CIRS Regulatory Newsletter | May 2026 – Regulatory Updates (II)
Published: Author: Source: CIRS

This issue explores Peru’s new GHS implementation rules, China’s major overhaul of cleaning product safety standards, practical insights into U.S. FDA NDI notification responses, and the rollout of China’s national medical device vigilance system –alongside other important developments shaping global regulatory compliance.

⭐Editor’s picks – key regulatory developments

In-depth Analysis of Peru's GHS: Specific Requirements for Chemical Classification, Labeling, and SDS

Peru’s implementing regulations for the Comprehensive Chemicals Management Law establish a National Chemicals Registry System and adopt the 6th revised edition of GHS, creating clearer requirements for classification, labeling, safety data sheets, and future notification. The rules set obligations for manufacturers, importers, and distributors, require Spanish labels and SDSs, and introduce detailed provisions such as Acute Toxicity Category 5 and small-container labeling. Companies should start assessing product scope, compliance systems, and documentation readiness now.➡️Read more

From Voluntary to Mandatory: China Overhauls Cleaning Product Safety Standards with New GB 26396–2026

China has approved the mandatory national standard Safety Technical Specification for Cleaning Products (GB 26396—2026), effective May 1, 2027, replacing the 2011 recommended standard. It sets unified requirements for raw materials, safety indicators, labeling, and pre-market safety assessment for cleaning products sold, made, or imported in China. The new standard marks a significant tightening of compliance obligations and will require companies to review formulations, sourcing, and safety management ahead of implementation.➡️Read more

US NDI Notification: A Step-by-Step Guide to Understanding FDA Letters

For companies marketing dietary supplements with new dietary ingredients in the U.S., understanding the FDA’s response to an NDIN is critical. Unlike GRAS notices, NDIN responses do not clearly state whether FDA has “no questions,” which often leads to confusion. This article explains the standard language typically seen in a “notified” letter, identifies four common categories of “non-notified” responses—including incomplete submissions, failure to meet the dietary ingredient definition, insufficient identity data, and insufficient safety evidence—and clarifies two common misinterpretations. It provides practical guidance for assessing FDA response letters and strengthening NDIN compliance strategies.➡️Read more

China Officially Implements National Medical Device Vigilance System

China has formally implemented a unified Medical Device Vigilance System, anchored by the Good Practice for Medical Device Vigilance (Trial) and related guidance, to strengthen full-lifecycle post-market surveillance for all medical devices sold in the country. The new regime places registrant responsibility at the center and requires overseas manufacturers to establish onshore vigilance structures, prepare product-specific vigilance plans, submit mandatory reports, and carry out ongoing risk control through their domestic responsible person in China. ➡️Read more

🔎What’s covered in this issue – at a glance

💻Free webinars

🧪Chemical news

💄Cosmetic news

🍽Food and food contact material (FCM) news

🩺Medical device news

Chemical news

Update to China's Hazardous Chemicals Classification Information Table! Involving 5 substances, including 3-Chloropropyne

On April 28, 2026, China’s Ministry of Emergency Management issued a notice to strengthen safety supervision for five newly added hazardous chemicals and released classification information for each substance. Companies involved in the production, operation, use, or import of these chemicals must understand the new hazard categories, safety requirements, and emergency measures, complete the required permits by July 31, 2026, and finish hazardous chemical registration in a timely manner to support compliant operations and reduce legal and safety risks. ➡️Read more

In-depth Analysis of Peru's GHS: Specific Requirements for Chemical Classification, Labeling, and SDS

Peru’s implementing regulations for the Comprehensive Chemicals Management Law establish a National Chemicals Registry System and adopt the 6th revised edition of GHS, creating clearer requirements for classification, labeling, safety data sheets, and future notification. The rules set obligations for manufacturers, importers, and distributors, require Spanish labels and SDSs, and introduce detailed provisions such as Acute Toxicity Category 5 and small-container labeling. Companies should start assessing product scope, compliance systems, and documentation readiness now.➡️Read more

Official Announcement: EU REACH Comprehensive Revision Plan (REACH 2.0) Put on Hold

EU Environment Commissioner Jessika Roswall has confirmed that the bloc will not move forward with a comprehensive revision of REACH, shelving the long-discussed REACH 2.0 overhaul. Instead, the European Commission will focus on simplifying and modernizing existing rules through targeted technical updates and stronger border and market enforcement, while a PFAS restriction proposal is still expected this year. For companies, the shift eases the prospect of sweeping near-term reform but keeps substance-specific controls and compliance scrutiny firmly in focus. ➡️Read more

Important Adjustments to South Korea’s Existing Chemical Substances List: 136 Substance Names Restored

On April 28, 2026, South Korea’s MCEE revised the Existing Chemical Substances List under K-REACH through Notice No. 2026-103. The update corrects substance names, adds CAS numbers for certain entries, and restores the original names of 136 substances previously protected under CBI rules after the protection period expired. Companies should review whether affected substances are used in their products and update compliance documents, SDS, and registration or exemption assessments accordingly.➡️Read more

US EPA Releases 2026 PFAS Disposal Guidance: High-Temperature Incineration and Underground Injection Listed as Low-Risk Options

On April 20, 2026, the U.S. EPA released its 2026 Interim Guidance on PFAS Destruction and Disposal and opened a 60-day public comment period. The update shifts the guidance to an annual cycle and revises EPA’s analysis of six PFAS material types and three disposal technologies. It also adds new data on incineration, landfills, and underground injection wells, giving companies a clearer view of current PFAS waste management expectations and regulatory direction. ➡️Read more

Comprehensive Interpretation of Brazil REACH: Registration, Exemptions, Fees, and Risk Management

Brazil REACH is moving from legislation to implementation, with the framework clarifying registration obligations, exemptions, tonnage bands, fees, and risk assessment criteria. Manufacturers, importers, and Only Representatives will need to assess whether substances meet the 1 ton/year threshold, prepare core substance data, and build internal compliance systems early. For companies in chemicals-related supply chains, proactive preparation will be essential to manage legal risk, maintain market access, and stay competitive in Brazil.  ➡️Read more

Cosmetic news

From Draft to Done: Full Interpretation of China's Technical Guidelines for Hair Dye Cosmetics

On April 15, 2026, China’s NIFDC published two trial technical guidelines for hair dye cosmetics covering product research and quality control requirements. The documents set out more detailed expectations for mechanism studies, raw material and formulation control, safety assessment, efficacy evaluation, quality standards, and labeling, while also revising several provisions from the draft versions. Hair dye companies should review the new guidance closely to align product development, testing strategies, and claims with China’s updated compliance expectations. ➡️Read more

SCCS Issued Final Opinion on Cannabidiol (CBD) Used in Cosmetic Products

On April 24, 2026, the EU SCCS released its final opinion on Cannabidiol (CBD) in cosmetics, updating its November 2025 preliminary opinion. Based on limited available data, the SCCS considers CBD safe at concentrations up to 0.19% in dermal and oral cosmetic products, with THC impurities safe up to 0.00025%, whether used separately or in combination. The opinion does not cover products that may expose users’ lungs by inhalation and notes that further data could refine the assessment. ➡️Read more

Global Cosmetics Regulatory Updates – Vol. 38 (April 2026)

As of April 2026, cosmetics regulators in China, Europe, Canada, the US, and South Korea issued a wide range of updates affecting ingredients, standards, labeling, safety assessment, and product reporting. Key developments include China’s inventory and standards changes, new SCCS opinions and EU ingredient restrictions, Canada’s fragrance allergen labeling phase-in, Minnesota’s PFAS reporting deadline extension, and South Korea’s expanding safety assessment framework. This roundup helps companies monitor global compliance trends. ➡️Read more

Compliance Practical Manual for Hair Perming Cosmetics in China Under the New Regulations

On April 15, 2026, China’s NIFDC released the Technical Guideline for Research on Hair Perming Cosmetics (Trial) and the Technical Guideline for Research on Quality Control Requirements for Hair Perming Cosmetics (Trial). Together, the two guidelines clarify the technical and compliance requirements for hair-perming cosmetics across nine key areas, including definitions and classification, product naming, formulation, manufacturing process, quality control, product testing, labeling and claims, safety assessment, and efficacy evaluation. The update also highlights several refinements from the draft versions, particularly in ingredient safety information, process requirements, quality control measures, and efficacy-related expectations. The new guidance gives companies a clearer framework for registration preparation and compliant market entry in China.➡️Read more

Permitted Hair Dye List Set for Accelerated Expansion in China as NMPA Projects 27 Cosmetic Standards

In April 2026, the NMPA released the 2026 Cosmetic Standards Project Plan, covering 27 standards across cosmetic ingredients, product standards, and testing methods. Among the most significant developments are six projected hair dye ingredient standards, reflecting an accelerated expansion of China’s permitted hair dye list. Two ingredients—2-methoxymethyl-p-phenylenediamine and its sulfate, and HC Blue No. 16—are especially noteworthy because they are widely used overseas but not yet listed in China’s existing ingredient inventory, suggesting they may enter the market through the standards conversion pathway. The plan also includes new ingredient standards, product standards for freeze-dried masks and rinse-free hair cleansing products, and new testing methods for cosmetics and toothpaste. Overall, the project plan signals continued strengthening of China’s cosmetics standards framework and creates important compliance opportunities for companies preparing for market entry. ➡️Read more

China GACC Clarifies Declaration Requirements for Import and Export Cosmetics Inspection and Quarantine

