The EU plans to mandatorily implement the newly added Entry 79 restriction clause under Annex XVII of the REACH Regulation from June 1, 2026, targeting amino acid chelates containing metals such as cobalt, copper, and nickel. This adjustment will directly affect Chinese exporters of amino acid chelates to Europe, especially those involved in niche sectors such as feed additives, agrochemicals, daily chemical auxiliaries, and electroplating intermediates, as the compliance preparation window has entered the countdown stage.

Event Overview

According to the announcement published on the official website of the European Chemicals Agency (ECHA) on April 21, 2024, Annex XVII of the REACH Regulation will add Entry 79, setting specific limit requirements for amino acid chelates containing metals such as cobalt, copper, and nickel, which will officially take effect from June 1, 2026. The new rule clearly requires downstream EU importers to provide a declaration of conformity and test reports issued by recognized third-party institutions. At present, the text of this clause has been made public, but implementing rules or transitional arrangements have not yet been released.

Which Sub-sectors Will Be Affected

Direct trading enterprises: As the main entities exporting amino acid chelates to the EU, they will need to bear the practical implementation pressure after the transfer of compliance responsibility. The impact is mainly reflected in extended delivery cycles (due to newly added testing and document review procedures), increased customs clearance uncertainty, and the potential risk of returns or rejection by importers.

Raw material procurement enterprises: If the amino acid chelates they procure are used in formulated end products exported to the EU (such as feed premixes containing trace elements), they will need to request supporting documents from upstream suppliers proving compliance with the new limits. The impact is mainly reflected in greater supply chain traceability difficulty, a narrower pool of qualified suppliers, and a structural increase in procurement costs.

Processing and manufacturing enterprises: Manufacturers that use amino acid chelates as intermediates to produce functional products (such as chelated trace element fertilizers, cosmetic stabilizers, and electroplating complexing agents) will need to reassess whether the migration level of target metals in finished products triggers the applicability of the new regulation. The impact is mainly reflected in a stronger need for formulation adaptation, increased small-batch validation costs, and possible process fine-tuning for some production lines.

Supply chain service enterprises: Including testing and certification bodies, compliance consulting service providers, and customs declaration agents, these businesses will directly benefit from the new compliance demand. The impact is mainly reflected in growing consultation volume for related testing projects and increased demand for synchronized multi-metal testing services, but service responsiveness and ECHA-recognized qualifications will become key differentiators.

What Key Points Should Relevant Enterprises or Practitioners Focus On, and How Should They Respond at Present

Pay attention to the subsequent implementing rules issued by ECHA and the list of recognized laboratories

The current announcement only clarifies the effective date of the limits and the categories of substances covered, but does not specify the exact test methods, limit thresholds, exemption scenarios, or the directory of recognized third-party testing institutions. Enterprises need to continuously track updates on the ECHA official website to avoid making ineffective preparations based on information from non-authoritative channels.

Sort out the specific categories of amino acid chelates exported to the EU and their corresponding metal content

Not all amino acid chelates are subject to these restrictions; only those containing cobalt, copper, and nickel and meeting specific structural characteristics are included in the regulation. Based on existing product technical data, enterprises should identify whether their products fall under the “metal-amino acid chelates” referred to in Entry 79 of Annex XVII, and prioritize preliminary testing for high-risk models (such as cobalt glycinate and copper glutamate).

Differentiate between policy signals and the actual pace of business implementation

Although the new rule is scheduled to take effect in June 2026, EU importers may carry out compliance reviews in advance. Some leading customers have already started requiring suppliers to provide preliminary conformity statements since Q2 2024. Enterprises should not simply equate the “effective date” with the “starting point of enforcement,” but should dynamically adjust communication and delivery strategies according to customers’ actual requirements.

Launch supply chain coordination and document contingency preparation in advance

It is recommended to complete three types of basic work within 2024: first, confirm the capability of upstream raw material suppliers to control metal impurities; second, select at least one testing institution with potential ECHA-recognized qualifications to conduct baseline testing; third, draft a declaration of conformity template to clarify responsibility boundaries and avoid having the exporter unilaterally bear all compliance obligations.

Editor’s Viewpoint / Industry Observation

From an industry perspective, this update to the REACH Annex is better understood as an extension of the EU’s systematic risk control over metal-complex chemical substances rather than an isolated technical adjustment. Analysis shows that the core signal it sends is that regulatory oversight of metal organic forms with bioavailability, environmental persistence, and potential sensitization is shifting from “total elemental content” to “specific chemical forms.” Observationally, this clause is still in the pre-effectiveness stage and has not yet formed operable enforcement rules, so it is closer to a clear compliance early-warning signal than an immediate implementation outcome. What the industry needs to keep watching is not only the clause itself, but also the potentially systematic regulatory logic the EU may form in the field of metal complexes—this may affect the compliance pathways of other similar structural substances in the future (such as EDTA-based and HEDTA-based chelating agents).

Conclusion

This newly added REACH limit clause marks a new stage of refined compliance management for amino acid chelating agents entering the European trade market. Its industry significance lies not in short-term disruption, but in driving exporters to transform from “product delivery” to “full-chain compliance capability.” At present, it is more appropriately understood as a forward-looking process of risk identification and preparation rather than an insurmountable market access barrier. The key to a rational response lies in using certain actions (such as product screening, testing drills, and document framework building) to address uncertain factors (such as the release timing of detailed rules and the degree of customer enforcement).

Information Source Notes

Main source: Official announcement on the European Chemicals Agency (ECHA) website (publication date: April 21, 2024);
Parts requiring continued observation: the subsequent implementing rules, limit values, testing method standards, and the list of recognized laboratories to be issued by ECHA.