Learn about the REACH Restriction on Hazardous Substances in Tattoo Inks

The popularity of tattoos as a fashion statement has soared in recent years, with more and more individuals embracing body art as a means of self-expression. However, alongside this growing trend comes a concerning revelation: negative health effects associated with tattooing.  Reports have emerged highlighting the presence of hazardous chemicals in tattoo inks available on the European Union (EU) market, raising alarms about potential risks to human health.  In response to these concerns, the Council of Europe has issued recommendations, such as ResAP(2003)2 and ResAP(2008)1, urging the adoption of safer practices in the tattoo industry.  Furthermore, some EU Member States have already implemented national legislation to address the issue, emphasizing the need for harmonized rules across the EU.

This article explores the reasons behind the push for restrictions on tattoo inks and the importance of safeguarding the health and well-being of both tattoo enthusiasts and artists.

 

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What Are the Objectives of the Restriction?

The objective of implementing restrictions on tattoo inks within the EU is to ensure a high level of protection for people's health.  By establishing harmonized rules, EU citizens can be equally safeguarded regardless of the country in which they choose to get a tattoo or whether the ink is manufactured within the EU or imported.  This initiative aligns with the principle of free movement of goods within the EU, guaranteeing that the same standards and safety requirements apply across member states. 

 

The restriction serves as an opportunity to increase consumer awareness, empowering individuals to make informed choices about the products they use on their bodies.  This creates a business opportunity for companies to develop and market safer tattoo inks, fostering a market that prioritizes health and well-being.  By implementing restrictions, the EU aims to set an international benchmark for safe tattoo practices and contribute to global efforts in protecting public health.

 

Restrictions under REACH

Restriction is considered one of the potential measures under the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) framework to effectively manage the risk associated with a substance.

Restrictions are implemented when it is determined that the risk of a substance is not adequately controlled through other means.  These restrictions can apply to various stages, including the manufacture, placing on the market (including importation), or use of a substance, whether it is used alone, in mixtures, or incorporated.  The measures imposed as part of restrictions can take different forms, such as outright bans, limitations on use, concentration limits in mixtures or articles, and the imposition of specific technical measures or labeling requirements. 

The specific restrictions are listed in Annex XVII of the REACH regulation, providing a comprehensive reference for the management of substances of concern and ensuring the highest level of protection for human health and the environment.

 

Preparatory Timeline

• June 2014: Consumer Safety Network Subgroup on Tattoos and Permanent Make-up gathered representatives from EU/EFTA national authorities and stakeholders

• September 2014: European Commission project on "Tattoos - Permanent Make-up" to provide regulators with scientific and technical basis to decide if EU measures needed to ensure tattoo/permanent make-up ink safety and protect consumers

• December 2015: European Commission asked ECHA to prepare a dossier and assess risks to human health of chemicals in tattoo and permanent make-up inks, and the need for EU-wide action beyond national measures Preparatory work

• October 2017: ECHA submitted the restriction dossier prepared in cooperation with Italy, Denmark and Norway and with the contribution of Germany • December

- June 2018: Consultations on the proposal • December

- February 2019: Consultations on draft opinion

• June 2019: ECHA submitted the opinions of the Committees for Risk Assessment and Socio-Economic Analysis to the Commission

 

How the Restriction is Passed

The process of passing the law regarding restrictions on tattoo inks within the EU involves several important steps and entities.  The REACH Committee, consisting of representatives from EU Member States, plays a crucial role in the decision-making process.  The committee assesses the scientific evidence, evaluates the risks associated with tattoo inks, and proposes measures to protect public health. Additionally, a Technical Barriers to Trade notification is issued to ensure transparency and allow for stakeholder input. 

This notification enables interested parties to provide feedback and express their concerns or support regarding the proposed restrictions.  Furthermore, the legislation undergoes scrutiny by both the European Parliament and the Council, where elected representatives thoroughly review the proposal and debate its merits. This scrutiny process ensures democratic accountability and allows for necessary adjustments and improvements before the law is finalized and enacted. 

Through these systematic processes and engagements, the EU strives to establish comprehensive and effective restrictions on tattoo inks, prioritizing the health and well-being of its citizens while maintaining transparency and democratic principles.

 

Scope of the EU's REACH Compliance

The scope of REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is defined by the European Chemical Agency.

- Use of a mixture ‘for tattooing purposes’: injection or introduction of the mixture into a person’s skin, mucous membrane or eyeball, by any process or procedure (including procedures commonly referred to as permanent make-up, cosmetic tattooing, micro-blading and micro-pigmentation), with the aim of making a mark or design on the body

- Substances with harmonized classification under the Classification, Labelling and Packaging (CLP) Regulation

- For carcinogenicity, mutagenicity or toxicity to reproduction, skin sensitisation, skin corrosion or irritation, serious eye damage or irritation

- Substances prohibited by the EU Cosmetic Products Regulation

- Impurities including heavy metals and PAHs, methanol and azo dyes not classified for carcinogenicity or mutagenicity but that may undergo decomposition or contain residual aromatic amines classified as carcinogenic or mutagenic Scope

- Restriction on the placing on the market of tattoo inks that do not meet requirements for max concentration of substances (specified in entry 75 and in Appendix 13)

- Inks not meeting requirements cannot be used for tattooing

- If several different classifications, lowest concentration limit applies

Dynamic links with:

- Cosmetic Product Regulation (CPR) – for new substances added to Annex II and Annex IV, restriction applies 18 months after entry into force of CPR amendment

- CLP Regulation – for new substances with relevant classifications added to Annex VI, restriction applies at the date of application of the CLP amendment (18 months after its entry into force)

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How Does The Restriction Process Work?

The process of implementing restrictions on tattoo inks within the EU is initiated either by the European Commission or a Member State.  In order to propose a restriction, a comprehensive "Annex XV dossier" is prepared by either the European Chemicals Agency (ECHA) or the relevant Member State.  This dossier includes vital information regarding the hazards and risks associated with the substance, potential alternatives, and a socio-economic assessment.

The dossier undergoes thorough examination and evaluation by the ECHA's Committees for Risk Assessment and Socio-economic Analysis.  During this process, consultations are opened to gather input from various stakeholders, allowing everyone to have a say in the decision-making process.  If the assessment concludes that the risk posed by the substance is deemed unacceptable, the European Commission takes the lead in preparing a proposal for the amendment of Annex XVII.  This proposal outlines the specific restrictions to be implemented, ensuring that they are effectively included within the existing regulatory framework.

 

Conclusion

In conclusion, the information regarding restrictions on tattoo inks within the EU is of utmost importance for both tattoo artists and responsible tattoo ink manufacturers. 

By understanding the implications of REACH compliance, the objectives of the restriction, the process of passing the law, and the measures involved, tattoo artists can make informed choices about the inks they use, prioritizing the health and safety of their clients. 

Responsible tattoo ink manufacturers, on the other hand, can utilize this information to develop and market REACH compliant inks, tapping into the growing demand for safer tattooing practices. 

By adhering to REACH standards and participating in the regulatory process, tattoo artists and manufacturers contribute to a safer tattoo industry and help protect the well-being of individuals who choose to get tattoos. 

Moreover, by staying informed and engaged in the ongoing discussions and consultations, they can actively shape the future of tattoo ink regulations, fostering an environment that prioritizes transparency, safety, and responsible practices. 

Ultimately, this information empowers tattoo artists and manufacturers to uphold high standards, gain consumer trust, and play a vital role in promoting the health and well-being of tattoo enthusiasts. 

With detailed review of legislation and safety practices, Xtreme Inks is extremely proud to be a leader in safe, responsible, and high-quality tattoo ink production and usage.

 

We Make Ink Do More

Paul Park, The Xtreme Team

For more information on our TATTOO INK sets, please take a look at our piece on Xtreme Inks: Artist Collections.

 

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