ECHA's Regulatory Assessment of Benzophenones: Key Findings and Proposed Actions

Substances Covered

The assessment includes a variety of benzophenone derivatives with different substituents such as halogens, carboxylic acids, amides, substituted anilines, methacrylates, alkoxy groups, alkoxyamines, ethoxylates, di-, trihydroxyl groups, and biphenyls. In total, 68 substances are evaluated, with 19 having full registration under REACH.

Hazard Identification

The substances were screened for potential hazards including carcinogenicity, reproductive toxicity, endocrine disruption, skin sensitisation, and specific target organ toxicity (STOT). The assessment also considered environmental hazards such as aquatic toxicity, persistence, bioaccumulation, and mobility (PBT/vPvB and PMT/vPvM properties).

Key Findings

1. Carcinogenicity: All substances are considered potential carcinogens based on structural similarity to benzophenone, which is classified as a Category 1B carcinogen.
2. Skin Sensitisation: Several substances are known or potential skin sensitisers.
3. Specific Target Organ Toxicity: Some substances exhibit STOT properties, impacting liver and kidney functions.
4. Reproductive Toxicity and Endocrine Disruption: Certain substances have potential reproductive toxicity and endocrine-disrupting properties.
5. Aquatic Toxicity: Many substances are hazardous to aquatic life.
6. Persistence, Bioaccumulation, and Mobility: Some substances are potentially persistent, bioaccumulative, and mobile in the environment.

Proposed Regulatory Actions

Based on the identified hazards, ECHA suggests the following regulatory actions:

1. Compliance Checks (CCH): To generate further data and confirm potential hazards for specific substances.
2. Harmonized Classification and Labelling (CLH): For substances confirmed to have carcinogenic, mutagenic, or reproductive toxic (CMR) properties, or environmental hazards (PBT/vPvB, PMT/vPvM).
3. Restrictions: For substances used in professional and industrial settings with potential for significant exposure and environmental release. This includes adhesives, sealants, coatings, paints, inks, and toners.
4. Self-Classification and Risk Management: For substances with limited use patterns, registrants should implement necessary risk management measures to ensure safe use in the workplace.

Where Benzophenones Are Used

The substances covered in this assessment are used in various applications, including:

• Coatings and Paints: Used in both professional and industrial settings.
• Adhesives and Sealants: Commonly reported uses by professional workers.
• Inks and Toners: Used in printing industries.
• Cosmetics and Personal Care: Although less common, some substances are used in these products.
• Anti-Freeze and De-Icing: Specific substances are reported in these applications.
• Laboratory Chemicals and Pharmaceuticals: Mainly in industrial settings with lower exposure potential.

The assessment by ECHA is an iterative process, aimed at ensuring the safety of substances used within the EU. The proposed regulatory actions will help mitigate risks associated with benzophenones, protecting both human health and the environment. ECHA will continue to monitor and update the regulatory needs as new information becomes available.