背景:根据REACH(注册,评价,化学品的授权和限制)限制,2022年1月4日之后在欧盟市场上投放的纹身和永久化妆(PMU)油墨不得含有甲基异噻唑啉酮,苯并异噻唑啉酮(BIT),辛基异噻唑啉酮(OIT),或浓度为10mg/kg或更高的其他皮肤致敏剂和浓度为100mg/kg或更高的苯氧乙醇(PE)或其他眼部刺激物或损害性物质。此外,防腐剂和化妆品法规附件II中列出的其他物质不得以0.5mg/kg或更高的浓度存在。
目的:本研究旨在量化来自意大利市场的99种纹身和39种PMU油墨中的14种防腐剂,并与REACH限制设定的浓度限值进行比较。
方法:采用基于液相色谱技术的有效分析方法对油墨进行分析。
结果:约24.0%,总样本的15.2%和1.5%含有BIT,PE和OIT,分别,浓度超过REACH浓度限值。不顺从的纹身墨水的数量(49.5%)将显著大于PMU墨水的数量(17.9%)。
结论:约40.6%的样品不符合防腐剂存在超过允许水平的限制。额外的浓度限制将适用于皮肤致敏防腐剂,以便在CLP下正确标记油墨(分类,标签和包装)法规。
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.
OBJECTIVE: 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.