Category: Cosmetics Reference: Cos 9/2021
Tattoo and makeup inks are considered personal care products and, in Spain, they are regulated by the Royal Legislative Decree 1/2015, of July 24, whereby the consolidated text of the Law of Guarantees and Rational Use of Medicals andhealth products, as well as the additional provision of Royal Decree 1599/1997, on cosmetic products.
Within personal care products, these inks are classified as aesthetic products, defined as those application products that do not have legal consideration decosmetic, medicines or health products, for their composition, indications, mechanism of action, application, of applicationor duration.
Its marketing as a aesthetics in Spain requires the coiality of a prior authorization by the Spanish Agency of Medications and Health Products (AEMPS).For this, the technical documentation related to the product must.
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Regulation 2020/2081, which was published on December 14, 2020, modifies Annex XVII of the aforementioned Regulation, relating to registration, evaluation, authorization and restriction of the support and chemical mixtures (REACH), in regard toSubstances contributed in inks for tattoo or permanent makeup, and adds the encentrate 75.Its application is mandatory in their elements and directly applicable in each Member State.
Establishes the restriction of the use of more than 4000 hazardous chemical substances in tattoos inks and permanent makeup, and introduces maximum concentration limits for individual substances or groups of substances used in tattoos or permanent inks.Among these chemical substances are certain azoic dyes, carcinogenic aromatic amines, polycyclic hydrocuroBridosaromatic (HAP), metals and methanol.
The new standards will be applied at level of January 4, 2022 and, in the case of the blue pigment 15: 3 and the green pigment 7, as of January 4, 2023.
This regulation also requires that themezclas destined for tattoos and permanent makeup mention this use in sustiquets.The label must also include a list of relevant ingredients and security declarings.
You cannot market or use tattoo and makeup inks that do not comply with the criteria established in the aforementioned regulation from January 4, 2022 (in the case of restrictions related to blue pigment 15: 3 and green pigment 7, from 4 of 4January 2023).Consequently, the units introduced in it will have to be withdrawn from the market before the date indicated.
For the granting of the national authorizations, the requirements established in the aforementioned regulation will be taken into account.
The AEMPS will periodically update unlisted with the products for permanent makeup (micropigmentation) and tattoo that are authorized and noted in their registration: relationship of products for permanent makeup (micropigmentation) and tattoo that are authorized and noted at the registration of the Spanish Medicines Agencyand health products