EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent 
make -up 
(Text wi th EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the  Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent 
make -up 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending  
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1) thereof,   
Whereas:  
(1) Annex XVII to Regulation (EC) No 1907/2006 lays down restrictions on the 
manufacture, placing on the market and use of certain substances  on their own, in 
mixtures or in articles.  
(2) The number of people in the U nion with tattoos or permanent make -up has been 
increasing steadily , in particular in the young population. The procedures used for 
tattooing  or permanent make -up (referred to collectively as ‘tattooing’), whether 
involving the use of needles or the application of some other technique such as micro -
blading , inevitably cause an injury  to the skin barrier . As a result , the inks or other 
mixtures used for tattooing are absorbed into the body . Mixtures used for tattooing 
generally consist of colorants and a uxiliary ingredients such as solvents, stabilisers, 
wetting agents, pH regulators, emollients, preservatives and thickeners. The mixtures 
are introduced  into the dermis layer of the human skin, inside the eyeball or into 
mucous membranes.  The colorants mostly r emain close to where the mixture is 
administered , so that the tatt oo or permanent make -up will remain visible. However, 
the soluble ingredients in the mixture are distributed within a matter of hours or days  
across the entire body.  In consequence, the skin  and other organs  are exposed to the 
effects of th ose soluble substances  over an extended period . Some of those substances  
have  hazardous properties that pose  a potential risk to human health. In addition, 
metabolism of the colorants  in the skin , decomposition due to solar radiation exposure 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  EN 2  EN and laser irradiation may also le ad to the release of hazardous chemicals from the area 
of the body where the tattoo or permanent make -up is located2.  
(3) Mixtures placed on the market for use for tattooing purposes  are products falling 
within the scope of  Directive 2001/95/EC of the European Parliament and of the 
Council3. Directive 2001/95/EC allows producers to place products on the market only 
if they are safe. Member States enforce this obligation by taking actions in respect of 
dangerous products on the market and notify ing those actions to the Commission 
through the Community Rapid Information S ystem (RAPEX) . RAPEX notifications 
on chemicals contained in mixtures used for tattooing purposes have be en increasing 
in recent years4. 
(4) In 2003, the Council of Europe adopted  resolution  ResAP (2003)25 on the safety of 
tattoos and permanent make -up. That resolution was superseded in 2008 by resolution 
ResAP  (2008) 16. The 2008 r esolution recommended a number of provisions relating to 
tattooing practices and the chemical composition of mixtures for tattooing purposes  to 
ensure that they do not endanger the hea lth and safety of the public . 
(5) Based on the Council of Europe recommendations, s even Member Sta tes put national 
legislation in place  regulating the chemical composition of mixtures for tattooing 
purposes7. 
(6) On 12 March 2015, the Commission asked the European Chemical s Agency (‘the 
Agency’) pursuant to Article 69(1)  of Regulation (EC) No 1907/2006  to prepare  a 
dossier  in order to  assess the risks to human health of certain chemicals contained in 
mixtures  used for tattooing purposes , and the need for Union -wide action beyond the 
national measures already in place in some Member States and beyond the mea sures 
based on the general safety requirements laid down in Directive 2001/95/EC . The 
dossier prepared by the Agency in response to the Commission’s request is referred to 
in this Regulation as ‘the Annex XV dossier’ .  
(7) The Agency prepared the Annex XV doss ier in cooperation with Italy, Denmark and 
Norway (the Agency and Italy, Denmark and Norway are together referred to as ‘the 
dossier submitters’) and with the assistance of the German Federal Institute for Risk 
Assessment and the German Federal Institute f or Occupational Health and Safety.  On 
6 October 2017, the dossier submitters  submitted the Annex XV dossier8. The dossier 
demonstrat ed that the risks to human health due to exposure to certain hazardous  
                                                 
2 JRC Science for Policy report  Safety of tattoos and permanent make -up: Final report , 2016 
https://ec.europa.eu/jrc/en/publication/eur -scientific -and-technical -research -reports/safety -tattoos -and-
perm anent -make -final-report  
3 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general 
product safety  (OJ L 11, 15.1.2002, p. 4 ). 
