Industry advises chemical suppliers to stay alert on incoming ECHA assessments

11 Jan 2024 --- A joint letter of recommendations for chemical industry members is released on the European Chemical Agency’s (ECHA) Assessment of Regulatory Needs reports (ARN).

Eurometaux, International Fragrance Association (IFRA), FuelsEurope and Downstream Users of Chemicals Co-ordination Group (DUCC) advise chemical suppliers to stay alert on the incoming assessments.

ARN is a preliminary step taken by ECHA to explore the need for potential regulatory risk management for substances. It is a tool to understand and enhance pre-screening assessment for chemical safety.

From 2019 to 2022, ECHA assessed around 5,000 substances in groups. Based on group assessments, approximately 60% of substances do not need further regulatory risk management. For the remaining 40%, additional data collection and generation is required, possibly through a compliance check, before potentially moving toward regulatory risk management.

The substances that would be reviewed could influence the fragrance industry and advise on which chemicals they should avoid.

Not legally binding
The joint statement says that the groups from ARN are built upon available information and use a practical approach to prioritize areas of interest based on common attributes like uses, hazards and chemical structure.

The ARN does not have any legal implications. The IFRA and other companies explain that its outcomes have no legal or regulatory relevance as they are not part of any formal regulatory management and decision-making processes.

The ARNs are developed voluntarily by the Agency, meaning the process uses selected information and assumptions for a screening-level assessment to help the Commission and member states understand if and where regulatory action might be needed.

ECHA will asses an additional 40% of substances for data collection and generation.Report recommendations
Eurometaux, IFRA, FuelsEurope and DUCC outline recommendations for chemical suppliers, consortia and downstream users:

• Read carefully: Understand assumptions in the report, considering missing information and the screening level nature.
• Update dossier: Keep your registration dossier up to date by correcting outdated information and filling identified data gaps. ARNs are based on current dossier information on chemical composition, tonnage and uses; if the right information is not updated, the ARN screening will provide wrong information.
• Feedback to ECHA: Find errors. Inform ECHA via the feedback button. Stakeholder input may trigger updates.
• Prepare for action: Collect data for upcoming public consultation and evidence gathering, e.g., more detailed use information or critical uses, anticipating potential regulatory actions and updating the dossiers proactively (if needed), especially where there’s a perspective for further regulatory action.
• Inform customers: Keep customers informed about potential regulatory actions.
• Stay informed: Timelines for regulatory actions vary. Stay alert through relevant channels like the PACT list, ECHA Newsletter, Restriction Roadmap and the Registry of Intention.

Transparency on authorities
Additionally, the associations draw attention to the fact that the ARN reports are not a definitive assessment — they do not give a final evaluation. They assert “robust justifications by authorities are needed for regulatory risk management.”

The peer-to-peer communication also shows the ARN reports help provide transparency and insights into authorities’ focus. However, they point out that it’s limited to a screening level and the industry’s responses to ARN outcomes are currently not publicly available.

The associations also state the reports help companies focus on substances needing further investigation or clarification, streamlining efforts. The ARN also allows the industry to prepare for potential regulatory actions based on informal signals.

Edited by Sabine Waldeck

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