G/TBT/N/EU/709  
7 April 2020  
(20-2756) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Commission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Tattoo inks 
or permanent make -up 
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and R estriction of Chemicals (REACH) as regards substances in tattoo inks or 
permanent make -up (10 page(s), in English; 12 page(s), in English)  
6. Description of content:  This draft Regulation relates to a new entry of Annex XVII to 
Regulation (EC) No 1907/200 6. 
It would restrict the placing on the market and the use of substances in mixtures for use 
for tattooing purposes.  
These substances are:  
i. substances with harmonised classification under Regulation (EC) No 1272/2008 
(CLP) as carcinogenicity, mutagenicity or toxicity to reproduction, skin 
sensitisation, skin corrosion or irritation and serious eye damage or irritation;  
ii. substances prohibited b y the Cosmetic Products Regulation, Regulation (EC) 
No 1223/2009 Annex II and Annex IV under specific conditions as listed in its 
columns g, h and i and  
iii. impurities exceeding the concentration limits as listed in the Appendix to the draft 
Commission Regula tion. 
Application of the restriction is deferred for 1 year to allow sufficient time to adapt and 
achieve compliance with the Regulation.  G/TBT/N/EU/709  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Tattoo and permanent make -up inks are mixtures administered by intentional 
injection into the dermis or inside the eyeball or in the mucous membranes. The insoluble 
pigments mostly remain in the skin, soluble constituents of the ink are distributed in the 
body being quickly systemically  available. The aim of the restriction is to prevent the 
exposure of the skin and other organs over an extended period of time to the effects of 
substances which have hazardous properties leading to a risk to human health. The 
transitional period (12 month s) before the application of the proposed restriction will allow 
stakeholders sufficient time to comply with the proposed restriction and to ensure 
adequate communication throughout the supply chain . 
8. Relevant documents:   
• Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH 
Regulation):  
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1423064258789&uri=CELEX:32006R1907   
• The opinions of the Committees for Risk Assessment (RAC) and Socio -economic 
Analysis (SEAC):  
https://echa.europa.eu/documents/10162/dc3d6ea4 -df3f-f53d-eff0-540ff3a5b1a0  
• Further background information is available at https://echa.europa.eu/nl/registry -of-
restriction -intentions/ -/dislist/details/0b0236e180dff62a  
9. Proposed date of adoption:  Second half of 2020 
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (the restriction will begin to apply one year after the date of entry into force)  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_2471_00_e.pdf  
https://members.wto.org/crnat tachments/2020/TBT/EEC/20_2471_01_e.pdf