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Italy Concludes Evaluation of Pigment Yellow 65

REACH
19
December 2024
•
400
Dr Steven Brennan
Italy concludes its evaluation of Pigment Yellow 65 (PY65) under the REACH framework, highlighting its environmental risks and future regulatory needs.
Yellow paint
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Italy’s National Institute of Health has completed the evaluation of Pigment Yellow 65 (PY65), a widely used monoazo dye, under the European Chemicals Agency’s REACH framework. The evaluation aimed to address concerns about its potential persistence, bioaccumulation, and environmental exposure. PY65 was found to be potentially persistent due to limited biodegradability, and while predictive models suggest moderate bioaccumulation potential, conclusive data is lacking. The evaluation also highlighted gaps in long-term toxicity data and uncertainties about the substance’s impact on sediments and terrestrial ecosystems. Although no immediate regulatory actions are recommended, further investigations may be necessary to clarify risks and inform potential risk management measures.

Why was Pigment Yellow 65 evaluated by Italy?

Italy’s National Institute of Health reviewed PY65 due to its suspected persistence, bioaccumulation, high production volume, and widespread dispersive use under the REACH Regulation.

What were the findings of the Pigment Yellow 65 evaluation?

The substance was found to be potentially persistent with moderate bioaccumulation risks, but significant data gaps remain regarding its long-term environmental impact.

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Italy’s National Institute of Health has concluded the evaluation of Pigment Yellow 65 (PY65) under the European Chemicals Agency (ECHA) 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).

Read the source story

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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