In-depth analysis of global chemical regulations for coatings: GHS (Good Manufacturing Practice) classification and labelling system for chemicals / SDS (Section 16) drafting / Comparison of EU Poison Centre Notifications (PCN/UFI codes) with chemical regulations in Asia-Pacific countries

Introduction: The “hexagonal red-bordered pictogram” on a paint can — GHS, the global chemical language

A pail of coating exported to the EU—the red-bordered pictograms (diamond/white background) on its label—such as flame (flammable), exclamation mark (health hazard), dead fish and dead tree (environmental hazard) are the globally harmonized GHS chemical hazard “visual language”. Workers and firefighters in any country—without needing to understand a foreign language—upon seeing this “dead fish and tree” pictogram—know that this product is “toxic to aquatic organisms—must not be discharged into sewers/rivers/lakes”. GHS (UN Globally Harmonized System of Classification and Labelling of Chemicals / UN Purple Book / released in 2003—revised every 2 years) is the “first hurdle” of coating export compliance. The GHS implementation versions of different countries/regions (GHS Rev.6 vs Rev.8) and the “localization differences” (e.g., Japan’s workplace GHS—which differs from the UN classification standards) are the most basic yet most complex compliance “maze” for coating enterprises in their internationalization.

I. The three major GHS hazard classification categories (>29 hazard classes)

FAQ

Q1: The “Confidential Business Information” (CBI) in Section 3 (Composition/Ingredient Information) of the SDS (Safety Data Sheet) — How to protect the formula while remaining compliant?Section 3 of the SDS must disclose: (1) The chemical name + CAS number + concentration/concentration range (e.g., 10-20%) of hazardous components that reach the GHS classification threshold — even if this component is the company’s “core formula secret,” compliance > confidentiality — must be disclosed; (2) Components that do not reach the GHS classification threshold — the chemical name may not be disclosed — replace it on the SDS with “Confidential Component/Perfume” etc. — this is the company’s “legal window” for formula confidentiality. The balance between compliance and confidentiality — (1) Keep key components of the core formula (functional additives/special resins) below the GHS classification threshold to be legally “concealed” under the CBI clause; (2) For components that inevitably need to be disclosed (e.g., xylene solvent) — their concentration is already an “open secret” in the industry with no confidentiality value — disclose directly.

Q2: The UFI code for EU PCN (Poison Centre Notification) — why must this 16-digit code be printed on the SDS and label?The UFI (Unique Formula Identifier) is used by poison centres of EU member states to quickly identify the exact product formulation (rather than a “generic formulation” of similar products) that the poisoned person was exposed to when receiving emergency calls about “poisoning incidents” (accidental ingestion/skin contact/inhalation of paint), so that the poison centre can provide precise first-aid guidance. The UFI code is automatically generated after the company submits the product formulation information via the ECHA Poison Centre Notification Portal (PCN Portal) — it must be printed in Section 1.3 of the SDS and on the product label.

Q3: GHS’s “Building Block Approach” — do different countries “pick” different hazard classes?GHS is a “menu” from which countries “select” the hazard classes and classification criteria applicable to themselves — (1) EU — fully adopts GHS (all hazard classes — CLP Regulation / EC 1272/2008 — aligned with GHS — the most comprehensive GHS implementation); (2) US partial adoption (OSHA Hazard Communication Standard 2012 — adopts GHS Rev.3 — but retains some US-specific classifications / e.g. “combustible dust” is not a GHS standard hazard class); (3) China — GB 30000 series — generally adopts GHS — but its classification criteria have a “version gap” with the latest GHS (Rev.8) (lag period > 2–4 years). Exporting to different countries — requires classification according to that country’s GHS version — the same product may have “different hazard classifications” for different countries. This is the practical complexity of GHS’s “Building Block Approach”.

Q4: SDS’s “Section 16” (Other Information)——Writing Tips and Common Mistakes?Section 16 “Final Summary” (1) State the SDS’s revision date and revision content (e.g., “Section 3——Component update——Added a certain CAS number”)——to help customers understand the SDS’s “version changes”; (2) List abbreviations and acronyms (e.g., PBT/vPvB/DNEL/PNEC——non-chemistry professionals——these “chemical codes” need explanation); (3) Disclaimer “The information in this SDS is based on our current knowledge——for reference on safe use only——does not constitute a guarantee of product performance” is a legal protection clause.

