Increasing the number of phthalates classified in the CLP Regulation as toxic for reproduction and having endocrine-disrupting properties

Thirteen phthalates are already banned or restricted due to their classification as toxic to reproduction, four of which are also identified as endocrine disruptors.

Medium-chain phthalates (meaning that the chain formed by carbon atoms consists of 4 to 6 atoms) are a group of substances used as plasticisers in various plastic items, polymers and adhesive products in our everyday lives.

Thirteen of these phthalates have already been banned or restricted at European level. They are classified under the CLP Regulation (for Classification, Labelling and Packaging of products) as toxic for reproduction. As a result, their use is restricted in products sold to the general public, and the use of three of them in toys and childcare articles is subject to specific restrictions. Among these phthalates, four of them have also been identified as endocrine disruptors for human health and two for the environment under the REACH Regulation.

Seven of these thirteen phthalates are also listed in Annex XIV of REACH, which lists substances subject to authorisation: apart from the clearly defined uses for which the European Commission has granted authorisation, these substances may no longer be used.

Expanding this classification to a broader group of phthalates to avoid any undesirable substitutions

Other phthalates are not yet regulated and could therefore be used to replace banned or restricted phthalates. In order to avoid undesirable substitutions with structurally similar phthalates that may have similar technological functions but also similar toxicological effects, ANSES proposes a grouped CLP classification.

Based on a specific toxicological expert appraisal, the Agency recommends applying the following CLP classification to a group of medium-chain phthalates:

• Reproductive toxicity, Category 1B (H360D: may damage the unborn child),
• Endocrine disruptor for human health, Category 1 (EUH380: may cause endocrine disruption in humans),
• Endocrine disruptor for the environment, Category 1 (EUH430: may cause endocrine disruption in the environment).

More than forty phthalates in all could be classified under the CLP Regulation.

In addition, ANSES proposes that mixtures containing several phthalates should be classified taking into account the fact that the toxicity of the mixture is the sum of the toxicity of the substances, as these substances have similar modes of action.  

Proven effects on the male reproductive system

To support its classification proposal, ANSES extrapolated the known toxicological effects of certain phthalates to other phthalates that are structurally similar and for which no toxicological data currently exist. To this end, the Agency carried out a comparative assessment of the available toxicological data, analysed the relationship between chemical structure and activity, and then selected those phthalates for which toxicological effects could be extrapolated.
With regard to human health, the proposed classification is based on studies showing that medium-chain phthalates disrupt the development of the male reproductive system through endocrine-disrupting action. The reprotoxic and endocrine-disrupting effects of phthalates in animals are well known to the scientific community under the term “phthalate syndrome”; in humans, it has been suggested that there is an equivalent known as “testicular dysgenesis syndrome”.

With regard to the environment, few data on endocrine-disrupting properties are available for non-mammalian species. Nevertheless, data from mammals has led to the proposal to classify it as an endocrine disruptor for the environment, which takes into consideration different wildlife species.  

Harmonised classification proposal submitted for public consultation

The harmonised classification proposal on medium-chain phthalates proposed by ANSES is available for public consultation on the ECHA website until 27 March 2026. This consultation gives all stakeholders the opportunity to comment on these proposals, while providing any additional scientific arguments and information they may have.

Following this consultation stage, ANSES will be asked to respond to the comments received. The initial proposal, comments and ANSES's responses to them will then be placed before ECHA’s Committee for Risk Assessment, which will issue an opinion on the classification of medium-chain phthalates.

Based on this opinion, the European Commission will draft regulatory texts allowing the proposed classifications to be included in the CLP Regulation.