EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Article 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  
(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 compl iance date, for reasons of 
serious workability concerns2. The Commission 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 would cons titute 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 mitig ating some unintended consequences that had 
only become apparent since the adoption of Regulation (EU) 2017/542.  
The Commission is now proposing to add paragraph (8) to  Article 25 as well as amend 
Annex  VIII of Regulation (EC)  1272/2008  as they  contain the solutions to solve those  
workability issues.  
In line with the empowerments given under Regulation (EC)  1272/2008 , amended through 
Regulation (EU) 2019/1243 , and in particular Article 53c thereof, the Commission shall adopt 
a separate delegate d act in respect of each power delegated to it. Since powers delegated for 
the amend ment of Article 25 and Annex  VIII are different, the Commission is proposing two 
separate delegated acts.  
This proposed act contains the addition of paragraph (8) to  Artic le 25  providing for a solution 
for bespoke paints . The act 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 n on-necessity to create a UFI for bespoke paints, being 
the other part of the solution, is stipulated in [Commission Delegated Regulation (EU) 
YYYY/XXX [OP: please insert reference to 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 order to improve the 
workability of information requirements related to emergency health response ].   
2. CONSULTATIONS  PRIOR  TO THE  ADOPTIO N 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 
                                                 
1 OJ L 78, 23.3.2017, p. 1 –12. 
2 For example the effects on compliance possibility of mixture s with a highly variable  composition due to 
the natural origin of their components ; the difficulty of knowing the exact composition of products in 
cases involving complex supply chains ; and the im pact of multiple suppliers of mixture components 
with the same technical properties and hazards.   
EN 2  EN Authorities for REACH and CLP (E02385)] according to the rules of the Interinstit utional 
Agreement on Better Law -Making of 13 April 20163.   
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  DELEGATED  ACT  
The legal act amends Regulation (EC)  1272/2008. The legal basis of this delegated act is 
Article 53(1) of Regulation (EC)  1272/2008.  
                                                 
3 OJ L 123, 12.5.2016, p. 1.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Article 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 besp oke paints  
(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 classific ation, labelling and packaging of substances and 
mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC)  No 1907/20064, and in particular Article 53(1) 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’ (UFI)  in the supplemental information pr ovided on the label of a hazardous 
mixture . Importers and downstream users are required 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) The pa ints sector has raised a specific concern  regarding the workability of the 
emergency health response requirements in the case of paints formulated in limited 
amounts on a tailor made basis for an individual consumer or professional user at the 
point of sal e. In order to satisfy customer demand for very specific paint shades, 
formulators can be asked to formulate and supply paints with an almost unlimited 
number of different compositions. Compliance with the emergency health response 
requirements would  therefore  require formulators either to submit information and 
create UFIs in advance for an extremely  large number of paints of  all possible colour 
combinations , many of which may never be supplied in reality , or else to postpone 
each supply at the point  of sale until the information had been submitted and the UFI 
had been created . Either approach would place a disproportionate burden on the 
bespoke paints industry.  
(3) In order to avoid disproportionate administrative burden, in particular for small and 
medium sized enterprises, for bespoke paints,  the requirements are to be amended by 
Commission Delegated Regulation (EU) YYYY/XXX [OP: please insert reference to 
Commission Delegated Regulation … amending Regulation (EC) No 1272/2008 of the 
                                                 
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 of substances and 
mixtures by adding an Annex on harmonised information rela ting to emergency health response (OJ L 
78, 23.3.2017, p. 1).   
EN 4  EN 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 ] to provide for the possibility to 
exempt bespoke paint s from the notification obligations in Annex  VIII to Regulation 
(EC) No 1272/2008 and from the obligation in that Annex to create a UFI.  However, 
in that case, in order to allow poison centres to formulate a suitable emergency health 
response, t he individu al mixtures contained in bespoke paints are to remain subject to 
all the requirements of Annex VIII .  
(4) In the light of that, it is appropriate to  amend Article 25 of Regulation (EC) No 
1272/2008 in order to lay down a rule for bespoke paints for which no information is 
notified and no corresponding UFI created requiring  the UFIs of all the mixtures 
contained in the bespoke paint to be indicated on the label  of the bespoke paint . In 
addition , if the concent ration of a mixture  with a UFI  contained in the bespoke paint 
exceeds 5%, the concentration should be included in the supplemental information 
indicated on the label  of the bespoke paint , since mixtures in bespoke paints of such 
concentration are more likely to be relevant for emergency health responses .  
(5) Regulation (EC) No 1272/2008 should therefore be amended accordingly ,   
 
HAS ADOPTED THIS REGULATION:  
Article 1  
In Article 25 of Regulation (EC) No 1272/2008 , the following paragraph is added:   
‘8. In the case of a bespoke paint for which no  submission in accordance with 
Annex  VIII has been made and no corresponding  unique formula identifier has been 
created, the unique formula identifiers of all the mixtures contained in the bespoke 
paint which  themselves are subject to notification under Ar ticle 45 shall be included 
in the supplemental information on the label  of the bespoke paint , located together 
and listed in descending order of  the mixtures’ concentration in the bespoke paint, in 
accordance  with the provisions of section  5 of Part A of A nnex  VIII.   
In a case falling within the first subparagraph , where th e concentration of a mixture  
with a unique formula identifier  in the bespoke paint exceeds 5 %, the concentration 
of that mixture shall also be included in the supplemental information on the label of 
the bespoke paint next to its unique formula identifier, in accordance with section 
3.4. of Part B of Annex  VIII.  
For the purposes of this paragraph, ‘bespoke paint’ means a paint that is formulated  
in limited amounts on a tailor made basis for an individual consumer or professional 
user at the point of sale by tinting or colour mixing .’ 
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 .  
EN 5  EN This Regulation shall be binding in its entirety and directly applicable in the Member States .  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen