Quantification of preservatives in tattoo and permanent make‐up inks in the frame of the new requirements under the REACH Regulation

Abstract

Background According to the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) restriction, tattoo and permanent make‐up (PMU) inks placed on the European Union market after January 4, 2022, shall not contain methylisothiazolinone, benzisothiazolinone (BIT), octylisothiazolinone (OIT), or other skin sensitizers in concentrations of 10 mg/kg or higher and phenoxyethanol (PE) or other eye irritants or damaging substances in concentrations of 100 mg/kg or higher. In addition, preservatives and other substances enlisted in Annex II to Cosmetic Product Regulation shall not be present in concentrations of 0.5 mg/kg or higher. Objectives This study aims to quantify 14 preservatives in 99 tattoo and 39 PMU inks from the Italian market and presents a comparison with concentration limits set by the REACH restriction. Methods Inks were analysed by applying validated analytical methods based on liquid chromatography techniques. Results About 24.0%, 15.2% and 1.5% of the overall samples contained BIT, PE and OIT, respectively, at concentrations exceeding REACH concentration limits. The number of noncompliant tattoo inks (49.5%) would be significantly greater than that of the PMU inks (17.9%). Conclusions About 40.6% of the samples would be noncompliant with the restriction for the presence of preservatives above the permitted level. Additional concentration limits will apply to skin sensitizing preservatives for proper labelling of inks under CLP (Classification, Labelling and Packaging) Regulation.

Hypersensitivity to permanent tattoos: Literature summary and comprehensive review of patch tested tattoo patients 1997–2022

“…The highest concentration was 634 mg/kg 60 . This is in line with a recent Italian investigation, where 40% of tattoo and 36% of PMU inks contained BIT in a hidden form 100 . The amount of detected BIT did not differ between both types of products (0.34–392.12 mg/kg).…”

“…60 This is in line with a recent Italian investigation, where 40% of tattoo and 36% of PMU inks contained BIT in a hidden form. 100 The amount of detected BIT did not differ between both types of products (0.34-392.12 mg/kg). Some tattoo ink manufacturers use pre-mixed pigment dispersions in their final product which may contain industrial preservatives leading to low concentrations in the final products.…”

“…Phenoxyethanol (up to 6475 ng/kg) was also found in tattoo inks and is labelled more reliably than BIT. 60,62,66,75,91,100 Sorbic acid, parabens, dehydroacetic acid, o-phenylphenol, benzoic acid, benzyl alcohol, chlorphenesin, chlorhexidine, 4-chloro-3,5-dimethylphenol and phenol (the latter mainly in cheap inks) are less frequently used preservatives. 60,62,75,91,100 Some PMU and tattoo inks contain Novoxx, a mineralic combination of Si-Ca-Na-P oxides with a preserving effect.…”

“…60,62,66,75,91,100 Sorbic acid, parabens, dehydroacetic acid, o-phenylphenol, benzoic acid, benzyl alcohol, chlorphenesin, chlorhexidine, 4-chloro-3,5-dimethylphenol and phenol (the latter mainly in cheap inks) are less frequently used preservatives. 60,62,75,91,100 Some PMU and tattoo inks contain Novoxx, a mineralic combination of Si-Ca-Na-P oxides with a preserving effect. 103 To create shades and colour gradients, tattooists frequently mix ink with water, ink dilutions (consisting of witch hazel, glycerine and distilled water) or 'eau de rose', a possible source of fragrance exposure.…”

Contact sensitization to benzisothiazolinone: IVDK‐data of the years 2002 to 2021

“…and chalk (apparently to preserve the carboxymethyl cellulose it contains). [2][3][4][5][6][7][8][9][10][11][12][13][14][15] BIT proved to be a weak skin sensitizer in the guinea pig maximization test (GMPT), in the local lymph node assay (LLNA) und in the human repeated insult patch test (HIRPT). [16][17][18] BIT is also a skin irritant in humans at concentrations above 0.05%, 19 and it is labelled with H315 (causes skin irritation) as well as H317 (may cause an allergic skin reaction).…”