HYPRSKN / SafetyGlobal Compliance
HYPRSKN is committed to upholding the highest standards of safety and compliance in the tattoo ink industry.
Prioritizing Safety
At HYPRSKN, we take pride in offering tattoo inks that prioritize safety and eliminate potential hazards associated with traditional pigments. Unlike most other tattoo inks, our non-toxic pigments are encapsulated, providing an extra layer of protection. Encapsulation technology ensures that our pigments do not pose risks such as being carcinogenic, mutagenic, toxic to reproduction, skin sensitizers, corrosive to the skin, or damaging to the eyes.
While regulatory bodies like the European Commission and EU Member States have implemented restrictions on hazardous chemicals used in tattoo inks and permanent make-up, our encapsulated pigments go beyond compliance. By encapsulating our non-toxic active ingredients, we prevent direct contact between the skin and further mitigate risks associated with tattoo ink formulations.
With HYPRSKN, you can express your creativity confidently, knowing that our encapsulated pigments provide a safe and biocompatible solution. Our commitment to innovation and safety means you can enjoy vibrant, long-lasting tattoos without compromising your well-being. Choose HYPRSKN for the highest standards of quality, safety, and peace of mind in the tattoo industry.
Modernization of Cosmetics Regulation Act
As part of our dedication to meeting regulatory requirements, HYPRSKN stays at the forefront of evolving safety regulations worldwide.
One significant development is the Modernization of Cosmetics Regulation Act (MoCRA), which came into effect in 2022. This landmark legislation grants the FDA expanded authority to regulate cosmetics, marking the most substantial expansion since 1938.
Under MoCRA, the FDA now has enhanced powers, including records access and mandatory recall authority, enabling them to further ensure the safety of cosmetic products. To align with these regulations, HYPRSKN adheres to requirements such as adverse event reporting, facility registration, product listing, and safety substantiation, ensuring transparency and compliance in every step of our operations.
FDA Regulations
The Food and Drug Administration (FDA) is one of the federal agencies in the United States responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and food.
The Global Standard
In Europe, HYPRSKN will adhere to the stringent REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulations. REACH, implemented in 2007, aims to protect human health and the environment by ensuring the safe use of chemicals.
Under REACH, we will fulfill our responsibilities by:
Registering Substances: Meticulously register and document the substances used in our tattoo ink formulations to demonstrate their safety.
Evaluation and Authorization: Actively evaluate the process to assess any potential risks associated with our products and obtain necessary authorizations.
Restricting Hazardous Substances: Strictly adhere to the restrictions on the use of hazardous substances, ensuring that our tattoo ink formulations are safe for both artists and clients.
Communication in the Supply Chain: Maintain clear communication with our suppliers, customers, and regulatory authorities to ensure compliance and exchange vital safety information.
By following the REACH regulations, HYPRSKN guarantees that our tattoo inks are manufactured and supplied in accordance with the highest safety standards, providing you with peace of mind and exceptional quality.
European Commission and Health Risks of Chemicals in Tattoo Inks
In 2015, the European Commission launched an assessment of health risks associated with tattoo inks and permanent make-up. This assessment, conducted by the European Chemicals Agency (ECHA) in collaboration with various authorities, examined hazardous chemicals that could potentially impact our health, particularly those known to be carcinogenic, mutagenic, toxic to reproduction, sensitisers, irritants, corrosive to the skin, and damaging to the eye.
The authorities carefully assessed the health risks posed by these chemicals and explored the availability of safer alternatives. They also considered the socio-economic impact of restricting their use, taking into account manufacturing and service sector jobs. Following extensive evaluations, both the Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) agreed that the proposed restrictions on hazardous chemicals in tattoo inks and permanent make-up were necessary and appropriate, with a few modifications.
The European Commission and EU Member States supported the adopted restriction in December 2020, harmonizing measures across the EU to protect citizens from hazardous chemicals. The restriction sets maximum concentration limits for individual or groups of substances used in tattoo inks and permanent make-up, including azodyes, carcinogenic aromatic amines, polycyclic aromatic hydrocarbons (PAHs), metals, and methanol. The new rules came into effect on January 4, 2022, with a transition period until January 4, 2023, for Pigment Blue 15:3 and Pigment Green 7.
To ensure long-term protection, the restriction will automatically limit chemicals with specific classifications, such as being carcinogenic, mutagenic, toxic to reproduction, skin sensitizers, skin corrosive, skin irritants, eye irritants, or eye-damaging. It also includes substances prohibited in cosmetic products or those with specific conditions on their use, as listed in the Cosmetic Products Regulation (CPR).