On May 11, 2026, China’s GACC issued Announcement No. 61 to support implementation of the revised import and export cosmetics measures (Decree No. 284), effective December 1, 2026. The announcement clarifies operational requirements for import declarations, importer record-keeping, pre-export inspection applications, and the scope of mandatory national technical specifications. It also details declaration rules for samples and semi-finished products, giving companies clearer compliance expectations for China cosmetics trade. ➡️Read more

From Voluntary to Mandatory: China Overhauls Cleaning Product Safety Standards with New GB 26396–2026

China has approved the mandatory national standard Safety Technical Specification for Cleaning Products (GB 26396—2026), effective May 1, 2027, replacing the 2011 recommended standard. It sets unified requirements for raw materials, safety indicators, labeling, and pre-market safety assessment for cleaning products sold, made, or imported in China. The new standard marks a significant tightening of compliance obligations and will require companies to review formulations, sourcing, and safety management ahead of implementation.➡️Read more

Food and food contact material (FCM) news

Overview of Approved GMM-Derived Ingredients in Taiwan, Including HMOs, Astaxanthin and trans-Resveratrol

Since 2020, Taiwan has gradually established approval conditions, use restrictions, and labeling requirements for six novel food ingredients produced using genetically modified microorganisms, including three 2′-fucosyllactose products, astaxanthin, Ganoderma microsporum globulin-like protein concentrate, and trans-resveratrol. Combined with the novel food ingredient guidelines released in January 2026, these approvals provide a clearer regulatory framework for companies developing GMM-derived food ingredients and help businesses better assess product positioning, compliance requirements, and commercialization opportunities in Taiwan. ➡️Read more

China's GACC to Launch Annual Random Inspection Program Including Imported Food Contact Products From June 1

China’s GACC has announced that, starting June 1, 2026, annual random inspections will apply to certain import and export goods outside the scope of statutory inspection, including imported food contact products. The inspections will be carried out under the existing administrative measures for random inspection of import and export commodities, while the 2025 announcement on the same program will be repealed. Companies involved in affected products should review compliance preparations and stay alert to potential inspection requirements.➡️Read more

Safety of Acute Exposure to the Food Additive Glycerol (E 422) from Beverages

EFSA has assessed acute exposure to glycerol (E 422) from slush ice drinks and de-alcoholised wine and concluded that estimated single-consumption exposure could exceed the acute reference dose for all population groups. The opinion also identifies beverage volumes and theoretical maximum glycerol levels that would remain within the safety threshold. The findings are likely to intensify EU attention on high-consumption scenarios and could influence future discussions on permitted use conditions, maximum levels, and compliance strategies for affected products.➡️Read more

CIRS Assists Shandong Weiyan in Obtaining GRAS Status for Its Astaxanthin

Shandong Weiyan Biotechnology has reached a key international compliance milestone, with its astaxanthin concluded as Generally Recognized as Safe (GRAS) by a GRAS panel with support from CIRS Group. Produced through synthetic biology using a production strain developed from a microorganism on the EU QPS list, the ingredient is considered safe for use in food in the U.S. under its intended conditions of use. The outcome supports the company’s market expansion and strengthens global commercialization prospects. ➡️Read more

China NHC Added D-allulose to the Terminated Review List of New Food Raw Materials

China’s National Health Commission has added a D-allulose product to the Terminated Review List of New Food Raw Materials after determining that it is substantially equivalent to the D-allulose already approved under NHC Announcement No. 4 of 2025. The product is manufactured from fructose using D-allulose-3-epimerase catalysis, followed by processing steps such as purification, crystallization, and drying. While the source of the enzyme differs, all other requirements must comply with the existing provisions for approved D-allulose. The update offers an important example of how China applies substantial equivalence in novel food ingredient review. ➡️Read more

US NDI Notification: A Step-by-Step Guide to Understanding FDA Letters

For companies marketing dietary supplements with new dietary ingredients in the U.S., understanding the FDA’s response to an NDIN is critical. Unlike GRAS notices, NDIN responses do not clearly state whether FDA has “no questions,” which often leads to confusion. This article explains the standard language typically seen in a “notified” letter, identifies four common categories of “non-notified” responses—including incomplete submissions, failure to meet the dietary ingredient definition, insufficient identity data, and insufficient safety evidence—and clarifies two common misinterpretations. It provides practical guidance for assessing FDA response letters and strengthening NDIN compliance strategies.➡️Read more

Medical device news

China Officially Implements National Medical Device Vigilance System

China has formally implemented a unified Medical Device Vigilance System, anchored by the Good Practice for Medical Device Vigilance (Trial) and related guidance, to strengthen full-lifecycle post-market surveillance for all medical devices sold in the country. The new regime places registrant responsibility at the center and requires overseas manufacturers to establish onshore vigilance structures, prepare product-specific vigilance plans, submit mandatory reports, and carry out ongoing risk control through their domestic responsible person in China. ➡️Read more

  

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