Guidance on harmonised information relating to emergency health response . Annex VIII to CLP.
Date: 2022-04-30
Institutions: European Chemicals Agency
Subjects: chemical industry, chemical product, chemicals legislation, classification, dangerous substance, environmental protection, labelling, packaging, public health, user guide

Guidance on harmonised information relating to emergency health response  

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Version 5.0 – April 2022  

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 5.0  
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LEGAL NOTICE 

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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-22-H-13-EN 
Cat. Number: ED-01-22-241-EN-N 
ISBN: 978-92-9468-121-8 
DOI: 10.2823/647205 
Publ.date:  April 2022 
Language:  EN 

© European Chemicals Agency, 2022 

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 

 
 
 
 
 
 
 
 
 
 
ffiECHA

EUROPEAN  CHEMICALS  AGENCY

Helsinki
22 April2022

Note to the reader

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

Dear  user of this Guidance,

When  reading this  ECHA  Guidance  document,  please  be aware that the consulted competent
authorities  of EU/EEA  Member  States were  unable  to reach  a consensus  on the interpretation
of duty holders underArticle  45 and the legal obligations  stemming  from Article   (10).

The authorities of the following Member  States disagree with the current Guidance  where this
considers  certain  operators,  namely  rebranders  and relabellers,  as distributors and  not
downstream  users (section  3.1.2):

Belgium
Germany
Greece
France

The authorities of Sweden  and Greece do not consider  that Article  4(10) poses legal obligations
on distributors  in relation  to Annex VIII as described in this ECHA  Guidance  document.

The authorities of Denmark are not in a position to express an opinion  on the matter.

This is reflected  in the CA/30/2OI9 (rev2)  document  which is available  on the dedicated
CIRCABC website  of the European  Commission (direct  access to the document  can be
req u ested to G ROW-CARACAL@ec.  eu ropa. eu o r ENV-CARACAL@ec.  eu ropa.  eu ).

Consequently, for information on the implementation  of the aspects  of Article  45 of the CLP
Regulation  covered  by this note and CA/3O/2O19 in these  Member  States,  the reader  is invited
to contact the competent  authorities of those Member  States.

t

alley
S
Acting  Executive  Director

P.O. Box 400,  FI-00121  Helsinki,  Finland I Tel. +358  9 686180  | echa.europa.eu

Guidance on harmonised information relating to emergency health response  

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DOCUMENT HISTORY 

Version 

Comment 

Version 1.0 

First edition 

Date 

February 2019 

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

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

Version 2.0 

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

July 2019 

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. 

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 

May 2020 

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Version 

Comment 

Date 

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 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 
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 

March 2021 

Version 4.0 

 
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Version 

Comment 

Groups. 

Version 5.0 – April 2022  

Date 

- 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. 

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 

April 2022 

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Version 

Comment 

Date 

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. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PREFACE 

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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 mixtures (CLP1). 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. The project started in April 2017 and the working group had meetings and 
continuous discussions to develop the guidance text until December 2017. Finally, version 1.0 
of the text was consolidated and edited by ECHA and underwent the formal consultation with 
ECHA Partners during 2018 and beginning of 2019. The document has been subsequently 
updated and consulted again with the same ECHA Partners to implement the changes in the 
legal text in 2020 and 2021. In 2022, it was revised to further develop specific sections mainly 
to reflect changes in the submission portal and practical experience. 

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). 

 
 
 
 
 
 
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Table of Contents 

NOTE TO THE READER  GUIDANCE ON HARMONISED INFORMATION RELATING TO 

EMERGENCY HEALTH RESPONSE – ANNEX VIII TO CLP .................................... 3 

DOCUMENT HISTORY .............................................................................................. 4 

PREFACE ................................................................................................................. 8 

1. INTRODUCTION .................................................................................................. 14 

1.1 General introduction ........................................................................................... 14 
1.2 Legal background ............................................................................................... 14 
1.3 Aim of this guidance ........................................................................................... 16 
1.4 Target audience of this guidance .......................................................................... 16 
1.5 Overview of the document ................................................................................... 16 
1.6 Links to legislation other than CLP ........................................................................ 17 

1.6.1 REACH Regulation ........................................................................................................ 17 
1.6.2 Other legislation ........................................................................................................... 17 
1.6.3 National legislation ....................................................................................................... 18 

2. ABBREVIATIONS/DEFINITIONS ......................................................................... 20 

3. OBLIGATIONS ..................................................................................................... 22 

3.1 Who is required to submit information? ................................................................. 22 

3.1.1 Activities leading to submission obligations according to Article 45 ..................................... 23 
3.1.1.1 Import activities ............................................................................................................................. 23 
3.1.1.2 Formulation activities ...................................................................................................................... 25 
3.1.1.3 Repackaging activities ..................................................................................................................... 27 
3.1.1.4 Import/manufacture of combination of mixture and article .................................................................. 28 

3.1.2 Activities leading to submission obligations according to Article 4(10) ................................. 29 

3.2 Who receives the information? ............................................................................. 36 

3.2.1 Member States’ appointed bodies ................................................................................... 36 

3.3 What is the scope of Article 45? ............................................................................ 36 

3.3.1 Which mixtures require information to be submitted? ....................................................... 37 
3.3.1.1 General exemption from CLP Regulation ............................................................................................ 37 
3.3.1.2 Exemptions from Article 45 of CLP .................................................................................................... 37 
3.3.1.3 Exemptions from the obligation to submit information under Annex VIII................................................ 38 
3.3.1.3.1 Exemption for bespoke paints .......................................................................................................... 38 
3.3.1.4 Submission of information made voluntarily ....................................................................................... 39 

3.4 Use types .......................................................................................................... 40 
3.5 Timelines ........................................................................................................... 41 

3.5.1 Compliance dates ......................................................................................................... 41 
3.5.2 Transitional period for mixtures already notified ............................................................... 43 
3.5.2.1 When national definitions of end use vary .......................................................................................... 44 
3.5.2.2 Annex VIII submissions before the relevant compliance date ............................................................... 44 

 
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4. GENERAL SUBMISSION REQUIREMENTS ............................................................. 44 

4.1 Overview ........................................................................................................... 45 
4.2 The UFI for mixtures and products ........................................................................ 46 

4.2.1 What is a UFI? ............................................................................................................. 46 
4.2.2 Generation of UFI ......................................................................................................... 47 
4.2.3 How to use the UFI ....................................................................................................... 48 
4.2.3.1 UFI and mixtures in a mixture .......................................................................................................... 51 
4.2.3.2 Use of the UFI along supply chain and for legal entity changes ............................................................. 52 

4.2.4 Toll formulator and UFIs ................................................................................................ 53 
4.2.5 UFI and non-EU suppliers .............................................................................................. 54 
4.2.6 How to manage UFIs .................................................................................................... 55 
4.2.7 New UFI as a result of composition changes .................................................................... 56 
4.2.7.1 Changes in MiM’s UFI ...................................................................................................................... 59 

4.2.8 Display, position and placement of UFI ............................................................................ 59 
4.2.8.1 Multi-component products ............................................................................................................... 61 
4.2.8.2 Exemption from labelling requirements [A.5.3] .................................................................................. 62 
4.2.8.3 Special labelling requirements for bespoke paints [Article 25(8)] .......................................................... 62 

4.3 EuPCS ............................................................................................................... 63 
4.4 Limited submission ............................................................................................. 63 

4.4.1 Contacts for rapid access to ‘additional detailed product information’ .................................. 64 
4.4.2 Availability and content of the additional information and rapid access ................................ 65 

4.5 Group submission ............................................................................................... 65 

5. INFORMATION CONTAINED IN THE SUBMISSION .............................................. 66 

5.1 Identification of mixture and submitter [Part B.1] ................................................... 66 

5.1.1 Product identification [B.1.1] ......................................................................................... 66 
5.1.2 Submitter details and contact point [B.1.2] ..................................................................... 66 
5.1.3 Details for rapid access to additional product information [B.1.3] ....................................... 67 

5.2 Hazard identification and additional information [Part B.2] ....................................... 67 

5.2.1 Classification of the mixture and label elements [B.2.1 and B.2.2] ...................................... 67 
5.2.2 Toxicological information [B.2.3] .................................................................................... 68 
5.2.3 Additional information [B.2.4] ........................................................................................ 68 

5.3 Information on mixture components [Part B.3]....................................................... 70 

5.3.1 General requirements [B.3.1] ........................................................................................ 70 
5.3.2 Components subject to submission requirements [B.3.3] .................................................. 71 
5.3.3 Information required on components .............................................................................. 72 
5.3.4 Limited submission [B.3.1.1] ......................................................................................... 81 

5.4 Group submission [A.4] ....................................................................................... 81 

5.4.1 Information to be provided in a group submission ............................................................ 83 
5.4.2 Mixture components in a group submission ...................................................................... 83 

5.5 Interchangeable component group (ICG) [B.3.5] .................................................... 88 

5.5.1 Grouping of components ............................................................................................... 88 
5.5.2 Conditions for grouping components in an ICG ................................................................. 89 
5.5.2.1 General rules for grouping components ............................................................................................. 89 

 
 
 
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5.5.2.2 Alternative rules for grouping components with specific hazard classifications ........................................ 90 

5.5.3 Information requirements .............................................................................................. 91 
5.5.3.1 Identification ................................................................................................................................. 91 
5.5.3.2 Concentration ................................................................................................................................ 91 
5.5.3.3 Classification .................................................................................................................................. 92 

5.5.4 Examples .................................................................................................................... 92 

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

Formulas [B.3.6] .............................................................................................. 98 

5.6.1 Standard Formulas ....................................................................................................... 98 
5.6.2 Using Standard Formulas: whole mixture composition vs part of the mixture composition 

(substances or MiMs) ............................................................................................... 99 

5.6.3 Standard Formulas vs SDS information ........................................................................... 100 
5.6.4 Examples .................................................................................................................... 100 

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

...................................................................................................................... 103 

5.7.1 Definition of fuels ......................................................................................................... 103 
5.7.2 Information requirements on composition ....................................................................... 104 

6. PREPARATION AND SUBMISSION OF INFORMATION: AVAILABLE TOOLS .......... 108 

6.1 UFI generator .................................................................................................... 108 
6.2 XML format ........................................................................................................ 108 
6.3 Tools for preparing IUCLID XML files ..................................................................... 109 
6.4 Submission of information ................................................................................... 109 

6.4.1 Validation of information ............................................................................................... 110 

6.5 Fees.................................................................................................................. 110 

7. POST-SUBMISSION ............................................................................................. 111 

7.1 General introduction ........................................................................................... 111 
7.2 Additional requests by appointed bodies ................................................................ 111 
7.3 Use of submitted information ............................................................................... 112 

7.3.1 Security and confidentiality of the submitted information .................................................. 112 

7.4 Keeping information up to date ............................................................................ 112 

7.4.1 Introduction................................................................................................................. 112 
7.4.2 Update rules according to Annex VIII .............................................................................. 113 
7.4.2.1 When declaring concentration ranges ................................................................................................ 114 
7.4.2.2 When declaring exact concentrations ................................................................................................ 114 
7.4.2.3 When referring to a Standard Formula included in Part D ..................................................................... 115 
7.4.2.4 When referring to a fuel included in Part B, Section 3.7 of Annex VIII ................................................... 116 

7.4.3 Other updates relevant for an emergency health response ................................................ 116 
7.4.4 How updates are technically handled .............................................................................. 117 
7.4.5 Updates – special cases with generic component identifiers ............................................... 120 
7.4.6 Updates – special cases with group submissions ............................................................... 120 

7.5  Validity of the submission .................................................................................. 123 

8. ADDITIONAL SUPPORT ....................................................................................... 124 

 
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Table of Figures 

Figure 1: Identification of information requirements and compliance date according to the use type ..... 42 

Figure 2: Identification of information requirements and compliance date for a mixture with end use not 
subject to Article 45 obligations .................................................................................................... 43 

