Cosmetics & Personal Care | Monthly bulletin | February 2024

Unlocking Insights: The Latest on Mono-n-hexyl Phthalate

We're excited to bring you the latest updates on mono-n-hexyl phthalate (MnHP) and its implications. Recently, the German Federal Institute for Risk Assessment (BfR) shed light on the presence of MnHP in urine samples from children. This substance, a metabolite of di-n-hexyl phthalate (DnHP), has raised concerns and prompted further investigation.

Phthalates, once widely used as plasticisers, have faced increasing scrutiny due to their potential health risks. In 2013, DnHP was classified as toxic to reproduction and was restricted under REACH regulations. Now, MnHP, a byproduct of DnHP, has come under the spotlight.

Germany's Environmental Protection Agency, UBA, is actively addressing these findings and working to assess the health implications of MnHP. Eurofins Cosmetics & Personal Care stands ready as your trusted partner, offering comprehensive analytical services tailored to your needs.

Our laboratory network is equipped to provide dedicated chromatography, specific LOQ for DnHP and other phthalates, as well as packaging materials testing to detect potential migration of these harmful substances. Together, we can ensure product safety and compliance with regulatory standards.

Don't hesitate to reach out to us to initiate analysis for phthalates or to inquire about testing for the presence of DnHP with the utmost sensitivity.

Stay informed, stay proactive, and let's work together towards safer products for all.

1,4-Dioxane: Eurofins, the high quality of its analyses

1,4-Dioxane is an impurity which may be present in trace amounts in certain cosmetic products such as shampoos, deodorants, toothpastes, etc.

As this substance is included in Annex II of the Regulation (EU) n°1223/2009, its use is therefore prohibited in formulations of cosmetic products. However, it may be formed as a by-product during the manufacturing process of certain ethoxylated cosmetic ingredients such as detergents, foaming agents, emulsifiers or solvents.

In 2015, the SCCS (Scientific Committee on Consumer Safety) conducted an independent risk assessment and concluded that quantities of 1,4-Dioxane in cosmetic products are considered safe for consumers at trace levels of ≤10 ppm. Despite these restrictions, ECHA recently expressed its willingness to publish new restrictions for 1,4-Dioxane to limit the manufacture and use of surfactants containing more than 1ppm of this substance. However, the cosmetics industry has submitted its defense report in 2023, and the project has been postponed until 2025.

Eurofins Cosmetics & Personal Care is therefore committed to offering you personalised support in the analysis of 1,4-Dioxane. In this process, our teams are there to ensure optimal sample preparation. We employ advanced several chromatographic techniques to meticulously analyse trace-level impurities, aiming to achieve the most optimal detection limits possible with today's technological capabilities and constraints.

Over the years, Eurofins Cosmetics & Personal Care has carried out countless analyses of a wide range of matrices and gained experience that guarantees and underlines the high-quality standard of our analytics.

Tattoo Products: Ensuring Regulation, Safety and Efficacy

Tattoos have become increasingly popular in the USA and France. As the demand for tattoos rises, so does the importance of regulating the products used in the tattooing process. Tattoo products include ink, needles, and equipment used by tattoo artists, and ensuring their safety is crucial to protect both the artists and their clients.

In the USA

The regulation of tattoo products in the USA falls under the jurisdiction of various federal and state agencies:

The Food and Drug Administration (FDA), at the federal level, oversees the safety of tattoo inks and pigments.
The Occupational Safety and Health Administration (OSHA) sets standards for workplace safety, including guidelines for tattoo studios to prevent the spread of bloodborne pathogens and ensure a hygienic working environment.

Despite existing regulations, there are still challenges and concerns regarding the safety of tattoo products in the USA, such as:

The lack of standardised testing and certification for tattoo inks and pigments;
The presence of potentially harmful ingredients in some tattoo inks;
Few controls specifically tailored to the unique requirements of tattoo inks.

In recent years, there have been efforts to improve the regulation of tattoo products in the USA. Some states have implemented stricter guidelines for tattoo studios and artists, including requirements for training, licensing, and inspections. Additionally, industry organisations such as the Alliance of Professional Tattooists (APT) and the National Tattoo Association (NTA) advocate for better standards and practices within the tattoo community.

In France

Tattooing is governed by the Regulation (EC) n°2020/2081 of 14 December 2020 amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation (EC) n°1907/2006 for tattoo ink. Tattoo products are also regulated by the law n° 2014-201 of 24 February 2014 concerning various provisions of adaptation to European Union law in the field of health regarding establishments and practices.

In particular, these provisions lay down obligations in terms of:

Declaration to the public authorities.
Manufacturing in compliance with Good Manufacturing Practices (GMP)
Product composition in accordance with the rules set out in Annex XVII, entry 75 of the REACH regulation
Safety assessment

Furthermore, the European Chemicals Agency (ECHA) regulates certain substances used in tattoo inks under the REACH regulation. This includes regulating the presence of substances known to be harmful or potentially harmful, such as certain heavy metals or aromatic amines.

Overall, the regulation of tattoo products in France aims to protect the health and safety of consumers by ensuring that tattoo inks and the tattooing process meet strict standards for quality, safety, and hygiene.

Eurofins Cosmetics & Personal care is here to help you with:

General approach of initially collecting and evaluating existing data;
Providing missing information through dedicated testing plan strategy: analytical, microbiological, in vitro, ex vivo and clinical testing.