Guidance on harmonised information relating to emergency health response - Annex VIII to CLP
Version 1.0 February 2019
Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
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 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 States 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.
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 the text was consolidated and edited by ECHA and underwent the formal consultation with ECHA Partners during 2018 and beginning of 2019.
This Guidance document is structured to present, after a general introduction, the main 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 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 under 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.
- 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.
- 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.
Table of Contents
1.1 General introduction
1.2 Legal background
1.3 Aim of this guidance
1.4 Target audience of this guidance
1.5 Overview of the document
1.6 Links to legislation other than CLP
1.6.1 REACH Regulation
1.6.2 Other legislation
1.6.3 National legislation
3.1 Who is required to submit information?
3.1.1 Activities leading to the obligation to submit information according to Annex VIII
22.214.171.124 Obligations and supply chain
3.1.2 Activities not leading to submission obligations according to Annex VIII
3.2 Who receives the information?
3.2.1 Member States’ appointed bodies
3.3 What is the scope of Article 45?
3.3.1 Which mixtures require information to be submitted?
126.96.36.199 General exemption from CLP Regulation and Article 45
188.8.131.52 Exemptions from the obligation to submit information under Annex VIII
184.108.40.206 Voluntary submission of information
3.4 Use types
3.5.1 Dates of application
3.5.2 Transitional period
4. GENERAL SUBMISSION REQUIREMENTS
4.2 The UFI for mixtures and products
4.2.1 What is a UFI?
4.2.2 Generation of UFI
4.2.3 How to use UFI
220.127.116.11 UFI and mixtures in a mixture
4.2.5 UFI and non-EU suppliers
4.2.6 How to manage UFIs
4.2.7 New UFI as a result of composition changes
18.104.22.168 Changes in MiM’s UFI
4.2.8 Display, position and placement of UFI
22.214.171.124 Multi-component products
126.96.36.199 Exemption from labelling requirements [A.5.3]
4.4 Limited submission
4.4.1 Contacts for rapid access to ‘additional detailed product information’
4.4.2 Availability and content of the additional information and rapid access
4.5 Group submission
5. INFORMATION CONTAINED IN THE SUBMISSION
5.1 Identification of mixture and submitter [Part B.1]
5.1.1 Product identification [B.1.1]
5.1.2 Submitter details [B.1.2]
5.1.3 Details for rapid access to additional product information [B.1.3]
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]
5.2.2 Toxicological information [B.2.3]
5.2.3 Additional information [B.2.4]
5.3 Information on mixture components [Part B.3]
5.3.1 General requirements [B.3.1]
5.3.2 Components subject to submission requirements [B.3.3]
5.3.3 Information required on components
5.3.4 Limited submission [B.3.1.1]
5.4 Group submission [A.4]
5.4.1 Information to be provided in a group submission
5.4.2 Mixture components in a group submission
6. PREPARATION AND SUBMISSION OF INFORMATION: AVAILABLE TOOLS
6.1 UFI generator
6.2 XML format
6.3 Tools for preparing IUCLID XML files
6.4 Submission of information
7.1 General introduction
7.2 Additional requests by appointed bodies
7.3 Use of submitted information
7.3.1 Security and confidentiality of the submitted information
7.4 Keeping information up to date
7.4.2 Update rules according to Annex VIII
188.8.131.52 When declaring concentration ranges
184.108.40.206 When declaring exact concentrations
7.4.3 Other (voluntary) updates relevant for an emergency health response
7.4.4 How updates are technically handled
7.4.5 Updates – special cases with generic product identifiers
7.4.6 Updates – special cases with group submissions
7.5 Validity of the submission
8. ADDITIONAL SUPPORT