4
 https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/conte
nt/pages/rapex/index_en.htm  
5 Council of Europe 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 - 
http://www.ctl -tattoo.net/Documents/PDF/eu_resap_2003_2.pdf  
6 Council of Europe Res olution ResAP(2008)1 on requirements and criteria for the safety of tattoos and 
permanent make -up (superseding Resolution ResAP(2003)2 on tattoos and permanent make -up), 
adopted by the Committee of Ministers on 20 February 2008 at the 1018th meeting of the  Ministers’ 
Deputies - https://rm.coe.int/16805d3dc4  
7 Belgium, France, Germany, the Netherl ands, Slovenia , Spain  and Sweden . 
8 Annex XV report -proposal for a restriction: substances in tattoo inks and permanent make up - October 
2017 -ECHA with Denmark, Italy and Norway -https://echa.europa.eu/documents/10162/6f739150 -
39db -7e2c -d07d -caf8fb81d153   EN 3  EN chemicals in mixtures used for tattooing purposes  are not adequately controlled  and 
need to be addressed on a Union -wide basis t o achieve a harmonised high level of 
protection to human health  and free movement of goods within the U nion. 
(8) The Annex XV dossier proposed a restriction prohibiting both the placing  on the 
market of mixtures for use for tattooing purposes  and the use of mixtures for tattooing 
purposes  if they contained any substances classified under Regulation (EC) No 
1272/2008 of the European Parliament and of the Council9 in the hazard class es 
carcinogenicity, mutagenicity or toxicity to reproduction category 1A, 1B or 2, skin 
sensitisation  category 1, 1A or 1 B , skin corrosion category 1, 1A, 1B, 1C or skin 
irritation category 2, or serious eye damage category 1 or eye irritation  category 2 . The 
Annex XV dossier also proposed the inclusion of certain substances listed in Annex II 
or IV to Regulation (EC) No 1223/2009  of the European Parliament and of the 
Council10 with specific conditions , and substances listed  in Table 1 of the Council of 
Europ e resolution  ResAP(2008) 1 based on the fact that they may either undergo 
decomposition to or contain residual aromatic amines classified  for carcinogenicity or 
mutagenicity . The Annex XV dossier proposed to exclude  from the restriction 
substances that were classified  in the hazard class es carcinogenicity or mutagenicity  
category  1A, 1B or 2 due to effects following exposure by inhalation only and not 
through any other route such as dermal or oral .  
(9) In addition, t he Annex XV dossier proposed a numbe r of labelling requirements , some 
of them modified following advice from the Agency’s Forum for Exchange of 
Information on Enforcement (‘the Forum’)  during the opinion development process . 
The labelling requirements  proposed in the Annex XV dossier include d a requirement 
to state the fact that the mixture was for use for tattooing purposes, a requirement to 
specify a unique reference number for identifying the specific batch , a requirement to 
list any ingredients  classified as hazard ous to human health in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 but not covered by th e proposed restriction , and any 
ingredients covered by the proposed restriction but used in the mixture  below the 
concentration limit  set by the proposed restriction . Furthermore, an ad ditional labelling 
requirement to indicate the presence of nickel and chromium (VI) was considered 
necessary, as these particular substances can induce new cases of skin sensitisation and 
potential ly trigger allergic reaction s in sensitised persons. The labelling requirements 
were proposed  in order to give consumers and tattooists  additional information , to 
facilitate implementation of the restriction , and to ensure that investigation s can be 
properly carried out  in the event of adverse health effects.  
(10) The Annex XV dossier set out two possible restriction options (RO1 and RO2 ), each 
with different concentration limits for the substances falling within  the scope of the 
restriction . RO1 contain ed lower concentration limits than RO2 . The two options also 
contained alternative approaches f or handling future updates to Annexes II and IV to 
Regulation (EC) No 1223/2009. RO1 suggested to apply  the restriction not only to 
substances currently listed in those Annexes (with the requisite conditions), but also to 
substances listed in those Annexes at any time in the future . In other words, the 
restriction would apply to those substances automatically without the need to start a 
                                                 
9 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1). 
10 Regulation (EC)  No 1223/2009 of the European Pa rliament and of the Council of 30 November 2009  
on cosmetic products  (OJ L 342, 22.12.2009, p. 59).  EN 4  EN further restriction process or to amend Annex XVII to Regulation (EC) No 1907/2006  
again . This approach is referred to as “dynamic”. RO2  suggested to apply  the 
restriction only to substances currently listed in those Annexes (with the requisite 
conditions) . This approach is referred to as “static” . Both options RO1 and RO2 
proposed a “dynamic ” restriction for substances classified under  Regulation (EC) No 
1272/2008 . This was  on the grounds that  it was necessary to ensure a sufficient level 
of protection against the human health risks posed by the presence of substances in 
mixtures used for tat tooing purposes  that are classified in the relevant categories under 
that Regulation . 
