The need for safety management of tattoo inks has been raised as the population of tattooing such as decorative tattoos and semi-permanent makeup has increased and side effects have continued to occur. Accordingly, the Ministry of Environment decided to control the tattoo inks after consultation bet...
The need for safety management of tattoo inks has been raised as the population of tattooing such as decorative tattoos and semi-permanent makeup has increased and side effects have continued to occur. Accordingly, the Ministry of Environment decided to control the tattoo inks after consultation between the related ministries. Since 2015, the Ministry of Environment has managed the tattoo inks. However, in accordance with the "Safety Measures for Living Chemical Products" established by the related ministries in 2016, it was decided that the products directly applied to the human body should be controlled by a unified regulatory body, the Ministry of Food and Drug Safety, in consideration of their expertise. As a result, the tattoo inks that have been managed by the Ministry of Environment will be transferred to the Ministry of Food and Drug Safety. The purpose of this study is to investigate and review the definition of tattoo inks, domestic and overseas status of regulation, and classify them appropriately in the Ministry of Food and Drug Safety and propose a safety management of tattoo inks.
The tattoo inks should be managed by a separate regulation. It is controversial to include them in the definition of drugs, quasi-drugs, cosmetics and medical devices. Tattoo inks are not much different from the legal definition of sanitary products. The management system of sanitary products is similar to the current management system of tattoo inks, because sanitary products can be set with individual standards and specifications.
Person who manufactures or imports tattoo inks shall be authorized or notified of the business by the regulatory body. In addition, sterilization is required because the risks of infection are relatively higher than those applied to skin, since tattoo inks are invasive products in the skin. It is recommended that the products be packaged in a disposable container as possible and be marked as 'one-time use only'. In the case of multiple uses, sterile conditions should be maintained for a certain period of time, and the period of safe use after opening should be indicated. Refill products are considered to be difficult to ensure sterility, therefore, it is necessary to consider restrictions on the manufacture and use of refill products.
Manufacturers need to report to the regulatory body in the event of any side effects associated with tattooing inks, and the regulatory body needs to monitor the collected side effects. Before using tattoo inks, be sure to make an allergy test for the ink ingredients.
In the future, it is necessary to carry out risk assessment for chemical substances of tattoo inks to strengthen the standards and to make international harmony considering international trends. It is also needed to investigate and study long-term safety of tattoo inks and those effects on the human body, including metabolic processes in the human body.
The need for safety management of tattoo inks has been raised as the population of tattooing such as decorative tattoos and semi-permanent makeup has increased and side effects have continued to occur. Accordingly, the Ministry of Environment decided to control the tattoo inks after consultation between the related ministries. Since 2015, the Ministry of Environment has managed the tattoo inks. However, in accordance with the "Safety Measures for Living Chemical Products" established by the related ministries in 2016, it was decided that the products directly applied to the human body should be controlled by a unified regulatory body, the Ministry of Food and Drug Safety, in consideration of their expertise. As a result, the tattoo inks that have been managed by the Ministry of Environment will be transferred to the Ministry of Food and Drug Safety. The purpose of this study is to investigate and review the definition of tattoo inks, domestic and overseas status of regulation, and classify them appropriately in the Ministry of Food and Drug Safety and propose a safety management of tattoo inks.
The tattoo inks should be managed by a separate regulation. It is controversial to include them in the definition of drugs, quasi-drugs, cosmetics and medical devices. Tattoo inks are not much different from the legal definition of sanitary products. The management system of sanitary products is similar to the current management system of tattoo inks, because sanitary products can be set with individual standards and specifications.
Person who manufactures or imports tattoo inks shall be authorized or notified of the business by the regulatory body. In addition, sterilization is required because the risks of infection are relatively higher than those applied to skin, since tattoo inks are invasive products in the skin. It is recommended that the products be packaged in a disposable container as possible and be marked as 'one-time use only'. In the case of multiple uses, sterile conditions should be maintained for a certain period of time, and the period of safe use after opening should be indicated. Refill products are considered to be difficult to ensure sterility, therefore, it is necessary to consider restrictions on the manufacture and use of refill products.
Manufacturers need to report to the regulatory body in the event of any side effects associated with tattooing inks, and the regulatory body needs to monitor the collected side effects. Before using tattoo inks, be sure to make an allergy test for the ink ingredients.
In the future, it is necessary to carry out risk assessment for chemical substances of tattoo inks to strengthen the standards and to make international harmony considering international trends. It is also needed to investigate and study long-term safety of tattoo inks and those effects on the human body, including metabolic processes in the human body.
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#tattoo ink safety management tattoo semi-permanent makeup
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