According to the recent estimations, as much as 12% of the EU population has at least one tattoo. Considerably the current tattooing practices comprise also introducing tattoo ink inside the eyeball or into mucous membranes. There is also a significant increase in the popularity of permanent make-up (a form of tattoo) with an intention to enhance eyebrows, lips, eyes, and even moles.
As the tattoo inks penetrate the skin and settle into the deeper layer of the dermis, long-term systemic exposure to the potentially harmful ingredients needs to be addressed.
Therefore, tattoo inks and permanent make-up pigments have been recently evaluated for long-term safety by ECHA. As a consequence, the European regulators have introduced new restrictions for tattoo inks and pigments under the REACH Regulation from January 4, 2022.
The new rules consider, among others:
- Application of new concentration limits for multiple substances used by the industry. For Pigment Blue 15:3 and Pigment Green 7 the restrictions will apply as of January 4, 2023;
- “Suppliers placing a mixture on the market for use for tattooing purposes shall ensure that, after January 4, 2022, the mixture is marked with the following information:
- the statement ‘Mixture for use in tattoos or permanent make-up’;
- a reference number to uniquely identify the batch” (EC, 2020);
- the list of ingredients in accordance with the nomenclature of Article 33 Regulation (EC) No 1223/2009, or IUPAC name or the CAS and EC number. Ingredients shall be listed in descending order by weight or volume of the ingredients;
- the statement ‘pH regulator’ indicating pH regulating substances;
- the statement ‘Contains nickel’ or ‘Contains chromium (VI)’ followed by: ‘Can cause allergic reactions.’- if the mixture contains nickel or chromium (VI) within the allowed concentration limits;
- any additional safety instructions for use to be stated on the label if not already required by Regulation (EC) No 1272/2008.
Additionally, ingredients classified within the EU as:
- Carcinogen, mutagen, or as toxic to reproduction (CMR substances);
- Skin sensitizer;
- Skin corrosive;
- Skin irritant;
- Eye irritant or eye-damaging;
- Substances listed in Annex II to the EU Cosmetics Regulation
- “Colorants listed in Annex IV to the EU Cosmetics Regulation with following conditions on their use:
- Not to be used in products applied on mucus membranes;
- Not to be used in eye products;
- Allowed only in rinse-off products; and
- Other conditions, such as for purity, listed in Annex IV” (ECHA, 2022)
And not being used as tattoo inks will be automatically restricted for this use as well.
The Regulation does not apply to the mixture for use for tattooing purposes, when placed on the market exclusively as a medical device or an accessory to a medical device, as per Regulation (EU) 2017/745
Kamila Rzewucka
Expert Consultant at R&D
04.01.2021
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Reference:
- ECHA. (2022). Tattoo inks and permanent make-up. Retrieved on 04/01/2022 fromTattoo inks and permanent make-up – ECHA (europa.eu)
- European Commission. (2020). Commission Regulation (EU) 2020/2081 of 14 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up. Retrieved on 04/01/2022 from EUR-Lex – 32020R2081 – EN – EUR-Lex (europa.eu)