European Union Pigment FAQ

On 30 June 2021, the EU Commission adopted the draft General Product Safety Regulation (GPSR) which, once enacted, is intended to replace the current GPSD. The GPSR proposes to broaden the GPSD’s scope in a number of ways, including through:

• New explicit duties for online marketplaces and other distance sellers, including more stringent communication requirements with market surveillance authorities in respect of safety issues;

• Expansion of a number of definitions, in particular:

• Broadening “product” to take account of the interconnection of items;

• Extending “safety” to reflect the ability for products to evolve and upgrade throughout their life;

• Improved harmonization of market surveillance, consistent with the obligations set down in the newly-implemented Market Surveillance Regulation ((EU) 2019/1020).

On the EU level, tattoos and similar procedures fall under Directive 2001/95/EC on General Product Safety (GPSD) which is requiring that only safe products are placed on the market.

Some Member States (Belgium, France, Germany, The Netherlands, Spain, Slovenia, and Sweden) have adopted national measures that are based on ResAP(2008), prohibiting the presence of tattoo inks containing certain chemicals on the market, whilst in other measures, the general safety requirements laid down in the General Product Safety Directive (GPSD) applies.

Tattooing inks and permanent makeup products that enter the EU market have to comply with the provisions of various legal acts, such as the General Product Safety Directive and the Regulation on the Classification, Labelling, and Packaging of products. In addition to this, they may be required to comply with the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals, if the products contain hazardous substances, and the Biocidal Products Regulation, if they contain certain preservatives. In other words, the substances used for tattooing and permanent makeup must comply with different regimens, which are determined on a case-by-case basis (including the GPSD, the CLP Regulation, the REACH regulation, and the BPR), while the equipment utilized for performing or removing the tattooing or the permanent makeup fall under the scope of the Medical Devices Regulation.

There’s also one regulation: EUR-Lex - 32020R2081 - EN - EUR-Lex (europa.eu), which amends some aspects of the REACH regulation.

In January 4, 2022, new restrictions to tattoo inks and permanent make-up pigments apply. The Regulation (EU) 2020/2081 foresees:

• New maximum concentration limits for several ink substances

• Additional label requirements for tattoo mixtures

You can read more on this topic on Obelis.net:

• Regulating Toxic Chemicals: Safer Tattooing Inks and Permanent Makeup for a Safer EU Market

• Tattoo inks and permanent make-up pigments: new restrictions

• EUR-Lex - 32020R2081 - EN - EUR-Lex (europa.eu)

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture, and electrical appliances. Therefore, the regulation has an impact on most companies across the EU. Some chemicals were banned and for others, several restrictions were imposed.

The new rules for Tattoo Inks, among others:

• Application of 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;

• Substances falling within one or more of the following points shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the substance or substances in question is or are present in the following circumstances:

  • carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only the following exposure by inhalation:

    • (a)in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;

    • (b)in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;

    • (c)in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;

  • The full list of the above mentioned substances you may find in the REGULATION (EC) No 1272/2008 - HERE.

  • The list of ingredients is in accordance with the nomenclature of Article 33 Regulation (EC) No 1223/2009, or IUPAC name or the CAS and EC number.

  • Warnings for allergens are put in the Instruction for Use.

For more information regarding new restrictions please see amendments to some aspects of the REACH regulation - EUR-Lex - 32020R2081 - EN - EUR-Lex (europa.eu).

Yes, our Biotouch PURE pigments are compliant with REACH.

Our ingredients can be used in tattoo inks:

• For Iron oxide - according to the notifications provided by companies to ECHA in REACH registrations no hazards have been classified.

• For Titanium dioxide – The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1% or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 µm. Liquid mixtures containing TiO2 do not require Carc. 2 classification.

Yes, Biotouch PURE Pigments are designed to meet the stringent regulations of the European Union.

You will not notice a difference between the two. There are only slight ingredient changes to comply with the different regulations.

No, they are not.

You can send them our compliance certificates to prove that the product is compliant with the latest regulations.

You can find them in the section below, or through this link: drive.google.com/drive/folders/1JOSDt5QiBDKtRupbZDZR1TvWrdNwnS-z?usp=sharing

This is to certify that the manufacturer declares that the products complies with the essential requirements of Directive 2001/95/EC. The Manufacturer has provided Obelis s.a. (EC REP) with all the appropriate declarations as per the Directive 2001/95/EC requirements, including the EC Declaration of Conformity confirming that their products are fulfilling the applicable requirements of the Directive 2001/95/EC.

Our European Authorized Representative (EAR) is Obelis s.a. Their address is: Bd. General Wahis 53, 1030 Brussels, Belgium

Obelis European Authorized Representative Center is a member of the European Association of Authorized Representatives (E.A.A.R.). Obelis s.a. is ISO 9001 : 2015 and ISO 13485 : 2016 certified.