Guidance on harmonised information relating to emergency health response - Annex VIII CLP / Vers. 6.0 2025

Guidance on harmonised information relating to
emergency health response - Annex VIII CLP / Vers. 6.0 2025

ID 24777 | 22.10.2025 / Attached

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

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 (CLP), as amended. CLP is based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and is implementing the provisions of the GHS within the EU. CLP now has relevance for European Economic Area (EEA) countries (i.e. it is implemented in the EU countries and in Norway, Iceland and Liechtenstein).

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

The first version of this guidance document was developed by ECHA with the support of a dedicated Working Group consisting of experts from Industry, Member State appointed bodies and poison centres and published in 2019. The document was further updated, in cooperation with the same ECHA partners, in 2020, 2021, and 2022.

This current version 6.0 reflects the end of the transitional period (31 December 2024) and changes to the CLP Regulation introduced by Regulation (EU) 2024/2865.
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Version 6.0 October 2025:

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

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

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

Section 2 Abbreviations/definitions updated

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

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

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

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

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

Section 8 Support - Updated the section for relevancy
Update via fast-track procedure to further clarify and complete existing interpretations or make corrections following practical implementation and release of new features in the submission portal. In particular: - Clarified in sections 3.1.1.1 and 4.2.5 obligations and options for importers and non-EU suppliers. - Clarified in sections 3.1.1.2 and 4.2.4 obligations and options in case of toll formulation. - Revised in section 3.5.2 interpretation of obligations during the transitional period to align with revised ECHA Q&A; clarification of obligations in case of Annex VIII notification made before relevant compliance date. - Removal in section 4.2.3.1 of information on MiM’s identification which is to be provided in section 5.3.3. Example moved to section 5.3.3. - Clarified in section 4.2.7 obligations to change UFI in case of GCIs. - Clarified in section 5.3.3 use of GCIs; example 21 revised. - Addition in section 5.5 of new footnote to address grouping of fully known MiMs in ICGs; addition of clarification about maximum concentration of a ICG in final mixture. - Addition in section 7.4.2 of reference to changes in mixture resulting in mixture being non-classified. - Clarified in section 7.4.5 obligations in case of splitting existing GCIs. - Clarified in section 7.4.6 update rules in case of group submissions. - Other minor corrections and clarifications throughout the document.

Fonte: ECHA



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Collegati
Regolamento (UE) 2024/2865
Regolamento (CE) n. 1272/2008 CLP