Tattoo Products

Ensuring Safety: Regulatory Vigilance in Tattoo Product Evaluation?

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. At the federal level, the Food and Drug Administration (FDA) oversees the safety of tattoo inks and pigments. However, it's important to note that the FDA does not explicitly approve tattoo inks or pigments before they are marketed. Instead, it regulates them as cosmetics, with the responsibility falling on manufacturers to ensure their products are safe and properly labeled.

Additionally, 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. OSHA regulations require tattoo artists to undergo training in bloodborne pathogens and follow strict protocols for sterilisation and disinfection of equipment.

Despite existing regulations, there are still challenges and concerns regarding the safety of tattoo products in the USA. One major issue is the lack of standardised testing and certification for tattoo inks and pigments. Unlike drugs or medical devices, which undergo rigorous testing and evaluation before being approved for market, tattoo inks are not subjected to the same level of scrutiny. This can lead to inconsistencies in product quality and safety.

Another concern is the presence of potentially harmful ingredients in some tattoo inks. While the FDA does provide guidelines for cosmetics ingredients, there is limited oversight specifically tailored to the unique requirements of tattoo inks. Some inks may contain contaminants or heavy metals that can cause adverse reactions or long-term health effects in both tattoo artists and their clients.

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 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: The opening and operation of any establishment manufacturing, packaging or importing tattoo products, even on an ancillary basis, is subject to a declaration to the public authorities.
• Manufacturing: The manufacture of products intended for permanent tattooing are subject to the provisions of article L. 513-10-3. Indeed, tattoo inks are required to be manufactured in accordance with Good Manufacturing Practices (GMP) and that they undergo a safety assessment before being placed on the market.
• Product composition: Tattoo products placed on the European Union market must comply with the rules (restrictions) set out in Annex XVII, entry 75, of the REACH regulation, which specify which substances are prohibited in inks and which are subject to concentration limits in the finished product.
• Safety assessment: Tattoo products put on the French market need to undergo an assessment of the safety for human health: evaluating the composition of the ink, ensuring it does not contain prohibited substances, assessing potential risks such as allergic reactions or carcinogenicity, and providing appropriate labeling with warnings and instructions for use.

Furthermore, the European Chemicals Agency (ECHA) regulates certain substances used in tattoo inks under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (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:

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