June 2026

On 9 June 2026, the U.S. Food and Drug Administration issued a final administrative order (OTC000039) adding bemotrizinol to the list of permitted active ingredients under the over-the-counter sunscreen monograph. This marks the first new sunscreen active ingredient added to this monograph since the late 1990s, and the first new ingredient added to any over-the-counter monograph under the streamlined process established by the CARES Act. Already in widespread use in Europe and many other countries, bemotrizinol is designated generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children aged 6 months and older, at concentrations up to 6 percent.

Bemotrizinol (BEMT) is a chemical ultra violet (UV) filter that absorbs both UVA and UVB rays, and doesn't break down easily when exposed to sunlight, making it more effective at protecting against skin cancer and preventing wrinkles. BEMT has been used in Europe, Asia and Australia for over 20 years.

Sunscreen products in the United States are governed by the Food and Drug Administration’s (FDA's) over-the-counter (OTC) monograph framework, administered by the Center for Drug Evaluation and Research (CDER). Under this framework, sunscreen products may enter the market without a separate drug application, provided they comply with established monograph conditions — including approved active ingredients, permitted uses, and dosage limits. Prior to this action, no new sunscreen active ingredient had been added to the OTC sunscreen monograph since the late 1990s, leaving the U.S. market behind Europe and other global markets where newer sunscreen ingredients have long been available.

The FDA finalized its administrative order on 9 June 2026, following a structured regulatory review process.

1. Scope

The FDA final order designates BEMT as generally recognized as safe and effective (GRASE) for use in sunscreens.

GRASE Coverage: Applicable for adults and children 6 months of age and olderApproved Concentration: permitted at concentrations up to 6% in OTC sunscreen formulations.

2. Implementation and Resources

The final order will take effect from 9 August 2026.

Manufacturers may proceed to market sunscreen products containing BEMT without a new drug application, subject to full compliance with all applicable OTC monograph requirements. The FDA retains authority to further modify the OTC monograph through subsequent administrative orders.

02 June 2026 – The European Commission has officially published Commission Regulation (EU) 2026/1168, amending Annex XVII Entry 78 to the REACH Regulation (EC No 1907/2006). This update refines the existing restriction rules under Entry 78 concerning synthetic polymer microparticles (commonly known as microplastics) by expanding certain exemptions for medicinal products and research, while introducing tighter criteria for microparticles enclosed in solid matrices.

Synthetic polymer microparticles are widely used as substances on their own or in mixtures across a variety of industrial, commercial, and consumer applications. Following the initial implementation of the microplastics ban under Commission Regulation (EU) 2023/2055, certain legal ambiguities and unintended regulatory burdens were identified.

Commission Regulation (EU) 2026/1168 published on 02 June 2026, introduces targeted corrections to address these issues, harmonizing the scope of exemptions for specific sectors while ensuring that environmental emission controls remain robust. This effectively amends Annex XVII Entry 78 to the REACH Regulation (EC No 1907/2006) regarding synthetic polymer microparticles. Key updates include explicit alignments for pharmaceutical clinical trials, a newly dedicated exemption for small-scale research and development, and a strict time-bound threshold for solid matrix trapping.

Key changes of REACH Annex XVII entry 78 are summarized as below.

Manufacturers, laboratory personnel, and downstream users handling microplastics or developing formulations embedded in matrices should re-assess their supply chain compliance and documentation to align with these newly clarified thresholds.

On 19 May 2026, the Japanese Cabinet approved an amendment to the enforcement order of Japan's Chemical Substances Control Law (in Japanese), jointly announced by the Ministry of Economy, Trade and Industry, Ministry of Health, Labour and Welfare, and Ministry of the Environment. In alignment with resolutions from 12th Conference of the Parties of the Stockholm Convention (April – May 2025) to eliminate these substances globally, the amendment formally designates four groups of chemical substances as Class I Specified Chemical Substances: (i) Long-chain perfluorocarboxylic acids and their salts, (ii) Long-chain perfluorocarboxylic acids-related substances, (iii) chlorpyrifos, and (iv) Medium-Chain Chlorinated Paraffins.

Key regulatory consequences include manufacturing and import restrictions, product-specific import prohibitions, and mandatory technical handling standards for certain products.

The amendment will be promulgated on 22 May 2026 and enters into force on 22 November 2026.

The Japanese Cabinet approved an amendment to the enforcement order of Japan's Chemical Substances Control Law (in Japanese), which was jointly announced by the Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of the Environment (MOE) on 19 May 2026.

Background:

The amendment is rooted in decisions made at the 12th Conference of the Parties (COP12) to the Stockholm Convention on Persistent Organic Pollutants (April – May 2025), which resolved to globally eliminate Long-chain perfluorocarboxylic acids (LC-PFCA) and its salts, LC-PFCA-related substances, chlorpyrifos, and Medium-Chain Chlorinated Paraffins (MCCP).

Japan's Chemical Substances Council — a joint session of the Pharmaceutical Affairs and Food Sanitation Council's Chemical Safety Subcommittee and the Central Environment Council's Environmental Health Subcommittee — reviewed the four substance groups and concluded that they satisfy all statutory criteria for Class I Specified Chemical Substances under Article 2(2) of the Chemical Substances Control Law because of their: (a) persistence in the environment; (b) high bioaccumulation potential; and (c) long-term toxicity to humans or higher predatory animals.