Table of Tables 

Table 1: Overview of operators and activities triggering (or not triggering) obligations to comply with 
Annex VIII ................................................................................................................................. 32 

Table 2: Concentration ranges applicable to hazardous components of major concern for emergency 
health response - Table 1 in Part B of Annex VIII ............................................................................ 76 

Table 3: Concentration ranges applicable to other hazardous components and components not classified 
as hazardous – Table 2 in Part B of Annex VIII ............................................................................... 77 

Table 4: List of fuels - Table 3, Part B of Annex VIII ...................................................................... 103 

Table 5: Variations of the concentration of components requiring a submission update (Table 4 of Annex 
VIII) ....................................................................................................................................... 115 

Table 6: Examples of possible changes requiring an update and their related scenarios. .................... 118 

Table of Examples 

Example 1: EU operator importing from outside the EU, placing on the market in one EU country ....... 24 

Example 2: EU operator importing from outside the EU, placing on several EU markets ..................... 24 

Example 3: Mixture placed on the market in several Member States ................................................ 26 

Example 4: Formulation, mixture to be placed on the market outside EU ......................................... 27 

Example 5: Submission made by re-labelling company placing on a new market ............................... 30 

Example 6: Formulation, mixture placed on the market in several Member States ............................. 31 

Example 7: 1 Mixture composition– 1 UFI – 1 product placed on the market ("SuperClean") .............. 48 

Example 8: 1 Mixture composition– 2 or more UFIs – 2 or more products placed on the market  with 
same composition ....................................................................................................................... 49 

Example 9: 1 Mixture composition – 1 UFI – 3 products placed on the market .................................. 49 

Example 10: 1 Mixture composition – 2 or more UFI – 1 product placed on the market...................... 49 

Example 11: 1 Mixture composition – 2 or more UFIs – 2 products placed on the market ................... 50 

Example 12: Three similar mixtures (1 Group submission) - one UFI, one or more products placed on 
the market ................................................................................................................................. 50 

Example 13: Three similar mixtures (1 Group submission) – several UFIs, one or more products placed 
on the market. ........................................................................................................................... 51 

Example 14: 1 Mixture (with 1 MiM identified via its UFI) - 1 UFI for the mixture – 1 product placed on 
the market ................................................................................................................................. 52 

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 ................................................................ 53 

Example 16: Import into the EU – Non-EU supplier acting via EU-based legal entity to protect CBI ..... 55 

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 ............................................................... 74 

Example 18: Aggregation of components from different sources ..................................................... 74 

 
 
 
 
 
 
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Example 19: Concentration ranges for components of “major” concern ............................................ 77 

Example 20: Concentration ranges for components not of “major” concern ...................................... 78 

Example 21: Use of generic component identifiers (single mixture) ................................................. 78 

Example 22: Use of generic component identifiers (mixtures varying in colourants only) ................... 80 

Example 23: Grouping of mixtures with difference in perfume components ...................................... 85 

Example 24: Grouping of mixtures with difference in perfume components ...................................... 86 

Example 25: Grouping interchangeable components having the same technical function .................... 92 

Example 26: Grouping components in different ICGs according to the technical function .................... 93 

Example 27: Grouping components having different technical functions ........................................... 94 

Example 28: Grouping components having different technical function in different ICGs .................... 96 

Example 29: Final mixture conforms with a Standard Formula ...................................................... 101 

Example 30: Only part of the final mixture conforms with a Standard Formula (not the final mixture as a 
whole) ..................................................................................................................................... 101 

Example 31: Submission of information for a fuel product listed in Table 3 of Annex VIII ................. 105 

Example 32: Mixture components with classification of major concern ........................................... 114 

Example 33: Mixture submitted with exact concentrations of components ...................................... 115 

Example 34: Changes in a group submission for two mixtures with a difference in perfume components, 
submitted to an appointed body. ................................................................................................ 121 

 
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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. 

The European Commission was assigned the obligation to carry out a review, as foreseen in 
Article 45 of the CLP Regulation, to assess the possibility of harmonising the information. The 
review was carried out in consultation with stakeholders and with the support of the European 

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 Please note that whenever there is a reference to the Union (EU) in this document, the term also covers 
the EEA countries Iceland, Liechtenstein and Norway. See footnote 2. 

 
 
 
 
 
 
 
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Association of Poison Centres and Clinical Toxicologists (EAPCCT). Following the review, 
Commission Regulation (EU) 2017/542 was adopted, adding Annex VIII to CLP. The new 
Annex VIII entered into force on 12 April 2017. The same Annex was amended twice: by 
Commission Delegated Regulation (EU) 2020/116 and subsequently by Commission Delegated 
Regulation (EU) 2020/1677 and Commission Delegated Regulation 2020/1676 of 31 August 
20207. The provisions of the Annex 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 Annex, 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 of the economic operator responsible 
for the placing on the market8, information on the composition and hazardous ingredient 
substances and on the intended use through a system of harmonised categories. 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 general 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 
State (the allowed use of the submitted information is discussed in section 7). The appointed 
bodies and poison centres (which are not necessarily the same entity, although in some 
Member States they are the same; see section 3.2 for more details), need to ensure the 
confidentiality of the information received. 

The amended CLP Regulation provides that ECHA specifies the harmonised format (i.e., Poison 
Centres Notification (PCN) format) for the preparation of information by economic operators. 
The PCN format also aims to facilitate the management and use of the submitted information 
by authorities and poison centres, who will receive the information and make it available in a 
database serving the emergency health response purpose.  

Additionally, Annex VIII foresees ECHA to facilitate the submission of information. For this 
purpose, ECHA has made available a centralised submission portal, which is a submission 
system that could be used as an alternative to the national submission systems where 
available (it is at the discretion of each Member State to indicate which system is to be used). 
More details are provided in section 6. 

The date for compliance with the new submission requirements are staggered and depend on 
the use type of the mixture (see section 3.4 for the definition of the different use types). 

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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Detailed information about timelines and compliance dates are given in section 3.5. 

1.3 Aim of this guidance 

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

This guidance provides information on:  

• 

the scope of Annex VIII to CLP, i.e. for which type of mixtures the required information 
has 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); 

•  who should submit information in accordance with Annex VIII to CLP and by when; 
• 
• 
• 
•  details of the information required to be submitted;  
•  applicability of specific workability solutions allowing deviation from the standard 

information requirements; 
the use of the common XML harmonised reporting format; 

• 
•  which changes or new information trigger the need for an update. 

Note that the IT tools provided to prepare and submit the information required by Annex VIII 
are referred to as the submission tools. 

1.4 Target audience of this guidance 

The main target audiences of this guidance are: 

• 

• 

companies placing certain hazardous mixtures on the market (i.e. that are classified as 
hazardous on the basis of 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, in particular 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 which allow setting the scene 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. 

9 It is to be noted that not in all Member States poison centres exist. Emergency service may be provided 
via different systems (see section 3.2.1 for further details). 

 
 
 
 
 
 
 
 
 
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•  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 Annex VIII of CLP. Therefore, section 3 clarifies who is required 
to submit information and to whom, by when and which mixtures fall under the scope 
of Annex VIII or are exempted from the requirements laid down in the same Annex.  

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

the harmonised European 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, which should be known before the duty 
holder starts preparing the submission.  

•  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. 

•  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, represent one of the main sources of information for the 
economic operator that is preparing a submission under Article 45 of CLP. The submitted 
information has to be consistent with the SDS11. 

1.6.2 Other legislation 

The EU legislation for biocides, plant protection products, cosmetics12 and tobacco products are 
examples of EU legislation with data submission requirements that are partially overlapping 
with the harmonised information required under the scope of CLP Article 45 and as specified in 

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 Please note, 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 Note that CLP does not apply to cosmetic products that are in the finished state intended for the final 
user (Article 1(5)(c)). 

 
 
 
 
 
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Annex VIII. 

Version 5.0 – April 2022  

As part of the biocides 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.  

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, for some of the respective legislative processes (i.e. 
where the legal text allows the competent authorities to do so), to assess and decide whether 
a procedure can be established in order to make information supplied under different EU 
legislations (as part of an obligatory authorisation or notification procedure) available to the 
appointed bodies under the scope of CLP, Article 45. 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 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 

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. 
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 

 
 
 
 
 
 
 
 
 
 
 
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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. 

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. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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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 and Regulation (EU) 2020/11 amending CLP 
as regards information relating to emergency health 
response. Subsequently amended by Regulation (EU) 
2020/11, Commission Delegated Regulation (EU) 
2020/1677 and Commission Delegated Regulation 
2020/1676 of 31 August 2020. 

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 

CPNP 

Distributor 

Downstream user 

EAPCCT 

EC 

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. 

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

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

Cosmetic Products Notification Portal 

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

European Association of Poisons Centres and Clinical 
Toxicologists  

European Community 

European Chemicals Agency 

European Economic Area 

European Standards (or European Norms) 

European Union (note that the reference to the EU, in 
this document, also covers the EEA countries) 

 
 
 
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EuPCS 

European Product Categorisation System 

Formulator 

Company that produces a mixture. 

GCI 

ICG 

Importer 

IUCLID 

LD50 

MiM 

Mixture 

MSCA 

PCN 

PPPR 

REACH 

SF 

SiA Guidance 

SDS 

SME 

Substance 

UFI 

A formulator established in the EU is a downstream 
user. 

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) 

Small and medium enterprise 

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) 

 
22 

VAT 

XML 

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Value added tax 

eXtensible Markup Language 

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 and which bodies receive the 
submitted information. The section clarifies also obligations which may need to be fulfilled by 
operators performing certain activities and not directly bound by Article 45, but following other 
provisions in the CLP (in particular Art. 4(10)).  

3.1 Who is required to submit information? 

The information required by Annex VIII has to be made available to the relevant appointed 
body, for each hazardous mixture (meeting certain criteria, see section 3.3) placed on the 
market. This is the information which is relevant for formulating preventative and curative 
measures in particular in the event of an emergency health response. The same information 
can also be used by appointed bodies to perform activities of toxicovigilance as foreseen by 
Article 45 (see section 7 for more information on the use of the submitted information). 

‘Placing on the market’ according to Article 2(18) of CLP ‘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.’  

Article 45 and Annex VIII to the CLP Regulation identify importers and downstream users 
placing certain hazardous mixtures on the market as responsible for the submission of the 
information to appointed bodies. The importers and downstream users 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. 

Companies in the supply chain of a mixture may have roles other than a downstream user or 
an importer and may not be required to submit the information according to Article 45 and 
Annex VIII. Distributors, who only store and place mixtures on the market, without 
undertaking any other activity on the mixture, do not need, in principle, to submit the 
information to the appointed body following Article 45 and Annex VIII. This is also the case 
when a distributor transports the mixture between different sites that they own without placing 
the mixture on the market18.  

However, distributors may also play an important role in the obligation placed on downstream 
users and importers to make information available to appointed bodies, which is eventually 
used by poison centres for the purposes of their work. This is relevant in particular for 
distributors that change the product identifiers of the mixture and/or sell the mixture in 
Member States other than the Member State where the downstream user or importer has 
supplied it. 

Art. 4(10) of CLP19 requires all substances and mixtures placed on the market to be compliant 
with CLP, conferring on all actors in a supply chain (i.e. also distributors, including re-branders 
and re-labellers) the obligation for the mixtures they place on the market to be compliant with 

18 Please, note that in this case obligations coming from the transport legislation may apply. 
19 Art. 4(10): “Substances and mixtures shall not be placed on the market unless they comply with this 
Regulation”. 

 
 
 
 
 
 
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Annex VIII to CLP. A national appointed body shall have at its disposal emergency health 
information for mixtures supplied in its Member State. A distributor placing on the market a 
mixture, which would jeopardise an appointed body’s access to that information, would 
therefore run the risk to be in breach of Article 4(10). 

The definitions of ‘downstream user’, ‘importer’ and other operators potentially part of the 
supply chain are given in Article 2 of the CLP Regulation 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). 

