EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of 
the Council concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of 
the Council concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  
(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 C ouncil 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 
131 thereof,  
Whereas:  
(1) Annex II to Regu lation (EC) No  1907/2006 lays down requirements for the 
compilation of safety data sheets, used to provide information on chemical substances 
and mixtures in the Union . 
(2) As of  1 January 2020 , Commission Regulation (EU) 2018/18812 amending  Annexes I, 
III and VI to XII to Regulation (EC) No  1907/2006 shall apply.  Regulation (EU) 
2018/1881  introduc es specific requirements for nanoforms of substances. As 
information related to those requirements is to be included in the safety data sheets , 
Annex II to Regulation (EC) No  1907/2006 should be modified accordingly . 
(3) The Globally Harmonised System of Classification and Labelling of Chemicals (GHS)  
developed in the framework of the United Nations , sets out internationally harmonised 
criteria for the c lassification and labelling of chemicals and rules on safety data sheets.  
The Union  confirmed its intention to incorporat e the GHS criteria into Union  law.  
(4) The instruments foreseen by GHS to communicate the hazards of substances and 
mixtures are labels an d safety data sheets. The GHS provisions on safety data sheets 
are included in  Regulation (EC) No 1907/2006. Therefore, t he requirements for safety 
data sheets laid down in Annex II to Regulation (EC) No  1907/2006 should be adapted 
to the rules for safety data sheets of  the sixth and seventh revision of the GHS.  
                                                 
1 OJ L  396, 30.12.2006 , p. 1. 
2 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 regards Annexes I, III,VI, VI I, VIII, IX, X, 
XI, and XII to address nanoforms of substances (OJ L 308, 4.12.2018, p. 1 ).  
EN 2  EN (5) Annex  VIII to Regulation (EC) No  1272/2008 of the European Parliament and of the 
Council3 will allow, inter alia, the possibility that the unique formula identifier be 
indicated only in the safety d ata sheet as regards hazardous mixtures supplied for use 
at industrial sites. It will also require for certain  mixtures which are not packaged that 
the unique formula identifier be indicated in the safety data sheet. As operators need to 
comply with the re levant obligations of Annex VIII to Regulation (EC) No  1272/2008 
as of 1 January 2021, f or reasons of consistency, Annex  II to Regulation (EC) 
No 1907/2006 should reflect those changes as well . 
(6) The Commission Communication of 7  November 2018  ‘Towards a com prehensive 
European Union framework on endocrine disruptors’4 indicate s that the Commission  is 
assessing how to improve the communication through the supply chain for endocrine 
disruptors under Regulation (EC) No 1907/2006 in the context of the work on saf ety 
data sheets. A number of specific requirements for safety data sheets have been 
identified as relevant for substances and mixtures with endocrine disrupting properties 
and Annex II of this Regulation should therefore be modified accordingly . 
(7) Specific concentration limits, multiplying factors and acute toxicity estimates set in 
accordance with Regulation (EC) No 1272/2008, are relevant for the safe use of 
substances and mixtures, and should therefore be provided in safety data sheets , if 
available . 
(8) Requiring economic operators who have already compiled safety data sheets, to update 
them immediately in accordance with the provisions of this Regulation  would impose 
a disproportionate burden  on them . Operators should rather  be allowed to continue 
using  safety data sheets provided, in accordance with Regulation (EC) No  1907/2006 , 
as amended by  Commission Regulation (EU) 2015/8305, to any recipient for a certain 
period . This is without prejudice to  the obligation to update the safety data sheets in 
accordance with Arti cle 31(9) of Regulation (EC) No  1907/2006 , including  the cases 
where  the unique formula identifier has to be added for the first time to  safety data 
sheets as provided for in section 5.3 of Part A of Annex VIII to Regulation (EC) No 
1272/2008 .  
(9) The measures provided for in this Regulation are in acc ordance with the opinion of the  
Committee  established under Article 133 of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Regulation (EC) No  1907/2006 is replaced by the  text in the Annex to this 
Regulation . 
                                                 
3 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 mixtur es, 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). 
4 COM(2018)734  
5 Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of 
the European Parliament and of the Council on the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH)  (OJ L 132, 29.5.2015, p. 8 ).  
EN 3  EN Article 2 
Safety data sheets provided to a recipient before 1 January 2020 may continue to be used and 
need not comply with the Annex to this Regulation until 31 December 2022 . 
 
The first p aragraph  shall not apply  in cases when the safety data sheets need to be updated as 
provided for in Article 31(9) of Regulation (EC) No  1907/2006 , including cases when  the 
unique formula identifier  has to be added to the safety data sheet , as provided for in  section 
5.3 of Part A of Annex  VIII to Regulation (EC) No  1272/2008 . 
Article 3 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1  January 2020 . 
 
This Regulation shall be  binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President