On June 1, 2026, the EU's "One Substance, One Assessment" (OSOA) will officially take effect. For the first time, this regulation legally requires all chemicals exported to the EU to complete registration in the public database of the European Chemicals Agency (ECHA), and to fully disclose ingredient lists, substitution plans for hazardous substances of very high concern, and traceability information across three supply chain tiers. This marks a substantive shift in EU chemical regulation from 'risk control' to 'full life-cycle transparent governance', and will create systematic compliance pressure on China's chemical export system.

Event Overview

The EU's "One Substance, One Assessment" (OSOA) will officially take effect on June 1, 2026. The regulation clearly stipulates that: all chemicals exported to the EU must complete mandatory registration on the ECHA platform; complete ingredient lists must be publicly disclosed (including content ranges, impurity profiles, and excipients); feasibility analysis reports for the substitution of substances of very high concern (SVHC) must be submitted; and three-tier traceability data covering manufacturers, first-tier suppliers, and second-tier raw material sources must be provided. Products that fail to complete pre-registration will be denied customs clearance, detained at EU ports, and prohibited from being distributed or used within the EU.

Which Sub-sectors Will Be Affected

Direct trading enterprises: As the primary responsible party for exports, they must bear statutory obligations such as registration filing, document signing, and issuance of compliance declarations. The impact is directly reflected in longer customs clearance cycles (estimated average increase of 7–15 working days), higher compliance costs (estimated registration service fee of 30,000–80,000 euros per product), and increased contract performance risk (buyers have already begun incorporating OSOA compliance clauses into payment terms for new orders).

Raw material procurement enterprises: They need to obtain from upstream suppliers ingredient declarations that meet OSOA requirements, impurity testing reports, and traceability certificates for bio-based raw materials (for example, the animal species, feeding method, and slaughter certification for keratin hydrolysate used in cystine production). The traditional procurement model that relies only on COA (Certificate of Analysis) is becoming unsustainable, and some small and medium-sized raw material suppliers lacking traceability capabilities are facing the risk of being dropped by customers.

Processing and manufacturing enterprises: Although they may not export directly, if they supply EU brands as OEM/ODM manufacturers, they will be incorporated into the supply chain traceability chain. Their process parameters (such as refining temperature and solvent residue control), packaging material compatibility data, and batch stability records may all be required by downstream brand owners as supplementary submissions to support the "use description" and "exposure scenario assessment" modules in their ECHA registrations.

Supply chain service enterprises: Including compliance consulting firms, testing laboratories, and traceability certification service providers. Current demand is concentrated in ECHA registration agency services, full-panel impurity profile testing (especially trace metals and genotoxic impurities), and deployment of blockchain-based three-tier traceability systems. However, observations show that there is still a severe shortage of service providers with EU local legal entity qualifications and familiarity with the REACH-OSOA integration logic, leaving a clear supply gap in the market.

Key Focus Areas and Response Measures for Relevant Enterprises or Practitioners

Immediately initiate product classification and registration priority assessment

Not all export products require the same level of response. Enterprises should classify products into A/B/C categories based on dimensions such as annual export volume, concentration of EU customers, whether SVHC is involved, and whether the product belongs to functional amino acid chemicals (such as cystine and tyrosine). Category A products (high value, high risk, high customer dependence) must complete ECHA account setup and preparation of the first draft of technical documentation before Q3 2025.

Reconstruct raw material quality agreements and traceability files

Existing procurement contracts generally lack OSOA mandatory fields such as species identification, geographic origin, and process control for bio-based raw materials. It is recommended that, starting from Q2 2025, an "OSOA Raw Material Compliance Appendix" be embedded into newly signed agreements to clarify upstream suppliers' obligations for data provision, update frequency, and liability mechanisms for breach of contract.

Carry out baseline impurity profile studies and pre-research on substitution pathways

OSOA requires disclosure of "substitution plans for hazardous substances of very high concern". For oxidants commonly used in cystine production (such as hydrogen peroxide residues) and potential solvent residues in tyrosine extraction (such as ethanol and acetone), enterprises need to complete quantitative analysis of impurity profiles for three batches before the end of 2025, while simultaneously evaluating the feasibility boundaries of lower-risk alternative technologies such as enzymatic processes and membrane separation.

Editorial Viewpoint / Industry Observation

Observably, OSOA not only raises technical thresholds but also redefines the locus of compliance responsibility — shifting from importer-led (under REACH) to exporter-accountable. This represents a structural recalibration of global chemical trade governance. Analysis shows that Chinese amino acid exporters, long accustomed to 'commodity-grade' certification models, now face a paradigm shift toward 'pharma-grade' data discipline. It is more accurate to interpret this not as a one-off regulatory hurdle, but as the first signal of a broader trend: regional sustainability statutes (e.g., US EPA's TSCA Modernization, Japan's CSCL revision) are converging on mandatory transparency — making traceability no longer optional, but foundational.

Conclusion

The implementation of OSOA is essentially the EU's institutional arrangement to deeply embed chemical governance into its Green Deal and industrial resilience strategy. For China's chemical exports, in the short term this means increased compliance costs and operational complexity, while in the medium to long term it will accelerate and compel enterprises to shift from a "scale-oriented" approach to building a new competitiveness based on "data-driven + green credibility". A rational observation leads to this conclusion: whether an enterprise can establish a verifiable, auditable, and iterative OSOA response mechanism within 2025 will become the key dividing line between leading companies and laggards in the industry.

Information Source Notes

Official European Commission document COM(2023) 423 final; ECHA official website notice "OSOA Implementation Timeline & Guidance for Non-EU Manufacturers" (updated version in March 2025); China Petroleum and Chemical Industry Federation's "Preliminary Assessment on the Impact of OSOA on China's Fine Chemical Exports" (internal bulletin in April 2025). Note: ECHA will subsequently publish specific explanations of registration template fields and a list of impurity profile testing methods, and the relevant content remains subject to ongoing observation.