Chapter X: Tattooing products

Tattooing products are defined as any colouring substance or preparation intended to create a mark on the superficial parts of the human body by breaking the skin, with the exception of products which are medical devices within the meaning of article L. 5211-1.

The opening and operation of any establishment manufacturing, packaging or importing tattoo products, even on an ancillary basis, as well as the extension of an establishment’s activity to include such operations, are subject to a declaration to the Agence nationale de sécurité du médicament et des produits de santé. This declaration is made by the person responsible for placing the tattoo products on the market, who is, depending on the…

Tattoo products must be manufactured in accordance with good manufacturing practice, the principles of which are defined by order of the ministers responsible for consumer affairs and health, issued on a proposal from the Agence nationale de sécurité du médicament et des produits de santé. Assessment of the safety for human health of these products is carried out in accordance with good laboratory practice, the principles of which are published…

Tattoo products placed on the market must not harm human health when applied under normal or reasonably foreseeable conditions of use, taking into account, in particular, the presentation of the product, the information on the label and any other information intended for consumers.

A tattooing product may only be placed on the market, whether free of charge or for a fee, if it meets the following conditions: 1° Its container and packaging must bear the name or company name and address of the person responsible for placing the product on the market, as well as any other information required by regulation; 2° The person responsible for placing the product on the market must…

The placing on the market of a tattoo product, whether free of charge or against payment, is subject to the transmission to the poison control centres mentioned in article L. 6141-4, designated by joint order of the ministers responsible for consumption, industry and health, of appropriate and sufficient information concerning the substances used in this product. The list of this information is set by joint order of the ministers responsible…

The person responsible for placing the tattoo product on the market shall make available to the public, by appropriate means, including electronic means, information relating to the composition and adverse effects of this product, as defined by regulation.

I. – The person responsible for placing a tattoo product on the market is obliged to participate in the national system of vigilance exercised over tattoo products by declaring, without delay, to the Agence nationale de sécurité du médicament et des produits de santé any serious adverse effects likely to result from the use of a tattoo product of which they are aware. It also notifies the Agency of any…

The person responsible for placing a tattoo product on the market is required, in the event of serious doubt as to the harmlessness of one or more substances, to provide the Director General of the Agence nationale de sécurité du médicament et des produits de santé with a list of his tattoo products containing one or more substances designated by him and the quantity of each of these substances present…

A decree of the Conseil d’Etat shall determine the procedures for applying this chapter, in particular: 1° The procedures for presenting and the content of the declaration provided for in article L. 513-10-2 ; 2° The information that must be included on the container and packaging of a tattoo product pursuant to 1° of article L. 513-10-5 ; 3° The content and storage procedures for the file referred to in…