ECHA Releases Five-Year Operation Report on REACH and CLP Regulations

Registration

Stable registration volume: approximately 18,911 initial registrations and 45,189 dossier updates received over five years, with about 3,800 initial registrations per year on average. New substance registrations average 361 per year, indicating the EU remains a key innovation hub.

Changing supply chain roles: Importers and Only Representatives (ORs) have increased in share (total 81%), while EU manufacturers have declined, but manufacturers still account for 45% of new substance registrations.

Insufficient information for some substance groups; challenges with opt-out mechanisms in joint submissions and data protection expiry.

Evaluation

Completed screening of all high-tonnage dossiers; ongoing substance evaluation.

Compliance checks (CCH): Over 10,000 dossiers evaluated in five years, with 1,198 decisions issued requiring 6,693 additional information items. Coverage of high-tonnage substances (>100 tonnes) reached 34.5%.

Substance evaluation (SEv): New cases significantly decreased (average 7.2 per year), but conclusions published increased (average 24.2 per year), with backlogs largely cleared. About 50% of cases required additional information, mainly on PBT/vPvB, endocrine disruption, and mutagenicity.

Substantial non-compliance in many dossiers; backlog in follow-up actions; severe lack of toxicological data on nanoforms, with most registrants failing to meet obligations.

Authorization

Candidate list (SVHC): 44 new Substances of Very High Concern added, reaching a total of 253. Most entries were due to reproductive toxicity or high persistence/bioaccumulation.

Authorization list: Three rounds of recommendations completed, recommending 19 substances for priority inclusion in Annex XIV.

Authorization applications: Approximately 230 applications received, nearly 90% related to chromium(VI) (Cr(VI)), leading to severe backlog due to downstream users submitting individual applications following a European Court of Justice ruling.

Workload backlog due to increase in candidate substances and complex applications

Restrictions

14 restriction dossiers received (8 from member states, 6 drafted by ECHA), the Committee completed 11 opinions. Most notably, the proposal for a 'universal restriction' on per- and polyfluoroalkyl substances (PFAS) has the highest assessment workload ever.

A more coordinated planning mechanism needed to improve predictability for all parties

Classification and Labeling (CLP)

Harmonized classification: 202 substances added or revised in CLP Annex VI over five years, including 63 classified as 1A/1B CMRs (carcinogenic, mutagenic, toxic for reproduction).

New hazard classes: New hazard classes introduced in 2023-2024, such as endocrine disruptors (ED), PBT/vPvB, PMT/vPvM, have been formally implemented, driving relevant classification work and guidance updates.

C&L Inventory: Moved to ECHA CHEM in May 2025, covering substances from 170,000 to 360,000, becoming one of the world's largest GHS classification databases.

Working groups and expert capacity increasingly important, workload rising

Scientific Committees

Production more consistent and transparent; improved IT and stakeholder participation

Workload, dossier complexity, exposure data gaps, decreasing number of members

Enforcement

10 coordinated enforcement projects over five years, more than 20,000 inspections, training over 1,000 inspectors;

32% of imported mixtures non-compliant with registration obligations; high non-compliance rates for safety data sheets (SDS), online chemical sales, and imported products.

Member states need to strengthen active leadership and resource investment

Tools and Guidance

Provide guides, templates, and IT services for downstream users; explore AI applications

Need to improve clarity and usability of supply chain communication tools