This issue covers the EU’s upcoming microplastics reporting deadline, South Korea’s proposed crackdown on IP-infringing cosmetics, Taiwan’s updated novel food guidelines, and China’s increasing overseas inspections of medical device manufacturers – alongside other key developments shaping global regulatory compliance.
⭐Editor’s picks – key regulatory developments
EU Microplastics Reporting Deadline Approaching: Relevant Enterprises Should Initiate Filing Without Delay
ECHA has issued detailed guidance on annual reporting obligations for synthetic polymer microparticles under the REACH microplastics restriction, with the first filing deadline set for May 31, 2026. The guidance outlines who must report, what data must be submitted, how emissions may be estimated, and how filings should be made through IUCLID and REACH-IT. Companies in plastics, pharmaceuticals, food additives, and in vitro diagnostics should start gathering data now and mapping reporting responsibilities across legal entities and uses.➡️Read more
South Korea Proposes Ban on IP-Infringing Cosmetics Alongside New Export Support
South Korea has proposed amendments to its Cosmetics Act to strengthen enforcement against IP-infringing cosmetics and introduce an export support mechanism. The proposal includes a clear prohibition on the sale of products infringing trademark, patent, or design rights, along with expanded enforcement powers for authorities. It also aims to support domestic companies facing IP disputes in overseas markets. The amendment reflects growing regulatory focus on brand protection, market order, and international competitiveness. ➡️Read more
Regulatory Compliance for Novel Food Ingredients in Taiwan: Definitions, Documentation, and Approval Process
Taiwan’s Guidelines for Safety Assessment of Novel Food Ingredients, released January 27, 2026, define novel food ingredients, outline required submission materials, and explain the TFDA review process, including additional documentation for ingredients produced using genetically modified microorganisms. The guidelines give food businesses a clearer regulatory roadmap, highlight when toxicology and 90-day feeding studies may be needed, and help applicants better assess compliance expectations before entering the Taiwan market. ➡️Read more
China's NMPA Overseas Inspection Escalation: Compliance of Overseas Medical Device Enterprises Cannot Be Delayed
China’s NMPA is stepping up overseas inspections of imported medical device manufacturers in 2026, with 33 overseas companies already included in the annual inspection plan. The trend points to more normalized and comprehensive oversight, with inspections expected to focus on data integrity, lifecycle traceability, risk management, and contract manufacturing controls under the revised 2025 GMP rules. Overseas manufacturers should strengthen quality systems, prepare complete inspection records, and address compliance gaps early to reduce market access risk in China.➡️Read more
🔎What’s covered in this issue – at a glance
💻Free webinars
Navigating the New Era of China REACH (Webinar Series)
🧪Chemical news
- China Expands Hazardous Chemicals Inventory with Five New Additions
- US EPA EPA Grants Third Extension for PFAS Reporting, Compliance Now Starts 2027
- New Requirements for MSDS Compilation in South Korea – Are You Aware?
- New Standard for Vehicles Carrying Dangerous Goods in China – To Be Implemented Soon!
- EU Amends REACH Regulation Annex XVII, Imposing Strict Restrictions on Carcinogen 2,4-Dinitrotoluene
- EU Microplastics Reporting Deadline Approaching: Relevant Enterprises Should Initiate Filing Without Delay
- US EPA Releases List of Expiring TSCA Confidential Business Information Claims
💄Cosmetic news
- South Korea Proposes Ban on IP-Infringing Cosmetics Alongside New Export Support
- China IECIC Update: Ingredient Name Changes and International Discrepancies to Note
- Six Technical Guidelines Published for Hair Dye, Perm, and Sunscreen Cosmetics in China
- SCCS Issued Final Opinion on Butylated Hydroxyanisole (BHA)
- South Korea Adds 18 New Cosmetic Ingredient Analytical Methods; Triclosan & Zinc Pyrithione Tests Revised
- Minnesota Announced Second Extension of PFAS Products Reporting Deadline to September 15, 2026
- EU Updates Cosmetic Regulation: Restrictions & Requirements Revision on 12 Cosmetic Ingredients
- SCCS Issued Final Opinion on Micron-sized Particulate Silver Used in Cosmetic Products
- China’s NMPA Unveils 2026 Cosmetics Standards Plan with 27 New and Revised Standards
🍽Food and food contact material (FCM) news
- Global Compliance Perspective on HMOs: Approvals and Applications in India
- China's CFSA Collects Public Comments on Expanding the Scope of Use for 3'-Sialyllactose and Carmin
- Regulatory Compliance for Novel Food Ingredients in Taiwan: Definitions, Documentation, and Approval Process
- China CFSA Collects Public Comments in Consultation on 4 New Food Ingredients
- China Reopens Public Comment on GB 13432 with Key Changes to Special Dietary Food Labeling and Claims
- China Health food will be strictly inspected – Have you crossed these advertising red lines?