As it will be clarified in this section, it is possible for a submission to be physically prepared 
and submitted by a party other than the one who has the legal duty to notify. The use of a 
third party does not relieve the duty holder under either Article 45 (i.e. importer or 
downstream user) or Article 4(10) (i.e. any actor placing certain hazardous mixtures20 on the 
market) from their obligations and responsibilities. 

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. 

Note: The tool provided by ECHA to prepare and submit the information, called ECHA 
Submission portal (more details are provided in section 6), also allows the submission of the 
information by a third party on behalf of the duty holder21, i.e. by outsourcing the preparation 
and submission of the information22. This could apply in various scenarios, for example: 

-  mother company/head-quarter submitting on behalf of a subsidiary (and vice versa),  

- 

consultant on behalf of the duty holder. 

3.1.1 Activities leading to submission obligations according to Article 45 

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

3.1.1.1 Import activities 

An economic operator that imports a hazardous mixture into the European Economic Area 
(EEA), which includes EU Member States and Iceland, Liechtenstein and Norway, 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/EEA 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.  

The definition of importer is provided in Article 2(17) of CLP. Details are provided in section 2.1 

20 When referring to hazardous mixtures in the context of Article 45, it is meant as classified for physical 
or human health hazards. This is explained in section 3.3. 
21 The availability of this option where national submission systems exist is to be checked with the 
relevant authorities.  
22 More information on ECHA accounts management is available in the ECHA accounts Manual available at 
https://idp-industry.echa.europa.eu/idp/. 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/echa-submission-portal.  

 
 
 
 
 
 
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of the Guidance on Registration23. 

Example 1: EU operator importing from outside the EU, 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 health 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: EU operator importing from outside the EU, 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. 

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. A submission is required in both Member States A and B since import is deemed to be 

23 Note that the Guidance on Registration, and its section 2.1, refer specifically to the obligations under 
the REACH Regulation. Nevertheless, the definition of importer and the examples provided are relevant 
for the purposes of Annex VIII to CLP. 

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 
 
 
 
  
 
 
 
 
 
 
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“placing on the market” (Member State A), and the mixture is placed subsequently on the 
market in Member State B. The submission obligations 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). 

Ideally, the non-EU supplier of the hazardous mixture discloses 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 (normally, as a minimum, information 
from the SDS should be available to the EU importer). An alternative way to work around this 
problem is to ask the non-EU supplier to make a voluntary submission via any 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 in their own. More practical details are 
provided in section 4.2.5. 

In any case it is ultimately the responsibility of the EU importer to demonstrate that they 
comply with Annex VIII (and other obligations under CLP) and thus to gather and submit the 
information required by Annex VIII. Therefore, it may be necessary to put additional effort in 
the communication with the non-EU supplier in order to obtain the necessary information. The 
EU importer is advised to document such efforts for enforcement purposes to justify cases 
where the provided information on components of a mixture is limited to the information 
obtained in an SDS (see information on identification of mixtures in mixture in section 5.3). 

A mixture can be imported also in combination with articles and in this case submission 
obligations may apply. See the section 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 economic operator 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 has to 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), an economic 
operator 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 operator. 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 on 
behalf of another company/brand name. Therefore, 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 mixture (or by transferring the mixture into 

 
 
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different containers), they would be a downstream user and would have submission obligations 
under Article 45 for the newly formulated (or repacked) 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 and labelled as flammable and irritating to the skin. It is sold 
in the Netherlands as well as to distributors in Belgium, Poland, Germany and Slovakia. The 
Dutch formulator must thus submit information in accordance with CLP Article 45 and Annex 
VIII to the appointed bodies in these five countries in their official language or in the 
language(s) as requested by the Member State in which the mixture is placed on the market. 
If the mixture is placed on the market in different packaging (e.g. shape and size) in the 
different Member States by the same Dutch formulator, the information of the packaging 
relevant for each Member State must be given in the submission. 

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 submission24. If the product is stored in a 
temporary 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 
user that formulates them, there are no obligations to submit information25. As long as there is 

24 Please, note that other obligations under CLP may also apply. 
25 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). 

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 
 
 
 
 
 
 
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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)26. 

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 for aspiration toxicity. 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 Member States 
(and in countries under the EEA agreement) there are no obligations to submit data for 
product B. 

Product A is placed on the Italian market, therefore a submission according to Annex VIII has 
to be made to the Italian appointed body.  

3.1.1.3 Repackaging 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 re-packaging 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).  

As the company is placing a mixture on the market which is chemically identical to the one of 
their supplier, they may decide to request that their supplier makes a submission on their 
behalf (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 can use the same UFI as the supplier, or alternatively, 
they can generate their own UFI. In both cases, the product can be specified as consisting of 
100% of the mixture purchased from the supplier (final repackaged mixture = 100% supplier’s 
UFI as Mixture in Mixture or “MiM”27). 

26 Obligations coming from the transport legislation may apply. 
27 This can be done only in case the UFI has been previously notified by the supplier as part of a 
submission in the same Member State. Otherwise the MiM cannot be identified via the UFI only, see 
section 5.3 for the available options. The ECHA Submission system includes automatic checks which 
support the submitter in the preparation of the submission; more information is provided in section 6 and 
on the Poison Centres website at https://poisoncentres.echa.europa.eu/tools. 

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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It is important to note that even in cases where this information is submitted by their supplier 
(under contract), the repackaging company, as the duty holder under Article 45, remains 
responsible for the information submitted. 

3.1.1.4 Import/manufacture of combination of mixture and article  

A company incorporating a mixture in an article in the context of its activity is a downstream 
user. An object fulfilling the definition of “article” is outside the scope of Annex VIII, therefore 
notification requirements and inclusion of UFI on the label do not apply, except where mixtures 
are placed on the market (including import) in combination with articles. 

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

An object can be a combination of one or more articles and one or more mixtures. In these 
cases, obligations under Annex VIII may apply to the mixture(s), if the mixtures are classified 
for health or/and physical hazards. 

The SiA Guidance, in chapter 2, explains that objects can be “classified” as: 

1.  Substance/mixture (as such), e.g. wax crayon, blasting grit; 
2.  Combination of an article (functioning as a container or a carrier material) and a 

substance/mixture, e.g. an inkjet printer cartridge, candles, wet cleaning wipes, 
desiccant bags; 

3.  Articles (as such), e.g. one-piece plastic spoon; 
4.  Article with an integral substance/mixture (i.e. the substance/mixture forms an 

integral part of the article), e.g. thermometer with liquid.   

A mixture belonging to group 1 (usually in solid state) is subject to all REACH and CLP 
requirements applicable to mixtures (including 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). 

Where an object, belonging to group 2, 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 belonging to groups 3 and 4 are considered as articles under REACH and CLP. In these 
cases, CLP Article 45 and Annex VIII 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 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), as 
they fulfil the REACH and CLP definition of article (see section 4 of the SiA Guidance). Article 
45 and Annex VIII do not apply to such mixtures in articles28. 

More details and guidance to assess each individual case is provided in the Guidance on 
requirements for substances in articles. 

28 Note, that other REACH or CLP obligations may apply. For instance, substances intended to be released 
from these articles may be required to be registered under REACH Article 7(1) when certain conditions 
are met.      

 
 
 
 
 
 
 
 
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3.1.2 Activities leading to submission obligations according to Article 4(10)  

All distributors, including re-branders and re-labellers, have to comply with Article 4(10) and 
can thus place only CLP-compliant mixtures on the market. That compliance requirement 
includes compliance with Article 45, which provides that a national appointed body shall have 
at its disposal emergency health information for hazardous mixtures supplied in its Member 
State. A distributor placing on the market a hazardous mixture, which would jeopardise an 
appointed body’s access to that information, would therefore run the risk to be in breach of Art 
4(10). The distributor, in order to be CLP-compliant, needs to consider the full supply chain. 
This is particularly crucial when a distributor supplies the product in different Member States 
than the Member State(s) where the supplier has placed the product on the market (and 
therefore made a submission) or changes trade/brand names, and/or labels.  

Distributors (e.g. re-branders) must make sure to 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. 

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. 

It is to be noted that the requirement to comply with Article 4(10) does not necessarily lead to 
an obligation for distributors to make a submission under Article 45. Rather, 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 he is distributing in different Member 
States), he has the duty to make sure that this information becomes available to the appointed 
body. This can be done either by informing the upstream notifier or by making a notification 
themselves. 

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) 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 has the option to include 
this information in their submission to all the relevant Appointed Bodies (even if the 
downstream user is not obliged to notify in Member States where the distributor places 
the mixture on the market). Note that the distributor is ultimately responsible for 
compliance with its notification obligations. 

-  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 will possibly 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 more details on information on 

 
 
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components)29. 

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It is to be noted that importers and downstream users remain responsible for the submission 
of information under Article 45. For actors other than these, orders or penalties can be 
imposed by virtue of Article 4(10). 

Example 5: Submission made by re-labelling company placing on a new market 

A company in France formulates and intends to sell “Super Wash” on the French market. The 
mixture is classified as hazardous for human health 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 Spain and Germany. 
The company re-labels the product, keeping the brand name “Super Wash”, and submits the 
relevant information to the Spanish and German appointed bodies. 

A customer (distributor) 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 distributor submits the required information to the Spanish appointed body 
themselves. 

29 Note, that currently 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).  
Communication should happen outside the submission system. 

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 

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 and labelled as causing severe eye damage. In accordance with Article 45 the 
relevant information must be submitted by the Swedish formulator to the appointed body in 
Sweden. Additionally, a submission needs to be made in those Member States where the 
retailer intends to sell the product (as Norway has also implemented the CLP Regulation 
though the EEA agreement, the information must also be submitted to the appointed body in 
Norway). Since the retailer is a distributor following Article 2(20) CLP, they do not have direct 
submission obligations under Art.45. Yet, he has the obligation by virtue of Article 4(10) to 
ensure that all relevant information is made available to the appointed bodies. The retailer can 
decide to either provide the information related to the distribution step to the supplier (i.e. the 
Swedish formulator, who includes the additional information in his submission; this scenario is 
depicted in the figure below) or, e.g. for confidentiality reasons, to make a submission to the 
appointed bodies of Denmark and Norway themselves instead. The label for the laundry 
detergent includes (in this example) all three languages.  

FORMULATOR Super Wash  Intends to sell on the Swedish market Super Wash  placed on SE market by selling to a retailer Super Wash placed on Swedish market also by RETAILERSubmission to Swedish ABSubmission to Danish ABSubmission to Norwegian AB Super Wash placed on Danish market by RETAILER Super Wash placed on Norwegian market by RETAILERProvision of relevant information about DK and NO markets 
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Table 1: Overview of operators and activities triggering (or not triggering) obligations to comply with Annex VIII 

Activity 

Operator 

Legal obligation 
to submit 
information? 
(duty holder)? 

Import 

Importer 

Formulation 

Re-packaging 

DU 

DU 

Yes 

Yes 

Yes 

Why? 

Options 

Legal text (Art.45) 

Legal text (Art.45) 

Activity is a use according to CLP and 
REACH (Transfer into new/different 
containers). 
See also ECHA Guidance for 
downstream users. 
(Art.45) 

A company may rely on their supplier or 
other company (e.g. mother company) to 
make the submission on their behalf - this 
submission would include their product 
details. They remain duty holder under Art.45 
(if applicable, i.e. re-packager and re-filler) 
but they are not the legal entity submitting 
the information in the submission system. 
Contractual agreement may be needed 
between the duty holder and the company 
preparing the submission on its behalf. This 
should address all possible scenarios: update 
responsibilities, access to the file, etc… 

Re-filling (see also 
above for re-
packaging) 

DU 

Yes 

Activity is a use according to CLP and 
REACH (Transfer into new/different 
containers). 
See also ECHA Guidance for 
downstream users. 
(Art.45) 

 
 
 
 
 
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Activity 

Operator 

Legal obligation 
to submit 
information? 
(duty holder)? 

