HSE opposes mandatory classification of three lithium salts

In August 2023, the UK Health and Safety Executive (HSE) recommended not to propose mandatory classification and labelling (MCL) for lithium carbonate, lithium chloride, and lithium hydroxide at this time. This is in contrast to the Opinion on lithium carbonate, lithium chloride and lithium hydroxide adopted by the European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC). The HSE concluded that further assessment of the three substances was necessary.

RAC Opinion on the classification of the three lithium salts

In September 2021 ECHA’s risk assessment committee published the RAC opinion which concluded  that the three lithium salts should be classified under the Classification, Labelling and Packaging Regulation (CLP) as follows:

• Reprotoxic Category 1A; H360D (May damage the unborn child)

• Reprotoxic Category 1B; H360F (May damage fertility)

• Effects on or via lactation; H362 (May cause harm to breast-fed children)

Agency technical report on the classification and labelling of lithium carbonate, lithium chloride, and lithium hydroxide

The HSE Agency Technical Report was published in August 2022. The RAC opinion was used as the basis for this report. The Agency agrees with the RAC that the data presented in the EU Harmonized Classification and Labelling (CLH) report support classification of the lithium salts as Reprotoxic 1A; H360D and Lactation; H362. However, the Agency did not agree that the criteria for classification as Reprotoxic 1B; H360F were also met. Instead, the Agency considered that the available data were more supportive of classification as Reprotoxic 2; H361f (Suspected of damaging fertility).

The Agency Technical Report identified additional information, relevant to the assessment of reproductive toxicity, that was not considered by the RAC during the preparation of the RAC Opinion. The Agency Technical Report also concluded that the inclusion of lithium hydroxide as an entry in the GB MCL list should be further considered in the Agency Opinion. This meets the criteria for triggering the Article 37A procedure and therefore the proposed classification for the three lithium substances requires further consideration and assessment under the Article 37A procedure of the GB CLP Regulation

Agency Opinion

In August 2023 the HSE published the Agency Opinion on the classification and labelling of lithium carbonate, lithium chloride, and lithium hydroxide. In the Agency Opinion it was concluded that the proposed mandatory classification and labelling for the three lithium salts requires further consideration under Article 37A of the GB CLP Regulation. Therefore no mandatory classification and labelling was proposed at that time. The justification for this is based on the need to consider the scientific issues raised in the Agency Technical Report in respect of reproductive toxicity. Furthermore new information that require further assessment has been identified and this information could affect the classification of the three lithium substances.

Facts about the three lithium salts