On 28 November 2023, the UK’s Health and Safety Executive (HSE) published a new batch of 6 Agency Opinions formally proposing mandatory classification and labelling (MCL) for the substances they contain. The Agency Opinions relate to substances for which the HSE (as the GB CLP Agency) published Agency Technical Reports in November 2022 under Article 37 of the GB CLP Regulation. The next batch of Agency Opinions is expected to be published in December 2023.

Mandatory Classification and Labelling

Substances and mixtures placed on the GB market must be classified and labelled in accordance with the GB Classification, Labelling and Packaging (GB CLP) Regulation. There are two types of classification:

• Mandatory classification is a classification that has been made legally binding within Great Britain (England, Scotland and Wales). It is in line with the 'harmonised classifications' established under EU CLP. Mandatory classifications and the associated hazard labelling (MCL) are listed in the GB Mandatory Classification and Labelling List (GB MCL List). In cases where a substance has an MCL for some or all hazard classes, suppliers to the GB market are required to implement this classification.

• Self-classification involves the supplier collecting and assessing all available data and subsequently comparing it with the classification criteria. Self-classification applies to all mixtures and to substances which do not have a mandatory classification. Substances with a mandatory classification are still subject to self-classification for all hazard classes not covered by the mandatory classification.

In October 2023, 98 chemical substances were added to the GB MCL list. This was the first batch of substances added to be added to the list after Brexit. Agency Opinions have been published for another 61 substances (including the latest 6). A second batch of 26 substances is expected to be added to the GB MCL list in the first quarter of 2024.

Included Substances

The table below summarises information on the substances included in the current batch of Agency Opinions.

The UK’s Health and Safety Executive (HSE) has launched two public consultations on two substances, Pigment Red 83 and Solvent Violet 13, used in tattoo and permanent make-up (PMU) inks. The two substances have been proposed for mandatory classification and labelling (MCL) under Great Britain’s Classification, Labelling and Packaging (CLP) Regulation and scientific or technical information and/or wider policy and impact considerations can be submitted via the HSE’s comment webform by 2 January 2024.

Restriction Proposal for Tattoo Inks

In its capacity as the Agency for UK-REACH, the HSE has prepared a proposal under Article 69(1) of UK­-REACH to restrict certain hazardous substances found in inks used for tattooing and permanent make-up (PMU). The proposed restriction applies to substances with a mandatory classification for various hazards, such as skin sensitisation (H317). It also includes substances that are banned for use in cosmetic products in the EU under Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (as amended), commonly known as the Cosmetics Regulation.

The proposed restriction includes a derogation for 19 substances including Pigment Blue 15:3 and Pigment Green 7. Initially Pigment Red 83 and Solvent Violet 13 were also included in the derogation, but these two substances were removed because a review by the HSE identified data indicating potential concerns for skin sensitisation for these substances.

Pigment Red and Solvent Violet

The HSE has reviewed the available hazard information and found that there is a potential concern for skin sensitisation for two substances: Pigment Red 83 and Solvent Violet 13. Mandatory classification for skin sensitisation category 1B (H317) would bring the substances within the scope of the proposed restriction.

Therefore, the HSE as the Agency for GB CLP has prepared targeted reports to propose the mandatory classification and labelling of Pigment Red 83 and Solvent Violet 13 for skin sensitisation. The MCL reports are available here and here.

Information on the two substances is given in the table below:

Anyone with relevant information is encouraged to share it with the HSE. Relevant information includes scientific or technical information associated with the proposed classification, as well as information on the potential effects of the classification both positive and negative.