Toll formulation 

DU 

Yes 

Production of 
combinations of 
mixture with article 

DU 

Importer 

Import of 
combinations of 
mixture with article  

Distribution 

Distributors 

Retail 

Distributor 
(retailer) 

Yes, if the object is 
to be considered a 
mixture itself 
(therefore not an 
article) or the 
combination of an 
article and one or 
more mixtures  

Possibly yes, if 
distributing in 
Member States other 
than the ones 
included in the 
original submission. 
Possibly yes, if 
distributing in 
Member States other 
than the ones 
included in the 
original submission. 

Why? 

Options 

Toll formulators are downstream 
users. See ECHA Guidance for 
downstream users. 
(Art.45) 

Article producers are potentially 
downstream users. 

Importer of articles are potentially 
also importer of mixtures. See ECHA 
Guidance for downstream users and 
Guidance on requirements for 
substances in articles. 
(Art.45) 
Legal text (Art.4(10)) 

Retailers are by definition 
distributors. Obligations to provide 
information through Art. 4(10). 
They store/place on the market 
mixtures to consumers without 
performing any activity qualifying as 
DU activity.  
See also ECHA Guidance for 
downstream users. 

Distributors cannot place on the market a 
mixture which is not compliant with CLP in 
general. Therefore, distributors have to make 
sure 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 (including re-labelling 
and re-branding) in different Member States 
than the one where the original submission 
was made or with trade names not included 
in the submission, the distributor may 

 
 
 
 
 
 
 
 
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Activity 

Operator 

Re-branding 

Distributor 

Legal obligation 
to submit 
information? 
(duty holder)? 

Why? 

Options 

Yes, if the 
trade/brand name is 
not included in the 
original submission 
or if distributing in 
Member States other 
than the ones 
included in the 
original submission. 

Actor who applies his own brand to a 
mixture that somebody else has 
formulated and places the product on 
the market. Even if the activity is not 
considered as a DU activity (see also 
ECHA Guidance for downstream 
users), they have the obligations to 
provide information through 
Art.4(10)). 

provide the relevant information to the 
original submitter for inclusion in the 
submission. Alternatively, they may decide to 
make their own submission to the relevant 
appointed body(ies). 

Re-labelling 

Distributor 

Yes, if the relevant 
information (e.g. 
UFI) is not included 
in the original 
submission or if 
distributing in 
Member States other 
than the ones 
included in the 
original submission. 

Actor that adapts corporate colours 
or identifiers on the label to a 
mixture or adapts the label in 
another manner. Even if the activity 
is not considered as a DU activity 
(see also ECHA Guidance for 
downstream users), they have 
obligations to provide information 
through Art. 4(10). 

 
 
 
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Activity 

Operator 

Legal obligation 
to submit 
information? 
(duty holder)? 

Why? 

Options 

Consultancy 

Commercial 
representative 
(=consultant) 

No 

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

The commercial representative may be 
assigned the task to submit in the name and 
on behalf of the duty holder via the “foreign 
user” functionality. 

Supply 

Non-EU 
Formulator/sup
plier 

No 

CLP does not apply to operators not 
established in the EU/EEA. 

The non-EU supplier may be assigned the 
task to prepare and submit on behalf of the 
duty holder via the “foreign user” 
functionality. 

 
 
 
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3.2 Who receives the information? 

The company that is required to submit the information according to Annex VIII, has to make 
sure that this information is submitted to the appointed bodies of all the Member States the 
mixture is placed on the market. This includes the Member States where the mixture is sold 
via their distributors (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 their 
poison centres and the personnel dealing with emergency responses in that Member State 
where the mixture is placed on the market. 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 regularly receive copies of data submitted to the 
appointed body to be fed into a local database. In any case specific security requirements will 
have to be guaranteed, as per provision of Article 45(2) of CLP. 

3.2.1 Member States’ appointed bodies 

Article 45(1) of CLP establishes that each Member State must appoint a body (or bodies)30 
responsible for receiving the information submitted by importers and downstream users 
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. The appointed body in a given Member State must have access to all 
the submitted information in order 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. 

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

The appointed bodies must ensure that the information received is kept confidential and is only 
used for the purpose of Article 45(1) and (2) of CLP. 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. Substances31 placed 
on the market on their own, either classified or not, are excluded from the obligation to submit 
information according to Article 45 of CLP. 

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 

30 Please note that the legal text (Article 45) foresees the possibility for a Member State to appoint more 
than one body, although it may not occur in practice. In subsequent text of the guidance all references 
are made to singular appointed body for readability purposes. 
31 Definitions in Article 2 of CLP apply. See Section 2 of this Guidance for a full list of relevant terms and 
definitions. 

 
 
 
 
 
 
 
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guidelines are provided in the Guidance for identification and naming of substances under 
REACH and CLP. 

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 to CLP 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) of CLP, 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 also uses that are not 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 of CLP 

Among the mixtures which fall under the scope of the CLP Regulation, 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 to CLP but are not themselves classified for health or physical hazards. 

 
 
 
 
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3.3.1.3 Exemptions from the obligation to submit information under Annex VIII 

The following mixtures, even if falling under the scope of the CLP Regulation, 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 (as defined in Article 2(30) of the CLP 

Regulation), 

•  mixtures for product and process oriented research and development (as defined in 

Article 3(22) of the REACH Regulation),  

•  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 Regulation (EC) No 
1272/2008);  

(2) explosives (unstable explosives and Divisions 1.1 to 1.6) (as defined in 
Annex I, 2.1 of Regulation (EC) No 1272/2008). 

3.3.1.3.1 Exemption for bespoke paints 

Bespoke paints are mixtures formulated on customer demand in a potentially unlimited 
number of colour variations. In the context of CLP 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.  

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 before placing them on the market, 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 final paint is never actually 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 consumer32 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 

32 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 5.3.2.5 of the Guidance on Labelling and Packaging. 

3.3.1.4 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 to Part 2 of Annex II to CLP). 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. 
babies, pre-existing pathological condition, 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, it 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 
submission made voluntarily, communicate the compositional information to the customer via 

 
 
 
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the UFI33 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.  

Submissions can be voluntarily made also on hazardous mixtures by an operator who does not 
have the obligation to do so. This can be the case for an EU-based legal entity appointed by a 
non-EU supplier (for more information about this scenario, see section 4.2.5). 

3.4 Use types 

The identification of the correct use type for the mixture for which submission is made is 
important as it defines the information requirements and the compliance date (see section 3.5 
and Figure 1 below) by which the obligations have to be fulfilled. 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’, Figure 1); 

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

users but not at industrial sites (e.g. ‘Decorative paints, Figure 1); 

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

only (e.g. Automotive coatings, Figure 1). 

The use types are based on the concept of end-use. End-use means the use of a mixture, as a 
last step before the end-of-life of the mixture, namely before the mixture (or each of its 
components) is emitted to waste streams or the environment, is included into an article or is 
consumed in a process by reaction during use (including intermediate use as defined by the 
CLP Regulation)34. In applying this approach to mixtures, this means that the use of a mixture 
continues when it is incorporated in another mixture until it reaches its end-of-life stage. 

Therefore, if a mixture formulated to be used in an industrial setting (“original mixture”) is 
subsequently also integrated by a downstream user into a mixture for professional or 
consumer use (“final mixture”), then the original mixture should be considered to be also for 
professional or consumer end-use and the corresponding information requirements must be 
fulfilled and the compliance date met. When exposed to the final mixture, professionals or 
consumers come into contact with the original mixture which is contained in the final mixture. 
For poison centres to be able to provide an appropriate emergency health response, 
sufficiently detailed information on the final mixture and its components needs to be available. 

While upstream formulators may not have a complete and detailed overview of all the final 
mixtures in which their original mixture (as a MiM) has been incorporated into, they often do 
have the general knowledge of whether their mixtures are incorporated into mixtures for 
professional or consumer use. In case of uncertainty, the company preparing the submission 
for the original mixture should, where possible, make an effort to gather such information. If 
new information about the use type of the original mixture becomes available after the 

33 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. 

34 Adapted from the ECHA Guidance R.12  Guidance on Information Requirements and Chemical Safety 
Assessment which is available at https://echa.europa.eu/guidance-documents/guidance-on-information-
requirements-and-chemical-safety-assessment. 

 
 
 
 
 
 
 
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submission, the information submitted under Annex VIII needs to be updated accordingly if 
needed. 

Note that the submission should reflect not only the use type of the original mixture as placed 
on the market by the submitter, but should also consider the use type of the final mixtures in 
which it may end up (see section 5.2.3). However, when original mixtures end up in final 
mixtures which are not subject to submission obligations (e.g. the final mixture is a cosmetic 
product, or the final mixture is not classified for health or physical hazards), the use types of 
these final mixtures do not need to be considered for submission purposes with regard to the 
original mixture. 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. In this case, the use type of the final mixture, which falls outside the scope of 
Article 45 and Annex VIII, does not need to be taken into consideration when defining the use 
type of the mixture to be notified. For example, if a mixture supplied for use in an industrial 
setting ends up in a final mixture for professional or consumer use, which is classified for 
environmental hazards only, a submission for mixtures for industrial use will suffice (relevant 
compliance date and option for limited submission). The same applies if the mixture supplied 
for use in an industrial setting has its final use in a mixture fulfilling the definition of a cosmetic 
product (provided that the mixture does not end up in any other mixtures subject to Article 
45). 

3.5 Timelines 

3.5.1 Compliance dates 

The compliance date for the submission of the information following the new requirements set 
by the amended CLP Regulation35 applies in a stepwise manner, according to the use type of 
the mixture i.e. consumer, professional or industrial use (see section 3.4). Importers and 
downstream users placing mixtures on the market not notified already under national 
legislation must comply with Annex VIII of the CLP Regulation from the following dates: 

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

•  Mixtures for industrial use: from 1 January 2024. 

Figure 1 below illustrates by means of an example how to identify the applicable date and 
information requirements on the basis of the use type. 

Where a mixture has several types of use, the earlier corresponding compliance date applies 
and related requirements must be 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 applies.   

Note that by 1 January 2025, a submission according to the harmonised Annex VIII 
requirements must be made by duty holders under Article 45 or 4(10) for all mixtures placed 
on the market (see also section 3.5.2), existing and new alike. 

Before these dates, mixtures continue to be subject to existing national requirements. 
Companies placing on the market mixtures falling under the scope of Article 45 should contact 
the appointed body in the country of interest for further information. A list of national 
appointed bodies is available at the ECHA Poison Centre website: 
https://poisoncentres.echa.europa.eu/ 

35 It is amended by Commission Regulation (EU) 2017/542 by adding Annex VIII and further amended by 
Commission Delegated Regulation (EU) 2020/11, Commission Delegated Regulation 2020/1677 and 
Commission Delegated Regulation 2020/1676 of 31 August 2020. 

 
 
 
 
 
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Companies can decide to make a submission in accordance with Annex VIII before the dates 
mentioned above. However, in that case it should be verified with the relevant appointed body 
whether it already accepts submissions in the new format also for industrial mixture and 
whether this releases from the duty to make a parallel submission according to national 
provisions being in force until the compliance date of Annex VIII.  

Relevant information on how each Member State plans to implement Annex VIII (e.g. fees and 
submission systems), has been reported in the “Overview of Member states decisions on 
implementing Annex VIII to the CLP” available from ECHA’s poison centre website at 
https://poisoncentres.echa.europa.eu/prepare-and-submit-a-pcn.  

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.  

Figure 1: Identification of information requirements and compliance date according 
to the use type  

 
 
 
 
 
 
 
 
 
 
 
 
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Figure 2: Identification of information requirements and compliance date for a 
mixture with end use not subject to Article 45 obligations 

3.5.2 Transitional period for mixtures already notified  

If a company has already submitted information relating to hazardous mixtures to an 
appointed body in accordance with Article 45(1) before the relevant compliance date (i.e. 
according to the notification requirements existing at that time in any given Member State and 
not already in accordance with Annex VIII), there is no obligation to comply with Annex VIII 
until 1 January 2025 (transitional period), except in cases where there is a need to provide 
updated information (see below).  

National requirements apply to notifications until the relevant compliance date, i.e., before 1 
January 2024 for mixtures intended for industrial use36 with no obligation to include the UFI on 
the label before that date. For new mixtures, placed on the market after the relevant 
compliance date, information needs to be submitted in accordance with Annex VIII. 

If the duty holder under Article 45 (i.e. downstream user or importer) or Article 4(10) (e.g. a 
distributor who changes the trade name or places on a market where the supplier has not 
submitted the information) intends to keep placing the same mixture on the market after 1 
January 2025, they have to submit a new notification in accordance with Annex VIII and 
include the UFI on the label by that date. As of 1 January 2025, ‘old’ submissions (according to 
national legislation) will be considered ‘archived’ and not relevant with regard to Annex VIII. 
Thus, operators must ensure that a new, Annex VIII compliant submission is made in due time 
to allow them to continue placing the mixture on the market after the end of the transition 
period. 

However, if there is a change in the mixture composition, product identifier or toxicological 
properties (as indicated in Part B, Section 4.1 of Annex VIII) during the transitional period (i.e. 

36 For mixtures intended for consumer and/or professional use, Annex VIII applied as of 1 January 2021. 

 
 
 
 
 
 
 
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after the relevant compliance date mentioned in Part A, Section 1.5. and before 1 January 
2025) the duty holder is required to submit information concerning the changed mixture in 
accordance with Annex VIII before it is placed on the market (relevant information is provided 
in section 7 of this Guidance, where the needs for an update are discussed). In this scenario, 
the duty holder must comply with Annex VIII; meaning that the UFI labelling requirement 
must also be fulfilled. If changes occur which are not listed in Part B, Section 4.1 of Annex 
VIII, there is no obligation to comply with Annex VIII until the end of the transitional period 
(therefore there is no need to generate a UFI and include it on the label). National update 
obligations may still apply. 

A mixture to which the transitional period applies and which is already made available to a 
distributor before 1 January 2025, does not need to be relabelled to include the UFI as the 
duty holder complied with the obligations before placing it on the market. This is valid as long 
as the distributor does not make any change (e.g. in the trade name) which would lead to 
obligations under Article 4(10). 

3.5.2.1 When national definitions of end use vary 

It may be that definitions of end use types have been implemented differently in different 
Member States before the entry into force of Annex VIII. For example, a mixture for industrial 
end use in one Member State may now be the equivalent of a professional end use under 
Annex VIII. In these cases, any submissions made according to the existing definition of end 
use in a specific Member State will remain valid and the duty holder does not need to comply 
with Annex VIII before the end of the transitional period. In other words, the duty holder will 
benefit from a transitional period even if the use of the mixture qualifies for a different end use 
type based on Annex VIII. 

3.5.2.2 Annex VIII submissions before the relevant compliance date 

Member States may decide, any time before the first compliance date, to accept submissions 
of information, required under Article 45, using the new ECHA Submission portal to fulfil their 
current national requirements (i.e. the Annex VIII format is simply the vehicle to transmit 
information which is required by national law). 

Where submissions are made through the ECHA Submission portal before a relevant 
compliance date, the information must comply with the Annex VIII requirements in order to 
pass the validation checks (see section 6.4). In this scenario, the use of the ECHA Submission 
portal does however not automatically trigger the obligation to include the UFI on the label 
before the compliance date. Nevertheless, in the absence of a previous national notification 
granting the benefit of the transitional period, a UFI will have to be included in the label before 
placing the mixture on the market after the compliance date. For mixtures for industrial use, a 
notification can be made in the same format as Annex VIII (via the ECHA Submission portal or 
a national system) any time without the need to apply a UFI on the product before 1 
January 2024. A UFI will have to be affixed by 1 January 2024 (therefore, the transitional 
period does not apply; the notifications are in accordance with Annex VIII). 

Useful information in this regard is provided in the Overview of Member states decisions on 
implementing Annex VIII to the CLP available on the Poison Centres website at 
https://poisoncentres.echa.europa.eu/prepare-and-submit-a-pcn.  

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. 

 
 
 
 
 
 
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These are explained in this section. 

4.1 Overview  

A company placing a mixture subject to obligations under Article 45 on the market, has to 
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 company submitting on behalf of the actual duty holder. This can be, for example, a 
legal representative or a distributor having entered into a contractual agreement with the duty 
holder to carry-out the submission on their behalf37. In other cases, distributors (including re-
branders and re-labellers) might have the obligation to submit the information by virtue of 
Article 4(10) (see section 3.1.2). The submission must be made either directly to the national 
appointed body via a national submission system or (when allowed by the Member State) 
using the submission portal provided by ECHA, and must be submitted by electronic means in 
a harmonised XML format provided by ECHA (see section 6 for the details on the available 
submission tools). 

In order to improve the emergency response and facilitate the work of poison centres in 
general, a new more specific means for the unique identification of a mixture has been 
introduced by Annex VIII. Labels for hazardous mixtures (within the scope of Article 45) placed 
on the market will generally be required to carry a Unique Formula Identifier (UFI)38. 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 CLP may not be placed on 
the market, if it does not carry a UFI which is linked to a valid submission. This is essential in 
order to ensure the functioning of the system of providing emergency information. Information 
on the generation and use of UFIs is provided in section 4.2.  

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 are met, to opt for a group submission which brings together 
multiple similar mixtures (differing for certain specific component types) into one 

37 Note that the responsibility for the submission remains on the duty holder. 
38 Part A, Section 5.2 of Annex VIII includes derogations for mixtures with multi-layer packaging and 
mixtures not packaged. Part A, Section 5.3 includes derogations for mixtures used at industrial sites (see 
section 4.2 for more details). In addition, Part A, Section 2 includes a derogation for bespoke paints from 
submission and labelling requirements, provided the obligations under Article 25(8) are fulfilled. This is 
explained in section 3.3.1.3.1. 

 
 
 
 
 
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submission. Information on the group submission option and the criteria to be met are 
provided in section 4.5. 

Additionally, specific provisions are foreseen 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 deviation 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 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 where practical, 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 this Guidance document. 

It is important to underline that the language used in the submission has to 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 operator places the same mixture on the market in more than one Member 
State, the individual submissions will need to be made in all the appropriate languages. 

The ECHA Submission portal supports multi-market submissions with the distribution of the 
dossier 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.  

4.2 The UFI for mixtures and products 

4.2.1 What is a UFI? 

Poison centres and appointed bodies have reported experiencing problems with the correct 
identification of the mixture in case of accidental exposure in up to 40 % of the calls they have 
received before the introduction of Annex VIII and its harmonised provisions. Therefore, as 
part of the harmonisation of information requirements, a unique alphanumeric code to be 
printed on or affixed to the label of a product was introduced as an additional means of 
identification of a mixture. This code, or UFI (Unique Formula Identifier) is a unique 16-digit 
alphanumeric code that unambiguously links the submitted information on a mixture (and 
hence information relevant for the treatment of patients) to a specific product placed 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 

 
 
 
 
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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). 

All products for which a submission is made with the same UFI need to share the same 
composition39. This applies to mixtures whose composition can be precisely defined and also to 
mixtures with a composition which can vary 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).  

However, different UFIs can be used for the same mixture, as long as those UFIs have been 
submitted to the appointed bodies. The same mixtures may be placed on the market under 
different trade names and by the same or different operators. In those cases, operators 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, operators 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. 

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. When entering the UFI in their databases, 
appointed bodies or poison centres may find several products and related submissions, but all 
those products or submissions will have or describe the same composition (or compositions 
with very limited differences, see for details section 5.3 where the generic component identifier 
is mentioned, section 5.4 on group submission and sections 5.5, 5.6 and 5.7 on products for 
which special provisions may apply). Below an example is given of what a UFI looks like: 

UFI: E600-30P1-S00Y-5079 

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. 

4.2.2 Generation of UFI 

Companies are responsible for the generation and management of the UFI for their mixtures. 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.  

The UFI of a specific mixture is based on the value added tax (VAT) number of a company and 

39 Note, in the case of group submission (addressed in sections 4.5 and 5.4) the same UFI could be used 
to refer to several similar mixture compositions. In the case of a single mixture submission where the so-
called generic component identifier “colouring agents” or “perfumes” is used (addressed in section 5.3.3), 
the same UFI could be used to refer to several mixture compositions differing for the colour or perfume 
only. 

 
 
 
 
 
 
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a formulation number assigned by the company to this specific mixture. The use of the VAT 
number is meant to ensure that there is no 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 generates a new UFI each time. The 
VAT number therefore is not supposed to be a means used for identification or tracking of 
companies or products. 

Companies are responsible for generating and managing the UFIs under a specific VAT 
number. They need to communicate internally and manage properly the formulation numbers 
used under a specific VAT number to ensure that every mixture composition has its own UFIs – 
in other words, the same UFIs must never be used for mixtures that have different 
compositions, except for group submissions where mixtures may differ in perfume components 
up to 5% (See section 4.5). A certain degree of flexibility is allowed in the use of the UFIs in 
order to ensure confidentiality of business information (see examples below in section 4.2.3). 

Note that 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, for example, due to confidentiality 
concerns. This possibility is available in both the UFI Generator tool itself and in the UFI 
generating algorithm (through a ‘company key’). More information and support is available on 
the UFI dedicated section of the ECHA Poison Centres website 
(https://poisoncentres.echa.europa.eu/ufi-generator). 

It is not necessary for each duty holder to generate UFIs individually. The same UFI can be 
used by different companies (including distributors), regardless the way how the code has 
been generated (i.e. by using a VAT number or a company key), as long as the composition of 
the mixture covered by that UFI remains the same. The use of the same UFI should be agreed 
among the interested operators. Section 3.1 provides examples of when this can happen, as 
well as section 4.2.3 below. 

4.2.3 How to use the UFI 

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: 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 (See section 4.5). 

Note that the same UFIs can be used across the EU market for the same mixtures, providing 
that for those mixtures submission including the UFIs has previously been done to the relevant 
Member States. 

Example 7: 1 Mixture composition– 1 UFI – 1 product placed on the market ("SuperClean") 

Mixture Composition AUFI 1Superclean 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Example 8: 1 Mixture composition– 2 or more UFIs – 2 or more products placed on the 
market  with same composition 

Example 9: 1 Mixture composition – 1 UFI – 3 products placed on the market 

Example 10: 1 Mixture composition – 2 or more UFI – 1 product placed on the market 

Mixture Composition AUFI 2SuperpulitoUFI 1UFI nSupercleanProduct nMixture Composition AUFI 1SupercleanSuperpropreSuperpulitoMixture Composition AUFI 2SupercleanUFI 1UFI 3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Example 11: 1 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 
 
 
 
 
 
 
  
 
 
 
 
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Example 13: Three similar mixtures (1 Group submission) – several UFIs, one or more 
products placed on the market. 

A single and the same UFI can be used to identify a mixture notified by referring to a Standard 
Formula, including when the mixture is placed on the market in different Member States 
and/or by different operators. The same UFI can be used by different companies to identify 
each of the fuels listed in Part B, Section 3.7 of Annex VIII. This is possible notwithstanding 
the fact that the variability in the composition is potentially higher than when the standard 
Annex VIII limits are applied. 
Similarly, one single UFI can be used in case of a mixture including one or more 
Interchangeable Component Groups, even if it is not known which interchangeable 
component(s) is(are) present at each point in time. 
Finally, a single UFI can be used when the mixture composition includes components identified 
by the same generic identifier, where the actual components may vary but there is no need to 
further specify them (see section 5.3.3 for more details about components identification). 

4.2.3.1 UFI and mixtures in a mixture 

As defined in Annex VIII, mixture components can include other mixtures, referred to as 
mixtures in mixtures (MiMs). 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, the MiM's UFI can instead be indicated in the submission together with its product 
identifier. 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. 

