Interpreting Japan＇s New Food Contact Materials Regulations: The Positive List System and the Future Development of the Food Contact Paper Market

Interpreting Japan's New Food Contact Materials Regulations: The Positive List System and the Future Development of the Food Contact Paper Market

On June 1, 2025, Japan will officially implement the "Positive List" system (PL) for Food Contact Materials (FCM), marking a significant policy reform in the country’s food safety sector. This new regulation requires that all substances used in food contact materials must undergo safety evaluations and be included in an official approved list. It also raises the safety standards for food contact materials, bringing far-reaching effects on manufacturers, suppliers, and the food industry.

Core Aspects of the New Regulation

Starting from June 1, 2025, Japan will fully implement the Positive List system for food contact materials (FCM), marking a significant step in enhancing food safety and regulatory compliance. This new system mandates that all new substances used in food contact materials must undergo a comprehensive evaluation process to ensure they meet safety standards. If a substance is not included in the Positive List, manufacturers must submit an application to the relevant authorities and obtain approval before the substance can be used in food contact materials. This process is designed to ensure that only substances deemed safe for human health are used in products that come into contact with food.

The evaluation process involves several key components. First, all new substances must undergo a safety evaluation that includes tests of their chemical properties, intended use, and potential migration into food. The safety evaluation will assess whether the substance poses any risks to human health when used as intended. Only those substances that are proven to be harmless to human health will be approved for use in food contact materials. This rigorous safety assessment will help protect consumers from potential hazards associated with food packaging and other food contact products.

In addition to the safety evaluation, the new regulation also requires migration testing. Migration testing ensures that chemicals from food contact materials do not migrate into the food at levels that could pose a health risk. All materials will be tested for their migration potential, and substances that exceed the prescribed migration limits will be prohibited from use. This is a crucial step in ensuring that food products remain free from harmful chemical contamination during packaging, storage, and transportation.

The Positive List system will be regularly updated to include new substances that pass the safety evaluation. As scientific knowledge evolves and new substances are tested, they will be added to the list, ensuring that the regulations remain relevant and up-to-date. However, if new safety data reveals that an already-approved substance poses a risk to human health, its approval for use will be revoked. This dynamic and ongoing evaluation process ensures that food contact materials remain safe as new materials and research emerge.

By implementing the Positive List system, Japan aims to further enhance food safety, align with international regulatory standards, and build consumer trust in the safety of food contact materials. This policy will also encourage innovation in the development of new, safer materials for food packaging, as manufacturers will need to ensure compliance with these rigorous standards. The new system represents a significant shift toward a more proactive and transparent approach to food safety, safeguarding both public health and the integrity of food products.

Food Contact Paper Market Size

Food contact paper, as a common food contact material, is widely used in food packaging, tableware, and placemats. As consumers' concerns about environmental protection and sustainability grow, the demand for food contact paper continues to rise. According to WENKH survey data, the global food contact paper market has been showing an upward trend in recent years. It is expected that by 2032, the global food contact paper market will exceed $25 billion, growing at an annual rate of about 6%.

Japan, as one of the world's important consumer markets, is also seeing increasing demand for food contact paper. With consumers becoming more aware of health, environmental protection, and food safety issues, the application of food contact paper in food packaging has become especially widespread. According to domestic data in Japan, the market size for food contact paper has already reached billions of yen, and this figure is expected to continue growing in the coming years. Food contact paper is not only used in fast food and convenience store food packaging but also widely applied in ready-to-eat foods and takeaway industries, driving market expansion.

Additionally, food contact paper manufacturers have started to focus more on the environmental and sustainability aspects of their materials, launching more products that meet international certifications. Environmentally friendly paper and biodegradable materials have gradually become the mainstream in the market, further driving the upgrade and innovation of the food contact paper industry.

Background and Purpose of the "Positive List" System

Japan has been managing food contact materials since 1962, but the original "Negative List" system only listed substances that were explicitly prohibited. This management approach had certain limitations, especially when facing new materials and technologies, resulting in regulatory lag and ambiguity.

In June 2020, with the revision of the Food Contact Materials Management Law, the new "Positive List" system began to be gradually implemented. Unlike the Negative List, the Positive List clearly lists substances that are allowed for use and requires all new materials to undergo safety evaluations before being approved for use in food contact materials. The primary goal of this system is to enhance the safety of food contact materials, protect public health, and strengthen alignment with international regulatory systems, thereby boosting the global competitiveness of Japan’s food industry.

Impact on the Industry

This new regulation has had a profound impact on the food contact materials industry, especially on manufacturers and suppliers. Implementing the Positive List system requires adjustments in several areas:

• Stricter Material Safety Evaluation Requirements: Manufacturers must ensure that all substances used in their products comply with safety standards and undergo safety testing within the legal framework. For businesses, this means investing more resources in research and development to ensure that their materials meet the new regulatory requirements.
• Complex Application and Review Process: The new regulation requires that all new substances must be approved before use, which involves a cumbersome and time-consuming process. This could result in delays for businesses when launching new products. Therefore, manufacturers need to plan ahead and ensure that all new materials are approved before use.
• Internationalization Challenges and Opportunities: Since Japan’s food contact material standards align with those of other regions, such as Europe and the United States, businesses must ensure that their products comply with regulations in other countries while meeting Japan’s standards. This poses a challenge for multinational companies but also provides an opportunity to enhance their competitiveness in international markets.
• Increased Industry Transparency: The Positive List system will publicly and transparently list all substances that meet the standards, which increases the trust of both the industry and consumers in the safety of food contact materials. Consumers will be more confident in using compliant products, and companies will gain higher credibility in the market.

Challenges in Implementing the Positive List System

Although the Positive List system has many advantages, there are some challenges in its implementation, especially for small and medium-sized enterprises:

• Technical and Financial Pressure: Conducting safety evaluations for new substances requires specialized technical support and significant financial investment. Smaller companies may face considerable pressure in this regard, particularly when conducting migration tests and other experimental tests, which can be costly.
• Adaptation to the Transition Period: Although the Japanese government has provided a transition period for the industry, some companies may still struggle to complete the compliance adjustments in a short time. Particularly when upgrading or replacing existing products and materials, businesses may need more time to adapt to the new regulations.
• Efficiency of the Administrative Approval Process: The new regulations require all new substances to undergo a strict approval process, which may slow down the approval speed and affect production cycles. Improving the approval efficiency and ensuring that companies can obtain approvals in a timely manner is an urgent issue.

Future Development of the Policy

As global food safety standards continue to rise and consumers' attention to food safety grows, the Positive List system not only represents an important update to Japan’s food contact material regulations but also signals a trend toward more stringent management of food contact materials globally. In the future, with technological advancements and increased international cooperation, Japan may push for more food safety standards worldwide, aligning more closely with international markets.

Additionally, as demand for new materials, such as nanomaterials and biodegradable materials, grows, how to promote the safe application of innovative materials while ensuring food safety will become a key issue in the future management of food contact materials.

Overall, Japan's new food contact materials regulations represent a modernization and internationalization of food safety regulations. The implementation of this system not only strengthens food safety management but also provides new standards and directions for global compliance and innovation in the food contact materials industry. For businesses, adapting early and ensuring necessary compliance preparations will help them gain a competitive edge in the future.

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