EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
ANNEX 1  
  
ANNEX    
EN 2   EN ANNEX  
'ANNEX VIII  
HARMONISED INFORMATION RELATING TO EMERGENCY 
HEALTH RESPONSE  
PART A  
GENERAL REQUIREMENTS   
1. Application  
1.1. Importers and downstream users placing on the market mixtures for consumer  use, 
within the meaning of section 2.5 of this Annex , shall comply with this Annex  from  1 
July 20 19. 
1.2. Importers and downstream users placing on the market mixtures for professional use, 
within the meaning of section 2.5 of this Annex , shall comply with this Annex  from  1 
July 2020.  
1.3. Importers and downstream users placing on the market mixtures for indust rial use 
within the meaning of section  2.5 of this Annex , shall comply with this Annex  from  1 
July 2023.  
1.4. Importers and downstream users having submitted information relating to hazardous 
mixtures to a body appointed in accordance with Article  45(1) of  Regulation  (EC) 
No 1272/2008 before the dates of applicability mentioned in sections 1.1, 1.2 and 1.3 
and which are not in accordance with this Annex,  shall not be required to comply with 
this Regulation until 1 January 2025.   
1.5. By way of derogation f rom section 1.4 , if one of the changes described in section  4.1 
of Part  B of this Annex occurs before 1  January  2025, importers and downstream users 
shall comply with this Annex  before placing that mixture, as changed, on the market.  
 
2. Purpose, definitions and scope   
2.1.   This Annex sets out the requirements that importers and downstream users placing 
mixtures on the market, hereinafter ‘submitters’, shall fulfil in respect of the 
submission of information relating to the tasks laid down in Art icle 45(2) . 
2.2. This Annex shall apply to downstream users placing mixtures on the market, whether 
or not they also qualify as distributors.  
2.3.  This Annex shall not apply to mixtures for scientific research and development and to 
mixtures for product a nd process oriented research and development as defined in 
Article 3(22) of Regulation (EC) No 1907/2006.   
EN 3   EN This Annex shall not apply to mixtures classified only for one or more of the 
following physical hazards:  
 (1) Gases under pressure;  
 (2) Explosives (Unstable explosives and Divisions 1.1 to 1.6).   
2.4.  In the case of mixtures placed on the market for industrial use only, submitters may 
opt for a limited submission, as an alternative to general submission requirements, in 
accordance with section 5.3 of this Part  and section 3.1.1 of Part B,  provided that a 
rapid access to additional detailed product information is submitted in accordance with  
section 1.3 of Part B.  
2.5.  For the purposes of this Annex the following definitions shall apply:  
(1) ‘Mixture f or industrial use’ means a mixture destined for use at industrial sites ; 
(2) ‘Mixture for consumer use’ means a mixture destined for use by consumers ; 
(3) ‘Mixture for professional use’ means a mixture destined for use by professional 
users but not at industrial s ites. 
3. Submission requirements  
3.1.  Before placing mixtures on the market, submitters shall provide information relating 
to mixtures classified as hazardous on the basis of their health or physical effects to 
the bodies appointed under Article 45(1) (hereinafter 'appointed bodies'), in the 
Member State or Member States where the mixture is placed on the market.  
The submission shall contain the information laid down in Part B. It shall be submitted 
by electronic means in a XML format provided by the Ag ency.  
3.2.  Further to a reasoned request from an appointed body, submitters shall provide to the 
appointed bodies any additional information necessary for the appointed body to carry 
out its tasks.  
3.3. The language used in the submission shall be the of ficial language or languages of the 
Member State or Member States where the mixture is placed on the market, except 
where a Member State allows submission in another language as an alternative.  
3.4. The intended use of the mixture shall be described in accordance with a harmonised 
product categorisation system provided by the Agency.  
3.5. A submission update shall be made as laid down in section 4 of Part  B in the case of a 
change in the product iden tifier or in the composition of a mixture, or when new 
toxicological information on its hazardous properties becomes available.  
4. Group submission  
4.1. A single submission may be provided for more than one mixture where all grouped 
mixtures have the same classification for health and physical hazards and the  
EN 4   EN information in that submission covers all the composition variants of the grouped 
mixtures in accordance with section 1.1.1  of Part B for each of those mixtures, 
hereinafter 'group submission '. 
4.2. A group submission shall only be permitted when the concentration level of a 
substance present in the group of mixtures belongs to the same concentration range , as 
provided in section 3.4 of  Part B.  
5. Unique Formula Identifier (UFI)  
5.1.  The submitter sha ll create a Unique Formula Identifier, hereinafter UFI, by electronic 
means made available by the Agency. The UFI is a unique alphanumeric code that 
unambiguously links the submitted information on the composition of a mixture to a 
specific mixture. The as signment of a UFI is free of charge and it shall be provided in 
the format set out in Part C.  
5.2.  The submitter shall print or affix the UFI on the label or packaging of a hazardous 
mixture supplied for consumer and/or professional use. The UFI shall be preceded by 
the acronym "UFI" in capital letters and it shall be clearly visible, legible and indelibly 
marked.  
5.3. In the case of a limited submission referred to in section 2.4, the UFI shall be indicated 
only in the Safety Data Sheet.  
6. Formats and t echnical support for submission of information  
6.1. The Agency shall specify, maintain and update the UFI generator, the XML formats 
for submissions and a harmonised product categorisation system and make them 
available free of charge on its website.  
6.2. The Agency shall provide technical and scientific guidance, technical support and 
tools facilitating the submission of information.  
 
