Permanent Makeup Training
New pigment and tattoo ink legislation explained
Apr
Understanding pigment legislation can be daunting and overwhelming. How do you know the product you use is safe and how can you find out the ingredients of your pigments? In this blog post we try to help you understand these questions as well as explain the new legislation that is coming into force on 4th January 2022 in Europe with the UK to follow within a few years with a similar UK REACH legislation..
How do I know my pigments are safe?
To find out if your pigments are safe you need to firstly make sure that you only buy from reputable manufactures which can supply you with the documentation needed to prove their safety. For example, Material Safety Data Sheets (MSDS) and reports of safety testing by trusted laboratories. At this moment in time pigments are required to adhere to ReSap2008 but new much stricter legislation is coming in 2022 (later more on this topic).
Where do I find the ingredients of my pigment?
You can find the ingredients on the packaging / bottle (*) and in the Material Safety Datasheets. Raw pigment materials can be identified by CI number. For example, you can find “CI-77266” in the ingredients list of your pigment. Simply Google this number and you will find that this is in fact Carbon Black. Other ingredients can be researched in the same way.
Your supplier should be able to provide you with other paperwork such as lab test results to prove they have been tested and adhere to the legislation. This is going to be particularly important under the new REACH legislation. More on that later.
(* ingredients should always be printed on the packaging / bottle, this is a legal requirement. If there are no ingredients on the bottle this should be a red-flag and you should contact your supplier to clarify. The REACH legislation will go even further and much more information will need to be provided on the packaging than what is currently required.)
Chemical compounds of Coloressense are REACH compliant
Did you know that it is estimated that between 3-20 % of the general population, depending on the EU Member State, may have had PMU procedures carried out (JRC, 2016b) and that the health effects reported after tattooing are mainly skin problems, 68% of persons being tattooed reported issues in one survey (Klugl, et al., 2010). However, the pigments in tattoo inks are known to distribute in the body and have been found in different organs such as the lymph nodes and the liver (Sepehri, et al., 2017a). In the same survey, 6.6 % of tattooed persons reported systemic reactions after tattooing. This does highlight the importance of these new restrictions coming into force. We have a responsibility as a professional industry, to our clients, to make sure we only use safe inks and pigments to protect their health.
New legislation from 2022
The European Chemicals Agency (ECHA) was asked by the European Commission to assess the health risks of certain chemicals used in permanent make-up pigments and tattoo-inks.
After their investigation and research, they have decided that over 4,000 chemicals currently found in inks and pigments are to be banned under new legislation know as REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) from January 2022 (Pigment Blue 15:3 and Pigment Green 7 are allowed till January 2023)
Certain substances used in pigments and inks can migrate from the skin to other organs such as the lymph nodes and the liver. This is one of the main reasons so many substances will be banned soon. When a tattoo is removed by laser for example the different components of the ink are broken down into smaller particles and released into the body. This can cause serious health concerns if harmful chemicals have been used in the manufacturing.
The new restrictions mainly cover many chemicals that are known to be carcinogenic or can cause genetic mutations. REACH also looks to ban substances that are potentially skin sensitisers and / or irritants.
Although the United Kingdom is no longer a member of the EU the same legislation will most likely apply here within a few years. In the Brexit Withdrawal bill this legislation was adopted and is known as UK REACH.
Not restricted but still banned
REACH legislation is much more than just banning certain pigments and substances, it goes much deeper to make sure the end products are deemed safe.
Under this new legislation every produced batch of every single colour will need to be tested and documented. These tests will show if certain readings are within the limits such as for heavy metals and other ingredients.
The tests will have to be carried out by approved laboratories and if passed the documentation needs to be signed by the manufacturer and supplied to the authorities.
This means that even if a certain pigment is not banned but the manufacturing process is not “clean” enough the product will not be allowed on the market under UK REACH legislation.
Not only raw pigments will be banned but also many other ingredients used such as certain preservatives, alcohols, and derivatives.
Under REACH another requirement is a standardization of the labelling of packaging of inks and pigments. This is required to ensure restrictions are correctly implemented. Hence mixtures will have to mention this type of use on their labels, together with a list of ingredients and relevant safety statements.
Some pigments under consideration to be banned
CI 10006 Pigment Green 8
CI 10020 Pigment Green 12
CI 11680 Pigment Yellow 1
CI 11710 Pigment Yellow 3
CI 11725 Pigment Orange 1
CI 11740 Pigment Yellow 65
CI 11741 Pigment Yellow 74
CI 11767 Pigment Yellow 97
CI 12075 Pigment Orange 5
CI 12085 Pigment Red 4
CI 12120 Pigment Red 3
CI 12310 Pigment Red 2
CI 12315 Pigment Red 22
CI 12370 Pigment Red 112
CI 12380 Pigment Red 14
CI 12385 Pigment Red 12
CI 12390 Pigment Red 17
CI 12420 Pigment Red 7
CI 12460 Pigment Red 9
CI 12465 Pigment Red 15
CI 12466 Pigment Red 269
CI 12477 Pigment Red 210
CI 12480 Pigment Brown 1
CI 12485 Pigment Red 146
CI 12490 Pigment Red 5
CI 15510 Pigment Orange 17
CI 15585 Pigment Red 53
CI 15800 Pigment Red 64
CI 15865 Pigment Red 48
CI 15880 Pigment Red 63
CI 16185 Pigment Red 193
CI 20040 Pigment Yellow 16
CI 21090 Pigment Yellow 12
CI 21095 Pigment Yellow 14
CI 21096 Pigment Yellow 55
CI 21100 Pigment Yellow 13
CI 21107:1 Pigment Yellow 87
CI 21108 Pigment Yellow 83
CI 21110 Pigment Orange 13
CI 21115 Pigment Orange 34
CI 21160 Pigment Orange 16
CI 42535:2 Pigment Violet 3
CI 42555:2 Pigment Violet 39
CI 51319 Pigment Violet 23
CI 71105 Pigment Orange 43
CI 73360 Pigment Red 181
CI 73900 Pigment Violet 19
CI 73915 Pigment Red 122
CI 74100 Pigment Blue 16
CI 74160 Pigment Blue 15 temporary allowed (3 years)
CI 74260 Pigment Green 7 temporary allowed (3 years)
CI 77603 Pigment Green 13
CI 77605 Pigment Red 104
Pigment Orange 74 Pigment Orange 74
Understanding REACH is a very complex process, we will try to keep you updated with more detailed information and latest developments.
Thank you to Holger Hoffman and Rene La Fontaine of Goldeneye Permanent System GmbH for your support in writing this article and creating a fabulous range of pigments in compliance with REACH.
I’d like to know the Material Safety Datasheet.
Where can i find it?
Also I’d like to know detail of ingredients of your pigments.
Please let me know.
Hi,
could you advise why CI21095 is looked at being banned ? and where is this USA/UK etc?
Many thanks