G/TBT/N/EU/680  
9 September 2019  
(19-5741) 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):  Chemicals  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex II to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council on the Registration, Evaluation, Authorisation and 
Restriction of Chemical s (REACH) (4 pages + Annex 36 pages, in English)  
6. Description of content:  This draft Regulation relates to an update of Annex II to 
Regulation (EC) No 1907/2006 (REACH) on requirements for safety data sheets (SDS):  
• Alignment with the Globally Harmonized  System of Classification and Labelling of 
Chemicals (GHS), 6th and 7th revisions, most prominently in Sections 9 (Physical 
and chemical properties) and 14 (Transport).  
• Alignment with the provisions of Annex VIII (on emergency health response) to 
Regulatio n (EC) No 1272/2008 on classification, labelling and packaging of 
substances and mixtures (CLP), in particular in relation to the Unique Formula 
Identifiers (UFIs) assigned to hazardous mixtures, in Section 1 (Identification).  
• Alignment with the new provis ions for nanoform substances, adopted on 
3 December 2018 through the revision of REACH Annexes I, III, and VI -XII to 
REACH (Commission Regulation (EU) 2018/1881), in Sections 1 (Identification), 
3 (Composition/information on ingredients) and 9 (Physical an d chemical 
properties).  
In addition to the above three main changes, a number of smaller amendments are 
proposed to the text, related to recent developments in the Commission's approaches to 
risk management of chemicals, such as on endocrine disruptors.  
Application of the amended Annex is deferred to 31 December 2022 to allow stakeholders 
sufficient time to adapt and achieve compliance.  G/TBT/N/EU/680  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  High level of protec tion of human health and the environment and free 
circulation of goods on the internal market.  
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  
• Regulation (EC) No 1272/2008 on the classification, labelling and packaging of 
substances and mixtures (CLP):  http://data.europa.eu/eli/reg/2017/542/oj  
• Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 
Sixth revised edition (2015):  
https://w ww.unece.org/trans/danger/publi/ghs/ghs_rev06/06files_e.html#c381
56 
• Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 
Seventh revised edition (2017): 
https://www.unece.org/trans/danger/publi/ghs/ghs_rev07/07files_e.html#c613
53 
• Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) 
No 1272/2008 of the European Parliament and of the Council on classification, 
labelling and  packaging of substances and mixtures by adding an Annex on 
harmonised information relating to emergency health response : https://eur -
lex.europa.eu/legal -content/EN/TXT/ ?uri=CELEX%3A32017R0542    
• Commission Regulation (EU) 2018/1881 of 3 December 2018 amending 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on 
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 
as reg ards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms 
of substances:  https://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32018R1 881&from=EN   
9. Proposed date of adoption:  First quarter of 2020.  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU. The deadline to apply the provisions of the amendment will be 31 December 2022, 
except for cases where the Unique Formula Identifier (UFI) has to be provided in the SDS, 
i.e. in the absence of a l abel carrying the UFI.  
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/2019/TBT/EEC/19_ 4918_00_e.pdf  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_4918_01_e.pdf