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Pigment Safety Review

Co-Written By Christine Comans
APAN Co-ordinator
Cosmetic Tattoo APAN Registered Practitioner
Cosmetic tattoo trainer and educator

Co-Written By Katherine McCann
M.HRM BSocSci
APAN Registered Practitioner
Nationally Accredited Cosmetic Tattooist

IGNORANCE is no excuse when it comes to pigment safety and ingredient confusion, with concerns being raised over incorrect advice, use and application due to a number of highly publicised botched tattooing procedures and an overall lack of awareness around what is actually being inserted into the skin.
In recent times, the spotlight shines brightly on Cosmetic Tattooing and debate continues to rage over industry regulation, ingredient classification and ambiguous merchant labelling. Sophisticated marketing techniques and products are also on the rise, compounding the level of confusion being felt by professionals when it comes to the selection of ‘the best’ products as well as their composite breakdown and correct application for use during cosmetic tattooing procedures.

In the Cosmetic Tattoo industry, we all strive to achieve great results for our clients and in order to do so, it is imperative to peel back the marketing and layers of manufacturer propaganda in order to identify what our intended purpose is and understand why we choose one product over another.

In this article we will take a closer look at the two separate categories of Pigments (both Organic and Inorganic) and attempt to de-mystify common assumptions, as well as clarify from a chemistry perspective some important considerations for professionals when choosing their desired pigment range. (Specific recommendations will be not be made as this is intended as information only).

Cosmetic tattoo pigments are split into two separate categories, organic (Lakes) and inorganic (Iron Oxides); both are available in a wide variety of colours, however understanding the ingredients for the use of cosmetic tattooing will determine the outcome of either semi permanent or permanent designs. Other than classification based in their chemical composition dyes can be classified according to their molecular size, being either nanoparticular, macroparticular or anything in between. Most are classified as nanoparticles.

Organic Pigments: It should be noted that the term ‘organic ‘ for cosmetic tattooing pigments is used in a chemistry context and should not be confused by marketing terms that imply the products are natural or chemical free as this is not the case. Organic simply means that these pigments contain a carbon based molecule. Please remember that this is purely a chemistry term that has absolutely nothing to do with our perception of the ingredients being chemical free.

Most organic pigments used by cosmetic tattooists are manufactured from carbon based dyes (organic) precipitated by metallic salts and are are called Lakes. The lake pigments are made by mixing a dye colour with an insoluble binderb substrate like alumina oxide. The mixing process causes the dye to become insoluble in water, which is useful for the purpose of tattooing as it means the particles cannot be removed by a person’s lymphatic system. The pigment is then combined with surfactants, carriers, thickeners and preservatives to produce the tattooing dye.

Synthetic dyes used in organic pigments are manmade which use a wide array of substances to create the different pigment colours we use for cosmetic tattooing, these dyes are made from synthetic resources such as petroleum by-products and it is worth noting that these dyes are not pure chemicals but may contain upwards of 10 percent impurities. For example yellow 5, which is the second widely used dye may contain up to 13 percent organic and inorganic chemicals.

“Did you know that these same dyes used to create cosmetic tattoo pigment colours are also used in the manufacture of coloured textiles and clothing?”

 

Inorganic pigments contain metal oxides like iron oxide, titanium dioxide and others. These include metal + oxygen and often some other elements too. Now, inorganic does not mean “unnatural” or “synthetic” as almost all inorganic metal oxide pigments do occur in nature as mineral compounds but the term means non-carbon based molecules. The pigment colours are derived from the earth’s tones of yellow, brown and red for iron oxides and white for titanium dioxide. These pigment colours are usually duller than organic pigments but are more resistant to heat and light and provide a longer lasting more stable colour.

Regardless if its metallic salt used in the organic pigment or and iron oxide in the inorganic pigment both pigment lines use compounds that are derived from the earth.

Iron Sulphate is an example of a metal salt. Iron sulphate has the chemical compound of FeSO4 and is often seen in the form of bright green crystals. All salts are made from metal; a simple example is table salt or sodium chloride, the metal in which is sodium.

During the manufacture of these pigments if the ingredients are sourced from reputable suppliers then the quality of the pigments are not considered an issue, as all ingredients in pigments must undergo testing.

Nanoparticles It is widely acknowledged that tattoo pigment suspensions unquestionably contain pigments composed of nanoparticles. This means any particle with a size of less than 10 microns is classified as a nanoparticle. In addition to size, there are a number of factors that are implicated in the behaviour and possible effects of Nanoparticles. These include shape, composition, and state of dispersion, surface area, aggregation state and surface chemistry.

Particle sizes in tattoo pigments have been measured by laser diffraction, electron microscopy and X-ray diffraction and are divided into three broad categories with black pigments being the smallest, white pigments being the largest and coloured pigments vary in a size in between the two.

Nanoparticles have higher levels of chemical activity than their larger particle equivalents due to higher surface area over volume ratio. However, assessment of the toxicity of cosmetic tattoo pigments has been the subject of little research and manufacturers are not obliged to disclose the exact composition of their products.

These parameters are currently proprietry information and are not disclosed in tattoo pigments however it is something that needs to be considered by practitioners and requires further investigation by the appropriate authorities.

In the past, tattooing has never been thought of as a method of introducing nanoparticles into the human body by the intradermal route and as such, it has never been a topic of research in nanotoxicology. The European Commission however has recently published an extensive report on nanoparticles and the associated risks to humans. This stemmed from a rise of tattoo pigments being found throughout the body and organs during health testing. The fact that they are migrating in the skin and entering the body via the systemic circulation/lymphatic system raised significant health concerns calling for sufficient risk assessments to be compiled and carried out. Although there is consensus that thorough and accurate particle characterization is an essential part of assessing the potential toxicity of nanoparticles in biological systems, further research in this area is required.

The need for Regulation:

Around the world there are a number of regulatory bodies responsible for the investigation and assessment of toxicity and ingredient levels found in pigments safe for human (insertion/consumption/absorption) is an ongoing process especially with the rate new products are being brought into the market. Two of the main regulators include the Federal Food and Drug Administration (FDA) or European Commission and in Australia the Therapeutic Goods Administration (TGA).

In 2003, the Council of Europe (CoE) published a resolution (ResAP), which outlines requirements and a criterion for the safety of pigment use in tattoos and permanent make-up. In 2008, the original report was superseded by a revised version (ResAP 2008).

The ResAP(2008)1 includes a list of negative substances that should not be present in tattoo and permanent make-up inks, these include colorants and aromatic amines, as well as the maximum concentrations for some impurities. The recommendation also provides criterion for the safety assessment of the used chemicals and encourages establishing a positive list of substances proved to be safe for their use under certain conditions.

Although non-binding, the ResAPs provide a reference for the development of national legislation and Member States such as France, Germany, the Netherlands, Spain and Sweden have it in place or as a draft, like Austria, Denmark and Latvia. The document is also recognised as the reference in New Zealand, but what about Australia?

Currently there is a requirement for products that are sold in the European Union (EU) to undergo testing to comply with certain parameters as set out by the Council of Europe. We urge Australian authorities to consider adopting this resolution in a measure to protect consumers because sadly many in the industry continue to source untested products which include cheap imports, counterfeiting, and non authorised selling. This is all very prevalent and is a measure to cut costs however cost cutting has consequences and practitioners that are taking shortcuts generally have a lack of education. We must remember that ignorance to the laws does not limit a practitioner’s liability.

Your Professional Responsibly:

Our advice to APAN members who are performing cosmetic tattooing procedures, is to undertake due diligence and utilise products that have been properly (formally) tested and comply with the Council of Europe Resolution ResAP (2008)1.

Christine Comans is a qualified and highly respected cosmetic tattooist based in Perth who specialises in medical cosmetic tattooing. Her work is highly regarded by several plastic surgeons who keep her busy through constant referrals of their patients to her for nipple areola tattooing after mastectomy and breast reconstruction surgery. Christine is also passionate about industry standards and has been appointed as the Co-ordinator for the APAN membership classification – COSMETIC TATTOO APAN REGISTERED PRACTITIONER.

Katherine McCann is a nationally accredited cosmetic tattooist, qualified beauty professional and tertiary postgraduate with a strong advisory background in Human Resource Management, training and strategic business development. Katherine has taught at both vocational and University level and has a keen interest in micro pigmentation and trauma resolution.