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:
Name |
IUPAC Name |
CAS no |
Pigment Red 83 |
1,2-dihydroxy-9,10-dihydroanthracene-9,10-dione |
72-48-0 |
Solvent Violet 13 |
1-hydroxy-4-(p-toluidino)anthraquinone |
81-48-1 |
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.