Q5: What is the relationship between the “entries” of China’s “Catalog of Hazardous Chemicals” (2015 edition/2828 types) and the “Catalog of Highly Toxic Chemicals”?The Catalog of Hazardous Chemicals (2015)——(1) Chemicals listed in the catalog must use GHS labels + SDS——register in the “Hazardous Chemical Registration Management System”——this is the statutory prerequisite for the production/import/operation of the chemical; failure to register > fines > production halt; (2) “Highly toxic chemicals” (>100 types)——require special permits (for purchase/transport/storage of highly toxic substances)In the coatings industry——currently mainly involve certain organotins (tributyltin TBT/already banned) and certain isocyanates (such as TDI/listed in the highly toxic catalog——requires special permit)China’s management of highly toxic substances is far stricter than the GHS health hazard classification (not all GHS “toxicity categories 1-2” are “highly toxic”)——this is China’s specific “regulatory threshold”.China’s hazardous chemical catalog——(1) Coatings production enterprises——must confirm that their products are not “highly toxic” (otherwise special permits are required)——conventional industrial coatings (epoxy/PU/acrylic) are not “highly toxic” (2) TDI-containing curing agents——TDI is listed in the highly toxic catalog——TDI-type curing agents require highly toxic substance purchase/storage/transport permits (apply to public security authorities)This is a compliance headache for Chinese curing agent enterprises.

Q6: What are the differences between the “registration” and “evaluation” under South Korea’s K-REACH (Chemical Control Act) and China’s REACH (MEE Order 12)?K-REACH (2015)is stricter than EU REACH(1)All existing chemical substances (>51,000 types—by 2024) andnew chemical substances (>1 ton/year)must be registeredwith no tonnage threshold(China and EU REACH—>1 ton/year);(2)K-REACH’s registration fee (>KRW/type) + testing fee (>100,000–1,000,000 USD/type)is a huge economic burden under K-REACH—blockinglarge numbers of chemicals from developing countriesfrom entering the Korean market—South Korea has in fact become a“chemical barrier”(3)China’s MEE Order 12 (2021)—similar to the EU REACH framework—>1 ton/year requires registrationwith costs far lower than K-REACHis an intermediate transition for China’s chemical management from “lenient” to “strict”—still relatively “lenient” compared to K-REACH but tightening every year.

Q7: Japan’s dual regulatory system of “Chemical Substances Control Law” (CSCL/1973) and “Industrial Safety and Health Law” (ISHL/1972)?CSCLnew chemical substances‘s “pre-market review” is similar to REACH in various countries. ISHLworkplace chemical safety management——(1) All chemicals used in the workplace——employers must provide SDS (in Japanese) to employees + conduct risk assessment; (2) Japan’s “GHS implementation” does not fully adopt UN GHS Japan has “JIS Z 7252:2019” (Japanese GHS classification standard) Differences from UN GHS——(a) Japan’s “flammable liquids” flash point threshold is different from UN GHS (e.g.——Japan——flash point <70°C is "flammable liquid"/UN GHS——flash point <23°C is "extremely flammable" 23-60°C is "flammable") Therefore, the same product may have different GHS labels in Japan and the EU——SDS must be prepared separately according to the target market.

Q8: The “fragmentation” and “rapid evolution” of chemical regulations in Southeast Asian countries (Thailand/Vietnam/Indonesia)?Thailand——Hazardous Substance Act (1992/2019 amendment)——(1) Type 1-3 classification——>Type 3——requires production/import license; (2) Thai GHS——adopts UN GHS Rev.4 as a whole——but implementation is slow. Vietnam——Law on Chemicals (2007)——(1) All chemicals must be registered with the Vietnam Chemicals Agency (VINACHEMIA)——(2) GHS——Vietnam adopts UN GHS Rev.5——mandatory. Indonesia——(1) Multiple departments in charge (Ministry of Industry/Ministry of Environment/Health/Labor) regulations are “fragmented”——companies need to communicate with multiple departments simultaneously; (2) Indonesian language——all SDS and labels must be translated into Indonesian. Chemical regulations in Southeast Asian countries are rapidly evolving from “no rules”→”with rules”. Coating companies exporting to Southeast Asia——need multi-country compliance teams. The regulatory differences among countries——”one product/multiple SDSs (in various national languages)” is the most complex compliance management challenge in internationalization.

Q9: GHS “version differences” (UN GHS Rev.6 vs Rev.8)——”classification upgrade” of the same product at different periods?GHS is updated every 2 years——a new version may——(1)add new hazard classes (e.g., Rev.7 added “desensitized explosives”); (2)modify thresholds of existing classifications (e.g., Rev.8’s classification criteria for “respiratory sensitization”——added “subcategory 1B”, more chemicals included in “sensitization” classification)——products labeled “free of sensitizing substances” under the old version——may be reclassified as “contains sensitizing substances (Sensitizer Category 1B)” under the new version——classification “upgrade”——the company’s SDS and labels must be re-prepared——failure to update promptly——constitutes a “misclassification” violation.