Classification of sodium 3-(allyloxy)-2-hydroxypropanesulphonate as a Category 1B reprotoxic substance
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News of 04/10/2021
The substance sodium 3-(allyloxy)-2-hydroxypropanesulphonate, used in adhesives, paints, coatings, resins and water treatment products, can cause severe eye damage and impaired fertility. To better inform consumers and workers and protect their health, ANSES has submitted a classification proposal for this substance under the European CLP Regulation on product classification, labelling and packaging. If adopted, this classification would have direct consequences at European level on the substance's conditions of use and on the labelling of products containing it. All stakeholders can currently contribute to this proposal, which is open for public consultation until 3 December 2021.
Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS ) is used in adhesives, sealants, paints, coatings, resin products and water treatment products for its corrosion inhibiting properties and as an anti-scale agent.
Eye damage and impaired fertility
This substance is not currently regulated for its toxic properties at European level. Following a toxicological assessment that focused on the ocular and reproductive effects, the Agency confirmed the substance's ability to cause serious eye damage based on an in vitro study, as well as its ability to induce impaired reproduction, from observation of a reduction or even a total absence of births in a study on rodents.
In order to protect people, the Agency is therefore proposing to classify and label this substance as follows:
- "Causes serious eye damage; Category 1 (H318)"
- "May damage fertility: Category 1B (H360F)"
"If this proposal is validated at the European level, measures to restrict the amount of substance in products for use by consumers and to protect workers will have to be implemented when this substance is handled, which will mainly involve an upstream substitution process" explains Dominique Brunet, Deputy Head of the Chemicals Unit at ANSES.
Classification proposal submitted for public consultation
This proposal was submitted for public consultation on the ECHA website on 4 October 2021, for a two-month period, to give all stakeholders the opportunity to present their positions, scientific arguments or any additional information at their disposal.
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 HAPS. On the basis of this opinion, the European Commission will make its final decision.
Regulation on Classification, Labelling and Packaging (CLP)
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, known as the CLP Regulation, is the legislation in force in the European Union to ensure the protection of workers, consumers and the environment. In particular, it aims to identify any hazards posed by a substance or substance mixture due to its physico-chemical properties and its effects on health and the environment. This Regulation defines how these substances and mixtures must be classified, labelled and packaged. It also has impacts on other European regulations, possibly leading to the prohibition or substitution of highly hazardous substances or mixtures. Once the substance or mixture has been classified with regard to the identified hazards, appropriate labelling informs the user about these hazards through pictograms and safety data sheets. The European Chemicals Agency is responsible for its implementation.