Public consultation of ANSES's proposal for classification of diisooctyl phthalate as toxic for reproduction | Anses - Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail

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French Agency for Food, Environmental and Occupational Health & Safety

Public consultation of ANSES's proposal for classification of diisooctyl phthalate as toxic for reproduction

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News of 04/04/2017

ANSES has submitted a classification proposal for diisooctyl phthalate as toxic for reproduction, category 1B for fertility and development, to the European Chemicals Agency (ECHA). This proposal has been open for public consultation on the ECHA website since 14 March 2017, to give all stakeholders an opportunity to present their position, their scientific arguments, or any additional information they may have. Following this public consultation, which is open for 45 days, a final opinion will be adopted by the Committee for Risk Assessment (RAC) at the ECHA and forwarded to the European Commission for a decision on whether or not to include ANSES’s proposed classification in the CLP regulation.

 

The chemical substance diisooctyl phthalate is used as a plasticiser for synthetic gums and vinyls, and cellulose or acrylic resins. In addition, it could potentially be used as a substitute for phthalates that have a harmonised classification.

Diisooctyl phthalate does not currently have a harmonised classification within the framework of the regulation on classification, labelling and packaging of chemical substances (CLP).

Currently available data indicate that diisooctyl phthalate has harmful effects on embryonal development in rodents, particularly on the male reproductive system of offspring. These effects are also observed with other medium-chain phthalates such as DEHP. This evidence led ANSES to propose classification of diisooctyl phthalate as per the CLP regulation for its effects on development and fertility. This proposal was opened to public consultation on the ECHA website on 14 March to give all stakeholders an opportunity to present their position, their scientific arguments, or any additional information they may have.

This public consultation is open for 45 days. Comments can be made via a specific form on the ECHA website

Following this consultation phase, ANSES will be charged with replying to the comments received.

The initial proposal, the comments, and the corresponding replies will be communicated to the Committee for Risk Assessment (RAC) at the ECHA, which will forward a final opinion to the European Commission within 18 months.
 
On the basis of this opinion, the European Commission will decide whether or not to include the harmonised classification proposed by ANSES in the CLP regulation.