REACH restriction for substances in inks used for tattooing and permanent make up

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 agreement of the Scottish and Welsh Governments, to prepare an Annex 15 restriction dossier assessing the risks to humans from substances in inks used for tattooing permanent make up (PMU).

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 consultation took place between May and November 2022.

Article 71(1) of UK REACH requires HSE to publish the draft socioeconomic opinion on the restriction and invite interested parties to submit comments on the draft opinion no later than 60-days from the publication of that draft opinion. This consultation fulfils this requirement.

Please note that only socioeconomic factors will be taken into account during this second consultation period. Comments on aspects of the risk assessment will not be taken into account (in particular sections 4.3 and 4.7.1). People wishing to submit information during this public consultation are encouraged to submit information as early as possible.

The following document is attached to this consultation:

• The Agency opinion (including the final risk assessment opinion and draft socioeconomic opinion)

UK REACH came into force at the end of the EU exit transition period (31^st 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 this survey.

The restriction opinion will take into account all comments which apply to the  socioeconomic information presented in the draft opinion. After the end of the restriction process HSE will publish lists of the comments that stakeholders submitted during the first and second public consultations, together with responses 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 the response to comments documents. 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.

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 60 days and closes at 23:59 London time (BST) on 14 April 2023.