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COUNCIL OF EUROPE
COMMITTEE OF MINISTERS
Resolution ResAP(2003)2
on tattoos and permanent make-up
(Adopted by the Committee of Ministers on 19 June 2003
at the 844th meeting of the Ministers' Deputies)
1. The Committee of Ministers, in its composition restricted to the representatives of
Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy,
Luxembourg, the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland
and the United Kingdom, member states of the Partial Agreement in the Social and Public
Health Field,
2. Recalling Resolution (59) 23 of 16 November 1959, on the extension of the activities
of the Council of Europe in the social and cultural fields;
3. Having regard to Resolution (96) 35 revising the Partial Agreement in the Social and
Public Health Field of 2 October 1996, whereby it revised the structures of the Partial
Agreement and resolved to continue, on the basis of revised rules replacing those set
out in Resolution (59) 23, the activities hitherto carried out and developed by virtue of
that resolution, these being aimed in particular at:
鈥? raising the level of health protection of consumers in its widest sense, including a
constant contribution to harmonising 鈥? in the field of products having a direct or indirect
impact on the human food chain as well as in the field of pesticides, pharmaceuticals and
cosmetics 鈥? legislation, regulations and practices governing, on the one hand, quality,
efficiency and safety controls for products and, on the other hand, the safe use of toxic
or noxious products;
鈥? integrating people with disabilities into the community: defining 鈥? and contributing to the
implementation at European level 鈥? of a model of coherent policy for people with
disabilities, which takes account simultaneously of the principles of full citizenship and
independent living; contributing to the elimination of barriers to integration, whatever their
nature, whether psychological, educational, family-related, cultural, social, professional,
financial or architectural;
4. Having regard to the action carried out over several years for the purposes of
harmonising their legislation in the public health field and, in particular, to specific issues
in the cosmetics sector;
5. Considering the increasing popularity of body adornment through tattoos or
permanent make-up (PMU);
6. Considering that tattoos and PMU may pose a risk to human health due to
microbiological contamination and/or the presence of harmful substances in the
products used for tattoos and PMU and the possibility of unhygienic practices and
premises;
7. Considering that risk assessment is an essential part of the decision-making process
on preventive measures aimed at protecting public health;
8. Taking into account the fact that in most member states tattoos, tattooing and PMU
are covered neither by specific national nor European Community regulations;
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9. Aware of the need to fill this gap in legislation and thus to adopt specific legislation on
the composition of the products used for tattoos and PMU and ensuring hygienic
management for tattooing and PMU practices;
10. Taking the view that each member state, faced with the need to introduce
regulations governing this matter, would find it beneficial for such regulations to be
harmonised at European level,
11. Recommends that the governments of the member states of the Partial Agreement
in the Social and Public Health field take into account in their national laws and
regulations on tattoos and permanent make-up the principles set out thereafter in the
Appendix to this resolution, each government remaining free to impose stricter
regulations.
Appendix to Resolution ResAP(2003)2
1. Field of application
This resolution applies to:
鈥? the risk evaluation required before products used for tattoos and PMU are placed on
the market;
鈥? the composition and labelling of products used for tattoos and PMU;
鈥? the conditions of the application of tattoos and PMU;
鈥? the obligation to inform the public and the consumer of the health risks of tattoos and
tattooing and PMU.
2. Definition
Tattooing is a practice whereby a permanent skin marking or design (a 鈥渢attoo鈥?) is
administered by the intradermal injection of colouring products.
A PMU consists of colouring products which are injected intradermally for the purposes
of enhancing the contours of the face.
鈥淪terile鈥? in this context means the absence of viable organisms, including viruses.
3. Specifications1
3.1. 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 based on recent toxicological data and knowledge. This evaluation should be
set out in a dossier readily available to the competent authorities.
3.2. Notwithstanding, and in addition to the requirements set out in 3.1, tattoo and PMU
products must only be used if they comply with all the following requirements:
鈥? they do not contain or release the aromatic amines listed in Table 1 of this appendix
under the conditions of appropriate test methods;
鈥? they do not contain the substances listed in Table 2 of this appendix;
鈥? they do not contain substances listed in Directive 76/768/EEC, (Annex II);
鈥? they do not contain substances specified in Directive 76/768/EEC, (Annex IV, columns
2 to 4);
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鈥? they do not contain carcinogenic, mutagenic and reprotoxic substances of category 1,
2 and 3 which are classified under Directive 67/548/EEC;
鈥? they do not contain preservatives;
鈥? they are sterile and supplied in a container which maintains the sterility of the product
until application;
鈥? they are supplied in a packaging size appropriate for single use on an individual
consumer.
3.3. Tattoo and PMU products should contain the following information on the packaging:
鈥? the name and address of the manufacturer or the person responsible for placing the
product on the market;
鈥? the minimal date of durability2;
鈥? the conditions of use and warnings;
鈥? the batch number or reference used by the manufacturer for batch identification;
鈥? the 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 ;
鈥? the guarantee of sterility of the contents.
3.4. Tattooing and the application of PMU 鈥? including treatment and maintenance of the
instruments, in particular their sterilisation and disinfection 鈥? must be carried out by the
tattooist in conformity with the hygiene regulations laid down by national public health
services.
4. Public information
4.1. Governments should issue regulations constituting the legal basis for the
information obligations incumbent upon the various players concerned. In this context,
the tattooist should necessarily provide the consumer with complete, reliable and
comprehensible information on the risks entailed by those practices3, including the
potential occurrence of sensitisation.
4.2. Potential consumers should be provided with reliable and evidence-based
information about the risks of tattooing or PMU by all appropriate means, for example,
through mass information campaigns, via the Internet.
References
Dr H.R.Reus and Dr R.D. van Buuren: Tattoo and Permanent Make-up Colorants.
Report number ND COS 012 (November 2001)
Note A
This resolution is based on negative lists, drawn up on the basis of current knowledge in
this field. Positive lists are likely to be drawn up in the future, thus entailing a revision of
this instrument.
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Note B
In addition to inorganic colorants, which have been traditionally used for tattoos, an
extensive series of organic colorants are currently applied in tattoos and PMU. At least
forty-one colorants have been identified in the member states. All the colorants in use
would appear to be of industrial grade. A large proportion are azo-colorants give rise to
aromatic amines. Many colorants are not permitted for use in cosmetic products.
Manufacturers do not produce colorants specially formulated for tattooing and PMU.
They do not appear to be aware of the possible use of their standard colorants for these
purposes. A series of different colourant-related medical complications have been
reported in the medical literature. Traditional inorganic colorants have been replaced in
recent years by organic colorants. The long-term health effects of this marked change
in the use of colorants remain unknown.
The results from a survey carried out in the Netherlands (see the above-mentioned
reference) on the chemical composition and microbiological contamination of products
used for tattoos and PMU give a glimpse of the health risks involved: sixty-three
samples of products used for tattoos and PMU from the Dutch market and taken from
opened and sealed containers were analysed for the presence of carcinogenic aromatic
amines and for the presence of several heavy metals. In addition, the samples were
also examined for the total bacteria count and the presence of pathogenic bacteria,
yeasts and moulds.
Eleven samples (18%) were found to be microbiologically contaminated. Of these eleven
samples, eight samples had been taken from opened containers and three from sealed
containers. In seven samples, more than 100 000 bacteria/ml were found. Six samples
(10%) contained the species Pseudomonas. The pathogen Pseudomonas aeruginosa
was identified in three samples (5%). Intradermal injection of these contaminated
products could result in serious infections. Azo-pigments, based on carcinogenic
aromatic amines, were identified in ten samples (17%).
Several samples contained one or more heavy metals in comparatively high
concentrations.
The removal of a tattoo or PMU by means of laser treatment may result in
decomposition of azo-colorants into aromatic amines.