Key Regulatory Changes:

(1) LC-PFCA and its salts, LC-PFCA-related substances, chlorpyrifos, and MCCP are formally designated as Class I Specified Chemical Substances. This classification imposes: Government authorization required for manufacture and import (prohibited in principle); restrictions on use; and import prohibition for government-designated products containing these substances.

(2) The following product categories cannot be imported into Japan when containing the specified substances:

• Lubricating oils and equivalent products when containing LC-PFCA and its salts,

• LC-PFCA-related substances,

• MCCP;

• Wood insecticides when containing chlorpyrifos.

(3) On a provisional basis, fire extinguishers, fire extinguisher agents, and foam fire extinguishing agents, when containing LC-PFCA and its salts or LC-PFCA-related substances, must comply with government-prescribed technical standards for handling.

Transitional Measures:

Appropriate transitional measures and supplementary provisions have been incorporated to allow for a structured compliance transition.

Implementation Schedule:

Promulgation Date: 22 May 2026

Enforcement Date for Items (1)–(3): 22 November 2026 (six months after promulgation)

On 28 May 2026, China's Ministry of Industry and Information Technology (MIIT) published Announcement No. 11 of 2026, releasing the Compliance Management Catalogue for Restricted Use of Hazardous Substances in Electrical and Electronic Products (2026 Edition) ("the Catalogue") and the Exemption List (2026 Edition) ("the Exemption List"). The Catalogue establishes mandatory content requirements for 10 hazardous substances across 33 electrical and electronic product categories, superseding the previous 2018 edition (MIIT Announcement No. 15 of 2018). Compliance deadlines are phased: 10 product categories must comply from 28 May 2026, with the remaining 23 categories required to comply by 1 August 2027. Products qualifying under the Exemption List may follow alternative, application-specific substance limits in lieu of general requirements.

The China's Ministry of Industry and Information Technology (MIIT), together with seven co-issuing government bodies, published Announcement No. 11 of 2026 on 28 May 2026, releasing the Compliance Management Catalogue for Restricted Use of Hazardous Substances in Electrical and Electronic Products (2026 Edition) ("the Catalogue"). The intent of this published announcement is to strengthen the reduction and substitution of hazardous substances in electrical and electronic products at the source. This supersedes the previous 2018 edition (Announcement No. 15 of 2018). Announcement No. 11 of 2026 was issued pursuant to China's Ecological Environment Code (《生态环境法典》) and the Management Measures for Restricted Use of Hazardous Substances in Electrical and Electronic Products.

1. Implementation Timeline (Annex 1)

Note: Products listed above, if used as components of products not covered by this catalogue, fall outside the scope of implementation of China RoHS. However, if such products are sold separately on the market without a specified end use, they shall fall within the scope of the implementation of China RoHS.

2. Exemption List

The Exemption List (Annex 2) permits certain restricted substance applications subject to specified limits.

Note: Products qualifying under the Exemption List may follow alternative, application-specific substance limits in lieu of general requirements.

3. Requirements and Test Methods:

• Requirements

Mandatory National Standard: GB 26572–2025 – Requirements for Restricted Use of Hazardous Substances in Electrical and Electronic Products, which includes four phthalates (DEHP, BBP, DBP, and DIBP), will be implemented on 1 August 2027, and will supersede current voluntary standard of GB/T 26572–2011, Limits of restricted substances in electrical and electronic products, on the same date.

Products manufactured or imported before 1 August 2027, may continue to be sold and used. Starting from the 13th month after the implementation of GB 26572–2025, all manufactured or imported products must comply with the new requirements of GB 26572–2025.

• Testing methods

GB/T 39560 series: Determination of certain substances in electrical and electronic products, which is fully aligned with IEC 62321 series: Determination of certain substances in electrotechnical products, with the objective to utilize the best common practices for testing electrical and electronic equipment.

Cabinet Office Notification No. 95 of May 2025 introduced a revision to the Specifications and Standards for Foods, Additives, etc. (MHLW Notification No. 370 of 1959) established under the Food Sanitation Act (Act No. 233 of 1947, commonly called the Japan Food Sanitation Law, JFSL).

On 30 May 2025, Japan issued Cabinet Office Notification No. 95, an amendment to the Ministry of Health, Labor and Welfare (MHLW) Notification No 370 of 1959, the Specifications and Standards for Foods, Additives, etc. This was established under the Food Sanitation Act (Act No. 233 of 1947). This Act is commonly referred to as the “Japan Food Sanitation Law (JFSL).

The enacted revisions mainly concern the following under specified clauses to Section 3 ‘Apparatus and Containers/Packaging’ under MHLW Notification No. 370 of 1959:

1. Under Clause B:

• Test methods have been removed or revised; related reagents and chemicals required in Clause C have been updated accordingly

• Simulants used in migration were added:

2. Under Clause D:

• For general specifications of synthetic resin utensils, containers and packaging, the requirements of Potassium permanganate consumption were removed, but overall migration was added

• Potassium permanganate consumption is listed as a specific requirement of regulated plastics

The revised requirements come into force on 1 June 2026. A transitional grace period applies until 1 June 2027; during this period, food‑contact utensils, containers, and packaging that have been sold, manufactured, or imported for sale or business use may still meet the earlier standards.