Cosmetics & Personal Care | Monthly bulletin | March 2022
Discover the impact of tattoo inks
Tattoo inks consist of pigments and carrier combined with additives and impurities. They are widely used in tattoos, permanent make-up, corrective medicine and other such activities.
Since the status of tattoo inks is quite complex and controversial (borderline products, side effects, application area…), the regulatory and toxicological landscape and associated tests vary from one country to another, with the main concern being their risks to health.
Substances or mixtures for tattooing purposes must be compliant with the REACH Regulation [entry 75 of Annex XVII of the REACH Regulation (Regulation (EC) No 1907/2006)]. However, there are currently no binding criteria according to which a safety assessment of tattoo inks should be carried out. Tattooing products are not subject to authorisation prior to their commercialisation. There is also a lack of suitable testing methods and data for health risk assessments.
The Eurofins testing strategy follows the general approach of initially collecting and evaluating existing data and then providing missing information through analytical, microbiological, in vitro and clinical testing.
1. Analytical Testing
Specifications of the ingredients of tattoo inks and the identification of the impurities, heavy metals, MOSH, and nanomaterials present are essential for risk assessment. This data is also needed for the planning of toxicological studies and their evaluation.
2. Microbiological Testing – Sterility Testing
Tattoo inks contaminated with microorganisms can cause infections and lead to serious health issues when introduced to the skin during tattooing.
3. In vitro studies
These are based on the EDQM document 'Safer Tattooing' of 201734 and on the REACH and CLP Regulations. For tattoo pigments, tests shall be carried out for the following endpoints: eye irritation/eye damage, skin irritation/skin corrosion, phototoxicity, skin sensitisation, genotoxicity, photogenotoxicity, cytotoxicity, carcinogenicity, etc…. Our experts also have the skills required to direct your test plan on non-cosmetic products.
4. Clinical studies
These are primarily used to mimic the consumer’s response to the tattoo inks and compare the safety requirements to the typical local and systemic consumer exposure to the product. Our experts will guide you in selecting the most appropriate tests.
Safety and Counterfeits
Counterfeiting of cosmetic products creates a shortfall for manufacturers of around €7 billion per year at EU level. In addition to the financial aspects and brand recognition, counterfeit cosmetics present risks to the consumer due to the lack of safety assessments (microbiological control, dermatological control, composition control) and control of the manufacturing conditions.
Several analytical methods exist to support brands to prove the risks linked to counterfeit products and get the support of authorities to remove these products from the market. Those methods can be applied to any kind of product, such as make-up, skin care and hair care.
Depending on the client’s needs, Eurofins experts will set up tailor-made test plans to compare counterfeit products to the original product including:
- Microbiological controls combined with preservatives analysis,
- Analytical screening of restricted or forbidden substances,
- Label review, toxicological assessment,
- Packaging assessment: material determination, size and shape check, migration studies.
- Analysis of specific ingredient categories in the formula
Materials exempted from REACH in the context of microplastics
According to the ECHA, specific derogations have been included in the restriction proposal where the polymers are not expected to be emitted to the environment in the form of a microplastic or in order to avoid double regulation
Some criteria have been set out to clarify that (bio)degradable polymers are exempt from the restriction on the basis that they do not contribute to microplastic concerns, even though they could remain in the environment for some time after use/release. The derogation is required to ensure that the restriction is targeted to the substances contributing to the identified risk.
In such cases it will be sufficient to demonstrate that the polymer meets the suggested criteria. In practice this may mean testing the polymer(s) prior to the formation of the particle.
At Eurofins Cosmetics & Personal Care, our network of companies can help you to define the regulatory and compliance framework that your products would need to comply with and thereby provide services, including testing biodegradability methods for microplastics under GLP or ISO 17025, in order to place a compliant product on the market.
