On April 19, 2026, the European Chemicals Agency (ECHA) officially added 12 new substances to the candidate list of Substances of Very High Concern (SVHCs), including two nitrogen-containing organic ligands of ethylenediaminetetraacetic acid derivatives. This update directly affects the market access and distribution of amino acid chelating agents, such as zinc glycinate and copper lysine, in the EU market, posing substantial compliance pressure on Chinese chemical, feed additive, micronutrient, and fine chemical companies engaged in the export of related products.

Event Overview

On April 19, 2026, ECHA officially announced the inclusion of 12 new substances in the SVHC candidate list. Among them are two nitrogen-containing organic ligands, belonging to the EDTA derivative category. According to Articles 7.2 and 33 of the REACH Regulation, from the date of inclusion, suppliers of articles containing ≥0.1% (by mass) of these substances in the supply chain must provide safety information to downstream recipients and consumers within six months. If the substance is subsequently included in the Annex XIV Authorisation List, authorization is required before it can be placed on the market. Currently, these substances are still in the SVHC candidate stage and have not yet entered the authorization process.

Which sub-sectors will be affected?

Direct trading enterprises

Companies whose main business is exporting amino acid chelates to the EU (such as Pengfa Biotechnology, an exporter specializing in this category) will face notification obligations if their existing product formulas involve the newly added SVHC substances or their derivatives. The main impact is that they need to complete the SVHC content declaration, update the Safety Data Sheet (SDS), and transmit supply chain information before export customs declaration; otherwise, they may be rejected by EU importers or face regulatory inquiries.

Raw material procurement companies

Companies that purchase EDTA ligands or their modified intermediates for the synthesis of amino acid chelates need to re-verify whether the substance identification information (EC number, CAS number) provided by upstream suppliers covers the newly added SVHCs. The impact is reflected in the fact that the general clauses regarding "REACH compliance" in existing procurement agreements may no longer apply, requiring the addition of specific compliance assurance clauses, and the initiation of traceability screening for historical batches of raw materials.

Processing and manufacturing enterprises

Enterprises engaged in the production of amino acid metal chelate complexes, microencapsulation, or formulations, if they use EDTA derivatives listed in this report as complexing aids or stabilizers in their processes, even if the residual amount of this substance in the final product is less than 0.1%, still need to be assessed to determine whether it constitutes an "intentional release" or "functional component" during the production process, thus affecting the classification determination. The main impact is that technical documents (such as CSRs and IUCLID files) need to be partially revised.

Supply chain service companies

Third-party organizations providing REACH compliance agency services, SDS preparation, notification submission, or authorized pre-assessment services will face a surge in client inquiries and expedited requests. The impact will manifest in a short-term increase in demand for specialized services such as toxicological and ecotoxicological data gap analysis and preliminary screening of alternative feasibility for EDTA derivatives, although no official alternative recommendation list has yet been released.

What key areas should relevant enterprises or practitioners focus on, and how should they respond at present?

Immediately verify the product's substance identification and SVHC matching relationship.

Refer to the complete list of 12 SVHCs published on the ECHA website (including EC number, CAS number, name, and structural formula), and compare each item with the ingredient declarations, raw material MSDS, and ligand types involved in the synthetic routes of the company's exported products. Pay particular attention to whether the two EDTA derivatives or their salts listed in the notification have been used. Avoid relying solely on trade names (such as "EDTA-Zn"); the specific chemical entity must be identified.

6-month countdown management for mandatory reporting to begin

For products confirmed to contain SVHCs at a concentration ≥0.1%, written notifications (including substance name, concentration range, and safe usage recommendations) must be completed with downstream customers by October 19, 2026, and notification records must be retained for at least 10 years. It is recommended to establish an internal notification ledger template and update it synchronously to the customer master data fields in the ERP or CRM system.

Distinguishing the differences in legal effect between the SVHC candidate and authorization stages

Currently, inclusion in the SVHC candidate list does not equate to a ban on use or mandatory authorization. Companies do not need to immediately cease exports, but should avoid misinterpreting this as "restricted." It is crucial to continuously monitor whether ECHA initiates a dossier review for the substance, a process that typically takes 12–24 months, which is a prerequisite for triggering an authorization application.

Prepare a technical feasibility assessment of alternative routes in advance.

While not mandatory, from a long-term compliance cost perspective, small-scale trials of the compatibility of non-EDTA ligands (such as HEDP and GLDA) in existing chelation systems can be initiated simultaneously. Note: Alternative solutions require new verification of stability, bioavailability, and compliance with EU regulations for downstream applications such as feed/food contact materials; they cannot be directly replaced.

Editor's Viewpoint / Industry Observation

From an industry perspective, this SVHC update should be understood as a targeted signal of strengthened regulation rather than a sudden compliance crisis. In recent years, ECHA has continuously strengthened its review of the entire life cycle of functional chemicals such as metal chelating agents, paying particular attention to their persistence and potential bioaccumulation in the environment. Analysis shows that EDTA derivatives, due to their high structural stability and difficulty in degradation, have long been at the top of the regulatory watch list; the inclusion of two specific derivatives this time reflects that the assessment has shifted from parent compounds to actual industrial applications. Currently, it is more noteworthy whether similar nitrogen-containing multidentate ligands will be added in future batches, and whether the EU will simultaneously tighten impurity limits for related chelates in feed additives or cosmetics.

In conclusion, this update to the REACH SVHC list is essentially a routine evolution of the EU's chemical risk management mechanism. Its industry significance lies in driving exporting companies to shift from "passively responding to notifications" to "proactively managing substance identification." While it is not an immediately effective market access barrier, it signifies that mature and widely used subcategories like amino acid chelating agents are entering a more refined stage of compliance management. Currently, it is more appropriate to understand this as a compliance baseline calibration—companies need to start with substance identification and solidify the information flow of their supply chain, rather than waiting for further policy tightening before taking action.

Information source explanation: Main source: Update announcement of the SVHC candidate list on the official website of the European Chemicals Agency (ECHA) (April 19, 2026);
The following points need to be observed: whether these 12 substances will be subsequently proposed for inclusion in the authorized list (Annex XIV), and whether they will trigger the European Commission's (EC) proposal to restrict the use of the relevant chelating agents (Annex XVII).