REACH Regulations in the EU – What does it mean?
The European Union has banned certain pigments used in tattoo inks due to concerns over their safety. This ban is part of the broader REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulations to ensure safer tattooing practices across the EU. The specific substances targeted by this ban include carcinogenic, mutagenic, and reprotoxic substances and chemicals prohibited in cosmetics, skin sensitizers, irritants, and certain pigments. The primary pigments under restriction are Pigment Blue 15 and Pigment Green 7, with the ban taking effect in January 2023 following an additional one-year derogation period granted for these two pigments. The EU allowed the derogation period to allow businesses more time to find safe alternatives.
The ban has sparked significant debate and concern within the tattoo industry. Many tattoo artists, such as Boris Pramatarov and Mikki Bold, have expressed concerns about how the restriction, especially on the blue and green pigments, limits their ability to create colorful tattoos, as these colors are integral to their work. With no substitutes currently available for these pigments, the ban could lead to the disappearance of a significant portion of the color palette used in tattoos.
Despite the restrictions, some scientific research suggests that the link between tattoo inks and cancer is not conclusively proven. While certain substances in tattoo inks have been identified as carcinogenic, a direct link between tattoo inks and cancer hasn’t been firmly established. The long-term health effects of tattoos, including their potential link to increased cancer risk, are still being investigated.
As a result of the ban, there is a concern that it could negatively impact the economic competitiveness of European tattoo artists and potentially lead to the rise of illegal tattooing practices. Additionally, there are efforts within the industry to find alternatives. For instance, biomedical engineering research explores the development of tattoo inks using nanotechnology, which could offer safer blue pigments with unique biomedical properties.
Overall, the EU’s move to ban certain tattoo ink pigments stems from a precautionary approach to public health, prioritizing eliminating potentially harmful chemicals. However, it also challenges the tattoo industry regarding artistic expression and economic impact.
What about the FDA and the new MOCRA law?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) in the United States represents a significant expansion of the Food and Drug Administration’s (FDA) authority to regulate cosmetics, marking the most substantial change in this area since the Federal Food, Drug, and Cosmetic Act of 1938. MoCRA aims to ensure the safety of cosmetic products used by consumers daily.
Critical elements of MoCRA include:
- Facility Registration: Manufacturers and cosmetics processors must register their facilities with the FDA. This registration must be renewed every two years, and any changes must be updated within 60 days.
- Product Listing: Responsible persons, the manufacturer, packer, or distributor whose name appears on the product label, must list each marketed cosmetic product with the FDA. This listing must include product ingredients and be updated annually.
- Adverse Event Reporting: MoCRA mandates that serious adverse events associated with the use of cosmetic products must be reported to the FDA within 15 business days.
- Safety Substantiation: Companies are responsible for ensuring and maintaining records to substantiate the safety of their cosmetic products.
- Increased FDA Enforcement Authority: The FDA now has broader authority, including mandatory recall authority for cosmetics that are determined to be harmful and the ability to suspend a facility’s registration.
- Compliance Deadlines: While the initial deadline for compliance with the facility registration and product listing requirements was December 29, 2023, the FDA has delayed enforcement until July 1, 2024. However, companies were expected to comply with other MoCRA requirements by the December 29, 2023 deadline.
Also, MoCRA does not prevent individual states from enacting laws to ban or restrict cosmetic ingredients. States like California, Colorado, Maryland, Maine, Minnesota, New York, Oregon, and Washington have passed various laws regulating chemicals in cosmetics.
Overall, MoCRA is a significant step towards enhancing the safety and regulation of cosmetic products in the United States, aligning with a growing consumer demand for safer personal care products and increased regulatory oversight.