Phthalates — a family of chemicals derived from phthalic acid and widely used in plastics to enhance flexibility, as well as in certain everyday products as solvents — have faced growing scrutiny from health authorities in recent years because of concerns about their potential adverse effects for human health or the environment.
Thirteen medium-chain phthalates — defined as compounds with carbon chains of four to six atoms — are currently banned or restricted at the European level because they are classified as toxic to reproduction. Of these, four are also recognized as endocrine disruptors affecting human health, and two are considered as harmful for the environment.
Other phthalates that are not yet regulated may be used as substitutes. However, these alternatives could have similar harmful effects, according to an expert review conducted by French Agency for Food, Environmental and Occupational Health & Safety (ANSES).
To prevent “regrettable substitutions” with phthalates that may exhibit “similar toxicological effects,” French Agency for Food, Environmental and Occupational Health & Safety (ANSES) is proposing to classify “more than forty phthalates in total” as toxic to reproduction and as endocrine disruptors for both human health and the environment.
The French health agency further recommends that mixtures containing multiple phthalates be classified similarly, noting that for substances with comparable modes of action, “the toxicity of the mixture equals the sum of the toxicities of the individual substances.”
For developing this classification, the agency extrapolated the known toxicological effects of certain phthalates to other structurally similar phthalates for which toxicological data are currently incomplete or missing.
Regarding human health, it relied on studies showing that phthalates disrupt the development of the male reproductive system via an endocrine-disrupting mode of action.
Comment period
France’s ANSES has submitted the scientific dossier supporting its proposed reclassification of medium-chain phthalates to the European Chemicals Agency (ECHA). The dossier is open for consultation and public comment until March 27 (available here). Following this period, ANSES will review and respond to the scientific feedback and stakeholder input.
This dossier, along with the comments and responses provided by ANSES, will then be forwarded to the ECHA Risk Assessment Committee, which will issue an opinion on the proposal. Based on this opinion, the European Commission will draft the regulatory texts that could amend the CLP Regulation (Classification, Labelling, and Packaging of Chemicals) [1].
The CLP regulation is intended to ensure the protection of workers, consumers, and the environment from chemical substances, in particular by identifying the hazards that a substance or mixture of substances may present due to its physicochemical properties and its effects on health and the environment.