PART B  
INFORMATION CONTAINE D IN A SUBMISSION  
1.  Identification of the mixture and of the submitter  
1.1. Product identifier of the mixture  
The product identifier shall be provided in accordance with Article 17(2) and Article  
18(3).  
The complete trade name or names of the mixture shall be provided, including, where 
relevant, brand name, name of the product and variant  names as they appear on the 
label, without abbreviations and enabling its specific identification.  
In addition, the UFI(s) shall be included in the submission.   
EN 5   EN 1.1.1. Group submission  
In the case of a group submission, all product identifiers for the re levant mixtures shall 
be provided according to the criteria listed in section 1.1.  
 
1.2. Details of the submitter   
 
The name, full address, telephone number, VAT number and e -mail address of the 
submitter shall be provided. This information shall be consistent with the data 
provided on the label in accordance with  Article 17(1)(a).  
 
1.3. Telephone number for rapid acce ss to additional product information  
In the case of a limited submission as laid down in section 2.4 of Part A, a telephone 
number for rapid access to additional detailed product information services shall be 
provided. It shall consist of a telephone numb er accessible 24 hours  per day, 7 days  
per week  at which rapid access to detailed additional product information is available 
for appointed bodies during emergencies.  
2. Hazards identification and additional information  
This section sets out the health and physical hazards of the mixture and the appropriate 
warning information associated with those hazards, as well as the additional 
information to be included in a submission.  
2.1. Classification of the mixture  
The classification of the mixture for health  and physical hazards (hazard class and 
category) shall be provided  in accordance with the classification rules in Annex I .  
2.2. Label elements  
At least the following labelling elements required in accordance with Article 17 shall 
be provided:  
– hazard pic tograms;  
– signal words;  
– hazard statements (including supplemental hazard information);  
– precautionary statements.  
2.3. Toxicological information  
The submission shall include the information on the toxicological effects of the 
mixture or its components co ntained in Section 11 of the Safety Data Sheet of the 
mixture, in accordance with  Annex II to Regulation (EC) No 1907/2006.  
2.4. Additional information   
EN 6   EN The following additional information shall be provided:  
– the type(s) and size(s) of the packaging used to place the mixture on the market 
for consumer or professional use;  
– the colour and the physical state of the mixture, as supplied;  
– the pH of the mixture (where applicable the pH shall be indicated for an 
aqueous solution of the mixture ; in that case the concentration shall be 
expressed in % w/w);  
– product categorisation (see section 3.4 of Part A);  
– use (consumer, professional, industrial).  
3.  Information on mixture components  
3.1.  General requirements  
The chemical identity and the concentrations of the components contained in the 
mixture shall be indicated in the submission in accordance with  sections 3.2, 3.3 and 
3.4.  
3.1.1.  Requirements for mixtures for industrial use  
In the case of a limited submission as laid down in section 2.4 of Part A, the 
information to be submitted on the composition of a mixture for industrial use may be 
limited to the information contained in the Safety Data Sheet in accordance with  
Annex II to Regulation (EC) No  1907/2006, provided that additional inform ation on 
the components is rapidly available on request in emergencies in accordance with  
section 1.3.  
3.2. Mixture components: product identifier  
3.2.  Substances  
The product identifier for the substances identified according to section 3.3 shall be 
