On 2026年5月16日, the European Chemicals Agency (ECHA) officially issued a notice of amendment to the REACH Regulation, adding restrictions on the use and placing on the market of amino acid chelates containing heavy metals such as nickel and chromium. This adjustment will take effect from 2026年6月1日 and will significantly impact all links in China’s amino acid chelate export industry chain, especially creating substantial compliance pressure for small and medium-sized export enterprises and customized production suppliers that rely on the EU market.

Event Overview

On 2026年5月16日, the European Chemicals Agency (ECHA) officially issued a notice of amendment to the REACH Regulation, adding restrictions on the use and placing on the market of amino acid chelates containing heavy metals such as nickel and chromium (such as nickel glycinate and chromium glutamate), requiring that from 2026年6月1日, all such products exported to the EU must complete SVHC candidate list relevance assessment and mandatory notification in the SCIP database.

Which Segments of the Industry Will Be Affected

Direct trading enterprises: As export entities serving end customers or distributors in the EU, they need to bear primary responsibility for product compliance. Under the new regulation, products that have not completed SVHC assessment and SCIP notification will be unable to clear customs, directly affecting order delivery cycles and contract fulfillment capability; some enterprises have not previously established a chemical compliance documentation system and will face multiple operational bottlenecks in the short term, including document completion, supplemental testing, and coordination with notification agents.

Raw material procurement enterprises: These mainly refer to upstream suppliers providing metal salts (such as nickel chloride and chromium nitrate) or amino acids (such as glycine and glutamic acid) to downstream chelate manufacturers. Although they do not export directly, the impurity profile, heavy metal residue levels, and traceability documents of their raw materials (such as declarations of conformity and batch analysis reports) will become key inputs for downstream SVHC assessments; if raw material specifications do not cover the new limit requirements, this will trigger revalidation of the entire supply chain.

Processing and manufacturing enterprises: This includes manufacturers producing amino acid chelates using hydrochloric acid hydrolysis, enzymatic hydrolysis, or coordination synthesis processes. The new regulation specifically states that “customized chelates” are also within the scope of supervision, meaning that non-standard models and small-batch trial samples must likewise fulfill SCIP notification obligations; differences in process routes (such as whether recycled metal sources are introduced and whether chromium-containing catalysts are used) will directly affect SVHC identification conclusions, forcing enterprises to carry out a reassessment of process compliance.

Supply chain service enterprises: These include testing laboratories, compliance consulting agencies, customs declaration agents, and SCIP notification service providers. Demand will surge sharply in the short term—especially a clear preference for service providers with REACH SVHC screening experience, familiarity with ECHA system operations, and the ability to provide Chinese-English bilingual technical documentation support; however, the current number of institutions capable of providing full-process services is limited, and service response cycles have generally been extended to 10–15 working days.

Key Focus Areas and Response Measures for Relevant Enterprises or Practitioners

Immediately initiate preliminary screening of existing export products for SVHC relevance

Based on the substance structural characteristics listed in the annex to ECHA’s latest notice, compare the coordination forms and free-state content of metal elements such as nickel and chromium in the company’s products to make a preliminary judgment on whether they fall within the regulatory scope; focus on nickel glycinate, chromium glutamate, zinc lysinate (if nickel impurities coexist), as well as any compounds containing free or weakly bound hexavalent chromium/nickel.

Review and upgrade the underlying data chain required for SCIP notification

Ensure that each exported product has complete composition information (CAS number, concentration range), safety data sheet (SDS), upstream raw material traceability records, and third-party test reports (especially total metal content and leachable metal content measured by ICP-MS). SCIP notification no longer accepts vague descriptions (such as “≤1%” and “trace amount”), and quantified ranges must be provided according to the ECHA template.

Assess the impact of the production process on SVHC formation pathways

For enterprises using hydrochloric acid hydrolysis or high-temperature complexation processes, it is necessary to verify whether reaction by-products, metal leaching from equipment, and residual heavy metals in recovered solvents may form new SVHC-type substances; where necessary, simulated migration tests should be carried out to support the technical justification of “no SVHC release risk”.

Reserve at least 4 weeks of buffer time for notification system debugging and document review

The ECHA SCIP system has strict validation rules for uploaded file formats, character encoding, and field logic; first-time notifying enterprises are often rejected due to issues such as mismatched SDS versions, incorrect CAS number entries, and inconsistent concentration units. It is recommended to prioritize service providers that have already passed ECHA-certified interface integration and complete test notifications in advance.

Editorial Viewpoint / Industry Observation

Observably, this amendment marks a structural shift from substance-by-substance restriction tofunction-driven regulation: ECHA is no longer targeting only the metal ions themselves, but their specific chelated forms that enhance bioavailability—and thus potential systemic exposure. Analysis shows that amino acid chelates were previously treated as “low-concern” due to presumed low bioaccessibility; the new clause signals a growing regulatory focus on speciation-dependent toxicity, especially for nutrients marketed in feed, food supplements and agrochemicals. From an industry perspective, it is more accurate to interpret this not as a technical barrier alone, but as a signal of converging regulatory expectations across EU’s Chemicals Strategy for Sustainability (CSS) and its ‘zero pollution’ ambition—where functional performance can no longer override exposure-based risk assessment.

Conclusion

This REACH amendment is not an isolated technical adjustment, but an important milestone in the evolution of the EU chemical governance system toward “full life-cycle exposure control”. For China’s amino acid chelate industry, the short-term challenge lies in rising compliance costs and disruptions to export rhythm, but in the long run, it will force enterprises to establish systematic compliance capabilities spanning raw material selection, process control, and data management, and may accelerate the industry’s shift from price competition to competition in quality credibility and data reliability. Rational observation indicates that enterprises capable of embedding SVHC assessment into the front end of R&D and realizing integrated management of testing-notification-traceability will gain a more sustainable market access advantage in the new round of regulatory adaptation.

Information Source Statement

Official source: announcement on the official website of the European Chemicals Agency (ECHA), "Annex XVII Amendment (2026/XX) on Amino Acid Chelates Containing Nickel and Chromium" (publication date: 2026-05-16, document number to be officially assigned by ECHA); Article 67 of the REACH Regulation and the latest draft amendment to Annex XVII (May 2026 version).
Content pending continued observation: whether ECHA will subsequently issue supporting guidance (such as "Chelate-Specific SVHC Screening Protocol"), the actual interception rate by customs authorities of member states for products missing SCIP notification, as well as the progress of judicial interpretation by the EU courts regarding the legal characterization of “chelate vs. complex vs. salt”.