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Suspending mandatory reproductive toxicity classification and labeling of lithium substances in the UK

Time：

2023-09-22

The UK Health and Safety Agency (HSE) has released a report on the classification and labeling of lithium carbonate, lithium chloride, and lithium hydroxide. According to this report, HSE has decided not to impose mandatory reproductive toxicity classification and labeling (GB MCL) on these substances.

Material Introduction:

Substance name	CAS Number	EC Number	Purpose
Lithium Carbonate	554-13-2	209-062-5	Used for the production of lithium-ion batteries, deoxidizers in metal smelting, and metal alloys in the aerospace and telecommunications industries, as well as the manufacturing of lithium-based lubricants; It is also applied in the ceramic and glass industries; It is also used to treat mental health disorders such as depression.
Lithium Chloride	7447-41-8	231-212-3	Used in the production of lithium-ion batteries, dehumidification systems, lithium metals, and the manufacturing of automotive components, as well as in the treatment of mental health disorders such as acute manic disorder.
Lithium Hydroxide	1310-65-2	215-183-4	Used in spacecraft and submarines to absorb carbon dioxide, for the manufacturing of other lithium salts, and for the production of lithium soap, lubricating grease, and alkyd resin; It is also used in lithium-ion batteries as an additive for electrolytes in alkaline batteries.

These three industrial chemicals are all regulated by the UK REACH regulations and are included in the UK-RECH "Grandfather Clause" registered substance list (July 2021). According to data from the European Chemical Administration (ECHA) in 2023, the manufacturing and/or import volumes of lithium carbonate, lithium chloride, and lithium hydroxide in the European Economic Area are ≥ 10000 to<100000 tons/year, ≥ 1000 to<10000 tons/year, and ≥ 10000 to<100000 tons/year, respectively.

In the technical report on the classification and labeling of lithium carbonate, lithium chloride, and lithium hydroxide released in August last year, HSE agreed with the opinion passed by the ECHA Risk Assessment Committee (RAC) in September 2021 to classify these substances as 1) Repr 1A; H360D (may cause harm to unborn infants); 2) Lact; H362 (May cause harm to breastfed infants). However, regarding the classification of RAC as Repr 1B; HSE holds a different view on H360F (which may harm fertility). HSE believes that the available data is more supportive of classifying it as a Repr 2; H361f (suspected of damaging fertility). According to Article 37A of the UK Chemical Classification, Labeling, and Packaging Regulations (GB CLP), when HSE considers that the evidence in the Risk Assessment Committee (RAC) opinion does not support the classification results, or there is additional information, or does not agree with the RAC's opinion conclusion, HSE may propose new or modified mandatory classification and labeling.

In this opinion report, HSE believes that it is necessary to consider the scientific issues raised in the technical report regarding reproductive toxicity. In addition, HSE has also learned some epidemiological information related to lithium carbonate and lithium chloride, and further research is needed to investigate the applicability between the two. Based on the assessment of HSE impacts and policies, the decision not to classify these three substances currently is not expected to have a significant impact on policies or socio-economic factors. In summary, HSE has decided not to impose mandatory classification and labeling on lithium carbonate, lithium chloride, and lithium hydroxide.

In March of this year, the European Commission also received additional information from stakeholders, and subsequently requested the RAC to re-examine the reproductive toxicity classification of lithium carbonate, lithium chloride, and lithium hydroxide in May. Let's continue to pay attention to the future decisions of the UK and EU regarding the classification and labeling of these three substances.