EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) 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 in order to 
improve the workability of information requirements related 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 Regulation  (EC) No 1272/2008 , 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)  2017/542 amended Regulation (EC)  1272/2008 by addin g an Annex harmonising the 
information to be provided relating to emergency health response (“Annex VIII”)1. 
Annex VIII was adopted in March 2017. After adoption, Member States and industry 
stakeholders called for amendments of Annex VIII before its compli ance date, for reasons of 
serious workability concerns2. 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 
Annex VIII was indeed necessary.  The amendment wo uld 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 interpretation of 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 a dd paragrap h (8) to  Article 25 as well as to amend 
Annex  VIII of Regulation (EC)  1272/2008  in order  to solve the workability issues .  
In line with the empowerments given under Regulation (EC)  No 1272/2008 , amended through 
Regulation (EU) 2019/1243 , and in particular Article 53c thereof, the Commission shall adopt 
a separate delegated act in respect of each power delegated to it. Since powers delegated for 
the amendment of Article 25 and Annex VIII are different, the Commission is proposing two 
separate delegated acts.   
This proposed act contains the amendment of Annex  VIII and addresses the concerns 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 same 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 a n interchangeable 
component group , as well as more sector specific solutions for gypsum, ready mixed concrete, 
cement and fuels  and bespoke paints.   
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 
Authori ties for REACH and CLP (E02385))  according to the rules of the Interinstitutional 
                                                 
1 OJ L 78, 23.3.2017, p. 1 –12. 
2 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 
used for components that are stored in the same recipient, or where complex supply chains ar e involved .   
EN 2  EN Agreement on Better Law -Making of 13 April 20163. This included also members of the 
European Association of Poison Centres and Clinical Toxicologists (EAPCCT).   
[Furthermore, the initiative was published for feedback during the period [insert]  under the 
title [insert]  (link). The public feedback received can be summarised as follows.  
[insert part on public feedback mechanism after ISC]  
3. LEGAL  ELEMENTS  OF THE  DEL EGATED  ACT  
The lega l act amends Regulation (EC)  No 1272/2008. The legal basis of this delegated act is 
Article 45(4 ) of Regulation (EC)  1272/2008.  
For the readers’ convenience, this version of Annex  VIII entirely repeals and replaces the 
previous version.  
 
                                                 
3 OJ L 123, 12.5.2016, p. 1.   
EN 3  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 packa ging of substances and mixtures in order to 
improve the workability of information requirements related 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)  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/EEC and 1999/45/E C, and amending Regu lation 
(EC)  1907/20064, and in particular Article 45(4 ) thereof,   
Whereas:  
(1) Regulation (EC)  No 1272/2008 was amended by Commission Regulation 
(EU)  2017/5425 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 
requirements were amended by Commission Delegated Regulation (EU) 2020/116. 
Importers and downstream users are require d to start complying with the requirements 
in stages, according to a series of compliance dates depending on the use for which a 
mixture is placed on the market   
(2) Concerns have been raised by various industry sectors regarding the workability of the 
emergen cy health response information requirements in certain cases , notably with 
regard to the difficulty  of knowing the exact composition of mixtures in cases where 
raw materials with a highly variable or unknown composition are used  in the 
manufacture of the m ixture , in cases where toxicologically very similar components 
supplied by multiple , different  suppliers are used together in the same production line , 
or in cases involving complex supply chains . Concerns have also been raised , in the 
case of bespoke mixtures,  about the impossibility of knowing in advance which exact 
bespoke mixtures are to be placed on the market .  
                                                 
4 OJ L 353, 31.12.2008, p.1.  
5 Commission 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 o f substances and 
mixtures by adding an Annex on harmonised information relating to emergency health response (OJ L 
78, 23.3.2017, p. 1).  
6 Commission Delegated Regulation (EU) 2020/11 of 29 October 2 019 amending Regulation (EC) 
No 1272/2008 of the Europea n Parliament and of the Council on classification, labelling and packaging 
of substances and mixtures as regards information relating to emergency health r esponse (OJ L 6, 
10.1.2020, p. 8 ). 
  