provided in accordance with Article 17(2) and Article 18(2).  
By derogation from the first paragraph,  the generic product identifiers ‘perfumes’, 
‘fragrances’ or ‘colouring agents’ may be used for mixture components where 
applicable, where the following conditions are met :  
– the mixture components are not classified for health hazards of major concern 
as defined in Section 3.4.1. ;  
– to the extent that the concentration of mixture components identified with a 
given generic product identifier does not exceed 10 % of the mixture in total.  
The chemical name of substances for which an alternative chemical name has been 
allowed in accordance with Article 24 shall be provided as well.  
3.2.1. Mixture in mixture   
EN 7   EN When a mixture is used in the composition of a second m ixture placed on the market, 
the first mixture is referred to as a mixture in mixture (hereinafter MIM).  
Information on the composition of substances contained in a MIM shall be provided in 
accordance with the criteria of this Section, unless the submitter does not have access 
to information on its full composition. In the latter case, information in accordan ce 
with Section 3 on known mixture components shall be provided and the MIM shall be 
identified by means of its product identifier in accordance with Article 18(3), together 
with its concentration and UFI, when available; the name, e -mail address and 
telep hone number of the MIM supplier shall also be provided.  
3.3. Mixture components subject to submission requirements   
The following mixture components (substances and MIM) shall be indicated:  
(1) Mixture components classified as hazardous  on the basis of their health or 
physical effects which : 
– are present in concentrat ions equal or higher than 0.1%;  
– are identified, even if in concentrations lower than 0.1% ; 
(2) Mixture components not classified as hazardous  on the basis of their health or 
physical effects  which are identified and present in concentrations equal to or 
greater than 1%.  
3.4. Concentration and concentration ranges of the mixture components  
Submitters shall provide the following information with regard to the concentration of 
the mixture components (subst ances and MIM), identified in accordance with  section 
3.3.  
3.4.1.  Hazardous components of major concern for emergency health response  
When mixture components are classified in accordance with  this Regulation for at 
least one of the hazard categories liste d below, their concentration in a mixture shall 
be expressed as exact percentage, in descending order by mass or volume:  
– Acute toxicity, Category 1, 2 or 3;  
– Specific target organ toxicity - Single exposure, Category 1 or 2;  
– Specific target organ toxicity - Repeated exposure, Category 1 or 2;  
– Skin corrosion, category 1, 1A, 1B or 1C;  
– Serious eye damage, Category 1.  
As an alternative to providing concentrations as exact percentages, a range of 
percentages may be submitted in accordance with Table 1.  
 
Table 1   
EN 8   EN Concentration ranges applicable to  hazardous components of major concern for 
emergency health response (substances or MIM)  
 
Concentration range of the 
hazardous component contained in 
the mixture (%)  Maximum width of the 
concentration range to be used 
in the submission  
≥ 25 - < 100  5 % units  
≥ 10 - < 25 3 % units  
≥ 1 - < 10 1 % units  
≥ 0.1 - < 1 0.3 % units  
>0 - < 0.1  0.1 % units  
 
3.4.2.  Other hazardous components  and non -hazardous components  
The concentration of the hazardous components  in a mixture not included in section 
3.4.1. and of the identified non -hazardous components present at 1  % or above shall be 
expressed, in accordance with Table 2, as ranges of percentages in descending order 
by mass or volume. As an alternative, exact per centages may be provided.  
 
