UK REACH – Restriction Proposals 003 - Substances and groups of substances that pose a risk to human health if they are present in tattoo inks and permanent make-up (PMU)

Overview

On 29 April 2021, the Health and Safety Executive (HSE) as the Agency for UK REACH received a request under Article 69(1) of UK REACH from the Defra Secretary of State, with the consent of the Scottish Government and the Welsh Government, to prepare an Annex 15 restriction dossier assessing the risks to humans from substances in tattoo ink and permanent make up (PMU). As of 4 January 2022, the European Union (EU) has restricted the presence of over 4000 potentially harmful substances in these preparations. This Annex 15 dossier prepared by HSE examines whether a similar restriction should be introduced into Great Britain (GB).

In the request, Defra asked HSE to include in this dossier all substances listed in Council of Europe resolution ResAP(2008)1 and also the following substances:

• Carcinogenic or mutagenic substances
• Substances that are toxic to reproduction
• Skin sensitisers
• Skin corrosive or irritant substances
• Substances that cause serious eye damage/eye irritant substances
• Substances that are prohibited for use in cosmetic products under the Cosmetic Products Regulation (EUR 2009/1223)

Article 69(6) of UK REACH requires HSE to publish proposals for restrictions on its website and invite interested parties to submit comments on the proposed restriction within 6 months of the date of publication. This public consultation fulfils this requirement.

An additional 60-day consultation on the draft socioeconomic opinion will be held at a later stage to invite comments and to inform the development of the final socioeconomic opinion. People wishing to submit information during these public consultations are strongly advised to submit information as early as possible and not to limit their comments to this second consultation. Only socioeconomic factors will be taken into account during this second consultation period.

The following documents are attached to this consultation:

• The public consultation information note outlining the reasons why this restriction is being proposed.
• The Annex 15 restriction dossier describing the risks to human health that these substances and groups of substances create if they are present in tattoo inks and the three restriction options that HSE is proposing to manage these risks. This dossier also provides socioeconomic information to demonstrate that the proposed restriction options are effective, practical and monitorable.
• The Annex to the restriction dossier which contains a cover note and links to two ECHA documents:
  • Document 1 ECHA 2019c rest_tattoo_inks_bd_final_annex_12671_en. This document is the annexes to ECHA’s restriction dossier
  • Document 2 ECHA 2019d rest_tattoo_inks_opinion_final_12673_en. This document is the final RAC/SEAC opinion on ECHA’s restriction proposal

These documents are being provide because they give relevant technical information for the GB restriction proposal.

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 Northern Ireland market.

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

HSE’s Confidentiality and GDPR statements

HSE tries to make its public consultations as thorough and open as possible.

Information provided in response to this public consultation 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 survey below. More detailed information should be provided in document(s) which can be submitted as attachments at the end of each section.

The restriction opinion will take into account all comments received in the consultation. After the end of the restriction process HSE will publish a list of the comments that were submitted, together with a response to those comments. It will be helpful if you can provide a “public” non-confidential version of your information to make it clear which of your information we can publish in this response to comments document. If you also want to provide confidential information in your submission, please additionally complete a “confidential version” and submit both versions as attachments. We will take account of both non-confidential and confidential information in the restriction opinion. 

When responding to this survey, please provide as much information and evidence as you can.

You have an opportunity to provide general comments and information relating to the specific questions we ask in this survey. If you need assistance to complete this survey, please use the general comments section to indicate what information you are willing to share and tick that you are willing to be contacted by HSE. 

By submitting information as part of this public consultation, you agree that any data provided (excluding your personal details) can be shared with the Environment Agency under obligations under Article 2B, our independent scientific advisers and the appropriate authorities (i.e., Defra, the Welsh and Scottish Governments).

The public consultation lasts for six months and closes at 23:59 London time (BST) on 01 October 2022.