On 2026年5月14日, the European Chemicals Agency（ECHA）officially updated the SVHC Candidate List, adding 12 high-concern substances. This update for the first time includes organometallic compounds containing metal-amino acid coordination structures, directly affecting China's export categories of amino acid chelates such as zinc, copper, and iron, and placing substantial pressure on supply chain compliance management in segmented fields such as feed additives, cosmetic raw materials, and pharmaceutical intermediates.

Event Overview

On 2026年5月14日, the European Chemicals Agency（ECHA）issued a notice adding 12 new substances to the Candidate List of Annex XIV（SVHC Candidate List）under the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals（REACH）. Among them, 2 organometallic compounds with metal-amino acid chelate structures are explicitly included（specific EC numbers to be confirmed after publication on the ECHA official website）, whose chemical characteristics highly overlap with the mainstream amino acid chelates of zinc/copper/iron exported by China. According to Articles 7 and 33 of the REACH Regulation, from the date of inclusion, enterprises whose articles contain SVHC concentrations ≥0.1%（w/w）and whose total annual export volume is ≥1 ton must submit complete notification information to the SCIP database; downstream importers must also simultaneously fulfill their supply chain information transmission obligations.

Which Segmented Industries Will Be Affected

Direct trading enterprises: As the primary liable exporters, they must complete substance identification, concentration calculation, SCIP code generation, and data submission before export. Failure to notify in time will lead to automatic interception by the EU customs system, extending the customs clearance cycle by an average of 7–15 working days, and repeated violations may trigger investigations by market regulatory authorities in member states.

Raw material procurement enterprises: If the procured amino acid chelate raw materials are not accompanied by REACH-compliant SDS（Safety Data Sheet）and SVHC declarations, compliance information cannot be passed upstream, thereby hindering the completion of SCIP declarations for their own exported products and creating supply chain breakpoints.

Processing and manufacturing enterprises: Enterprises that use amino acid chelates as intermediates to produce feed premixes, cosmetic active ingredients, or pharmaceutical excipients may not export directly, but under Article 33 of REACH, they must provide downstream customers with the name, concentration, and safe-use recommendations of SVHC-containing substances——this means they need to trace back the SVHC disclosure status of all raw material suppliers and establish an internal substance dossier database.

Supply chain service enterprises: Including compliance consulting, testing and certification, SCIP declaration agents, and cross-border logistics service providers, business demand will increase significantly in the next 6–12 months; however, service capability differentiation will intensify, and providers offering only template-based filing services will find it difficult to meet professional requirements such as structural analysis and concentration threshold determination for metal-amino acid complexes.

Key Points of Attention and Response Measures for Relevant Enterprises or Practitioners

Immediately carry out SVHC screening of export products

Focus on common categories such as Zinc glycinate, Copper lysinate, and Iron methioninate, and compare your own product formulations and impurity profiles with the CAS numbers and structural formulas published by ECHA to confirm whether they fall within the scope of this newly added SVHC batch.

Review and update the supply chain information transmission mechanism

Launch REACH compliance questionnaires to all suppliers involving amino acid chelates, requiring them to provide SVHC declarations and the latest version of SDS（including Section 3 composition information and Section 15 regulatory compliance statements）, and establish a dynamically updated ledger to ensure that SCIP declaration data is traceable and verifiable.

Assess the feasibility and time window of substitution solutions

For products already confirmed to fall within the SVHC list, simultaneously initiate technical evaluations of substitution routes using non-chelated inorganic salts or new organic ligands（such as hydroxy acid types）; note that substitute substances themselves must also undergo SVHC screening, and the performance verification cycle for new formulations, such as stability and bioavailability, is usually no less than 3 months.

Prioritize completion of initial registration in the SCIP database

Enterprises not yet registered in the SCIP system should complete account activation, enterprise identity verification, and basic data import before the third quarter of 2026; registered enterprises must complete supplementary declaration of information for products corresponding to this newly added SVHC batch before 2026年11月30日 to avoid missing the grace period deadline set by ECHA.

Editorial Viewpoint / Industry Observation

Observably, this SVHC update marks a structural shift in EU regulatory focus—from classical persistent/toxic substances toward functionally complex organic-metal coordination compounds. Analysis shows that the inclusion criteria now explicitly consider ‘structural features enabling bioaccumulation or endocrine disruption potential’, rather than relying solely on hazard endpoints. From an industry perspective, the real challenge lies not in data submission per se, but in the lack of standardized analytical protocols for quantifying metal-amino acid chelates in multi-component matrices—a gap currently forcing reliance on supplier declarations with limited verification pathways. It is more appropriate to understand this as a signal of escalating upstream due diligence expectations, rather than a one-off compliance hurdle.

Conclusion

This SVHC update is not an isolated event, but a key step in the evolution of EU chemicals regulation toward “molecule-level precise control”. For enterprises, compliance has shifted from back-end declaration to front-end R&D collaboration and full-chain data governance. Rationally speaking, short-term pressure objectively exists, but enterprises with substance identification capabilities, supply chain transparency, and rapid response mechanisms may instead use this opportunity to strengthen technical barriers and customer trust, transforming regulatory costs into differentiated competitiveness.

Information Source Notes

European Chemicals Agency（ECHA）official website announcement（2026-05-14, Ref: ECHA/PR/26/08）; original text of the REACH Regulation（(EC) No 1907/2006）Articles 7, 33, and 59; SCIP database operation guide（v3.2, revised edition of 2026年4月）. Continued observation is required regarding: whether ECHA will issue dedicated technical guidance for metal-amino acid substances; whether EU member state customs authorities will introduce transitional implementation rules; and whether this category of substances will enter the Authorisation List（Annex XIV）during the 2027 SVHC evaluation process.