CIRS Regulatory Newsletter | June 2026 - Regulatory Update (II)
Published: Author: Source: CIRS

As regulators around the world continue to introduce new requirements and reforms, businesses face an increasingly complex compliance landscape. In this edition, we highlight key developments across chemicals, biocides, cosmetics, food, feed, and medical devices – from proposed changes to MEE Order 12 (China REACH) and new biocides timelines in the EU and Great Britain, to the FDA's approval of a new sunscreen active ingredient and practical guidance for navigating NMPA renewals.

These Editor's Picks are just a selection of the stories featured in this issue, alongside additional regulatory updates and insights from around the globe.

⭐Editor’s picks – key regulatory developments

Biocides Companies Gain Planning Window as EU and GB Extend Key Regulatory Deadlines

Recent EU and GB biocides developments have given companies more time for compliance planning, while also pointing to possible longer-term regulatory convergence. The EU has extended certain data protection periods to the end of 2030, and Great Britain has postponed key active substance expiry dates until July 31, 2031. At the same time, the UK has indicated that biocides are expected to fall within a future UK-EU SPS agreement, making this an important moment for businesses to review authorisation, data-sharing, and market access strategies. ➡️Read more

Breaking News! The Registration System for New Chemical Substances in China Undergoes a Major Overhaul

On June 11, 2026, China’s Ministry of Ecology and Environment released for comment a major draft revision of the Measures for the Environmental Management Registration of New Chemical Substances (China REACH), aligned with the upcoming Ecological Environment Code. The proposal would reshape registration applicants, remove record-filing, revise exemption rules, tighten polymer and supply chain management, and increase penalties. With implementation planned for August 15, 2026, companies should promptly review existing registrations, supply arrangements, and future compliance strategies.➡️Read more

US FDA Approves Bemotrizinol as New Sunscreen Active Ingredient

On June 9, 2026, the FDA approved Bemotrizinol for inclusion in the OTC sunscreen monograph, with the final order taking effect on August 9, 2026. It is the first new active ingredient added to the U.S. sunscreen monograph in more than two decades and is considered GRASE for use in adults and children six months and older. The approval gives sunscreen companies greater formulation flexibility and signals continued modernization of the U.S. sunscreen regulatory framework. ➡️Read more

Food and Feed May Face New Chemical Substance Registration with China's MEE

China’s June 11, 2026 draft revision of MEE Order 12 would significantly expand China REACH by bringing products already regulated elsewhere—including food, food additives, feed, feed additives, cosmetics, pharmaceuticals, pesticides, and fertilizers—into new chemical substance registration if they are not listed in the IECSC. For food and feed businesses, that could mean parallel filings with both sector regulators and the MEE before import or market entry, making IECSC screening and registration planning immediate priorities. ➡️Read more

Full-Scenario Compliance Solutions for NMPA Renewal Registration: Six Special Scenarios Including Standard Updates, Classification Adjustments, and Overdue Renewal Handling

NMPA medical device renewal becomes more complex when companies face special scenarios such as mandatory standard updates, classification changes, conditional approval obligations, overdue filings, or import-agent switches. In these cases, routine renewal rules may no longer apply, and mistakes can trigger rejection, certificate invalidation, or product withdrawal. For overseas manufacturers, the key takeaway is to assess scenario-specific risks before expiry, complete change registrations in the right order, and verify agent, standards, and post-market obligations early to preserve access to China.➡️Read more

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

💻Free webinars

🦠Biocides news

Biocides Companies Gain Planning Window as EU and GB Extend Key Regulatory Deadlines

🧪Chemical news

ECHA Risk Assessment Committee Classifies Trifluoroacetic Acid (TFA) and Its Salts as PMT/vPvM Substances

Breaking News! The Registration System for New Chemical Substances in China Undergoes a Major Overhaul

UK Revises GB CLP, Abolishing Classification and Labelling Notification

ECHA to Disclose C&L Notifier Names on July 1!

Expansion of the UK REACH Candidate List: 15 SVHCs Officially Added

EU Publishes Packaging and Packaging Waste Regulation (PPWR) Guidance Document

EU Reaches Agreement on Simplifying Regulations on Cosmetics, Chemicals, Labeling, and Fertilizers

Dual-Use Exports to the US Further Restricted: 10 US Entities Added to China's Export Control List

Rhode Island Amends Consumer PFAS Ban Act, Adding Product Exemptions

💄Cosmetic news

US FDA Approves Bemotrizinol as New Sunscreen Active Ingredient

Over 100 New Cosmetic Ingredients Filed in China in 2026

China Released Two Mandatory National Standards Concerning Cosmetic Adverse Reactions for Public Comments

Global Cosmetics Regulatory Updates – Vol. 39 (May 2026)

Alert: New Chemical Substances in Finished Cosmetic Products May Be Brought Under Registration Management in China!

China Cosmetic Testing Requirements: CMA, CNAS, and ISO 17025 Explained

CIRS to Sponsor EFfCI’s 26th Annual Conference in Athens

🍽Food and food contact material (FCM) news

Food and Feed May Face New Chemical Substance Registration with China's MEE

Weekly Summary – Updates on the Approval and Review of “Three New Foods”

🩺 Medical device news

Caution: NMPA Certificate Invalidation | Full Process for Medical Device NMPA Renewal Registration

Full-Scenario Compliance Solutions for NMPA Renewal Registration: Six Special Scenarios Including Standard Updates, Classification Adjustments, and Overdue Renewal Handling

Free webinars

Understanding the Revision of China’s New Chemical Substance Registration Regime: From the Ecological and Environmental Code to Compliance Management for New Chemical Substances

This webinar explains how China’s draft revision of the new chemical substance registration regime, issued alongside the coming Ecological and Environmental Code, could reshape compliance for chemicals, pharmaceuticals, agrochemicals, cosmetics, advanced materials, and related supply chains. Rather than minor rule changes, the reform points to a structural redesign affecting applicants, exemptions, polymers, inventory inclusion, post-registration supervision, and liability. For businesses, the key value is early insight into likely impacts on registration strategy, costs, timelines, and internal compliance planning. 

  • English – June 30, at 2pm BST
  • English – June 30, at 6pm BST
  • Chinese – June 23 at 3am BST
  • Japanese – June 25 at 6.30am BST

➡️Find out more and register here.

Analysis of Policy Trends in Cross-Border E-Commerce for Imported Health Foods & Blue Hat Registration and Filing

China’s cross-border e-commerce rules for imported health foods are moving toward tighter risk control, even as market access remains comparatively flexible. This webinar August 12 at 12pm EST, in collaboration with HPA-Global & HPA-China will help companies understand where compliance expectations are rising and how to prepare for stricter ingredient, platform, recall, and Blue Hat-related regulatory pressures. ➡️Find out more and register here.

Biocides news

Biocides Companies Gain Planning Window as EU and GB Extend Key Regulatory Deadlines

Recent EU and GB biocides developments have given companies more time for compliance planning, while also pointing to possible longer-term regulatory convergence. The EU has extended certain data protection periods to the end of 2030, and Great Britain has postponed key active substance expiry dates until July 31, 2031. At the same time, the UK has indicated that biocides are expected to fall within a future UK-EU SPS agreement, making this an important moment for businesses to review authorisation, data-sharing, and market access strategies. ➡️Read more

Chemical news

ECHA Risk Assessment Committee Classifies Trifluoroacetic Acid (TFA) and Its Salts as PMT/vPvM Substances

At its June 2026 RAC-77 meeting, ECHA’s Risk Assessment Committee agreed for the first time to classify trifluoroacetic acid (TFA) and its inorganic salts as PMT and vPvM substances, while also adding or tightening several health hazard classifications, including reproductive toxicity. As a widespread PFAS degradation product, TFA is relevant across sectors such as refrigerants, pesticides, firefighting foams, and chemical intermediates. If adopted by the European Commission, the decision will trigger important labeling, SDS, and supply chain compliance obligations in the EU.➡️Read more


Breaking News! The Registration System for New Chemical Substances in China Undergoes a Major Overhaul

On June 11, 2026, China’s Ministry of Ecology and Environment released for comment a major draft revision of the Measures for the Environmental Management Registration of New Chemical Substances (China REACH), aligned with the upcoming Ecological Environment Code. The proposal would reshape registration applicants, remove record-filing, revise exemption rules, tighten polymer and supply chain management, and increase penalties. With implementation planned for August 15, 2026, companies should promptly review existing registrations, supply arrangements, and future compliance strategies.➡️Read more

UK Revises GB CLP, Abolishing Classification and Labelling Notification

On May 21, 2026, the UK brought into force amendments to the GB CLP Regulation through SI 2026/484. The changes remove classification and labelling notification obligations, eliminate the related public database requirement, and introduce a simplified framework for mandatory classification proposals, including a fast-track route. While the core GHS classification criteria and labelling elements remain unchanged, the update is expected to streamline compliance and reduce administrative burdens for suppliers in the UK chemicals market.➡️Read more

ECHA to Disclose C&L Notifier Names on July 1!

Under the revised CLP Regulation, ECHA will begin publishing the names of notifiers and certain registrants in the C&L Inventory from July 1, 2026. Companies may request confidentiality if they can justify that disclosure would harm commercial interests, but such requests must be submitted in the IUCLID dossier before June 30, 2026. The change creates an immediate compliance deadline for businesses wishing to keep notifier identity information non-public.➡️Read more

Expansion of the UK REACH Candidate List: 15 SVHCs Officially Added

On June 15, 2026, the UK HSE added 15 substances and substance groups to the UK REACH Candidate List of SVHCs, marking the first substantive update since the Brexit transition ended. The move immediately activates legal duties for article and mixture suppliers, including substance communication, consumer-response, SDS, and possible notification obligations. For companies in electronics, food contact materials, cosmetics, textiles, and related sectors, the priority now is to review portfolios, check the 0.1% threshold, and update compliance documentation.➡️Read more

EU Publishes Packaging and Packaging Waste Regulation (PPWR) Guidance Document

On June 5, 2026, the European Commission published guidance on the Packaging and Packaging Waste Regulation, clarifying key concepts such as what counts as packaging, who qualifies as the manufacturer or producer, how import structures are treated, and how the PFAS restriction in food contact packaging will apply from August 12, 2026. For businesses, the guidance turns legal uncertainty into concrete compliance tasks around product scope, responsibility allocation, technical documentation, and packaging strategy.➡️Read more

EU Reaches Agreement on Simplifying Regulations on Cosmetics, Chemicals Labeling, and Fertilizers

On June 17, 2026, EU negotiators reached a political agreement on the Omnibus VI package covering cosmetics, CLP, and fertilizer rules. The deal would accelerate the withdrawal of cosmetics containing CMR substances, reintroduce nanomaterial notification, adjust label legibility and digital labeling rules for chemicals, and simplify parts of the fertilizer framework. For companies, the short-term benefit is clearer, more workable transition periods, but the longer-term message is the same: prepare for faster substance replacement, labeling changes, and more agile compliance planning.➡️Read more

Dual-Use Exports to the US Further Restricted: 10 US Entities Added to China's Export Control List

On June 22, 2026, China’s MOFCOM added 10 U.S. entities to the Export Control List, prohibiting exports and third-country transfers of Chinese-origin dual-use items to those parties, with immediate effect. The move directly affects business involving drones, robotics, aerospace, defense, and rare earths, and it raises urgent screening and transaction-control expectations for exporters worldwide. Companies should quickly identify listed counterparties, suspend impacted activities, and evaluate whether any exceptional licensing request to MOFCOM may be needed. ➡️Read more

Rhode Island Amends Consumer PFAS Ban Act, Adding Product Exemptions

Rhode Island’s amendment to its Consumer PFAS Ban Act gives companies clearer rules on exemptions, penalties, cosmetics trace contamination, firefighting foam, protective equipment, and product deadlines. While the law offers more flexibility through a formal exemption mechanism and confirms that unavoidable trace PFAS in cosmetics is not automatically a violation, it also reinforces upcoming restrictions beginning in 2027 and 2029. For businesses, the practical priority is to reassess product scope, documentation, labeling, and any need for exemption requests now.➡️Read more

Cosmetic news

US FDA Approves Bemotrizinol as New Sunscreen Active Ingredient

On June 9, 2026, the FDA approved Bemotrizinol for inclusion in the OTC sunscreen monograph, with the final order taking effect on August 9, 2026. It is the first new active ingredient added to the U.S. sunscreen monograph in more than two decades and is considered GRASE for use in adults and children six months and older. The approval gives sunscreen companies greater formulation flexibility and signals continued modernization of the U.S. sunscreen regulatory framework. ➡️Read more

Over 100 New Cosmetic Ingredients Filed in China in 2026

According to NMPA filing information, 10 new cosmetic ingredients completed filing between June 1 and 12, 2026, bringing the total number of new cosmetic ingredient filings in China this year to 103. The latest filings include fermentation-derived materials, plant extracts, peptides, saccharides, and specialty esters, with both domestic and U.S. companies represented. The update reflects the accelerating pace of ingredient innovation and filing activity in China’s cosmetics sector. ➡️Read more

China Released Two Mandatory National Standards Concerning Cosmetic Adverse Reactions for Public Comments

On June 15, 2026, China’s NMPA issued for public comment two draft mandatory standards on cosmetic adverse reactions: one on cosmetic cheilitis and one on cosmetic contact urticaria. The drafts set out technical criteria for identifying and handling these reactions and are intended to support China’s adverse reaction monitoring system under the CSAR. The consultation runs until August 15, 2026, and is relevant for companies reviewing internal reporting and risk-management procedures. ➡️Read more

Global Cosmetics Regulatory Updates – Vol. 39 (May 2026)

This May 2026 cosmetics roundup highlights how quickly compliance expectations are shifting in China and globally. In China, authorities moved on import/export oversight, technical standards, washing-product safety, packaging controls, and local pilot programs. Internationally, regulators advanced new rules on ingredients, labeling, GMP, advertising, and safety warnings across the EU, Canada, Australia, South Korea, Japan, Thailand, and Taiwan. For brands, the practical takeaway is to strengthen horizon scanning, update compliance systems, and plan formulations and market-entry strategies earlier.➡️Read more

Alert: New Chemical Substances in Finished Cosmetic Products May Be Brought Under Registration Management in China!

China’s June 11, 2026 draft revision of MEE Order 12 could significantly reshape cosmetics compliance by removing cosmetics from the exemption scope of new chemical substance registration. If adopted, imported finished cosmetics containing ingredients not listed in the IECSC may face additional pre-market registration requirements, while liability, reporting exposure, and penalties would also increase. For cosmetics companies, the practical priority is to screen formulations early, confirm the correct China-based applicant, and prepare for tighter environmental compliance across the full product lifecycle.➡️Read more

China Cosmetic Testing Requirements: CMA, CNAS, and ISO 17025 Explained

For cosmetic brands entering China, laboratory accreditation is not a technical detail—it directly affects whether test reports are accepted, whether studies must be repeated, and how quickly products reach the market. This article explains how CMA supports regulatory acceptance in China, how CNAS reflects technical competence aligned with ISO/IEC 17025, and why many testing programs need both. The practical takeaway is clear: choosing the wrong lab can delay registration, increase costs, and jeopardize market entry.➡️Read more

CIRS to Sponsor EFfCI’s 26th Annual Conference in Athens

CIRS is pleased to sponsor the 26th Annual Conference of the European Federation for Cosmetic Ingredients (EFfCI) to be held in Athens on September 30–October 1. The conference is a key forum for dialogue across the cosmetics value chain, covering regulatory developments, scientific progress, sustainability, and innovation. Day one will welcome a broader audience of policymakers, regulators, and industry experts, while day two will focus on in-depth technical and regulatory discussions for EFfCI members.➡️Read more

Food and food contact material (FCM) news

Food and Feed May Face New Chemical Substance Registration with China's MEE

China’s June 11, 2026 draft revision of MEE Order 12 would significantly expand China REACH by bringing products already regulated elsewhere—including food, food additives, feed, feed additives, cosmetics, pharmaceuticals, pesticides, and fertilizers—into new chemical substance registration if they are not listed in the IECSC. For food and feed businesses, that could mean parallel filings with both sector regulators and the MEE before import or market entry, making IECSC screening and registration planning immediate priorities. ➡️Read more

Weekly Summary – Updates on the Approval and Review of “Three New Foods”

China’s latest “Three New Foods” notices show how applications are moving through the system, with 16 approval notices, 40 extension notices, 16 negative review opinions, and 5 non-approvals across raw materials, additives, and food-related products. The update gives applicants a clearer read on both opportunity and risk: some ingredients are nearing commercialization, while many others still face data gaps or technical obstacles. For companies, filing quality and evidence strength will remain decisive for approval timing and market access. ➡️Read more

Medical device news

Caution: NMPA Certificate Invalidation | Full Process for Medical Device NMPA Renewal Registration

In China, renewing an NMPA medical device registration certificate may be routine, but for overseas manufacturers it is one of the most common points of compliance failure. Missing the six-month application window, overlooking change-registration sequencing, or failing to adapt to updated standards or classification changes can force a full de novo registration and interrupt sales. The key takeaway for companies is to start renewal checks early, resolve changes first, and manage agent coordination and documentation proactively to protect market access. ➡️Read more

Full-Scenario Compliance Solutions for NMPA Renewal Registration: Six Special Scenarios Including Standard Updates, Classification Adjustments, and Overdue Renewal Handling

NMPA medical device renewal becomes more complex when companies face special scenarios such as mandatory standard updates, classification changes, conditional approval obligations, overdue filings, or import-agent switches. In these cases, routine renewal rules may no longer apply, and mistakes can trigger rejection, certificate invalidation, or product withdrawal. For overseas manufacturers, the key takeaway is to assess scenario-specific risks before expiry, complete change registrations in the right order, and verify agent, standards, and post-market obligations early to preserve access to China.➡️Read more

  

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