CIRS Regulatory Newsletter | April 2026
Published: Author: Source: CIRS

Wishing everyone who celebrates a very happy easter! This issue delves into the EU’s PFAS restriction proposal, the U.S. adverse event monitoring system for cosmetics, the potential end of the dual food system for the EU and the UK, and so much more.

⭐Editor’s picks – key regulatory developments

ECHA Launches Public Consultation on PFAS Restriction Proposal

The European Chemicals Agency (ECHA) has launched a global consultation following its Socio-Economic Analysis Committee’s (SEAC) preliminary assessment of the PFAS restriction proposal. Stakeholders are invited to submit feedback via structured questionnaires by May 25, 2026, focusing on alternatives, costs, and socio-economic impacts. The input will support the development of SEAC’s final opinion, expected by the end of 2026, which will inform the European Commission’s proposed restriction measures under REACH. ➡️Read more

U.S. FDA Launches New Adverse Event Monitoring System

The U.S. FDA has introduced a new Adverse Event Monitoring System (AEMS), bringing together safety reports for drugs, biologics, vaccines, cosmetics, and other regulated products into a unified platform. The system will replace multiple legacy databases and provide real-time access to adverse event data. By improving data transparency and analytical capabilities, AEMS aims to strengthen post-market surveillance while reducing operational costs and simplifying access to safety information for stakeholders. ➡️Read more

UK-EU SPS Framework: Is the Era of Dual UK-EU Novel Food Notifications Coming to an End?

The planned UK–EU SPS Agreement, expected to take effect in 2027, marks a shift from regulatory divergence to alignment in food and feed regulations. Current UK requirements remain in place, but future changes may allow EU-authorized products to enter the UK market without separate approvals. During this transition, companies should evaluate their submission strategies, as duplicating UK and EU applications may become inefficient. Monitoring upcoming guidance from UK authorities will be key to ensuring efficient market access planning. ➡️Read more

CIRS Group Shines at KIMES 2026 in South Korea, Concludes Thematic Seminar with Success

From March 19–22, 2026, CIRS Group participated in KIMES 2026 at COEX, Seoul, hosting a seminar on FDA, CE MDR, and NMPA clinical evaluation. Senior experts provided in-depth guidance on global certification challenges, clinical evaluation practices, and regulatory compliance strategies. The seminar attracted strong engagement, with one-on-one consultations following presentations. CIRS’ presence reinforced its industry influence, supporting Chinese, Korean, and global medical device enterprises in achieving regulatory compliance and expanding successfully into domestic and international markets. ➡️ Read more

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

🏢Company news

💻Free webinars

🧪Chemical news

💄Cosmetic news

🍽Food and food contact material (FCM) news

🩺Medical device news

Chemical news

China Issues Ecological and Environmental Code, Illegal Fines for New Chemical Substances Soar to a Maximum of 2 Million Yuan

The Ecological and Environmental Code of China, approved on March 12, 2026, establishes a legally binding registration system for new chemical substances, requiring “registration first, then manufacturing/importing.” Three prohibitions cover unregistered production, noncompliant use, and violations of certificate conditions. Penalties are significantly increased compared to previous regulations, with fines up to 2 million yuan (approx. €125,170/ $145,124), production restrictions, certificate revocation, and potential business closure. Enterprises should verify registration, review suppliers, plan new product registrations, and monitor supporting regulatory revisions ahead of the August 15, 2026, effective date.➡️Read more

Exempt from Identification = Not Hazardous? Q&A on Chemical Physical Hazard Identification Is Here!

The Law on the Safety of Hazardous Chemicals, effective December 27, 2025, establishes a catalog management system and requires physical hazard identification and classification for chemicals with unknown hazard characteristics. Identification evaluates flammability, explosiveness, oxidizing properties, and more, while classification determines hazard categories. Exemptions apply to substances listed in the 2016 exemption catalog or those used under 1 ton/year for R&D. Companies must ensure proper SDS preparation, labeling, registration, and safety management to comply with the law.➡️Read more

UK Launches Consultation on Revised Persistent Organic Pollutants (POPs) Regulations

The UK Defra launched a public consultation on March 18, 2026, to amend Persistent Organic Pollutants (POPs) Regulations. Proposed updates include adding five new POPs – MCCPs, LC-PFCAs, chlorpyrifos, UV-328, and Dechlorane Plus – adjusting unintentional trace contaminant (UTC) limits, and providing transitional exemptions for critical industries. Stakeholders are invited to submit feedback on technical feasibility, economic impact, and regulatory alignment with the EU by May 13, 2026. These changes aim to strengthen POPs control and protect human health and the environment.➡️Read more

China Draft of Hazardous Properties Inspection Code of Dangerous Goods-General Specifications Released for Comment!

