Pigment (general)

 Currently, most clinics use pigments imported from overseas. There are two big problems. Sterilization issues and ingredient content issues.

According to a report in an academic journal in 2018, when examining microbial contamination of pigments for tattoos and permanent makeup sold in the United States, 42 out of 85 samples were found to be contaminated with bacteria or fungi. It is in a new and unopened state. 34 of them were pathogens that are harmful to humans (Microbiological survey of commercial tattoo and permanent makeup inks available in the United States J Appl Microbiol 2018 May;124(5):1294-1302).

There is also a 2020 review report by the same author (Microbial contamination of tattoo and permanent makeup inks marketed in the US: a follow-up study Lett Appl Microbiol. 2020 Oct;71(4):351-358). 17 dyes from 42 dyes that were contaminated with bacteria in the previous survey and 4 dyes from 43 dyes that were not contaminated in the previous survey were re-inspected. As a result, no bacteria were detected from the 4 previously negative samples, but bacterial contamination was confirmed again in 11 of the 17 previously contaminated samples.

In this way, there is no guarantee that foreign-made dyes are sterile even if they are brand new and unopened. The only workaround is to re-sterilize it yourself.

Figure 4  

An example of resterilization method for commercially available dyes. The dye is sucked out with a syringe, capped, and sterilized with high pressure steam. A change in volume due to a change in temperature can be dealt with by moving the inner cylinder.

 Next to the issue of sterilization is the issue of ingredient content.

Globally, EU member states are the most stringent as of December 2022 when it comes to regulations on ingredient content. From January 2022, the EU's REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) has been expanded to include permanent makeup pigments. All ingredients must be listed, and the use of high-risk substances is prohibited, or the upper limit of concentration is stipulated.

As for the United States, the FDA (Food and Drug Administration), which is equivalent to Japan's Ministry of Health, Labor and Welfare, states, “No pigment additives are approved for tattoos or permanent makeup”, “FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics”, “When we identify a safety problem associated with a cosmetic, including a tattoo ink, we investigate and take action, as appropriate, to prevent consumer illness or injury”, “The pigments used in the inks are color additives, which are subject to premarket approval under the Federal Food, Drug, and Cosmetic Act” and “Because of other competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments, FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks” on its website. This is much looser than EU regulations. Basically, it is self-responsibility, and it seems that the FDA's intervention should be kept to a minimum.

There is an episode that provides insight into the activities of the FDA. From 1988 to 2003, the FDA received only 5 side effect reports regarding permanent makeup, but in 2003 there were more than 150 reports. In response to this, the FDA has announced a product that is the cause and has issued a warning：“Because of other competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments, FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks”.

Figure 5  

A case of allergic contact dermatitis after eyebrow permanent makeup cited in the 2007 FDA report.

 In Japan, permanent makeup pigments are neither pharmaceuticals nor medical devices. When I asked the PMDA (Pharmaceuticals and Medical Devices Agency) what it was, they answered that it was a miscellaneous item. Miscellaneous goods are, for example, such as the paper towels you use to wipe your hands after washing your hands at the clinic.

In short, they are all miscellaneous goods that are used in clinics but are neither pharmaceuticals nor medical devices.

The reason why I contacted PMDA was that permanent makeup pigments enter the body, so I thought that they might be subject to some kind of regulation, but that doesn't seem to be the case. They are even no cosmetics, so it can be said that the regulations are looser than in the United States.

This lax regulation may have something to do with the fact that permanent makeup is considered a medical practice in Japan. It can also be taken as an implication that the doctor who performs the treatment bears full responsibility for the dye, and that the Ministry of Health, Labor, and Welfare and the PMDA are not involved.

Can you say that permanent makeup pigments used within the EU member states are safe? Here is an interesting report. This is the result of an Italian public agency verifying how much preservatives, whose concentration limits are set by new EU regulations, are actually contained in products （Quantification of preservatives in tattoo and permanent make-up inks in the frame of the new requirements under the REACH Regulation Contact Dermatitis. 2022 Sep;87(3):233-240）.

40.6% of the dyes had added preservatives above the REACH limit. It was 49.5% for tattoo pigments and 17.9% for permanent makeup pigments, which was less for permanent makeup pigments. By country of origin, products made in the United States, Italy, and Taiwan exceeded the upper limit of concentration, while products made in Germany were fine.

Considering the true safety of permanent makeup pigments from the above situation, what should we use? If you buy a commercially available one, as of January 2023, it means that the German one is good. In the case of the author, I considered that there was no choice but to obtain materials with guaranteed safety and make an original ink by myself. It is also commercially available and there is an advertisement at the end of the book, so please refer to it.

For reference, here is a specific method for confirming whether the ingredients of permanent makeup pigments made overseas are approved in the EU.

For example, let's say that there is an American-made red permanent makeup pigment for lips that says “ingredients: Red 254, glycerin, isopropyl alcohol” as ingredients (it actually exists).

“Red 254” can be presumed to be “pigment red 254” by searching on Google.

The EU regulations related to permanent makeup are (EU) No 2020 2081, (EC) No 1223 2009, (EC) and No 1272 2008, (EC), so search the internet and download them as a PDF document to your PC first. This is for opening with Acrobat and using the search function.

By the way, (EC) No 1272 2008 has a list of general dangerous substances and (EU) No 2020 2081 describes their permissible concentrations. (EC) No 1223 2009 has “List of substances that must not be used in cosmetics” and “List of substances that may be used in cosmetics”, and (EU) No 2020 2081 defines this list as a permanent makeup pigment. It also states that it applies to (EU) No 2020 2081 and establishes permissible concentrations for specific substances. For example, the upper limit for mercury is set at 0.00005% by weight, so mercury compounds, which have been reported as typical causes of allergies by red pigments, cannot be used in the EU from now on.

Open each document with Acrobat, display the search window with Ctrl + F, and enter “pigment red 254”. If there is a description about this pigment in the document, it will be highlighted, so you can read it. Just in case, check the CAS RN (Chemical Abstracts Service Registry Number) of pigment red 254, namely 84632-65-5, and search in the same way. For all three documents, “Document search by Adobe acrobat has ended. There are no matches.” So it turns out that there is no description.

In other words, pigment red 254 is a dye that is not listed on either the positive list or the negative list in the EU. It's a dye that isn't positively endangered, but it's also not approved.

You can check the FDA's “Color Additives Permitted for Use in Cosmetics” site for dyes that are approved for use in cosmetics in the United States. Pigment red 254 is not listed here either. The FDA considers permanent makeup pigments to be cosmetics rather than pharmaceuticals, but considering that such products are openly sold, it does not seem to be willing to actively intervene in this matter.

As mentioned above, permanent makeup pigments are not even “cosmetics” in Japan. They are treated as “miscellaneous goods”, can be imported and sold freely, and are not subject to any regulations. This is because permanent makeup is considered a medical practice, and safety is left to the judgment of medical professionals. We shouldn't be relieved just because “ingredients are disclosed” and not start using it without finding out what chemicals they are.

Another source of information is the allergen database provided by the Contact Dermatitis institute (https://www.contactdermatitisinstitute.com/database.php). Substances for which sensitization was a clinical problem would be listed. You can also search by entering “pigment red 254” in Pubmed (National Center for Biotechnology Information (nih.gov)), which is a medical literature search site.