🩺Medical device news
Chemical news
China Expands Hazardous Chemicals Inventory with Five New Additions
China has updated its Inventory of Hazardous Chemicals (2015 Edition), adding five new substances with immediate effect. The revision, issued by the Ministry of Emergency Management and other authorities, strengthens oversight of chemicals posing risks to health, safety, and the environment. Companies involved in the production, storage, or transport of these chemicals must comply with regulatory obligations, including registration and licensing. Businesses should review the updates to ensure continued compliance and risk management. ➡️Read more
US EPA EPA Grants Third Extension for PFAS Reporting, Compliance Now Starts 2027
The US EPA has issued a final rule extending the start of PFAS reporting obligations under TSCA Section 8(a)(7) to January 31, 2027, marking the third postponement since the rule was first finalized in 2023. The delay is mainly due to ongoing development of the electronic reporting platform. While the submission timeline has shifted, the core reporting requirements remain unchanged. EPA is expected to issue further updates addressing exemptions and additional regulatory issues ahead of the new start date.➡️Read more
New Requirements for MSDS Compilation in South Korea – Are You Aware?
South Korea’s Ministry of Employment and Labor has revised its chemical classification and MSDS requirements to include K-REACH regulatory status in Section 15 of Material Safety Data Sheets. The updated format becomes mandatory from July 1, 2026, while older MSDS may continue to be used until revised. The change aims to improve transparency on chemical regulatory status under K-REACH. Companies should review and update MSDS management systems to ensure timely compliance with the new requirements.➡️Read more
New Standard for Vehicles Carrying Dangerous Goods in China – To Be Implemented Soon!
China has released a new mandatory national standard, GB 21668-2025, for vehicles transporting dangerous goods, effective July 1, 2026, replacing three previous standards. The revision enhances safety requirements, standardizes vehicle markings, and introduces new technical specifications, including requirements for active safety systems and onboard equipment. Notably, it establishes conditions for using battery electric vehicles in limited categories of dangerous goods transport. The update reflects a comprehensive effort to improve road safety, modernize technical standards, and strengthen regulatory oversight.➡️Read more
EU Amends REACH Regulation Annex XVII, Imposing Strict Restrictions on Carcinogen 2,4-Dinitrotoluene
The EU has adopted Regulation (EU) 2026/859, restricting the use of 2,4-dinitrotoluene (2,4-DNT) in articles under REACH Annex XVII. Effective May 10, 2027, the measure sets a 0.1% concentration limit, addressing previous gaps that allowed imported articles to contain the substance. The restriction applies broadly to professional and consumer uses, with specific exemptions and transitional periods—particularly for the automotive sector. This update strengthens chemical safety controls and aligns EU market requirements for domestically produced and imported goods.➡️Read more
EU Microplastics Reporting Deadline Approaching: Relevant Enterprises Should Initiate Filing Without Delay
ECHA has issued detailed guidance on annual reporting obligations for synthetic polymer microparticles under the REACH microplastics restriction, with the first filing deadline set for May 31, 2026. The guidance outlines who must report, what data must be submitted, how emissions may be estimated, and how filings should be made through IUCLID and REACH-IT. Companies in plastics, pharmaceuticals, food additives, and in vitro diagnostics should start gathering data now and mapping reporting responsibilities across legal entities and uses.➡️Read more
US EPA Releases List of Expiring TSCA Confidential Business Information Claims
On April 24, 2026, the U.S. EPA released a public list of TSCA confidential business information claims scheduled to expire automatically, starting with claims expiring between June 22 and July 31, 2026. The agency will update the list monthly and requires companies seeking continued protection to submit extension applications through CDX at least 30 days before expiration, with supporting substantiation. Businesses should review the list promptly, as missed deadlines could result in disclosure without further notice. ➡️Read more
Cosmetic news
South Korea Proposes Ban on IP-Infringing Cosmetics Alongside New Export Support