On March 16, 2026, China’s WTO/TBT-SPS National Notification and Enquiry Center published drafts for GB 19458-XXXX and related hazardous goods inspection codes, replacing GB 19458-2004. Updates include revised definitions for dangerous goods and explosives, alignment with UN transport recommendations (23rd edition), updated normative references, and revised labeling and inspection rules. Stakeholders may submit comments within 60 days. The new standards are slated to take effect three months after approval, modernizing China’s hazardous goods safety framework.➡️Read more

The UK Just Proposed Its First New SVHCs Since Brexit – Why This Matters

The UK HSE has opened its first post-Brexit consultation on adding 15 Substances of Very High Concern (SVHCs) to the UK REACH Candidate List, with submissions accepted until April 20, 2026. These substances already have harmonized hazard classifications, reflecting a risk-based approach. Inclusion triggers supply chain communication obligations and potential future authorization requirements. This consultation marks a strategic shift in UK SVHC management, with regular updates expected, requiring companies to review their portfolios and plan compliance measures accordingly.➡️Read more

Why 2026 Is Now the Only Deadline That Matters for Turkey REACH (KKDIK) Compliance

The updated KKDIK regulation in Turkey requires companies to complete full or interim registration for all substances by September 30, 2026, marking a major shift from previous phased timelines. Pre-registration is no longer sufficient, and reliance on Lead Registrants has decreased. Interim registration now serves as a strategic compliance tool. Companies must assess their substance portfolios, identify data gaps, and act promptly to secure market access, minimize regulatory risks, and avoid supply chain disruption. ➡️Read more

ECHA Launches Public Consultation on PFAS Restriction Proposal

The European Chemicals Agency (ECHA) has launched a global consultation following its Socio-Economic Analysis Committee’s (SEAC) preliminary assessment of the PFAS restriction proposal. Stakeholders are invited to submit feedback via structured questionnaires by May 25, 2026, focusing on alternatives, costs, and socio-economic impacts. The input will support the development of SEAC’s final opinion, expected by the end of 2026, which will inform the European Commission’s proposed restriction measures under REACH. ➡️Read more

Japan to Designate Chlorpyrifos and Three Other Substances as Class I Specified Chemical Substances

Japan has proposed amendments to the Enforcement Order of the Chemical Substances Control Law (CSCL), designating several substances, including long-chain PFAS, chlorpyrifos, and MCCPs, as Class I Specified Chemical Substances. These substances are persistent, bioaccumulative, and toxic, and would be subject to strict controls, including bans on manufacture, import, and use, as well as restrictions on products containing them. The proposal aligns with international obligations under the Stockholm Convention and is open for public comment until April 18, 2026.➡️Read more

Complete PCN Notification: Unlock the "Compliance Accelerator" for Mixture Trade

ECHA is intensifying enforcement of Poison Centre Notification (PCN) requirements for hazardous mixtures, with recent inspections identifying gaps in notification, classification accuracy, and UFI labeling. Member States are conducting detailed dossier reviews, and non-compliance may result in penalties or enforcement action. With broader inspections planned under the REF-14 project, companies should ensure accurate PCN submissions, consistent SDS and labeling information, and proper use of UFI codes to maintain compliance and protect market access in the EU. ➡️Read more

Major Revision of Existing Chemical Substance Names in South Korea: Comments Due by April 16

South Korea’s Ministry of Climate and Energy Environment has proposed amendments to the existing chemical substances inventory, focusing on substances previously listed under generic names due to data protection. The revision restores original chemical names for 136 substances following the expiry of protection periods, and updates CAS numbers and naming details for several others. The changes aim to improve transparency and accuracy in the inventory. Stakeholders are invited to submit comments by April 16, 2026, before the amendments are finalized. ➡️Read more

Cosmetic news

Regulatory FAQs: Ordinary Cosmetics Filing in China (Vol. 8)

China has released new FAQs clarifying requirements for ordinary cosmetics filing, covering key areas such as ingredient safety data, product testing, labeling, and electronic labels. The guidance confirms that most ingredient safety information does not need to be submitted but must be retained by companies, and provides detailed instructions on testing requirements, packaging image submissions, and labeling restrictions. It also introduces guidance on electronic labels and QR code use, helping companies improve compliance and streamline filing processes.➡️Read more

Starting April 12, 2026: Health Canada Mandates Fragrance Allergen Disclosure on Cosmetic Labels

Health Canada is introducing new regulations requiring cosmetic manufacturers to disclose specific fragrance allergens on product labels, replacing the current practice of listing them under “fragrance.” The phased implementation begins April 12, 2026, starting with 24 allergens and expanding to 81 by August 2028. The rules also update Cosmetic Notification Form requirements and apply threshold-based disclosure for rinse-off and leave-on products. The changes aim to improve transparency and align Canada’s labeling framework more closely with EU standards. ➡️Read more

China New Ingredient Filing Status: Four New Cosmetic Ingredients Have Been Filed

China’s National Medical Products Administration (NMPA) reported four new cosmetic ingredient filings between March 13 and 20, 2026, bringing the total number of filings to 49 in 2026. The latest filings include a mix of peptide-based, plant-derived, and polymer ingredients, highlighting ongoing innovation across the sector. While technical specifications have not yet been disclosed, the continued pace of filings reflects sustained industry interest and regulatory activity in China’s new cosmetic ingredient framework.➡️Read more

U.S. FDA Launches New Adverse Event Monitoring System

The U.S. FDA has introduced a new Adverse Event Monitoring System (AEMS), bringing together safety reports for drugs, biologics, vaccines, cosmetics, and other regulated products into a unified platform. The system will replace multiple legacy databases and provide real-time access to adverse event data. By improving data transparency and analytical capabilities, AEMS aims to strengthen post-market surveillance while reducing operational costs and simplifying access to safety information for stakeholders. ➡️Read more

New UV Filter, New Rules: Korea's Cosmetic Safety Standards Revised

South Korea has amended its Regulation on Safety Standards for Cosmetics, introducing updates to ingredient management and testing requirements. The changes include reorganizing hair dye ingredient lists to improve regulatory clarity, adding a new UV filter (phenylene bis-diphenyltriazine), and revising test methods for substances such as dioxane, formaldehyde, and free alkali. Effective March 18, 2026, the amendments aim to streamline safety management and enhance testing efficiency for cosmetic products in the market.➡️Read more

Panoramic Analysis: Current Regulatory Status and Compliance Challenges of Exosome Cosmetics Worldwide

The global regulatory landscape for exosome cosmetics varies significantly across regions, with differing approaches to safety, ethics, and ingredient sourcing. While markets such as the U.S. allow certain exosome-based products, many regions—including the EU, China, and South Korea—impose strict restrictions or prohibitions on human-derived ingredients. Other jurisdictions, such as Taiwan and Japan, apply case-by-case approvals or specific guidelines. These differences create complex compliance challenges, requiring companies to closely monitor regulatory developments and adapt strategies for safe market entry. ➡️Read more

Food and food contact material (FCM) news

China NHC Updates on the Three New Foods

China's NHC issued notifications regarding the acceptance of “three new foods”. The applications for two new food materials, two new food additives and three new food-related products have been received. ➡️Read more

EFSA Establishes Provisional Safe Level for Cannabidiol (CBD) Intake in Adults

EFSA sets a provisional safe intake level for CBD at 0.0275 mg/kg body weight/day for healthy adults, highlighting ongoing data gaps. Safety for under-25s, pregnant or breastfeeding individuals, and those on medication remains unestablished, with further risk assessments planned. ➡️Read more

Compliance Path for D-allulose Export to Japan and South Korea

D-allulose, a novel sugar substitute, is gaining attention worldwide. In Japan and South Korea, regulatory requirements differ from China: only the D-allulose-3-epimerase enzyme preparation used in production must be approved, while the final product does not require marketing authorization. Exporters to South Korea must ensure enzyme preparation certification by October 1, 2026, per MFDS regulations. Compliance with local safety evaluations and documentation is essential to maintain market access, highlighting the importance of early regulatory preparation for international trade.➡️Read more

Pathway for U.S. FDA Approval of Biosynthetic Food Colors: A Case Study of Beetroot Red

The U.S. FDA has approved beetroot red as a color additive for use in human food, establishing a new regulation under 21 CFR Part 73. Produced via fermentation using genetically engineered yeast, the additive is exempt from batch certification and intended to replace traditional beetroot-based colorants. The FDA concluded that beetroot red is safe under intended conditions of use, supported by toxicological and dietary exposure data. The approval reflects continued growth in biosynthetic colorants within the food industry. ➡️Read more

Expanded Use of Pasteurised Akkermansia in the EU: Now Permitted for Adolescents Aged 12 and Above

The EU has expanded the approved use of pasteurized Akkermansia muciniphila (AKK), a postbiotic ingredient, to include adolescents aged 12–18. The update introduces age-specific intake limits based on new safety data and reflects a more refined scientific understanding of the ingredient. Originally approved in 2022 for adult use, AKK can now be used in foods for special medical purposes and food supplements for a broader population, excluding pregnant and breastfeeding women. This development is expected to support innovation and growth in the postbiotic market. ➡️Read more

Exporting Food Additives to the EU in 2026: Detailed Interpretation of the Updated EFSA Administrative and Scientific Guidance

The European Food Safety Authority (EFSA) has updated its scientific and administrative guidance for food additive authorization applications, reflecting recent technological developments. The revisions introduce more detailed data requirements, standardized dossier formats, and updated exposure assessment tools, while strengthening expectations for manufacturing, toxicology, and risk assessment. The new scientific guidance will apply from July 20, 2026, with EFSA encouraging early adoption. Companies should review the updated requirements to ensure their dossiers meet the latest standards and avoid delays in approval. ➡️Read more

UK-EU SPS Framework: Is the Era of Dual UK-EU Novel Food Notifications Coming to an End?

The planned UK–EU SPS Agreement, expected to take effect in 2027, marks a shift from regulatory divergence to alignment in food and feed regulations. Current UK requirements remain in place, but future changes may allow EU-authorized products to enter the UK market without separate approvals. During this transition, companies should evaluate their submission strategies, as duplicating UK and EU applications may become inefficient. Monitoring upcoming guidance from UK authorities will be key to ensuring efficient market access planning. ➡️Read more

Q&A on Registration of FSMP Under the New National Standard

China’s State Administration for Market Regulation (SAMR) has released Q&A guidance on the registration of foods for special medical purposes (FSMP) under new national standards. The document clarifies key requirements, including application timing, classification of changes versus new registrations, and expectations for clinical trials, labeling, and supporting materials. It also outlines transitional arrangements for products registered under previous standards. The guidance aims to support compliant applications and ensure a smooth transition to the updated regulatory framework. ➡️Read more

N-acetylneuraminic Acid Added to the Terminated Review List of New Food Raw Materials in China

China’s National Health Commission has added a new N-acetylneuraminic acid application to the terminated review list for new food raw materials. The product, produced via microbial fermentation using glucose, was considered substantially equivalent to an already approved ingredient, leading to termination of the review process. This update highlights the importance of demonstrating clear differentiation in new food applications, as products deemed similar to existing approvals may not proceed further through regulatory review. ➡️Read more

Cross-border Food Retail Imports Temporarily Exempt from GACC Registration

China’s General Administration of Customs has issued implementation details for Decree 280, which will take effect on June 1, 2026, and updates the registration requirements for overseas manufacturers of imported food. The guidance clarifies the scope of products requiring registration, introduces revised application and renewal procedures, and outlines specific requirements for storage facilities and import declarations. Overseas manufacturers should assess whether their products fall within the updated catalog and ensure registration remains valid to avoid disruption to exports to China. ➡️Read more

Global Compliance Perspective on HMOs

Human Milk Oligosaccharides (HMOs) are found exclusively in human milk and represent the third largest solid component after lactose and lipids. They possess a wide range of functions, including modulation of the gut microbiota, enhancement of cognitive development, and improvement of irritable bowel syndrome. There are numerous types of HMOs, and we have summarized the approvals and applications in:

Medical device news

CIRS Group Shines at KIMES 2026 in South Korea, Concludes Thematic Seminar with Success

From March 19–22, 2026, CIRS Group participated in KIMES 2026 at COEX, Seoul, hosting a seminar on FDA, CE MDR, and NMPA clinical evaluation. Senior experts provided in-depth guidance on global certification challenges, clinical evaluation practices, and regulatory compliance strategies. The seminar attracted strong engagement, with one-on-one consultations following presentations. CIRS’ presence reinforced its industry influence, supporting Chinese, Korean, and global medical device enterprises in achieving regulatory compliance and expanding successfully into domestic and international markets. ➡️ Read more

Company news

Helioscience and Uviva Visit CIRS Testing to Discuss Global Collaboration

On March 22, 2026, CIRS Testing welcomed a delegation from Helioscience and Uviva to explore industry trends and collaboration opportunities. David Wan and the CIRS team showcased the lab’s one-stop testing services, covering efficacy, toxicology, and physicochemical analyses. Discussions compared Chinese and European cosmetic regulations and compliance strategies, followed by a tour of advanced laboratory facilities. The visit strengthened international partnerships and positioned CIRS to expand its testing and regulatory services for cosmetics, consumer goods, and chemicals. ➡️ Read more

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

  

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