G/TBT/N/EU/714  
23 April 2020  
(20-3204) 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):  Recently 
classified carcinogenic , mutagenic and reproductive toxicants (CMR) category 1A and 1B as 
substances on their own, as constituents of other substances or in mixtures that are placed 
on the market or used for supply to the general public, devices covered by EU Regulation 
2017/745  on medical devices, persistent organic pollutants, certain liquid substances or 
mixtures, nonylphenol, azocolourants.  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex XVII to Regulation (EC) N o 1907/2006 of the 
European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or 
reproductive toxicant (CMR) substances, devices covered by Regulati on (EU) 2017/745 of 
the European Parliament and of the Council, persistent organic pollutants, certain liquid 
substances or mixtures, nonylphenol and testing methods for azocolourants (5 page(s), in 
English; 4 page(s), in English)  
6. Description of conten t: In the first place, this draft Commission Regulation aims to 
include within the scope of entries 28 to 30 of Annex XVII to Regulation (EC) 
No 1907/2006 several substances, with the effect of restricting their placing on the market 
or use for supply to t he general public as substances on their own, as constituents of other 
substances or in mixtures and to impose the requirement to mark packaging with the label 
"restricted to professional users". This is consequent on the recent classification of these 
substances as CMR category 1A or 1B under 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, as amended by Commission Regulation 
(EU) 2018/1480 and Commission Delegated Regulation (EU) 2020/217.  
Moreover, this draft Commission Regulation aims to:  
• delete three entries from Annex XVII to the REACH Regulation, as the substances G/TBT/N/EU/714  
 
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  concerned have been, or are about to be, incorporated into Regulation 2019/2012 
on persistent organic pollutants;  
• include an exemption, from the aforementioned entries 28 to 30 , for devices covered 
by Regulation (EU) 2017/745 on medical devices;  
• delete an obsolete paragraph mandating a review of the restriction on liquid 
substances or mixtures;  
• delete obsolete references to "R phrases" from the restriction on liquid substances o r 
mixtures;  
• delete obsolete references to CMR classifications under Directive 67/548 from the 
titles of Appendixes 1 -6 of Annex XVII;  
• update the references to testing methods for azocolourants in Appendix 10 of Annex 
XVII, to reflect technical progress;  
• and finally delete the CAS and EC numbers from entry 46 of Annex XVII, as their 
inclusion, in 2009, inadvertently reduced the scope of this entry, and the original 
intention of the legislator should be reflected again.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The abovementioned substances recently received new harmonised 
classifications as CMR category 1A or 1B. In accordance with Article 68(2) of Regulation 
(EC) 1907/2006 (REACH), the Commission may pro pose a restriction on the use of these 
substances and mixtures containing them by consumers. The other proposed changes aim 
to increase legal clarity and consistency, facilitate implementation and/or avoid double 
regulation.  
8. Relevant documents:   
• Regula tion (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  
9. Proposed date of adoption:  4th quarter of 2020  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU. The provisions will apply from different deadlines in accordance with Article 2(2) of 
the Act.  
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_2866_00_e.pdf  
https://members.wto.org/crnattachments/2 020/TBT/EEC/20_2866_01_e.pdf