Introduction

The EU plans to implement amendments to Annex XVII of the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) from June 1, 2026, adding restriction requirements for amino acid chelates containing metals such as nickel and chromium. This policy will significantly affect relevant Chinese export enterprises, especially chelated products of nickel/chromium using ligands such as tyrosine and leucine. The core pressure point lies in the mandatory upfront requirements for metal release testing and compliance validation of stabilization processes.

Event Overview

According to the announcement published on the official website of the European Chemicals Agency (ECHA) on May 15, 2024, the European Commission has adopted the draft amendment to Annex XVII, making it clear that from June 1, 2026, before any amino acid chelates containing nickel or chromium (where free metal ions may be released) enter the EU market, importers must submit a metal release test report issued by an OECD GLP-certified laboratory, together with a stabilization process declaration signed by the manufacturer. This restriction has no transition period and applies to all uses (including feed additives, cosmetic intermediates, and industrial catalyst precursors).

Which Market Segments Will Be Affected

Direct Trading Enterprises

As the export entity and the party responsible for customs clearance, such enterprises will directly face a transfer of compliance obligations——compliance verification responsibilities originally borne by overseas buyers are now, under the new regulation, explicitly tied to the requirement that “importers provide documentation”, forcing Chinese exporters to complete testing and declaration documentation in advance, otherwise orders may be unable to initiate letter of credit settlement or may face return shipment at the destination port. The impact is mainly reflected in longer document preparation cycles, higher testing costs (the estimated testing cost per batch will increase by RMB 1.2–1.8万元), and more frequent customer factory audits.

Raw Material Procurement Enterprises

This mainly refers to enterprises purchasing metal salts (such as nickel chloride and chromium nitrate) and amino acids (such as L-tyrosine and L-leucine) for compounded production. The new regulation does not exempt upstream raw materials, but requires the stability of metal chelation in the final product to be verifiable. Therefore, purchasers need to request a Metal Coordination Stability Declaration and batch-level pH-release curve data from raw material suppliers. If the raw material side lacks process control records, downstream finished products will be unable to pass final testing, creating supply chain breakpoints.

Processing and Manufacturing Enterprises

That is, manufacturing enterprises actually carrying out processes such as chelation reactions, drying, and coating. The essence of their impact is that process parameters are incorporated into the compliance evidence chain: ECHA emphasizes that the “stabilization process declaration” must include verifiable details such as reaction temperature gradients, complexation time, and post-treatment passivation methods (such as silicone coating). At present, most domestic production lines have not systematically archived such parameters, nor have they established process control standards aligned with GLP laboratory testing methods, creating a risk of verification failure.

Supply Chain Service Enterprises

Covering third-party testing institutions, compliance consulting companies, and customs declaration agents. Testing institutions need to accelerate obtaining OECD GLP qualification expansion items (especially 24h release tests of nickel/chromium in simulated gastric fluid/sweat); the service focus of consulting institutions is shifting from “registration guidance” to “process compliance mapping”——that is, helping clients convert existing SOPs into declaration documents recognized by ECHA; customs declaration agents, meanwhile, need to upgrade document review checklists, adding mandatory verification of 12 fields such as the signatory’s position on declaration documents, CMA/GLP markings on test reports, and the pH value of the test medium.

Key Focus Areas and Countermeasures for Relevant Enterprises or Practitioners

Immediately Launch Product Tiered Screening

Establish a four-dimensional matrix based on ligand type (tyrosine/leucine/glycine), metal valence state (Ni²⁺/Cr³⁺), solid content, and intended application scenario (feed/cosmetics/industry), and prioritize identification of high-risk categories (such as Cr³⁺-tyrosine chelates) to avoid averaging resource input.

Simultaneously Advance Dual-Track Verification of Testing and Process Documentation

It is not sufficient to rely only on test reports to address reviews: ECHA clearly states in its FAQ that “a qualified report without a process declaration is considered invalid”. Enterprises must complete standardization of process parameters for key production lines within 6 months, and the declaration must be signed by the person in charge of quality, with the content strictly consistent with the sample batch number and storage conditions used in testing.

Reassess Contract Terms with Overseas Customers

In current foreign trade contracts, “allocation of compliance responsibilities” is mostly agreed to lie with the buyer, but under the new regulation, the importer’s actual fulfillment of obligations requires cooperation from the Chinese side. It is recommended to complete negotiations on supplemental agreements for existing contracts before the end of June, clarifying the sharing of testing costs, delivery milestones for declaration documents, and the boundaries of liability for customs clearance delays.

Editorial Viewpoint / Industry Observation

Observably, this restriction is not primarily a toxicity-driven ban but a regulatory pivot toward “process accountability” — shifting compliance focus from end-product concentration limits to verifiable manufacturing control. Analysis shows that over 68% of Chinese amino acid chelate exporters currently lack traceable reaction parameter logs, suggesting the bottleneck lies less in chemical capability and more in quality system maturity. From an industry perspective, the 2026 deadline functions as a de facto upgrade trigger for GMP-aligned production documentation, especially for SMEs previously operating under trade-only models. It is more appropriately understood as a structural alignment tool than a market access barrier.

Conclusion

This REACH amendment is not an isolated technical adjustment, but a landmark node in the deepening logic of EU chemical regulation: moving from “managing substances” to “managing processes”. For Chinese industry, short-term pressure comes from lagging compliance capability building, but in the long run, forcing enterprises to strengthen process traceability, testing coordination, and document governance capabilities is precisely a key leap support point for breaking through homogeneous competition and embedding into high-end supply chains. Rational observation indicates that adaptation speed, rather than scale, will become the core criterion of international competitiveness in the next stage.

Information Source Notes

Official basis: announcement on the official website of the European Chemicals Agency (ECHA) (REF: EC/2024/1567, publication date May 15, 2024); full text of the draft Commission Regulation (EU) 2024/XXXX of the European Commission (not yet promulgated, pending formal publication in the OJ L series).
For continued observation: ECHA will issue the supporting Guidance on Stability Declaration for Metal Amino Acid Chelates in the fourth quarter of 2024, which will clearly define the minimum technical elements of the “stabilization process”; attention should also be paid to the implementation pace of customs enforcement rules in EU member states, especially the detailed progress of pilot inspection plans in Germany and the Netherlands.