Services: Electrical testing and certification, environmental or chemical testing

language
- English
- 中文

400-9269-886

NEWS CENTER

Industry News

Company News

Knowledge

The largest revision of the EU REACH regulation in 20 years is expected to be passed by the end of 2025

Time：

2025-04-14

The largest revision of the EU REACH regulation in 20 years aims to simplify registration requirements, improve enforcement through new audit tools, accelerate the digitization of supply chain communication, and modernize risk management procedures. It is expected to be passed by the end of 2025.

On April 3, 2025, the European Commission outlined its latest proposal to revise the REACH Regulation. These updates are part of a broader package plan for the chemical industry. The public consultation is now open until April 25, 2025, and the target for the final legislative proposal is set for the fourth quarter of 2025. This revision aims to simplify registration requirements, improve law enforcement through new audit tools, accelerate the digitization of supply chain communication, and modernize risk management procedures. These proposals together constitute the most significant update to the REACH regulation since its promulgation.

▲ REACH Revision Schedule

Main changes after REACH revision

01. Reform of the registration system

The registration validity period will be limited to 10 years. ECHA may revoke registration numbers in several situations, including expiration of validity period, failure to submit required updates after evaluation decision, lack of complete dataset for previously notified substances (NONS), or incompleteness discovered during special integrity checks.

If a substance is identified as a substance of high concern (SVHC), new filing requirements need to be updated.

Cancel the requirement to reduce NONS.

The new obligations of polymers include:

Notification of all polymers exceeding 1 ton per year.

Strengthen regulations, encourage data sharing among registrants, and reduce duplicate research. The data access mechanism will be applicable to the study of structurally similar substances, especially after the expiration of the data protection period.

According to Directive 2010/63/EU, strengthen the commitment to reduce animal testing. Testing of vertebrates must be avoided as much as possible, and even testing recommendations are needed for some lower level endpoints (see attachments 7 and 8).

02. Strengthen evaluation and compliance checks

The revised version of REACH introduces several changes aimed at improving the effectiveness, transparency, and impact of records and substance assessments.

ECHA reserves the right to revoke the registration number in the event of continued non-compliance with the assessment decision. When the registrant fails to update or decide to take action in accordance with the requirements published by ECHA, this applies to file and substance assessments.

The compliance check process will be clarified, especially regarding the use of available information that is currently not part of the archive. This aims to make ECHA's decisions more predictable and legally sound.

ECHA will gain greater authority to require specific adjustments, such as reading or deriving derived no effect levels (DNEL) or predicted no effect concentrations (PNEC), instead of default animal testing.

In addition to potential risks, the substance assessment procedure will also explicitly allow for selection based on hazard issues. Substances can also be selected based on their similarity to other chemical substances, including degradation products or components.

03. Simplify the authorization process

The revised version of REACH introduces greater flexibility and clearer priorities in the authorization system.

The candidate list will become a universal tool for prioritizing risk management.

The new substance prioritization criteria will focus on high-yield chemicals, chemicals with limited uses, or potential alternatives to existing Annex 14 substances.

The revised method allows for the inclusion or exclusion of purposes outside of Annex 14, thereby achieving tailored combinations of authorization and restrictions in appropriate circumstances.

More use of Regulatory Management Options Analysis (RMOA) will help determine the optimal regulatory path in the early stages of the process.

Basic DMEL is being considered to simplify decision-making.

04. More targeted and efficient restriction procedures

The modification of the restriction program aims to reduce delays and improve feasibility.

Restricting proposals will receive better priority and scope, avoiding overload and unnecessary complexity.

The general risk management approach will be extended to more hazard categories, especially for consumer use.

Early information on usage, exposure, and alternatives will support more targeted proposals.

The forum suggests incorporating it directly into the restriction program to improve its enforceability.

Basic usage concepts will also play a role in simplifying and limiting decision-making.

05. Strengthen law enforcement and market supervision

In order to create a fair competitive environment throughout the European Union, the Commission recommends strengthening enforcement mechanisms:

The new European audit capability will enable the committee to evaluate the enforcement systems of member states.

Customs control will be improved through the following methods:

Mandatory provision of Safety Data Sheets (SDS) during import.

Automatically verify registration and authorization numbers.

Potential integration with the EU Customs Single Window environment.

The European Anti Fraud Office (OLAF) will have the authority to investigate serious cross-border REACH violations.

06. Solve remote sales problems and promote public participation

Remote sales entering the EU will require designated EU economic operators to ensure REACH compliance.

Individuals and organizations will be allowed to submit substantial concerns about violations.

Member states will be required to implement protection for whistleblowers and adhere to the principles of the Aarhus Convention on access to justice.

07. Digitization of Supply Chain Communication

Digital transformation is the core of the proposal, especially in terms of safety data sheets and product traceability:

Introduce a unified SDS electronic format to support digital exchange throughout the entire supply chain.

The Digital Product Passport (DPP) gradually integrates items, initially covering batteries and later expanding to toys, detergents, textiles, and furniture.

Its purpose is to reduce administrative burden while increasing transparency regarding material existence.

08. Clarification of Nanomaterial Requirements

The revised version of REACH will be consistent with the EU's definition of nanomaterials in 2022.

Clear registration and reporting rules will enhance predictability and transparency, especially for downstream users and nanomorphology characterization.