More 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 only with no other information required. 

Mixture Composition A2UFI 1SupercleanMixture Composition A1Mixture Composition A3GROUP SUBMISSIONUFI 1, UFI 2, UFI 3SuperpropreSuperpulitoUFI 2UFI 3 
 
 
 
 
 
 
 
 
 
 
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Example 14: 1 Mixture (with 1 MiM identified via its UFI) - 1 UFI for the mixture – 1 product 
placed on the market 

4.2.3.2 Use of the UFI along supply chain and for legal entity changes 

As long as the mixture composition remains the same, the same UFI can (but does not 
necessarily have to) be used by other downstream users/formulators in the supply chain (in 
case of a formulator, this would become the UFI of a MiM). In other words, if a downstream 
user purchases a product with a UFI and does not modify the mixture, they can choose to use 
the same UFI for their own products and in their own submission. Alternatively, the 
downstream user may generate and submit a new UFI.  

In practice, the downstream user will have the following options: 

- 

- 

Include in their submission the full mixture composition if provided by the supplier; the 
downstream user can assign to the mixture (and include in the submission) a new UFI 
or the same UFI as the supplier. 

Indicate in the submission that the composition is constituted of 100% of one MiM, 
which is the mixture provided by the supplier; this MiM can be identified with the 
supplier’s UFI if this was previously notified in the same Member State (or, as a last 
resort, by the compositional information from the SDS, see section 5.3); the 
downstream user can assign to the final mixture a new UFI or still use the same UFI as 
the supplier. 

There may be cases (during the transitional period) where suppliers may decide to include the 
UFI on the labels already before making the submission (i.e. there is no obligation to submit 
yet, and the UFI is printed on the label voluntarily). In these cases, it is strongly recommended 
to clearly communicate to the downstream user (that may use that mixture as MiM) that the 
information on the MiM has not been submitted yet. The inclusion of the UFI on the label 
should ideally be followed by the submission within a short period of time.  

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). 

Mixture 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 Toll formulator and UFIs 

The toll formulator as a duty holder under Article 45 (see more details in 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, they can include the original UFI provided by the 
toll formulator on their label (when the toll formulator does not provide the product already 
labelled). Alternatively (option 2), the toll formulator’s customer can create their own UFI 
(instead of or in addition to the supplier’s UFI) if desired 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). It is also possible that the toll formulator’s customer may want to make the 
submission themselves (option 3) relieving the toll formulator of the task. This should be 
agreed between both parties bearing in mind that the toll formulator remains the duty holder 
under Article 45. 

In some cases, when submitting via the submission tool provided by ECHA, a ‘foreign user’ can 
perform actions on behalf of a duty holder via the duty holder’s ECHA account40, such as 
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. 

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 

40 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. 

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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4.2.5 UFI and non-EU suppliers 

The non-EU supplier does not have obligations under the CLP Regulation. In addition, they are 
not permitted to submit a notification using their own ECHA account41 in the ECHA Submission 
portal. The obligation to submit the notification, including the mixture composition, lies with 
the importer. If the non-EU supplier does not wish to disclose the compositional details of the 
mixture to the EU importer, then the UFI can be used to protect the confidentiality of the 
mixture information. 

Firstly, the non–EU supplier needs to have a legal entity based in the EU (or a contractual 
agreement with an EU-based legal entity), which creates a UFI and makes a submission 
voluntarily42 to the Member States where the EU importer intends to place the mixture on the 
market. The non-EU supplier informs their customer (the EU-importer, directly or via the EU-
based legal entity) about this UFI and confirms that the submission is done. Subsequently, the 
EU importer, who is the actual duty holder, makes their own submission with a reference to 
this UFI in relation to the compositional information. The importer could therefore make 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, and the non-EU supplier wants to protect the confidentiality of the information on the 
mixture they supply to the EU importer. The obligation to place UFI on the label lies with the 
EU importer. It is possible for the non-EU supplier to already label their product with the 
correct UFI before supplying it to the EU importer. 

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 is the duty holder and therefore responsible for compliance with 
all obligations under CLP. 

41 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.   
42 The non-EU entity is not legally required to do so under CLP (they do not place the mixture on the EU 
market). More about submissions made voluntarily in section 3.3.1.3. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Example 16: Import into the EU – Non-EU supplier acting via EU-based legal entity to protect 
CBI 

4.2.6 How to manage UFIs  

Companies will need to keep an overview in their internal systems of which mixture 
corresponds to which UFI and keep track of changes and updates (the main reasons being 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 used to generate the UFI 

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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•  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” 43 the UFI is normally generated 
on the basis of a company VAT number 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.  

As an alternative to the use of the VAT number, the online tool can also automatically assign a 
“company key” which is used by the same algorithm for the generation of the UFI (example of 
Company key is “1828639338661”). 

Normally companies identify their products with an internal code; it is highly unlikely that such 
internal codes can be used directly for the generation of the UFIs since the former often 
contain letters, special characters or more than 9 digits. Therefore, if the company's internal 
coding system cannot be adapted to be used directly in the UFI tool, it is necessary to convert 
the original internal code and generate a new internal company formulation number based on 
which a UFI can be created. 

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, physic-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. 

4.2.7 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 composition44. Annex VIII to CLP requires that a new UFI be created in case the 
mixture composition changes according to certain criteria. In particular, a new UFI has to be 
created when there is: 

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 UFI45. 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 

43 Available at https://poisoncentres.echa.europa.eu/ufi-generator.  
44 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. 
45 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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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 have to 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 that 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.  

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. Therefore, components originally covered 
by a single GCI could be split into several GCI (e.g. to specify differences in the 
classification for physical hazards) or identified individually according to the standard 
rules. An update of the submission is required. 

The addition of a GCI in a submission which did not originally include one, requires an 
update with 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 b 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 submission has to be provided accordingly. If 
the change of the actual concentration is within the original range, there is no 
requirement to 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 b on 
information on mixture components). If the new concentration exceeds the allowed 
variation, a new UFI has to be created and therefore an update of the submission has 
to be provided 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 b). 

This is valid also for components identified with a GCI. 

 
 
 
 
 
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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”46), 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 submission 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 update with regard to the 
composition, a submission update has to be submitted. This will have to include a new 
UFI when the changes lead to the mixture not being conform with the original Standard 
Formula anymore. In this case the changes require an update of the submission in line 
with the normal notification provisions (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 
added47. 

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 
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 submission 
update including a new UFI has to be submitted (see section 7.4 for more information).  

It should be noted that the changes discussed in this section concern components which are 
required to be indicated in the original submission, so besides triggering the need to create a 
new UFI these changes trigger at the same time the need to update the whole submission. 
More details are provided in section 7.4. Please note that 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 as a result 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 is 
required the same way as for the mandatory change of UFI. 

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

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

 
 
 
 
 
 
 
 
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4.2.7.1 Changes in MiM’s UFI 

When a mixture is used by an operator downstream 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 

Article 25(7)48 of CLP defines the UFI as supplemental information that should be located with 
the other CLP-labelling elements, for example near the hazard pictograms. Therefore, 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. The UFI must be printed on or 
affixed to the label of a hazardous mixture to which submission obligations apply (see 
derogations mentioned in section 4.2.8.2). 

By derogation from Article 25(7), Article 29(4a) 49 provides some flexibility by stating that the 
UFI can be printed on or affixed to the inner packaging, as long as it is with the other label 
elements and clearly visible (i.e. not necessarily within the label, refer to Section 5, Part A of 
Annex VIII). This is meant to ensure that the UFI is easily identifiable by checking the label or 
next to the label. 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 with regard to 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 SDS50. In the specific case of hazardous mixtures listed in Part 5 of Annex II 
to CLP that are supplied to the general public the UFI has to be included in the copy of the 
label elements provided for in Article 29(3), e.g. attached to the delivery note. 

48 Regulation (EU) 2017/542 amended CLP by adding the new Annex VIII and the additional paragraph 7 
to Article 25 (Additional labelling information). 
49 Regulation (EU) 2020/11 amended CLP by adding the new paragraph 4a to Article 29 (Exemption from 
labelling and packaging requirements). 
50 Section 1.1 of Annex II to REACH.  

 
 
 
 
 
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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. 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. 

In addition to the requirements described above, the following suggestions are provided 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 code51.  

•  Affixing the UFI to the label is possible instead of printing directly on the label. The 

sticker is to be affixed firmly so that it cannot easily be separated from the actual label. 
Affixing the UFI may seem to be a useful option in the following cases: 

o  To avoid wasting labels printed before the applicability of Annex VIII and where 

still valid (though without UFI printed);  

o  To mitigate the need of frequent changes to the label, in case the product 

changes the composition dynamically (e.g. seasonal changes or frequent 
changes of suppliers). 

•  To help distinguish the acronym from the beginning of the UFI, an optional space may 
be placed after the colon (e.g. if it can improve the legibility using the selected font).  

The three hyphens separating the blocks of the UFI must be printed. 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. 

This leads to the most preferred strings such as  

UFI:VDU1-414F-1003-1862 
(23 characters) 

UFI: VDU1-414F-1003-1862 
(24 characters) 

Alternatively, the following strings are also allowed. 

UFI: VDU1-414F  
     1003-1862 
(23 characters on two lines) 

UFI: 
VDU1-414F 
1003-1862 

(22 characters and 3 lines) 

51 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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Font colour also needs to be considered. For example, black on a light background is a good 
option; conversely, a light coloured font should be used on a dark background. In principle, 
any colour can be used, notably in order to consider the printing equipment capabilities, 
provided it meets the requirements of being clearly and indelibly marked.  

Monospaced style fonts have proven to be suitable - especially when printing the UFI on two 
lines, as shown above, as they tend to improve the legibility of individual characters. The size 
of the font is recommended to be adapted to the font style to ensure that the UFI is legible for 
a person with average eyesight (e.g. legibility could be improved by using a slightly larger font 
size for a bolder font; more details can be found in section 5.2 of the Guidance on Labelling 
and Packaging in accordance with CLP52). 

The Guidance on Labelling and Packaging in accordance with CLP, provides, in particular but is 
not limited to, information on: 

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

packaging, use of fold-out labels 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. 

4.2.8.1 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, samplers or testing kits). In these 
cases, each single mixture bears the label relevant to that mixture, where required53. 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 some cases, mixtures are placed on the market as parts of a multi-component product, 
where each mixture is in a separate container, but the containers are purchased together. A 
new mixture may be created upon the use of the product (e.g. certain adhesives, resin with an 
hardener, paint with an activator) following active mixing by the user or automatic mixing by 
means of the provided device part of the packaging. Certain multi-component products may 
consist of mixtures not intended to be mixed but rather acting separately (e.g. dish washing 
tablets, laundry tabs). The company placing multi-component products on the market must 
provide a UFI for each component-mixture in separate submissions54. 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 

52 See Guidance on Labelling and Packaging in accordance with Regulation (EC) 1272/2008 in the 
Guidance section of the ECHA website. 
53 See Guidance on Labelling and Packaging in accordance with Regulation (EC) 1272/2008 in the 
Guidance section of the ECHA website.  
54 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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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 which 
are part of a multi-component product, but have to be notified individually, by means of a PCN 
Multi-component identifier. 

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 operators (i.e. do not benefit from the limited submission which will be described 
later, in section 4.4). 

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 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. 

 
 
 
 
 
 
 
 
 
 
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4.3 EuPCS 

A harmonised European product categorisation system (EuPCS) maintained by ECHA55 is used 
to describe the intended use of a mixture for which information according to Annex VIII has to 
be submitted (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"56. 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 
the main intended use, which in this case, the main intended use 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 published57 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 consumers 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 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 (i.e. compliance date for submission from 1 January 2021) 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 

The 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 alternative to the 
general submission requirements [A.2.3]. This option applies also to mixture included in final 

55 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/.  
56 The latest version of the EuPCS is available from the ECHA Poison Centre website at 
https://poisoncentres.echa.europa.eu/eu-product-categorisation-system.  
57 The EuPCS Practical Guide is available at https://poisoncentres.echa.europa.eu/eu-product-
categorisation-system. 

 
 
 
 
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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 such cases, information on the composition of their 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) 2017/542,58 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,59 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 
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. 

In the case when there is a difference in the definitions of industrial, professional or consumer 
use under national and the harmonised systems, no obligations apply for this reason only until 
the end of the transitional period (1 January 2025). 

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

The submitters who have chosen the ‘limited submission’ must, according to section 2.3 of Part 
A and section 1.3 of Part B of Annex VIII, provide in the submission 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 

58 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. 
59 Guidance on the compilation of safety data sheets, in particular section 3.3 ‘Composition/ information 
on ingredients’. 

 
 
 
 
 
 
 
 
 
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from an appointed body or an 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. 

Note that 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.  

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. Operators 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 certain elements. Therefore, 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 except for certain perfumes 

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

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

 
 
 
 
 
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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 identification [B.1.1] 

Poison centre operators must receive information to enable them to rapidly and accurately 
identify the responsible product in the event of a poisoning incident. Following a poisoning 
accident, this information is normally provided by the person making the call, who ideally 
should have the relevant product identifiers at hand on the label of the product itself. The 
product identifiers needed for the purposes of Article 45 and the poison centre work are laid 
out in Annex VIII to CLP in accordance with Article 18(3)(a) of the same Regulation. 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]. The same mixture could be placed on the market under several trade names and 
for different intended uses. As long as the composition does not change, all these trade names 
can be included in the same submission60. The provision of all the exact names in the 
submission as they appear on the label is necessary for the poison centres as there are cases 
where different products exist with the same main name (e.g. brand name or trade name) and 
different other names. The latter would therefore facilitate a correct identification. 

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 considered to be that of the relevant duty holder who is referred to 
as the “submitter” (see section 3.1). 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 
or representative of the submitter, but who may physically prepare and make the submission 
(see section 3.1). 

60 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. 

 
 
 
 
 
 
 
 
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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)61. 

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 
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 has to 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. 

61 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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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. 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 

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) 

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. 

 
 
 
 
 
 
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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 62, 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 
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. 

62 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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-  Use types (consumer, professional, industrial). 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 since the final end-use of the 
mixtures determines the compliance date for submission and information requirements. 
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. The use types are defined in section 3.4 of this document. 

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 operator 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. 

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) 

 
 
 
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-  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 
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. 

Normally, the substances contained in a MiM should be reported individually, as for all other 
substances. When the composition of the MiM is fully known, its components should be 
considered as components of the final mixture and indicated accordingly. However, if the 
submitter does not have access to information on the full composition of the MiM, it is possible 
to report the MiM as such in the submission. For further information, see section 5.3.3 below. 

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 or it has been communicated to him 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 

 
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common treatments. When a Specific Concentration Limit (SCL)63 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).  

Note: 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. An example of such mixtures are certain plant protection 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 shall be included in the submission. In 
the submission, it is thus recommended to also indicate (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 

A) Identification of the components [B.3.2] 

Substances in a mixture must be identified in accordance with Article 18(2) of the CLP 
Regulation:  

-  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 of CLP must be provided as well. 

As regards mixtures in mixtures (MiMs), information on the substances contained in a MiM 
must be provided: 

•  As a rule, in accordance with what is stated about substances above. Substance 

components of a MiM (when the composition of the MiM is fully known) should be 
regarded as components of the final mixture. Information regarding same substances 
(originating from MiM and/or on added on their own) should be presented in 
aggregated form. Where MiM components or substances are the same (i.e. have the 

63 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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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. 

•  Alternatively, if the submitter does not have access to information on the full 

composition of the MiM but is provided with the MiM’s UFI, this MiM must be identified 
by means of its product identifier i.e. trade name or designation (according to Article 
18(3)(a) of CLP), together with its concentration (exact value or range) and the UFI 
(see point C below for information about concentration and classification). When the 
information on the MiM, including the UFI, is available to the appointed body as part of 
a prior submission there is no need to indicate any of the MiM’s components. 
Nevertheless, the known MiM components could be still provided (e.g. based on the 
SDS), and this should be done in separated form, i.e. not aggregated64. It should be 
noted that, if the full composition is not known, a mixture purchased from different 
suppliers who assign different classifications cannot be considered to be chemically the 
same mixture. Enforcement authorities may enquire how the duty holders have 
complied with this legal requirement so as to account for the provision of 
partial/incomplete information. 

•  As a last resort, in the absence of a UFI or if this UFI and the information on the MiM 
has not been previously submitted to the relevant appointed body, the MiM must be 
identified by means of its product identifier (according to Article 18(3)(a) of CLP) and 
by indicating the components available from the SDS. In addition, the name, email 
address and telephone number of the MiM supplier must be indicated65. If known, the 
UFI of the MiM has to be provided. Appointed bodies and Poison centres will hence be 
able to use it once and if a submission is made by the supplier, without the need for an 
update. This scenario was envisaged to address temporarily the issues that may occur 
during the transition period until 2025, when it comes to communication in the supply 
chain. It is expected that after 2025, all compositional information is provided within 
the two above scenarios (at least when the final mixture is notified in the same 
Member State as the MiM). In the meantime, if a submitter does not receive the UFI of 
the MiM from their supplier, this does not discharge the notifier from their legal 
obligations as regards information provision on (known) components. Such information 
may be, for example, “accessible” upon request; the duty holders would then have met 
the legal condition if they demonstrate that they contacted the suppliers by email and 
they received the reply that the requested information cannot be provided because it is 
confidential. Enforcement authorities may enquire about how the duty holders have 
complied with this legal condition for lower information requirements (no access to 
information). 

64 In case the composition of the MiM is not fully known, information should be provided for each known 
component separately, in order to reduce the risk of confusing information for emergency responders. 
65 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. 

 
 
 
 
 
 
 
 
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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 

In the absence of UFI and in the absence of SDS (for mixtures not classified for any hazards, 
where no obligations to create an UFI and to provide an SDS exist), the submitter should 
retrieve relevant information 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 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). 

Ingredients purchased by 
Company A 

Concentration in final 
mixture 

Composition  

Mixture X (MiM X) 

20% 

Mixture Y (MiM Y) 

30% 

Substance 1 

Substance 2 

Water 

5% 

10% 

35% 

Substance 1 - 30% 

Substance 3 – 40% 

Substance 4 – 30% 

Substance 2 – 15% 

Substance 3 – 25% 

Substance 5 – 60% 

Not applicable 

Not applicable 

Not applicable 

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 

Mixture Composition A:Substance 1,Substance 2,Substance 3, UFI MiM1SupercleanUFI AMiM2:     .Composition           from SDS      .Supplier sName     Telephone     Mail 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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SuperClean: 

Component 

Substance 1 

Substance 2 

Substance 3 

Substance 4 

Substance 5 

Water 

Concentration in final 
mixture 

6 (20% x 30%)+ 5 = 11% 

4.5 (30% x 15%)+ 10 = 
14.5% 

8 (20%x40%) + 7.5 
(30%x25%) = 15.5% 

6% (20% x 30%) 

18% (30% x 60%) 

35% 

A generic component identifier (GCI) – “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 perfumes; 

o  25% for the sum of colouring agents 

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

Mixtures whose composition differs only in components which can be identified by the same 
generic component identifier, can be included in the same submission. Such mixtures may be 
placed on the market under multiple trade names which can be also indicated in the same 
submission. 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 remains the same (i.e. 5% for perfumes and or 25% for 
colourants).   

Note: using generic component identifiers is optional and at the discretion of the submitter. 

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

The CLP regulation provides 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 
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(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 form66. 

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

When mixture components are classified in accordance with the CLP Regulation 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 

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 

66 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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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). 

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. 

 
  
 
 
 
 
 
 
 
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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: 3-6%, 4-7%, 5-8% or 6-9%. Also narrower 
ranges can be applied such as 5-6%. 

C) 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 
hazardous67. 

In other words, at least for all the component substances that would need to be indicated on 
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 indicated on a voluntary basis). 

In the cases where the mixture for which a submission needs to be made contains one or more 
MiM(s) (for which full composition is not known) the notifier should provide the classification of 
the MiM itself. The classification of the components of the MiM(s) which are available and 
indicated has to be provided as well. This applies regardless of the identifiers provided for the 
MiM (i.e. both when the MiM’s UFI is available or not). The components of the MiM are 
effectively components of the final mixture. 

Where the MiM composition is fully known, the classification for health and physical hazards of 
the substances contained in the MiM should be indicated following the rules above. Information 
on classification for environmental hazards is not required. 

Components identified via a generic component identifier 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. 

67 See ECHA’s Guidance on the compilation of safety data sheets. 

 
 
 
 
 
  
 
 
 
 
 
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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. 

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 

 
 
 
 
 
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• 

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) 

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% 

Classificatio
n 

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. 

 
 
 
 
 
 
 
 
 
 
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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 

20-30 % 

20-30 % 

30-35 % 

14–22 % 

Additional notes to the example: 

•  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. 

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: 

 
 
 
 
 
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•  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. 

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. 

 
 
 
 
 
 
 
 
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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: 

• 

• 

‘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 classified68).  

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). 

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 has 
to 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 

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

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

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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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’). 

GROUPING OF MIXTURES WITH DIFFERENCE IN PERFUME COMPONENTS 

UFIs: 

- N200-U0CW-5009-QWHJ 

- G500-C029-F00T-D83M 

Product names: 

- Trade name 1 

- P800-U0RP-S009-1KPP 

- Trade name 2 

Classification: # 

Product Category: # 

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 

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.  

Name 

Perfume 

Classificationa 

Conc. range  Actual 
conc.b 

Trade name 1 

Perfume chemical name 1 

Other 

1 - 2 % 

1.2 % 

UFI: N200-U0CW-
5009-QWHJ 

UFI: G500-C029-
F00T-D83M 

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 

Perfume chemical name 2 

Major concern 

0.3 – 0.6 % 

0.4 % 

UFI: P800-U0RP-
S009-1KPP 

Perfume chemical name 4 

Other 

1 – 3 % 

Perfumes (GCI) 

Not classified 

n.a. 

Perfume chemical name 5 

Other 

1 – 4 % 

1.4 % 

1.4 % 

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.  

 
 
 
 
 
 
 
 
 
 
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Compliance with Annex VIII requirements: 

• 

• 

• 

• 

• 

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%. 

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 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
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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% 

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% 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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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 of this perfume a 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 
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 

 
 
 
 
 
 
  
 
 
 
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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 MiMs69. 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. 
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: 

69 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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- 

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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’; 
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. 

 
 
 
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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 
interchangeable components are present at each point in time and in which concentration. 

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. 

 
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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: 

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 

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 
 
 
 
 
 
 
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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.  
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 

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 

 
 
 
 
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D2 

D3 

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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 

A 

B 

C 

D 

E 

F 

G 

H 

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 

9 

6.5 

Set of properties S3 

Not applicable 

Aspiration hazard, cat. 1 

9 

Set of properties S4 

 
 
 
 
 
 
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Eye irritation, cat. 2 

I 

Not classified 

7 

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. 
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 

 
 
 
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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 

D 

E 

Solvent 

Not classified 

not relevant 

82.3 – 82.6 

Detergent base 

Acute toxic oral, cat. 4; Acute Toxic 
dermal cat. 4; Acute toxic inhalation, 
cat. 4; Skin corrosion, cat 1B; Eye 
damage, cat. 1; Specific target organ 
toxicity, single exposure, Cat. 3 
(respiratory irritation) 

not relevant 

11 

Solubiliser 

Not classified 

Surfactant 

Acute toxic oral, cat. 4; Eye damage, 
cat. 1 

not relevant 

not relevant 

0.3 

1.9 

Specific components recipe 1 

C1 

Wetting agent 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

2.6 

 
 
 
 
 
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F1 

C2 

F1 

C1 

F2 

F3 

C2 

F2 

F3 

Emulsifier/corrosion 
inhibitor 

Skin corrosion, cat 1B; Eye damage, 
cat. 1 

Acidic (<7) 

1.6 

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) 

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 
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). 