Table 2  
Concentration ranges applicable to  other hazardous components and  
non-hazardous components (substances or mixtures in mixture MIM)  
 
Concentration range of the 
component contained in the mixture 
(%) Maximum width of the 
concentration range to be used 
in the submission  
≥ 25 - < 100  20 % units  
≥ 10 - < 25 10 % units  
≥ 1 - < 10 3 % units  
>0 - < 1 1 % units  
 
3.5. Classification of mixture components (substances and MIM)  
The classification of mixture components for health and physical hazards (hazard 
classes, hazard categories and hazard statements) shall be provided. This includes  the 
classification for at least all substances referred to in Point 3.2.1 of Annex II to 
Regulation (EC) No 1907/2006 on requirements of the compilation of Safety Data 
Sheet. Alternatively, in the case of a MIM, only its classification may be provided.  
 
4.  Submission update   
EN 9   EN 4.1. Where one of the following changes applies to a mixture, submitters shall provide a 
submission update before placing that mixture, as changed, on the market:  
– when the mixture product identifier (including the UFI) or the mixture 
classification for health and physical hazards has been changed;  
– when new toxicologi cal information contained in Section 11 of the Safety Data 
Sheet becomes available on the hazardous properties of the mixture or its 
components;  
– if a change in the composition of substances in the mixture fulfils one of the 
following conditions:  
(a) addition, substitution, or deletion of one or more components in the 
mixture that shall be indicated in accordance with  Section 3.3;  
(b) change in the concentration of a component in the mixture beyond 
the concentration range provided in the original submission;  
(c) when th e exact concentration of a component was provided, in 
accordance with  section 3.4.1., and a change occurs to that 
concentration beyond the limits identified with Table 3.  
 
 
Table 3  
Variations of the concentration of components requiring a submission updat e 
 
Initial concentration range of the 
component  contained in the mixture 
(%) Variations (±) of the initial 
substance concentration 
requiring a submission update  
> 25 - ≤ 100  5 %  
> 10 - ≤ 25 10 %  
> 2.5 - ≤ 10 20 %  
≤ 2.5  30 %  
 
4.2. Content of the submission update  
The submission update shall consist in a revised version of the previous submission 
containing the new information available as described in Section 4.1  
   
EN 10   EN  
PART C  
SUBMISSION FORMAT  
1.1. Submission  Format  
The submission of information to  appointed bodies in accordance with Article 45 shall be in a 
format to be provided by the Agency. If required in accordance with this Annex it shall 
include the following data:  
1.2. Identification of the mixture and of the submitter  
Product identifier  
– Com plete trade name of the product (in case of group submission, all product 
identifiers shall be listed)  
– Other names, synonyms  
– Unique Formula Identifier (UFI)  
– Others identifiers (registration number, authorisation number, company 
product codes)  
 
Contact details of the submitter  
– Name  
– Address (street, city, postal code, country)  
– Telephone number  
– E-mail 
– VAT number  
 
Contact details for rapid access to additional product information (24 hours/7 days). Only for 
limited submission.  
– Name  
– Telephone number (24 hours per day, 7 days per week)  
 
1.3. Classification of the mixture, label elements and toxicology  
Classification of the mixture and label elements  
– Hazard class and category  
– Hazard pictograms code (Annex V)  
– Signal word  
– Hazard statement code (Annex III incl uding supplemental hazard information)   
EN 11   EN – Precautionary statement code (Annex IV)  
 
Toxicological information  
– Description of the toxicity of the mixture or its components (as specified in 
Section 11 of the Safety Data Sheet in accord ance with  Annex II to Regul ation 
No 1907/2006  
 
Additional Information on the mixture  
– Colour  
– pH 
– Physical state  
– Packaging (type and size)  
– Intended use (Product categorisation Code)  
– Uses identification (indicate all uses: consumer, professional or industrial)  
 
1.4 Product identifiers of the mixture components  
Product identifiers of the mixture components (substances and mixtures in mixtures where  
applicable)  
– Chemical name of the components  
– CAS number ( where  applicable)  
– EC number ( where  applicable)  
– UFI ( where  applicable)  
– Exact concentration or maximum/minimum concentration  
– Hazard classification ( where  applicable)  
– Additional identifiers  (where applicable and relevant for health response) '