(11) On 20 November 2018 , the Agency’s Committee for Risk Assessment (RAC ) adopted 
an opinion concluding that the proposed restriction , with certain modifications 
proposed by RAC , was the most appropriate Union -wide measure to address the 
identified risk arising from the various substances  in question , in terms of both 
effectiveness in reducing the risk, practicability and monitorability . 
(12) RAC considered that all relevant health  hazard classes were  covered by the 
Annex  XV dossier and agreed  with the hazard assessment for the substances and 
group of substances . In addition to  the restriction options proposed under RO1 and 
RO2, RAC proposed  a modified version of the RO1 concentrati on limits. RAC 
considered these modifications necessary  because the concentration limits for some 
substances in RO1 and RO2 did not provide sufficient protection . For other 
substances, more practicable concentration limits could be proposed , in RAC’s view,  
while still minimising the risk for human health.  
(13) RAC did not agree with the proposal to exclude two primary aromatic amines listed in 
Table 1 of the ResAP (2008)1  from the scope of the proposed  restriction , namely 6-
amino -2-ethoxynaphthaline  (CAS No 2937 33-21-8) and 2,4 -xylidine  (EC No 202-
440-0; CAS No 95-68-1). 
(14) However, RAC agree d with the dossier submitters ’ proposal  to exclude carcinogenic 
and mutagenic  substances  of category 1A, 1B or 2 that present this hazard due to 
effects following exposure by inhalation  only. RAC considered that substances 
presenting such a hazard due to effects following exposure by inhalation  only were not 
relevant in the case of intradermal exposure to mixtures used for tattooing purposes . In 
addition, RAC support ed the modi fication put forward by the dossier s ubmitter s in 
response to advice given by the Forum  during the opinion -making process . The Forum  
proposed  to exempt substances that are gases at standard temperature and pressure , 
since they are not expected to be found in mixtures used for tattooing purposes  due to  
their physical state . The only exception would be formaldehyde since the public 
consultation indicated that formaldehyde can be found in tattoo inks in a dissolved 
state. RAC also agreed that risks of exposure by tattoo artists to mixtures administered 
by them for tattooing purposes  are out of the scope of the Annex XV dossier .  
(15) RAC did not support the dossier submitter s’ proposal  for exclusion  from the scope of 
the restriction  of 21 colorants  (19 non -phthalocyanine and 2 phthalocyanine 
pigments) . Those colorants  are banned by Annex  II to Regulation (EC) No 1223/2009  
for use in hair colours . However , the blue phthalocyanine colorant (Pigment Blue 
15:3) is allowed by Annex IV  to that Regulation for use in other cosmetic products  
while the green phthalocyanine  colorant (Pigment Green 7)  is allowed for other 
cosmetic products other than eye products . RAC considered that the risk of cancer and 
possible non-carcinogenic hazards could not be ruled out for the majority of these 
colorants , primarily due to the lack of adequate information  on their hazard properties EN 5  EN and on the risk for human health . Moreover, RA C noted that during the public 
consulta tion stakeholders pointed out that  only two of these colorants , namely the two 
phthalocyanine -based colorants Pigment Blue 15:3 and Pigment  Green 7, were 
essential for tattooing on account of the fact that there were no safer and technically  
adequate alternatives available  for them . 
(16) RAC supported a dynamic link with both Regulation (EC) No 1223/2009  and 
Regulation (EC) No 1272/2008  as such links  provide greater protection for human 
health .  
(17) RAC  agreed with the dossier submitter s that, as regards the da te when the new 
restriction should begin to apply , a transitional period of 12 months  would allow 
sufficient time for actors in the supply chain to meet the new requirements .  
