France | Regulatory Management Options Assessment (RMOA) Project on 1,3-Diphenylguanidine (DPG)

The French Agency for Food, Environmental and Occupational Health & Safety (Anses) has initiated a Regulatory Management Options Assessment (RMOA) project concerning the substance 1,3-Diphenylguanidine (DPG). The consultation, taking place from December 1 to December 29, 2023, focuses on evaluating and managing the risks associated with DPG, primarily used as a vulcanization accelerator in rubber manufacturing.

The project stems from the need for regulatory scrutiny following an Anses evaluation under the REACH regulation in December 2020. Results indicated reproductive toxicity, prompting a reevaluation of the harmonized classification of DPG and an exploration of risk management measures through the RMOA.

Anses, in collaboration with public consultation, is assessing exposure levels, dismissing endocrine disruption concerns, and proposing regulatory options for both human health and environmental risks. Despite identifying potential risks for workers and consumers, Anses suggests primarily updating registration dossiers to reflect safe exposure levels. Environmental risks, especially concerning water contamination, indicate the need for proper industrial waste management.

The RMOA project considers regulatory options such as designating DPG as a Substance of Very High Concern (SVHC), establishing a professional exposure limit, and adding DPG to water and industrial emission monitoring lists. Potential REACH restrictions may be considered if unacceptable risks persist after data updates, including risks related to imported articles. The public consultation aims to gather input on Anses' analysis, contributing to the finalization of the RMOA and potential regulatory measures to safeguard health and the environment.

The consultation period concludes on December 29, 2023.

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