Hello, Sung Mu Administrative Law office, an administrative law office specializing in medical device licensing.
While importing and manufacturing tattoo needles, licensing for tattoo dye (pigmentation) is also underway.
The tattoo dye is a pigment used for tattoos and is prepared along with the tattoo needle import declaration. It is used in various fields such as hair loss tattoos, lips, and eyebrows as well as skin tattoos.
Ministry of Environment Notice No. 2022-19 (Partial Revision of January 19, 2022) According to the designation of household chemical products subject to safety confirmation and safety labeling standards, tattoo dyes are designated as the target type.
As tattoo dyes have been designated as daily chemical products subject to safety confirmation, some pigments have been designated as containing prohibited pigments, and the use of preservatives is also strictly prohibited.
List of prohibited substances in the product.
사진 설명을 입력하세요.
The following is based on the color name and the content of substances in the product that are prohibited from being contained in the tattoo dye.
사진 설명을 입력하세요.
If a restricted substance is detected in the prohibited product of the above substances, the test will be rejected.
There are also standards for usable preservatives and preservatives in the product. In other words, in order to guarantee the expiration date of the product, if biological substances and preservatives are intended to be used for storage or preservation of the product, only the following substances and products can be used.
- Related grounds National Institute of Environmental Research Notice No. 2021-32 -
1) Substances approved as biological substances that may be used in preservatives pursuant to Article 12 of the Act and Article 12 of the Act
Biological substances recognized as low in risk pursuant to Article (1) 1 and notified by the Minister of Environment after deliberation by the Management Committee [Attachment 3]
2) Existing biological substances that can be used in preservatives notified pursuant to Article 18 (3) of the Act (limited to cases where detailed uses reported pursuant to Article 18 (2) of the Act are related to the relevant item). However, it can only be used within the approval grace period for each substance [Attachment 4]
3) Biological products approved as preservatives pursuant to Article 28 (1) 1 of the Act
We need to review the products that apply to the substances below in advance, so please check them in advance and contact us.
The documents necessary for the test inspection, etc. require MSDS, and you will apply for it with information such as MSDS' raw material composition.
In the case of tattoo dyes, the test cost is about 1.2 million won excluding VAT, and the test period takes about a month, so you can prepare for imports considering the processing period.
If you have any questions about household chemical products subject to safety confirmation such as tattoo dye, please
contact us anytime.
Thank you.
free free to contact us.
행정법률 전문 사무소 승무행정사
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