4.1 General Safety

When applied and used as intended, tattoo and PMU products must not endanger the health or safety of persons or the environment. To this end, the manufacturer or person responsible for placing the product on the market should perform a risk evaluation for each ingredient and the total ink based on recent toxicological data and knowledge. This evaluation has to be sent to the competent authorities before placing the ink on the market. Each health complaint reported to the manufacturer or the person responsible for placing the product on the market has to be reported to the competent authorities.

4.2 Safety of Ingredients

Notwithstanding, and in addition to the requirements set out in paragraph 4.1, tattoo and PMU products must only be used if they comply with all the following requirements. Tattoo inks shall not contain the following substances:

• carcinogenic and mutagenic substances category 1A, 1B or 2 excluding those substances classified only with the hazard statements H350 (inhalation) (may cause cancer by inhalation), H351 (inhalation) (suspected of causing cancer by inhalation), H340(inhalation) (may cause genetic defects via inhalation) and H341 (inhalation) (suspected of causing genetic defects by inhalation) which are classified under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP]. Unless specific concentrations are defined in Table 1, the concentrations should be as low as technical achievable;

• substances toxic to reproduction category 1A  or 1B in concentrations greater than 0.0014 % w/w, category 2 in concentrations greater than 0.014% w/w which are classified under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP] 

• sensitizers category 1, 1A and 1B in concentrations greater than 0.1% which are classified under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP]; 

• substances classified as irritants or corrosive category 1A, 1B, 1C, and 2 under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP] in concentrations able to cause these effects. If no data are available or provided that justify higher limits, a generic concentration limit of 1% applies for each substance. 

• substances classified as acute toxic category 1-3 and 4 under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP] in concentrations able to cause these effects. If no data are available or provided that justify higher limits, a generic concentration limit of 0.1% (group 1-3) or 1% (group 4) applies.  

• substances listed in Table 1 exceeding the specified concentration limits;

• raw materials that do not fulfil the minimum requirements for substances set in the Annex of Regulation (EU) 231/2012 [specifications for food additives]

• The ink should have a pH value shall be between 4.0 and 10.0 when tested in accordance with EN ISO 787-9

For all substances that are subject to more than one defined concentration limit, the strictest limit (smallest concentration) applies. For the referred Regulation (EC) 1907/2006 [REACH], Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP] and Annex of Regulation (EU) 231/2012 [specifications for food additives], the respective amended versions are binding.

4.3 Pigments

Notwithstanding, and in addition to the requirements set out in paragraph 4.1 and 4.2,

• pigments used shall fulfil the minimum safety requirements defined in paragraph 4.7;

• pigments listed in paragraph 5.3 were pre-assessed and fulfil minimal toxicological requirements

• pigments that upon cleavage at azo and/or amide structures would release carcinogenic or mutagenic primary aromatic amines of categories 1, 2 or 3 which are classified under Regulation (EC) 1907/2006 [REACH] or in Part 3 of Annex VI to Regulation (EC) 1272/2008 [harmonized substances, CLP]. This might be controlled by either identifying the pigment itself or proving the release of such structures by the harmonized method set in paragraph 5.4;

• pigments not compliant with any of the requirements stated above in this paragraph, shall not be present in tattoo inks with no specific concentration limit applying.

4.4 Preservatives

Preservatives should only be used to ensure the preservation of the product after opening and by no means as a correction of insufficient microbiologic purity in the course of manufacture and of inadequate hygiene in tattooing and PMU practice. Preservatives should only be used after a safety assessment and in the lowest effective concentration. Only preservatives listed in paragraph 5.3.2 shall be used in tattoo inks.

4.5 Declaration

Tattoo and PMU products should contain the following information on the packaging:

• The intended use of the mixture as a tattoo or PMU ink
• the name and address of the manufacturer or the person responsible for placing the product on the market;
• the date of manufacture and minimum durability;
• the warning “Ingredients of this tattoo ink did only undergo basic safety testing. For some of the ingredients data on their carcinogenicity, mutagenicity, reprotoxicity, short- and long-term toxicity are not available due to the renunciation of animal testing for this voluntary procedure” has to be placed on the ink bottle. Safety endpoints that have been provided for all ingredients present in the ink can be deleted from the warning;
• the batch number or other reference used by the manufacturer for batch identification;
• full list of ingredients according to their International Union of Pure and Applied Chemistry (IUPAC) name, CAS number (Chemical Abstract Service of the American Chemical Society) or Colour Index (CI) number. This also accounts for pre-mixed components added to the ink;

The labelling shall be clearly visible, easily legible and appropriately durable. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market. Where necessary because of the size of the package, the labelling information shall be included in the instructions for use. The information on the label shall be made available to any person before undergoing the tattooing procedure by the person performing the procedure.

4.6. Sterility of Ink, Packaging and During Tattooing

Tattooing and the application of PMU – including treatment and maintenance of the instruments, in particular their sterilisation and disinfection – must be carried out in accordance with the CEN TC 435 standard “Tattooing Services —Safe practice and hygiene requirements”.

Tattoo inks have to be sterile and supplied in a container which maintains the sterility of the product until application, preferably in a packaging size appropriate for single use. In case multi-use containers are used, their design should ensure that the contents will not be contaminated during the period of use. The sterility of the ink is tested by harmonised methods [?].

4.7. Required Toxicological Safety Data and Testing

The full ink product shall be tested for dermatological safety for sensitive skin [method?]. For all ingredients, available data and additional minimal toxicological tests should be conducted, if no data is available, cf. 5.1.

4.8 Consent and Customer Information

Tattoo artist are mandatory to provide the consumer with complete, reliable and comprehensible information on the risks entailed by those practices, including the potential occurrence of sensitisation, care following the application of a tattoo, reversibility and removal of tattoos, and the advice of consulting a physician in case of medical complications [list required?] at least a day before getting informed consent on the procedure. The tattooist has to store the following information for 10 years as well to hand it to the client: Name of the client; date(s) of the tattooing procedure; for each ink used: the name and address of the manufacturer AND the person/company responsible for placing the product on the market, name of the ink colour, the batch number or other reference used by the manufacturer for batch identification, and the full list of ingredients.