South Korea has proposed amendments to its Cosmetics Act to strengthen enforcement against IP-infringing cosmetics and introduce an export support mechanism. The proposal includes a clear prohibition on the sale of products infringing trademark, patent, or design rights, along with expanded enforcement powers for authorities. It also aims to support domestic companies facing IP disputes in overseas markets. The amendment reflects growing regulatory focus on brand protection, market order, and international competitiveness. ➡️Read more
China IECIC Update: Ingredient Name Changes and International Discrepancies to Note
China has completed the fourth dynamic adjustment of the Inventory of Existing Cosmetic Ingredients in China (IECIC), adding one ingredient to IECIC II and revising 49 ingredient names in IECIC I. Some updated names differ from EU and US ingredient databases, creating potential compliance challenges for international trade. Companies should carefully review ingredient naming, update product labels, and monitor global regulatory updates to avoid issues in product registration, notification, and customs clearance across different markets. ➡️Read more
Six Technical Guidelines Published for Hair Dye, Perm, and Sunscreen Cosmetics in China
China’s National Institutes for Food and Drug Control has released six technical guidelines covering the study and quality control of hair dye, perm, and sunscreen cosmetics. As “special cosmetics” under the Cosmetic Supervision and Administration Regulation (CSAR), these products are subject to stricter registration and safety requirements. The guidelines provide clearer technical direction on product testing, specifications, and quality management. Companies should review these updates to ensure compliance with evolving regulatory expectations for high-risk cosmetic categories in China. ➡️Read more
SCCS Issued Final Opinion on Butylated Hydroxyanisole (BHA)
The EU’s Scientific Committee on Consumer Safety (SCCS) has issued its final opinion on Butylated Hydroxyanisole (BHA), confirming it is safe for use in cosmetic products at concentrations up to 0.07% for dermal application. The assessment excludes oral and inhalation exposure and does not address environmental risks. As BHA remains unregulated under the EU Cosmetics Regulation, this opinion provides important guidance for industry use. Companies should review formulations and exposure scenarios to ensure alignment with SCCS recommendations. ➡️Read more
EU Updates Cosmetic Regulation: Restrictions & Requirements Revision on 12 Cosmetic Ingredients
On April 28, 2026, the European Commission issued Regulation (EU) 2026/909, revising Annexes II, III, IV, and V of the EU Cosmetics Regulation to update the use of multiple cosmetic ingredients. The changes include new prohibitions, revised concentration limits, ingredient warnings, preservative and UV filter conditions, and impurity controls, with transition deadlines starting in 2027. Cosmetic companies should now assess formulas, ingredient portfolios, raw material specifications, and labeling to prepare for compliance across the EU market. ➡️Read more
SCCS Issued Final Opinion on Micron-sized Particulate Silver Used in Cosmetic Products
On April 24, 2026, the EU SCCS issued its final opinion on silver in cosmetic products, updating its earlier assessment after reviewing new dermal penetration data. The committee concluded that micron-sized particulate silver is safe at specified concentrations in rinse-off, leave-on, oral hygiene, nail, and certain children’s products, while propellant-based sprays remain outside the scope of the opinion. The revised conclusion provides greater regulatory clarity for companies using silver in cosmetic formulations. ➡️Read more
China’s NMPA Unveils 2026 Cosmetics Standards Plan with 27 New and Revised Standards
China’s NMPA has issued its 2026 Cosmetics Standard Project Initiation Plan, setting out 27 standards for the cosmetics sector, including one revision and 26 new standards. The projects cover ingredient requirements, toxicology and analytical test methods, manufacturing process validation, sunscreen water resistance, facial masks, hair cleansing products, and multiple toothpaste-related standards. The plan strengthens the technical framework for cosmetics regulation and gives companies an early opportunity to review product portfolios, testing approaches, and compliance preparation in China. ➡️Read more
Food and food contact material (FCM) news
Global Compliance Perspective on HMOs: Approvals and Applications in India
