1. Terms of reference

The Commission was requested by Member States to review the safety of tattoos and to propose legislation in order to better protect public health. After consideration of this request within the services of the Commission, it was determined that such products did not fall under the classification of cosmetic products and that perhaps such products would be classified as general consumer products. Follow up, on an informal basis, with Member State administrations demonstrated that this was the case.

2. Mandate

As tattoos are administered by injection of appropriate inks intradermally, they do not fall under the Cosmetics Directive. The recitals of the original Directive 76/768/EEC demonstrate that this is the case. The 5th Whereas of the preamble of the Directive states :

"Whereas this Directive relates only to cosmetic products..., whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics;".

Whilst it would not be appropriate for the SCCNFP to review the safety of tattoos within their remit on cosmetic products, the safety of tattoos may fall under their competence in their responsibility for non-food products.

3. Opinion

A tattoo is widely used to adorn the human body. Pigments are applied permanently into the skin. This procedure is also used for cosmetic purposes, the so-called 'permanent makeup tattooing' e.g., lip lining, eyebrow lining.

There is a large number of colours and pigments used. In part the chemical identity of these agents as well as their toxicological characterisation is incomplete or unknown. Thus their safety evaluation is not possible.

Well recognised adverse effects of tattoos are known. Examples of these include amongst others granuloma formation, phototoxicity, contact dermatitis, and koebnerisation of skin diseases such as psoriasis and lichen planus.

Important additional health concerns include the transmission of infective agents such as human papilloma viruses, hepatitis and HIV.

For the adequate assessment of the toxicological aspects of tattoos it is necessary for the chemical identity of the colours and pigments to be provided. Therefore, it is recommended that the identity of these substances and materials (e.g., tools and appliances) used in the procedure be obtained so that a formal assessment can take place.

Annex

Colours used for permanent make-up (tattooing) - Provisional list -

Blue

- Indigo (Vat blue 1)

- Indigo Carmine

- Pigment Blue 15

- Cobalt Blue (Cobalthaltige Alaunerde)

- Ultramarine Blue

- Prussian Blue

- Tetor Blue

- Ocean Blue

Yellow

- Curcuma Yellow (Curcumine, Natural Yellow 3)

- Pigment Yellow 87

- Pigment Yellow 74 (Nile Green)

- Pigment Yellow 83 (Imperial Yellow)

- Cadmium Gelb ("strahlendes Gelb")

Red

- Natural Red 22/23

- Natural Red 24

- Lithol Rubine B Ca (D&C Red No 7 Calcium lake)

- Lithol Rubine B Ba (D&C Red No 6 Barium lake)

- Pigment Red 122

- Pigment Red 22 (Devil's Red)

- Pigment Red 23

- Pigment Red 170

- Pigment Red 7

- Cadmium Selenid (Cadmium Rot)

Green

- Pigment Green 7

- Pigment Green 36

- Chromoxid Grün (Casalis Grün)

- "Guignet's Grün ("Smaragd Grün", "Pannetiers Grün")

Violet

- Pigment Violet 19 (Dark Violet)

- Manganviolett

Orange

- Pigment Orange 16 (Florida-Orange)

Pink

- Helidone pink (Vat Red 1)

White

- Titan Weiß

- Zink Weiß

- Zinkoxid ("Chinesisches Weiß")

Black

- Carbon

- Eisen-Oxid ("Schwarzed Oxid" or "Magnet-Oxid")

- Campecheholz des Baumes Haematoxylon campecianum ("Campecheholz-Schwarz" or "Diamant-Schwarz"

Brown

- Ocker (Chinesische Erde, Mars Gelb, Mars Orange, Mars Rot, Mars Braun)

Addendum :

In general also other kinds of Metallic pigments and dye-lakes, in aqueous solutions, are in use. Even in detailed catalogues and lists only the colour as such is given without any hint as to nature (organic/inorganic) or other uses (food, cosmetics); or as to quality standards. Thus an enormous "grey area" exists.

In the interest of consumer safety and consumer's health from the point of view of the members of the SCCNFP regulations are indispensable.