REACH Registration: Insights from the latest CARACAL meeting
CARACAL (Competent Authorities on REACH and CLP Implementation) meetings are held twice a year, providing a forum for representatives from the European Commission, the European Chemicals Agency (ECHA), Member States, and various stakeholders, including non-EU countries, to discuss key developments in the REACH and CLP regulations and their implementation.
During the CARACAL meeting held on 3 April 2025, the European Commission presented its perspectives on the REACH revision, incorporating the views of Member States. It is important to note that while these views reflect ongoing discussions, they do not represent a final proposal for agreement. Nonetheless, the views shared provide valuable insights into the direction of the REACH revision, and it is crucial for industry to stay informed.
The REACH revision covers all processes under REACH — Registration, Evaluation, Authorisation, Restriction, and enforcement actions. In this newsletter, we will focus specifically on the REACH Registration process and the key proposed changes at the latest CARACAL meeting.
The Aim of the REACH Revision
The primary objective of the REACH revision is to streamline procedures for both industry and regulatory authorities, modernize the regulation after nearly two decades of implementation, and strengthen enforcement mechanisms. The European Commission is expected to present a formal legislative proposal by the fourth quarter of 2025. This package will include:
- a legislative proposal adopted under the Ordinary Legislative Procedure (OLP), and
- a set of delegated acts adopted through the Comitology procedure.
The OLP involves co-decision by the European Parliament and the Council, offering full legislative scrutiny, whereas Comitology allows the Commission to adopt implementing or delegated acts with more limited involvement from the co-legislators, typically through advisory or examination committees.
Key Changes Suggested to the REACH Registration Process
As part of the REACH revision, the European Commission has outlined several significant updates to the registration process, particularly regarding the registration of substances and polymers. These updates aim to streamline current requirements and introduce more efficient, transparent processes.
To help companies assess the potential impact of these proposed changes on their company and substance portfolio, we have prepared a comparison highlighting the current substance registration status versus the proposed updates per category.
Category | Current Situation | Proposed Change |
Registration
| REACH registrations do not expire but | Registrations would be limited to a 10-year validity period, placing an obligation on businesses to update and renew their REACH registrations. |
Ad-Hoc
| ECHA performs regular completeness
| ECHA would conduct ad-hoc checks to assess the completeness of registrations, ensuring that the registration dossiers meet current standards.
|
Updated
| Substances notified under previous
| Substances notified under previous legislation would need to meet the full set of current REACH requirements, with updates based on the substance volume.
|
Revocation of
| ECHA may revoke a REACH registration Registrations may be temporarily revoked
| ECHA would have the authority to revoke registration numbers in several new situations, including:
|
Dossier Update
| Registrants must update their REACH
| A new requirement would be introduced to update dossiers when a substance is identified as a substance of very high concern (SVHC).
|
Physicochemical
| Registrant may submit only
| Dossiers containing only physicochemical information would need to be updated to meet full Annex VII requirements.
|
Phase-In
| Phase-in substances are subject to specific provisions. Certain phase-in substances continue to benefit from reduced information requirements if they are registered at the lowest tonnage band (1-10 t/yr) and do not meet the criteria listed in Annex III of REACH. | Provisions for phase-in substances would be removed, requiring all substances to meet registration requirements more promptly. |
Testing | Testing proposals are typically required only when vertebrate animal tests are conducted to fulfill the information requirements specified in Annexes IX and X. | Testing proposals would be required for all in vivo tests and complex endpoints, including substances listed in Annexes VII and VIII. |
Alignment with | Under REACH animal testing must be | Article 13 would be aligned with Directive 2010/63/EU, emphasizing non-animal testing methods wherever possible, including for embryonic life stages. |
Chemical Safety
| A Chemical Safety Assessment (CSA)
| The CSA would include evaluations of persistent, mobile, and toxic (PMT) substances, as well as very persistent and very mobile (vPvM) substances and endocrine disruptors (EDs).
|
Risk Levels and
| Derived Minimal Effect Levels (DMELs)
| DMELs and other risk levels would be considered more systematically, including methods for combined exposure, such as the Mixture Allocation Factor (MAF) for substances produced in quantities greater than 1000 t/y. |
Encouragement
| Data sharing is encouraged under REACH | Data sharing would be promoted to minimize animal testing, ensuring registrants can access existing safety data for similar substances.
|
Data Exclusivity
| A 12-year period during which test data
| A 12-year data exclusivity period would be introduced, allowing access to study data beyond registered substances to also include structurally similar substances, which are currently not covered under the existing 12-year rule.
|
Post-Exclusivity
| After the data exclusivity period expires, Use of read-across data is still not | After the 12-year exclusivity period, robust study summaries and full study reports could be used for adapting registration dossiers for other substances.
|
Suggested Changes Specific to polymers
The Commission is proposing specific updates related to the registration of polymers as follows:
- Polymer Notification Requirement: All polymers produced or imported in the EU in quantities exceeding 1 ton per year will need to be notified to identify Polymers Requiring Registration (PRR) based on hazard criteria. Around 200.000 polymers available in the EU market will need to be notified, and up to 30.000 may need to be registered.
- Limited information will be required for all polymers, with more data needed for PRR.
- Grouping of Polymers: Criteria for grouping PRRs will be defined to streamline the registration process.
- Hazard and Risk Data for PRRs: Registration of PRRs will require the generation of hazard and risk data, with joint submissions possible for similar polymers.
These suggested changes signal a significant review of the REACH registration process, with a strong emphasis on improving data quality, enhancing efficiency, and addressing categories such as polymers. The goal is to create a more cohesive system that links registration with enforcement mechanisms more effectively.
Preparing for potential changes
The ongoing revision of the REACH registration process represents a significant shift that will affect how companies manage both existing and future registrations. While the European Commission’s proposed updates aim to modernize and streamline the regulation, it is important to note that these are not yet final proposals or decisions to be adopted. However, businesses should closely monitor these developments, as several key aspects are still under discussion, and some uncertainties remain.
It is crucial for companies to stay up-to-date and prepare, as the proposed changes could impact workload, substance portfolios, timelines, available resources, and potential costs. Companies marketing polymers in the EU in quantities above 1 tonne/year might need to adhere to new notification and registration requirements. Consequently, early preparation will be essential to ensure compliance.
By understanding the proposed changes and staying informed, businesses can better manage risks, facilitate a smoother transition, and meet future compliance obligations. Since some aspects of the process are still being refined, it’s important for REACH registrants and for companies placing polymers on the EU market to remain engaged and maintain open communication throughout their supply chain.
If you need assistance with REACH or navigating the potential upcoming changes, please do not hesitate to contact us at sales@reachlaw.fi.