India has approved six human milk oligosaccharide (HMO) ingredients under its non-specified food regulatory pathway, reflecting growing interest in these functional compounds. Widely used in infant nutrition, HMOs are increasingly being incorporated into broader food applications. With strong growth in Asia-Pacific and established markets in Europe and North America, companies are actively expanding approvals and product development. Businesses should closely monitor evolving regulatory frameworks and global market trends to support timely compliance and commercialization strategies. ➡️Read more
This is part of a series:
China's CFSA Collects Public Comments on Expanding the Scope of Use for 3'-Sialyllactose and Carmin
China has opened public consultation on expanding the use of the food additive carmine and the nutrient enhancer 3'-sialyllactose sodium salt. The proposal includes extending applications of 3'-sialyllactose to complementary foods for infants and young children, marking another step in broadening HMO use following 2'-fucosyllactose. The development highlights growing regulatory support for functional ingredients in early-life nutrition. Stakeholders should review the proposed changes and assess potential impacts on product formulation and compliance strategies. ➡️Read more
Regulatory Compliance for Novel Food Ingredients in Taiwan: Definitions, Documentation, and Approval Process
Taiwan’s Guidelines for Safety Assessment of Novel Food Ingredients, released January 27, 2026, define novel food ingredients, outline required submission materials, and explain the TFDA review process, including additional documentation for ingredients produced using genetically modified microorganisms. The guidelines give food businesses a clearer regulatory roadmap, highlight when toxicology and 90-day feeding studies may be needed, and help applicants better assess compliance expectations before entering the Taiwan market. ➡️Read more
Minnesota Announced Second Extension of PFAS Products Reporting Deadline to September 15, 2026
The Minnesota Pollution Control Agency has extended the initial PFAS product reporting deadline under Amara’s Law from July 1 to September 15, 2026, with a one-time 90-day extension available for eligible manufacturers. The rules apply to products with intentionally added PFAS sold in Minnesota, including online sales, and reporting will be submitted through the PRISM system. The extension gives companies more time to confirm PFAS uses, gather supplier data, and prepare reporting strategies ahead of annual updates. ➡️Read more
China Reopens Public Comment on GB 13432 with Key Changes to Special Dietary Food Labeling and Claims
China’s April 17, 2026 draft revision of GB 13432 would reshape labeling rules for prepackaged special dietary foods, including product naming, mandatory nutrition facts items, serving-size labeling, tolerance ranges, claims, and category classifications. The proposal also further aligns the standard with GB 7718-2025 and GB 28050-2025. With public comments open until June 6, 2026, companies should review the draft closely to assess potential label updates, claim restrictions, and operational compliance impacts.➡️Read more
China Health food will be strictly inspected – Have you crossed these advertising red lines?
China’s SAMR has launched a six-month campaign to strengthen governance of the internet advertising market, with health food identified as a key enforcement focus. The notice highlights heightened scrutiny of illegal health-function and disease-treatment claims in live e-commerce, celebrity and influencer endorsements, and AI-generated or fabricated expert identities. Businesses marketing health food in China should review ads and labels carefully, as violations can trigger fines, publication restrictions, and even business license revocation.➡️Read more
Medical device news
NMPA Overseas Inspection Escalation: Compliance of Overseas Medical Device Enterprises Cannot Be Delayed
China’s NMPA is stepping up overseas inspections of imported medical device manufacturers in 2026, with 33 overseas companies already included in the annual inspection plan. The trend points to more normalized and comprehensive oversight, with inspections expected to focus on data integrity, lifecycle traceability, risk management, and contract manufacturing controls under the revised 2025 GMP rules. Overseas manufacturers should strengthen quality systems, prepare complete inspection records, and address compliance gaps early to reduce market access risk in China.➡️Read more
This newsletter was originally published as a shorter version on LinkedIn on May 1. You can subscribe and read all previous issues here.
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