with health benefits based on scientific evidence without government approval. It aims to improve public health by providing reliable information about functional foods whilst still encouraging innovation among manufacturers. Over 3,000 functional foods have been notified so far.
However, the “beni koji” red yeast rice case highlighted concerns about system transparency and compliance. The contaminated supplement caused severe health issues, including kidney problems and deaths.
In response to this case, the Consumer Affairs Agency revised the FFC system, with the amended Food Labelling Standards officially published on August 23, 2024, to enhance product safety and consumer health. Several significant changes will come into effect starting from April 1, 2025:
- Extended notification period: The pre-market notification period for supplement products containing novel ingredients has been extended to 120 days from the previous 60 days to allow time for a more thorough review process.
- Improvement of scientific evidence quality: FFC manufacturers must now follow PRISMA 2020 guidelines, replacing PRISMA 2009. PRISMA 2020 highlights inclusivity, transparency, detailed reporting, and adaptability to new technologies for clearer, more comprehensive reporting in systematic reviews and meta-analyses.
- GMP standards compliance: Starting September 2024, FFC supplements must meet GMP standards to ensure product consistency and address contamination and mislabelling issues. Notifiers must conduct self-inspections and set up necessary systems. The CAA will perform on-site inspections. Although GMP certification is optional, non-compliance may result in hefty fines, possibly millions of yen.
- Additional warnings: By September 1, 2026, FFC products must comply with specific labelling requirements. These include warnings about the risks of overdose and potential interactions with pharmaceuticals. Furthermore, a statement must be included indicating that the product is not intended for prevention or treatment purposes.
Update on nutrition claims conditions and nutrient labelling
The Japanese Dietary Intake Standards for 2025 have introduced new Recommended Dietary Allowances (RDAs), prompting changes to the conditions for making nutrition claims and mandating the labelling of nutrients.
For instance, calcium’s RDA increased by 20 mg, while sodium’s RDA decreased by 0.2 g, affecting the criteria for “high in calcium” and “low in sodium”. Additionally, nutrients such as vitamins and minerals, which were historically exempt from ingredient listings, will now be mandated to be listed on label to enhance consumer awareness.
Manufacturers have three years to meet new claim conditions and five years to update fortified food product labels.
Food Contact Materials (FCM) Positive List (PL)
This final version of the PL system for plastic will come into effect on June 1, 2025, following the end of the one and half year transitional period. Companies have two months left to fully comply with the new regulations.
On June 1, 2025, 13 new substances will be added to the Positive List. Additionally, a couple of final adjustments have been made to the regulation.
Keeping confidentiality of newly developed substances: The confidentiality of newly developed substances is safeguarded by the Consumer Affairs Agency, which refrains from amending the publicly available positive list. The Agency ensures that sensitive information regarding these substances remains protected while still offering essential details for compliance and safety assessments.
Prohibition of Class I Specified Chemical Substances: Class I Specified Chemical Substances, as defined by the Act on the Regulation of Manufacture and Evaluation of Chemical Substances, are identified due to their persistence, high accumulation, and long-term or chronic toxicity to higher predators. These substances are listed as prohibited substances in the FCM regulation.
How Leatherhead can help
For in-depth support on Japanese regulations and upcoming regulations in other markets, please get in touch at [email protected]. Leatherhead’s experienced team of scientists and regulatory experts can support you every step of the way.
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