Slide background
Slide background




Draft Guidance Annex VIII to CLP Vers. 2.0 2019

ID 8459 | | Visite: 503 | Documenti Chemicals ECHAPermalink: https://www.certifico.com/id/8459

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.

_________

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

Collegati:

Pin It


Tags: Chemicals Regolamento CLP Abbonati Chemicals

Articoli correlati

Ultimi archiviati Chemicals

Pridina
Ott 21, 2019 24

Piridina

Piridina Monografie IARC vol 77 (2000) e Vol 119 (2019) E' usata come solvente nella sintesi di prodotti chimici e nell'industria. E anche usata come denaturante in miscele di alcol e antigelo, come solvente per vernice, gomma e resine in policarbonato, come intermedio nella produzione di… Leggi tutto
Rapporti ISTSAN 19 2
Ott 21, 2019 22

Rapporto ISTSAN 19 | 2

Rapporti ISTSAN 19|2: I tatuaggi: sicurezza d’uso e criteri di controllo Negli ultimi decenni è stato osservato un aumento della diffusione della pratica del tatuaggio considerata, allo stato attuale, principalmente come una forma di arte del corpo che coinvolge sia le donne che gli uomini e in… Leggi tutto
Solvents for acetylene filling
Ott 17, 2019 61

Solvents for acetylene filling

Solvents for acetylene filling EIGA, Doc. 225/19 Acetylene is a chemically unstable gas which can decompose violently under pressure. The acetylene gas is dissolved into a liquid solvent within the cylinder to improve the acetylene’s chemical stability. This reduces the hazards involved in filling,… Leggi tutto
DDT
Ott 11, 2019 140

Para-diclorodifeniltricloroetano (DDT): R40 possibilità di effetti cancerogeni

Para-diclorodifeniltricloroetano (DDT): R40 possibilità di effetti cancerogeni ID 9263 | 11.10.2019 Il para-diclorodifeniltricloroetano o DDT è un solido incolore altamente idrofobico, con un leggero odore di composto aromatico clorurato; è quasi insolubile nell'acqua ma ha una buona solubilità… Leggi tutto
Ott 11, 2019 129

Regolamento delegato (UE) 2019/1701

Regolamento delegato (UE) 2019/1701 della Commissione del 23 luglio 2019 recante modifica degli allegati I e V del regolamento (UE) n. 649/2012 del Parlamento europeo e del Consiglio sull’esportazione e importazione di sostanze chimiche pericolose GU L 206/1 dell'11.10.2019 Entrata in vigore:… Leggi tutto
Ott 10, 2019 140

Regolamento (CE) n. 1354/2007

Regolamento (CE) n. 1354/2007 Regolamento (CE) n. 1354/2007 del Consiglio, del 15 novembre 2007 , che adegua il regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consiglio, concernente la registrazione, la valutazione, l’autorizzazione e la restrizione delle sostanze chimiche (REACH), a… Leggi tutto
Regolamento di esecuzione  2019 1692
Ott 10, 2019 143

Regolamento di esecuzione (UE) 2019/1692

Regolamento di esecuzione (UE) 2019/1692 | Regime transitorio per le sostanze soggette a un regime transitorio Regolamento di esecuzione (UE) 2019/1692 della Commissione del 9 ottobre 2019 relativo all’applicazione di talune disposizioni del regolamento (CE) n. 1907/2006 del Parlamento europeo e… Leggi tutto

Più letti Chemicals

Regolamento  CE  852 2004
Mar 06, 2019 20637

Regolamento (CE) N. 852/2004

Regolamento (CE) N. 852/2004 Regolamento (CE) N. 852/2004 del Parlamento europeo e del Consiglio del 29 aprile 2004 sull'igiene dei prodotti alimentari GU L 139/1 del 30.4.2004 Testo consolidato 2009Modificato da: Regolamento (CE) n. 1019/2008 della Commissione del 17 ottobre 2008 (GU L 277 7… Leggi tutto
Mar 02, 2019 20098

Regolamento (CE) n. 2023/2006 (Regolamento GMP)

Regolamento (CE) n. 2023/2006 Regolamento (CE) N. 2023/2006 della Commissione del 22 dicembre 2006 sulle buone pratiche di fabbricazione dei materiali e degli oggetti destinati a venire a contatto con prodotti alimentari (Regolamento GMP - Good Manufacturing Practices) ... Il presente regolamento… Leggi tutto