The European Chemicals Agency (ECHA) has published a comprehensive assessment of regulatory needs (ARN) for a group of substances classified as complex inorganics from non-metallurgy processes. This assessment aims to identify the necessary regulatory actions to manage risks associated with these substances effectively.
Overview of the Group
The group includes various complex inorganic substances that originate from processes other than metallurgy. These substances encompass ashes and other residues from thermal processes, mineral-like solids, glasses, ceramics and frits, substances from pulping processes, cementitious materials, and pigments. A total of 32 substances are covered in this assessment, with 26 having full registrations, four with intermediate registrations, one with classification and labelling (C&L) notification, and one without registrations or notifications.
Key Findings
- Hazardous Substances:
- Five substances are self-classified for carcinogenicity and/or reproductive toxicity due to the presence of lead, cadmium, boron, or nickel compounds.
- One substance is self-classified as carcinogenic due to its fibre morphology.
- The remaining substances are not classified as category 1 carcinogenic, mutagenic, or toxic to reproduction.
- Use and Exposure:
- The substances are widely used as fillers, stabilisers, pH regulators, binders, and flame retardants in consumer, professional, and industrial applications.
- They are found in coatings, paints, construction materials, adsorbents, fertilisers, water treatment products, and cosmetics.
- Regulatory Actions:
- Immediate and subsequent regulatory actions are proposed to address identified concerns. For instance, data generation through compliance checks is suggested as an initial step to confirm hazards.
- If hazards are confirmed, regulatory risk management actions may be considered for the entire group, subgroups, or individual substances.
- Potential Hazards:
- Substances like manganese compounds, which are used in fertilisers, have shown evidence of reproductive toxicity, neurotoxicity, and aquatic toxicity. Regulatory actions are proposed pending hazard confirmation via classification and labelling harmonisation (CLH).
Conclusions and Proposed Actions
ECHA's conclusions and actions are based on information available from REACH registration dossiers and other public assessments. The following are notable regulatory suggestions:
- Professional Use Restrictions:
- Widespread professional uses in coatings, paints, and fertilisers have led to proposals for restrictions. These restrictions aim to introduce controls at the market level rather than at the usage level, ensuring better efficiency and effectiveness in managing risks.
- Exemptions and Further Actions:
- Some substances may be used in paints for historic building restoration. The restriction process will clarify whether these uses should be included in the scope of restrictions.
- Currently, no further EU regulatory risk management actions are proposed for substances with low exposure and release potential. However, reassessment may be necessary if new information arises or registration statuses change.
Substances with Proposed Regulatory Action
Substances such as 'Frits, chemicals' (EC 266-047-6) have been identified with a potential hazard for carcinogenicity and reproductive toxicity. Likewise, 'Feldspar minerals, hematite and quartz, calcination products of copper mining residues' (EC 701-090-0) and 'Feldspar minerals, magnetite and quartz, calcination products of copper mining residues' (EC 944-188-0) are flagged for reproductive toxicity. The 'Inorganic residual from kraft or soda pulping separated from green liquor in the chemical recovery cycle' (EC 923-511-9) is under scrutiny for reproductive toxicity hazard due to manganese compounds. Regulatory actions are proposed to mitigate the risks associated with these substances, subject to hazard confirmation.
Implications for Industry
The publication of ARNs facilitates companies in tracking the regulatory status of their substances of interest, allowing them to anticipate potential regulatory actions and make informed strategic decisions regarding their chemical portfolios. ECHA encourages stakeholders to consult its website for detailed information on regulatory assessments and proposed actions.
