G/TBT/N/EU/719  
12 May 2020  
(20-3534) Page: 1/3 
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 [   ], 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):  Hazardous 
mixtures  
5. Title, n umber of pages and language(s) of the notified document:  Draft 
Commission Delegated Regulation amending Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council on classification, labelling and packaging of 
substances and mixtures in orde r to improve the workability of information requirements 
related to emergency health response accompanied by an Annex (6 page(s), in English; 
28 page(s), in English)  
6. Description of content:  According to Article 45(1) of the CLP Regulation, EU Member 
States' appointed bodies shall be responsible for receiving information from importers and 
downstream users on the hazardous chemical mixtures they place on the market. 
Commission Regulation (EU) No  2017/542 amended the CLP Regulation by adding an 
Annex harm onising the information to be provided relating to emergency health response 
("Annex VIII").  
Annex VIII was adopted in March 2017. Shortly before adoption, EU Member States and 
industry stakeholders called for amendments of Annex VIII before its compliance  date, 
for reasons of serious workability concerns (notably the difficulty or impossibility of 
knowing the exact composition of products in cases where raw materials with highly 
variable or unknown composition are used, where multiple suppliers are being u sed for 
components that are stored in the same recipient, or where complex supply chains are 
involved). The Commission services commissioned a study to assess the legitimacy of the 
claims and the impact on duty holders and concluded that an amendment of An nex VIII 
was indeed necessary. The amendment would constitute a second amendment to the 
Regulation, after the adoption of Regulation (EU) 2020/11, which deferred the compliance 
date for mixtures for consumer use and aimed at a more streamlined interpretati on of G/TBT/N/EU/719  
 
- 2 - 
 
  the rules, improving internal coherence and mitigating some unintended consequences 
that had only become apparent since the adoption of Regulation (EU) 2017/542.  
The Commission is now proposing to amend Annex  VIII of Regulation (EC) 1272/2008 in 
order to solve the workability issues.  
The enclosed act and annex (replacing the current Annex VIII) improve the workability of 
information requirements related to emergency health response. The amendment of 
Annex  VIII addresses the conce rns raised, i.e. the difficulty or impossibility of knowing 
the exact composition of products in cases where raw materials with highly variable or 
unknown composition are used, where multiple suppliers are being used for components 
that are stored in the s ame recipient, or where complex supply chains are involved, as 
well as the impossibility to know in advance which exact bespoke mixtures will be placed 
on the market.  
This proposed act introduces a general solution with the concept of an interchangeable 
component group, as well as more sector specific solutions for gypsum, ready mixed 
concrete, cement and petroleum products and bespoke paints.    
This draft act and annex are closely interlinked with the "Draft Commission Delegated 
Regulation amending Articl e 25 of Regulation (EC) 1272/2008 of the European Parliament 
and of the Council on classification, labelling and packaging of substances and mixtures 
as regards bespoke paints" that contains the addition of paragraph (8) to Article 25 
providing for a solut ion for bespoke paints. The latter constitutes only part of the solution, 
namely the consequence for the labelling obligations in Article 25 of Regulation (EC) 
1272/2008 of the non -necessity to create a UFI for bespoke paints. The non -necessity to 
create a  UFI for bespoke paints, being the other part of the solution, is stipulated in 
proposed amendment of Annex VIII.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Ensuring the proper functioning of the EU internal mark et; Protection of 
human health or safety; Protection of the environment  
8. Relevant documents:   
• Regulation (EC) 1272/2008 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.) http://eur -
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN :PD
F 
• Commission Regulation (EU) No 2017/542 amended the CLP Regulation by 
adding an Annex harmonising the information to be provided relating to 
emergency health response (OJ L 78/1, 23.3.2017, p.1) 
http://data.europa.eu/eli/reg/2017/542/oj   
• Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 amending 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council on 
classification, labelling and packaging of substances and mixtures as regards 
information relating to eme rgency health response (OJ L 6, 10.1.2020, p. 8 –14) 
http://data.europa.eu/eli/ reg_del/2020/11/oj  
9. Proposed date of adoption:  3rd quarter 2020  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU (about a month after adoption).  
10. Final date for comments:  60 days from notification  G/TBT/N/EU/719  
 
- 3 - 
 
  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_3164_00_e.pdf  
https://members.wto.org/crna ttachments/2020/TBT/EEC/20_3164_01_e.pdf