 
 
 
 
 
 
 
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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 

Part D of Annex VIII includes a list of 23 Standard Formulas: 

-  20 Standard Formulas related to cement, 
-  one Standard Formula related to gypsum binder, 
- 

two Standard Formulas related to ready-mixed concrete . 

The list is exhaustive. 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 can be broader than what is allowed 
by 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 of exposure, do not 
change within the concentration ranges specified for the mixture’s composition in the Standard 
Formula and included in the notification. 

Standard Formulas can be used in a submission to describe the final mixture (i.e. the final 
mixtures’s composition conforms to the Standard Formula) or part of the final mixture 
(substances or MiMs). (this is explained in section 5.5.2 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).  

“Conforming” with a Standard Formula means that the mixture or part of a mixture contains 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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only and all the components specified in the relevant Standard Formula and within the ranges 
indicated in it. There is the possibility though that some of the components may not always be 
present, for example, in each batch of the product (when the concentration range as provided 
in the Standard Formula includes ‘zero’ as lower limit). This is due to the nature of the 
components (e.g. natural origin) or of the production process. 
For mixtures or part of the mixture conforming with one of the Standard Formulas, the 
information on identification of components and their concentration ranges can be reported as 
in the Standard Formula itself70. 

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 (Part B, section 3.3 of Annex 
VIII), 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 normal 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) and the hazard 
identification and product information has to be provided as required in Section 2 of Part B 
(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, and explained in section 5.3.3 of this Guidance. 

The name and product description of the Standard Formula as indicated in Part D of Annex VIII 
should 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). 

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 

70 Note that the information available in the SDS may have to be provided instead, see section 5.6.3 
below. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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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 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 VII, 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 indicated71, 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 some of the components (e.g. a MiM), 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 
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”. 

71 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 
%. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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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 single components has to be provided as for any standard 

notification. 

Generally speaking, there are two main ways how Standard Formulas can be of use: 

1.  Final mixture A conforms to Standard Formula. 
2.  Final mixture A does not conform with any Standard Formula but part of it does (i.e. 
contains at least one mixture component that conforms with a Standard Formula). 

Example 29: Final mixture conforms with a Standard Formula 

The final mixture A (i.e. the mixture to be notified) conforms with SF1 included in Part D of 
Annex VIII. All its components are reported as in SF1 (all the components which are part of 
the Standard Formula are also part of the mixture composition): 

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: Only part of the final mixture conforms with a Standard Formula (not the final 
mixture as a whole) 

The following scenario aims to exemplify a case where a Standard Formula is used to describe 
a part of the final composition. The full composition of the final Mixture A does not conform 
with any specific Standard Formula. One or more components of the final mixture are reported 
as in a Standard Formula.  

Scenario 1 

The final mixture A itself (i.e. mixture to be notified) does not conform with any Standard 
Formula included in Part D, but includes one MiM which does conform with SF1 listed in Part D. 
In this example, the Standard Formula is included as a MiM in the final mixture: 

Identification  Concentration  Classification 

Composition 
of final 
mixture A 
Component A 

Component B 

As in B.3.2 

As in B.3.4 

As in B.3.2 

As in B.3.4 

To be 
provided 
To be 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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provided 
To be 
provided 
To be 
provided 

Component C 

As in B.3.2 

As in B.3.4 

Concentration of 
MiM in final 
mixture to be 
given according 
to B.3.4. 

MiM D (SF1) 

The MiM 
conforms 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 

The final mixture A (i.e. mixture to be notified) does not conform with any of the Standard 
Formulas included in Part D but part of its composition does conform with Standard Formula 
listed in Part D. 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 

As in Gypsum 
Binder Standard 
Formula: 
231-900-3 

This part 
conforms with 
Standard 
Formula 
“Gypsum 
binder 
Standard 
Formula” 

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 

To be 
provided 
To be 
provided 
To be 
provided 
To be 
provided 

To be 
provided 

As in Gypsum 
Binder Standard 
Formula: 
≥50% and ≤ 
100% 
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: 
(e.g. <5%) 
NB: as above 

Component E: 
Calcium 
dihydroxide 

As in Gypsum 
Binder Standard 
Formula: 215-
137-3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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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. 

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 

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 

Liquefied Petroleum Gas used as fuel  

 
 
 
 
 
 
 
 
 
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LNG 

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 stabilizers;  
-  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.  

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 

 
 
 
 
 
 
 
 
 
 
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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 

Composition of fuel 
product 
Component A 

As in SDS 

Identification 

Concentration 

Classification 

Component B 

As in SDS 

Component C 

As in SDS 

Component D 

As in SDS 

Component E 

Component F 

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 

Hazardous, 
classification to 
be provided 
Hazardous, 
classification to 
be provided 
Hazardous, 
classification to 
be provided 
Hazardous, 
classification to 
be provided 
Hazardous 

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) 
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 

 
 
 
 
 
 
 
 
 
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Component G 

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 

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% 

481-740-
5 

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) 

618-882-
6 
700-571-
2 
267-015-
4 

Fatty acids, C16-18 and 
C18-unsatd. methyl 
esters 
Fatty acids, vegetable 
oil, methyl esters 
Fatty acids, C14-18 and 
C16-18-unsatd., Me 
esters 
Performance additive A  UFI A 

273-606-
8 
267-007-
0 

2-EHN cetane 

248-363-
6 

0-100%  Asp. Tox 1 (H304) 

0-7% 

Not classified 

0-7% 

Not classified 

0-7% 

Not classified 

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. 

 
 
 
 
 
 
 
 
 
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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 SDS72: 

•  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 (Section 3.3, Part B), 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. 

-  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 

72 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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in table below. 

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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) 

6. Preparation and submission of information: available tools  

The submission of the required information has to be done electronically and using the XML 
format provided by ECHA [A.3.1]. The tools developed and maintained by ECHA assist both the 
submitters and the Member States appointed bodies in fulfilling their obligations and 
performing their tasks. The tools support the preparation of the submission in the correct 
format, allow the submission of the information and facilitate the distribution and accessibility 
of the submitted 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 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]. 

 
 
 
 
 
 
 
 
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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 format is available for download from ECHA’s Poison Centres website 
(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 XML files 

There are three ways to prepare dossiers (IUCLID XML files). The submitter can decide which 
one to use based on their specific business needs and IT systems. 

•  Online in the ECHA Submission portal: The portal features IUCLID Cloud, an online 
tool to guide the user through the preparation of a dossier, allowing to enter data 
manually and store the information in the ECHA Cloud. 

•  Offline in IUCLID 6: In IUCLID 6, data can be entered manually using a specific 

poison centres notification interface. 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.  

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) CLP. Submissions must be made to the 
appointed bodies by electronic means endorsed by them for that purpose. It is at the 
discretion of each Member State to define the technical means of submission, including the 
possibility to ‘outsource’ this task and allow the submission of information centrally via the 
ECHA Submission portal. Submitters are invited to carefully verify the conditions and 
instructions for the submission of the information with the countries where the mixture is 
placed on the market. 

Dossiers can be submitted through the ECHA Submission portal in one of two different ways, 
either: 

•  Directly online through the portal: Regardless of whether or not 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 XML file. This means that a single submission 
can reach several Member States. 

•  Through a system-to-system (S2S) transfer service: An automatic S2S transfer 
service allows companies that have created IUCLID XML 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.  

The ECHA Submission portal can be accessed from the ECHA Poison Centre website at 
https://poisoncentres.echa.europa.eu/echa-submission-portal. 

 
 
 
 
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More information on the S2S service is available at 
https://poisoncentres.echa.europa.eu/system-to-system-service.  

Secure access to the information by designated authority users is available on the ECHA Poison 
Centre website at https://poisoncentres.echa.europa.eu/tools-for-authorities. 

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 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. The list of validation rules is also published on ECHA’s Poison Centres website 
at https://poisoncentres.echa.europa.eu/poison-centres-notification-format. 

The validation rules 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 can be downloaded manually together with a submission report; 

submissions are received automatically via system-to-system integration (i.e. eDelivery 
solution). 

•  access to submissions in a central data base (view and search) hosted by ECHA. 

6.5 Fees 

The usage of XML formats, UFI generator, EuPCS 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. 
The document “Overview of Member State decision on implementing Annex VIII to the CLP” 
available on the Poison Centres website provides an overview of the available information. 

 
 
 
 
 
 
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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. 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 
“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 and 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.  

 
 
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-  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, undertake statistical analysis to identify 
where improved risk management measures may be needed. 

Appointed bodies or poison centres may undertake statistical analysis of the submitted 
information to identify where improved risk management measures may be needed. 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 
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 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 

 
 
 
 
 
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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. 

It should be noted that existing submissions made in accordance with national rules 
are valid until 1 January 2025 (see section 3.5). However, if a change described in Section 4, 
Part B takes place before that date (and after the relevant compliance date according to the 
use type described in section 3.4), a submission update has to be made in accordance with 
Annex VIII.  

7.4.2 Update rules according to Annex VIII 

The updating rules apply to both new submissions in the harmonised format and to mixtures 
already notified in accordance with the existing national rules before the entering into force of 
Annex VIII and the relevant compliance date (see section 3.5.1 above). 

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 

indicated73, 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 Table 3 of Annex VIII and reported in table 5 below (i.e. Table 4 of Annex VIII). 

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, part B, 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 group, 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 

73 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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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 31. 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. 

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 

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 32 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. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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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 3 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. 

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, 

 
 
 
 
 
 
 
 
 
 
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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 
available74. 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 

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 Other updates 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 

74 See Article 31(9) of REACH. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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the relevant appointed body(s). 

Changes other than those listed in Section 4.1 Part B of Annex VIII may take place and these 
may be relevant for the purposes of the CLP Regulation, in particular for an emergency health 
response (e.g. a change in the contact details of the submitter or in the physical parameters of 
the mixture). Furthermore, the submitter may want 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 packaging 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 changes. 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: 

(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 5 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).

 
 
 
 
 
 
 
 
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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 

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’.  

Note that a new UFI must 
be provided. 

- Supplier changes MiM’s UFI due to 
compositional changes of MiM, which 
impact composition of final mixture. 

(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. 

New notification 
after significant 
change in 
composition 

 
 
 
 
 
 
 
 
 
 
 
 
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Changes 

Scenario triggered 

Technical option 

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. 

Note that 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’.  

Note that 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’.  

Note that a new UFI must 
be provided. 

New notification 
after significant 
change in 
composition 

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’.  

Note that 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. 

 
 
 
 
 
 
 
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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. 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.  

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 

 
 
 
 
 
 
 
 
  
 
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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 

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]. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Notes to the tables: 

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(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. 

• 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). 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
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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 can 
still request additional information from submitters, if needed for emergency reasons or 
statistical analysis for improved risk management measures in the context of 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, which may be relevant 
and is currently available:  

ECHA Poison Centres Website (https://poisoncentres.echa.europa.eu/)  

-  ECHA Submission portal and  

o  PCN: a practical Guide 

o  ECHA accounts manual 

-  Overview of Member States decisions in relation to implementation of Annex VIII to the 

CLP; 

- 

‘News’ updates on the ECHA poison centre project; 

-  Frequently asked Q&As which are regularly updated on a range of Annex VIII related 

topics; 

-  UFI generator and the user guide in all EU languages; 

-  PCN format and support documentation (including data model); 

-  European product categorisation system and manual; 

-  Targeted support pages e.g. for industry (“Step for industry” which supports in fulfilling 

the obligations step by step); 

-  Publications e.g. ‘In brief’ material; 

-  Animations. 

ECHA Website, support section (https://echa.europa.eu/support), which contains a range 
of support material besides the Guidance, including: 

-  Webinars 

-  Helpdesk support   

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 

 
 
 
 
EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU