EU REACH 2022?

[Calvin Ku]

Hello,
My name is ******** I am an owner of a Beauty school for permanent makeup and a permanent makeup shop, based in Eastern Europe, Sofia, Bulgaria. We have worked with Biotouch pigments for the past 10 years in the school and as resellers. Our distributor so far has been **********

In Bulgaria though, we were informed about new regulations from the directive REACH 2022 of European Union. This directive bans most substances in permanent makeup and tattoo pigments for Europe that I am afraid Biotouch uses in its products.

As a result most companies stopped selling their lines worldwide and developed a new purified line with substitutes for all iron oxides, heavy metals and titanium dioxide /like Perma Blend for example, detailed info on Reach 2022 Eu is on their site/

I recently post a question in an email to you and waited a couple of weeks for an answer, but I haven’t received one. In order to continue legally work and resell Biotouch in our area and teach students in our school with this brand, my questions are:
- are all pigments not meeting the new REACH 2022 standards or are there some colors of either of bioituch lines that meets the new requirements?
- Is the import legal for Europe?
-Is Biotouch planning on developing a new purified formula?

I would be thankful for any suggestions and to hear your position on this new /as of 01/2022/ situation and recommendations as I would be glad to continue doing business with Biotuch Inc.

Hopefully I can receive your assistance on this matter as we have had great work relationships with the company so far.

Sincerely,
***************

[EU Pigment Discussion]

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.

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).