(18) On 15 March  2019, the Agency’s  Committee for  Socio -economic Analysis  (SEAC ) 
adopted an opinion, indicating that the proposed restriction, with the modifications 
proposed by RAC  and SEAC , was the most appropriate Union -wide measure to 
address the identified risks in terms of its socio -economic be nefits and socio -economic 
costs.  SEAC reached th at conclusion based on the best available information , taking 
into account  that the significant benefits to society , in terms of  the adverse skin effects 
and other health impacts  that would be avoided , were likely to be higher than the 
complia nce costs  for industry . Moreover, SEAC concluded  that t he restriction would 
not have a significant negative economic impact on the supply chains  affected , that it 
would be affordable  in terms of price increase s to consumers and that the restriction 
would  minimise risks of regrettable substitution.   
(19) SEAC agreed with the conclusions in the Annex XV dossier and with RAC that a 
transitional period of 12 months seem ed reasonable and sufficient to enable actors 
involved in the supply chains to comply with the restriction .  
(20) SEAC also support ed creating a dynamic link with Regulation (EC) No 1272/2008 
that would take into account any future changes to the classification of substances 
listed in Part 3 of Annex VI  of that Regulation  on the grounds that it would pro duce 
human health benefits  more quickly . With regard to future changes to Annex II or 
Annex  IV to Regulation (EC) No 1223/2009, SEAC expressed a slight  preference for a 
static link . In SEAC’s opinion, a lthough a static link may result in a delay in achieving 
the health benefits provided by the restriction, it would allow for a proper scientific 
scrutiny  of the concentration limits appropriate for the specific use of the substances in 
tattoo ing procedures  and also for a proper assessment of the availability of 
alternatives.  
(21) SEAC agree d with RAC that it was appropriate to restrict the 19 colorants banned in 
cosmetic products as , according to the information available , some  are not currently 
used for tattooing purposes  and there are alternatives av ailable . However , for Pigment 
Blue 15:3  and P igment Green 7 , comments raised during the public consultation 
indicated that there were no safer and technically feasible alternatives  available  to 
cover this spectrum of colours . As regards Pigment Green 7 , comments indicated that 
it was largely replaced by the brominated Pigment Green 36 although  RAC considered 
that Pigment Green 36 was no t a less hazardous  alternative . Therefore, SEAC 
recommend ed a time -limit ed derogation of 36 months for both pigments  considering 
the time needed by manufacturers to reformulate the mixtures . In addition, SEAC 
supported the exemption for gases at standard temperature and pressure  in line with 
RAC’s conclusion that such gases are not expected to be found dissolved in mixtures EN 6  EN for tattooing purposes . Based on information from the public consultation  SEAC also 
supported the ex clusion of formaldehyde from that  exemption .  
(22) SEAC supported the inclusion of labelling requirements and recommended  the 
alignment of the labelling requirem ents with the requirements of Regulation (EC) No 
1272/2008 , to prevent duplication  of information.   
(23) The Forum was consulted on the proposed restriction in accordance with Article 
77(4)(h) of Regulation (EC) No 1907/2006 and its recommendations have been taken 
into account.  
(24) On 11 June  2019 , the Agency submitted the opinions of RAC and SEAC11 to the 
Commission.  
(25) Taking into account the Annex XV dossier  and the RAC and SEAC opinions , the 
Commission considers  that there is an unacceptable risk to human health arising from 
certain substances in mixtures  for use for tattooing purposes  above specific  
concentration  limits . The Commission also considers that the risk needs to be 
addressed on a Union -wide basis.  
(26) The Commi ssion agrees with RAC and SEAC that , above a certain concentration 
threshold, a wide range of hazardous substances identified for the purpose s of 
Regulation (EC) No 1272/2008, Regulation (EC) No 1223/2009 and Council of  
Europe r esolution ResAP  (2008) 1 should not be used in tattooing procedures. 
Moreover, the restriction should also ban the placing on the market of mixtures  for use 
for tattooing purposes  if they contain any such substance  above the specified 
concentration threshold . By way of an ancillar y requirement, s uppliers placing 
mixtures on the market for use for  tattooing purposes , within the parameters permitted  
by the restriction , should be required to provide sufficient information to encourage  
safe use of their mixtures.  
(27) The Commission agrees  with RAC and SEAC that the restriction should not apply to 
carcinogenic and mutagenic substances with harmonised classification due to effects 
following exposure by inhalation  only, as the risk has been demonstrated only from 
mixtures introduced intradermally . The same analysis applies to repro ductive toxicants  
even though no repro ductive toxic ant is currently classified due to  inhalation exposure  
only. Therefore, repro ductive toxicants  with harmonised classification  due to effects 
following expo sure by inhalation  only should also be excluded from the scope of the 
restriction.  
(28) The Commission agrees with RAC and SEAC that the restriction should not apply to 
gaseous substances  other than formaldehyde  as they are not expected to be present in 
that state in mixtures used for tattooing purposes .  
(29) The restriction should cover not just substances  currently classified in the relevant 
hazard categories in Part 3 of  Annex VI to Regulation  (EC)  No 1272/2008  but also 
substances classified in those hazard categories at any point in the future , following an 
amendment to that Part adding or changing the classification of a substance . 
Classification under Regulation (EC) No 1272/2008  is based on a careful assessment 
of the hazard properties of substance s. The way that mixtures are administered for 
tattooing purposes  i.e. by introducing them into a part of the body also gives sufficient 
indications about  the potential exposure to t hese substances. In summary, both the 
                                                 
11 Compiled version prepared by the ECH A Secretariat of RAC's opi nion (adopted 20 November 2018) 
and SEAC's opinion (adopted 15 March 2019)  https://echa.europa.eu/documents/10162/dc3d6ea4 -df3f-
f53d-eff0-540ff3a5b1a0  EN 7  EN potential hazard (s) of the substances  and the way people are exposed to them leads to 
the conclusion that these substances present a general  level of risk to human health 
that is unacceptable and needs to be addressed by this restriction in accordance with 
the requirements set out in Title VI II of Regulation (EC) No 1907/2006 .  
(30) For any substance that subsequently comes within the terms of the restriction  as a 
result of a subsequent amendment to Part 3 of Annex VI to Regulation (EC) No 
1272/2008 , the restriction should begin to apply to that su bstance when the 
classification in that Part begins to apply . This is usually 18 months after the substance 
has been included in Annex VI  to that Regulation .  The 18-month period will provide 
sufficient time for formulators to find safer alternatives , in p articular in those cases 
that might otherwise lead to regrettable substitution. It is not necessary to address the 
availability of alternatives for substances classified in the future , as the need to ensure 
a high level of protection of human health take s precedence over considerations 
related to technical and economic feasibility of alternatives  as regards  substances used 
in tattoo inks .  
(31) Similarly, the restriction should cover not only substances currently listed with the 
relevant conditions in Annex  II or Annex IV  to Regulation (EC) No 1223/2009  but 
also substances listed with any of those conditions at any point in the future , following 
an amendment to those Annexes listing or changing the listing of a substance. If the 
substance raises sufficient safet y concerns to be restricted in cosmetic products  applied 
on the skin, it must raise at least the same safety concerns when present in mixtures 
administered for tattooing purposes , which are introduced intradermally into the 
human body.  It is not necessary to address the availability of alternatives for 
substances falling within the scope of the restriction in the future  as the  need to protect 
human health take s precedence over  considerations related to  technical and economic 
feasibility of alternatives .  
(32) Neverthel ess, as regards those substances that subsequently come within the terms of 
the restriction as a result of a future amendment to Regulation (EC) No 1223/2009 , an 
additional period of time should be allowed, after the relevant amendment takes effect , 
in order to give formulators time to adapt to the consequences of the substance coming 
within the terms of the restriction or to find a safer alternative to it. This is because the 
assessment required before a substance can be listed in Annex II or Annex IV to 
Regulation (EC) No 1223/2009 does not allow for  specific scrutiny of the substance as 
regards its effects in mixtures placed on the market for use for tattooing purposes . The 
additional period of time should be set at 18 months after entry into force of the 
relevant amendment of Annex II or IV  to Regulation (EC) No 1223/2009 .   
(33) RAC recommended a reduced concentration limit of 0,01 % for substances classified 
in the hazard classes skin or eye irritant, s kin corrosive or serious eye damage on the 
basis that the 0,1 % limit  proposed by the dossier submitters did not provide sufficient 
protection in the case of a mixture administered intradermal ly. During the SEAC 
consultation it was highlighted  that, for so me acids and bases used as pH regulators in 
tattoo mixtures , a concentration  of 0,01 % or lower may not be sufficient to achieve 
their function of adjusting the pH of the mixture.  Acids and bases  exhibit their irritant 
or corrosive properties because of their extreme pH values . However, the irritancy or 
corrosivity of a mixture containing such acids and bases will depend mostly on the 
overall pH of the mixture  itself , rather than on the pH and concentration  level of 
individual substances within in. In the  light of these factors, it is appropriate to specify 
a concentration limit  of 0,1 % for irritant or corrosive substances when they are   used 
as pH regulators .  EN 8  EN (34) Currently, labelling requirements for mixtures used for tattooing purposes are not 
harmonised across the Union. Given the inherent health risks related to substances  in 
tattoo mixtures and the increasing number of people seeking tattoos and permanent 
make -up, harm onisation  of what is written on the packaging is required to ensure 
proper implementation of the restriction, and thus establish confidence in a Union -
wide market of safe products for tattooing purposes , allow essential monitoring and 
enforcement by authorities, and address and prevent fragmentation of the internal 
market .  
(35) The Commission considers that, to ensure proper implementation of the restriction and 
permit direct traceability in case of adverse health effects, a mixture placed on the 
market in the Union for use for tattooing purposes should be marked with a list of  
substances  added during the process of formulation  and present in the  mixture for use 
for tattooing  purposes . The requirement to indicate a  full list of ingredients  serves to 
address a possible  patchwork of national rules , achieve economies of scal e for 
formulators and harness the full benefits of market harmonisation. Moreover , 
providing such a full list is also necessary to ensure that the restriction of an extensive 
list of substances is practically enforceable, monitorable, and effective through out the 
Union.  
(36) To complement the full list of ingredients  and any potential labelling requirements 
under Regulation (EC) No 1272/2008 , the Commission agrees with RAC and SEAC  
as regards the other pieces of information that should be marked on mixtures for use 
for tattooing purposes , in particular the unique batch number, the presence of any 
nickel and chromium (VI), and further safety information on the packaging or in the 
instructions of use.  
(37) To facilitate complian ce of tattoo ists with th is restriction, only mixtures that are 
marked with the statement ‘Mixture for use in tattoo s or permanent make -up’ should 
be used for tattooing purposes.   
(38) Taking into account the Annex XV dos sier, the opinions of RAC and SEAC, the 
socio -economic impact and the availability of alternatives, the Commission concludes 
that the restriction  proposed in  the Annex XV dossier , with the modifications 
described , is the most  appropriate Union -wide measure  to address the risk  identified to 
human health , without imposing a significant burden on  suppliers , tattooists or 
consumers . 
(39) Stakeholders should be allowed sufficient time to take appropriate measures to comply 
with the new restriction . The Commission considers that a period of 12 months is 
sufficient for laboratories  to establish, and gain the necessary experience with, the 
analytical methods developed or being developed by the Member States and other 
stakeholders for checking compliance with th e restriction . 
(40) The Commission agrees with SEAC ’s recommendation  that a  longer period should be 
allowed for Pigment Blue 15:3 and Pigment Green 7  because of the lack of safer and 
technically adequate alternatives and the time needed by  manufacturers to reform ulate 
their mixtures . The Commission considers , that 24 months is sufficient to find safer 
alternatives  and to remove mixtures placed on the market for use for tattooing 
purposes  containing these pigments from the market .  
(41) Mixtures placed on the market for use for tattooing purposes are administered for a 
variety of reasons, including both aesthetic and medical reasons. Such mixtures may 
fall within the scope of Regulation (EU) 2017/745  of the European Parliament and of EN 9  EN the Council12. When placed on the market or used exclusively for medical purposes 
within the meaning of Regulation  (EU) 2017/745 , the restriction established by this 
Regulation should not apply to them . In order to ensure a consistent regulatory 
approach between Regulat ions (EU) 2017/745  and (EC) No 1907/2006 and to 
guarantee a high level of protection of human health, when the placing on the market 
or use of such mixtures may be for  both, medical and non -medical purposes, the 
specific obligations and requirements laid d own in both Regulations should apply 
cumulatively.  
(42) Regulation  (EC) No 1907/2006 should therefore be amended accordingly.  
(43) The measures provided for in this Regulation are in accordance with the opinion of 
the Committee  established by Article 133(1) of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth  day following that  of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen  
  
                                                 
12 Regulation  (EU) 2017/745 of the European parliament and the Council  of 5 April 2017 on medical 
device s, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC  (OJ L 117, 5.5.2017, p. 1).