EN 4  EN (3) It is necessary  to address the situation where different but toxicologically very similar 
components are used in a mixture,  and where  it is unknown which component is 
present in a particular mixture placed on the market at a given time . To ensure that the 
emergency health response requirements can be complied with properly in practice , 
importers and downstream users should be allowed to grou p toxicologically similar 
components of a mixture together in an interchangeable component group and provide 
information on the total concentration of those components present in the mixture, 
without having to specify their separate concentration s. In orde r to allow poison 
centres to formulate a suitable emergency health response, components should only be 
grouped in an interchangeable component group  if their classification for health and 
physical effects is identical  and if the hazards identification and the additional hazard 
information are identical for all possible combinations of the resulting final mixture 
incorporating those components . For components classified for certain hazard classes, 
it should also be necessary for them to have the same technic al function and the same 
toxicological profile  in order  to be grouped .  
(4) In order to address particular difficulties encountered by the gypsum, ready -mixed 
concrete and cement  sector s and to allow them to comply with the emergency health 
response requirements  without reducing the level of safety , it should be possible for 
emergency health response information relating to certain standardised mixtures 
within those three sectors to be submitted by reference to a standard composition . 
However, i n order to allow poison centres to formulate a suitable emergency health 
response, this option should only be available in cases where the mixture classification 
does not change according to the mixture’s composition within the concentration 
ranges specifi ed in the standard  formula , and where the information on composition is 
at least as detailed as the information contained in the mixture’s safety data sheet, 
drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006 (“safety 
data sheet”) . In the event that the information contained in the safety data sheet is 
more detailed  than the information on the composition in the standard, importers and 
downstream users should be required to notify the information in the safety data sheet 
instead.  
(5) In order to address particular difficulties anticipated for certain fuels , and taking into 
account the fact s that fuels  placed on the market normally conform to a technical 
standard and that poison centres have communicated a low number of poisoning 
incide nts with fuels , it should be possible, until a more suitable solution is found, to 
submit emergency health response information by reference to the information 
contained in the safety data sheet, as well as any other known information  on the 
products ’ chem ical composition .  
(6) In order to satisfy customer demand for very specific paint shades, formulators are 
sometimes asked to formulate and supply paints on a bespoke basis at the point of sale. 
These bespoke paints could have an almost unlimited number of dif ferent 
compositions. Therefore, without any mitigating measures, c ompliance with the 
emergency health response requirements in Annex  VIII to Regulation (EC) No 
1272/2008 would require formulators of bespoke paints either to submit information 
and create unique formula identifiers ( UFIs ) in advance for an extremely large number 
of paints of all possible colour combinations, many of which might never be  supplied 
in reality, or to postpone each supply until the information had been submitted and the 
UFI had been created. Either approach would place a disproportionate burden on the 
bespoke paints industry , in particular small and medium sized enterprises, without 
improving the level of safety significantly .  
EN 5  EN (7) Poison centres have not communicated a significant nu mber of accidents related to 
paints. In light of the apparently lower risks compared to other mixtures, it is justified 
to allow a more flexible approach, as this would not be reducing the current level of 
safety.  
(8) It is therefore appropriate to provide for  the possibility to exempt bespoke paints from 
the notification obligations in Annex  VIII and from the requirement to create a UFI . 
However, in that case, in order to allow poison centres to formulate a suitable 
emergency health response, the individual mixtures contained in bespoke paints 
should remain subject to all the requirements of that Annex . Alongside this 
Regulation, Commission Delegated Regulation (EU) YYYY/XXX [OP: Please insert 
reference to the act amending Article 25 of Regulation (EC) No 1272/ 2008 of the 
European Parliament and of the Council on the classification, labelling and 
packaging of substances and mixtures as regards bespoke paints]  amends Article 25 
of Regulation (EC) No  1272/2008 to add a new rule, in the case of bespoke paints for 
which no  submission in accordance with Annex VIII has been made and no 
corresponding  UFI has been created,  requiring the UFIs of all the individual mixtures 
contained in the bespoke paint to be indicated on the label  of the bespoke paint , 
together with the specific concentration of each such mixture with a UFI that is present 
in a concentration exceeding 5% .  
(9) Given the number of changes to Annex VIII to Regulation (EC) No 1272/2008, it is 
appropriate to  replace  the whole Annex  for the sake of legal clarity .  
(10) Regulation (EC)  No 1272/2008 should therefore be amended accordingly ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex VIII to Regulation (EC) No 1272/2008 is replaced by the text in the Annex to this 
Regulation.  
Article 2 
This Regulatio n shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen