Guidance on harmonised information relating to emergency health response . Annex VIII to CLP.
Date: 2025-10-31
Institutions: European Chemicals Agency
Subjects: chemical industry, chemical product, chemicals legislation, classification, dangerous substance, environmental protection, labelling, packaging, public health, user guide

G U I D A N C E  

Guidance on harmonised information 
relating to emergency health response – 
Annex VIII to CLP 

Guidance to Regulation (EC) No 1272/2008 on classification, labelling 
and packaging (CLP) of substances and mixtures 

Version 6.0  
October 2025 

 
 
 
 
 
 
1 

LEGAL NOTICE 

This document aims to assist users in complying with their obligations under the CLP 
Regulation. However, users are reminded that the text of the CLP Regulation is the only 
authentic legal reference and that the information in this document does not constitute legal 
advice. Usage of the information remains under the sole responsibility of the user. The 
European Chemicals Agency does not accept any liability with regard to the use that may be 
made of the information contained in this document. 

Guidance on harmonised information relating to emergency health response – Annex 
VIII to CLP 

Reference: ECHA-25-H-01-EN 
Cat. Number: ED-01-25-024-EN-N 
ISBN: 978-92-9468-512-4 
DOI: 10.2823/0316986 
Publ.date:  October 2025 
Language:  EN 

© European Chemicals Agency, 2025 

If you have questions or comments in relation to this document please send them (quote the 
reference and issue date) using the information request form. The information request form 
can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Telakkakatu 6, Helsinki, Finland 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DOCUMENT HISTORY 

Version 

Comment 
New text added to clarify new provisions in the 
CLP Regulation. Text improvements, clarifications 
and removal of redundant or repeated information 
were also made throughout the document. More 
specifically: 

Date 

Version 6  

The Note to reader removed as the reference was 
to distributors obligations under Article 4(10) 

Section 1 Introduction: Changes to accommodate 
new provisions and passing of transitional and 
compliance dates. 

Section 2 Abbreviations/definitions updated 

Section 3 Obligations: Removal and restructuring 
of sections and redundant text, including, 
references to Article 4(10) reduced and 
acknowledgement of differences of interpretation 
of distributors by different MS inserted as a 
footnote. Updated text on distribution activities 
and example 6 improved. Table 1 updated and 
refers to enhanced alignment with text. 
Clarification on mixtures for scientific research 
and development, voluntary submissions. 
Changes to end use/use types section as it was 
linked with compliance dates. Compliance dates 
and transitional period information heavily 
reduced following the passing of all dates. 
Removal of text regarding obligations for 
distributors following the transitional period and 
the update of ECHA FAQ 1727. Figure 1 and 2 
removed as compliance dates not relevant and is 
self-evident from the text. New section 3.1.1.6 
‘Non-EU supply via distance or online sales’ 

Section 4 General submission requirements: 
Changes to UFI chapters to improve readability 
and clarity, update the text on UFI display and 
placement according to changes in the CLP 
Guidance.  

Section 5 Information contained in the 
submission: Product identifiers section updated to 
reflect latest interpretation. Improved readability 
for GCIs. Updated information for Standard 
Formulas resulting from the updated definition, 
plus general improvements on readability. Section 
5.3.3.2 created to clarify identification of MiM 
components and removal of outdated text 
following the end of transition period. 

Section 6 Preparation and submission of 
information: Updated the language used 

Section 7 Post-submission: Updated the update 
reasons stemming from changes in the legal text 

Section 8 Support – Updated the section for 
relevancy 

October 2025 

 
 
 
 
 
 
 
 
 
Guidance on harmonised information relating to emergency health response  
Version 6.0 – October 2025 

3 

Version 

Comment 

Date 

Update via fast-track procedure to further 
clarify and complete existing interpretations 
or make corrections following practical 
implementation and release of new features 
in the submission portal. In particular: 

- Clarified in sections 3.1.1.1 and 4.2.5 
obligations and options for importers and 
non-EU suppliers. 

- Clarified in sections 3.1.1.2 and 4.2.4 
obligations and options in case of toll 
formulation. 

- Revised in section 3.5.2 interpretation of 
obligations during the transitional period to 
align with revised ECHA Q&A; clarification of 
obligations in case of Annex VIII notification 
made before relevant compliance date. 

- Removal in section 4.2.3.1 of information 
on MiM’s identification which is to be 
provided in section 5.3.3. Example moved to 
section 5.3.3. 

- Clarified in section 4.2.7 obligations to 
change UFI in case of GCIs. 

- Clarified in section 5.3.3 use of GCIs; 
example 21 revised. 

- Addition in section 5.5 of new footnote to 
address grouping of fully known MiMs in 
ICGs; addition of clarification about 
maximum concentration of a ICG in final 
mixture. 

- Addition in section 7.4.2 of reference to 
changes in mixture resulting in mixture being 
non-classified. 

- Clarified in section 7.4.5 obligations in case 
of splitting existing GCIs. 

- Clarified in section 7.4.6 update rules in 
case of group submissions. 

- Other minor corrections and clarifications 
throughout the document. 

Update to implement the amendment of the 
legal text due to Commission Delegated 
Regulation 2020/1677 and Commission 
Delegated Regulation 2020/1676 of 31 
August 2020 (the “workability 
amendments”). In particular: 

- Added in section 3.1.1.4 reference to 
articles with integral substance or mixture 
intended to be released. 

- Added in section 3.3 clarification about the 

April 2022 

March 2021 

Version 5.0 

Version 4.0 

 
Version 

Comment 

Date 

borderline between mixture and substance. 

- Added new section 3.3.1.3.1 to address the 
exemption for bespoke paints. 

- Added in section 3.4 a clarification about 
mixture with end use not subject to 
notification requirements. 

- Added in section 4.1 an introduction on the 
new workability solutions. 

- Added in section 4.2.1 a clarification of the 
UFI concept applied to Interchangeable 
Component Groups, Standard Formulas and 
Fuels. 

- Added in section 4.2.7 clarification about 
the need to update the UFI in the case of 
notifications concerning Standard Formulas, 
fuels or containing Interchangeable 
Component Groups. 

- Added new section 4.2.8.3 to provide 
details on the labelling requirements for 
bespoke paints. 

- Added in section 5.3.1 clarification about 
the extended exemption to the obligation not 
to notify components which are not present. 

- Added in section 5.3.2 a recommendation 
to report the presence of microorganisms in 
the mixture when relevant. 

- Clarified in section 5.3.3 the identification 
requirements for mixtures in mixture. 

- Added new section 5.5 on the 
Interchangeable Component Group solution. 

- Added new section 5.6 on the special 
provisions for ready-mixed concrete, gypsum 
and cement products (Standard Formulas 
solution). 

- Added new section 5.7 on the special 
provisions for certain fuels. 

- Added in section 7.3.1 clarification about 
security of submitted information. 

- Added new section 7.4.2.3 clarification 
about update rules applying to submissions 
made referring to Standard Formulas. 

- Added new section 7.4.2.4 clarification 
about update rules applying to submissions 
for fuels made referring to the safety data 
sheet. 

- Other editorial changes and typos 
corrected. 

Guidance on harmonised information relating to emergency health response  
Version 6.0 – October 2025 

5 

Version 

Comment 

Date 

Update to implement the amendment of the 
legal text due to Commission Delegated 
Regulation 2020/11 of 29 October 2019. In 
particular: 

- Removed reference to Generic Product 
Identifier “Fragrances” throughout the 
document. 

- Added in section 3.1.1 new subsection on 
import/manufacturing of combination of 
mixture and article. 

- Added example 11 in section 4.2.3. In 
addition, clarified labelling and SDS 
requirements in the case of multiple UFIs in 
the notes to the examples. 

- Amended section 4.2.8 on labelling 
requirements and UFI placement and aligned 
with Guidance on Labelling and Packaging. 

- Clarified in section 4.2.8.2 that exemption 
to labelling requirements applies to mixture 
used at industrial site. 

- Added contact point in section 5.1.2, in 
addition to submitter details. 

- Clarified and further developed pH 
requirements in section 5.2.3. 

- Amended section 5.3.3 with regard to 
requirements for identification of MiMs when 
composition is not fully known. Clarified that 
for MiM not requiring an SDS, the 
compositional information is not mandatory. 

- Editorial changes and typos corrected.   

In addition, removal of Portugal from the list 
of countries mentioned in the Note to the 
reader. 

Update via fast-track procedure to complete 
section 3 on duty holders. Details about 
obligations related to distribution steps have 
been added. In particular: 

- Modified introductory section 3.1 to clarify 
the activities leading to submission 
obligations for downstream users and 
importers under Article 45 and certain 
distributors under Article 4(10). 

- Modified example 4 (section 3.1.1) to 
include the scenario where the distributor 
makes the submission. 

- Restructured sections 3.1.1 and 3.1.2 to 
present separately activities leading to 

May 2020 

July 2019 

Version 3.0 

Version 2.0 

 
Version 

Comment 

Date 

obligations under Art.45 and Art.4(10). 

- Moved example 6 to section 3.1.2 and new 
figure added. 

- Updated table 1 to include obligations for 
distributors. Removed column on 
“Obligations along the supply chain”. 

In addition: 

- Revised section 6.3 to reflect the updated 
terminology referring to the submission tool 
provided by ECHA. 

- Revised section 6.4 to reflect the updated 
list of features provided by the ECHA 
submission tool. 

- Replacement of “deadline” by “date of 
applicability” with reference to the timeline 
to meet the obligations. 

- Updated the additional support section. 

- Editorial changes and typos corrected. 

Version 1.0 

First edition 

February 2019 

 
 
 
Guidance on harmonised information relating to emergency health response  
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PREFACE 

This document is the Guidance on the harmonised information relating to emergency health 
response. It is a comprehensive technical and scientific document on the implementation of 
Article 45 and Annex VIII to Regulation (EC) No 1272/2008 on the classification, labelling and 
packaging of substances and mixtures1 (CLP), as amended. CLP is based on the Globally 
Harmonised System of Classification and Labelling of Chemicals (GHS) and is implementing the 
provisions of the GHS within the EU. CLP now has relevance for European Economic Area (EEA) 
countries (i.e. it is implemented in the EU countries and in Norway, Iceland and 
Liechtenstein)2. 

The objective of this document is to provide detailed guidance on the obligation to submit to 
Member State’s responsible bodies relevant information on hazardous mixtures placed on the 
market for formulating preventative and curative measures in case of accidents. The guidance 
is developed to primarily assist companies placing hazardous mixtures on the market in 
complying with their obligations. It is also intended to be a support tool for the appointed 
bodies in the Member States. 

The first version of this guidance document was developed by ECHA with the support of a 
dedicated Working Group consisting of experts from Industry, Member State appointed bodies 
and poison centres and published in 2019. The document was further updated, in cooperation 
with the same ECHA partners, in 2020, 2021, and 2022. This current version 6.0 reflects the 
end of the transitional period (31 December 2024) and changes to the CLP Regulation 
introduced by Regulation (EU) 2024/2865.   

1 Regulation (EC) No 1272/2008 of the European Parliament and Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 [OJ L 353, 31.12.2008, p. 1]. 

2 CLP was incorporated in the EEA Agreement by Decision of the EEA Joint Committee No 106/2012 of 15 
June 2012 amending Annex II (Technical regulations, standards, testing and certification) to the EEA 
Agreement (OJ L 270, 4.10.2012, p. 6–28). 

 
 
 
 
 
 
 
Table of Contents 

PREFACE ................................................................................................................. 7 

1. INTRODUCTION .................................................................................................. 13 

1.1 General introduction ........................................................................................... 13 
1.2 Legal background ............................................................................................... 13 
1.3 Aim of this guidance ........................................................................................... 14 
1.4 Target audience of this guidance .......................................................................... 15 
1.5 Overview of the document ................................................................................... 15 
1.6 Links to legislation other than CLP ........................................................................ 16 

1.6.1 REACH Regulation ........................................................................................................ 16 
1.6.2 Other legislation ........................................................................................................... 16 
1.6.3 National legislation ....................................................................................................... 17 

2. ABBREVIATIONS/DEFINITIONS ......................................................................... 18 

3. OBLIGATIONS ..................................................................................................... 20 

3.1 Who is required to submit information? ................................................................. 20 

3.1.1 Activities leading to submission obligations according to Article 45 ..................................... 21 
3.1.1.1 Import activities ............................................................................................................................. 21 
3.1.1.2 Formulation activities ...................................................................................................................... 22 
3.1.1.3 Repackaging/refilling activities ......................................................................................................... 24 
3.1.1.4 Distribution activities ...................................................................................................................... 25 
3.1.1.5 Import/manufacture of combination of mixture and article .................................................................. 28 
3.1.1.6 Non-EU supply via distance or online sales ........................................................................................ 28 

3.2 Who receives the information? ............................................................................. 32 

3.2.1 Member States’ appointed bodies ................................................................................... 32 

3.3 What is the scope of Article 45? ............................................................................ 32 

3.3.1 Which mixtures require information to be submitted? ....................................................... 33 
3.3.1.1 General exemption from CLP Regulation ............................................................................................ 33 
3.3.1.2 Exemptions from Article 45 .............................................................................................................. 33 
3.3.1.3 Exemptions from the obligation to submit information under Annex VIII................................................ 34 
3.3.1.4 Special rules for bespoke paints ....................................................................................................... 34 
3.3.1.5 Submission of information made voluntarily ....................................................................................... 35 

3.4 Use types of mixtures ......................................................................................... 36 

3.4.1 Mixtures with an end-use not subject to notification.......................................................... 36 

3.5 Timelines ........................................................................................................... 37 

3.5.1 Compliance dates ......................................................................................................... 37 
3.5.2 End of transitional period for mixtures already notified ...................................................... 37 

4. GENERAL SUBMISSION REQUIREMENTS ............................................................. 37 

4.1 Overview for duty holders .................................................................................... 37 

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4.1.1 Supporting poison centres ............................................................................................. 39 

4.2 The UFI for mixtures and products ........................................................................ 39 

4.2.1 What is a UFI? ............................................................................................................. 39 
4.2.1.1 The relationship between a UFI and a mixture composition .................................................................. 40 

4.2.2 Generation of UFIs ....................................................................................................... 40 
4.2.3 UFI management ......................................................................................................... 41 
4.2.4 Working with “the one UFI, one composition” principle ...................................................... 41 
4.2.4.1 UFI and mixtures in a mixture .......................................................................................................... 44 
4.2.4.2 Use of the UFI along supply chain ..................................................................................................... 45 
4.2.4.3 Use of the UFI when the legal entity changes ..................................................................................... 45 

4.2.5 Toll formulator and UFIs ................................................................................................ 45 
4.2.6 UFI and the EU importer/non-EU supplier ........................................................................ 46 
4.2.7 New UFI as a result of composition changes .................................................................... 48 
4.2.7.1 Changes in MiM’s UFI ...................................................................................................................... 50 

4.2.8 Display, position and placement of UFI ............................................................................ 50 
4.2.8.1 UFI and multi-mixture / multi-component products ............................................................................. 53 
4.2.8.2 Exemption from labelling requirements [A.5.3] .................................................................................. 53 
4.2.8.3 Special labelling requirements for bespoke paints [Article 25(8)] .......................................................... 54 

4.3 EuPCS ............................................................................................................... 54 
4.4 Limited submission ............................................................................................. 55 

4.4.1 Contacts for rapid access to ‘additional detailed product information’ .................................. 56 
4.4.2 Availability and content of the additional information and rapid access ................................ 56 

4.5 Group submission ............................................................................................... 57 

5. INFORMATION CONTAINED IN THE SUBMISSION .............................................. 57 

5.1 Identification of mixture and submitter [Part B.1] ................................................... 57 

5.1.1 Product identifiers of the mixture [B.1.1] ........................................................................ 57 
5.1.2 Submitter details and contact point [B.1.2] ..................................................................... 58 
5.1.3 Details for rapid access to additional product information [B.1.3] ....................................... 58 

5.2 Hazard identification and additional information [Part B.2] ....................................... 58 

5.2.1 Classification of the mixture and label elements [B.2.1 and B.2.2] ...................................... 58 
5.2.2 Toxicological information [B.2.3] .................................................................................... 59 
5.2.3 Additional information [B.2.4] ........................................................................................ 60 

5.3 Information on mixture components [Part B.3]....................................................... 61 

5.3.1 General requirements [B.3.1] ........................................................................................ 62 
5.3.2 Components subject to submission requirements [B.3.3] .................................................. 62 
5.3.3 Information required on components .............................................................................. 63 
5.3.3.1 Identification of the substance components [B.3.2.1] .......................................................................... 63 
5.3.3.2 Identification of the mixture in mixture components [B.3.2.2] .............................................................. 64 
5.3.3.2.1 Identification of non-hazardous MiMs ................................................................................................ 65 
5.3.3.2.2 Generic component identifiers .......................................................................................................... 66 
5.3.3.3 Concentration and concentration ranges of the mixture components [B.3.4] .......................................... 67 
5.3.3.4 Classification of mixture components [B.3.8] ..................................................................................... 69 
5.3.3.4.1 Classification of GCIs ...................................................................................................................... 70 

 
5.3.4 Limited submission [B.3.1.1] ......................................................................................... 73 

5.4 Group submission [A.4] ....................................................................................... 73 

5.4.1 Information to be provided in a group submission ............................................................ 74 
5.4.2 Mixture components in a group submission ...................................................................... 75 

5.5 Interchangeable component group (ICG) [B.3.5] .................................................... 79 

5.5.1 Grouping of components ............................................................................................... 79 
5.5.2 Conditions for grouping components in an ICG ................................................................. 80 
5.5.2.1 General rules for grouping components ............................................................................................. 80 
5.5.2.2 Alternative rules for grouping components with specific hazard classifications ........................................ 81 

5.5.3 Information requirements .............................................................................................. 82 
5.5.3.1 Identification ................................................................................................................................. 82 
5.5.3.2 Concentration ................................................................................................................................ 82 
5.5.3.3 Classification .................................................................................................................................. 83 

5.5.4 Examples .................................................................................................................... 83 

5.6 Special provisions for ready-mixed concrete, gypsum and cement products: Standard 

Formulas [B.3.6] .............................................................................................. 89 

5.6.1 Standard Formulas ....................................................................................................... 89 
5.6.2 Using Standard Formulas: whole mixture composition vs part of the mixture composition 

(substances or MiMs) ............................................................................................... 90 
5.6.3 Standard Formulas vs SDS information ........................................................................... 91 
5.6.4 Examples .................................................................................................................... 92 

5.7 Special provisions for fuels conforming with standards or technical specifications [B.3.7]

...................................................................................................................... 94 

5.7.1 Definition of fuels ......................................................................................................... 94 
5.7.2 Information requirements on composition ....................................................................... 96 

6. PREPARATION AND SUBMISSION OF INFORMATION: AVAILABLE TOOLS .......... 100 

6.1 UFI generator .................................................................................................... 100 
6.2 Extensible markup language (XML) format ............................................................. 100 
6.3 Tools for preparing IUCLID files ............................................................................ 100 
6.4 Submission of information ................................................................................... 101 

6.4.1 Validation of information ............................................................................................... 101 

6.5 Fees.................................................................................................................. 102 

7. POST-SUBMISSION ............................................................................................. 102 

7.1 General introduction ........................................................................................... 102 
7.2 Additional requests by appointed bodies ................................................................ 102 
7.3 Use of submitted information ............................................................................... 103 

7.3.1 Security and confidentiality of the submitted information .................................................. 103 

7.4 Keeping information up to date ............................................................................ 104 

7.4.1 Introduction................................................................................................................. 104 
7.4.2 Update rules according to Annex VIII .............................................................................. 104 
7.4.2.1 When declaring concentration ranges ................................................................................................ 105 
7.4.2.2 When declaring exact concentrations ................................................................................................ 106 

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7.4.2.3 When referring to a Standard Formula included in Part D ..................................................................... 107 
7.4.2.4 When referring to a fuel included in Part B, Section 3.7 of Annex VIII ................................................... 107 

7.4.3 Updates for other changes relevant for an emergency health response ............................... 108 
7.4.4 How updates are technically handled .............................................................................. 108 
7.4.5 Updates – special cases with generic component identifiers ............................................... 111 
7.4.6 Updates – special cases with group submissions ............................................................... 112 

7.5  Validity of the submission .................................................................................. 114 

8. ADDITIONAL SUPPORT ....................................................................................... 115 

Table of Tables 

Table 1: Overview of operators and activities triggering (or not triggering) obligations to comply with 
Article 45 ................................................................................................................................... 29 

Table 2: Concentration ranges applicable to hazardous components of major concern for emergency 
health response - Table 1 in Part B of Annex VIII ............................................................................ 68 

Table 3: Concentration ranges applicable to other hazardous components and components not classified 
as hazardous – Table 2 in Part B of Annex VIII ............................................................................... 69 
Table 4: List of fuels - Table 3, Part B of Annex VIII ........................................................................ 95 

Table 5: Variations of the concentration of components requiring a submission update (Table 4 of Annex 
VIII) ....................................................................................................................................... 106 

Table 6: Examples of possible changes requiring an update and their related scenarios. Error! Bookmark 
not defined. 

Table of Examples 

Example 1: An EU company importing from outside the EU, and placing on the market in one EU country
 ................................................................................................................................................ 21 
Example 2: An EU company importing from outside the EU, and placing on several EU markets .......... 21 
Example 3: Mixture placed on the market in several Member States ................................................ 23 
Example 4: Formulation, mixture to be placed on the market outside EU ......................................... 24 
Example 5: Submission made by a rebranding company ................................................................ 26 

Example 6: Formulation, mixture placed on the market in several Member States – options for the 
retailer. ..................................................................................................................................... 27 
Example 7: One mixture composition: 1 UFI -> 1 product "SuperClean" placed on the market ........... 42 

Example 8: One mixture composition: 2 or more UFIs –> 2 or more products placed on the market with 
same composition ....................................................................................................................... 42 
Example 9: One mixture composition: 1 UFI –> 3 products placed on the market ............................. 42 
Example 10: One mixture composition: 2 or more UFI –> 1 product placed on the market ................ 42 
Example 11: One mixture composition: 2 or more UFIs –> 2 products placed on the market .............. 43 

Example 12: Three similar mixtures (1 Group submission) - one UFI, one or more products placed on 
the market ................................................................................................................................. 43 

Example 13: Three similar mixtures (1 Group submission) – several UFIs, one or more products placed 
on the market. ........................................................................................................................... 44 

Example 14: 1 Mixture (with 1 MiM identified via its UFI) - 1 UFI for the mixture – 1 product placed on 
the market ................................................................................................................................. 44 

 
 
 
 
Example 15: 1 Mixture by a toll formulator - 1 or more UFIs for the composition – a third company 
places on the market/rebrands – Original UFI or new UFI ................................................................ 46 

Example 16: Import into the EU.  Non-EU supplier acting via EU-based legal entity to protect 
confidential business information .................................................................................................. 47 

Example 17: 1 Mixture (with 2 MiMs, the first identified via its UFI, the second via its SDS) - 1 UFI for 
the mixture + SDS MiM – 1 product placed on the market ............................................................... 65 
Example 18: Aggregation of components from different sources ..................................................... 65 
Example 19: Concentration ranges for components of “major” concern ............................................ 68 
Example 20: Concentration ranges for components not of “major” concern ...................................... 69 
Example 21: Use of generic component identifiers (single mixture) ................................................. 70 
Example 22: Use of generic component identifiers (mixtures varying in colourants only) ................... 71 
Example 23: Grouping of mixtures with difference in perfume components ...................................... 76 
Example 24: Grouping of mixtures with difference in perfume components ...................................... 78 
Example 25: Grouping interchangeable components having the same technical function .................... 83 
Example 26: Grouping components in different ICGs according to the technical function .................... 84 
Example 27: Grouping components having different technical functions ........................................... 85 
Example 28: Grouping components having different technical function in different ICGs .................... 87 
Example 29: Final mixture fully conforms with a Standard Formula ................................................. 92 

Example 30: The final mixture includes all the components included in the Standard Formula plus 
additional components ................................................................................................................ 92 
Example 31: Submission of information for a fuel product listed in Table 3 of Annex VIII ................... 96 
Example 32: Mixture components with classification of major concern ........................................... 105 
Example 33: Mixture submitted with exact concentrations of components ...................................... 106 

Example 34: Changes in a group submission for two mixtures with a difference in perfume components, 
submitted to an appointed body. ................................................................................................ 112 

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1. Introduction 

1.1 General introduction  

A large number of chemical products (e.g. detergents, paints, adhesives) are placed on the EU 
market and used both by the general public in their everyday lives as well as by professionals 
in their working environments. 

Chemical products are in general considered to be safe when their use instructions are 
followed. Nevertheless, unintentional exposure to chemicals can occur, for example due to 
inappropriate use or accidents. When this happens, immediate access to relevant information 
on the chemical product is crucial for medical staff and those who provide emergency 
responses. 

1.2 Legal background 

In 1988, Council Directive 88/379/EEC3 required the Member States to appoint a body 
responsible for receiving information, including chemical composition, relating to preparations 
placed on the market and considered dangerous. This information was to be used to meet any 
medical demand by formulating preventative and curative measures, in particular in 
emergencies. In 1999, the Directive was repealed by Directive 1999/45/EC4, which provided 
for a similar obligation. 

Therefore, many Member States already had in place a system for collecting information from 
companies that were placing dangerous mixtures on the market and have established bodies, 
called poison centres, to provide medical advice in health emergencies. The information 
collected has been used to meet medical demands of the poison centres. Depending on the 
Member State, physicians and other medical staff, workers and the general public were also 
able to contact the poison centres to receive advice on medical treatment in the event of a 
poisoning or accidental exposure incident. 

The existing requirement for the EU Member States5 to appoint a body for receiving this 
information, was incorporated in Article 45 of the CLP Regulation ((EC) No 1272/2008) which 
entered into force on 20 January 2009, repealing Directive 1999/45/EC. 

Under the previous legislative regime and under the CLP, the absence of harmonised 
information requirements led to considerable variation in the existing national notification 
systems, data formats and information requirements. Thus, companies placing mixtures on the 
market in different Member States needed to submit similar information multiple times and in 
different formats. This diversity led to inconsistencies in the information available to medical 
personnel in cases of poisoning or accidental exposure incidents in different Member States. 

Commission Regulation (EU) 2017/542 introduced Annex VIII to CLP, which entered into force 
on 12 April 2017. The Annex has been amended by Commission Delegated Regulations (EU) 

3 Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to the classification, packaging and labelling of 
dangerous preparations. 
4  Directive  1999/45/EC  of  the  European  Parliament  and  of  the  Council  of  31  May  1999  concerning  the 
approximation of the laws, regulations and administrative provisions of the Member States relating to the 
classification, packaging and labelling of dangerous preparations. 
5 Any reference to the Union (EU) in this document, also covers the EEA countries Iceland, Liechtenstein 
and Norway. See footnote 2. 

 
 
 
 
 
2020/116, (EU) 2020/1677 and (EU) 2020/16767, and by Regulation (EU) 2024/2865 of the 
European Parliament and of the Council of 23 October 2024, which also introduced relevant 
changes to Article 45. The provisions of the Annex started to apply to mixtures for consumer 
use and to mixtures for professional use from 1 January 2021, and to mixtures for industrial 
use from 1 January 2024.  

Annex VIII sets provisions to harmonise, in terms of format and content, the information 
relating to emergency health responses that companies placing hazardous mixtures, as 
specified in the CLP Regulation, on the EU market are required to submit to the bodies 
appointed by each Member State (i.e., the “appointed bodies”). The required information 
includes, among other things, the clear identification of the mixture and its intended use, the 
company responsible for the placing the mixture on the market8, information on the 
composition and hazardous ingredient substances. The information must be submitted by 
electronic means in a specified format, which enables the appointed bodies to easily retrieve 
the relevant information. A unique formula identifier (“UFI:” addressed in detail in section 4) 
will allow the poison centres to unambiguously identify the mixture and propose the 
appropriate medical treatment in the event of poisoning.  

The information required by Annex VIII is available for use by the poison centres, who have 
the task to provide medical advice to the public and medical practitioners in the event of an 
emergency. The information can, according to Article 45 CLP, also be used to carry out 
statistical analysis to improve risk management measures, where requested by the Member 
States, the Commission or ECHA (the allowed use of the submitted information is discussed in 
section 7). The appointed bodies and poison centres need to ensure the confidentiality of the 
information received (see section 3.2 for more details). The appointed body and the poison 
centre can be separate entities, although in some Member States they are the same.  

1.3 Aim of this guidance 

The aim of this guidance is to assist companies, appointed bodies and poison centres in the 
implementation of the tasks and requirements outlined in Article 45 and Annex VIII to CLP. 

This guidance provides information on:  

• 

the scope of Annex VIII to CLP, i.e. for which types of mixtures the required information 
has to be submitted;   

•  who should submit information in accordance with Annex VIII to CLP, and by when; 
• 
• 
• 
•  details of the information required to be submitted;  

issues to consider when preparing for a submission of information; 
the use of the “Unique Formula Identifier” (UFI); 
the use of the harmonised European Product Categorisation System (EuPCS); 

6 Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 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. 
7  Commission  Delegated  Regulation  (EU)  2020/1677  of  31  August  2020  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  relating  to 
emergency health response. Commission Delegated Regulation 2020/1676 of 31 August 2020 amending 
Article 25 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, 
labelling and packaging of substances and mixtures as regards bespoke paints.  
8 According to Article 2(18) of CLP “placing on the market means supplying or making available, whether 
in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the 
market.” 

  
 
 
 
 
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•  applicability of specific derogations from the standard information requirements; 
• 
•  what changes or new information triggers the need for an update. 

the use of the harmonised reporting format; 

1.4 Target audience of this guidance 

The main target audiences of this guidance are: 

• 

• 

companies placing certain hazardous mixtures on the EU market (i.e. those that are 
classified as hazardous based on their health or physical effects) and who are required 
to submit information relevant to poison centre activities. 

the Member States’ Competent Authorities and the appointed bodies who are 
responsible for receiving information on such hazardous mixtures which are being 
placed on the market. 

•  poison centres who are the end users of the submitted information for the purposes of 
formulating preventative and curative measures, when providing an immediate health 
response9. 

1.5 Overview of the document 

This Guidance document is structured to present, after a general introduction, the main 
concepts of making a poison centre notification and the framework for providing the required 
information. The main elements relevant to all the operators involved are then clarified before 
going into the details of the specific legal obligations. The obligations are then described by 
following the same section structure of Annex VIII. 

•  Section 1 presents the legal background, scope and target of this document in general 

terms. 

•  Section 2 provides a list of definitions and clarifies the main terms used throughout the 

Guidance. 

•  Section 3 provides relevant information for the reader to understand whether they have 

obligations according to Article 45 and Annex VIII of CLP. Therefore, section 3 clarifies 
who is required to submit information and which mixtures fall under the scope of Annex 
VIII or are exempted from the requirements laid down in that Annex.  

•  Section 4 presents the need to identify the mixture using a unique formula identifier, 

the harmonised European Product categorisation system (EuPCS) and the possibility to 
opt for a limited or a group submission. This section further explains the basic elements 
and options linked to the submission of information.  

•  Section 5 describes in detail the information to be submitted to the appointed body, as 
required in Annex VIII. Special provisions applying to certain situations or products are 
explained in the same section. 

•  Section 6 presents the available tools and the system put in place to allow industry and 

authorities to comply with the legal obligations. 

9 Poison centres do not exist in all Member States. Emergency service may be provided through different 
systems (see section 3.2.1 for further details). 

 
 
 
 
 
 
•  Section 7 explains what happens after the submission. This includes a description of the 
possible uses of the information submitted to the appointed bodies, the requirement 
that the submitter must keep the information up to date, and which changes trigger the 
obligation to update the submission. 

•  Section 8 lists the main available additional supporting tools. 

1.6 Links to legislation other than CLP 

There is a network of EU legislation which relies on CLP classification (a detailed list of 
concerned legislation is available in the Introductory Guidance on the CLP Regulation). 

1.6.1 REACH Regulation 

The provisions of Article 45 and Annex VIII to CLP are indirectly related to certain provisions of 
the REACH Regulation10. 

In particular, the safety data sheets (SDS), which are to be compiled following the 
requirements in Annex II to REACH.  While the preparation of an Article 45 submission relies 
on the same elements of an SDS, especially the composition of the mixture, it should be noted 
that some information needs to be present in both the SDS and in the Article 45 submission, 
and further, that the submitted information must be consistent with the SDS11.  

1.6.2 Other legislation 

The EU legislation for biocidal products, plant protection products, cosmetic products12 and 
tobacco products are examples of EU legislation with (additional) data submission 
requirements that are partially overlapping with the harmonised information required under 
Article 45 and as specified in Annex VIII. 

As part of the biocidal and plant protection products authorisation procedures (and which is 
required before they are placed on the market), under the Biocidal Products Regulation13 (BPR) 
and the Plant Protection Products Regulation14 (PPPR), full information on the identification, 
composition and hazards of the mixture, including any mixture used in its composition, is 
required by the authorising Member State Competent Authority (MSCA).  

Under the Tobacco Products Directive15, a notification of information on the identification, 
composition and hazards of e-liquid mixtures is required before placing on the market.  

10 Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH). 
11 Even when it is technically possible to attach the SDS to the submitted information, this will not 
replace the obligation to provide the information on the mixture or on its components. 
12 CLP does not apply to cosmetic products that are in the finished state intended for the final user 
(Article 1(5)(c)).  
13 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 
concerning the making available on the market and use of biocidal products (BPR). 
14 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC. 
15 Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the 
approximation of the laws, regulations and administrative provisions of the Member States concerning 
the manufacture, presentation and sale of tobacco and related products and repealing Directive 
2001/37/EC. 

 
 
 
 
 
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The Cosmetic Products Regulation16 requires that responsible persons and, under certain 
conditions, the distributors of cosmetic products submit some information about the products 
they place on the market through a dedicated Cosmetic Products Notification Portal (CPNP). 

It remains at the discretion of each MSCA, where the applicable legal text allows the competent 
authorities  to  do  so,  to  assess  and  decide  whether  information  supplied  under  different  EU 
legislations  (as  part  of  an  obligatory  authorisation  or  notification  procedure)  can  be  made 
available  to  the  appointed  bodies  under  Article  45  of  CLP.  However,  information  required  by 
Annex VIII of CLP must be submitted to the appointed body/bodies by the duty holder regardless 
of whether the appointed body/bodies  can use relevant  existing information received through 
requirements  under  other  EU  laws.  In  addition,  information  submitted  according  to  Article  45 
cannot be used for purposes other than those specified therein. Furthermore, the submission of 
the information under CLP must be provided in the harmonised format as outlined in Annex VIII. 

1.6.3 National legislation 

It is to be noted that Annex VIII to CLP is exhaustive, meaning that no additional information 
can be required under national legislation to that specified in Annex VIII for the purposes 
provided for under Article 45. However, certain aspects are left to the discretion of Member 
States, such as the establishment of acceptance criteria for submissions, the acceptance of 
information in languages other than official language(s), the application of fees before 
processing the submissions, reference to submission systems, etc. 

Nevertheless, Member States may have in place submission requirements for substances or 
mixtures outside the scope of Article 45 for purposes broader or other than those defined in 
that same Article. This can be regulated by national legislation and in general under a legal 
framework which is different from Article 45 and Annex VIII17. For more information it is 
recommended to contact the responsible authority in the specific Member State. 

Note the following: 

- in this Guidance Document the reference to specific Parts and Sections of Annex VIII to CLP 
is provided within square brackets […]. 

- all ECHA Guidance documents referred to in this document, are available in the Support 
section of the ECHA website, under the tab for the relevant regulation, at: 
https://echa.europa.eu/guidance-documents/guidance-on-reach  

Translated versions of the Guidance documents are available by changing the language of the 
webpage, selected on the upper right-hand side. 

16 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on 
cosmetic products. 
17 As an example, Norway, Denmark, Sweden and Finland have maintained the obligation to notify 
chemicals (substances and mixtures) to the national Product Registry in addition to the obligations under 
Article 45 and Annex VIII. Scope and information requirements may be partially overlapping, but the 
information submitted under the two different legal frameworks is used for different purposes by possibly 
different bodies. 

 
 
 
 
 
 
 
 
 
 
2. Abbreviations/definitions 

Standard term / Abbreviation  

Explanation  

Annex VIII 

Annex VIII to CLP, as added by Regulation (EU) 
2017/542 amending CLP by adding an Annex on 
harmonised information relating to emergency health 
response. Subsequently amended by Regulation (EU) 
2020/11 of 29 October 2019, Commission Delegated 
Regulation (EU) 2020/1677 of 31 August 2020, 
Commission Delegated Regulation 2020/1676 of 31 
August 2020 and Regulation (EU) 2024/2865 of 23 
October 2024. 

Article 45 

Article 45 of CLP 

ATP 

Adaptation to Technical Progress 

Bespoke paint (in the context 
of submission of information 
under Annex VIII) 

BPR 

CLP 

Distributor 

Downstream user 

ECHA 

EEA 

EN 

EU 

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. 

Biocidal Products Regulation. Regulation (EU) No 
528/2012. 

Regulation (EC) No 1272/2008 on classification, 
labelling and packaging of substances and mixtures. 
Also referred to as ‘the CLP Regulation’. 

Any natural or legal person established within the EU, 
including a retailer, who only stores and places on the 
market a substance, on its own or in a mixture, for 
third parties (Article 2(20) of CLP). 

Any natural or legal person established within the EU, 
other than the manufacturer or the importer, who 
uses a substance, either on its own or in a mixture, in 
the course of their industrial or professional activities 
(Article 2(19) of CLP).  

European Chemicals Agency 

European Economic Area 

European Standards (or European Norms) 

European Union (the reference to the EU, in this 
document, also covers the EEA countries unless stated 
otherwise) 

EuPCS 

European Product Categorisation System 

Formulator 

Company that produces a mixture. 

A formulator established in the EU is a downstream 
user. 

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GCI 

ICG 

Importer 

IUCLID 

LD50 

MiM 

Mixture 

MSCA 

PCN 

PPPR 

REACH 

SF 

SiA Guidance 

SDS 

Substance 

UFI 

Generic component identifier 

Interchangeable Component Group 

Any natural or legal person established within the EU 
who is responsible for import (Article 2(17) of CLP), 
where the latter means the physical introduction into 
the customs territory of the EU  

(Article 2(16) of CLP). 

International Uniform Chemical Information Database 

Median lethal dose 

Mixture in a mixture 

A mixture or solution composed of two or more 
substances (Article 2(8) of CLP). 

Member State Competent Authority 

Poison Centre Notification 

Plant Protection Products Regulation. Regulation (EC) 
No 1107/2009. 

Registration, Evaluation, Authorisation of Chemicals. 
Regulation (EC) No 1907/2006. 

Standard Formulas (Part D of Annex VIII) 

ECHA Guidance on requirements for substances in 
articles 

Safety data sheet (see Guidance on the compilation of 
safety data sheets for more details) 

A chemical element and its compounds in the natural 
state or obtained by any manufacturing process, 
including any additive necessary to preserve its 
stability and any impurity deriving from the process 
used, but excluding any solvent which may be 
separated without affecting the stability of the 
substance or changing its composition (Article 2(7) of 
CLP).  

Unique Formula Identifier (see section 4.2 of this 
Guidance) 

 
 
 
 
 
3. Obligations 

This section of the Guidance defines the general framework of the provisions of Article 45 of 
CLP and Annex VIII. It clarifies who may play a role or has potential obligations related to 
these provisions. It therefore explains which activities may trigger the obligation to submit 
information under Article 45, which mixtures are affected, namely mixtures that are classified 
as hazardous on the basis of their human health or physical effects, and which bodies receive 
the submitted information.  

The section also stresses that suppliers in a supply chain (as well as outside the supply chain) 
must cooperate to meet the CLP requirements for classification, labelling and packaging 
(Article 4(9)) and that substances and mixtures may not be placed on the market unless they 
comply with CLP (Article 4(10)), including the requirements of Article 45 and Annex VIII. 

3.1 Who is required to submit information? 

Article 45 and Annex VIII to CLP identify importers and downstream users placing certain 
hazardous mixtures on the market as responsible for the submission of the information to 
appointed bodies. These companies are also referred to as duty holders under Article 45 or, in 
the context of CLP Article 45 and Annex VIII, as “submitters”. They have therefore the 
responsibility of submitting the information according to Article 45. 

From 1 January 2027, Regulation (EU) 2024/2865, new Article 1(1)(f) of CLP clarifies an 
obligation for downstream users, importers and distributors referred to in Article 45(1b) and 
(1c) to submit information relevant to an adequate emergency health response to appointed 
bodies in accordance with Annex VIII. Furthermore, from that date, Article 45(1c) introduces 
an obligation for distributors (distribution activities are outlined in Table 1 of this document) to 
submit poison centre notifications in certain cases. This obligation will apply where distributors 
further distribute hazardous mixtures in other Member States or where they rebrand or relabel 
them. This ensures the appointed bodies and poison centres receive all the required and 
relevant information to carry out their daily tasks. 

Regulation (EU) 2024/2865 also introduces an explicit provision (Article 4(11)) applicable from 
1 July 2026, by which a substance or mixture can be placed on the EU market only if a supplier 
established in the EU, complies with all relevant CLP duties, including the notification of 
information set out in Annex VIII (see section 3.1.1.6 ‘Non-EU supply via distance or online 
sales’). This scenario should not be confused with importer activities leading to submission 
obligations.  

The definitions of ‘downstream user’, ‘importer’ and other operators potentially part of the  
supply chain are given in Article 2 of CLP and are consistent with the REACH  
Regulation. The same definitions are reported in section 2 of this Guidance. The Guidance for 
Downstream Users provides more information on the different roles and operators along the  
supply chain (including distributors). 

In the sections below it is clarified which activities carried out by the different operators may  
confer on them the obligations to submit information to the appointed bodies in order to be  
compliant with CLP. 

  
 
 
 
 
 
 
 
 
 
 
 
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3.1.1 Activities leading to submission obligations according to Article 45 

The following activities carried out by companies confer on them the obligation to submit 
information related to an emergency health response directly from Article 45: 

3.1.1.1 Import activities 

A company that imports a hazardous mixture into the EU is an importer. Therefore, they place 
the mixture on the market according to Article 2 of CLP and have the obligation to submit 
information required by Annex VIII. Companies importing mixtures from outside the EU must 
ensure that the information is submitted in the official language, or any other allowed 
language, of the Member State where the mixture is placed on the market.  

Example 1: An EU company importing from outside the EU and placing on the market in one 
EU country.  

A German company imports from Switzerland (a non-EU supplier) a mixture called Superglue 
and places it on the German market. This mixture is classified as hazardous for human health 
or physical effects. The German company needs to obtain from the Swiss supplier all the 
information needed to fulfil the Annex VIII requirements. The German importer will have to 
submit the information to the German appointed body. 

Example 2: An EU company importing from outside the EU, and placing on several EU 
markets. 

If Superglue (see example above) is then intended to be placed on the market in multiple 
countries by the German importer (from example 1), this company will have to submit the 
information to the appointed bodies of the relevant EU countries before placing the mixtures 
on the market in those countries.  

German importer of  Superglue Swiss supplier of  Superglue  provides the informationPlacing on German marketSubmission of the information to appointed body in GermanySwiss supplier of  Superglue  provides the informationGerman importer of  Superglue French marketGerman marketItalian marketSubmission to appointed body in FranceSubmission to appointed body in GermanySubmission to appointed body in Italy 
 
 
 
 
The imported mixture may be used at the first place of import by the importer themselves or 
may be imported in Member State A and subsequently placed on the market also in Member 
State B (by the same company). A submission is required in both Member States A and B since 
import is deemed to be “placing on the market” (Member State A), and the mixture is placed 
subsequently on the market in Member State B. The submission obligations to appointed 
bodies of Member State A and Member State B apply to the importer. 

The imported mixture could be used by the same importer to formulate another mixture. If 
this second mixture is hazardous and placed on the market, the same company has to fulfil the 
obligations for the imported as well as for the formulated mixture (they would be both 
importer and downstream user). 

In practice, the non-EU supplier of the hazardous mixture would ideally disclose the entire 
mixture formulation information to their customer (the EU importer), so that the latter can 
make their submission. Nevertheless, there are cases where complete information pursuant to 
Annex VIII is not available or not given because of confidentiality reasons. An alternative work 
around is for the importer to ask the non-EU supplier to make a submission of information 
through an EU-based legal entity to whom they are willing to provide the full information 
required by Annex VIII. The EU importer will then be able to refer to this submission (and the 
UFI) in their own. More practical details are provided in section 4.2.6 ‘UFI and the EU 
importer/non-EU supplier. 

In any case it is ultimately the responsibility of the EU-based importer to ensure and 
demonstrate that they comply with Annex VIII (and other obligations under CLP) and thus to 
gather and submit the information required. Therefore, it may be necessary to put additional 
effort in the communication with the non-EU supplier to obtain the necessary information. The 
EU importer is advised to document such efforts for enforcement purposes.  

A mixture can be imported also in combination with articles and in this case submission 
obligations may apply. See the section 3.1.1.5 on “Import/manufacture of combination of 
mixture and article” below. 

3.1.1.2 Formulation activities 

A company that produces a mixture is a formulator and is covered by the definition of 
downstream user under the CLP Regulation. Therefore, any company that formulates and 
places on the market a hazardous mixture meeting certain criteria (see section 3.3) has the 
obligation to submit the information in accordance with Annex VIII. The submission must be 
made in all the Member States where the mixture is placed on the market in the official 
language of the relevant Member State (unless the Member State concerned provides 
otherwise; this aspect is further explained in section 3.2). 

For business reasons (e.g. economic advantage, staying competitive, logistics), a company 
may decide to outsource formulation to a third party. This third party may even provide the 
mixture label with the contact details and brand name of their customer, the contracting 
company. The nature of such contractual arrangements between companies is described using 
a broad range of terminology, including brand name and private label. “Toll formulator” will 
be used in this Guidance to describe a company formulating a mixture for another company in 
accordance with the requirements set out by that company (see more in ‘Toll formulators and 
UFIs’ in section 4.2.5).  

The toll formulator in the EU is the entity that first supplies and makes the mixture available 
on the EU market and has the obligations associated with Article 45 of CLP. In practice, the toll 
formulator should have the relevant compositional information required by Annex VIII and 
therefore will be in the position to respond to any request for additional information from the 
authorities in the cases foreseen by the legislation (see section 7). If the toll formulator’s 
customer simply stores and places the mixture on the market, they would be a distributor. 
However, if the same company uses that mixture, for example in the formulation of another 

  
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mixture (or by transferring the mixture into different containers), they would be a downstream 
user and would have submission obligations under Article 45 for the newly formulated (or 
repackaged) mixture. 

Example 3: Mixture placed on the market in several Member States 

A company in the Netherlands formulates a cleaning product under the company brand name. 
The cleaning product is classified as hazardous for human health or physical effects . It is 
placed on the market in the Netherlands as well in Belgium, Poland, Germany and Slovakia by 
the same company. The Dutch formulator must submit the required information to the 
appointed body of each Member State where it is placed on the market (and in their official (or 
accepted) language(s)).  

A company that formulates a mixture exclusively for export, and does not place it on the EU 
market, does not have the obligation to make the submission18. If the product is temporarily 
stored in a warehouse before being exported outside the EU, this may qualify as placing on the 
market and therefore the obligations according to Annex VIII apply. This would be the case if, 
for example, the formulator makes available the mixture, whether in return for payment or 
free of charge, to a third party which stores the mixture in the warehouse before delivering it 
to a non-EU company. If the mixtures are stored in a warehouse by the same downstream 

18 Please, note that other obligations under CLP may also apply. 

Cleaning product produced by NL formulatorCleaning product to be placed on the market in PLSubmission to appointed body in NLSubmission to appointed body in BESubmission to appointed body in PLSubmission to appointed body in DESubmission to appointed body in SKCleaning product to be placed on the market in BECleaning product to be placed on the market in NLCleaning product to be placed on the market in DECleaning product to be placed on the market in SK 
 
 
 
 
 
 
 
 
user that formulates them, there are no obligations to submit information19. As long as there is 
no placing on the market (i.e. making the mixture available to a third party), the warehouse 
that belongs to the downstream user can be located in a different place from where the 
formulation takes place (the same or a different Member State)20. 

Example 4: Formulation, mixture to be placed on the market outside EU 

A formulator in Italy formulates two cleaning products (product A and product B) which are 
classified as hazardous for health or physical effects . Product A is placed on the Italian 
market, therefore a submission according to Annex VIII has to be made to the Italian 
appointed body.  

Product B is stored in a warehouse owned by the same formulator before being exported to 
Turkey, i.e. out of the EU. As the data submission requirements under the scope of CLP Article 
45/Annex VIII only apply in the EU there are no obligations to submit data for product B. 

3.1.1.3 Repackaging/refilling activities  

A company that repacks/refills a mixture by transferring it from one container to another (and 
either keeps or modifies the content of the original label) is performing activities that qualify as 
downstream user activity according to CLP. This repackaging/refilling company is therefore a 
duty holder for the purposes of Annex VIII and Article 45. This is the case even if the re-
packaging company does not perform any other activity with the mixture (e.g. no changes in 
the composition).  

If the company is placing a mixture on the market which is chemically identical to the one of 
their supplier, they may agree with their supplier that the supplier includes new and relevant 
information (resulting from the activities of the repackager/refiller including but not limited to 
new packaging information) in their notification(a contractual agreement would be needed). 
This will not only alleviate the administrative burden for the repackaging company, but it will 
also resolve the issue where the repackaging company often does not have access to the full 
composition. However, where their supplier does not include the information from the 
repackaging company in their notification, the repackaging company must make a separate 
submission themselves. In this case, the repackaging company must make their own separate 
submission and indicate that the composition constitutes 100% of the mixture composition 
provided by the supplier. In other words, the final repackaged mixture composition = 100% of 
the supplier’s UFI as a Mixture in Mixture or ‘MiM’).  

It is important to note that the repackaging company, as the duty holder under Article 45 is 
responsible for the provision of information – either in their own notification or for the 
information they provide to their supplier for inclusion as part of the supplier’s notification. 

19 CLP does not apply to mixtures which are subject to customs supervision, provided that they do not 
undergo any treatment or processing, and which are in temporary storage, or in a free zone or free 
warehouse with a view to re-exportation, or in transit (Article 1(2)(b)). 
20 Obligations stemming from the transport legislation may apply. 

IT formulatorIT label incl. UFISubmission to appointed body in ITNo submission requiredStored in own warehouse in IT before exportCleaning product B to be exported outside EUCleaning product A to be placed on the market in IT 
 
 
 
 
 
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3.1.1.4 Distribution activities  

A distributor that subsequently distributes a hazardous mixture in other Member States or that 
rebrands or relabels a hazardous mixture must submit a poison centre notification, unless the 
distributor can ensure and demonstrate that the appointed body already received the same 
information from their upstream supplier or original notifier (new Article 45(1.c)).  

In other words, distributors (e.g. re-branders) can only place CLP-compliant products on the 
market and ensure that all product identifiers (in particular trade/brand names) and UFIs 
under which the mixture is placed on the market are covered by a submission to the relevant 
appointed body. 

The distributor should discuss the available options with the supplier to demonstrate that the 
information has been submitted to the appointed body, for example, written confirmation or a 
transcript of the submission report, as per their contractual agreement. 

This means that a distributor cannot place a mixture on the market where the appointed body: 

-  has not received the corresponding Annex VIII submission; or 

-  has received a submission by the supplier, but not all the relevant distributor’s product 

identifiers, including e.g. trade names and UFIs, have been indicated. 

If a distributor has the knowledge that certain information is not included in the original 
notification because it is not known to the original notifier (e.g. the fact that they are 
distributing in different Member States), the distributor has the duty to make sure that this 
information becomes available to the appointed body(s). The objective of ensuring that the 
relevant appointed body will have at its disposal the emergency health response information 
for all mixtures supplied in its Member State can be ultimately achieved in the following ways: 

-  The distributor communicates upstream to their supplier(s)21 all the relevant 

information about the distribution step (e.g. country of placement and/or new identifier 
if one or both are different from the supplier). In this case the supplier is encouraged to 
include this information in their submission (as an update) to all the relevant appointed 
bodies (even if the supplier is not obliged to notify in Member States where the 
distributor places the mixture on the market).  

-  Alternatively, if the distributor does not want to disclose the information upstream, or 

the original submitter refuses to include the distributor’s information in their 
submission, the distributor will need to make their own submission. In this case the 
submission will include the full set of information required by Annex VIII, including the 
composition (the distributor may indicate that the mixture composition is made 100% 
by the mixture purchased from the supplier; if this mixture is identified using a UFI, 
then this UFI and the information on the mixture should be available to the relevant 
appointed body; see section 5.3 for detailed information on components)22. 

For those distributors of a hazardous mixture who only store and place the mixtures on the 
market, without undertaking any other activity on the mixture, it’s packaging or labelling, or 
without distributing it to another Member State, they do not need, in principle, to submit the 

21 Communication should happen outside the submission system. 

22 Note, that the ECHA Submission portal does not provide the possibility for the distributor to indicate in 
their submission who is the actual duty holder under Article 45 (i.e. the supplier).  

 
 
 
 
 
 
 
information to the appointed body following Article 45. This is also the case when a distributor 
transports the mixture between different sites that they own, without placing the mixture on 
the market23.  

Example 5: Submission made by a rebranding company  

A company in France formulates and intends to sell “Super Wash” on the French market. The 
mixture is classified as hazardous for health or physical effects and the formulator has 
submitted all relevant information to the appointed body in France.  

The company decides to open up markets and to sell the same product in Germany and Spain. 
The company relabels the product accordingly, but keeps the brand name “Super Wash”, and 
submits the relevant information to the German and Spanish appointed bodies. 

A customer (rebrander) in Spain decides to sell this product (with no changes in the 
composition) with their own brand “Ultra Clean”. As the distributor does not want to disclose to 
their upstream supplier the fact that they place the same mixture on the market under a 
different name, the rebrander submits the required information to the Spanish appointed body 
themselves (and rebrands/relabels accordingly). 

23 Please note that in this case obligations coming from the transport legislation may apply. 

FORMULATOR Super Wash  Intends to sell on the French marketFORMULATOR Super Wash  submission to the appointed body in Germany Super Wash placed on German market by FORMULATOR Ultra Clean  placed on Spanish market by REBRANDERFORMULATOR Super Wash  submission to the appointed body in SpainREBRANDER Ultra Clean  submission to the appointed body in Spain Super Wash  placed on Spanish market by FORMULATORFORMULATOR Super Wash  notification to the AB in France 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Example 6: Formulation, mixture placed on the market in several Member States – options for 
the retailer. 

A formulator in Sweden formulates a laundry detergent for consumer use and sells it to a large 
Swedish retailer selling the product in Sweden, Denmark and Norway. The laundry detergent is 
classified as hazardous for health or physical effects. In accordance with Article 45 the relevant 
information must be submitted by the Swedish formulator to the appointed body in Sweden. 

Additionally, a submission must be made in Denmark and Norway, where the retailer intends 
to sell the product. Since the retailer is distributing in other Member States, the retailer must 
then ensure that the information is available to the relevant appointed bodies. Therefore, the 
retailer can decide to employ option 1 or 2 below: 

Option 1. The retailer openly communicates their activities to the supplier (i.e. the Swedish 
formulator), who includes the additional information in their submission (as depicted in the 
figure below). The supplier in turn communicates the successful submission to the retailer e.g. 
by sharing the submission report or some other means.  

Option 2. The retailer has the knowledge that certain information is not included in the 
original notification because it is not known to the original notifier (in this case, discretion 
concerning distribution in additional Member States) and must therefore make a submission to 
the appointed bodies of Denmark and Norway.  

RETAILERPlaces  SuperWash  on Swedish marketFORMULATORSubmits to Swedish ABRETAILERplaces  SuperWash  on Danish & Norwegian marketsFORMULATORFormulates  SuperWash Supplies to Swedish retailerFORMULATORSubmits to Danish and Norwegian ABCommunication channel openRETAILERPlaces  SuperWash  on Swedish marketFORMULATORSubmits to Swedish ABRETAILERplaces  SuperWash  on  Norwegian marketRETAILERSubmits Information to Danish & Norwegian ABFORMULATORFormulates  SuperWash Supplies to Swedish retailerRETAILER places  SuperWash  on Danish market 
 
 
  
3.1.1.5 Import/manufacture of combination of mixture and article  

An object fulfilling the definition of “article” is outside the scope of Annex VIII, therefore 
notification requirements do not apply.  

An “article” is defined in Article 2(9) of the CLP Regulation. That definition should be 
interpreted as explained in the Guidance on requirements for substances in articles24 (SiA 
Guidance) and it should be considered by companies importing or producing such objects.  

However, an object can be considered as a substance or a mixture (and not an article), or a 
combination of an article and of a substance or of a mixture. In these cases, obligations under 
Annex VIII may apply to those mixture(s), if they are classified for health or/and physical 
hazards. More details and guidance to assess individual cases is provided in SiA Guidance, 
which explains (in chapter 2) that objects can be “classified” as: 

A substance/mixture (as such), e.g. wax crayon, blasting grit. A mixture belonging to this 
group (usually in solid state) is subject to all REACH and CLP requirements applicable to 
mixtures. These include obligations under Article 45 and Annex VIII relating to mixtures placed 
on the market that are classified as hazardous based on their physical and health effects. 

A combination of an article (functioning as a container or a carrier material) and a 
substance/mixture, e.g. an inkjet printer cartridge, , wet cleaning wipes, desiccant bags. 
Where an object, belonging to this group, is considered to be a combination of an article 
(functioning as a container/carrier material) and a mixture (according to the criteria defined in 
the SiA Guidance), is placed on the market and the mixture is classified as hazardous based on 
its physical or health effects, then this mixture is subject to the submission obligations under 
Article 45 and Annex VIII. 

Objects such as a one-piece plastic spoon (an article) or a thermometer with liquid (article in 
which the substance/mixture forms an integral part of that article) are considered as articles 
under REACH and CLP. In these cases, Article 45 and Annex VIII of CLP will not apply even 
when the object contains a liquid mixture (e.g. electrolytes in a battery, liquid in a 
thermometer, adhesive in a tape for fixing carpets). This is also the case with some articles 
with an integral substance or mixture that is intended to be released from them (e.g. scented 
articles, such as scented children’s toys), if they fulfil the REACH and CLP definition of an 
article. Article 45 and Annex VIII do not apply to such mixtures in articles25. 

3.1.1.6 Non-EU supply via distance or online sales 

The new provision reflected in Article 4(11) ensures that a consumer does not, by default, 
become an importer, with all the regulatory consequences, when buying a hazardous mixture 
via online platforms or distance sales from outside the EU. Applicable from 1 July 2026, the 
new provision states that a substance or mixture can be placed on the EU market only if a 
supplier established in the EU, in the course of an industrial or professional activity, complies 
with all relevant CLP duties, including the notification of information set out in Annex VIII. This 
includes the identification of the EU supplier on the label. Please refer to the Guidance on 
Labelling and Packaging for more details. 

24 Guidance on requirements for substances in articles can be found from the ECHA website: 
https://echa.europa.eu/guidance-documents/guidance-on-reach  
25 Other REACH or CLP obligations may apply. For instance, substances intended to be released from 
these articles may be required to be registered under Article 7(1) of REACH when certain conditions are 
met.      

 
 
 
 
 
 
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Table 1: Overview of operators and activities triggering (or not triggering) obligations to comply with Article 45  

Activity 

Operator 

Legal 
obligation to 
submit 
information?  

Import 

Importer 

Yes 

Formulation 
(includes toll 
formulators) 
Repackaging 

Downstream user  Yes 

Downstream user  Yes 

Why? 

Options 

Article 45 obligation  

Article 45 obligation 

Importers and downstream users have 
submission obligations under Article 45 and 
may use the ECHA submission tools to fulfil 
their obligations. 

Article 45 obligation. Transfer into 
new/different containers is a downstream 
user activity. 

It is possible that third parties may be 
involved (contractual agreement 
recommended) to: 

Refilling  

Downstream user  Yes 

Production or 
import of 
mixture/article 
combinations 

Downstream 
user/importer 

Yes, if the object is 
identified as either  
a mixture and not 
an article, or if the 
object is the 
combination of an 
article and one or 
more mixtures. 

Article 45 obligation. Transfer into 
new/different containers is a downstream 
user activity. 

Article producers or importers of articles 
are potentially also downstream 
users/importers of mixtures and may have 
submission obligations. 

- assist the duty holder with the 
preparation and submission of information 
i.e. through the ECHA account of the duty 
holder (e.g. a consultant working as a 
‘foreign user’, or, 

- prepare/submit on behalf of the duty 
holder, i.e. a third party makes a submission 
via their own account (e.g. a mother 
company providing information required by 
the daughter company).  

For more details, click on the hyperlinks 
below to refer back to more information and 
options in sections: 

3.1.1.1 Import activities 
3.1.1.2 Formulation activities 
3.1.1.3 Repackaging/refilling activities 
3.1.1.5 Import/manufacture of combination 
of mixture and article 

 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
30   

Activity 

Operator 

Retailing 

Distributor 
(retailer) 

Rebranding / 
relabelling 

Retailers are 
distributors who 
only store and 
place on the 
market a 
substance, on its 
own or in a 
mixture, for third 
parties.  

Distributor: 
‘Rebranders’ are 
distributors who 
apply their own 
brand to a 
mixture that 
another company 
has formulated 
and placed on the 
market.  

Distributor: 
‘Relabellers’ are 
distributors that 
adapt the label or 
the identifiers of 
a mixture that 
has been placed 
on the market.  

Legal 
obligation to 
submit 
information?  

In cooperation with 
the other actors in 
the supply chain, 
the distributor 
must ensure that 
the relevant 
appointed bodies 
receive the 
information.  

In cooperation with 
the other actors in 
the supply chain, 
the distributor 
must ensure that 
the relevant 
appointed bodies 
have receive the 
information, 
including e.g. the 
new identifiers.  

Why? 

Options 

Where retail distribution concerns placing 
on the market in other Member States, 
submission of the relevant information is 
to be ensured by the cooperative efforts in 
the supply chain (Article 4(9)).  

From 2027, Article 45(1.c) clarifies the 
obligation. 

Where distribution concerns cases of 
rebranding/relabelling, submission of the 
relevant information is to be ensured by 
the cooperative efforts in the supply chain 
(Article 4(9)). From 2027, Article 45(1.c) 
clarifies the obligation. 

Distributors must ensure they do not 
distribute a mixture: 

- in a Member State where a submission has 
not been made; or 

- with a product identifier which was not 
included in a submission to the relevant 
appointed body. 

In case of distribution where the information 
is not available to relevant appointed bodies, 
the distributor must: 

1. provide the necessary information to the 
original submitter for inclusion in their 
submission, or, 
2. decide to make their own submission to 
the relevant appointed bodies. 

For more details, refer to more information 
and options in section 3.1.1.4 Distribution 
activities  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
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Activity 

Operator 

Legal 
obligation to 
submit 
information?  

Why? 

Options 

Consultancy 

Commercial 
representative 
(=consultant) 

No 

The commercial representative is not an 
actor for CLP purposes, so not subject to 
Article 45 or Article 4(10).  

The commercial representative may use 
ECHA’s submission tools to assist the duty 
holder to prepare and/or submit a notification 
through the account of the duty holder e.g. 
via the foreign user concept. See section 4.1 
Overview for duty holders for more details. 

Supply 

Non-EU 
formulator or 
supplier 

No 

The CLP Regulation does not directly apply 
to operators not established in the EU. 
However, a hazardous mixture must not 
be placed on the EU market unless there 
is an EU-established supplier complying 
with the CLP obligations. 

The non-EU supplier may assist the importing 
duty holder with their legal obligations 
through an EU-based legal entity. See section 
4.2.6 UFI and the EU importer/non-EU 
supplier for more details. 

In case of non-EU supply directly to 
consumers, e.g. online or distant sales, the 
submission of Annex VIII information must 
be made by an EU-based supplier on behalf 
of the non-EU supplier. See section 3.1.1.6 
Non-EU supply via distance or online sales 

 
 
 
 
 
 
32 

3.2 Who receives the information? 

A company required to submit the information according to Annex VIII, must make sure that 
this information is submitted to the appointed bodies of all the Member States where they 
place a hazardous mixture (meeting certain criteria) on the market. The submitted information 
should also be submitted to Member States where the mixture is sold via any distributor, 
unless the distributor chooses to notify themselves (see section 3.1). 

The information will be made available by the appointed body of each Member State to the 
poison centres and the personnel dealing with emergency responses in that Member State 
where the mixture is placed on the market, either via the Poison Centre Notification i.e. ‘PCN’ 
database or eDelivery service. How the data is transferred will depend on the situation in each 
Member State. In particular, where the appointed body and the poison centres are different 
institutions, the latter may obtain direct access to the data from the appointed body. 
Alternatively, they may receive copies of data which is then fed into a local database. In any 
case specific security requirements will have to be guaranteed, as per provision of Article 
45(2). 

3.2.1 Member States’ appointed bodies 

Article 45(1) establishes that each Member State must appoint a body (or bodies)26 
responsible for receiving the information submitted by importers, downstream users and 
distributors related to mixtures placed on the market that are classified as hazardous based on 
their health or physical effects. The national appointed body or bodies may be a Member State 
Competent Authority on CLP (MSCA), a poison centre, a National Health Authority or another 
body appointed by the MSCA. Article 45(1a.), applicable from 1 January 2027, further clarifies 
that a Member State may appoint ECHA as a body responsible for receiving information 
relating to emergency health response and preventative measures. The appointed body in a 
given Member State must have access to the information submitted to them to carry out their 
tasks related to emergency health response. In those cases where the appointed body is not 
the poison centre, the national appointed body will typically make the submitted information 
available to the poison centres. The appointed bodies must ensure that the information 
received is kept confidential and is only used for the purposes of Article 45. See section 7.3 for 
further information about the use of the submitted information.  

3.3 What is the scope of Article 45? 

This subsection provides guidance on the scope of Article 45 and Annex VIII to CLP. It clarifies 
for which mixtures there is an obligation to submit information to the appointed bodies 
according to the legal text, which mixtures are exempted from the obligation, and which 
information could be submitted on voluntary basis. 

It is important to clarify that Article 45 and Annex VIII apply to mixtures. Substances27 placed 
on the market on their own, either classified or not, are excluded from the obligation to submit 
information according to Article 45. Mixtures can be as simple as a single substance diluted in 
a solvent. Nevertheless, case by case assessment may be needed in certain situations to 
conclude whether the product is indeed a mixture or should rather be considered a substance. 
In case of a substance there would be no obligation to submit a notification and include a UFI 
on the label. More details and guidelines are provided in the Guidance for identification and 
naming of substances under REACH and CLP. 

26  A list of national appointed bodies is available at the ECHA Poison Centre website: 
https://poisoncentres.echa.europa.eu/  

27 Definitions in section 2 of this Guidance. 

 
 
 
 
 
 
 
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Sections 4 and 5 below provide more information on the content of the submission as well as 
special situations including limited information requirements. 

3.3.1 Which mixtures require information to be submitted? 

Annex VIII requires the submission of information about mixtures that are placed on the EU 
market and classified as hazardous based on their health or physical effects. It means that all 
mixtures meeting the criteria defined in Part 2 and Part 3 of Annex I fall under the scope of 
Article 45 and Annex VIII. Nevertheless, some exemptions apply; these are explained below. 

3.3.1.1 General exemption from CLP Regulation 

Pursuant to Article 1(2), (3) and (5), the Regulation (and therefore Annex VIII provisions) 
does not apply to: 

• 

• 

“radioactive substances and mixtures […]”;  

“substances and mixtures which are subject to customs supervision, provided that they 
do not undergo any treatment or processing, and which are in temporary storage, or in 
a free zone or free warehouse with a view to re-exportation, or in transit”;  

• 

“non-isolated intermediates” 

•  mixtures used in scientific research and development, provided they are not placed on 

the market and they are used under controlled conditions in accordance with EU 
workplace and environmental legislation;  

•  waste; and  

• 

certain mixtures in the finished state, intended for the final user:  

o  medicinal products,  

o  veterinary medicinal products,  

o  cosmetic products,  

o  medical devices which are invasive or used in direct physical contact with the 

human body, and in vitro diagnostic medical devices, and  

o 

food or feeding stuffs.  

It is to be noted that if the same mixture has uses, other than those listed above, the 
exemption does not apply with reference to these uses. 

Additionally, pursuant to Article 1(4) “Member States may allow for exemptions from this 
Regulation in specific cases for certain substances or mixtures, where necessary in the 
interests of defence.” 

3.3.1.2 Exemptions from Article 45 

Among the mixtures which fall under the scope of CLP, for the following the obligations under 
Annex VIII do not apply because they are excluded by Article 45 (other obligations under CLP 
may apply): 

•  mixtures classified for environmental hazards only; 

•  mixtures which are subject to supplemental labelling requirements according to Part 2 

of Annex II but are not themselves classified for health or physical hazards. 

 
 
 
 
 
34 

3.3.1.3 Exemptions from the obligation to submit information under Annex VIII 

The following mixtures, even if falling under the scope of CLP, classified for health or physical 
hazards and placed on the market, are exempted from the obligation to submit information in 
accordance with Annex VIII. This is specified in section 2, Part A of Annex VIII: 

•  mixtures for scientific research and development (SRD, as defined in Article 2(30) of 

CLP) and mixtures for product and process-oriented research and development (PPORD, 
as defined in Article 3(22) of the REACH Regulation)28 

•  mixtures classified only for one or more of the following physical hazards:  

o 

o 

(1) gases under pressure (as defined in Annex I, 2.5 of CLP);  

(2) explosives (unstable explosives and Divisions 1.1 to 1.6) (as defined in 
Annex I, 2.1 of CLP). 

3.3.1.4 Special rules for bespoke paints 

Bespoke paints are mixtures formulated on customer demand in a potentially unlimited 
number of colour variations. In the context of Article 25(8), Article 45 and Annex VIII, the 
definition of bespoke paints also includes the pre-requisite that the final paint is formulated at 
the point of sale. This does not apply to bespoke resins or plasters. 

Compliance with the standard obligations under Annex VIII would require including the UFI of 
the mixture on the label and the submission of information before placing on the market each 
imaginable colour variation, or else to postpone each supply at the point of sale until the 
information had been submitted and the UFI created. This would place an unnecessary burden 
on the point of sale and there would be limited benefit for emergency response, especially 
where a particular paint colour may never actually be placed on the market. 

To avoid disproportionate administrative burden, Annex VIII, part A, section 2.2a., provides for 
a possibility to opt not to submit information regarding bespoke paints when they are 
formulated for an individual and professional consumer29 at the point of sale. In addition, the 
special provisions allow duty holders to not generate a UFI for the final paint. This includes also 
the case where consumers or professional users pre-order (e.g. online) but they only conclude 
the sales contract by paying at the place where the paint is formulated, then the place of 
formulation and point of sale normally coincide and the exemption under Article 25(8) of CLP 
applies. 

Bespoke paints that are not formulated at the point of sale are not covered by the exemption. 
This means that pre-orders where the sales contract is concluded from a place other than where 
the  paint  is  formulated  (e.g.  it  can  be  the  case  of  on-line  sales  where  payment  takes  place 
online), require the generation of a UFI and the submission of information on the final paint as 
supplied,  in  accordance  with  the  standard  Annex  VIII  requirements.  Indeed,  the  formulator 
typically  has  more  time  to  submit  a  notification  and  attach  a  UFI  before  handing  over  or 
delivering the paint to the consumer or professional user. 

Bespoke paints in the context of the exemption are paints formulated in limited amounts where 
the final tailor-made colouring takes place on demand by an individual customer – consumer or 

28 The obligation to submit a poison centre notification in accordance with Annex VIII does not apply to 
mixtures used in scientific research and development or mixtures for product and process-oriented research 
and  development.  This  is  the  case  even  when  the mixture  falls  under  the  scope  of  CLP  is  classified  for 
health or physical hazards and is placed on the market. Such mixtures are exempted from the obligation 
to submit information based on point 2.2 of Part A of Annex VIII.  
29 Paints intended for industrial users are not covered by the definition of bespoke paints in Article 25(8) 
and are subject to submission of information under Annex VIII. 

 
 
 
 
 
 
 
 
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professional  user  -  at  the  point  of  sale.  The  requested  colour  can  be  achieved  by  the  below 
means:  

•  Systems where relatively small quantities of “tinters” are added to a tintable paint base  

The tinters are highly concentrated pigment dispersions and cannot be used as such to 
paint an object, as they do not have the properties of a paint. The paint base has all the 
desired properties of the final paint, except the right colour. The addition of the tinters 
to the paint base is an automated process using tinting machines that can perform very 
accurate dosing. 

•  Systems where the right colour is produced by mixing together several toners:  

The system uses a series of toners, where each toner has all the properties of the final 
paint but contains only one pigment. The ratio of the toners used depends on the colour 
desired. The process of colour mixing is typically done manually, supported by IT 
systems to provide the composition and to calculate any required corrections in case 
the mixed paint does not show an exact colour match.  

It should be noted that information on the component mixtures of the bespoke paint (the paint 
base, the tinter mixtures and toners), when they are subject to notification under Article 45, 
must be submitted by the formulator(s) or importer(s) of those mixtures before they place the 
mixtures on the market. Hence, each of the component mixtures will have its own UFI. When a 
duty holder decides not to submit the information on a final bespoke paint falling under the 
scope of Article 45, they will need to include on the label of the final bespoke paint the UFIs of 
all the component mixtures, present in the paint above 0,1% and subject themselves to Article 
45. The classification of the actual final bespoke paint has to be reflected on the label. The 
specific labelling provisions that apply are described in section 4.2.8.3 of this Guidance and 
further details are provided in section 5.3.3 of the Guidance on Labelling and Packaging30. 

3.3.1.5 Submission of information made voluntarily 

For mixtures which are not subject to submission obligations or are exempted from Annex VIII 
(see sections 3.3.1), a submission in accordance with Annex VIII may be done on a voluntary 
basis. This could be the case for example for mixtures classified for environmental hazards 
only, or mixtures classified as gases under pressure only (or a combination of the two), or 
non-classified mixtures (possibly those subject to supplemental labelling information in 
accordance with Part 2 of Annex II). Additionally, also mixtures falling under the definition of 
“bespoke paints” can be notified on a voluntary basis. 

In fact, although it is not mandatory, submission of relevant information about mixtures not 
classified on the basis of their health or physical effects is encouraged, to facilitate the 
appointed bodies and poison centres’ activities. A mixture, although not classified as hazardous 
on the basis of health or physical effects, may be harmful in certain poisoning cases (i.e. very 
young children, pre-existing pathological conditions, etc.). The availability of information even 
on such mixtures would significantly decrease possible uncertainties in case of emergency calls 
and therefore it could support a quicker and more effective identification of curative measures. 

Mixtures for which submission of information is not required can be also used in the 
formulation of other classified mixtures (mixture in a mixture or MiM) generating potential 
gaps in the knowledge of mixture composition. When the duty holder does not know the 
composition of the MiM, they would rely on the Safety Data Sheet (SDS) of that mixture (if 
available), which does not provide all the relevant information. The supplier could, following a 

30 Available from the ECHA website Guidance documents - ECHA 

 
 
 
 
 
 
 
36 

submission made voluntarily, communicate the compositional information to the customer via 
the UFI31 while ensuring the protection of confidential business information. Lack of detailed 
compositional information could hamper the medical advice in the event of an emergency or in 
the establishment of risk management measures by authorities. In cases where the appointed 
body and poison centre do not have access to the full composition of the mixtures, the 
response in case of an emergency could potentially lead to incorrect medical advice and /or 
overtreatment. A submission made voluntarily for a mixture to be used in another mixture can 
allow the emergency responder to retrieve all the necessary information.  

A voluntary submission of regulatory data made through the ECHA Submission portal32 should 
also be accurate and remain up-to-date. The contact details of the submitter, as provided in 
the notification, may be used by relevant national authorities, in case of any follow up if 
needed.  

3.4 Use types of mixtures 

The identification of the correct use type for the mixture for which submission is made is 
important as it defines the information requirements, i.e. standard or limited information 
requirements. Annex VIII, Part A, Section 2.4 defines three types of use as follows:  

-  Mixture for consumer use means a mixture intended to be used by consumers, e.g. 

‘Craft and hobby paints’. 

-  Mixture for professional use means a mixture intended to be used by professional 

users but not at industrial sites, e.g. ‘Decorative paints’. 

-  Mixture for industrial use means a mixture intended to be used at industrial sites 

only, e.g. ‘Automotive coatings’. 

However, if a mixture formulated to be used in an industrial setting (“original mixture”) is 
subsequently also integrated (as a MiM) by a downstream user into a mixture for professional 
or consumer use (“final mixture”), then the original mixture is considered to be for 
professional or consumer end-use. Further information on how to report use types in a 
IUCLID dossier are included in section 5.2.3 Additional Information (-use types).  

3.4.1 Mixtures with an end-use not subject to notification 

Annex VIII defines a ‘mixture with an end use not subject to notification’ as a mixture, 
incorporated in another mixture, where the latter is intended to be used by consumers or 
professional users, but which is not subject to the information requirements in Article 45 (e.g. 
the final mixture is a cosmetic product, or the final mixture is not classified for human health 
or physical hazards).  

Notifiers of a mixture with an end-use not subject to notification have two options; 1. to make 
a submission fulfilling the standard information requirements, select the consumer, 
professional, industrial uses (where relevant) and indicate the product category as ‘Mixture for 
further formulation’. Option 2 is selecting a limited submission for industrial use only (ensuring 
the specific requirements for this possibility can be met) as explained in detail in section 4.4. It 
should be noted that if the mixture is notified for a limited submission (industrial use only) and 

31 For mixtures not subject to Annex VIII it is not mandatory to generate and submit a UFI, even when a 
submission is made voluntarily. Nevertheless, it is recommended to include the UFI to facilitate its 
identification when used in the formulation of another mixture downstream. 
32 ECHA Submission Portal T&C (Ch. 6 point (c)) https://echa.europa.eu/support/dossier-submission-
tools/echa-cloud-services   

 
 
 
 
 
 
 
 
 
 
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that the mixture ends up in a mixture for consumer or professional use subject to Article 45, 
then the notification will be required to be updated to include the general information 
requirements and the relevant use types indicated. 

3.5 Timelines 

3.5.1 Compliance dates  

Importers and downstream users placing mixtures on the market not notified already under 
national legislation must have complied with Annex VIII from the following dates: 

•  Mixtures for consumer and professional use: from 1 January 2021. 

•  Mixtures for industrial use: from 1 January 2024. 

Where a mixture has several types of use, the earlier corresponding compliance date applied 
and the related requirements must have been met. For instance, in the case of a glue classified 
as hazardous for health effects and placed on the market for both professional use and 
industrial use, the earlier date of 1 January 2021 applied.   

A transitional period was foreseen, meaning that by 1 January 2025, a submission according to 
the harmonised Annex VIII requirements had to be made by duty holders under Article 45 for 
all mixtures placed on the market (see also section 3.5.2), existing and new alike33. 

3.5.2 End of transitional period for mixtures already notified  

In some cases, a company may have submitted information relating to hazardous mixtures to 
an appointed body in accordance with Article 45(1) before the relevant compliance date 
according to the notification requirements existing at that time in a particular Member State 
(i.e. not in accordance with Annex VIII). For these submissions, the transitional period applied, 
and the submitted information did not have to comply with Annex VIII until 1 January 2025 
Thus, companies who benefitted from the transitional period must have already ensured that a 
new, Annex VIII compliant submission has been made to allow them to continue placing the 
mixture on the market after this time. 

4. General submission requirements 

This section of the Guidance introduces the obligations under Article 45 and the main elements 
concerning the submission of information as required by Annex VIII. Once the duty holder and 
their need to fulfil the obligations are identified as explained in section 3, certain concepts and 
the possible ways forward should be understood before starting to prepare the submission. 
These are explained in this section. 

4.1 Overview for duty holders 

A company placing a mixture subject to obligations under Article 45 on the market, must 
provide the information required by Annex VIII to the appropriate appointed body in the 
Member States where the mixture is placed on the market. In some instances, this may be 
done by a third-party company assisting the duty holder with the physical activities of 
preparing and submitting information through the duty holder’s ECHA account, or, submitting 
on behalf of the actual duty holder, via the third party’s ECHA account. In any case, the use of 
a third party does not relieve the duty holder or any actor placing certain hazardous mixtures 

33 Independent from any obligation under Annex VIII, obligations at national level (established under 
different legal frameworks and for purposes other than those defined by Article 45) may also remain valid 
and may still need to be fulfilled regardless of the submission having been made under the new format.  

 
  
 
 
 
 
 
38 

on the EU market from their submission obligations and responsibilities34.  

Duty holders under Article 45 are also required to provide information on the main intended 
use of the mixture (e.g., detergent, construction product, plant protection product) which is 
important for both emergency response and statistical analysis purposes. In order to facilitate 
the transmission of such information and its use by the receiving bodies, a European Product 
Categorisation System (EuPCS) has been developed. Section 4.3 illustrates the concept and 
provides relevant links. 

The company which is required to make the submission should be aware that besides the 
standard submission, Annex VIII allows a limited submission for mixtures intended for 
industrial use only (see section 3.4 on use categories). This option is available also for 
mixtures which end up in final mixtures intended for professional or consumer uses but which 
are outside the scope of Article 45 and Annex VIII. This option is presented in section 4.4. 

Companies can also decide to submit information: 

• 

• 

for single mixtures (placed on the market with one or multiple trade names, which 
can be included in the same submission) or,  

if certain criteria apply, to opt for a group submission which brings together multiple 
similar mixtures (differing only in perfume components by up to 5%) into one 
submission. Information on the group submission option and the criteria to be met are 
provided in section 4.5. 

Additionally, specific provisions are laid down for certain mixtures whose composition is highly 
variable or cannot be precisely defined at each point in time. Annex VIII provides for specific 
provisions which allow for the derogation from the standard information required on the 
mixture composition and a greater degree of variability. This is the case in the following 
situations: 

•  when certain components can be grouped under a so-called interchangeable component 
group (ICG) without the need to indicate the concentration of each of them (see section 
5.5 for the details and the criteria on when components can be grouped); 

•  when certain mixtures conform with specific industry Standard Formulas listed in the 
legal text itself (in Part D of Annex VIII) and for certain fuels listed in Part B, Section 
3.7. For such mixtures information on components identified and concentration can be 
provided according to the relevant Standard Formula or the SDS (see section 5.6 and 
5.7 of this Guidance for detailed information). 

The information to be submitted includes the physical, chemical and toxicological properties of 
the mixture, its composition and its classification. Much of this information should be available 
in the SDS, however an SDS under REACH usually does not contain all the information 
required by Annex VIII. Duty holders under Article 45 will thus normally need to complement 
information from other sources or consult their supplier for more specific information, 
especially regarding composition, unless the special provisions allowed by Annex VIII apply. 
The specific information requirements for the different submission types (standard and limited, 
individual and by group) and for the cases where derogations from standard information on the 
composition apply, are listed in Part B of Annex VIII and detailed in the following section 5 of 

34 Such a third party can submit the notification but cannot take over the obligations of the importers. If 
such a solution is used, ECHA recommends that the submitting entity must be able to document that it 
has been mandated to act on behalf and in the name of the duty holder who acknowledge that they 
remain solely and fully responsible to fulfil all their obligations associated with the notification. The 
documentation may need to be made available to the competent authorities and to the relevant 
enforcement authorities. 

 
 
 
 
 
 
 
 
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this Guidance document. 

The language used in the submission must be that of the Member State where the mixture is 
being placed on the market, unless the Member State specifies otherwise. Some of the 
Member States may accept submissions in more than one language or in English as an 
alternative to their own language(s). Information on the language(s) accepted in each Member 
State for the submission is available on ECHA’s Poison Centre website in the Overview of 
Member states decisions on implementing Annex VIII to the CLP. When the company places 
the same mixture on the market in more than one Member State, the information will need to 
be provided in all the appropriate languages. 

The ECHA Submission portal supports multi-market submissions with the distribution of the 
notification to the relevant appointed bodies. The portal allows providing part of the 
information in the specific language(s) of the relevant Member State(s), for example by means 
of a structured format containing standard phrases (see section 6.2). For certain other 
information, the format provides for multi-language fields which have to be filled in manually 
in each relevant language.  

4.1.1 Supporting poison centres 

In order to improve the emergency response and facilitate the work of poison centres in 
general, labels for hazardous mixtures (within the scope of Article 45) placed on the market 
are now generally required to carry a Unique Formula Identifier (UFI). A UFI enables rapid and 
unambiguous identification of the information submitted on the mixture by any poison centre 
called upon to provide advice on dealing with a poisoning incident. A mixture being subject to 
the notification obligation according to Annex VIII may not be placed on the market, if it does 
not carry a UFI which is linked to a valid submission which contains all of the required 
information. This is essential to ensure the provision of relevant information in the event of an 
emergency response.  

4.2 The UFI for mixtures and products 

4.2.1 What is a UFI? 

The UFI is a Unique formula identifier and consists of a unique 16-character alphanumeric 
code. A single UFI is assigned to a specific mixture composition, submitted as part of the 
notification and then included on the mixture label (or packaging). This unambiguously links 
the submitted information on a mixture to a specific product on the market. Here, we refer to 
a mixture as a formulation containing the chemical components having associated properties 
for example composition, toxicological properties, colour(s), and pH; while a product refers to 
the mixture in the form in which it is supplied to the user and defining the other aspects for 
example trade name, packaging, and product category (i.e. intended use). 

The UFI is meant to complement the other means used by poison centres to identify the 
mixture, such as the product and/or brand name. The inclusion of the UFI on the label should 
coincide with the submission of information. When entering the UFI in their databases, 
appointed bodies or poison centres can rapidly identify the exact mixture involved which is 
especially important if there are two mixtures with the same trade name. The UFI must always 
be preceded by the acronym ‘UFI:’ and the code itself is separated into four blocks which 
consists a combination of numbers and upper-case letters - except those considered 
ambiguous letters ’O’, ’I’, ’L’, ’B’, and ’Z’.  

An example of what a UFI looks like: UFI: E600-30P1-S00Y-5079 

While the UFI is an information requirement to be submitted to the appointed body according 
to Annex VIII, a submission made voluntarily for mixtures not subject to Annex VIII, should 
preferably include the UFI as well. This will allow the link with the submitted information in 
case the mixture is used as MiM identified with the UFI. 

 
 
 
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4.2.1.1 The relationship between a UFI and a mixture composition 

A UFI must only be ever assigned to one, and only one, mixture composition. In other words, 
all products for which a submission is made with the same UFI need to share the same 
composition. This applies to mixtures whose composition can be precisely defined and also to 
mixtures with a composition which can vary only within certain limits: 

-  within the boundaries of a Standard Formula (when applicable, see section 5.6); or 

-  within the boundaries of the composition from the SDS (when applicable, see sections 

5.6 and 5.7); or 

-  according to the specific interchangeable component(s) included in an ICG and present 

at some point in time (see section 5.5); or 

-  within the variation allowed in a group submission (see sections 4.5 and 5.4); or 

-  within the variation given by the components identified under the same Generic 

Component Identifier (see section 5.3.3).  

However, different UFIs can be used for the same mixture, as long as those UFIs have been 
submitted to the relevant appointed bodies. The same mixtures may be placed on the market 
under different trade names and by the same or different companies. In those cases, 
companies can decide to use the same UFI, as long as the mixture composition does not 
change, or the variation is limited and does not have an impact on the toxicological information 
(see section 5 for details). For marketing and/or confidentiality reasons, companies may also 
decide to generate and affix on the label of each product a different UFI although the mixture 
composition of those products remains the same. In such case, all UFIs assigned to the 
mixture must be provided as part of the submission for that mixture. It is to be noted that 
using more than one UFI on the label or package would defy the objective of the UFI to be a 
rapid identification tool and could seriously hamper a rapid emergency response and should be 
avoided (note that bespoke paints are a special case). 

4.2.2 Generation of UFIs 

Companies are responsible for the generation and management of UFIs for their mixtures 
(section 4.2.3). A software application (the UFI Generator) has been developed to allow 
industry to generate UFIs. Alternatively, a UFI generating algorithm is also available for users 
who wish to incorporate the UFI Generator into their own systems. The tools and support are 
available on the ECHA Poison Centres website at https://poisoncentres.echa.europa.eu/ufi-
generator .  

UFI generation is based on the value added tax (VAT) number of a company (or a specific 
company key35) and a formulation number assigned by the company to a specific mixture. The 
use of the VAT number is meant to ensure uniqueness and avoid duplication between UFIs 
generated by two different companies. Indeed, different companies will use similar formulation 
numbers, but as long as they use different VAT numbers, the algorithm will generate a 

35 It is possible for companies to generate UFIs even if they do not have a VAT number or prefer not to 
use it for the generation of their UFIs with a ‘company key’. This possibility is available specifically for 
companies using the UFI generator algorithm. For companies using the UFI Generator tool, you can avoid 
using the VAT number and a specific company key by declaring that your ‘company does not have a VAT 
number or has chosen not to use it to generate a UFI’ directly in the tool. More information and support 
are available on the UFI dedicated section of the ECHA Poison Centres website 
(https://poisoncentres.echa.europa.eu/ufi-generator). 

 
 
 
 
 
 
 
 
 
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different UFI. The VAT number therefore is not supposed to be a means used for identification 
or tracking of companies or products. 

4.2.3 UFI management  

Companies will need to keep an overview in their internal systems of which mixture 
corresponds to which UFI, which formulation numbers were used under a specific VAT number 
or company key, and keep track of changes and updates, in order to avoid the use of the same 
UFI for mixtures with different compositions.  

It is strongly recommended that the data management system allows maintaining and 
recording for internal use the relation between the following values for every mixture:  

•  The UFI; 
•  The VAT number (or company key) used to generate the UFI; 
•  The internal formulation number used to generate the UFI; 
•  The internal formulation code of this mixture, if different from the formulation number. 

As described in the user guide on “UFI generator application” 36 the UFI is normally generated 
on the basis of a company VAT number (or company key) and on an internal formulation 
number. The latter needs to be a number between 0 and 268435455 (maximum 9 digits) and 
therefore companies need to keep their own records/cross referencing and manage an internal 
mapping of their formulation codes with the internal formulation numbers.  

Normally companies identify their products with an internal code; if these codes contain 
letters, special characters, or are more than 9-digits, they cannot be used directly for the 
generation of the UFIs. Therefore, the company's internal coding system will need to be 
adapted to use the UFI Generator. As such, it will be necessary to convert the original internal 
code and generate a new internal company formulation number first. 

In addition, if a single existing internal company code is used to represent different mixtures, it 
could be necessary to generate new different internal codes for each mixture to be used in the 
UFI generation. This may be necessary in order to ensure different UFIs are assigned to 
mixtures with differences in composition (this is likely to be the case when mixture 
management or SDS generation tools are used by the company).  

It is strongly advised to record the information mentioned above. Mapping should be 
established in the system that companies/submitters will use to manage their submissions in 
order to guarantee that a correct relation is maintained between the mixture information 
stored (company, trade name, composition, physical-chemical properties, classification) and its 
UFI. This will be useful for the efficient management of the current products (e.g. different 
batches of the same mixture for which labels have to be created) and to keep track in case of 
updates. 

4.2.4 Working with “the one UFI, one composition” principle  

In this section a number of examples are presented showing with increasing level of 
complexity how and when a UFI has to, or can be, generated; graphical representations are 
also provided to support the reader. The following examples illustrate the flexibility around UFI 
generation and its use, while ensuring the essential condition is fulfilled: one UFI – one 
composition. Note that the same UFI(s) can be used for several products (and by different 
companies) only if those products share the same composition according to concentration 
ranges defined in Annex VIII.  The same UFI(s) can also be used across the EU market for the 

36 Available at https://poisoncentres.echa.europa.eu/ufi-generator.  

 
 
 
 
 
 
 
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same mixtures, providing that for those mixtures, a submission including the UFIs has 
previously been made in the relevant Member States. 

Example 7: One mixture composition: 1 UFI -> 1 product "SuperClean" placed on the market  

Example 8: One mixture composition: 2 or more UFIs –> 2 or more products placed on the 
market with same composition 

Example 9: One mixture composition: 1 UFI –> 3 products placed on the market 

Example 10: One mixture composition: 2 or more UFI –> 1 product placed on the market 

Mixture Composition AUFI 1SupercleanMixture Composition AUFI 2SuperpulitoUFI 1UFI nSupercleanProduct nMixture Composition AUFI 1SupercleanSuperpropreSuperpulitoMixture Composition AUFI 2SupercleanUFI 1UFI 3 
 
 
 
 
 
 
 
 
 
 
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Example 11: One mixture composition: 2 or more UFIs –> 2 products placed on the market 

Note to examples 7 to 11 When several UFIs have been generated and assigned to one mixture, all 
those UFIs need to be included in the submission to the relevant Member State and can be submitted 
individually or in the same submission. When more than one UFI is assigned to the same product 
(containing the same mixture), it is sufficient and recommended to include only one UFI (among those 
notified to the relevant appointed body) on the label of the product (examples 10 and 11). Note that it is 
not mandatory to include the UFI in the SDS unless the mixture is unpackaged (Annex VIII, Section 5.3 
of Part A), but it can be included voluntarily. The inclusion of multiple UFIs on the SDS is not 
recommended, and the UFI(s) used on an SDS should be notified to the relevant appointed body. 

For group submissions, one UFI can be used to cover the whole group of mixtures (although it 
is not an obligation) even though the mixtures in a group do not necessarily have the exact 
same composition. This is illustrated in examples 12 and 13 below. Note that the allowed 
differences in the composition of mixtures in a group submission are limited (see section 4.5 
and 5.4 for details).  

Example 12: Three similar mixtures (1 Group submission) - one UFI, one or more products 
placed on the market 

Mixture Composition AUFI 2SuperpulitoUFI 1UFI 3SupercleanUFI 4Mixture Composition A2UFI 2SupercleanMixture Composition A1Mixture Composition A3GROUP SUBMISSIONSuperpropreSuperpulito 
 
 
 
 
 
  
 
44 

Example 13: Three similar mixtures (1 Group submission) – several UFIs, one or more 
products placed on the market. 

4.2.4.1 UFI and mixtures in a mixture 

As defined in Annex VIII, mixture components can include other mixtures, referred to as a 
mixture in mixture (MiM). By default, duty holders under Article 45 need to submit information 
on the full composition of their mixture and therefore include information on the MiMs’ 
composition. However, when there is no access to the full composition of the MiM supplied (as 
is most often the case), the MiM's UFI can be indicated in the submission together with its 
product identifier. Therefore, the UFI can be used to identify the MiM without the need to 
indicate any of its components, only when the submission for the MiM, including its UFI, has 
been previously made to the appointed bodies in the Member States where the final mixture(s) 
(containing that MiM) is(are) placed on market. In this case the UFI of the MiM will allow 
appointed bodies (and ultimately the poison centres) to link the mixture submission with the 
submission of the MiM and retrieve the relevant information in case of an emergency involving 
the mixture containing such MiM. Full details about information requirements for mixtures and 
their components is provided in section 5. In particular section 5.3.3 explains how a MiM can 
be identified and the conditions under which this can be done using the UFI.  

Example 14: 1 Mixture (with 1 MiM identified via its UFI) - 1 UFI for the mixture – 1 product 
placed on the market 

Mixture Composition A2UFI 1SupercleanMixture Composition A1Mixture Composition A3GROUP SUBMISSIONUFI 1, UFI 2, UFI 3SuperpropreSuperpulitoUFI 2UFI 3Mixture Composition B:Substance 4,Substance 5,Substance 6, MiM UFI ASupercleanUFI BMixture Composition ASubstance 1,Substance 2,Substance 3 UFI A Supply to Formulator B producing Mixture BFormulator B submits to MS XSubmission in MS X 
 
 
 
 
 
 
 
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4.2.4.2 Use of the UFI along supply chain 

With careful management, the same UFI can be used by different companies as long as the 
composition of the mixture covered by that UFI remains the same. The use of the same UFI 
should however be agreed among the interested companies. Section 3.1 provides examples of 
when and how this can happen.  

4.2.4.3 Use of the UFI when the legal entity changes 

If the company generating the original UFI changes legal entity or ceases its activity, the UFI 
already generated remains valid and can continue to be used by the company successor, as 
long as the mixture composition remains the same (in the allowed concentration ranges 
defined in Annex VIII). This means that following a legal entity change, when the company 
successor becomes the duty holder of any mixtures already notified, they will need to make 
their own submission with the choice of re-using the relevant UFI or assign new ones. 

4.2.5 Toll formulator and UFIs 

The toll formulator as a duty holder under Article 45 (see section 3.1.1.2) is generally expected 
to generate a UFI for the mixture being placed on the market, include it in their submission 
and provide it to their customer (see option 1 in example 15 below). If the customer does not 
change the formulation or partake in other activities e.g. rebranding/relabelling or, distributing 
in additional market areas where a notification has not been made, they can include the 
original UFI provided by the toll formulator on their label (if the toll formulator does not 
provide the product already labelled).  

Alternatively (option 2), the toll formulator’s customer can create their own UFI if desired 
(instead of or in addition to the toll formulator’s UFI) which needs to be included in the toll 
formulator’s submission to the Member States where it is placed on the market (and include it 
on the label). If the customer makes other changes e.g. to the product identifiers, packaging, 
or places the mixture on other markets, this information can also be included in the toll 
formulator’s notification. 

It is also possible that the toll formulator’s customer may want to make the submission 
themselves (option 3) either in addition to the toll formulator’s submission or relieving the toll 
formulator of the task. In the latter case, this should be agreed between both parties bearing 
in mind that the toll formulator remains the duty holder under Article 45. 

When submitting via the ECHA Submission portal, a third-party user, i.e., a ‘foreign user’, can 
perform actions via the duty holder’s ECHA account37, to assist them with preparing and 
submitting a poison centre notification. If there are no confidentiality concerns, a foreign user 
can be, for example, the customer of the toll formulator. 

37 More information on ECHA accounts management is available in the ECHA accounts Manual available at 
https://echa.europa.eu/support-echa-accounts-and-eu-login. The possibility to assign a “foreign user” is 
included. Relevant information on Legal Entity management is provided also in the PCN: a practical Guide 
available at https://poisoncentres.echa.europa.eu/prepare-and-submit-a-pcn. 

 
 
 
 
 
 
 
 
 
 
 
 
46 

Example 15: 1 Mixture by a toll formulator - 1 or more UFIs for the composition – a third 
company places on the market/rebrands – Original UFI or new UFI 

4.2.6 UFI and the EU importer/non-EU supplier 

The non-EU supplier does not have direct obligations to make a poison centre notification. In 
addition, they are not permitted to submit a notification using their own ECHA account38 in the 
ECHA Submission portal. The obligation to submit the notification, including the mixture 
composition, lies with the importer, whose contact details appear on the label. If the non-EU 
supplier does not wish to disclose the compositional details of the mixture to the EU importer, 
the non-EU supplier can still assist the importer with their submission obligations while 
protecting the confidentiality of the mixture information. 

A non-EU supplier can support the EU-importer with their notification obligations according to 
the following steps:  

1.  The non–EU supplier establishes a legal entity based in the EU (or a contractual 

agreement with an EU-based legal entity), who creates a UFI and makes a submission39 
to the Member States where the EU importer intends to place the mixture on the 
market. This EU-based legal entity can be anything from a commercial office belonging 
to the non-EU supplier to a service provider or another supplier in the same or different 
supply chain.   

2.  2.  The non-EU supplier then informs their customer (the EU-importer), directly or via 

the EU-based legal entity, about this UFI and confirms that the submission has been 

38 The non-EU supplier has the possibility to prepare and submit a notification acting the same way as a 
consultant e.g. as a foreign user, but in this way the information is shared with the EU-based legal entity 
or the duty holder. More information is available on the ECHA Accounts Manual at 
https://echa.europa.eu/support-echa-accounts-and-eu-login.   
39 The non-EU entity is not legally required to do so under CLP (they do not place the mixture on the EU 
market).  

TollFormulatorMixture AThird company places on the market with same label and UFI 1Submission and labelling including UFI 1 of the mixtureOption 1Submission including UFI 2 of the mixture provided by customer Option 2Third company  places on the market with UFI 2Third company generates own UFIx and prepares own submissionSubmission including UFIx instead and on behalf of duty holderThird company places on the market with UFIx SupplyOption 3 
 
 
 
 
 
 
 
 
 
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made. It is possible for the non-EU supplier to already label their product with the 
correct UFI (#1) before supplying it to the EU importer.   

3.  Subsequently, the EU importer, who is the actual duty holder, makes their own 

submission (with their own UFI #2) with a reference to this UFI (#1) in relation to the 
compositional information i.e. a submission for a mixture containing 100% of the MiM 
supplied by the non-EU supplier. This option could be useful also when the EU importer 
uses the mixture to formulate another mixture.   

The EU importer and non-EU supplier are strongly recommended to enter into a contractual 
agreement to cover the details of the submission approach chosen. It should be kept in mind 
that the EU importer remains the duty holder and therefore responsible for compliance with all 
obligations under CLP. 

Example 16: Import into the EU.  Non-EU supplier acting via EU-based legal entity to protect 
confidential business information 

Appointment of EU-based LE + (possibly) UFI#1 generationVoluntary submission (in the MS where the EU importer intends to place the final mixture on the market)Non-EU supplier(non duty holder)Generation UFI#2(normally using EU importer VAT number)No further formulationFurther formulationMandatory submissionUFI#3Composition:x% UFI#1+ w% component D+ j% component E= 100%UFI#1 communicatedUFI#1Full composition:x% component A + y% component B + z% component C = 100%EU-based LE (non duty holder)EU importer (duty holder)Mandatory submission (in the MS where the EU importer intends to place the final mixture on the market):UFI#2Composition: 100% UFI#1Generation UFI#3(normally using EU importer VAT number) 
 
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4.2.7 New UFI as a result of composition changes 

Since the main purpose of the UFI is to unambiguously link a product on the market and the 
corresponding information relevant for an emergency health response, the UFI is always linked 
to a specific composition40. Annex VIII to CLP requires a new UFI to be created in case the 
mixture composition changes according to the below criteria, and an update made.  

1.  A change of components (addition, substitution or deletion of one or more 

components) - the addition, substitution or deletion of one or more components is 
considered a major change requiring the creation of a new UFI41 and an update of the 
whole submission as a ‘new notification following a significant change in composition’ 
must be made accordingly. Note that this applies to the components which are required 
to be indicated in the submission (e.g. the change in a component which is not 
classified for health or physical effects and present in concentration < 1% would not 
require a new UFI). Two derogations to this principle are provided: 

a.  No change of UFI is required for mixtures in a group submission containing 

perfumes if the change in the composition only relates to those components. To 
be noted that if a perfume component is removed from all the mixtures of the 
group an update of the submission is required (see section 7.4.6; according to 
B.3.1 perfume components must be present in at least one mixture of the 
group). 

b.  No change of UFI is required for mixtures containing an ICG if the change only 
concerns one or more components included in an ICG already present in the 
original submission. To be noted that if a component is added, replaced or 
removed from an existing ICG an update of the submission is required (see 
section 7.4). 

Note on ICGs: a new UFI is required also in case a new ICG is added, or an existing 
individual component is replaced by an ICG. This is because the new composition may 
include components not originally present.  

Note on GCI’s: if the original submission contains components identified with a generic 
component identifier (GCI), (see section 5.3.3 for more details), changes in the 
identification of such components does not require a new UFI. However, if components 
originally covered by a single GCI are split into several GCI (e.g. to specify differences 
in the classification for physical hazards) or identified individually according to the 
standard rules, a new UFI is required. Further, the addition of a GCI in a submission 
which did not originally include one, requires a new UFI. 

2.  A change in concentration beyond the concentration range provided in the 

original submission – For the declaration of the concentration of mixture components 
(including an ICG) it is possible to use concentration ranges (see section 5.3.3.2 on 
information on mixture components). If the new concentration of a particular 
component exceeds the given range (indicated in the original submission) a new UFI 
has to be created, and an update of the whole submission as a ‘new notification 
following a significant change in composition’ has to be made accordingly. If the change 
of the actual concentration is within the original range, there is no requirement to 

40 Note, in the case of group submission the same UFI could be used to refer to several similar mixture 
compositions. In the case of submissions referring to Standard Formulas or including interchangeable 
component groups, the same UFI can be used to refer to a limited variable composition. 
41 To be noted that the substitution of one component with another with identical composition and hazard 
profile (possibly following a change of supplier) does not trigger the need for an update or a new 
submission. 

 
 
 
 
 
 
 
 
 
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update the UFI and no requirement to update the submission. This is valid also for 
components identified with a GCI. 

3.  A change in concentration beyond the limits allowed for exactly declared 
concentrations - For the declaration of the concentration of mixture components 
(including an ICG) it is possible to use the exact concentration, in which case 
concentration changes are allowed within certain limits (see section 5.3.3.2 on 
information on mixture components). If the new concentration exceeds the allowed 
variation, a new UFI must be created and therefore an update of the whole submission 
as a ‘new notification following a significant change in composition’ has to be made 
accordingly. If the new concentration does not exceed the allowed variation, (which is 
always measured against the initial submission, regardless of the number of possible 
subsequent voluntary updates), the submission can be voluntarily updated without the 
need for a new UFI. The same applies in case of further changes as long as the new 
concentration does not exceed the total allowed variation. Furthermore, a concentration 
initially provided with an exact value, can be updated to a range without the need for a 
new UFI, as long as the range is within the allowed limits (addressed in section 
5.3.3.2). 

This is valid also for components identified with a GCI. 

4.  A change in the composition of a mixture that conforms with a Standard 
Formula (as a whole or partly) listed in Part D, in a way that it does not 
conform to that Standard Formula anymore – if a new component, not included in 
the Standard Formula, is added or the new concentration of an existing component is 
outside the range specified in the Standard Formula, or a component listed in the 
Standard Formula is removed (unless the original concentration range includes “0”42), a 
new UFI is required. This is the case also when a Standard Formula is used to identify 
part (i.e. one or more components) instead of the full composition of the final mixture 
and the changes concern this part of the composition. To be noted that these changes 
require an update of the whole submission as a ‘new notification following a significant 
change in composition’ with the provision of the full standard requirements (i.e. the 
mixture or the part of it does not conform with the Standard Formula anymore and 
cannot benefit from the special provisions; see section 7.4). 

5.  A change in the composition of a mixture which originally conformed with a 

Standard Formula listed in Part D, but was notified by providing composition 
information from the SDS, in a way that Section 3 of the SDS requires update 
and the mixture does not conform with the Standard Formula anymore – If for 
any reason Section 3 of the SDS of the mixture needs an update with regard to the 
composition, a new UFI is required and an update of the whole submission as a ‘new 
notification following a significant change in composition’ has to be made accordingly 
with the provision of the full standard requirements (i.e. the mixture does not conform 
with the Standard Formula anymore and cannot benefit from the special provisions; see 
section 7.4). This can be the case when a component to be indicated in Section 3 of the 
SDS in accordance with Annex II of REACH and not present in the original Standard 
Formula is added43. 

6.  A change in the composition of a fuel listed in Part B, Section 3.7 of Annex VIII 
which was notified by providing composition information from the SDS, in a 

42 The reason for this is that the component could have been already absent from the original mixture. 
43 Please, refer to the ECHA Guidance on the compilation of safety data sheets for details about the 
relevant provisions. 

 
 
 
 
 
 
 
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way that Section 3 of the SDS requires update – If for any reason Section 3 of the 
SDS of the mixtures needs to be updated with regard to the composition, a new UFI is 
required and an update of the whole submission as a ‘new notification following a 
significant change in composition’ has to be made accordingly (see section 7.4 for more 
information).  

The changes discussed in this section concern components which are required to be indicated 
in the original submission, trigger the need to create a new UFI and the need to update the 
whole submission as a ‘new notification following a significant change in composition’44. 
However, it is to be noted these changes will not necessarily change the classification of the 
mixture and therefore an update of the label in this regard would usually not be triggered (it 
may nevertheless need to be updated because of the new UFI, when this is printed on it; see 
next section for more details on the labelling options). 

It is also to be noted that changes to the UFI may occur because of a commercial decision of 
the company, even if none of the above conditions are fulfilled (the composition remains the 
same and a change of the UFI is not legally required). A company may decide to change the 
UFI voluntarily whenever other changes occur, possibly because of their internal change 
management system (an example would be a change of packaging which is considered by the 
company as a new product). For voluntary changes of UFI, an update of the submission as ‘a 
change in the product identifier’ is required. 

Special considerations apply to group submissions. Details are provided in section 7.4.6. 

4.2.7.1 Changes in MiM’s UFI 

When a mixture is used by a downstream user company as component of another mixture, a 
change in the UFI of this MiM may trigger the need to update the UFI of the final mixture.  

It may be in some cases that a MiM supplier changes the UFI either for commercial reasons 
(i.e. they can guarantee that the mixture composition remains the same), or the mixture 
composition has changed. In both cases the submission for the MiM needs to be updated to 
add the new UFI.  

Where the MiM composition has changed, the new MiM UFI will also need to be reflected in the 
submission of information for the final mixture (see the examples in section 7.4.4) and this 
requires also the UFI of the final mixture to be changed. 

If the UFI of the MiM changes for commercial reason only (i.e. no changes in the composition) 
there is no impact on the final mixture and therefore in principle its UFI does not need to be 
changed. This is possible if the downstream user has information from the supplier that the 
MiM composition is actually the same.  

4.2.8 Display, position and placement of UFI 

According to Annex VIII, the Unique Formula Identifier (UFI), if applicable, must be added to, 
i.e. printed on or affixed to, the supplemental section of the label of mixtures falling under the 
scope of Article 45 and Annex VIII. Alternatively, the UFI can be printed or affixed to the inner 
packaging. 

44 When the mixture composition changes beyond the allowable limits defined in Annex VIII, by default, 
this  leads  to  two  chemically  different  mixtures  on  the  market.  In  this  case,  a  new  notification  must  be 
linked to the previous notification. 

 
 
 
 
 
 
 
 
 
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The UFI should be located with the other CLP-label elements, for example near the hazard 
pictograms. The inclusion of the UFI will follow the normal labelling rules, including the options 
foreseen by Article 29(1) for particular shapes or sizes of the packaging and must be printed 
on or affixed to the label or directly on the packaging of a hazardous mixture to which 
submission obligations apply (see exceptions mentioned in section 4.2.8.2).  

When the UFI is printed on or affixed to the inner packaging, it must be with the other label 
elements and clearly visible. If the inner packaging is too small or shaped in a way which 
cannot easily accommodate the UFI, it can be printed or affixed to the outer packaging along 
with the other label elements. This is meant to ensure that the UFI is easily identifiable by 
checking the label or next to the label.  

Affixing the UFI to the label or the packaging with a sticker that cannot be easily separated 
may be a useful option, for example, for mitigating the need of frequent changes to the label, 
in case the product changes composition dynamically (e.g. seasonal changes or frequent 
changes of suppliers). 

In case of multiple-layer packaging, it is not necessary to include the UFI on each layer, as 
long as it is included on the inner packaging. This may reduce the burden, for example, in 
cases where frequent formulation changes occur requiring a new UFI to be indicated. In any 
case, the exact positioning of the UFI is left to the discretion of the person responsible for 
designing the label or designing the packaging, though as a rule, the UFI must be easy to 
locate and read.  

In cases where the shape or size of the inner packaging does not allow the inclusion of the 
UFI, this can be affixed on a fold-out label, a tie-on tag or an outer packaging, always with the 
other label elements. Section 4.8 of Guidance on Labelling and Packaging in accordance with 
CLP provides more details about labelling requirements and options. 

In general, the inclusion of the UFI in the safety data sheet is not a standard requirement. In 
cases where a hazardous mixture is used at an industrial site, the UFI may be indicated in 
Section 1.1 of the SDS (in this case the inclusion on the label or packaging is not mandatory; 
see section 4.2.8.2 for further details). 

In the case of hazardous mixtures which are sold not packaged, the UFI must be indicated in 
Section 1.1 of the SDS45. In the specific case of hazardous mixtures listed in Part 5 of Annex II 
to CLP (ready mixed cement, concrete in the wet state, mixtures supplied at a filling station 
and directly pumped, vehicle fuels) that are supplied to the general public, the UFI has to be 
included as specified in the relevant provision.  

The UFI code itself (wherever it is used) must be preceded by the acronym "UFI:" in capital 
letters and must be clearly visible, legible and indelibly marked once printed. The acronym 
“UFI:” must always be used using the Latin alphabet, independent of the country, language 
and national alphabet(s) and must be followed by a colon. 

To enhance the recognition of the UFI by users and consumers and to assist the 
communication with appointed bodies and poison centres, no additional marker than “UFI:” 
should appear before the actual UFI code46. The three hyphens separating the blocks of the 
UFI must be printed. To help distinguish the acronym from the beginning of the UFI, an 

45 Section 1.1 of Annex II to REACH.  
46 In exceptional circumstances when the same label is used in different countries where different UFIs 
are used, a country code should be used in proximity of the UFI code (see section 5.3.1.1 of the 
Guidance on labelling and packaging in accordance with CLP). 

 
 
 
 
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optional space may be placed after the colon (e.g. if it can improve the legibility using the 
selected font): 

UFI:VDU1-414F-1003-1862 

-  23 characters on a single line (most preferred 

string) 

UFI: VDU1-414F-1003-1862 

-  24 characters on a single line 

Alternatively, the UFI can be printed on two lines and the second hyphen omitted. In the latter 
case, using a monospaced font is strongly advised to keep the blocks aligned: 

UFI: VDU1-414F 
       1003-1862 

UFI:  
VDU1-414F 
1003-1862 

-  23 characters on two lines 

-  22 characters on three lines 

The minimum font size of the characters is established in Table 1.3 of Annex I and must be 
applied from 1 January 2027 at the latest. The size depends on the capacity of the package 
with an absolute minimum of 1,2 mm for packages not exceeding 0,5 litres. To facilitate its 
function, the UFI may stand out from the rest of the text on the label, e.g., by printing it in 
bold or printing it in a larger size. Section 1.2.1.5 of Annex I gives further requirements for the 
text of label elements according to Article 17, applicable from 1 January 2027. The text must 
have the following characteristics: 

•  Printed in black on a white background. 

•  The distance between two lines must be equal or above 120% of the font size. 

•  A single font must be used that is easily legible and without serifs. The letter spacing must 

be appropriate for the selected font to be easily legible. 

More details can be found in section 5.2 of the Guidance on Labelling and Packaging in 
accordance with CLP47). This afore cited Guidance also provides, but is not limited to, 
information on: 

•  Exemptions for labelling requirements in specific cases in section 5.3 (e.g. small 

packaging and outer packaging). 

•  Specific rules for transport labels and labelling outer, inner and single packaging in 

section 5.4. 

•  Example labels e.g. for multi-component products in section 6. 

47 See ECHA Guidance on Labelling and Packaging in accordance with Regulation (EC) 1272/2008 
https://echa.europa.eu/guidance-documents/guidance-on-clp 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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4.2.8.1 UFI and multi-mixture / multi-component products 

Mixtures can be placed on the market not only as products containing a single mixture, but 
also as part of a set of multiple mixtures (e.g. reagents, packs with multiple samplers48 or 
testing kits). In these cases, each single mixture bears the label relevant to that mixture, 
where required. Each mixture that is part of a set and is classified as hazardous regarding 
human health or physical effects, has to have its own UFI, which needs to be included on the 
respective label. 

In other cases, mixtures are placed on the market as part of a multi-component product, 

•  where each mixture is in a separate container, but the containers are purchased 

together. A new mixture will then be created upon the use of the product following 
active mixing by the user or automatic mixing by means of the provided device part of 
the packaging (e.g. certain adhesives, resin with a hardener, paint with an activator).  

•  where the mixtures are not intended to be mixed but rather acting separately (e.g. dish 

washing tablets, laundry tabs).  

In any case, the company placing multi-component products on the market must provide a UFI 
for each component-mixture in separate submissions49. Nevertheless, information concerning 
the final mixture is also potentially important for the emergency response and should be 
provided (if available and relevant) in the submission of the component mixtures (e.g. in the 
toxicological section). The intended way how the mixtures are expected to act (e.g. expected 
to mix or not) and the proportion in which the component mixtures are foreseen to be mixed in 
the final mixture (if relevant) is an example of such final mixture related information which 
could be provided. Additionally, it may be useful to indicate whether the mixing ratio can be 
influenced by the user or not. Section 6.2 of the Guidance on Labelling and Packaging in 
accordance with CLP provides relevant additional information and examples on the labelling of 
these specific products.  

The PCN format used to prepare PCN dossiers in the submission portal provides for the 
possibility to link different mixtures (and thus notifications) which are part of a multi-
component product, by means of a PCN Multi-component identifier. Including this identifier in 
each mixture’s submission shows that the mixtures belong together as part of a multi-
component product. 

4.2.8.2 Exemption from labelling requirements [A.5.3] 

For mixtures which are intended to be used at industrial sites it is not mandatory to include the 
UFI on the label (or packaging) provided it is indicated in the SDS. It is to be noted that this 
option is not limited to mixtures eligible for a limited submission (i.e. mixtures intended to be 
used at industrial sites only, as described later in section 4.4). It applies also to mixtures which 
are supplied to industrial sites but are included in consumer or professional products by 
downstream users (i.e. do not benefit from the limited submission which will be described 
later, in section 4.4). 

48 Not to be confused with samples for scientific research and development 
49 The rationale is that the obligation to submit information concerns mixtures actually placed on the 
market, i.e. the single mixtures which are part of the product, and not the mixture created upon use or 
the set of mixture constituting a kit. Furthermore, the label of the product bears the information on the 
component mixtures (and hence their UFIs) and not of the final mixture. 

 
 
 
 
 
 
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4.2.8.3 Special labelling requirements for bespoke paints [Article 25(8)]  

The duty holder may decide to generate a UFI and submit information for the bespoke paint 
itself. In this case, the standard provisions apply and only the bespoke paint’s UFI will be 
included on the label. Alternatively, if the duty holder decides to benefit from the exemption 
for bespoke paints (see section 3.3.1.3.1), specific provisions apply. 

When information has not been submitted on the final bespoke paint, the UFIs of each of the 
component mixtures present in the final paint above a concentration of 0.1%, and subject 
themselves to notification obligations, must be added to the supplemental labelling information 
of the final paint. These have to be 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 Annex VIII. Examples on how this can be done are given in Section 6.3 of the 
Guidance on labelling and packaging. 

This means that the UFIs of the paint base and of the relevant individual tinter mixtures, or of 
all the toners used in a final paint (where they are subject to the obligation to submit 
information under Article 45 CLP and present above 0.1%) need to be displayed on the 
bespoke paint’s label in order to allow the emergency operator to identify the hazardous 
components and hence to retrieve the information required for appropriate medical response 
related to exposure to the final paint. More details on the display of the UFIs are provided in 
section 4.2.8. 

It should be noted that when the concentration of any mixture with a UFI in the bespoke paint 
exceeds 5%, the concentration of that mixture must be included next to its UFI in the 
supplemental information on the label of the bespoke paint, in accordance with section 3.4. of 
Part B of Annex VIII. The indication “≤5%” could be voluntarily added next to the UFI of other 
components that have to be indicated. 

4.3 EuPCS 

A harmonised European product categorisation system (EuPCS) maintained by ECHA50 is used 
to describe the intended use of a mixture for which information according to Annex VIII has to 
be submitted (refer to section 3.4 of part A of Annex VIII). Examples of product categories 
from the EuPCS include "Hand dishwashing detergents", "Adhesives and sealants for 
construction", "Decorative paints and coatings"51. The product category does not cover 
toxicological information, composition or type of packaging, which should be provided in other 
sections of the submission format.  

Information on a mixture's product category may be used to support poison centres and 
appointed bodies in a harmonised approach to statistical analyses and reporting of poisoning 
cases between EU Member States. In addition, the EuPCS may serve as an additional aid to 
poison centres in the identification of the product in a poisoning case where no other 
information for identification is available.  

When making a submission for a hazardous mixture, duty holders must assign a product 
category which best defines the intended use of the product(s). The same principle is followed 
in the case of mixtures that may fit multiple product categories, for example, a 2-in-1 laundry 
detergent also containing a stain removal agent: it is the responsibility of the notifier to select 

50 The current EuPCS is based on the system originally developed by the Commission following the “Study 
on a Product Category System for information to be submitted to poison centres” available at 
http://ec.europa.eu/growth/sectors/chemicals/poison-centres/.  
51 The latest version of the EuPCS is available from the ECHA Poison Centre website at 
https://poisoncentres.echa.europa.eu/eu-product-categorisation-system.  

 
 
 
 
 
 
 
 
 
 
 
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the main intended use, which in this case, would likely be a laundry detergent. In the specific 
case where a mixture has a dual use, one of which has either a biocidal use or a plant 
protection product use (e.g. a detergent that is also a biocide), the main intended use must 
always be categorised according to the corresponding biocidal or plant protection product 
category. An EuPCS practical guide has been published52 to support categorising products 
according to their main intended use. 

It should be noted that the main intended use referred to in this section is different from the 
intended use types, i.e. a mixture for consumer use, professional use, or industrial use, as 
described in section 3.4. The ‘use type’ is based on the final end user of the mixture (and 
determines the information requirements) while the ‘main intended use’ is based on the user 
next in the supply chain. To illustrate this, consider an ‘original mixture’ for example a raw 
material fragrance mixture, which is eventually incorporated into a ‘final mixture’ for example 
a detergent that is subsequently placed on the consumer market. As the raw material has a 
consumer end use, the submission will need to be made fulfilling the information requirements 
for mixtures for consumer use and its intended use must be categorised as code ‘F’ - ‘Mixtures 
for further formulation’. 

ECHA is responsible for the maintenance and any changes to the EuPCS. Requests for updates 
or adaptations can be made following the procedure detailed on the ECHA Poison Centre 
website. 

4.4 Limited submission 

Importers and downstream users of hazardous mixtures placed on the market for industrial 
use only, have the possibility to opt for a ‘limited submission’ as an optional alternative to the 
general submission requirements [A.2.3]. This option applies also to a mixture included in a 
final mixture intended for professional or consumer uses, when the latter are outside the scope 
of Article 45 and Annex VIII (“mixtures with an end use not subject to notification”). 

In a limited submission, information pertaining only to the composition of industrial mixtures 
submitted to the appointed body may be limited to the information contained in the SDS. 
However, it must be ensured that additional detailed information on the composition of such 
mixtures is rapidly available on request, in the event of an emergency health incident [A.2.3 
and B.3.1]. The rationale for this specific regime is provided in Recital 11 of Regulation (EU) 
2017/542,53 which specifies that  

“on 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 
industrial use should be allowed to fulfil limited information requirements.”  

The regulatory burden for the industry is thus tailored proportionally upon the specific needs of 
the ‘industrial use’. 

Companies which intend to make a limited submission are invited to consult ECHA’s Guidance 
on the compilation of safety data sheets,54 providing comprehensive guidance on the 
compilation and handling of SDSs. Typically, an SDS is less detailed than what is required in a 
‘full submission’ pursuant to Annex VIII to the CLP. See section 5.3.4 for more information.  

It needs to be noted that if a submission was made for a mixture originally intended for 

52 The EuPCS Practical Guide is available at https://poisoncentres.echa.europa.eu/eu-product-
categorisation-system. 
53 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 relating to emergency health response. 
54 Guidance on the compilation of safety data sheets, in particular section 3.3 ‘Composition/ information 
on ingredients’. 

 
 
 
 
56 

industrial use only (limited submission) and this mixture starts being used in consumer or 
professional products, the full set of information required for a standard submission needs to 
be submitted before placing on the market the products with the new use type. 

4.4.1 Contacts for rapid access to ‘additional detailed product information’  

The submitters who have chosen the ‘limited submission’ approach, must, according to section 
2.3 of Part A and section 1.3 of Part B of Annex VIII, provide the contact’s details for rapid 
access to ‘additional detailed product information’. 

These contact details must include as a minimum:  

•  a telephone number accessible 24 hours per day and 7 days per week, where ‘detailed 
additional product information’, which is not included in the SDS but can be relevant for 
emergency  response  purpose,  can  be  obtained  by  the  personnel  who  is  providing  the 
emergency  response  in  the  language  accepted  by  the  specific  Member  State.  The 
requester normally belongs to bodies or institutions recognised by the appointed body or 
to the appointed body itself; this additional information refers normally to the complete 
compositional information; 

•  an  email  address  for  follow-up  exchange  of  information  between  the  submitter  (or  a 
knowledgeable  person  designated  by  the  submitter)  and  the  responsible  authority  or 
medical personnel. 

Please note that the contact details could belong to the submitter or to a third party appointed 
under the responsibility of the submitter in charge to deliver the required information. The person 
who is requested to provide the additional information may want to verify that the request comes 
from  an  appointed  body  or  emergency  response  personnel.  As  an  example,  a  reference  to  a 
submission  identifier  could  serve  this  purpose  as  it  should  be  available  to  the  submitter  and 
authorities only. 

4.4.2 Availability and content of the additional information and rapid 
access 

The ‘additional detailed product information’ within the meaning of Annex VIII must be such to 
allow a responsible authority or medical personnel dealing with a poisoning/health incident, to 
formulate adequate preventative and curative measures. The information on the composition 
required for a ‘full submission’ pursuant to section 3.4 of Part B of Annex VIII, is considered 
sufficient for this purpose. It must be kept readily accessible to be supplied on request to the 
responsible authority or medical personnel dealing with a poisoning/ health incident.  

As it is not possible to safely define “rapid” access, the information is expected to be provided 
without delay. 

Rapid access must be provided in a language(s) of a Member State where the mixture is 
placed on the market. Additionally, the telephone number should not generate 
disproportionate cost to the Member State (e.g. ‘premium’ phone numbers or numbers located 
outside of the EU).  

Pursuant to Article 45.2 of the CLP, the requested information can be used to meet a medical 
demand by formulating preventative and curative measures in the event of an emergency. 
Annex VIII (section B.1.3) indicates that rapid access to detailed information, in case of limited 
submission, has to be available, but does not specify who can make the request. It is normally 
poison centres (or bodies other than the appointed bodies) who are dealing with poisoning 
accidents and will need rapid access to the information. In any case the appointed bodies 
remain responsible for receiving and making the information submitted under Article 45 and 
Annex VIII available to the emergency responders. Therefore, the person requesting the 
additional information should be authorised by the relevant authority.  

 
 
 
 
 
 
 
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If, following receipt of the ‘additional detailed product information’, the appointed body makes 
a ‘reasoned request’ according to Section 3.2 of Part A of Annex VIII to the submitter that 
further additional information or clarification is necessary, the submitter must provide the 
necessary information or clarification requested without undue delay (see section 7.2 for more 
details). 

It should be noted that the ‘limited submission’ is optional. A company dealing with hazardous 
mixtures for industrial use and who are required to make the submission, can also decide to 
comply with the general (full) submission requirements, thus being exempted from the 
obligation to provide 24/7 contact details for additional information. 

4.5 Group submission 

Companies may sometimes have in their product portfolio a high number of similar mixtures 
which may only slightly differ in perfume components. Therefore, in this case Annex VIII 
allows to submit, under certain conditions, information for several mixtures with a single 
submission, which is called ‘group submission’. 

A group submission is possible if: 

•  all mixtures in the group contain the same composition and  

o 

for each of the components, the reported concentration or concentration range is 
the same, with the exception for certain perfumes under specific conditions; and 

•  all mixtures in the group have the same classification for health and physical hazards.  

Section 5.4 provides more details on the information required for a group submission. 

5. Information contained in the submission 

The company that intends to place a hazardous mixture on the market for which they have to 
make a submission under Article 45 (as clarified in section 3), is required to submit the 
information specified in Part B of Annex VIII to CLP. 

This section provides guidance on which information is needed according to the legal text in 
the case of a full submission as well as in the case of limited (see section 4.4) and group (see 
section 4.5) submissions. Furthermore, information required when specific derogations apply 
are also detailed. The reference to the relevant section of the legal text is indicated in square 
brackets next to each heading. 

5.1 Identification of mixture and submitter [Part B.1] 

5.1.1 Product identifiers of the mixture [B.1.1] 

The product identifiers needed for the purposes of Article 45 and the poison centre work are 
laid out in Annex VIII in accordance with Article 18(3)(a). In addition, the Unique Formula 
Identifier (UFI) code is one of the main information elements on the label (as already 
mentioned in the previous sections) that a caller should relay to the poison centre operators to 
allow the identification of the poisoning agent (see section 4.2). 

In addition to this, there are other elements from the label which are important to poison 
centre operators such as the “complete trade name(s) of the mixture […], including, where 
relevant, brand name(s), name of the product and variant names as they appear on the label 
[…]” [B.1.1].  All names as they appear on the label are required, without abbreviations or 
non-numerical symbols to enable the specific identification of the product. The submission 
format allows other identifiers to be included in a notification such as any authorisation 
numbers or company product codes if available.  

 
 
 
 
 
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The same mixture could be placed on the market under several trade names, UFIs and for 
different intended uses. If the composition does not change, all these trade names can be 
included in the same submission55. Similarly, all identifiers must be provided for mixtures in a 
group submission. In either case, where multiple trade names/UFIs exist, the submission 
format allows notifiers to link each product identifier to the corresponding UFI (See section 
5.2.3). Further, all trade names and identifiers must be individually included in the available 
submission format, i.e. the names should not be concatenated, linked or grouped together as 
one entry.  

5.1.2 Submitter details and contact point [B.1.2] 

The responsibility for submitting information on hazardous mixtures in the context of CLP 
Article 45 and Annex VIII is that of the relevant duty holder who is referred to as the 
“submitter”. Annex VIII requires that the details of the submitter, such as their name, full 
address, telephone number and email address are to be provided in the submission. 

A distinction must be made between the submitter, who bears the legal obligation to provide 
the necessary information in a submission, and another natural person acting as a third-party 
representative of the submitter, e.g. a consultant, but who may physically prepare and make 
the submission. 

In addition, and where relevant, it is possible to indicate also the details of an additional point 
of contact for authorities to obtain information which may be necessary for providing an 
emergency response if the information is not included in the submission (appointed bodies 
may consider that additional information may be needed in case of emergency). This contact 
can be used also for queries concerning clarifications regarding the content of the submission, 
to correct potential errors or to discuss details relevant for follow up and toxicovigilance 
activities. This additional contact point could be used in case the submitter cannot provide such 
information themselves or decides not to be the qualified person to be contacted to discuss 
emergency health related issues in the context of the specific submission. In this case the 
name, full address, telephone number and email address also of this contact point have to be 
included in the submission. To be noted that this contact does not need to be available 24/7. 

5.1.3 Details for rapid access to additional product information [B.1.3] 

Submissions made for industrial mixtures which qualify for reduced information requirements, 
i.e. a limited submission, require a mandatory additional specific contact for the purpose of 
providing an emergency responder with more information if required in case of emergency. In 
order to provide rapid access to this information, the submission must contain a telephone 
number and email address and be accessible 24 hours a day, seven days a week. This service 
must be provided in the national language(s) or another language accepted by the Member 
State(s) where the product is placed on the market (see section 4.4 Limited Submissions)56. 

5.2 Hazard identification and additional information [Part B.2] 

5.2.1 Classification of the mixture and label elements [B.2.1 and B.2.2] 

The classification of the mixture for health and physical hazards has to be provided in the 
submission. There is no requirement for providing information regarding the possible 
classification of the mixture as hazardous to the environment. Environmental hazards are not 

55 Note that a limited variability in composition may still exist if, for example, generic component 
identifiers are used to cover different components or an ICG is used to cover different interchangeable 
components. See following subsections for more details. 
56 Note that this is not supposed to be the contact of the Poison Centre, but rather a number the 
emergency operator can contact to obtain more information on the mixture.  

 
 
 
 
 
 
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related to the information needed for an emergency health response but can be voluntarily 
provided for completeness. 

The classification for health and physical hazards needs to indicate the hazard classes and 
associated hazard categories relevant for the mixture actually placed on the market (e.g. 
“Acute Tox. (oral) 4”, “Flam. Liq. 2”). 

The labelling elements associated with the classification for health and physical hazards 
according to the rules set in Annex I to CLP must be provided. This includes the hazard 
pictogram code (e.g. GHS07), the signal word (Danger/Warning), the hazard statement codes 
(including supplemental hazard information) (e.g. H302) and precautionary statement codes 
(e.g. P264). 

Information about the mixture classification and the associated labelling elements must be 
consistent with the information provided in Sections 2.1 and 2.2 of the SDS of the mixture as 
specified in Annex II to REACH. Classification for environmental hazards does not need to be 
provided. It should be noted that all applicable P-statements, covering all use(s) of the 
mixture, have to be included even if all may not be required to be included in the SDS (e.g. 
statements relevant only for consumers). Note that even in situations where Annex I to CLP 
allows for reduced label elements, the full set of label elements indicated in Section B.2.2 of 
Annex VIII (and reported above) has to be included in the submission. 

5.2.2 Toxicological information [B.2.3] 

Annex VIII Part B, section 2.3, specifies that the submission has to include the information on 
the toxicological effects of the mixture or its components that is required in Section 11 of the 
SDS of the mixture. The information requirements for an SDS are specified in Annex II to the 
REACH Regulation. Note that the SDS is not an information requirement but can be attached in 
the notification (along with other information such as a copy of the label), and is encouraged 
to, in order to support the work of poison centres and appointed bodies . The information to be 
included in the submission thus has to include as a minimum all the relevant and available 
information on the toxicological health effects related to each of the health hazard classes 
covered by Annex I to CLP: 

(a) acute toxicity; 
(b) skin corrosion/irritation; 
(c) serious eye damage/irritation; 
(d) respiratory or skin sensitisation; 
(e) germ cell mutagenicity; 
(f) carcinogenicity; 
(g) reproductive toxicity; 
(h) STOT-single exposure; 
(i) STOT-repeated exposure; 
(j) aspiration hazard 
(k) endocrine disruption for human health 

For each of the above hazard classes the submission should include the information required 
for Section 11 of the SDS, which will allow the poison centres to provide adequate advice in 
case of exposure to the mixture. This could include, when available, the result of the test, 
reference to the species and test method used, and possibly information on the exposure 
period. Examples are illustrated below:  

-  Acute toxicity, oral: LD50 1310 mg/kg bodyweight (rat)   

-  Skin corrosion/irritation: Corrosive (rabbit, OECD 404, 4h) 

-  Skin sensitisation: Not sensitising (guinea pig, OECD 406) 

 
 
60 

Toxicological information specific for the mixture which should be included in the submission, 
includes, for example the acute toxicity estimate (ATEmix) where a mixture as a whole has 
been classified for acute toxicity using it. 

Annex VIII does not prescribe any specific structure for reporting such information. 
Considering that it is not possible to define in general terms what information is needed for the 
purposes of this Annex, the full content of Section 11 of the SDS could be considered 
potentially relevant for the poison centres and emergency responders. The full content of 
Section 11 of the SDS may, for example contain information on toxicokinetics, metabolism and 
distribution as well as more elaborate information on the toxicological effects and test 
methods. 

The submitter has to make sure that the required toxicological information is provided, in order 
for the poison centre to have access to the relevant information. Information included in the 
submission should not contain cross-references to other sections of the SDS. 

This information should be integrated, if needed, with relevant information concerning the final 
mixture generated upon use in the case of multi-constituent products (see section 4.2.7.1). 

5.2.3 Additional information [B.2.4] 

Additional information about the packaging, physical appearance, pH, intended use and user 
types of the mixture has to be provided in the submission. Some of the information below is 
normally contained in Section 9 of the SDS of the mixture, as specified in Annex II to REACH. 
In some cases, the submission covers multiple trade names under which the mixture is placed 
on the market (which may differ for various product’s characteristics). Some of the information 
may need to be adequately linked to the specific trade name/product to ensure that the 
emergency responders can properly identify the risks. 

The additional information is specified in Part B, Section 2.4, and includes the following: 

-  The type(s) and size(s) of the packaging used to place the mixture on the market for 

consumer or professional use. The type relates to the form of the packaging as 
supplied, for example a bottle, a box, a tube, a dispenser, etc. The type does not relate 
to the nature/composition of the packaging material. The size has to be given as the 
nominal volume(s) or weight(s) of the packaging(s). If a mixture is supplied in different 
types and sizes of packaging in any given Member State, information of all the relevant 
types and sizes placed on the market in that Member State has to be contained in the 
submission. Information about the specific type of packaging linked to each trade name 
is useful information, for both emergency response and statistical analysis purposes. 

-  The colour(s) and the physical state(s) of the mixture, as supplied. This information 

relates to the general appearance of the mixture (see section 9 of the SDS). In case the 
submission covers a mixture where the colouring agent(s) relevant to a specific trade 
name varies 57, it is not necessary to indicate the specific colour of each trade name but 
basic generic colour names can be used. It is important that colour information is 
provided taking into account its purpose, i.e. for an emergency health response and 
under the consideration that this information may be provided by a caller to the poison 
centre operator who needs to identify the mixture. The dossier preparation tools 
provided by the Agency support the identification of colours by providing the list of 
colours identified as appropriate in this context (including the possibility of indicating 

57 For both standard and group submission this is possible only if the colouring agents meet specific 
criteria which allow use of the same generic identifier, see section 5.3 for more details on information on 
mixture’s components. 

 
 
 
 
 
 
 
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multiple colours as well as colourless mixtures and, additionally, the intensity). 

-  The pH. The pH value referring to the mixture as placed on the market (i.e. 100% 

solution concentration) has to be provided.  

In the case of mixtures supplied in solid form, the pH should refer to a solution of the 
same solid mixture. Where the pH has been measured by diluting the mixture in water, 
the concentration of the solution must also be provided.  

If for any reason the pH cannot be provided, a justification must be indicated. The 
provision of a pH value does not apply to mixtures in a gaseous state. In some other 
cases it may not be meaningful to provide a pH value due to, e.g., the mixture being 
insoluble in water (the justification should be always provided). 

In general, the information has to be consistent with the SDS (Section 9 of the SDS) 
but always in compliance with the aforementioned criteria. 

-  Product category. The product category according to the EuPCS describing the intended 
use of a mixture must be provided. In case the same mixture is placed on the market 
under different trade names with different intended uses, an appropriate product 
category can be allocated to each of them. Support for selecting the most suitable 
product category can be found in the EuPCS practical manual available on the ECHA 
website https://poisoncentres.echa.europa.eu/tools. See also section 4.3 in this 
document on the EuPCS. 

-  Use types (consumer, professional, industrial) (see also section 3.4 ‘Use types of 

mixtures’. The relevant use type(s) of the mixture as supplied by the submitter has to 
be indicated in the submission. As use type is based on end-use, the end-user group 
must also be reflected. For example, in case the mixture is supplied for professional use 
but is also available for consumer use, then consumer use has also to be reflected in 
the submission. Similarly, the submission concerning a mixture supplied for industrial 
use needs to additionally reflect the consumer end-user if it finally ends up in a mixture 
(as a MiM) for consumer use subject to Article 45. Note that an update may be required 
for mixtures submitted as a limited submission if they later end up in mixtures for 
consumer or professional use (when subject to Article 45). 

In case of uncertainty, the company preparing the submission for the original mixture is 
recommended to include all three use types in their notification. If a new use type of 
the original mixture becomes available after the submission, the use type information 
submitted under Annex VIII should be updated accordingly to avoid situations where 
that would not be covered.   

5.3 Information on mixture components [Part B.3] 

This section provides guidance on which components contained within the mixture have to be 
indicated in a submission, and on the information to be provided for each component. 

The information to be provided on the components of a mixture varies according to the type of 
submission the company has to or has decided to prepare, for example whether it is a standard 
submission, a group submission or a limited submission for industrial use only. It can to a certain 
extent  vary  also  depending  on  the  knowledge  the  submitter  has  on  the  mixture  content.  In 
addition, special provisions are available with regard to the composition information for certain 
specific products. This and the following sections provide guidance on the information required 
in each case. 

 
 
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5.3.1 General requirements [B.3.1] 

Ideally, the full composition of the mixture should be indicated. Both hazardous and non-
hazardous components may manifest adverse effects on human health after, for example, 
unintended uses. Therefore, poison centres and emergency response personnel may 
potentially need information on all components. 

Nevertheless, for practical reasons components do not legally need to be indicated when 
present in the mixture below certain concentration thresholds. Furthermore, in the case of a 
mixture for industrial use only, for which a limited submission is made (see section 4.4 of this 
guidance), information on composition may be limited to the information available in the safety 
data sheet for that mixture (see section 5.3.4). 

For each component that is required to be listed (see section 5.3.2), the following is to be 
specified in the submission: 

• 

• 

Its chemical identity (see section 5.3.3 below), and 

Its concentration (exact concentration or range – see section 5.3.3) 

Furthermore, the classification of the component is normally required, except when certain 
conditions apply (see section 5.3.3). 

It is normally not allowed in a submission to list a component which is not present in the 
mixture, or in at least one mixture in a group of mixtures in the case of a group submission. 
Specific derogations exist in the following situations: 

-  Perfume components in a group submission that may be present only in certain 

mixtures of the group but not all (see section 5.4). 

- 

Interchangeable components notified as part of an ICG that may not be present at each 
point in time or in each batch of the mixture; nevertheless, these components have to 
be present at some point (i.e. they have to be among the components effectively used 
in the formulation of the mixture). (See section 5.5) 

-  Components notified in accordance with one of the Standard Formulas listed in Part D 

or Section 3.7, Part B of Annex VIII, when the lower limit of their concentration range is 
zero (see sections 5.6 and 5.7). Due to natural variation of the raw material and the 
specific production process, certain minor components may not be present in each 
batch of the same mixture. 

-  Different components, not necessarily always present at the same time, which can be 

covered by the same generic component identifier (see section below for more details). 
It is not necessary in this case to specify further their individual identity. 

5.3.2 Components subject to submission requirements [B.3.3] 

A component of a mixture can be one of the following: 

•  A substance, as defined in Article 2(7) of CLP (see section 2); 

•  A mixture in mixture (MiM) – i.e. a mixture (as defined in Article 2(8) of CLP; see 

section 2) used in the formulation of a second mixture that is placed on the market and 
is the subject of the current submission. 

To be noted that a “generic component identifier” can be used to indicate certain components 
(either a substance or a MiM). This is explained later in this section. 

 
 
 
 
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A component, whether a substance or a MiM, must be included in the submission when it is: 

1.  Classified as hazardous on the basis of physical or health effects, and either 

−  present in a concentration equal to or greater than 0.1%; or 

− 

identified and present at concentrations below 0.1% - unless the submitter can 
demonstrate that it is irrelevant for the purposes of emergency health response 
and preventative measures; 

2.  Not classified as hazardous on the basis of physical or health effects, when identified 
and present at concentrations equal to or greater than 1%. This includes components 
not classified or classified for environmental hazards only. 

‘Identified’ means that the submitter knows the component is present, for example because 
they have added it intentionally and it is on the label, or it has been communicated to the 
submitter by a supplier in, for example a safety data sheet. Submitters are not legally required 
to analyse their mixtures to determine the presence of components. Nevertheless, it is 
recommended to make an effort in actively seeking missing information from their suppliers, 
as it may be important for the activities of the emergency responders.  

There is no specific scientific method to demonstrate the irrelevance of a substance or 
mixture for an emergency health response. The decision not to indicate a component, which is 
present below 0.1%, should be based on considerations which include the hazard type (e.g. 
none of the hazard classes considered to be of major concern), relevance of the route of 
exposure (e.g. the substance is classified for inhalation only but its physical state does not 
allow inhalation), concentration (e.g. trace levels can normally be disregarded), and possible 
interaction with common treatments. When a Specific Concentration Limit (SCL)58 exists for a 
substance, this may be used as a basis to conclude on the irrelevance of the substance (e.g. 
substance to be considered as relevant when the SCL < 0.1% and the substance concentration 
is between SCL and 0.1 %). There is no obligation to include the justification in the 
submission. This can be the object of a “reasoned request” by the appointed body if it decides 
so (see section 7.2).  

Hazardous mixtures that are subject to the obligation to submit a poison centre notification 
may, in addition to substances and mixtures, contain micro-organisms which are out of the 
scope of CLP. Examples of such mixtures are certain detergents, plant protection products and 
biocidal products. The presence of a micro-organism can be relevant for emergency response, 
in particular because of their potential to produce toxins and to cause allergic reactions. 
Specific labelling information is required for products containing micro-organisms under the 
Biocidal Products and Plant Protection Products legislations. This information is part of the 
obligatory supplemental information section of the CLP label and it is thus recommended to 
also indicate in the notification (when adding the relevant supplemental labelling element) the 
micro-organisms present, providing sufficient information for their identification, including the 
scientific name and taxonomic group. 

5.3.3 Information required on components 

5.3.3.1 Identification of the substance components [B.3.2.1] 

Substances in a mixture must be identified in accordance with Article 18(2):  

58 SCL are assigned to substances according to Article 10 of CLP and are available in Annex VI and in the 
C&L Inventory. 

 
 
 
 
 
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-  name and an identification number as given in Part 3 of Annex VI to CLP; 

- 

- 

- 

if the substance is not included in Part 3 of Annex VI to CLP, a name and an 
identification number as they appear in the Classification and Labelling (C&L) 
Inventory; 

if the substance is neither included in Part 3 of Annex VI to CLP nor in the C&L 
Inventory, the CAS number and the IUPAC name, or the CAS number and another 
international chemical name, for example the name in INCI nomenclature, where 
applicable; or 

if no CAS number is available and none of the above apply, the IUPAC name or another 
international chemical name, for example the name in INCI nomenclature where 
applicable. 

An INCI name, a colour index name or another international chemical name may also be used, 
provided the chemical name is well known and unambiguously defines the substance identity. 
The chemical name of substances for which an alternative chemical name has been allowed in 
accordance with Article 24 must be provided as well. To support notifiers to identify their 
substances in their notification, there is a list of substances from the substance inventory 
available in IUCLID.  

5.3.3.2 Identification of the mixture in mixture components [B.3.2.2] 

If a notifier has access to the full composition information (e.g. as provided by the MiM 
supplier/upstream notifier, or when the submitter themselves is the formulator of the MiM), 
substance components should be regarded as components of the final mixture. In other words, 
information regarding same substances (originating from the MiM and/or added on their own) 
should be presented in aggregated form.  

Where MiM components or substances are the same (i.e. have the same chemical identity) but 
are classified differently by different suppliers, it is recommended that the submitter contacts 
the suppliers to investigate the reasons for such difference with the aim to agree on a common 
classification. 

When access to the full compositional information of the MiM is not available, the 
submitter must identify the MiM first and foremost by the UFI. Note that since the passing of 
the transition period, all in-scope hazardous mixtures must contain a notified UFI. 

Therefore, the MiM’s identity must include its: 

-  UFI as notified to relevant appointed bodies 

- 

trade name or designation (product identifiers according to Article 18(3)(a) of CLP) 

-  MiM concentration in the final mixture59.  

In some cases, the UFI may not be known or available to the relevant appointed body e.g. the 
final mixture containing the MiM will be placed on a different market. In this case, the MiM 
must still be identified by the UFI, the product identifiers and concentration in the final mixture 
and the compositional information contained in the SDS (but not in aggregated form). In 

59 It should be noted that, if the full composition is not known, a ‘same’ mixture purchased from different 
suppliers who assign different classifications cannot be considered to be chemically the same mixture. 

 
 
 
 
 
 
 
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addition, the name, email address and telephone number of the MiM supplier must be 
indicated60. The SDS is not an information requirement but can be included in the notification 
to support the work of poison centres and appointed bodies and may possibly reduce their 
need for additional follow up contact in case of any doubt. 

It should be noted that a notification containing an un-notified MiM UFI will be alerted to both 
the notifier and the relevant appointed body(s) (via the validation report, see section 6.4.1 
Validation of Information). Therefore, communication and cooperation between the supplier 
and downstream user is encouraged so it is understood by both parties on which markets the 
MiM’s UFI has been notified or will be notified. It is also recommended that the MiM supplier 
may update their notification to include additional market areas and support the downstream 
user with their obligations. This is particularly relevant for complex supply chains.  

5.3.3.2.1 Identification of non-hazardous MiMs  

In the absence of a UFI and in the absence of an SDS (for mixtures not classified for any 
hazard, where no obligations to create a UFI nor to provide an SDS exist), the submitter 
should retrieve relevant information about the components available from the supplier and 
other sources (e.g. CAS number, name of main component(s) used when purchasing, chemical 
nature, etc.). Eventually the MiM (for which an SDS is not required) could be identified by 
means of its product identifier and the contact details of the supplier only.  

Example 17: 1 Mixture (with 2 MiMs, the first identified via its UFI, the second via its SDS) - 
1 UFI for the mixture + SDS MiM – 1 product placed on the market 

Example 18: Aggregation of components from different sources 

A company purchases 2 mixtures (MiMs) and 2 substances from different suppliers to 
formulate their product SuperClean which they intend to place on the EU market.  
The company has knowledge of the full composition of these ingredients (see table below). 
Same substances are included in the final mixture as components of the MiMs X and Y as 
substances as such (1 and 2).  

60 Please note that the EU importer is responsible for the mixtures imported into the EU. A non-EU 
supplier has no obligations to provide additional information in case the appointed body sees the need 
and should not be used for the identification of the MiM. 

Mixture Composition A:Substance 1,Substance 2,Substance 3, UFI MiM1SupercleanUFI AMiM2:     .Composition           from SDS      .Supplier sName     Telephone     Mail 
 
 
 
 
 
 
 
 
 
 
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The company will indicate in the submission the components of their final mixture in an 
aggregated form. The concentration of each substance will refer to the final mixture 
SuperClean: 

5.3.3.2.2 Generic component identifiers 

A generic component identifier (GCI) – for “perfumes” or “colouring agents” - can be used 
to identify one or several components of the mixture, if they are used exclusively to add 
perfume or colour, respectively, to the mixture. This can apply to both substances and MiMs, if 
the criteria explained below are met. The generic component identifier is used instead of the 
actual chemical identity or product identifier of the relevant component(s), and may be used 
where the following conditions are met: 

•  The relevant component(s) is/are not classified for any health hazard, and 

•  The total concentration of the components covered by the generic component identifier 

does not exceed: 

o  5% for the sum of perfume components; 

o  25% for the sum of colouring agent components. 

Note that in case the component used to add colour or perfume is included as a MiM (which 

Ingredients purchased by Company A Concentration in final mixture Composition  Mixture X (MiM X) 20% Substance 1 - 30%   Substance 3 – 40%   Substance 4 – 30% Mixture Y (MiM Y) 30% Substance 2 – 15%   Substance 3 – 25%   Substance 5 – 60% Substance 1 5% Not applicable Substance 2 10% Not applicable Water 35% Not applicable  Component Concentration in final mixture Substance 1 6 (MiM: 20% x 30%) + 5 = 11% Substance 2 4.5 (MiM: 30% x 15%) + 10 = 14.5% Substance 3 8 (MiM: 20% x 40%) + 7.5 (MiM: 30% x 25%) = 15.5% Substance 4 6% (MiM: 20% x 30%) Substance 5 18% (MiM: 30% x 60%) Water 35%   
 
 
 
 
 
 
 
 
 
 
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may include for example stabilisers or binders in addition to a substance), the criteria of being 
not classified for any health hazard applies to the MiM as a whole. 

In practical terms, this means that multiple components can be included in the notification as 
one single component identified with a GCI. The same generic component identifier can be 
used once (to cover one or multiple components meeting the same criteria) or more than once 
in the same submission (if, for instance, the submitter intends to indicate separately perfumes 
components identified with the same GCI but with a different classification for physical 
hazards). In both cases the maximum allowed total concentration of components covered by 
the same type of GCI remains the same (i.e. 5% for perfumes and or 25% for colourants). The 
concentration to be indicated in the notification will follow the same rules as per any other 
component, as explained in the subsection below. This means that the concentration assigned 
to the component identified with the GCI will have to consider all the actual components it 
covers. 

Mixtures whose composition differs only in components which can be identified by the same 
generic component identifier, can be included in the same submission. This is mainly because 
these components do not necessarily need to be individually specified. Such mixtures may be 
placed on the market under multiple trade names which can be also indicated in the same 
submission. Note: using generic component identifiers is optional and at the discretion of the 
submitter.  

5.3.3.3 Concentration and concentration ranges of the mixture components 
[B.3.4] 

The CLP regulation includes different provisions for mixture components (substances and 
MiMs) that are considered of ‘major’ concern and ‘other’ components. This distinction is defined 
in section 3.4 of Part B of Annex VIII. The submitter is required to provide the concentration or 
concentration ranges of each component according to the hazard class as described below 
(including when the component is identified with a GCI). 

In the case of MiM for which the composition is fully known, the concentration of its 
components should refer to the final mixture. In case the same components come from 
different sources (e.g. as component of a MiM and as single substance), the information should 
be provided in aggregated form61. 

B.1) Hazardous components of major concern for emergency health response and preventative 
measures 

When mixture components are classified for at least one of the hazard categories listed below, 
their concentration in a mixture must be expressed as exact percentages, 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 

61 This should not be done in case the composition of the MiM is only partially known as it may lead to 
misleading information for poison centres and emergency responders. 

 
 
 
 
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As an alternative to providing concentrations as exact percentages, a range of percentages 
may be submitted in accordance with Table 1 in Part B of Annex VIII (reported in Table 2 
below), in descending order by mass or volume. 

Where the exact concentration is higher than 1%, the upper and lower limits of the 
concentration bands should preferably be rounded to a maximum of one decimal; where the 
exact concentration is lower than or equal to 1%, a maximum of two decimals should 
preferably be used. 

Table 2: Concentration ranges applicable to hazardous components of major concern 
for emergency health response - Table 1 in Part B of Annex VIII 

Concentration range of the hazardous 
component contained in the mixture 
(%) 

Maximum width of the concentration 
range to be used in the submission 

≥ 25 - < 100 

≥ 10 - < 25 

≥ 1 - < 10 

≥ 0,1 - < 1 

> 0 - < 0,1 

5% units 

3% units 

1% unit 

0,3% units 

0,1% units 

In case a range is used, its width should be chosen in a way that for each possible value within 
that range, Table 1 in Part B of Annex VIII (table 2 above) is complied with. This means that if, 
e.g., the exact concentration is 26% and a width of 5% units is used, its lower limit should be 
not less than 25. Any concentration value below 25% would require a maximum width of 3%. 

Example 19: Concentration ranges for components of “major” concern 

In the case of a substance (hazardous component of “major” concern) in a mixture with an 
exact concentration of 26%, the submitter can choose among different ranges to report, 
provided that the exact concentration is comprised within this range and the maximum width 
of the concentration range is 5% units: 23-26% (since the exact value can possibly be < 25, a 
maximum range of 3% units has to be used), 24-27%, 25-28%, 25-29%, 25-30%, 26-31%.  

Also narrower ranges can be applied such as 25-27% etc. 

B.2) Other hazardous components and components not classified as hazardous 

The concentration of components classified for hazard classes not listed above or components 
not classified as hazardous should be expressed, in accordance with Table 2 in Part B of Annex 
VIII (reported in Table 3 below), as concentration ranges in descending order by mass or 
volume. As an alternative, the exact concentration can be provided. 

This applies also to components identified by means of generic component identifiers. 

Where the exact concentration is higher than 1%, the upper and lower limits of the 
concentration bands could be rounded to a maximum of one decimal; where the exact 
concentration is lower than or equal to 1%, a maximum of two decimals could be used. 

All components classified as hazardous on the basis of their health or physical effects may 
need to be included in the submission even if present in concentrations below 0.1% if 
identified, unless demonstrated to be irrelevant for emergency health response and 
preventative measures (see section 5.3.2 above). 

 
 
 
 
 
  
 
 
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Table 3: Concentration ranges applicable to other hazardous components and 
components not classified as hazardous – Table 2 in Part B of Annex VIII 

Concentration range of the 
component contained in the mixture 
(%) 

Maximum width of the concentration 
range to be used in the submission 

≥ 25 - < 100 

≥ 10 - < 25 

≥ 1 - < 10 

> 0 - <1 

20% units 

10% units 

3% units 

1% unit 

Also, with regard to components of minor concern, in case a range is used, its width should be 
chosen in a way that for each possible value within that range Table 2 in Part B of Annex VIII 
(Table 3 above) is complied with. 

It is to be clarified that the distinction between “components of major concern” and “other 
hazardous components” in this case is based on the perspective of emergency health response 
where acute and short-term effects are more relevant. Furthermore, the severity resulting 
from the exposure to components classified for those hazards is also taken into consideration. 
This is why components classified for some serious hazards such as carcinogenic, mutagenic 
and toxic to reproduction are included in the second category. 

Example 20: Concentration ranges for components not of “major” concern 

In the case of a substance (not classified, or classified as hazardous but not of major concern) 
in a mixture with an exact concentration of 6%, the submitter can choose among different 
ranges provided that the exact concentration is comprised within this range and the maximum 
width of the concentration range is 3% units: e.g. 3-6%, 4-7%, 5-8% or 6-9%. Also narrower 
ranges can be applied such as 5-6%. 

5.3.3.4  Classification of mixture components [B.3.8] 

The classification for health and physical hazards of the mixture components must be provided. 
This includes hazard classes, categories and statements of, at least, all the identified 
substances which are referred to in Section 3.2.1 of Annex II to the REACH Regulation 
(requirements for the compilation of SDSs). Section 3.2.1 lists the criteria for identifying the 
component substances that have to be indicated in the SDS of a mixture itself classified as 
hazardous62. 

In other words, at least for all the component substances that would need to be indicated in 
the SDS of the mixture, their classification is to be provided in the submission. Annex II to 
REACH also includes an obligation to provide information on substances classified for 
environmental hazards only. For the purposes of Annex VIII, for components classified for 
environmental hazards only, the classification does not need to be indicated (although it can 
be made, and is recommended to be, on a voluntary basis). 

62 See ECHA’s Guidance on the compilation of safety data sheets https://echa.europa.eu/guidance-
documents/guidance-on-reach 

 
 
 
 
 
 
 
 
 
 
 
 
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Where a final mixture contains one or more MiMs, the notifier must first provide the 
classification of the MiM itself. In addition, the classification of any MiM components which are 
available and have been indicated must be provided as well. Similarly, information on 
classification for environmental hazards is not required but can be provided voluntarily for 
completeness.  

5.3.3.4.1 Classification of GCIs 

Components identified by a GCI may present physical hazards which would need to be 
indicated. 

Example 21: Use of generic component identifiers (single mixture) 

In option A, all components are included in the submission with the ‘chemical name’, 
health/physical hazard classification and concentration in the mixture (either a concentration 
range or an exact concentration). There are eight perfume components (1-8) and three other 
components (A, B, C).  

The use of generic component identifiers is illustrated in the option B below where perfume 
components are grouped. Note: the indicated concentrations, classifications and number of 
components are chosen with the sole purpose of explaining the requirements. 

OPTION A – ALL COMPONENTS INDICATED WITH A ‘CHEMICAL NAME’ 

Components 

Classification 

Concentrations 

Chemical name component A 

not classified 

Chemical name component B 

not classified 

Chemical name component C 

major concern 

Perfume chemical name 1 

not classified 

Perfume chemical name 2 

not classified 

Perfume chemical name 3 

not classified 

60-80% 

13% 

11-14% 

1-4% 

1% 

0.5% 

Perfume chemical name 4 

acute toxicity, cat 1 

0.3-0.6% 

Perfume chemical name 5 

skin corrosion, cat 1C 

Perfume chemical name 6 

skin sens. cat. 1 

2-3% 

2% 

Perfume chemical name 7  

aspiration toxicity, cat 1 

3-6% 

Perfume chemical name 8 

not classified 

4% 

This composition can alternatively also be submitted as presented in option B (below).  
Perfume components 1 to 3 are indicated with the generic component identifier “Perfumes”. 
This is allowed since these components are not classified for a health hazard and the total 
concentration of the components covered by the given generic component identifier does not 
exceed 5% [B.3.2.3].  
‘Perfume chemical name 4 to 7’ cannot be indicated with a generic component identifier 
because these components are classified for a health hazard. 

 
 
 
 
 
 
 
 
 
 
 
 
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OPTION B – SOME COMPONENTS INDICATED WITH A GENERIC COMPONENT 
IDENTIFIER 

Components 

Classification 

Percentage 

Chemical name component A 

not classified 

Chemical name component B 

not classified 

Chemical name component C  major concern 

60-80% 

13% 

11-14% 

Perfumes (GCI) 

not classified 

3%, 2-5% 

Perfume chemical name 4 

acute toxicity, cat 1 

0.3-0.6% 

Perfume chemical name 5 

skin corrosion, cat 1C 

Perfume chemical name 6 

skin sens. cat. 1 

2-3% 

2% 

Perfume chemical name 7  

aspiration toxicity, cat 1 

3-6% 

Perfume chemical name 8 

not classified 

4% 

Additional notes to the example: 

• 

‘Perfume chemical name 1’ was indicated in option A with a concentration range of 1-
4%. The actual concentration apparently was 1.5% (only known to the submitter) so 
the total concentration is 1.5+1+0.5=3%. 

•  Not all non-classified perfumes can be grouped within the same generic component 

• 

identifier because if ‘Perfume chemical name 8’ is included, the total concentration is 
7%. Other non-classified perfume components must be indicated individually with their 
chemical name.  
It would also have been possible to, for example, indicate ‘Perfume chemical name 2’ 
and ‘perfume chemical name 8’ with a generic component identifier “Perfumes” since 
the total concentration does not exceed 5%. In that case the other non-classified 
perfume components (1 and 3) must be indicated individually with their chemical name. 
•  The same generic component identifier “perfumes” could be used more than once in the 
same submission, without the need to further specify the identity of the components. 
This could be relevant in the case of perfumes with different classifications (e.g. some 
not classified and others classified for physical hazards). 

•  On the indicated concentration: 

The generic component identifier can be indicated with an exact concentration (the sum 
of the components covered by the same generic identifier, 3% in the example) or a 
range according to table 2 of Annex VIII, for example 2-5% (3% units bandwidth 
allowed; with a maximum of 5%). 

Example 22: Use of generic component identifiers (mixtures varying in colourants only) 

 
 
 
 
 
 
 
 
 
 
 
 
 
72 

In this example, a formulator produces a mixture and places it on the market under different 
trade names (i.e. different products). The composition of the mixture is always the same with 
the exception of the components used only as colourants. The mixture composition in each 
product contains a different blend of colourants. These are not classified for any health (or 
physical) hazard. 

The total concentration of the colourants in each product varies but does not exceed 25%. In 
addition, the variation in concentration in each composition falls within the limits set by table 2 
of Annex VIII. 

COMMON COMPOSITION 

Components 

Classification 

Concentrations 

Chemical name component A 

Minor concern 

Chemical name component B 

Minor concern 

Chemical name component C 

Major concern 

COLOURANTS 

20-30% 

20-30% 

30-35% 

Classification 

Trade name 
Shining Blue 

Trade name 
Shining Red 

Trade name 
Shining Green 

Colourant 1 

Colourant 2 

Colourant 3 

Not classified 

8 % 

Not classified 

21% 

Not classified 

10% 

7% 

9% 

A single submission can include the three trade names and the mixture composition where the 
colourant components are indicated with the generic component identifier “Colouring agents”. 
The concentration of the generic colourant component has to be provided within the maximum 
breadth of range, in accordance with table 2 of Annex VIII, on the basis of the actual 
concentration. 

The submitter can decide to assign one single UFI or multiple UFIs, according to their business 
decision. 

SUBMISSION 

Trade name ABC – Trade name DEF – Trade name GHI 

UFI: WQYN-341E-V00P-YHNT 

Components 

Classification 

Percentage 

Chemical name component A 

Minor concern 

Chemical name component B 

Minor concern 

Chemical name component C 

Major concern 

“Colouring agents” (GCI) 

Not classified 

Additional notes to the example:  

20-30 % 

20-30 % 

30-35 % 

14–22 % 

•  The total concentration of the colourants in the individual mixtures is 18% (Shining 

Blue), 21% (Shining Red) and 16 % (Shining Green). Therefore, a range of maximum 
10 %-units can be used in the submission to cover all the variants. In this case, 
voluntarily a narrower 8 %-unit range has been chosen. 

• 

If one or more colourants classified only for a physical hazard are added to all mixtures, 
these should be included separately even if still identified with a generic component 
identifier. It is indeed possible to use multiple times the same generic component 
identifier to identify different components included in the submission. 

 
 
 
 
 
 
 
 
 
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5.3.4 Limited submission [B.3.1.1] 

When a company decides to opt for a limited submission (possible for mixtures intended for 
industrial use only and for mixtures with an end use not subject to submission) the list of 
components to be provided may be limited to that included in Section 3.2 of the SDS. The 
information to be provided on the concentrations of such components may be also limited to 
that contained in the SDS. 

Detailed information on the compilation of the SDS, and in particular of Section 3, is available 
in the ECHA’s Guidance on the compilation of safety data sheets. 

In practice, the information provided in this case will be less detailed than a standard 
submission and the poison centre will not have access to the full composition of the mixture. 
For example, Annex II to REACH (on the compilation of SDS) does not require the indication of 
not classified components, and sets for the hazardous components to be indicated 
concentration thresholds and ranges which are less strict than Annex VIII to CLP (e.g. 
hazardous components may need to be included in a standard submission even if present in 
concentration <0.1%). 

Additionally, in this case information on the packaging is not required and can be provided on 
voluntary basis.  

5.4 Group submission [A.4] 

Information on multiple mixtures with limited differences in the composition can be provided in 
the same submission: this is referred to as a ‘group submission’. The general conditions under 
which such a ‘group submission’ is allowed are specified in Section 4, part A of Annex VIII. 

Mixtures can be grouped in the same submission if they: 

•  have the same classification for health and physical hazards (this means that a 

difference in classification for environmental hazard is allowed); 

•  have very similar composition; the only differences can concern certain perfumes 

• 

(see section 5.4.2 for details);  
the same components are reported in the same concentration or concentration 
range.  

Besides substances indicated with their own chemical name, as explained in section 5.3, the 
mixtures’ components can include MiM, and components which are allowed to be indicated with 
‘generic component identifiers’ (see section 5.3.3). 

All mixtures in the group must contain the same components, except for perfume components, 
as referred to in Section A.4.3 of Annex VIII. The latter can differ between mixtures in the 
group under certain conditions (see section 5.4.2 below). 

Under the conditions described above, a group submission is basically possible for mixtures 
with compositions that differ, under certain conditions, in perfumes. These would be ‘product 
variants’ (possibly marketed under different trade names), for example detergents with a 
difference in perfumes. 

Note: the grouped mixtures all have to be placed on the market by the same importer or 
downstream user (and their distributors). A group submission can only include the details of 
one ‘legal submitter’ (i.e. duty holder). It is not possible to group mixtures that are placed on 
the market by different duty holders under Article 45. 

 
 
 
 
 
 
74 

Ultimately, the difference between a standard and a group submission concerns the possibility 
to group mixtures with variation in perfumes which cannot be indicated with a generic 
component identifier. As explained earlier in this section, also in a standard submission 
multiple trade names can be included, as long as the composition of the mixture remains the 
same.  

Note: The decision whether to provide a standard or group submission (when the conditions 
are fulfilled) lays with the duty holder and could be based on the specific portfolio. Group 
submission is an option provided to facilitate the fulfilment of the obligations: the duty holder 
may always decide to submit a standard submission for each mixture without grouping it with 
other mixtures.  

5.4.1 Information to be provided in a group submission 

Information described in Part B of Annex VIII should be provided for each of the mixtures in 
the group. 

The information provided on mixture components in a group submission should apply to all the 
mixtures in the group, except for perfumes that may only apply to some mixtures in the group 
under certain conditions (see section 5.4.2 below). 

Most of the information will be the same but there might be a difference in: 

• 

• 

‘All product identifiers of the mixture’: a group submission (as well as a standard 
submission) may cover mixtures placed on the market with different trade names 
and/or to which different UFIs could be assigned. 
‘Additional information’ items listed in Part B, Section 2.4, of Annex VIII: 

o  Colour and physical state of the mixture; 
o  pH; 
o  Types and sizes of the packaging; 
o  Use types (consumer, professional, industrial) as described in section 3.4 of this 

Guidance. 

Trade names, colour, packaging, use types and UFIs should be indicated for every individual 
mixture in the group. This information may be useful for the emergency responders in order to 
promptly identify the relevant information for the specific product.  

Nevertheless, for the colour, a limited range of standard types can be used (no need to 
indicate the exact shade). Exceptionally and for practical reasons, a generic indication of the 
colour field can be accepted for paints and other similar categories for example inks, where 
high numbers of products with great colour variability can be included in the same group 
submission (provided they are not classified63).  

Regarding the packaging, the specific type is potentially relevant to identify the appropriate 
emergency response measures to assist with possible product identification. This information 
should be provided for each mixture of the group placed on the market with a specific trade 
name.  

The pH value can be indicated for the group as a whole; a range applicable to the whole group 
can be used. Where the pH value is particularly low or high (i.e. <3 or >10), the range to be 
indicated should not be bigger than one unit (e.g. 2.5 – 3.5). 

63 In this case the use of the generic component identifier “colouring agent” can possibly cover different 
colorants. 

 
 
 
 
 
 
 
 
 
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It is assumed that the toxicological information (as required in Section 2.3, Part B of Annex 
VIII) should not normally vary across the mixtures of the group. In case of differences, it must 
be clear to which mixture the information refers to. 

5.4.2 Mixture components in a group submission 

Mixtures in a group submission should contain the same components in the same 
concentration or concentration range, except for perfumes components. Those components 
may only differ between the mixtures of the group under the conditions described below 
(Section A.4.3 and B.3.1 of Annex VIII). The total concentration of the perfumes which differ in 
each mixture of the group cannot exceed 5%. In case the concentration of the differing 
perfumes in a mixture is above this threshold, the mixture cannot be included in the same 
group submission. 

The intention of this rule is to allow grouping of the mixtures only if their compositions are 
very similar (and hence the toxicological information does not vary). This means that for a 
maximum of 5% of the composition, the mixtures’ compositions may differ in perfumes 
content. 

It is to be underlined that the calculation of the 5% threshold should take into account only the 
perfumes in each mixture which vary from the others (i.e. which are not present in all the 
mixtures of the group, but in one or some of them only). In practice this means that if the 
mixtures contain common perfumes indicated by their chemical name or GCI, the 5% 
threshold does not refer to those common perfumes. 
The perfumes contained in each mixture of the group must be listed to identify the perfumes 
they contain, including their classification. 

The information required on the mixture composition in a group submission is illustrated by 
examples 23 and 24. References to the relevant legal text are made in the notes to the 
examples (in square brackets) to indicate compliance with the requirements on group 
submission as well as with requirements on component identification/information where 
relevant for grouping. For detailed guidance on component identification and information 
requirements, please see section 5.3 of this guidance document. 

It is important to note that these examples are presented in a simplified form with the sole 
purpose of illustrating the requirements for group submission. In the examples different 
formats are used to present the information, but the same principles apply.  

Special case: perfume components not requiring concentration 
In the case of perfume components in a group submission that are not classified as hazardous 
for human health or are classified only for skin sensitisation Category 1, 1A or 1B or aspiration 
toxicity, submitters are not obliged to provide information on their concentration. This applies 
to both types of perfumes, those which vary across the mixtures of the group and those which 
are common to all the mixtures. It is the responsibility of the submitter to make sure the real 
concentration of these components is considered when calculating the 5% threshold (if 
relevant). 

For colouring agents with a generic component identifier, the table above (section 5.3.3) 
applies. 

 
 
 
 
 
 
 
 
 
 
 
 
 
76 

Example 23: Grouping of mixtures with difference in perfume components 

Mixtures in the group have a difference in some perfume components that are classified for a 
health hazard (therefore those components cannot be indicated with a ‘generic component 
identifier’). 

Since some of the perfumes vary between the mixtures contained in the group, a list must be 
provided of the mixtures and the perfumes they contain, including their classification.  

Note to the tables of example 23: 

(a) Classifications are indicated in this example with three categories: ‘major concern’ (list of 
classifications in B3.4.1), ‘other’ (all other hazard classifications) and ‘not classified’. 

(b) Actual concentrations are reported for internal calculation purposes only; they are not 
necessarily required to be indicated in the submission.  

Compliance with Annex VIII requirements: 

GROUPING OF MIXTURES WITH DIFFERENCE IN PERFUME COMPONENTS UFIs: - N200-U0CW-5009-QWHJ - G500-C029-F00T-D83M - P800-U0RP-S009-1KPP Classification: # Product Category: # Product names: - Trade name 1  - Trade name 2 Components Percentage Classificationa Chemical name component A 60-80% Not classified Chemical name component B 7-10% Other Chemical name component C 11-14% Major concern Chemical name component D 1-2% Major concern  Name Perfume Classificationa Conc. range Actual conc.b Trade name 1 UFI: N200-U0CW-5009-QWHJ UFI: G500-C029-F00T-D83M Perfume chemical name 1 Other 1 - 2 % 1.2 % Perfume chemical name 3 Major concern 0.4 - 0.7 % 0.6 % ‘Perfume MiM’  A67T-VHG2-DMM4-NH2A (UFI and relevant MiM’s information known to the relevant appointed body) Other 0.5 – 1.5 % 1 %  Perfume chemical name 5 Other 1 – 4 %  Trade name 2 UFI: P800-U0RP-S009-1KPP Perfume chemical name 2 Major concern 0.3 – 0.6 % 0.4 % Perfume chemical name 4 Other 1 – 3 % 1.4 % Perfumes (GCI) Not classified n.a. 1.4 %  Perfume chemical name 5 Other 1 – 4 %    
 
 
 
 
 
 
 
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• 

• 

• 

• 

• 

All mixtures in the group have the same components in the same concentration or 
concentration ranges [A4.2], except for the components ‘Perfume chemical name 1 - 4’, 
‘Perfume MiM’ and the perfumes indicated with the generic component identifier 
“perfumes” that are at least present in one of the mixtures [A4.3]. The component 
‘Perfume chemical name 5’ is a common component of all the mixtures in the group. 
Therefore, its concentration is not considered in the allowed limit of perfumes in 
mixtures part of a group submission. 
The difference between the mixtures concerns only perfumes and ‘the total 
concentration of the perfumes which differ in each mixture does not exceed 5%’ 
[A.4.3]. This concerns the sum of ‘actual concentrations’ (which are known to the 
submitter, see below) of these components while a concentration range is indicated in 
the submission. 
If the composition of a MIM is not fully known, the UFI has to be provided as long as 
the relevant appointed body has received it as part of a valid submission for the MiM 
[B.3.2.2]. 

The specific concentration of the components included under GCI “Perfumes” does not 
have to be indicated as the perfume is not classified [B.3.4.2]. 

The concentration of the perfumes components has to be provided as exact value or as 
ranges of percentages following the same rules as for any other component. 

Trade name 1: 
Perfume chemical name 1 - indicated 1-2% - actual concentration 1.2%.  
Perfume chemical name 3 - indicated 0.4-0.7% - actual concentration 0.6%. 
Perfume MiM - indicated 0.5-1.5% - actual concentration 1%. 
The actual concentration of differing perfume components in the mixture is 2.8%. 

Trade name 2: 
Perfume chemical name 2 - indicated 0.3-0.6% - actual concentration 0.4%.  
Perfume chemical name 4 - indicated 1-3% - actual concentration 1.4%. 
Perfumes – not indicated – actual concentration 1.4%  
The actual concentration of differing perfume components in the mixture is 3.2%. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Example 24: Grouping of mixtures with difference in perfume components 

GROUP SUBMISSION  

UFI: C4P7-GHVS-ED8M-42DH 

Product category: All-purpose (or multi-purpose) non-abrasive cleaners 

CLP classification:  Serious eye damage cat.1 + Skin sensitiser cat.1 

Product trade names: ABC, BCD, CDE 

Product- trade name ABC + Product- trade name BCD + Product-trade 
name CDE 

Components 

Classification 

Concentration 

S
T
N
E
I
D
E
R
G
N
I
N
O
M
M
O
C

Surfactant 123 

Serious eye damage cat.1 

Surfactant 456 

Serious eye damage cat.1 

Soap xyz 

Not classified 

5-6% 

8-9% 

2-5% 

Sodium carbonate 

Serious eye irritation cat. 2 

7-10% 

Processing aid xxx  Not classified 

Water 

Not classified 

1-2% 

66-76.4% 

Perfumes 
components 

As attached or not classified 

5-7 % 

Perfume components: 

Product- trade name ABC 

Components 

Classification 

UFI or SDS components 

Concentration 

Perfume mixture a 

MIM: Skin sens. 
Cat. 1 

UFI A67T-VHG2-DMM4-
NH2A 

Not needed 
[B.3.4.2] 

Perfume  
mixture b 

Skin sens. Cat 1B 
+ Asp. tox. Cat. 1 

(UFI not available) 

MiM: 0.5-1.5% 

Substance A 

Substance B 

Substance C 

SubA: 10-15% 

SubB: 20-30% 

SubC: 15-25% 

Product- trade name BCD 

Components 

Classification 

UFI or SDS components 

Concentration 

« Perfume »  
(Generic 
component 
identifier) 

Not classified 

Not applicable 

0.6-1.6% 

 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Product- trade name CDE 

Components 

Classification 

UFI or SDS components 

Concentration 

Perfume  
mixture b 

Skin sens. Cat 1B 
+ Asp. tox. Cat.1 

(UFI not available) 

MiM: 0.5-0.9% 

Substance A 

    SubA: 10-15% 

Substance B 

Substance C 

    SubB: 20-30% 

    SubC: 15-25% 

Perfume (GCI) 

Not classified 

Not applicable 

0.1- 1.1% 

Notes to the tables of example 24:  

•  Total “perfume a” + “perfume b” in product- trade name ABC should not exceed 5% 
because both are perfumes components which varies (i.e. are not common to all the 
mixtures of the group) [A.4.3]. 

•  Total “perfume b” + "perfume" (GCI) in product-trade name CDE should not exceed 5% 

for the same reason as above [A.4.3]. 

•  Components of “perfume a” are included in the submission by a supplier upstream (link 

with UFI). 
"Perfume" (GCI) does not contain any hazardous component [B.3.2.3]. 

• 
•  The concentration of the MiM “Perfume mixture b” components refers to the MiM itself 

(MiM composition not fully known).  

List of perfumes in Group submission 

Perfume name 

Classification 

Products of the GS where 
the perfume is present 

Perfume mixture a 

Skin sens. Cat 1 

Product- trade name ABC 

Perfume mixture b 

Skin sens. Cat 1B + 
asp. tox. 

Products- trade names 
ABC+CDE 

Perfume (GCI) 

NC 

Products- trade names 
BCD+CDE 

5.5 Interchangeable component group (ICG) [B.3.5] 

5.5.1 Grouping of components 

Providing the standard information on components as required in Annex VIII to CLP (and 
described in the previous sections), can be challenging in specific situations where very similar 
components, possibly purchased from different suppliers, are used together in the same 
production line. It may be difficult to know which exact components are present in the 
composition at each point in time (e.g. in each batch), and at which concentration.  

Different components may be grouped in a so-called ‘Interchangeable component group’ 
(ICG), when they are not chemically identical, but are sufficiently similar to be considered 
equivalent regarding their hazard and, but not necessarily, regarding their technical function in 
the final mixture. The final mixture might contain only one of the interchangeable components 
at a time or a blend of several interchangeable components where the individual 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
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concentrations of the components in the blend cannot be precisely identified (e.g. when the 
interchangeable components are stored in the same storage container or as a result of mixing 
different batches of the final mixture afterwards). In other words, the components in an ICG 
do not have to be mutually exclusive (i.e. one does not necessarily exclude the presence of 
others), but more than one can be present at the same time. When specific conditions for an 
ICG are met, the submitter is allowed to indicate information on the concentration at ICG level, 
instead of indicating the concentration of each individual component within the group (as these 
individual concentrations may simply be unknown). 

The application of this approach implies that not all the components grouped in an ICG are 
necessarily always present in each batch of the mixture placed on the market. This is a specific 
derogation in Annex VIII from the prohibition to notify components which are not present in 
the mixture. Each component included in an ICG must nevertheless be currently used in the 
production of the final mixture. The ICG solution is not intended for notifying components 
which might possibly be used only in the future and therefore should not be used in order to 
avoid the need to update the submission. Components in an ICG can be added or removed 
when needed via an update (see section 7). 

Section 5.5.2 below provides details on when the ICG approach can be applied. Section 5.5.3 
clarifies the information requirements when an ICG is used. It is to be emphasised that even 
when the criteria for ICG are met, using the ICG approach is optional. The information 
normally required by Annex VIII is recommended to be provided whenever this is possible. 
Submitters are encouraged to limit the use of the ICG approach to the specific situations for 
which this workable solution was envisaged. 

5.5.2 Conditions for grouping components in an ICG 

Components can be grouped in an ICG when they meet one of the two sets of conditions 
described in Section 3.5, Part B of Annex VIII. These two sets allow certain flexibility in the 
application of the ICG approach, for example by not limiting it only to components with the 
same technical function in the final mixture. 

An ICG can include substances or MiMs64. Where multiple components fulfil the criteria to be 
grouped in an ICG, it is not mandatory to necessarily group all of them in an ICG. Their 
concentration, if known, should be reported according to the standard rules. 

The two sets of criteria are described in sections 5.5.2.1 and 5.5.2.2 below. 

5.5.2.1 General rules for grouping components 

Components in a mixture may have the same technical function even if they are not chemically 
exactly the same. For example, when they are purchased from different suppliers to ensure 
continuity of the supply. It is possible to group the components in an ICG when three 
conditions are met by each individual component in the specific ICG.  

All components in the same ICG must have: 

- 

- 

Identical technical function(s) in the final mixture placed on the market.  

Identical classification for health and physical hazard(s). This means that both the 
hazard class and the hazard category are identical. To be noted that the legal text 
allows for differences in the subcategory (relevant for certain hazard classes only, e.g. 

64 A fully known MiM can be grouped in an ICG as a MiM as such even if it will be identified with its 
product identifier and its full composition (i.e. the concentration of the MiM’s components will refer to the 
MiM itself). 

 
 
 
 
 
 
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Skin Corr 1A/1B/1C). 

-  Same toxicological properties, at least both target organ(s) and the type of toxicological 
effects must be the same for all the components in the ICG. Conclusions could be based 
on the mechanisms of toxicity of the components. 

Information on the toxicological properties of the components is not part of the submission. 
The submitter should nevertheless be able to provide this information to the appointed body 
on their request. 

In addition to the conditions above, the variation of interchangeable components in the final 
mixture must not influence the classification and labelling information of the final mixture. The 
following information has to be always the same, regardless of the interchangeable 
component(s) present and their individual concentration: 

- 

- 

- 

the classification and the labelling elements of the final mixture, referred to in Sections 
2.1 and 2.2, Part B; and 

the toxicological information of the final mixture referred to in Section 2.3, Part B; and 

the additional information on the final mixture referred to in Section 2.4, Part B: 

o 

o 

o 

the types and sizes of the packaging used to place the mixture on the market for 
consumer or professional use; 

the colour(s) and the physical state(s) of the mixture, as supplied; 

the pH, if available, of the mixture as supplied; 

o  product category (EuPCS); 

o  use: consumer, professional, industrial, or a combination of any of the three. 

5.5.2.2 Alternative rules for grouping components with specific hazard 
classifications 

An alternative set of criteria applies to components which are classified only for one or more of 
the following hazards: 

o  skin corrosion or irritation, 

o  eye damage or irritation, 

o  aspiration toxicity, 

o 

respiratory or skin sensitization. 

Using the ICG solution under this alternative set of criteria is only possible if the ICG does not 
contain more than five components. 

The criteria which have to be met by components in order to be grouped in an ICG are the 
following: 

-  all the components must have the same classification for health and physical hazard(s) 

(classifications listed above). 
This means that both the hazard class and the hazard category are identical. 
Differences in the subcategory (relevant for certain hazard classes only) are allowed. 

- 

the pH for all components, where applicable, is the same, i.e., either acidic, neutral or 
alkaline. This applies to components classified for skin corrosion, skin irritation, eye 
damage and eye irritation. A certain flexibility is allowed for the grouping of 
components. Components with a pH between 6 and 8 can be considered ‘neutral’; 

 
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components with a pH below 7 are considered as acidic, components with a pH above 7 
are considered as alkaline for the purposes of the ICG. The variability in the pH cannot 
nevertheless affect the hazardous properties of the components and the emergency 
response. The possibility to measure the pH depends on the physic-chemical 
characteristics of the compound. Similar considerations in order to determine the 
circumstances when the pH cannot be measured as those made about the final mixture 
(see section 5.2.3) apply here. However, the pH of the components does not need to be 
included in the submission and a justification why the pH is not available does not need 
to be provided. The submitter may nevertheless be asked by the appointed body for 
information on the pH of the individual components in the ICG. 

The toxicological properties of components are not an information required to be included in 
the submission. Nevertheless, in order to facilitate a proper emergency response, it is 
recommended to only group components with very similar toxicological properties. If it is 
known that the toxicological properties are different (despite identical classification), the 
submitter should consider refraining from using an ICG. 

As for the first set of criteria explained in section 5.5.2.1 above, the components can be 
grouped in an ICG only if the information on the final mixture remains the same, regardless of 
the possible combinations (this means identical hazard identification and identical additional 
information required by Section 2 of Part B on the final mixture). This is important in particular 
when the submitter decides to group components which have some (possibly limited) 
differences in the toxicological properties. 

It is to be underlined that, unlike the criteria explained in section 5.5.2.1, this alternative set 
of criteria does not require the interchangeable components to have an identical technical 
function. 

5.5.3 Information requirements 

5.5.3.1 Identification 

When components are notified as part of an ICG, a meaningful name has to be provided for 
the group itself. The legal text requires the name to reflect the technical function(s) of the 
grouped components. This name should normally allow the emergency operator to promptly 
identify at least the nature and kind of components covered by the group, without the need to 
look at the full list.  

When an ICG groups components with different technical functions, all these have to be 
reflected in the name. 

Preferably the name should also be toxicologically relevant, such as a chemical group name. 
‘Anionic surfactant’ is an example of a combination of ‘function’ and ‘chemical group’ which is 
toxicologically relevant. Another example is ‘Air-entraining agent with main components 
surfactants’. 

Additional information on the identification of the ICG may have to be provided to the 
appointed body upon their request, if this is considered necessary. 

Each component (substances or MiMs) in an ICG must be identified following the standard 
rules for any other component, as described in section 5.3.3 of this Guidance (i.e. in 
accordance with Section 3.2.1. or 3.2.2 of Annex VIII, Part B, as applicable). 

5.5.3.2 Concentration 

For components which are reported as part of the same ICG, there is no need to provide the 
concentration of the individual components. Instead, the concentration is to be provided for 
the ICG as a whole. This reflects a reality where the submitter does not know which 

 
 
 
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interchangeable components are present at each point in time and in which concentration. The 
submitter is nevertheless required to indicate the total concentration of the components 
covered by the ICG. 

The concentration for the ICG can be provided as an exact value or as a range of percentages, 
following the rules described in section 5.3.3 of this Guidance. 

In principle, there is no limit in the concentration of an ICG in the final mixture. Nevertheless, 
it is important to underline that the ICG has to be used to group components actually used in 
the formulation of the same final mixture. 

5.5.3.3 Classification 

The classification for health and physical hazards can in practice be reported either for each 
component of the group or for the ICG as a whole. This includes hazard classes, categories and 
statements as for any other component of the mixture. If the classification of the components 
in an ICG is exactly the same, it is recommended to provide it for the ICG only. 

5.5.4 Examples 

Example 25: Grouping interchangeable components having the same technical function 

In this example, a formulator mixes components A and B plus the complexing agent C in a 
continuous production process to formulate a final product. Component C is purchased from 
three different suppliers to ensure the continuity of supply. The formulator does not know 
whether the components are chemically identical, irrespective of the supplier. Nevertheless, 
the components have the same technical function in the final mixture and can be used 
interchangeably. Without the ICG approach, the formulator would need to submit several 
notifications, one for each combination of components. Yet in a continuous production process, 
it is not possible to know exactly which component, C1, C2 or C3, is present in the final mixture 
that is placed on the market. In such cases, the ICG approach can provide a workable solution, 
provided that the components C1, C2 and C3 fulfil the required conditions set in Section 3.5 of 
Part B. 

Components C1, C2 and C3 have the following characteristics: 

A + BComplexing agentBatchesC1C2C3•A + B + C1•A + B + C2•A + B + C3•A + B + (any combination of C1-2-3)C1, C2and C3can be part of an ICGICG 
 
 
 
84 

Components supplied by multiple suppliers 

Component 

Technical function 

Hazard classification 

Toxicological properties  

C1 

C2 

C3 

Complexing agent 

Acute toxic oral, cat. 3 

Set of properties S1 

Complexing agent 

Acute toxic oral, cat. 3 

Set of properties S1 

Complexing agent 

Acute toxic oral, cat. 3 

Set of properties S1 

Components C1, C2 and C3 all have the same technical function, same classification for health 
and physical hazards and same toxicological properties (as a minimum the same target organs 
and toxicological effects). The total concentration of the complexing agent C is known to be 4-
5% following the formulation process, and regardless of the combinations or blends of 
components C1, C2 and C3, at this concentration the hazard identification of the final mixture is 
always the same. The additional information required by Annex VIII (Section 2 of Part B) on 
the product does not change either. Therefore, these components can be grouped in one ICG. 
The ICG is named ‘Complexing agent’. 

Components A and B are reported with their identifiers and concentrations as required by 
Annex VIII. 

Each of the components C grouped in the ICG are identified in accordance with the standard 
rules for substances or MiMs (explained in section 5.3 of this Guidance). The concentration is 
provided for the ICG as a whole as exact value (5%) or with a range, in accordance with Table 
1 of Annex VIII (due to the classification of the mixture; maximum 1% unit in this case). 

Example 26: Grouping components in different ICGs according to the technical function 

In this example, the formulator relies on different sources for two of the components used in 
the formulation of the final mixture: a complexing agent C and a dehydrating agent D.  

 
 
 
 
 
 
 
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Three alternative components (C1, C2 and C3) are used as complexing agents and three 
alternative components (D1, D2 and D3) used as dehydrating agent.  
These have the following characteristics: 

Components supplied by multiple suppliers 

Component 

Function 

Hazard classification 

Toxicological properties 

C1 

C2 

C3 

D1 

D2 

D3 

Complexing agent 

Acute toxic oral, cat. 3 

Set of properties S1 

Complexing agent 

Acute toxic oral, cat. 3 

Set of properties S1 

Complexing agent 

Acute toxic oral, cat. 1 

Set of properties S2 

Dehydrating agent 

Flammable liquid, cat. 3 

Set of properties S3 

Dehydrating agent  

Flammable liquid, cat. 3 

Set of properties S3 

Dehydrating agent 

Flammable liquid, cat. 3 

Set of properties S3 

Components A and B are reported with their identifiers and concentration as required by Annex 
VIII. 

Regarding the complexing agent C, even if all three alternatives have the same technical 
function in the final mixture, C3 does not have the same classification as C1 and C2. Therefore, 
they cannot all belong to the same ICG, even if the hazard identification of the final mixture 
remains the same. 

Components  C1  and  C2  have  the  same  classification  and  toxicological  profile  and  their 
combination  leads  to  identical  hazard  identification  of  the  final  mixture  as  well  as  identical 
additional information. Therefore, they can be grouped in one ICG. 

Regarding the dehydrating agents D, all the alternative components have the same classification 
and toxicological properties. The hazard identification of the final mixture remains the same as 
well as the additional information on the product. Consequently, they can be grouped in another 
ICG. 

C3 has to be reported individually with its own concentration. For the case when C3 is present 
while C1 and C2 are absent, a separate submission with a different UFI is needed.  

Several submissions and UFIs may be needed also if the variability of C3, D or the ICG (grouping 
C1 and C2) exceeds the limits of the ranges allowed by Table 1 or 2 as applicable. 

Example 27: Grouping components having different technical functions 

In this example, the formulator mixes nine components in the mixture. The submitter is not in 
a position to know the exact concentration of five components (B, C, D, E, F) or whether they 
are all always present in the final mixture. This is due to the components being used 
depending on their availability, and they are fed into a continuous production process. These 
components are purchased from different suppliers and cannot be regarded as the same from 
a chemical point of view. The properties of the nine components are the following: 

Components in the mixture 

Component  Hazard classification 

pH 

Toxicological properties 

 
 
 
 
 
86 

A 

B 

C 

D 

E 

F 

G 

H 

I 

Acute toxic oral, cat. 3 

12 

Set of properties S1 

Aspiration hazard, cat. 1 

7 

Set of properties S2 

Aspiration hazard, cat. 1 

6.5 

Set of properties S2 

Eye damage, cat. 1 

10 

Set of properties S3 

Aspiration hazard, cat. 1 

7.5 

Set of properties S2 

Eye damage, cat. 1 

Not classified 

Aspiration hazard, cat. 1 
Eye irritation, cat. 2 

Not classified 

9 

6.5 

9 

7 

Set of properties S3 

Not applicable 

Set of properties S4 

Not applicable 

Components A, G, H and I are reported individually with their identifiers and concentration as 
required by Annex VIII (either exact concentrations or ranges in accordance with Table 1 or 2, 
as applicable). 

Components B, C and E could be grouped in one ICG following the alternative set of criteria 
(section 5.5.2.2 of this Guidance): all three have the same classification and are classified for 
aspiration hazard only. The pH, even if not exactly the same, is within a range which can be 
considered as being neutral for the grouping purpose (i.e. between 6 and 8). Additionally, the 
submitter is able to provide the concentration range according to Table 2 of Annex VIII for the 
ICG. Furthermore, this ICG groups fewer components than the permitted maximum of five. 
This is possible even when the technical function is not the same for each component in the 
final mixture.  

Toxicological sameness is not considered in the grouping of components B, C and E. 

 
 
 
 
 
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Nevertheless, their toxicological properties can be expected to be similar based on the fact that 
they have the same classification and limited differences in pH (see 5.6.2.2). 

Components D and F can also be grouped in a separate ICG, following the second set of 
criteria: they have the same classification (Eye damage cat. 1 only), are all alkaline (pH > 7, 
not necessarily exactly the same but similar enough not to affect hazard properties and 
emergency response), and there are fewer than five components. Also, in this case, the 
technical function in the final mixture does not have to be the same and the toxicological 
properties can be expected to be very similar. The submitter also in this case is able to provide 
the concentration range according to Table 2 of Annex VIII for the ICG. 

Several submissions and UFIs may still be needed depending on the concentration of both 
ICGs in the final mixture, in particular if the variability of the ICGs exceeds the limits of the 
ranges allowed by Tables 1 or 2, as applicable. 

The hazard identification of the mixture placed on the market is the same for all possible 
combinations, regardless the individual concentration of components A, H, I and ICGs in the 
resulting final mixture. The information referred to in Section 2 of Part B is also identical. 

Example 28: Grouping components having different technical function in different ICGs 

A formulator regularly manufactures batches of a hard surface cleaner concentrate. They 
source wetting agents (identified as C1 and C2) from two different suppliers and these are 
used interchangeably. The product also includes an ingredient (F1) which functions as a 
corrosion inhibitor and emulsifying agent. This can be substituted with two separate 
ingredients (corrosion inhibitor F2) and emulsifying agent (F3). Therefore, there are four 
potential recipes 1, 2, 3 and 4 which could be used depending on the availability of 
ingredients. 

Components common to all recipes 

Component  Technical function 

Hazard class and category 

pH 

Concentration 
(%) 

A 

B 

Solvent 

Not classified 

not relevant 

82.3 – 82.6 

Detergent base 

Acute toxic oral, cat. 4; Acute Toxic 
dermal cat. 4; Acute toxic inhalation, 

not relevant 

11 

 
 
88 

D 

E 

C1 

F1 

C2 

F1 

C1 

F2 

F3 

C2 

F2 

F3 

cat. 4; Skin corrosion, cat 1B; Eye 
damage, cat. 1; Specific target organ 
toxicity, single exposure, Cat. 3 
(respiratory irritation) 

Solubiliser 

Not classified 

Surfactant 

Acute toxic oral, cat. 4; Eye damage, 
cat. 1 

not relevant 

not relevant 

Specific components recipe 1 

Wetting agent 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Emulsifier/corrosion 
inhibitor 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Specific components recipe 2 

Wetting agent 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Emulsifier/corrosion 
inhibitor 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Specific components recipe 3 

Wetting agent 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Corrosion inhibitor 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Emulsifier 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Specific components recipe 4 

Wetting agent 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Corrosion inhibitor 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

Emulsifier 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

0.3 

1.9 

2.6 

1.6 

2.6 

1.6 

2.6 

1.2 

0.7 

2.6 

1.2 

0.7 

After manufacture and quality control approval, each batch is pumped to a bulk storage tank 
to release the blending vessel for another product. As orders are received, product from the 
bulk storage tank will be packaged into containers. The bulk storage tank will normally contain 
some product before transfer of a batch takes place, and hence different batches of product 
get mixed in the storage tank. Therefore, it would be practically very difficult for the formulator 
to make a submission according to the requirements of Annex VIII, as the precise composition 
of the product at the point of packaging is unknown.  

Components A, B, D and E are reported individually with their identifiers and concentration as 
required by Annex VIII (either exact concentrations or ranges in accordance with Tables 1 or 
2, as applicable). 

Components C and F could be all grouped in one ICG, following the alternative set of criteria 
(section 5.5.2.2 of this Guidance): all components used as wetting agent, emulsifier and/or 
corrosion inhibitor have the same classification and are classified for the skin corrosion hazard 

 
 
 
 
 
 
 
 
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only. The pH, even if not exactly the same, is acidic (<7) within a limited range which does not 
affect hazardous properties and emergency response. Furthermore, this ICG groups fewer 
components than the permitted maximum of five. This is possible even when the technical 
function is not the same for each component in the final mixture. 

Toxicological sameness is not considered in the grouping of components B, C and E. 
Nevertheless, their toxicological properties can be expected to be similar based the fact that 
they have the same classification and the pH is below 6 for all possible components (see 
5.5.2.2). 

5.6 Special provisions for ready-mixed concrete, gypsum and cement 
products: Standard Formulas [B.3.6] 

Providing the required information can be very difficult where raw materials with a highly 
variable or unknown composition are used in the formulation of the mixture. In these 
situations, it may not be possible to know the exact composition of the mixtures, which could 
vary from batch to batch, and to provide the concentration of each component within the limits 
set in Annex VIII. 

In order to address potential difficulties encountered by the gypsum, ready-mixed concrete 
and cement sectors in complying with the standard requirements of Annex VIII, the legal text 
includes in Part D a list of Standard Formulas which can be used for the submission of the 
information relevant for emergency health response. Suppliers of mixtures within the three 
sectors mentioned above, subject to the obligations under Article 45 and conforming with one 
of those Standard Formulas, are allowed to deviate from the information requirements 
regarding the composition of the mixture. 

The intention of the provisons related to Standard Formulas is to allow duty holders to comply 
with the emergency health response requirements without reducing the level of safety. The 
information provided on these specific mixtures by using the Standard Formulas is considered 
as detailed enough for the poison centres to be able to provide effective emergency response 
in the case of accidents with these specific products. 

5.6.1 Standard Formulas 

A mixture ‘composition conforming with a Standard Formula specified in Part D’, means a 
composition which includes all the components listed in one of the Standard Formulas (referred 
to in Part D), where those components are present in the concentrations within the ranges 
specified in that Standard Formula.  

Part D of Annex VIII includes an exhaustive list of 23 Standard Formulas: 

-  20x Standard Formulas related to cement, 
-  1x Standard Formula related to gypsum binder, 
-  2x Standard Formulas related to ready-mixed concrete. 

Only mixtures belonging to these three product types and conforming (as a whole or in part) 
with one of the Standard Formulas included in Part D can benefit from the special provisions 
described in this section. 

For each of these Standard Formulas, the information in Part D includes the list of components 
with their identifiers and concentration ranges. The latter may be listed as broader than what 
is allowed when applying Tables 1 and 2 of Part B of Annex VIII. This is based on the 
assumption that the hazard of the mixture and the emergency measures to be adopted in case 

 
 
 
 
 
 
 
 
 
 
 
90 

of exposure, do not change within the concentration ranges specified for the mixture’s 
composition in the Standard Formula and included in the notification. 

In general, components not present in a mixture are not to be notified, however, where 
Standard Formula components listed in Part D, include the range from ‘zero’, they shall be 
indicated in the notification even if that component: 

- 

is not present at the time of notifying but it is known that it will be present in the 
mixture in the future, or, 

- 

is known to never be a component in the mixture. 

Standard Formulas can be used in a submission to describe the final mixture (i.e. the final 
mixture’s composition conforms to the Standard Formula) or part of the final mixture 
(substances or MiMs) - this is explained in section 5.6.2 below. In the latter case, the final 
mixture compositon may contain additional components besides those included in the Standard 
Formula. 

The assumption behind the use of a Standard Formula is that the classification of the final 
mixture does not change within the components’ concentration ranges specified in the same 
Standard Formula (regardless the fact that the Standard Formula describes the whole or part 
of the mixture).  

It is important to underline that the derogation from information requirements concerns the 
composition only. This means that the duty holder is allowed to deviate from the standard 
requirements concerning which components have to be indicated [Annex VIII, Part B, section 
3.3], how the components should be identified [Part B, Section 3.2 of Annex VIII] and how the 
concentration should be reported [Part B, Section 3.4 of Annex VIII]. All the remaining 
information about the mixture and the product as required by Part B of Annex VIII has to be 
provided as per a standard submission. This means that: 

•  The product has to be identified as required in Section 1 of Part B (explained in section 

5.1 of this Guidance)  

•  The hazard identification and product information has to be provided as required in 

Section 2 of Part B (explained in section 5.2 of this Guidance). 

•  The classification of the components has to be provided as set out in Section 3.8, Part 

B of Annex VIII (explained in section 5.3.3.3 of this Guidance). 

•  The name and product description of the Standard Formula as indicated in Part D of 

Annex VIII has to be included in the submission. 

5.6.2 Using Standard Formulas: whole mixture composition vs part of the 
mixture composition (substances or MiMs) 

Annex VIII foresees the possibility to use a Standard Formula either to report the whole 
composition of the mixture which is intended to be notified or only a part of it.  

In the first case, all the components of the final mixture are those (and all) listed in the 
Standard Formula, i.e. the final mixture’s composition conforms to the Standard Formula. The 
information on identity and concentration ranges of all the components can be provided as in 
the Standard Formula (as an alternative to the standard requirements of Sections 3.2, 3.3 and 
3.4 of Part B of Annex VIII). 

 
 
 
 
 
 
 
 
 
 
 
 
 
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In the second case, the final mixture itself does not conform to a Standard Formula, but part 
of it (i.e. one or more of its components) does. In this case, there are two possibilities: 

-  A MiM component can be identified by using a Standard Formula, providing its product 
identifier (e.g. name of Standard Formula and, if available, the UFI) and composition 
accordingly (i.e. the compositon of the MiM corresponds to the Standard Formula). 
Individual components which together correspond to the Standard Formula in its 
entirety can be identified as in the Standard Formula itself at the level of the final 
mixture; this means that identification and concentration of the substance components 
can be provided as in the Standard Formula included in Part D of Annex VIII. 

- 

In both cases all other components (not conforming to a Standard Formula) of the final 
mixture have to be notified in accordance with Sections 3.2 or 3.4 of Annex VIII, Part B, as 
explained in section 5.3 of this Guidance. See examples below. 

When components are reported by using a Standard Formula, their identification and 
concentration ranges have to be reported exactly as in that Standard Formula, unless more 
detailed information is available (see next section 5.6.3). 

When a mixture composition conforms with a Standard Formula, not all components 
necessarily need to be notified as specified in it. Some of the components can still be notified 
in accordance with the normal rules in Sections 3.2 to 3.4 of Annex VIII, Part B. 

A note to the tables in Part D of Annex VIII indicates that heavy metals and other elements 
may be present at very low concentrations. When the concentrations are lower than the 
concentrations indicated65, the elemental substances do not need to be reported even if their 
presence is known. 

5.6.3 Standard Formulas vs SDS information 

Even when a mixture or part of it qualifies for the derogation described in this section, the duty 
holder is required to provide the most detailed information available to them. Therefore, when 
the SDS of the mixture contains more detailed information than what would be provided by 
using a Standard Formula, the information on the identity and concentration of all the 
mixture’s components as specified in the Safety Data Sheet has to be provided instead of 
using the Standard Formula. 

The above is applicable not only when the full mixture composition of the final mixture 
conforms with a Standard Formula, but it may also be applicable where a Standard Formula is 
used to identify part of the composition, while other components are reported in accordance 
with the Annex VIII requirements. If this information as a whole is less detailed than that 
given in the SDS for the final mixture, the information on the identity and concentration of all 
the mixture’s components conforming with the Standard Formula has to be provided as given 
in the SDS. 

This can be the case when, e.g., the concentration ranges shown in the SDS are narrower than 
those in the Standard Formulas for the same components. The comparison between Standard 
Formula and SDS shoud take into account the completeness of the composition and the width 
of the concentration ranges. 

The duty holder is therefore still allowed to deviate from the Annex VIII standard information 

65 This includes: As, Ba, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Sb, Sn, Te, Tl, V below 0,1 w/w % and Mn, Sr, 
Zn below 1 w/w %. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
92 

requirements with regard to the composition (points 3.2, 3.3 and 3.4 of Part B) for the 
components conforming to the Standard Formula, but the more detailed available information 
from the SDS has to be provided. 

5.6.4 Examples 

In this section, the use of the Standard Formulas included in Part D of Annex VIII is explained 
by means of examples intended to address different possible submission scenarios. In all the 
examples, the duty holder is expected to submit a notification for a generic ‘mixture A’ which 
they intend to place on the EU market. Except where clearly indicated otherwise, the reference 
is to a generic Standard Formula “SF1”. 

Note. The following is applicable to all the example scenarios: 

-  Classification and labelling information and other additional information as requested in 

Annex VIII, Part B, has to be provided for the final mixture A. This includes: 

o  Product identifier of the mixture and submitter details (see section 5.1). 
o  Toxicological information (section 5.2.2). 
o  Additional information on the product (section 5.2.3). 

-  Classification information on individual components has to be provided as for any 

standard notification. This applies to the part of the composition conforming with the 
Standard Formula and the additional components (if any) that are not part of the 
Standard Formula. 

Generally speaking, there are two main ways how Standard Formulas can be of use: 

1.  Final mixture ‘A’ fully conforms to Standard Formula (i.e. no additional components 

besides those listed in the relevant Standard Formula). 

2.  Final mixture ‘B’ does not fully conform to any Standard Formula but part of it does (i.e. 

contains all the components indicated in one of the Standard Formulas plus other 
additional components). 

Example 29: Final mixture fully conforms with a Standard Formula 

The final mixture A (i.e. the mixture to be notified) includes all and only the components 
indicated in SF1 included in Part D of Annex VIII. All of its components are therefore reported 
as in SF1. In other words, all the components which are part of the Standard Formula are also 
part of the mixture composition, with no extra components. 

Composition 
of final 
mixture A 
Component A 

Component B 

Component C 

Component D 

Identification 

Concentration 

Classification 

The whole 
final 
composition 
conforms with 
SF1 

As in SF1 

As in SF1 

As in SF1 

As in SF1 

As in SF1 

As in SF1 

As in SF1 

As in SF1 

To be 
provided 
To be 
provided 
To be 
provided 
To be 
provided 

Example 30: The final mixture includes all the components included in the Standard Formula 
plus additional components 

The following scenario aims to exemplify a case where a Standard Formula is basically used to 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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describe a part of the final composition. The full composition of the final Mixture B includes 
additional components which are not part of any Standard Formula. 

Scenario 1 

The final mixture B (i.e. mixture to be notified) includes one MiM which can be notified using  
SF1 listed in Part D. In this example, the Standard Formula is therefore included as a MiM in 
the final mixture: 

Composition 
of final 
mixture B 
Component A 

Component B 

Component C 

MiM D (SF1) 

Identification  Concentration  Classification 

To be 
provided 
To be 
provided 
To be 
provided 
To be 
provided 

As in B.3.2 

As in B.3.4 

As in B.3.2 

As in B.3.4 

As in B.3.2 

As in B.3.4 

Concentration of 
MiM in final 
mixture to be 
given according 
to B.3.4. 

The MiM is 
notified with 
SF1 

Name of 
Standard 
Formula “SF1” 

Composition 
information as 
in SF1 

Concentration 
of components 
of MiM to be 
given according 
to SF1 

Scenario 2 

Also in this example, the final mixture B (i.e. mixture to be notified) includes all the 
components listed in one of the Standard Formulas included in Part D as well as additional 
components. The Standard Formula “Gypsum binder” is taken as an example for simplicity as 
it contains two components only. 
In this example, the components from the Standard Formula “Gypsum binder” are notified 
individually as components of the final mixture (as an alternative to the scenario above). 

Composition 
of final 
mixture A 
Component A 

Component B 

Component C 

Component D: 
Gypsum 
sulphate 

Identification  Concentration  Classification 

As in B.3.2 

As in B.3.4 

As in B.3.2 

As in B.3.4 

As in B.3.2 

As in B.3.4 

This part 
conforms with 
Standard 
Formula 
“Gypsum 

As in Gypsum 
Binder Standard 
Formula: 
231-900-3 

As in Gypsum 
Binder Standard 
Formula: 
≥50% and < 
100% 

To be 
provided 
To be 
provided 
To be 
provided 
To be 
provided 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
94 

binder 
Standard 
Formula” 

Component E: 
Calcium 
dihydroxide 

As in Gypsum 
Binder Standard 
Formula: 215-
137-3 

NB: this value, 
taken from the 
Standard 
Formula in Part 
D, refers to the 
composition of 
the final mixture 
As in Standard 
Formula 
Gypsum 
Binder:>0 and 
≤5%) 
NB: as above 

To be 
provided 

5.7 Special provisions for fuels conforming with standards or technical 
specifications [B.3.7] 

Annex VIII includes special provisions for specific fuels, listed in Section 3.7, Part B of the 
same Annex. These products are normally formulated from naturally occurring substances, 
which vary in composition. Fuel products are produced to meet EN standards and/or technical 
specifications. These standards define the required technical performance of the products 
rather than the detailed composition. This means that while the major mixture components are 
well understood, the specific composition (as per the Annex VIII requirements) may vary due 
to the natural variations in the natural base material (crude oil). Furthermore, petroleum 
products (i.e. mixtures) are produced as a continuous blending process, meaning that there 
can be frequent small incremental compositional changes. These changes could lead to a need 
for frequent notification updates.  

Ultimately, fuels placed on the market normally conform to a technical standard and/or 
technical specifications rather than a specific chemical composition. Different batches of what 
industry considers to be the ‘same’ commercial product (under relevant standards such as e.g. 
EN590, which describes the characteristics that all automotive diesel fuels must meet if it is to 
be sold in the EU and Switzerland) can have sufficiently different chemical compositions to 
necessitate, in principle, separate Annex VIII notifications. This would also result in multiple 
UFI numbers being generated for the ‘same’ commercial product, containing the same 
ingredients (albeit in different concentrations). EN standards and technical specifications 
provide requirements in terms of chemical compositions of petroleum products with wide 
ranges of concentrations and generic description of components, which can be hazardous or 
non-hazardous chemicals.  

In order to address such issues, and considering the low number of poisoning incidents with 
fuels reported by Poison Centres, a derogation from the standard requirements for Annex VIII 
notifications is foreseen for the fuels listed in table 3 under Section 3.7, part B. 

Instead of providing exact concentrations or ranges according to tables 1 and 2 in Annex VIII, 
it is allowed to submit compositional information as contained in the safety data sheet, 
complemented with the identity and concentration of any other known component (including 
for instance non-hazardous components), so as to reduce to the minimum the uncertainty 
regarding the composition. The submitter should normally aim at providing the full 
composition, in cases when the information is available to him. 

5.7.1 Definition of fuels 

A fuel is a material that is burned to produce heat or power for a plant, vehicle or machine. 

 
 
 
 
 
 
 
 
 
 
 
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The derogation from the normal notification regime applies to the fuels listed in Table 3, 
Section 3.7, Part B of Annex VIII. 

Table 4: List of fuels - Table 3, Part B of Annex VIII  

Fuel name 

Product description 

Gasoline EN228  

Automotive fuels - Unleaded petrol  

Gasoline E85 

Automotive fuels –Ethanol (E85) automotive fuel 

Gasoline alkylate 

Motor fuels – special petrol for powered implements 

LPG 

LNG 

Liquefied Petroleum Gas used as fuel  

Liquefied Natural Gas used as fuel 

Diesel fuel 

Automotive fuels - diesel engine fuels with/without biofuel  

Paraffinic  diesel  fuels 
(e.g.,  GTL,  BTL  or 
HVO) 

Heating oil 

MK 1 diesel 

Automotive  fuels  -  Paraffinic  diesel  fuel  from  synthesis  or 
hydrotreatment 

Liquid mineral fuels with the characteristics of domestic fuel oil   

Automotive fuels – Diesel fuel oil of environmental class 1 and 2 
for high-speed diesel engines  

Aviation fuels 

Aviation turbine engine and piston engine fuels  

Kerosene - Illuminating 
paraffin 

Illuminating paraffin lampoil Type B and C 

Heavy fuel oil 

All grades of heavy fuel oil  

Marine fuel  

Marine fuels, containing or not biodiesel 

Fatty 
acid  methyl 
esters (FAME) – Diesel 
B100 

Fatty  acid  methyl  esters  (FAME)  for  use  in  diesel  engines  and 
heating applications  

All commercially available fuels conform to either an international or a national standard or 
another technical specification. Some examples include:  

ISO 8127 Petroleum products — Fuels (class F) — Specifications of marine fuels 

- 
-  ASTM D1655 - Standard Specification for Aviation Turbine Fuels 
-  EN589 - Automotive fuels. LPG 
-  ÖNORM C 1109 – Liquid fuels - Domestic fuel oil - Gasoil for heating purposes (Austria) 

Enforcement authorities may inquire about the documentation of the standard and/or technical 
specification met by a product placed on the market. 

A typical composition of a fuel is a mix of:  

-  one or more petroleum fuel substances and its stabilisers;  
-  one or more non-petroleum components and its stabilisers with concentration varying 

from zero to a certain level;  
specific well identified additives which can be e.g. colourants for tax purposes; 

- 
-  performance additives, usually proprietary.  

The compositions of such blends vary due to the complex supply chains and continuous 
blending process except for the performance additives. The concentration of the latter does not 
normally vary as they are often added at the step before delivery to customer.  

 
 
 
 
 
 
 
 
96 

5.7.2 Information requirements on composition 

The submission for fuels can deviate from the standard information requirements with regard 
to: 

-  Section 3.2, Part B: Identification of mixture components; 
-  Section 3.3, Part B: Mixture components subject to submission requirements; 
-  Section 3.4, Part B: Concentration and concentration ranges of mixture components. 

Section 3.7, Part B specifies that the identification and concentration of the components can be 
reported as in the SDS and do not need to follow the standard Annex VIII requirements. The 
identity and concentration of any other known component not listed in the SDS has to be 
reported as well. Non-hazardous known components present in concentrations equal or greater 
than 1% and known hazardous components present in concentrations equal or greater than 
0.1% should at least be included. Known components not included in the SDS should be 
reported according to the standard rules (i.e. with regard to identity and concentration). 
Industry is researching and introducing more sustainable and often less hazardous substitutes 
of fuels’ components. An example is the use of non-hazardous component Fatty Acid Methyl 
Esters (FAME) instead of certain hazardous components in diesel fuels EN 590, listed in Table 3 
of Annex VIII, Part B as “Diesel fuel - Automotive fuels - diesel engine fuels with/without 
biofuel”. Being non-hazardous, FAME does not need to be included in section 3 of the SDS 
even if it partially substitutes some of the hazardous components listed there. Therefore, when 
it is not listed in the SDS, it is not required to be included in the submission, unless its 
presence in the fuel is known.  

The classification of the components has to be provided as required in Section 3.8, Part B of 
Annex VIII, as explained in section 5.3 of this Guidance. 

All other information required by Annex VIII has to be provided according to standard rules: 

- 

information on the identification of the mixture, submitter and, if relevant, contact point 
(section 5.1 of this Guidance); 

-  hazard identification of the mixture (section 5.2 of this Guidance); 
-  additional information on the product (section 5.2 of this Guidance). 

Example 31: Submission of information for a fuel product listed in Table 3 of Annex VIII 

The submission to the relevant appointed bodies for a fuel product listed in Table 3 of Annex 
VIII needs to include information on the composition as shown in the generic table below: 

Fuel type and name as mentioned in Table 3, Section 3.7, Part B of Annex VIII 

Identification 

Concentration 

Classification 

Composition of fuel 
product 
Component A 

As in SDS 

Component B 

As in SDS 

Component C 

As in SDS 

Component D 

As in SDS 

As in SDS 
(i.e., deviating from 
B.3.4) 
As in SDS 
(i.e., deviating from 
B.3.4) 
As in SDS 
(i.e., deviating from 
B.3.4) 
As in SDS 
(i.e., deviating from 
B.3.4) 

Hazardous, 
classification to 
be provided 
Hazardous, 
classification to 
be provided 
Hazardous, 
classification to 
be provided 
Hazardous, 
classification to 
be provided 

 
 
 
 
 
 
 
 
 
 
 
 
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Component E 

Component F 

Component G 

Not listed in SDS 
because 
concentration is 
below threshold for 
inclusion (REACH 
Annex II). If known, 
provide 
identification 
according to 
standard Annex VIII 
rules 
Listed in the SDS 
even if not required 
according to Annex 
II to REACH). 
Identification to be 
provided as in the 
SDS. 
Not listed in the 
SDS. If known, 
identification to be 
provided according 
to standard Annex 
VIII rules 

Hazardous 

Not listed in SDS 
because concentration 
is below threshold for 
inclusion (REACH 
Annex II). If known, 
provide concentration 
according to standard 
Annex VIII rules 

Provide as in the SDS 

Not hazardous 

If the presence is 
known, provide as per 
Annex VIII, Part B, 
section 3.4 rules. 

Not hazardous 

Based on the generic table above, the compositional information to be included in a submission 
for (as an example) a diesel fuel meeting the standard EN590 and which is included in the list 
in Section 3.7, Part B as “Diesel fuel: Automotive fuels – Diesel engine fuels with/without 
biofuel”, would have to be notified as illustrated below. 

The composition of the product varies seasonally and geographically according to the 
availability of components and operational requirements. A typical composition of a diesel fuel 
is shown in the table below: 

Chemical Name 

EC No. 

Fuels, diesel 

269-822-
7 

Concent
ration 
w/w% 
0-100% 

Classification 

Flam. Liq. 3 (H226), Acute Tox. 4 
(H332), Carc. 2 (H351), Asp. Tox. 1 
(H304), Skin Irrit. 2 (H315), STOT RE 2 
(H373), Aquatic Chronic 2 (H411) 
Flam. Liq. 3 (H226), Asp. Tox. 1 
(H304) 

481-740-
5 

0-100% 

C8-C26 – branched and 
linear hydrocarbons – 
Distillates  
Renewable 
hydrocarbons (diesel 
type fraction) 

618-882-
6 
700-571-
2 
267-015-
4 

0-100%  Asp. Tox 1 (H304) 

0-7% 

Not classified 

0-7% 

Not classified 

0-7% 

Not classified 

Fatty acids, C16-18 and 
C18-unsatd. methyl 
esters 
Fatty acids, vegetable 
oil, methyl esters 
Fatty acids, C14-18 and  267-007-

273-606-
8 

 
 
 
 
 
 
 
98 

C16-18-unsatd., Me 
esters 
Performance additive A  UFI A 

0 

2-EHN cetane 

248-363-
6 

300 ppm  Asp. Tox 1 (H304), Skin Irrit 2. (H315), 
Eye Irrit. (H319), Skin Sens. 1 (H317), 
Carc. 2 (H351), STOT SE 3 (H336), 
Aquatic Chronic 2 (H411) 
Acute Tox 4 (H302), Aquatic Chronic 2 
(H411) 

1-8.5 
ppm 

The information in Section 3 of the SDS for the same product is given in table below. 

Chemical Name 

EC No. 

Fuels, diesel 

C8-C26 – branched 
and linear 
hydrocarbons – 
Distillates  
Renewable 
hydrocarbons (diesel 
type fraction) 

269-
822-7 

481-
740-5 

618-
882-6 
700-
571-2 

Concentr
ation 
0-100% 

0-100% 

Classification 

Flam. Liq. 3 (H226), Acute Tox. 4 
(H332), Carc. 2 (H351), Asp. Tox. 1 
(H304), Skin Irrit. 2 (H315), STOT RE 2 
(H373), Aquatic Chronic 2 (H411) 
Flam. Liq. 3 (H226), Asp. Tox. 1 (H304) 

0-100% 

Asp. Tox 1 (H304) 

The following components are not listed in section 3 of the SDS in accordance with the 
requirements in section 3.2 of Annex II of REACH on SDS66: 

•  Fatty acids, C16-18 and C18-unsatd. Me esters: not hazardous 
•  Fatty acids, vegetable oil, methyl esters: not hazardous 
•  Fatty acids, C14-18 and C16-18-unsatd., Me esters: not hazardous 
•  Performance additive A: hazardous but concentration below 0.1% 
•  2-EHN cetane: hazardous but concentration below 1% 

In addition to the components listed in section 3 of the SDS, the submitter must provide the 
information on the components which are not listed in the SDS but are known to him. 
According to the general rules of Annex VIII [Part B, Section 3.3, non-hazardous components 
which are identified have to be notified when are present in concentrations equal or above 1%, 
while classified components should be notified even when are in concentrations under 0.1%, if 
known and relevant. 
Applying these rules to the example, the components not included in section 3 of the SDS will 
be handled as follows for the notification: 

-  The 3 non-hazardous fatty acid methyl esters and their know ranges will be included in 
the notification. Standard rules apply (unless these components are included in section 
3 of the SDS), therefore the concentration should be given either as exact percentage 
or with a range in accordance with Table 2 of Annex VIII. 

-  The cetane improver, given the low concentration, low level of toxicity (Acute toxicity 4) 
and the fact that the component “Fuel, diesel” classified as acute tox 4 and present in 
higher concentration is notified, will not be mentioned in the notification. The submitter 
considers it irrelevant for emergency response and is able to demonstrate it in case of 
inquiry from the relevant authorities. 

66 These components can be voluntarily included in the Section 3 of the SDS. In this case the 
concentration can be provided as in the SDS. 

 
 
 
 
 
 
 
 
 
 
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-  The performance additive A will be included because, despite its concentration being 

below 0.1%, it is considered relevant for the emergency response due to the skin sens. 
1. 

The submitter cannot report the components which are not known to him and it is not required 
to investigate further. Examples are colourants or specific performance additives. 

In the notification format, it should be mentioned which type of fuel product from table 3, 
section 3.7, Part B of annex VIII the product conforms to. 

Applying this to the example of diesel B7, the notification will contain the information as given 
in table below. 

In this example the three FAME components are not listed in Section 3 of the SDS, therefore 
the concentration has to be provided in accordance with Table 1 of Annex VIII. 

Diesel fuel: Automotive fuels – Diesel engine fuels with/without biofuel 

Component 

Fuels, diesel 

Identificati
on 
269-822-7 

Concentrati
on 
0-100% 

Classification 

Flam. Liq. 3 (H226), Acute 
Tox. 4 (H332), Carc. 2 (H351), 
Asp. Tox. 1 (H304), Skin Irrit. 
2 (H315), STOT RE 2 (H373), 
Aquatic Chronic 2 (H411) 
Flam. Liq. 3 (H226), Asp. Tox. 
1 (H304) 

C8-C26 – branched 
and linear 
hydrocarbons – 
Distillates 
Renewable 
hydrocarbons (diesel 
type fraction) 
Fatty acids, C16-18 
and C18-unsatd. 
methyl esters 
Fatty acids, vegetable 
oil, methyl esters 
Fatty acids, C14-18 
and 
C16-18-unsatd., 
methyl esters 
Performance additive 
A 

481-740-5 

0-100% 

618-882-6 
700-571-2 

0-100% 

Asp. Tox 1 (H304) 

267-015-4 

0-1% 

Not classified 

273-606-8 

0-1% 

Not classified 

267-007-0 

0-1% 

Not classified 

UFI A 

300 ppm 

Asp. Tox 1 (H304), Skin Irrit 2. 
(H315), Eye Irrit. (H319), Skin 
Sens. 1 (H317), Carc. 2 
(H351), STOT SE 3 (H336), 
Aquatic Chronic 2 (H411) 

 
  
 
 
 
 
 
 
 
 
100 

6. Preparation and submission of information: available tools  

The submission of the required information has to be done electronically and using the XML67 
format provided by ECHA [A.3.1]. The tools developed and maintained by ECHA assist both the 
submitters and the Member States appointed bodies (and eventually the Poison Centres) in 
fulfilling their obligations and performing their tasks. The tools support the end to end process 
of 1. generation of the UFI; 2. preparation of the information in the correct format; and 3. the 
submission of information to the relevant Member State(s).  

6.1 UFI generator  

The generation of the UFI(s) can be done at any time before the actual submission. It should 
be preferably done during the mapping and analysis of the portfolio while preparing the 
submission strategy. Generation and use of UFI is explained in section 4 (in particular 
subsection 4.2) which addresses the general submission requirements. 

6.2 Extensible markup language (XML) format  

Annex VIII to CLP mandates ECHA to specify, maintain and update the electronic XML-based 
format that must be used for the submission of the harmonised information [A.6]. 

The use of this format is mandatory and alternatives (e.g. paper submissions or other 
electronic formats) are not allowed. The format is harmonised and it applies in all Member 
States. 

ECHA, being strongly engaged in the OECD international initiatives aiming to promote the 
definition and use of commonly agreed formats for the electronic exchange of information on 
chemicals, developed the XML format in the IUCLID application (International Uniform 
Chemical Information Database). 

The poison centre notification (PCN) format is a subset of the IUCLID format and is available 
for download from ECHA’s Poison Centres website if needed 
(https://poisoncentres.echa.europa.eu/poison-centres-notification-format) and its use is free 
of charge. The usage of the format and creation of submission files containing required 
information can be executed offline using the IT systems available to duty holders. 

6.3 Tools for preparing IUCLID files 

There are three ways to prepare dossiers (IUCLID.i6z files which are XML compatible). The 
submitter can decide which one to use based on their specific business needs and IT systems. 

•  Online in IUCLID Cloud: IUCLID Cloud is an online tool to guide the user through the 

preparation of a dossier, allowing to enter and store data in the ECHA Cloud. 

•  Offline in IUCLID 6: This option is available for companies using local installations of 
IUCLID. The desktop and server versions of the software can be downloaded from the 
IUCLID 6 website. 

•  Using the PCN format in the company’s own system: companies can prepare and 

create a dossier directly in their own systems, using the IUCLID-compatible PCN 
format.  

67 XML stands for ‘eXtensible Markup Language’ 

 
 
 
 
 
 
 
 
 
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6.4 Submission of information 

The dossier, once prepared and containing the required information, must be submitted to the 
appointed bodies, as stipulated by Article 45(1).  

Dossiers can be submitted through the ECHA Submission portal in one of two different ways, 
either: 

•  Directly online (in the Cloud) through the ECHA Submission portal68: Regardless 
of whether a dossier has been created online or offline, the ECHA Submission portal will 
make available the dossier to all Member States indicated in the IUCLID file. This 
means that a single submission can reach several Member States. 

•  Through a system-to-system (S2S) transfer service69: An automatic S2S transfer 
service allows companies that have created IUCLID files in their own systems to make 
their submission through the ECHA Submission portal. Dossiers are then made available 
to all the relevant Member States.  

Whether the submissions are received by Member States centrally through the ECHA 
Submission portal, or locally through Member States submission systems, it is still the Member 
States that are responsible for any enforcement related to the submission of information, 
including compliance with the date for submission, content, quality and update of the 
submissions etc. 

6.4.1 Validation of information  

Dossiers  submitted  through  the  ECHA  Submission  portal  are  also  subject  to  validation  rules, 
developed in cooperation with appointed bodies, poison centres and industry. Incompliance with 
some of these rules may lead to non-acceptance of the notifications (i.e. submissions are not 
successfully dispatched to the relevant appointed bodies). Other rules may trigger a warning, 
which do not prevent the submission but generate and forward a validation report (containing 
the warnings) along with the dossier to the receiving Member State.  

A validation assistant is made available by ECHA to industry in order to validate the information 
before submission. It must be noted that some rules can only be checked upon submission – 
these are the portal-based rules that cross check information already contained in the system.  

The validation rules70 concern the specific aspects of the dossier content, which can be 
expected to be checked by an automated tool without expert judgement: 

•  presence of information (preventing submission of dossiers not in compliance with the 

information required by Annex VIII); 

•  quality of certain pieces of information (ensuring that information provided is 

meaningful to operations of poison centres); 

• 

internal dossier consistency (ensuring that information in various sections of the dossier 
is not contradictory); 

•  dossier accuracy with previously submitted information (updates). 

For Member States the following main features are provided: 

• 

submissions are received automatically via system-to-system integration (i.e. eDelivery 

68 The ECHA Submission portal can be accessed from the ECHA Poison Centre website at Prepare & 
submit poison centre notifications (PCN) - Poison Centres  
69 More information on the S2S service is available at https://poisoncentres.echa.europa.eu/system-to-
system-service 
70 The updated validation rules are published on ECHA’s Poison Centres website at 
https://poisoncentres.echa.europa.eu/poison-centres-notification-format. 

 
 
 
 
 
102 

solution) and/or 

•  access to submissions and submission reports in a central data base (view, search, and 

manual download) hosted by ECHA. 

6.5 Fees 

The usage of the submission format, UFI generator, and the ECHA Submission Portal provided 
by the Agency is free of charge.  

However, it needs to be noted that while most Member States have indicated that they will not 
solicit a fee, this may be levied in some Member State for each submission. It is at the 
discretion of the competent authority of the Member State where the submission is to be made 
to decide whether fees are applicable for submission to the national appointed body/bodies and 
how they are paid. The document “Overview of Member State decisions on implementing 
Annex VIII to the CLP” available on the Poison Centres website provides an overview of the 
available information71. 

7. Post-submission 

7.1 General introduction 

Successful submission of the information to the appointed body is the basic requirement before 
placing the product containing the mixture on the market of the relevant Member State(s). 
This requires the submission to be compliant with the requirements of Annex VIII. 

It is to be noted that some of the Member States currently require additional information that 
goes beyond the scope of Article 45 and Annex VIII to be submitted before placing the product 
on their market. This information is normally requested within different legal frameworks and 
for purposes potentially different from those described in this guidance (see section 7.3). No 
additional information can be requested under national legislation to that specified in Annex 
VIII for the purposes provided for under Article 45. The XML format defined for the purpose of 
Annex VIII implementation does not foresee such additional requirements. 

Submitters have to make sure that the submitted information is constantly up to date in order 
to ensure that poison centres have the relevant information on the products available on the 
market at their disposal. Changes which trigger a mandatory update of the submission are 
detailed in section 7.4. 

7.2 Additional requests by appointed bodies 

Appointed bodies may perform a quality check of the submitted information, either on a 
regular basis or following specific criteria (for example on the basis of the warnings resulting 
from execution of validation rules by the ECHA Submission portal - see section 6.4 - or other 
“alerts”, e.g. under indication of the poison centre). Should the appointed bodies identify areas 
that are deficient, unclear or maybe considered conflicting, they could contact the company 
who made the submission and request clarification or justification for any open or conflicting 
areas (e.g. regarding the quality of toxicological information provided or its consistency with 
other information). These checks are related to the overall compliance of the submitted 
information with the requirements of the Annex VIII. 

Additionally, according to Section A.3.2 of Annex VIII, an appointed body can make a 

71 https://poisoncentres.echa.europa.eu/appointed-bodies  

 
 
 
 
 
 
 
 
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“reasoned” request for additional information or clarification if this is necessary to carry out its 
tasks under Article 45. In the case of an emergency, unforeseeable situations or in general on 
an ad hoc basis, appointed bodies may request under Section A.3.2 other information 
(potentially exceeding the boundaries of Annex VIII) which is necessary to perform the 
activities under Article 45 (see section 7.3 below). These requests should be justified, limited 
to particular cases, cannot be made on a systematic basis but can occur at any point in time. 

These requests should be addressed to the contact point indicated in addition to the submitter 
and mentioned in section 5.1 of this Guidance. 

Examples of a reason for requesting additional information could be the following: 

-  A need for more detailed information as a result of the analysis of warnings delivered 

by the ECHA Submission portal. 

-  A need for access to more detailed data, based on which the toxicological information 

was prepared by the submitter. 

-  To evaluate the correctness of an assigned product category according to EuPCS.  

-  To enquire about possible presence of non-classified components which are not required 
to be included in the submission (low concentration thresholds) but could be relevant to 
assess the hazard (e.g. synergistic effects) or the potential exposure (e.g. bittering 
agents). 

-  To enquire about relevant toxicological information related to components grouped in 

an ICG (e.g. to verify the sameness of the toxicological information). 

-  To enquire about packaging information not included in the submission following 

incidents involving children (e.g. child-resistant fastening). 

-  To discuss and obtain information relevant for toxicovigilance activities. 

7.3 Use of submitted information 

As indicated in Article 45 of CLP, appointed bodies have to ensure that the submitted 
information is used only to: 

(a)  meet medical demand by formulating preventative and curative measures, in 

(b) 

particular in the event of an emergency; and  
where requested by the Member State, the Commission or ECHA, 
undertake statistical analysis to identify where improved risk management 
measures may be needed. 

Statistical analysis to identify where improved risk management measures may be needed can 
be undertaken, where requested by the Member State, the Commission or the Agency. These 
data can help to identify particular trends in incidents or to adjust the focus of preventative 
actions. 

7.3.1 Security and confidentiality of the submitted information 

Information submitted to appointed bodies may contain sensitive and confidential elements. 
Systems which handle this information should be designed to follow strict security standards. 
The information can only be used by personnel authorised by the appointed bodies. 

ECHA guarantees the security of the information submitted and stored in its protected IT-
infrastructure. Submission portal and data base are secured according to the same security 
practices as other ECHA databases which contain sensitive registration data. Access to the 

 
 
104 

searchable database is strictly controlled, its security settings are hardened, and security is 
continuously monitored as well as content of the database is regularly backed up. 

Appointed bodies and poison centres, which have access to the searchable database through 
ECHA’s standard secure remote access system, have to provide all requisite guarantees for 
maintaining the confidentiality of the information received. In the event of emergency, they 
are required to provide health response without disclosing directly confidential business 
information, unless it is necessary to inform health care professionals about a specific 
substance to ensure the patient receives the correct treatment. 

7.4 Keeping information up to date 

7.4.1 Introduction 

This section provides guidance on when the information submitted has to be updated and 
covers in particular Section 4, Part B of Annex VIII. It covers also voluntary updates following 
changes not explicitly listed under B.4.1. After a submission, changes may be made to the 
mixture as placed on the market or new information about it may become available. It is 
necessary to ensure that the information submitted to the appointed body is relevant and up 
to date for every product being and having been placed on the market. Duty holders are 
required to provide the relevant information in compliance with Annex VIII before placing a 
product on the market. This will make sure that adequate advice can be given in poisoning 
accidents by poison centres and medical services. The legal text indicates which changes 
trigger specific actions from the submitter. 

7.4.2 Update rules according to Annex VIII 

According to Section B.4.1 of Annex VIII, a submission update is required when: 

1.  the name of the mixture (the product identifier, e.g. trade name/brand/identification of 

the mixture) or the UFI is changed, or 

2.  the mixture classification for health or physical hazards changes, or 

3.  relevant new toxicological information that is required in Section 11 of the safety data 

sheet becomes available on the hazardous properties of the mixture or its components, 
or 

4.  the composition of the mixture is changed following:  

a)  Addition, substitution or deletion of one or more of the components that needs to be 

indicated72, or 

b)  Change in the concentration range provided in the original submission; i.e. the 

concentration of a component of the mixture, is changed beyond the concentration 
range provided in Table 1 and 2 Annex VIII, or 

c)  Change in the exact concentration provided in the original mixture; i.e. the 

concentration of a component in the mixture is changed beyond the limits indicated 
in in table 5 below (i.e. Table 4 of Annex VIII). 

5.  when there are other changes to a mixture placed on the market which are relevant for 

the emergency health response referred to in Article 45 (see section 7.4.3). 

72 To be noted that the substitution of one component (substance or MiM) by another with identical 
composition and hazard profile (possibly following a change of supplier) does not trigger the need for an 
update or a new submission. 

 
 
 
 
 
 
 
 
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The submission must be updated before placing the mixture in question, as changed, on the 
market. 

With regard to submissions made by referring to Standard Formulas included in Part D (for 
ready-mixed concrete, cements and gypsum products as explained in section 5.6 of this 
Guidance) and for fuels listed in Part B, section 3.7 of Annex VIII, specific provisions apply 
with regard to the update obligations under point 4 above. These are addressed in detail in the 
sections 7.4.2.3 and 7.4.2.4 below.  

Note that whenever changes listed above occur, an update of the submitted information is 
required before the mixture, as changed, is placed on the market. 

When a submission includes one or more interchangeable component groups (ICG), the 
submission has to be updated if a component is added, deleted or replaced within an existing 
ICG. However, there is no need to change the UFI. 

Note that a change in the mixture composition and/or the information available (i.e. revision of 
classification criteria in Annex I to CLP or new toxicological information) could be such that the 
mixture is no longer classified for any health or physical hazards. Also, in this case an update 
of the notification is required. This is to avoid misleading and confusing information which may 
lead to over-treatment (both original mixture and mixture as changed may be simultaneously 
on the market or available to users). In the case of changes in the composition, the UFI has to 
be changed as well (or ultimately no UFI is needed if the new mixture falls outside the scope of 
Article 45 or Annex VIII). 

7.4.2.1 When declaring concentration ranges 

Changes in the mixture component concentration ranges, for instance for a hazardous 
component of major concern (see Table 1 in Part B of Annex VIII), can be illustrated in 
example 32. The component ‘B’ present at a concentration of 20.5%, can be reported using a 
range of 3% (for instance 19.9-22.9%). If the new concentration falls out of this range (e.g. 
the new concentration is 23.5%), an update of the submission is required and a new UFI has 
to be created. However, if the change in the concentration stays within the mentioned range 
(e.g. the new concentration is 22.1%), there is no obligation to update the submission (and no 
need to update the UFI). 

The same applies when: 

- 

components are grouped in an ICG and its concentration is reported with a range; 

-  one or more components are covered by a single component identified with a GCI and 

its concentration is reported with a range. 

Example 32: Mixture components with classification of major concern 

MIXTURE COMPONENTS WITH CLASSIFICATION OF MAJOR CONCERN 

Component 

Exact 
concentration 
in the mixture 
(%) 

Concentration 
ranges provided in 
the original 
submission (%) 

New concentration 
requiring a submission 
update (%) 

Comp A 

Comp B 

Comp C 

3.5 

20.5 

76 

3.2-4.2 

19.9-22.9 

71-76 

<3.2 or >4.2 

<19.9 or >22.9 

<71 or >76 

 
 
 
 
 
 
 
106 

7.4.2.2 When declaring exact concentrations 

When declaring the exact concentration of mixture components, only limited changes to the 
exact value are allowed within a certain variation without the need to update. Allowed 
variations are listed in Table 4 of Annex VIII (see Table 5 below). If the new concentration 
exceeds the allowed variation, an update is required and a new UFI has to be created.  
Example 33 illustrates that if a component is present in a mixture in a concentration of 72% 
when the original submission is made, an allowed variation of ±5% (or more) of the initial 
concentration triggers the need to update the submission. Therefore, an update is needed if 
the new concentration is <68.4% or >75.6%. 

The same applies when: 

- 

components are grouped in an ICG and its concentration is reported with an exact 
value; 

-  one or more components are covered by a single component identified with a GCI and 

its concentration is reported with an exact value. 

Table 5: Variations of the concentration of components requiring a submission 
update (Table 4 of Annex VIII) 

Exact concentration of the component 
contained in the mixture (%) 

Variations (±) of the initial 
component concentration requiring a 
submission update 

> 25 - ≤ 100 

> 10 - ≤ 25 

> 2,5 - ≤ 10 

≤ 2,5 

5% 

10% 

20% 

30% 

Example 33: Mixture submitted with exact concentrations of components 

MIXTURE SUBMITTED WITH EXACT CONCENTRATIONS OF CLASSIFIED 
COMPONENTS 

Component 

Exact 
concentration 
provided in the 
submission (%) 

Variations (±) of 
component concentration 
requiring a submission 
update (%) 

New 
concentration 
requiring a new 
UFI (%) 

Comp D 

Comp E 

Comp F 

Comp G 

1 

5 

22 

72 

30 

20 

10 

5 

<0.7 or >1.3 

<4 or >6 

<19.8 or >24.2 

<68.4 or >75.6 

Note: the use of Table 4 of Annex VIII deserves some clarification: the reference 
concentration to define whether a UFI change is required should be always the original one. 
This allows avoiding the situation where many small changes (followed by voluntary updates) 
and not requiring a UFI update lead to the situation where eventually the concentration has 
changed significantly from the original one, yet the UFI remains the same. 

 
 
 
 
 
 
 
 
 
 
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7.4.2.3 When referring to a Standard Formula included in Part D 

When the whole or a part of a mixture composition is provided by using a Standard Formula 
included in Part D of Annex VIII, a submission update is required when the composition of the 
full mixture or that part changes in a way that it does no longer conform with the Standard 
Formula. This can be the case when: 

-  A new component is added, which is not included in the Standard Formula. 
-  The concentration of an existing component changes and it exceeds the concentration 

ranges listed in the relevant Standard Formula. 

-  A component listed in the Standard Formula is removed from the mixture (a component 

where the lower limit of the allowed concentration range is above zero). 

When such changes occur, the mixture (or part of it) no longer conforms with the Standard 
Formula listed in Part D. Therefore, the special provisions can no longer be applied, and an 
update is required, with new UFI and the full information required by Annex VIII. 

For mixtures conforming with one of the Standard Formulas listed in part D, for which the 
information from the SDS is provided because it is more detailed than the Standard Formula, 
an update of the submission is required when Section 3.2 of the SDS is updated (a new UFI is 
needed when the Section 3 of the SDS is updated with regard to the composition in a way that 
the mixture does not conform anymore with the original Standard Formula; this is addressed 
in section 4.2.7).  

The requirements for compiling an SDS are laid down in Annex II to REACH. For mixtures, the 
substances to be included in Section 3.2 are specified in section 3.2.1 of Annex II to REACH. 
Further details are given in the Guidance on the compilation of safety data sheets available at 
https://echa.europa.eu/guidance-documents/guidance-on-reach. 
To be noted that, among other triggers, the need to update the SDS is triggered when new 
information affecting the risk management measures or new information on hazard becomes 
available73. An update of section 3.2 of the SDS due to the addition of a component classified 
for the environment only would also trigger a need to update the submission.  

If the initial submission contains other substances in addition to those in the Standard Formula 
(i.e. only part of the mixture conforms to the Standard Formula), changes in these other 
components may trigger the need to update the submission (including the UFI). These are the 
cases described earlier in this section 7.4.2 of this Guidance. 

In this case the part of the final composition conforming with the Standard Formula continues 
to benefit from the derogation from the standard Annex VIII requirements. 

7.4.2.4 When referring to a fuel included in Part B, Section 3.7 of Annex VIII 

When a submission for a fuel listed in Section 3.7, Part B, is made by providing the information 
on component identity and concentrations from the SDS, an update is required when Section 3 
of the SDS is updated. This means that an update of the submission is required even if there 
are no changes in the actual composition but the Section 3 of the SDS is nevertheless, for any 
reason, updated. 

The requirements for compiling an SDS are laid down in Annex II to REACH. This defines 
specific concentration thresholds which trigger the need to indicate the component. As an 
example, when the following occur the submission needs to be updated: 

-  a substance which is required to be included in Section 3 of the SDS is added, and 

73 See Article 31(9) of REACH. 

 
 
 
 
 
 
 
 
 
 
 
108 

therefore the SDS is updated; or 

-  a substance which was required to be included in Section 3 of the SDS is removed, and 

- 

therefore the SDS is updated; or 
the concentration of an existing substance included in Section 3 of the SDS exceeds the 
original range, and therefore the SDS is updated. 

Changes in the composition requiring update of Section 3 of the SDS, trigger the need to 
update both submission and UFI. 

Normal update rules apply to components not listed in the SDS but included in the submission 
because they are known. A change in their concentration will trigger the need for an update 
including a new UFI if the variation exceeds the limit in Table 4 of Annex VIII (in the case of 
exact values) or the new concentration falls outside the original range. 

7.4.3 Updates for other changes relevant for an emergency health 
response 

It is an obligation for the duty holder to make sure that a submission containing all the 
relevant information on a product placed on the market and required by Annex VIII, is made to 
the relevant appointed body(s). 

Changes other than those listed in indents 1-4 in Section 4.1 Part B of Annex VIII may take 
place and these may be relevant for an emergency health response (indent 5 Section 4.1 Part 
B).  

Furthermore, the submitter may need to correct information for different reasons (e.g. spelling 
mistakes, which are particularly relevant when affecting mixture identifiers) or update a 
submission with new information (e.g. change in use type). 

The submitter is required to update the submission as soon as one or more pieces of the 
information not listed in Section 4.1 Part B of Annex VIII and that are relevant to an 
emergency health response, changes. This may include, but are not limited to, a change in: 

• 

contact details of the submitter 

•  product category 

•  packaging details  

•  classification of components 

In any event, this must take place before placing that mixture, as changed, on the market. It 
is important that a submission always reflects the most recent information about a product. 
Change of UFI is not required in these cases. 

7.4.4 How updates are technically handled 

While all the changes described above require or should trigger an update of the information 
submitted (depending on the legal or voluntary reason), they may be handled differently at the 
technical level by the system provided by ECHA in order to respond to the need of the ultimate 
users, i.e. the poison centres. 

From the submitter’s perspective it may always appear as being an update of the submitted 
information, but from a technical point of view, different changes (either listed under Section 
B.4.1 of Annex VIII or not) may trigger different “scenarios” which have different 
consequences for the end user (i.e. the appointed bodies and poison centres). These are: 

 
 
 
 
 
 
 
 
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(i) 

(ii) 

(iii) 

addition of information (e.g. new additional trade name, new additional packaging, 
new additional UFI for MiM component); the information originally submitted 
remains relevant for the poison centre (e.g. mixture keep being placed on the 
market with the original name in addition to the new one). In the system this is 
referred to as an “update” where the mixture composition remains the same. Both 
versions remain potentially relevant for the poison centres and appointed bodies.  

replacement of old, no longer relevant information with new relevant information 
(e.g. new classification due to changes in the criteria - the original classification is 
not relevant anymore; new contact information for rapid access to additional 
product information – the original contact details are not valid anymore); the 
information originally submitted is not relevant anymore for the emergency 
responders even for products already on the market; only the new information 
should be considered. In the system this is also referred to as an “update” where 
the mixture composition remains the same, as in the previous case. 

creation of a technically new ‘submission’ as a change in composition leads de facto 
to two different mixtures on the market; the two sets of information (referring to 
the original and new composition) remain relevant (both products may remain on 
the market for potentially a long time). It is still an update from a regulatory point 
of view but technically it becomes a “new notification after significant change 
of composition”. 

Examples and clarifications 

Table 6 below presents some examples of changes and the associated scenarios. In most cases 
they apply to both single and group submissions. Information specific for updates of group 
submissions, when different from single submissions, can be found in the next section (7.4.5). 

Table 6: Examples of possible changes requiring an update and their related 
scenarios. 

Changes 

Scenario triggered 

Technical option 

Addition of a new trade name only(a). 

Scenario (i) – addition of 
information. 

Update 

Addition of a new UFI only(a). 

Scenario (i) – addition of 
information. 

Update 

Modification of the classification for 
health or physical hazard(b) following 
change in classification criteria. 

Scenario (ii) – replacement 
of old (i.e. no longer 
relevant) with new 
information. 

Update 

 
 
 
 
 
 
 
 
110 

Changes 

Scenario triggered 

Technical option 

Addition of new toxicological information 
(e.g. results from new tests on the 
mixture become available). The existing 
information remains valid. 

Scenario (i) – addition of 
information. 

Update 

New packaging  

Scenario (i) – addition of 
information. 

Update 

Note, the mixture in original packaging 
may remain on the market for long time. 

Addition of a component in an existing 
ICG (e.g. from a new supplier). 

Scenario (i) – addition of 
information. 

Update 

Change in telephone number for rapid 
access to additional product information. 

Scenario (ii) – replacement 
of old with new information. 

Update 

-  Addition, substitution(c), deletion of 
component(s). 

Scenario (iii) – creation of a 
technically new ‘notification’.  

- Supplier changes MiM’s UFI due to 
compositional changes of MiM, which 
impact composition of final mixture. 

A new UFI must be 
provided. 

New notification 
after significant 
change in 
composition 

(For group submissions with perfumes or 
generic product identifiers, see below 
7.4.5). 

The composition changes and cannot be 
considered the same as the original one. 

Modification of reported concentration 
ranges, beyond the indicated range. 

Scenario (iii) – creation of a 
new ‘notification record’.  

The composition changes and cannot be 
considered the same as the original one. 

A new UFI must be 
provided. 

New notification 
after significant 
change in 
composition 

Modification of reported exact 
concentration beyond the indicated 
range. 

The composition changes and cannot be 
considered the same as the original one. 

Scenario (iii) – creation of a 
new ‘notification record’.  

A new UFI must be 
provided. 

New notification 
after significant 
change in 
composition 

Modification in reported concentration 
range of one or more components, 
beyond the range indicated in the 
Standard Formula. 

The composition changes and cannot be 
considered the same as the original one. 

Scenario (iii) – creation of a 
new ‘notification record’.  

A new UFI must be 
provided. 

New notification 
after significant 
change in 
composition 

 
 
 
 
 
 
 
 
 
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Changes 

Scenario triggered 

Technical option 

Addition of an ICG which was not 
present in the original submission 
(regardless of whether it includes an 
existing component). 

Scenario (iii) – creation of a 
new ‘notification record’.  

A new UFI must be 
provided. 

New notification 
after significant 
change in 
composition 

Notes to the table: 

(a) Rationale: products with the old identifier may still be on the market for an unspecified 
period of time. 

(b) The classification of a mixture may change when a new harmonised classification of a 
component in the mixture is agreed or when new information becomes available. 
Furthermore, the classification criteria in Annex I to CLP may be revised via ATPs. In that 
case, an update is required no later than when the new classification becomes applicable. 

(c) Substitution is in this case intended with a component which is chemically different. If a 
component is replaced by another one which is chemically the same (i.e. same composition 
and hazard profile) but (e.g.) from a different supplier, it is not considered to be substitution. 

7.4.5 Updates – special cases with generic component identifiers 

When ingredients covered by the generic component identifiers “perfumes” or “colouring 
agents” are included (see section 5.3), an update is not required if a perfume or colouring 
agent for which a generic component identifier can be used is added, substituted or removed 
from the mixture. This applies as long as the total concentration of ingredients covered by the 
generic component identifier remains below the allowed maximum level (5% for perfumes and 
25% for colouring agents) and none of those ingredients is classified for any health hazard.  

If the concentration or concentration range of the component identified with the GCI exceeds 
the allowable limits as described in section 7.4.2 of this Guidance, an update with a new UFI is 
required. An exception to this is when existing components originally notified together under 
one single GCI are split into several GCI (e.g. to reflect a different classification for physical 
hazards) or are identified individually with their proper identifiers. 

In addition, for perfume components in a group submission which are not classified or only 
classified for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, there is no need to 
provide the concentration (exact or range) of the single components as long as the total 
concentration does not exceed 5%. This means that variations in the components' 
concentration within the limits mentioned above do not require to update the submission. This 
specific provision applies to perfume components not necessarily identified with a generic 
component identifier.  

When changes are made to components declared as generic product identifiers in a group 
submission, refer to section 7.4.6 below.  

 
 
 
 
 
 
 
 
 
 
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7.4.6 Updates – special cases with group submissions 

Notification for a mixture initially made as a standard submission, is updated to a 
group submission 

When a mixture is initially notified with a standard submission (i.e. not a group submission), it 
is possible to update it to a group submission to include one or more mixtures differing for 
perfumes only (the total concentration of the differing perfumes is not more than 5%). A new 
UFI is not required (i.e. the same UFI can be used for all the mixtures in the group, or 
alternatively, each mixture could also be assigned a different UFI). 

Addition, substitution, deletion of perfumes (covered and not covered by generic 
component identifiers) in a group submission 

When the perfumes in a group submission change (if added, substituted or removed) in one or 
more of the mixtures in the group, the list of mixtures and the perfumes they contain as 
required in Annex VIII Section 3.1 must be updated. If the change of perfumes is the only 
change, a new UFI is not required. Nevertheless, if a perfume covered by the generic 
component identifier is added to a mixture already containing such a generic component 
identifier, but the total concentration of the generic component identifiers remains <5 %, no 
update is required. 

It is to be reminded that if the change leads to an increase in the content of differing perfumes 
in a certain mixture above 5%, this cannot be part of the same group submission and a new 
submission for that mixture is required. The original group submission does not need an 
update as it is assumed that the original mixture may remain on the market. 

Note: The rules for updates are one of the factors to be taken into consideration when it is 
possible to decide between standard and group submission. The decision needs to take into 
account not only the convenience of preparing the initial submission, but also the 
consequences for the updates in the future. 

Examples and clarifications 

Example 34: Changes in a group submission for two mixtures with a difference in perfume 
components, submitted to an appointed body. 

GROUP SUBMISSION OF TWO MIXTURES WITH DIFFERENCE IN PERFUME 
COMPONENTS 

UFI: C4P7-GHVS 

Product names: 

       ED8M-42DH 

- Trade name 1 

Classification: # 

- Trade name 2 

Product Category: # 

Common components 

Percentage 

Actual conc.a  Classificationb 

Chemical name comp. A 

60-80% 

Chemical name comp. B 

7-10% 

Chemical name comp. C 

11-14% 

Chemical name comp. D 

1-2% 

Not classified 

Other 

Major concern 

Major concern 

 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
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Perfume components in 
Trade name 1 

Percentage 

Actual conc.a  Classificationb 

Chemical name perfume 1 

1-4% 

Chemical name perfume 3 

1-2% 

‘Perfume MiM’  

1-4% 

1.5 

1.1 

1.8 

Other 

Major concern 

Other 

UFI: A67T-VHG2-DMM4-
NH2A  

Perfumes components in 
Trade name 2 

Percentage 

Actual conc.a  Classificationb 

Chemical name perfume 2 

0.3-0.6% 

0.4 

Major concern 

Chemical name perfume 4 

not applicable 

0.5 

(but <5%) 

Other (skin sens. cat. 
1) 

Perfumes (Generic 
component identifier) 

3-5% 

2 

Not classified 

The total concentration of perfumes identified with a given generic component identifier in 
each mixture cannot exceed 5% [B.3.2.3]. 

Perfumes not classified or only classified for skin sensitisation Category 1, 1A or 1B or 
aspiration toxicity do not need information on concentration if the total concentration of such 
perfumes) in each mixture does not exceed 5% [B.3.4.2]. 

Notes to the tables: 

(a) Actual concentrations are reported for internal calculation purposes only; they are not 
necessarily required to be indicated in the submission. 

(b) Classifications are indicated in this example with three categories: ‘major concern’ (list of 
classifications in B3.4.1], ‘other’ (all other hazard classifications) and ‘not classified’. 

The following changes may occur affecting the information included in the submission 
exemplified above: 

• Change of concentration of generic component identifiers 

If the total concentration of components indicated with GCI perfumes is changed 
beyond the original interval, but still does not exceed 5 %, an update is required but 
the UFI can remain the same.  

• Change of concentration of classified perfume component 

If the concentration of Chemical name perfume 2 is changed to <0,3 % or >0,6 % an 
update with a new concentration interval for Chemical name perfume 2 is required, but 
an updated list is not. No need for a new UFI. 

 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
114 

• Addition of classified perfume to a mixture in a group submission 

- 

- 

If Chemical name perfume 1 is added to Trade name 2 an updated list is required. No 
need for new UFI. 
If a classified perfume, not declared among the components, is added to either of the 
mixtures, Trade name 1 or Trade name 2, an update of the components is required, as 
well as an updated list. No need for new UFI. 

• Addition of not classified perfume to a mixture in a group submission 

- 

- 

If a perfume not classified for any health hazards is added (i.e. which can be identified 
via the GCI), but the total concentration of the components identified via the same 
generic component identifier remains within the original range, no update is required. 
If a perfume not classified for any health hazards is added and it is indicated with the 
chemical name, an update of the composition is needed. If the total concentration of 
this perfume together with the components identified via the generic component 
identifiers remains <5 %, the concentration does not need to be indicated [B.3.4.2]. 

• Deletion of a classified perfume in a mixture in a group submission 

- 

If Chemical name perfume 3 is removed from Trade name 1 an update of the 
components is required as well as an updated list. No need for new UFI. 

Note: the total concentration of all perfumes contained in each mixture of the group could 
exceed 5% when considering both perfumes which vary and common perfumes. If the 
perfumes which vary in a specific mixture exceed 5%, this mixture cannot be grouped and a 
separate submission is required for that mixture (with a new UFI). 

7.5  Validity of the submission 

In practice, many products may remain on the market (on shelves, in storehouses or in 
households) for years after a company has ceased marketing those products. Information may 
still be needed by poison centres in case of accidental exposure to those products. Therefore, 
submissions related to those products cannot just be retracted or deleted upon the cease of 
marketing or after the last placing on the market.  

It is not possible to establish for every product – based on the type, use and market – a 
specific deadline after which the possibility of exposure to a mixture by consumers, 
professionals and even industrial users can reasonably be excluded. For this reason, in 
principle, the information remains available to appointed bodies and poison centres (and in 
general for the personnel dealing with emergency response) indefinitely. 

It is the responsibility of the importer/downstream user to make sure that the submission is 
correct at any time and keep it up to date until the last date of placing on the market. 
Nevertheless, companies have the possibility to indicate to authorities the ceasing of their 
activity with regard to a specific mixture (i.e. the mixture is no longer placed on one or more 
markets). In case new relevant information becomes available to the company after the last 
placing on the market, it is recommended that the information submitted for the purposes of 
Annex VIII is voluntarily updated in order to facilitate the emergency response work. It should 
be noted that after the last placing on the market, appointed bodies and/or poison centres may 
still request additional information from submitters, if needed for emergency reasons or 
statistical analysis for improved risk management measures in the context of Section 3.2. of 
Part A of Annex VIII. It is at the discretion of each Member State to decide whether to apply a 
cut-off date to 'clean' information from their databases for practical reasons, for example 20-
25 years after the submitter indicated cease of the activity (diminishing the likelihood of an 
incident), or after, for example, 10 years if there has been no incident involving the mixture 
during that period. 

 
 
 
 
 
 
 
 
 
 
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8. Additional support 

Below is a list of additional sources of information and support tools currently available:  

ECHA Poison Centres website (https://poisoncentres.echa.europa.eu/)  

-  ECHA Submission portal and accompanying guide ‘PCN: a practical Guide’ 

-  UFI generator and the user guide in all EU languages; 

-  PCN format and support documentation and a list of validation rules 

-  European product categorisation system and manual; 

- 

‘News’ updates on the ECHA poison centre website; 

ECHA website, support section (https://echa.europa.eu/support), which contains a range of 
support material besides the Guidance, including: 

-  Webinars, Helpdesk support and Frequently asked Q&As which are regularly updated on 

a range of Annex VIII related topics; 

National Helpdesks 

National Helpdesks have been established as the first point of contact for questions on 
regulatory advice in your own language. You can find more details on your National Helpdesk 
here: https://echa.europa.eu/support/helpdesks  

LinkedIn groups ECHA's poison centre notification group - Annex VIII to CLP and ECHA's 
system-to-system (S2S)submission support network 

 
116 

EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU