EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 emergency health response  
(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 EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
According to Article 45(1) of the CLP Regulation, Member States' appointed bodies shall 
receive 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 (EC) No 1272/2008  by adding an Annex harmonising the information to be 
provided relating to emergency health response (“ Annex VIII ”). Annex VIII was adopted in 
March 2017 and w as intended to  become applicable on 1 January 2020.  
The Commissi on is proposing an amendment to Annex VIII before its applicability date that 
would contain uncontentious clarifications of the text, so as to allow a more streamline 
interpretation  of the text , improve internal coherence and mitigate some unintended 
conse quences made apparent only after the adoption of the Annex.  
The Commission is also proposing an amendment of the first compliance deadline (identical 
with the applica bility  date of Annex VIII ) from 1  January  2020 to 1  January  2021 given that 
there have been calls for more extensive amendments to Annex  VIII before its applica bility  
date, for reasons of workability concerns. The Commission has examined the workability for 
all sectors, as certain workability issues of Commission Regulation (EU)  2017/542  were 
identified, such as the effects of high variability in mixture composition due to the natural 
origin of components,  the difficulty of knowing the exact composition of products in cases 
involvin g complex supply chains, and the impact of multiple suppliers of mixture components 
with the same technical properties and hazards . Once solutions how to address these 
workability issues will have been developed, any ensuing changes will need to be made to  the 
new rules before the first compliance date. A  postponement of the first compliance deadline  
would allow Member States and ECHA to be ready in time and allow industry to comply with 
Annex VIII by the deadline.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Pursuant to Article 53a(4) of Regulation (EC) No 1272/2008  experts designated by each  
Member State were consulted in the relevant expert group CARACAL  [Competent 
Authorities for REACH  and CLP (E02385) ] according to the rules of the Interinstitutional 
Agreement on Better Law -Making  of 13 April 20161.   
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal act amends Regulation (EC) No 1272/2008. The legal bases of this delegated act are 
Article 45(4) and Article 53(1) of Regulation (EC) No  1272/2008.  
                                                 
1 OJ L 123, 12.5.2016, p. 1 .   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 emergency health response  
(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 1272/2008 of the European Parliament and of the 
Council of 16 December 2008 on classification, labelling and packaging of substances and 
mixtures, amending and repealing Directives 67/548/EEFC and 1999/45/EC, and amending 
Regulation (EC) No 1907/20062, and in particula r Articles 45(4) and 53(1) thereof,  
Whereas:  
(1) Regulation (EC) No 1272/2008 was amended by Commission Regulation 
(EU)  2017/5423 to add certain requirements for the submission of information relating 
to emergency health response and for the inclusion of a “unique formula identifier ” in 
the supplemental information  provided on the label  of a hazardous mixture . The 
amendment s are expressed to apply from 1  January 2020 , but importers and 
downstream users are only required to start complying with the new rules in stages,  
according to a series of compliance dates depending on the use for which a mixture is 
placed on the market.  The first such compliance date is 1 January 2020.  
(2) After adoption of Regulation  (EU)  2017/542, several drafting suggestions were made 
during discussions with national authorities and other stakeholders  with a view to 
facilitat ing implementation of the new rules introduced by that Regulation and 
clarifying their meaning. The new rules introduced by that Regulation  should therefore 
be amended to allow for a more streamline d interpretation of them , to improve internal 
coherence  and to mitigate some unintended consequences that have only become 
apparent since adoption  of that Regulation . In particular, since the unique formula 
identifier (UFI) may need to be updated frequently, the new rules should provide for 
the UFI to be shown either on the label of the hazardous mixture or on its packaging in 
close proximity to the label.  Article 31(5) of Regulation (EC) No 1272/2008  already  
also includes the option of putting all the label elements on the packaging  rather than 
on a label . In addition , Article 29( 3) of Regulation (EC) No 1272/2008 addresses the 
situation where a mixture is supplied without any packaging.   
                                                 
2 OJ L 353, 31.12.2008, p.1.   
3 Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of 
the European Parliament and of the Council on classificati on, labelling and packaging of substances and 
mixtures by adding an Annex on harmonised information relating to emergency health response (OJ L 
78, 23.3.2017, p. 1).    
EN 3  EN (3) In addition  to the drafting suggestio ns, national authorities and other stakeholders have 
raised certain issues concerning the workability of the new rules introduced by 
Regulation (EU)  2017/542 , for example the effects of high variability in mixture 
composition due to the natural  origin of  components,  the difficulty of knowing the 
exact composition of products in cases involving complex supply chains,  and the 
impact of multiple suppliers of mixture  components with the same technical properties 
and hazards.  Once any solutions needed to address these issues  have been developed , 
any resulting changes to the new rules will have to be made before the first compliance 
date when importers and downstream users are required to start complying with the 
new rules  as regards mixtures for consumer use . It is therefore appropriate to defer the 
first compliance date from 1  January  2020 to  1 January 2021 in order to allow 
sufficient time to develop  the necessary solutions and make any necessary changes  to 
the new rules . This postponement  does not affect the need for Member States  to have 
their systems operational in good time before 1  January  2021  in order to allow 
importers and downstream users sufficient time to prepare for their submissions  before 
that date .  
(4) Regulation (EC) No 1272/2008 should therefore be amended accordingly.  
(5) The date of application of this Regulation should be deferred in order to align it with 
the date of application of Regulation (EU) 2017/542,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 1272/2008 is amended as  follows:  
(1) in Article 25, paragraph 7 is replaced by the following:  
 ‘7. Where under Annex VIII the submitter creates a unique formula identifier, it shall 
be included in the supplemental information  on the label  in accordance with the provisions of 
section 5 of Part A of that Annex .’;  
(2) in Article 29, the following paragraph is inserted:  
 ‘4a. Where under Annex VIII the submitter creates a unique formula identifier,  the 
submitter may , instead of including it in the supplemental information on the label,  opt to 
show it in another way permitted by section 5 of Part A of that Annex.’;   
(3) Annex VIII is amended as set out in the Annex to this Regulation . 
Article  2 
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 202 0.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker