UK REACH – restriction proposals 002 - Call for evidence: substances in tattoo inks and permanent make-up (PMU)

Overview

We are gathering information and evidence to support the development of a UK REACH restriction dossier (report) on risks to human health arising from the use of certain pigments and other substances in tattoo ink and permanent make-up (PMU). UK REACH came into force at the end of the EU exit transition period (31st December 2020) and regulates the access of chemicals to the GB market. Under the Northern Ireland Protocol, EU REACH continues to regulate the access of chemicals to the Northern Ireland market.

Please support your contribution with references and reliable data (facts and figures).

Background note

Tattoos and permanent make-up (PMU) have increasing popularity. The need for tattoo inks and PMU, and the equipment used to apply these products, to be sterile is widely recognised. However, less attention has been paid to risks that could arise from the chemical ingredients used to make these inks and PMU.

The pigments used in tattoo inks are not necessarily specifically produced for tattooing, i.e. injection under the skin. These pigments are often of low purity and can contain, intentionally or as an impurity, hazardous substances. Exposure to these hazardous substances can lead to health effects. Surveys have shown that a significant proportion of people report skin problems, such as bleeding, crusts, and itching after tattooing.

More serious issues (e.g. allergies caused by substances used in ink and possible carcinogenicity) could also arise from exposure to these substances.

Tattoo inks and permanent make up, unlike cosmetics, are not currently subject to any specific regulations that control their composition.

From January 2022, the European Union (EU) will restrict the use of certain harmful chemicals in tattoo inks and PMU. You can learn more about the EU action on the website of the European Chemical Agency (ECHA).

The EU restriction aims to prevent the use of chemicals in tattoo inks and PMU that we know have specific hazardous properties which make it more likely that someone might experience harmful effects.

HSE intends to examine the evidence presented in the restriction dossier prepared by ECHA along with other available information, particularly where it describes the situation in Great Britain (GB), to decide if a restriction on certain harmful chemicals in tattoo inks and PMU is an appropriate regulatory measure for GB. HSE will analyse the risks to human health presented by certain chemicals if they are used in tattoo ink or PMU, the availability of alternatives and the socio-economic impacts of a possible restriction if this was implemented in GB. HSE is holding this call for evidence to gather information that will help with this analysis.

This call targets companies (manufacturers, importers, distributors, retailers) and professional users of tattoo inks and PMU, trade associations, environmental organisations, consumer organisations, medical professionals and any other organisations and members of the public holding relevant information.

We are seeking information on the following topics:

• Substances that are used in tattoo inks and PMU and their function e.g., pigment, diluent, solvent etc
• Quantities that are supplied and used
• Costs
• The availability of alternatives, including information about their cost, hazard and risk profile and technical characteristics (e.g., will these alternatives affect the quality of the tattoo or PMU)
• Tattooing and PMU services
• Existing regulations and standards governing the safety of tattoo ink and PMU and the enforceability of these regulations/standards

We welcome any information on these general topics.

HSE’s Confidentiality and GDPR statements

HSE tries to make its call for evidence procedure as thorough and open as possible.

Information provided in response to this call for evidence may be subject to publication or disclosure in accordance with the access to information regimes (these are primarily the Freedom of Information Act 2000 (FOIA), the General Data Protection Regulations (GDPR) and the Environmental Information Regulations 2004 (EIR)). Statutory Codes of Practice under the FOIA and EIR also deal with confidentiality obligations, among other things.

If you would like us to treat any of the information you provide as confidential, please make this clear in your response. If we receive a request under FOIA or EIR for the information you have provided, we will take full account of your explanation, but we cannot give an assurance that confidentiality can be maintained in all circumstances.

An automatic confidentiality disclaimer generated by your IT system will be disregarded for these purposes. Requests for confidentiality should be made explicit within the body of the response.

HSE will process all personal data in accordance with the GDPR. This means that personal data will not normally be disclosed to third parties and any such disclosures will only be made in accordance with the Regulations.

How to submit comments

Basic information can be provided in the call for evidence survey below. More detailed information should be provided in document(s) which can be submitted as attachments at the end of each section. We will not automatically publish information submitted in response to a call for evidence. However, it will be helpful if a “public version” of your information can be provided to help us understand which information we can include in the restriction proposal which will be published. If you also want to include confidential information in your submission, please additionally complete a “confidential version” and submit both versions as attachments.

The call for evidence lasts for 8 weeks (unless otherwise specified) and closes at 23:59 London time (BST).