EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION 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 by adding an 
Annex on harmonised information relating to emergency health response  
(Text with EEA rele vance)    
EN 2   EN COMMISSION 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 by adding an 
Annex on harmonised information relating to emergency health response  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the T reaty 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 Di rectives 67/548/EEFC and 1999/45/EC, and amending 
Regulation (EC) No 1907/20061, and in particular Article 45(4)  thereof,  
Whereas:  
(1) In order to carry out their responsibilities, bodies appointed in accordance with Article 
45(1) of Regulation (EC) No 1272/2008 need  information about mixtures classified as 
hazardous  that are placed on the market. That information is submitted to appointed 
bodies  at national level  by importers and downstream users  and it commonly  includes 
product identification, hazard identification and toxicological information.  Poison 
centres rely heavily  on information provided by those appointed bodies , and 
sometimes constitute such bodies themselves.  
(2) The Commission carried out t he review  provided for by Article 45(4) of Regulation 
(EC) No 1272/2008, and its findings, which were based on thorough expert 
consultation, were published in January 2012.  The review concluded  that there is 
considerable variety in the  current  notification  systems, data formats and country -
specific requirements regarding the request ed information in  the Member States. T his 
implies that importers and downstream users placing mixtures on the market in 
different Member States, need to provide  multiple submissi ons and in different 
formats, regarding  information that is often similar . The review also showed  that th is 
diversity leads to inconsistencies in the information available to medical personnel and 
the general public in cases of poisoning incidents  in different Member States . 
(3) The findings of the review were supported by a Commission cost benefit study 
completed in March 20152, which confirmed that, in addition to improved health 
response , the harmonisation of information to be provided to appointed bodies  would 
lead overall to significant cost savings .  
(4) The relevant stakeholders, such as the European Association of Poison Centres and 
Clinical Toxicologists (EAPCCT) have been consulted, in particular in the framework 
of the cost benefit study and thro ugh a number of workshop s. 
                                                 
1 OJ L 353, 31.12.2008, p.1.   
2 Study to support the harmonisation of the information to be submitted to poison centres, according to  
article 45 of Regulation (EC) No 1272/2008 (CLP Regulation) 03.03. 2015  
EN 3   EN (5) It is therefore appropriate to harmonis e the information to be received by  appointed 
bodies  from importers and downstream users, as well as to establish  a format for the 
submission of the information .  
(6) It is necessary to specify which  information  needs to be  submi tted to an appointed 
body . This includ es information regarding the identification of the mixture and of the 
submitter, the hazard identification and  the mixture components . Due to the fact that 
mixtures ’ formulation s can be  subject  to frequent slight  modifications  with little or no 
impact on the emergency health response  to be provided , requiring information about  
the components of the mixt ure in exact percentage s would  be disproportionate . 
Therefore , it should be all owed to provide concentration ranges  to inform about  
mixture components.  The width of those ranges should be  determined  depending  on 
the hazard of the substance  and the relevance of the information for the health 
response .  
(7) Regulation (EC) No 1272/2008  provides that the information to be transmitted to 
appointed bodies  is to include the chemical composition of mixtures placed on the 
market and classified as hazardous. In view of the fact that mixtures classified as 
hazardous may also contain non -hazardo us components, it is necessary to entitle 
appointed bodies to receive information on the latter components where needed to 
formulate preventive or curative action.  
(8) The format for the submission of the information should be harmonised in order to 
allow users and importers  operating in different Member States  to use the same 
submission or submission format in different Member States . The submission s should 
be made  electronically in a harmonised XML format maintained by the European 
Chemical s Agency.  
(9) In order  to facilitate the transmission of information , on the intended us e of a mixture  
and to ease  the statistical analysis on related poisoning cases , a European product 
categori sation system should be developed by the European Chemical s Agency  and 
used in the submission  of information . 
(10) According to a Commission study , poison centres  and other appointed bodies  
experience  problems with  the correct identification of the mixture concerned  in up to 
40 percent of the calls they receive . This can lead to wrong treatme nt of patients and 
unnecessary overtreatment and hospitalisation for precautionary reasons. Therefore, as 
part of the harmonisation of the information, it is necessary to require identification of 
a mixture by a unique alphanumeric code (U nique Formula Ide ntifier ) to be affixed to 
the product .  
(11) Most calls to poison centres and other appointed bodies concern accidental exposure to 
hazardous mixtures used by consumers and to a lesser extent by professionals. Only a 
small number of calls concern mixtures for industrial use, which are use d in industrial 
installations.  In addition, o n industrial sites there usually is a greater knowledge of the 
mixtures used and medical treatment is generally available. Therefore, importers and 
downstream users of mixtures for i ndustrial use should be allowed to fulfil limited 
information requirements . 
(12) In order to spread the necessary work of adapting the format for data submission, and 
to prioritise information provision where it is most needed, it is considered reasonable 
and p roportionate to lay down a stepwise applicability of the new information 
requirements set by this Regulation  according to the use of the mixture .   
EN 4   EN (13) In order to ensure a smooth transition and avoid disproportionate costs, t he 
submissions provided to appointe d bodies  before the date of applica tion of this 
Regulation should remain valid for a certain time after this Regulation starts to apply . 
However, if significant change s in the formulation , product identifier or toxicology of 
the mixture occur  in the meanti me, a submission  update  pursuant to this Regulation 
should be required .  
(14) The measures provided for in this Regulation are in accordance with the opinion of  the 
Committee established by  Article 54(1) of Regulation (EC) No 1272/2008,  
HAS ADOPTED THIS REGULATION:  
Article 1  
In Regulation (EC) No 1272/2008 , Annex VIII is added  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 E uropean Union . 
It shall apply from 1 July 2019.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker