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Draft Guidance Annex VIII to CLP Vers. 2.0 2019

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Guidance ECHA draft may2019

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

Draft version 2.0 - May 2019

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). 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.

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 the text was consolidated and edited by ECHA and underwent the formal consultation with ECHA Partners during 2018 and beginning of 2019.

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Table of Contents
DOCUMENT HISTORY
PREFACE
1. INTRODUCTION
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
2. ABBREVIATIONS/DEFINITIONS
3. OBLIGATIONS
3.1 Who is required to submit information?
3.1.1 Activities leading to submission obligation according to Article 45
3.1.2 Activities leading to submission obligations according to Article 4(10)
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?
3.3.1.1 General exemption from CLP Regulation and Article 45
3.3.1.2 Exemptions from the obligation to submit information under Annex VIII
3.3.1.3 Voluntary submission of information
3.4 Use types
3.5 Timelines
3.5.1 Dates of application
3.5.2 Transitional period
4. GENERAL SUBMISSION REQUIREMENTS
4.1 Overview
4.2.1 What is a UFI?
4.2.2 Generation of UFI
4.2.3 How to use UFI
4.2.3.1 UFI and mixtures in a mixture
4.2.3.2 Use of the UFI along supply chain and for legal entity changes
4.2.4 Toll formulator and UFIs
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
4.2.7.1 Changes in MiM’s UFI
4.2.8 Display, position and placement of UFI
4.2.8.1 Multi-component products
4.2.8.2 Exemption from labelling requirements [A.5.3]
4.3 EuPCS
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
6.5 Fees
7. POST-SUBMISSION
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
7.4.1 Introduction
7.4.2 Update rules according to Annex VIII
7.4.2.1 When declaring concentration ranges
7.4.2.2 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

Fonte: ECHA

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