CIRS Regulatory Newsletter | October 2026 – Regulatory Updates (II) - Newsletter

⭐Editor’s picks – key regulatory developments

EU Proposes Approval of Ethanol as a Biocidal Active Substance

The EU has notified the WTO of a draft measure approving ethanol for biocidal Product‑Types 1, 2 and 4, with a minimum purity of 92.6% w/w and an approval window from May 1, 2028 to April 30, 2038. As noted, Product‑Type 1 requires particular attention to toddler exposure, while Product‑Types 2 and 4 impose Article 58(3) treated‑article labeling obligations. Adoption is expected in February 2027, with WTO comments due November 23, 2026. ➡️Read more

Türkiye KKDIK Update: Pre-Registration Closes with over 42,000 Dossiers Submitted

Following the September 30, 2026, KKDIK pre‑registration deadline, Türkiye has shifted to full regulatory enforcement, confirming that chemicals entering the market must carry a valid registration or temporary application number. Over 42,000 applications have been submitted, forming the national inventory. Companies must prepare for the December 31, 2026, full‑registration deadline for ≥1,000‑ton and high‑hazard substances, ensure fee payment within 15 days, and verify OR coverage to avoid customs detention or loss of market access. ➡️Read more

Vietnam Releases Draft Decree on Management of Cosmetics, Proposed to Take Effect on January 1, 2027

Vietnam’s draft Cosmetics Management Decree proposes a full regulatory overhaul, including a new Management Number system, Group A–C risk classification, enhanced import controls (CFS and GMP evidence), updated notification rules and expanded post‑market obligations. As noted, imported products will clear customs “through online verification of the Management Number status,” and changes to names, uses, or production sites will require re‑notification. Transitional provisions allow existing numbers to remain valid until the end of 2028. Comments close November 1, 2026.➡️Read more

China SAMR Seeks Public Comment on Draft Amendment to the Food Safety Law

SAMR’s draft amendment significantly expands China’s Food Safety Law, adding new sections, revising 93 articles, and strengthening oversight across production, online food operations, school food safety and cross‑border e‑commerce. The draft promotes “Internet + AI” regulation, mandates surveillance at key risk points, tightens labeling and inspection rules, and introduces differentiated penalties and personal liability. Infant and young children complementary foods are formally incorporated into the special‑foods framework. Public comments close November 10, 2026.➡️Read more

The draft Law amendment also proposes streamlined registration pathways for health foods, simplified procedures for first‑time imported products using catalog ingredients, and updated mandatory label wording. ➡️Read more

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

💻Free webinars

🦠Biocides news

EU Proposes Approval of Ethanol as a Biocidal Active Substance

🧪Chemical news

💄Cosmetic news

🍽Food and food contact material (FCM) news

Free webinars

South Korea GHS Compliance: 2026 Updates for K-REACH, SDSs and Labels

South Korea’s chemical hazard communication requirements are changing. For companies supplying chemicals to the Korean market, understanding the latest K-REACH, GHS, SDS, and labeling requirements is essential for maintaining compliance.

Join CIRS Group and EPY S.R.L. for a practical 60-minute webinar covering the key regulatory changes affecting chemical companies in South Korea in 2026.

Date: Wednesday, October 21, 2026
Time: 10:00–11:00 AM BST

Introduction to Melanin Research & Skin Barrier Repair: In-vitro Model Construction and Efficacy Evaluation

The webinar will demonstrate how in‑vitro efficacy evaluation—using 2D cell assays, reconstructed 3D skin models and visualized endpoints—supports scientific validation of cosmetic actives, formulations and finished products. The session highlights “melanin research and skin barrier repair,” with Cecilia Feng presenting hierarchical evaluation models, case studies and methods for translating lab data into market‑ready claims.

Date: Wednesday, October 28, 2026
Time: 09:00–09:30 GMT.
Register and find out more here

Biocides news

EU Proposes Approval of Ethanol as a Biocidal Active Substance

Chemical news

South Korea NICS Revises GHS Classification and Labeling Regulation: 38 Substances Added, Updates Due by July 1, 2027

NICS Notification No. 2026‑17 adds 38 substances—ranging from phosphoric acid and barium salts to piperazine, organic peroxides and vanadium pentoxide—to Annex 4 of Korea’s GHS classification list, while revising 9 existing entries. As stated, the update “takes effect on the date of issuance,” with a labeling transition period until July 1, 2027. Companies exporting or using affected chemicals must update hazard classifications, pictograms, H‑codes, M‑factors and SDSs, and monitor future NICS amendments.➡️Read more

Türkiye KKDIK Update: Pre-Registration Closes with over 42,000 Dossiers Submitted

California Proposes Adding Herbicide Atrazine to Proposition 65

OEHHA has proposed adding Atrazine to California’s Proposition 65 list after confirming it meets statutory criteria based on IARC’s carcinogen classification. As noted, the comment period runs until November 9, 2026, but is limited to whether IARC has identified Atrazine as a carcinogen. If listed, businesses must provide exposure warnings within one year and prevent discharges into drinking‑water sources within 20 months. Companies using Atrazine should begin evaluating exposure pathways and compliance controls.➡️Read more

ECHA Officially Publishes Its Opinion on the Classification of Trifluoroacetic Acid (TFA) and Its Salts

ECHA’s final CLH opinion confirms that TFA and its inorganic salts will be classified as PMT, vPvM and Repr. 1B substances, with tightened acute‑toxicity values and new hazard statements (H360Df, EUH450, EUH451, EUH071). As noted, the opinion has been “submitted to the European Commission,” which will determine inclusion in Annex VI of CLP. Companies should prepare for updated labels, SDS revisions, supply‑chain communication and potential REACH restrictions once adopted.➡️Read more

Japan's Three Ministries Release CSCL Violation Cases: Unnotified New Chemical Substances Face Immediate Halt

Japan’s ministries have published a detailed compilation of CSCL violations, outlining common errors—from misjudging new chemical substances and exceeding confirmed quantities to poor coordination with overseas suppliers—and the countermeasures required to prevent them. As noted, new substances “must not be manufactured or imported without completing required procedures,” and simplified schemes still require strict quantity and lead‑time management. Companies should centralize volume tracking, strengthen cross‑departmental controls, and conduct regular audits to maintain compliance. ➡️Read more

Cosmetic news

China NIDC Seeks Public Comments on Updated Information of 913 Existing Cosmetic Ingredients

NIDC has refined CAS numbers, structural formulas, molecular formulas and molecular weights for 913 existing cosmetic ingredients and opened a public‑comment window until November 25, 2026. As noted, the finalized data will become “an important basis” for formulation development, ingredient quality control, registration and filing. Cosmetic enterprises should evaluate changes against current use, update internal databases and submit comments through the Information Platform for Existing Cosmetic Ingredients. ➡️Read more

China NIDC Released the Guiding Principles for the Determination of New Cosmetic Ingredients in China for Public Comment

NIDC has published draft Guiding Principles for the Determination of New Cosmetic Ingredients, establishing a unified approach for evaluating substance identity, intended use and safety risks. The principles “apply to the evaluation and supporting research of all new cosmetic ingredients” and must be followed alongside existing regulations. Companies should review ingredients under development, assess submission pathways and plan early compliance before the October 25, 2026 comment deadline.➡️Read more

China NMPA Issued Rules for Implementing Revisions to the STSC for Cosmetics: Comparison with Draft for Comments

NMPA’s Announcement No. 99 (2026) finalizes implementation rules for the revised STSC, detailing compliance pathways for registered/filed products, items under technical review and new submissions. The final version adds refined terminology, clearer enforcement dates and new provisions on test‑method alignment, fragrance adjustments and change‑application timing. Manufacturers must conduct self‑inspections, plan formula updates, and ensure dossiers—including IFRA documentation—are updated before enforcement. The rules now explicitly cover toothpaste. Our article compares the draft and the final version. Read more

Philippines FDA Seeks Comments on Draft Inspection Mode Rules for Health Product Establishments, Including Cosmetics

The Philippine FDA’s draft Circular proposes a risk‑based inspection framework for health‑product establishments, introducing on‑site, remote and hybrid inspections. As noted, all initial LTO applications and major variations “shall in all cases be subject to on-site inspection,” while companies with strong compliance records may be eligible for remote inspections. The draft also confirms that home‑based cosmetic operations fall under inspection scope. Comments are open until October 27, 2026. ➡️Read more

Philippines FDA Pilots Automatic Notification System for Cosmetic Products

The Philippine FDA’s Advisory No. 2026‑1544 introduces a pilot automatic notification system enabling immediate CPN issuance for select cosmetics. As emphasized, acceptance “does not constitute… prior technical evaluation,” and products must still meet all ACD requirements. Pilot products will undergo immediate post‑market surveillance, including PIF audits, recalls and verification checks. MAHs must maintain full documentation and ensure formulas and claims comply, as non‑conformities may lead to suspension or cancellation. The pilot may expand to additional categories. ➡️Read more

Vietnam Releases Draft Decree on Management of Cosmetics, Proposed to Take Effect on January 1, 2027

Vietnam’s draft Cosmetics Management Decree proposes a full regulatory overhaul, including a new Management Number system, Group A–C risk classification, enhanced import controls (CFS and GMP evidence), updated notification rules and expanded post‑market obligations. As noted, imported products will clear customs “through online verification of the Management Number status,” and changes to names, uses or production sites will require re‑notification. Transitional provisions allow existing numbers to remain valid until end‑2028. Comments close November 1, 2026.➡️Read more

Food and food contact material (FCM) news

CIRS Supports Kingdomway in Obtaining a “FDA Has No Questions” Letter for Brazzein

With CIRS support, Kingdomway has secured an FDA “No Questions Letter” for fermentation‑derived brazzein, confirming the agency’s acceptance of its GRAS conclusion. As noted, brazzein is a “naturally occurring sweet‑tasting protein… 500–2000 times sweeter than sucrose,” and precision fermentation enables scalable, cost‑effective production. The decision strengthens Kingdomway’s position in the global high‑intensity sweetener market and aligns with industry demand for clean‑label, sugar‑reduction solutions. The Letter will facilitate U.S. and international commercialization➡️Read more

Entering China: A Five Part Video Guide for International Dietary Supplement Brands

To support international supplement brands entering China, CIRS and HPA‑Global have released a five‑part video series addressing key regulatory hurdles—from general trade vs. CBEC and direct shipping vs. bonded warehouses to GACC manufacturer registration and China’s Blue Hat system. As noted, choosing the wrong pathway “can cost companies significant time and money.” The series also outlines common mistakes, timelines and costs. CIRS provides full regulatory support across health food registration, Three New Foods, GRAS, NDI and global novel‑food pathways. ➡️Read more

Major Upgrade to China's Regulation of Complementary Foods for Infant and Young Children: Classified as Special Foods and Subject to Strict Filing Requirements

China’s draft Food Safety Law amendment would bring infant and young children complementary foods under the special‑foods regulatory framework, requiring manufacturers to file detailed information on ingredients, formulas, processes, labels and packaging. As noted, these products “share the same target population as infant formula,” and a filing system balances strict oversight with practical industry realities. The reform establishes full‑chain safety management and aims to standardize the sector while preventing excessive compliance burdens.➡️Read more

China SAMR Seeks Public Comments on Draft Amendment to the Food Safety Law: Health Food Filing Process Expected to Be Simplified

SAMR’s draft amendment introduces notable updates for health foods, including risk‑based on‑site registration inspections, simplified review procedures for first‑time imported products using catalog ingredients, and revised mandatory label wording. As noted, imported health foods using catalog ingredients “may be appropriately simplified,” offering meaningful efficiency gains. The new label requirement—“Health foods are not drugs and cannot replace drugs in treating diseases”—will require updates to precaution statements in future submissions. ➡️Read more

China SAMR Seeks Public Comment on Draft Amendment to the Food Safety Law

SAMR’s draft amendment significantly expands China’s Food Safety Law, adding new sections, revising 93 articles, and strengthening oversight across production, online food operations, school food safety and cross‑border e‑commerce. As noted, the draft promotes “Internet + AI” regulation, mandates surveillance at key risk points, tightens labeling and inspection rules, and introduces differentiated penalties and personal liability. Infant and young children complementary foods are formally incorporated into the special‑foods framework. Public comments close November 10, 2026.➡️Read more

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