Japan’s Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade, and Industry (METI), and the Ministry of the Environment have concluded a public consultation on new regulations under the Chemical Substances Control Law. The updated regulations address the use of specific hazardous chemicals, including perfluoroalkyl and polyfluoroalkyl substances (PFAS), to meet international environmental and public health standards.
New Chemical Regulations Target Persistent Organic Pollutants
The updated regulatory framework, based on Japan’s Chemical Substances Control Law, specifies the addition of several first-class substances known for their persistence in the environment, bioaccumulative properties, and long-term toxicity risks. Among these, perfluorooctanoic acid (PFOA) and its related compounds, recognised globally as persistent organic pollutants (POPs), will now be restricted. These compounds are particularly concerning for their resistance to natural degradation and potential to cause environmental damage. Japan will thus add PFOA and related chemicals to its list of restricted substances, effectively prohibiting their manufacture, import, and use, with only limited and regulated exceptions.
Detailed List of Regulated Substances
The new ordinance regulates a range of PFAS compounds, including those with heptadecafluorodecyl and pentadecafluorooctanyl structures, which degrade into PFOA in natural settings. Specific regulated chemicals include heptadecafluorodecanesulfonic acid, pentadecafluorooctanoate, and their corresponding salts (such as ammonium, lithium, and sodium salts). The regulation further encompasses various polyfluoroalkyl compounds that can produce PFOA-related derivatives, such as specific phosphonic and sulfonic acid derivatives that are environmentally persistent and pose bioaccumulation risks in both human and wildlife populations.
Compliance and Reporting Obligations
Under the revised ordinance, companies that manufacture or import these substances must implement precise monitoring and reporting measures. This includes the development of quantifiable detection methods for these chemicals, even when present as unintended by-products in products. Companies must establish self-imposed thresholds and report these results on an annual basis. Should the concentrations exceed specified limits, businesses are required to submit plans to reduce these chemical levels, thus mitigating environmental exposure risks.
For imported goods containing regulated substances, companies must disclose the presence of these chemicals, even if they are residual or unintentional. Best-available technology (BAT) reporting is mandated for cases where such chemicals are not intentionally added. In situations where suitable analytical standards or testing methods are lacking, companies are urged to work with international testing agencies to develop appropriate detection protocols.
Industry Concerns and Government’s Response
Several industries, including electronics, motor production, and industrial coatings, expressed concerns during the consultation about the complexities of replacing PFAS compounds. These substances are used extensively in products such as insulation, lubricants, coatings, and seals, with alternatives often not readily available. Respondents noted that transitioning from PFAS could take five to ten years, especially within intricate global supply chains.
The Japanese government acknowledged these challenges, allowing limited exemptions for essential uses where viable substitutes cannot yet be secured and where risks to the environment remain minimal. However, the government clarified that products containing these substances and designed for direct environmental release are still subject to strict import restrictions, with serious penalties for non-compliance.
Implementation Timeline and Environmental Impact
Effective from 10 January 2025, this ordinance aligns Japan’s chemical management framework with global standards, aiming to reduce hazardous chemical exposure within ecosystems. The timeline provides industries with a transition period to adapt processes, secure alternative substances, and meet Japan’s stringent environmental standards.
This regulation is part of Japan’s broader commitment to reducing pollution from persistent organic pollutants and to ensuring environmental sustainability in alignment with international protocols.
