Every tattoo studio in Sweden receives supervision from its municipality annually or every other year. The supervision normally costs between 2000 SEK to 10,000 SEK depending on the scope and municipality. Usually the visit is announced a few weeks in advance. In order not to end up in conflict, risk a return visit and a fine or even a business ban in your municipality, we advise you to familiarize yourself with what applies.

What do I need to keep an eye on?

There is currently an intense hunt for “reach-friendly” tattoo ink. Here is how you should stay up to date on what is available. Here is a checklist that is good to keep track of.

• Have all the safety data sheets (SDS) collected for the paints you use. The documents should be in Swedish. Preferably in a nice index.

• Keep an eye on the date marking. Did you know that you should write on the bottle the date it was opened? The shelf life is indicated by a symbol, such as 6M or 12M, which means that the bottle is okay to use for 6 or 12 months after opening.

• Store your paints in a dark and cool space.

• How do you declare colors for your customers? By law, you must declare for each customer which colors you intend to use, including batch number. You must notify the safety regulations that are stated on the bottle. Today, there is an app that Sweden's Registered Tattoo Artists has developed together with Lundberg Custom that makes this much easier. check it out here: https://srt.se/tda/

• Check that your supplier has registered the colors with the Swedish Medicines Agency. You can find the list here: https://www.lakemedelsverket.se/sv/tatueringsfarger/regler-for-tatueringsfarger/anmalan-till-register-for-tatueringsfarger/lista-over-foretag

• Check your supplier for safety. How do you know this paint is up to standard? There are a plethora of brands that claim to be REACH compliant but in reality it is a scam or misleading information.

The tattoo artist's responsibilities:

Tattoo artist means that you use tattoo ink in your professional activity. As a tattoo artist, you may have more than one role of responsibility. If you purchase tattoo ink from a supplier in Sweden or the EU/EEA and use the tattoo ink in your activity, the following requirements apply:

• According to point 8, column 2, entry 75 of Annex XVII to the REACH Regulation, you may only use tattoo inks that are labelled “mixture for use in tattoos or permanent make-up” when tattooing.
• you must ensure that you have labelling information in accordance with point 7, column 2, entry 75 of Annex XVII to the REACH Regulation for your tattoo inks. You must provide the customer with such labelling information for the tattoo ink(s) you intend to use for the tattoo prior to tattooing
• you must ensure when purchasing the paints that they comply with the concentration limits in the restriction in entry 75 Annex XVII of the REACH‍-‍Regulation
• you should use the tattoo ink according to the labeling, instructions for use and safety data sheet that comes with the product
• According to the Regulation (2012:503) on tattoo inks, you may only use tattoo inks that are sterile and that are packaged in packaging that maintains sterility until use in accordance with the requirements in Section 2 of the Medical Products Agency's regulations (HSLF‍-‍FS 2022:16) on tattoo inks.
• According to the Medical Products Agency's regulations (HSLF‍-‍FS 2022:16) on tattoo inks, you may only use tattoo inks that are labeled according to Section 7 a (company name), b (shelf life marking) and c (sterile marking)
• you may only use tattoo inks whose labeling meets the language requirements in Section 8 of the Medical Products Agency's regulations (HSLF‍-‍FS 2022:16) on tattoo inks
• not to use tattoo inks whose expiration date has expired.

To check that the requirements of entry 75 of Annex XVII to the REACH‍‍-‍‍Regulation are complied with, the tattoo artist can, for example, ask the supplier specific questions about compliance with concentration limits and labelling requirements in the restriction. Choose an established supplier who is aware of the rules and follows them.

The questions and answers should be documented.

The tattoo artist must provide the customer with information

Tattoo artists may only use products labeled "mixture for use in tattoos or permanent makeup" when tattooing.

Before tattooing, the customer should receive information from the tattoo artist about the tattoo inks to be used, including content information.

The content information should enable people who are sensitive to certain substances to avoid such tattoo inks. The information also makes it possible to trace the inks used if, for example, the customer has suffered an adverse health effect.

Information to be provided

Information that the tattoo artist, according to entry 75 point 7 of Annex XVII to the REACH Regulation, must provide to the customer before tattooing is:

The statement “Mixture for use in tattoos or permanent make-up”.

A reference number (batch number) to uniquely identify the lot. Please note that batch numbers may vary between different tattoo colors.

A list of the ingredients.

The additional indication ‘pH‍-‍regulator’ for substances covered by point 1(d).

The statement “Contains nickel. May cause an allergic reaction.” if the mixture contains nickel below the concentration limit specified in Appendix 13.

The statement “Contains chromium (VI). May produce an allergic reaction.” if the mixture contains chromium (VI) below the concentration limit specified in Appendix 13.

Safety instructions for use, if not already required to be included on the label in accordance with Regulation (EC) No 1272/2008.

Note that a certain part of the labeling that must be provided to the customer must meet Sweden's language requirements in Section 8 of HSLF-FS 2022:16.

Labeling rules

In addition to the requirements in the list above, the Swedish Medical Products Agency also recommends that the customer is provided with information about:

name of the tattoo color

name, address and contact details of the tattoo parlor that will perform the tattoo

date of the day the tattoo is to be performed.

The tattoo artist needs to prepare documents so that he can provide the customer with the information before the tattoo.

Example

• Tattoo ink for tattoo
• Ink King Pitch Black
• Mixture for use in tattoos or permanent makeup
• Mixture for use in tattoos or permanent make-up
• Batch number: 12345
• Table of Contents (For example: Contents: Aqua, CI 72266)
• Warning texts
• “Contains nickel. May cause an allergic reaction.” and
• "Contains chromium (VI). May cause an allergic reaction."
• Applies if the tattoo ink contains these substances below the permitted concentration limit specified in Appendix 13.
• Any safety instructions.
• About the tattoo artist
• Tattoo parlor name, address and contact details
• Date the tattoo is to be performed: YYYY‍-‍MM‍-‍DD

Good links to keep an eye on:

Swedish rules:

Tattoo inks on the Swedish market must, in addition to EU legislation, comply with Swedish legislation in the form of the Ordinance (2012:503) on tattoo inks and the Swedish Medical Products Agency's regulations (HSLF-FS 2022:16) on tattoo inks.

Regulation (2012:503) on tattoo inks
HSLF-FS 2022:16 – Basic regulation

EU regulations:

Tattoo inks are mixtures of substances regulated by Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH Regulation). The Swedish Chemicals Agency is the competent authority for the REACH Regulation in Sweden, while the Swedish Medical Products Agency is responsible for supervision and regulatory guidance related to tattoo inks regulated in entry 75 of Annex XVII to the REACH Regulation.

Rules for tattoo inks in entry 75 of Annex XVII to the REACH Regulation are set out in Commission Implementing Regulation (EU) 2020/2081.

EU Commission Regulation 2020/2081 amending the Registration, Evaluation, Authorisation and Restriction of Chemicals in Tattoo Inks or Permanent Make-up

Detailed information on specific rules for tattoo inks under entry 75 of Annex XVII to REACH can be found on the pages Content rules, Labeling rules and About use and information for those who are going to be tattooed.

What else should you keep in mind before a visit from the municipality?

• Keep track of other chemicals. Including safety data sheets. For example, surface disinfection, etc.

• Cleaning routines should be documented. Think of a schedule for the toilet and a description of how you do it.

• How do you store your cleaning equipment? Think about how far away from the place you are tattooing and in a ventilated space.

• How do you handle residual waste? Waste water, hazardous waste container for needles. Separate sink for waste water.

• Do you have any idea about sterile labeling on disposable products?

• Work clothes, aprons, hand hygiene.

Lundberg Custom Supplies Sweden AB has collected all important documents or links to documents under the tab "Information - Product Documents" at the bottom of the website. www.lundberg-custom.com

Lundberg Custom Supplies Sweden AB focuses 100% on helping our customers do the right thing.

Consider buying paint from a Swedish retailer who registers their paints with the Swedish Medical Products Agency's product register. The list of companies that have registered paints can be found here: https://www.lakemedelsverket.se/sv/tatueringsfarger/regler-for-tatueringsfarger/anmalan-till-register-for-tatueringsfarger/lista-over-foretag

This means that companies that are not on this list are not reliable companies when it comes to tattoo inks in Sweden.

Thank you for your words/ Mattias Lundberg