03/08/2020 2 min

ANSES proposes classifying three lithium salts considered toxic to fertility and prenatal development

On 4 December 2019, ANSES submitted a proposal to the European Chemicals Agency (ECHA) for harmonised classification of lithium carbonate, lithium chloride and lithium hydroxide under the CLP Regulation (Classification, Labelling and Packaging of products). These three salts are hazardous to fertility and foetal development. This proposal has been the subject of a public consultation on the ECHA website since 3 August 2020, giving all stakeholders the opportunity to express their views and provide any additional information they may have. A final opinion by ECHA's Committee for Risk Assessment will then be sent to the European Commission, which will decide on the relevance of adding the lithium salts to the CLP Regulation. This will have direct consequences on product labelling and could eventually lead to a more restrictive regulatory framework for their use in Europe.

Lithium carbonate, lithium chloride and lithium hydroxide are mainly used in batteries, but also in the glass and construction industries. In addition, lithium carbonate is used in medicinal products for the treatment of bipolar disorder. These compounds are chemically similar, and it is considered that any effects observed with one salt can be extrapolated to the other two.

These substances are not currently covered by harmonised European classifications under the CLP Regulation (see below). Their mutagenic and carcinogenic properties and toxic effects on reproduction and development were therefore assessed by ANSES, with the aim of proposing a harmonised classification.

Effects observed in rodents and humans      

Effects on male reproduction have been observed in several good quality studies in rodents exposed to lithium carbonate. On the basis of these results obtained in animals, the toxic effect of lithium salts on human fertility is "presumed", which corresponds to Category 1B of the CLP Regulation. In addition, an association has been identified between exposure to lithium – used by pregnant women to treat bipolar disorder – and the development of malformations in the foetus. As a result, lithium salts are to be regarded as having proven toxic effects on human foetal development, which corresponds to Category 1A of the Regulation.

On the other hand, this expert appraisal came to no conclusion on the mutagenic or carcinogenic nature of lithium salts, due to the inadequate quality of the data currently available.

The classification proposal submitted for public consultation         

This evidence led ANSES to propose a classification according to the CLP Regulation. If the proposal is accepted, the lithium salts in question will have to be labelled as follows: "May damage fertility or the unborn child: Category 1A (H360FD)".

This proposal was submitted for public consultation on the website of the European Chemicals Agency (ECHA) on 3 August 2020, to give all stakeholders the opportunity to present their positions, scientific arguments or any additional information they may have. This public consultation will remain open for 60 days. Comments can be sent via a dedicated form on the ECHA website. Following this consultation stage, ANSES will be asked to respond to the comments received. The initial proposal, comments and their responses will be brought to the attention of ECHA's Committee for Risk Assessment, which will submit a final opinion to the European Commission. On the basis of this opinion, the European Commission will decide whether or not to include the harmonised classification in the CLP Regulation.

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 that could lead 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.