February Regulatory Updates

REACH:

CoRAP: EU’s Rolling Action Plan for Substance Evaluation

Overview of CoRAP: The Community Rolling Action Plan (CoRAP) lists substances that have been or will be evaluated by EU Member States over the coming years. These evaluations aim to assess potential risks associated with chemical substances and determine whether regulatory action is needed.

What the CoRAP List Includes: For each substance, the CoRAP table provides:

• The evaluating Member State responsible for the assessment.
• The planned year of evaluation.
• A short description of the concerns that led to its inclusion on the list.

Evaluation Process and Documentation:

• Documents related to substance evaluation are available, including:
  • Justification for selection.
  • Decisions requesting further information.
  • Final evaluation reports from Member States once assessments are completed.
• Substances included in CoRAP have not yet been fully evaluated, meaning their risks are still being clarified.

Key Considerations:

• In cases where two Member States are indicated, the first one leads the evaluation.
• If an EC Number is unavailable, a unique number assigned by ECHA is used.
• Inclusion in CoRAP does not confirm hazard classification; concerns are preliminary and require further investigation.

Hazard Classifications Used in CoRAP:

• Suspected PBT/vPvB: Potentially Persistent, Bioaccumulative, and Toxic.
• Suspected PMT/vPvM: Potentially Persistent, Mobile, and Toxic.
• CMR: Carcinogenic, Mutagenic, or Reprotoxic.
• Sensitiser: Known or suspected sensitizing properties.
• RCR (Risk Characterisation Ratio): A measure used to evaluate exposure risks.

Next Steps: The substance evaluation process helps identify whether additional data or risk management measures are required under REACH. Contact details for the evaluating Member States are available for further inquiries.

 

ECHA Launches Study on Substances of Concern in Packaging Under PPWR

Objective of the Study: The European Chemicals Agency (ECHA) has begun a study to identify substances of concern in packaging, following new responsibilities under the Packaging and Packaging Waste Regulation (PPWR), which took effect on 11 February 2024. The study aims to prioritize substances for potential restriction under REACH and improve the safety and circularity of the packaging sector.

Key Areas of Focus: The study will help the European Commission:

• Label packaging where substances of concern are present.
• Assess recyclability, ensuring chemicals do not hinder reuse and recycling.
• Evaluate PFAS content, with potential regulatory modifications in four years.

Scope of the Study: ECHA will analyze:

• Chemical properties and their regulatory status under various EU laws.
• Substances used in packaging production, including potential contaminants from reuse and recycling.
• Impact on recyclability, determining whether substances make reuse impractical or uneconomical.
• Risks to workers and the environment, ensuring alignment with existing REACH, POPs, and food contact materials regulations.

Timeline and Next Steps:

• Intermediate draft due by 20 March 2026 for preliminary findings.
• Final study submission by 21 September 2026.

 

Biocides:

Temporary Authorization for Disinfectants Under Article 55 of BPR

Regulatory Update: The Italian Ministry of Health has issued a temporary authorization under Article 55 of Regulation (EU) No. 528/2012, allowing the marketing and use of disinfectants for intact skin before medical treatment. The decree was published in the Official Gazette (G.U. n. 44) on 22 February 2025.

Scope of Authorization:

• Applies to biocidal disinfectants that align with previously authorized medical-surgical devices.
• Covers intact skin disinfectants containing 2% chlorhexidine digluconate.
• Permitted packaging sizes: 100ml, 250ml, and 500ml.

Legal Recourse: Interested parties may challenge the decree by:

• Filing a jurisdictional appeal with the Regional Administrative Court within 60 days.
• Submitting an extraordinary appeal to the Head of State within 120 days.

For further details, the full decree is available on the Ministry of Health’s website (www.salute.gov.it).

 

ECHA:

Regulatory Needs Assessment List: Overview and Process

Purpose of the List:
The Regulatory Needs Assessment List includes substances that are either under evaluation or have completed assessment to determine if further regulatory action is required.

Key Information in the List:
For each substance, the table provides details on:

• The assessing authority (submitter).
• The concern identified.
• The status of the assessment.
• The suggested follow-up action.
• The latest update date.

Additional process details and relevant documents can be accessed via the ‘Details’ icon for each listed substance.

Regulatory Management Option Analysis (RMOA):

• RMOAs are assessments used to determine regulatory needs.
• Their publication began in February 2013 with the launch of the SVHC Roadmap.
• Since 2019, authorities, including ECHA, have shifted toward evaluating groups of substances rather than individual ones.

Authority Responsibility and Ongoing Updates:

• The assessing authority is responsible for the content and conclusions of each assessment.
• Other authorities may conduct independent evaluations of the same substance or group of substances.
• Conclusions may change over time as new data becomes available or further assessments are conducted.

For the full list: Assessment of Regulatory Needs – ECHA

 

CLP:

Registry of CLH Intentions: Monitoring Harmonized Classification Proposals

Purpose of the Registry:
The Registry of Classification and Labelling (CLH) Intentions tracks new or revised harmonized classifications submitted to ECHA. These proposals come from Member State competent authorities, manufacturers, importers, or downstream users seeking regulatory updates on specific substances.

Process and Stakeholder Involvement:

• The registry allows interested parties to follow the progress of a proposal from its initial notification to the final Risk Assessment Committee (RAC) opinion.
• Advance notice enables stakeholders to plan and prepare for commenting during the consultation phase.
• Anyone with relevant information on substance identity or hazard properties is encouraged to submit data early in the process or during the consultation period.

Tracking Proposal Status:

• Once the RAC adopts an opinion, the status changes to ‘Opinion Adopted’.
• Classification details for substances that have been reviewed are available in the ‘Corrigenda to the RAC opinions’ document.

This registry serves as a transparent tool for monitoring regulatory developments in substance classification and labelling, ensuring public and industry engagement in the decision-making process.

For the full list: Registry of CLH Intentions Until Outcome – ECHA