The UK Health and Safety Executive (HSE), as the implementing agency for UK REACH, is currently consulting on different potential options for a UK REACH restriction on substances to be used in tattoo inks and permanent make-up.
The proposed restriction would be in line with a similar restriction introduced in the EU through Commission Regulation (EU) 2020/2081, which entered into force in January 2022.
According to the HSE, uncertainties about the substances causing tattoo-related complications and their prevalence, it is difficult to quantify the level of risk that is associated with substance use for tattoo inks and permanent make-up. The restriction is therefore proposed on a precautionary basis, and it seeks to address the lack of UK regulations on the topic.
In line with the existing EU restriction, the UK restriction proposal would address the following groups of substances, imposing conditions on their use in tattoo inks and permanent make-up:
- Substances that have a harmonized hazard classification under the UK CLP for one of the following hazards:
- Carcinogenic, mutagenic, or toxic to reproduction (categories 1A, 1B or 2)
- Skin sensitising (categories 1, 1A or 1B)
- Skin irritant or corrosive (categories 1A, 1B, 1C or 2)
- Eye damaging and irritant (categories 1 or 2)
- Substances that have been prohibited under the EU Cosmetics Regulation (listed in Annex II therein)
- Colorants subject to use conditions under the EU Cosmetics Regulation (as specified in its Annex IV)
For these substance groups, HSE is proposing three alternative restriction options. While the restriction proposal contains several exceptions, the overarching approaches are depicted in the table below. A further point of differentiation is the automatic implementation of changes to the EU Regulation.
Substance group |
Option 1 |
Option 2 |
Option 3 |
Harmonized through UK CLP |
Concentration limits |
Concentration limits |
Concentration limits |
Annex II of the EU Cosmetics Regulation |
Cannot be used if prohibited
|
Concentration limits |
Concentr |
Annex IV of the EU Cosmetics Regulation |
Cannot be used if prohibited |
Concentration limits |
Concentration limits |
Automatic incorporation of list updates |
Yes for all |
Yes for UK CLP
No for EU Regulation Annexes
|
Yes for all |
Additionally, the restriction would also introduce some labelling requirements to complement existing regulations on the topic:
- The labelling of all ingredients that would not be identified under the UK CLP
- The highlight of the presence of nickel and chromium VI if applicable
- The provision of a manufacturer’s reference number
- The identification of the intended use of a mixture as tattoo ink or in permanent make-up, and instructions for use
Consultation on the scope of the restriction and on the proposed restriction options is open until November 6, 2022. An additional consultation will be held at a later stage on the socioeconomic impacts of the restriction.