Table 1 鈥? List of aromatic amines, particularly with regard to their carcinogenic,
mutagenic, reprotoxic and sensitising properties, which should not be present
in or released from azo-colorants in tattoo and PMU products
CAS4 Catalogue EC-number Substances
number number
92-67-1 612-072-00-6 202-177-1 Biphenyl-4-ylamine
92-87-5 612-042-00-2 202-199-1 Benzidine
95-69-2 202-411-6 4-chloro-o-toluidine
91-59-8 612-022-00-3 202-080-4 2-naphtylamine
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97-56-3 611-006-00-3 202-591-2 o-aminoazotoluene
99-55-8 202-765-8 5-nitro-o-toluidine
106-47-8 203-401-0 4-chloroaniline
615-05-4 210-406-1 4-methoxy-m-phenylenediamine
101-77-9 612-051-00-1 202-974-4 4,4'-methyleendianiline
91-94-1 612-068-00-4 202-109-0 3,3'-dichlorobenzidine
119-90-4 612-036-00-X 204-355-4 3,3'-dimethoxybenzidine
119-93-7 612-041-00-7 204-358-0 3,3'-dimethylbenzidine
838-88-0 612-085-00-7 212-658-8 4,4'-methyleendi-o-
toluidine
120-71-8 204-419-1 6-methoxy-m- toluidine
101-14-4 612-078-00-9 202-918-9 4,4'-methylenebis(2-chloroaniline)
101-80-4 202-977-0 4,4'-oxydianiline
139-65-1 205-370-9 4,4'-thiodianiline
95-53-4 612-091-00-X 202-429-0 o- toluidine
95-80-7 612-099-00-3 202-453-1 4-methyl-m-phenylenediamine
137-17-7 205-282-0 2,4,5-trimethylaniline
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90-04-4 612-035-00-4 201-963-1 o-anisidine
60-09-3 X X 4-aminoazobenzene
X X 4-amino-3-fluorphenol
95-68-1 X X 2,4-xylidine
87-62-7 X X 2,6-xylidine
293733-21-8 X X 6-amino-2-ethoxynaphthaline
Table 2 鈥? Non-exhaustive list of substances, particularly with regard to their
carcinogenic, mutagenic, reprotoxic and sensitising properties, which tattoo and
PMU products should not contain (BC/CEN/97/29.11)
CI5 Name CAS6 Number CI Number
Acid Green 16 12768-78-4 44025
Acid Red 26 3761-53-3 16150
Acid Violet 17 4129-84-4 42650
Acid Violet 49 1694-09-3 42640
Acid Yellow 36 587-98-4 13065
Basic Blue 7 2390-60-5 42595
Basic Green 1 633-03-4 42040
Basic Red 1 989-38-8 45160
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Basic Red 9 569-61-9 42500
Basic Violet 1 8004-87-3 42535
Basic Violet 10 81-88-9 45170
Basic Violet 3 548-62-9 42555
Disperse Blue 1 2475-45-8 64500
Disperse Blue 1 2475-45-8 64500
Disperse Blue 106 12223-01-7 -
Disperse Blue 124 61951-51-7 -
Disperse Blue 3 2475-46-9 61505
Disperse Blue 35 12222-75-2 -
Disperse Orange 3 730-40-5 11005
Disperse Orange 37 12223-33-5 -
Disperse Red 1 2872-52-8 11110
Disperse Red 17 3179-89-3 11210
Disperse Yellow 3 2832-40-8 11855
Disperse Yellow 9 6373-73-5 10375
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Pigment Orange 5 3468-63-1 12075
Pigment Red 53 2092-56-0 15585
Pigment Violet 3 1325-82-2 42535:2
Pigment Violet 39 64070-98-0 42555:2
Solvent Blue 35 17354-14-2 61554
Solvent Orange 7 3118-97-6 12140
Solvent Red 24 85-83-6 26105
Solvent Red 49 509-34-2 45170:1
Solvent Violet 9 467-63-0 42555:1
Solvent Yellow 1 60-09-3 11000
Solvent Yellow 2 60-11-7 11020
Solvent Yellow 3 97-56-3 11160
Note 1 See Note A.
Note 2 The date of minimum durability of a tattooing and PMU product should be the date until which this produ
stored under appropriate conditions, continues to fulfil its initial function and, in particular, remains, in conformity
with the requirements that such products must not endanger the health or safety of man or the environment. Th
date of minimum durability should be indicated by the words: 鈥淭o be used before the end of鈥?.鈥? Followed by
either: the date itself (month and year), or details of where the date appears on the packaging. If necessary, thi
information should be supplemented by an indication of the conditions which must be satisfied to guarantee the
stated durability.
Note 3 See Note B.
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Note 4 Chemical Abstract Service of the American Chemical Society.
Note 5 Colour Index.
Note 6 Chemical Abstract Service of the American Chemical Society.
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