Italy’s National Institute of Health has concluded the evaluation of Pigment Yellow 65 (PY65) under the REACH framework. This widely used monoazo dye was assessed for potential environmental risks, bioaccumulation, and regulatory implications, as part of the REACH Regulation's Community Rolling Action Plan (CoRAP).
Concerns Highlighted in the Evaluation
Pigment Yellow 65 (EC No. 229-419-9, CAS 6528-34-3) was flagged for evaluation due to its suspected persistence, bioaccumulation, and toxicity (PBT). With an estimated annual production of 100-1,000 tonnes, it is used extensively in industrial and consumer products such as coatings, inks, and polymers. Italy’s evaluation aimed to clarify potential risks posed by its widespread dispersive use and high environmental exposure.
Key Findings
The evaluation determined that PY65 is potentially persistent (P/vP) due to its limited biodegradability (5% degradation over 28 days). While predictive models indicated moderate bioaccumulation potential, direct evidence remains inconclusive, necessitating further investigation.
Existing toxicity data showed no significant short-term effects on aquatic organisms, but the lack of long-term data and methodological limitations raise concerns. Moreover, PY65's low water solubility and tendency to partition into sediments and soil complicate its environmental hazard assessment. Current data gaps on sediment and terrestrial ecosystem impacts emphasize the need for more comprehensive studies.
Regulatory Implications
Although Pigment Yellow 65 is not classified as hazardous under the CLP Regulation, the Italian evaluation highlights uncertainties that require resolution. Pending the outcome of follow-up dossier evaluations, the substance may be revisited for further regulatory actions, including potential risk management measures to address long-term environmental and bioaccumulation concerns.
The evaluation conducted by Italy underscores the importance of addressing data gaps for substances like Pigment Yellow 65. Its potential persistence and bioaccumulation risks, combined with its extensive industrial and consumer applications, demand vigilant monitoring and future research to ensure environmental safety.
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