ECHA Updates REACH Annexes Requiring Enhanced Data on Endocrine Disruptors

ECHA Strengthens the Focus on Endocrine Disruptors

The European Chemicals Agency (ECHA) and the European Union are placing greater emphasis on identifying and assessing endocrine-disrupting chemicals (EDCs). Endocrine disruptors are substances that can interfere with the endocrine system and potentially cause adverse effects in humans, animals or ecosystems.

Under REACH, companies manufacturing or importing chemicals in the EU/EEA are required to provide information about the intrinsic properties of their substances. The information requirements depend on the quantity manufactured or imported and are primarily set out in REACH Annexes VII to X. (European Chemicals Agency)

The EU has also introduced dedicated endocrine-disruption hazard classes under the Classification, Labelling and Packaging (CLP) Regulation, increasing the importance of reliable data on these properties. (EUR-Lex)

What Are Endocrine Disruptors?

Endocrine disruptors are chemicals that can alter functions of the endocrine system and cause adverse effects in an organism, its offspring or populations.

Hormones regulate numerous biological processes, including development, reproduction, growth and metabolism. As a result, identifying substances with endocrine-disrupting properties is an important part of chemical hazard assessment.

ECHA maintains an endocrine disruptor assessment list covering substances undergoing or having undergone assessment by its Endocrine Disruptor Expert Group. ECHA reported 138 unique substances or entries in the database as of 27 April 2026. (European Chemicals Agency)

How REACH Information Requirements Work

REACH establishes different standard information requirements according to the quantity of a substance manufactured or imported:

• Annex VII: 1 tonne or more per year

• Annex VIII: 10 tonnes or more per year

• Annex IX: 100 tonnes or more per year

• Annex X: 1,000 tonnes or more per year

Higher tonnage bands generally require additional information and testing. ECHA explains that registrants must first collect and assess existing information and use scientifically justified alternative approaches where appropriate before conducting additional testing. (European Chemicals Agency)

Why Enhanced Data on Endocrine Disruption Matters

The European Commission has noted that current REACH information requirements provide only limited information specifically addressing endocrine disruption. At the same time, endocrine-disrupting substances can be addressed under REACH through mechanisms such as substance-of-very-high-concern (SVHC) identification, authorisation and restrictions, where the relevant regulatory conditions are met. (EUR-Lex)

More comprehensive information can therefore help regulators evaluate whether a substance may require further regulatory action.

For companies, this means that endocrine-disruption data can become increasingly important when maintaining registration dossiers and responding to regulatory evaluations.

Implications for Chemical Manufacturers

Chemical manufacturers and importers should pay close attention to developments affecting REACH information requirements. Companies may need to:

• Review existing REACH registration dossiers.

• Identify potential data gaps related to toxicological and ecotoxicological properties.

• Evaluate available information on endocrine activity and potential adverse effects.

• Monitor ECHA assessments and regulatory updates.

• Keep safety and compliance documentation up to date.

• Consider appropriate alternative methods before conducting additional animal testing.

ECHA states that registrants must gather relevant available physicochemical, toxicological and ecotoxicological information, while testing on vertebrate animals should only be used as a last resort. (European Chemicals Agency)

Connection With the EU CLP Regulation

The increased attention to endocrine disruption also connects REACH requirements with developments under the EU CLP Regulation.

In 2023, the EU introduced specific hazard classes for endocrine disruption for human health and the environment. These include Category 1 for known or presumed endocrine disruptors and Category 2 for suspected endocrine disruptors. (EUR-Lex)

The changes mean that companies need to consider not only traditional toxicity and environmental endpoints but also whether available scientific evidence indicates endocrine-disrupting properties.

What Companies Should Do Now

Companies operating under REACH should regularly review their registration information and monitor developments from ECHA and the European Commission.

A practical compliance approach includes checking whether existing studies adequately address relevant endpoints, reviewing new scientific evidence, identifying information gaps and ensuring that regulatory dossiers remain consistent with current requirements.

Companies should also distinguish between informal or scientific assessments and formal regulatory decisions. ECHA's endocrine disruptor assessment list, for example, indicates substances undergoing or having undergone assessment, but inclusion itself does not constitute a formal regulatory decision. (European Chemicals Agency)

The growing regulatory attention to endocrine disruption demonstrates the importance of maintaining complete and scientifically supported chemical data. For manufacturers, importers and downstream users, continued monitoring of REACH and CLP developments will be important for managing regulatory obligations and communicating relevant hazard information throughout the supply chain.

Sources

1. European Chemicals Agency (ECHA) – Information Requirements under REACH
   ECHA – Information Requirements

2. ECHA – Endocrine Disruptor Assessment List
   ECHA – Endocrine Disruptor Assessment List

3. European Commission – Commission Regulation (EU) 2022/477 amending REACH Annexes VI–X
   EUR-Lex – Regulation (EU) 2022/477

4. European Union – Commission Delegated Regulation (EU) 2023/707 on endocrine-disruption hazard classes
   EUR-Lex – Regulation (EU) 2023/707