Slide background
Slide background

Guidance on harmonised information relating to emergency health response

ID 7875 | | Visite: 275 | Documenti Chemicals ECHAPermalink:

ECHA guidance 01 03 2019

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 1, presents the legal background, scope and target of this document in general terms.
- 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 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? General exemption from CLP Regulation and Article 45 Exemptions from the obligation to submit information under Annex VIII Voluntary submission of information
3.4 Use types
3.5 Timelines
3.5.1 Dates of application
3.5.2 Transitional period
4.1 Overview
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 UFI and mixtures in a mixture Us
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 Changes in MiM’s UFI
4.2.8 Display, position and placement of UFI Multi-component products 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
5.1 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
6.1 UFI generator
6.2 XML format
6.3 Tools for preparing IUCLID XML files
6.4 Submission of information
6.5 Fees
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 When declaring concentration ranges 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


Fonte: ECHA



Tags: Chemicals Regolamento CLP Abbonati Chemicals Guida ECHA

Articoli correlati

Ultimi archiviati Chemicals

Decreto 2 aprile 2019 Suppl  9 7
Apr 18, 2019 36

Decreto 2 aprile 2019 | Suppl. 9.7 Farmacopea europea 9ª ed.

Decreto 2 aprile 2019 | Suppl. 9.7 Farmacopea europea 9ª ed. Decreto 2 aprile 2019 Entrata in vigore dei testi, nelle lingue inglese e francese, pubblicati nel Supplemento 9.7 della Farmacopea Europea 9ª edizione e eliminazione delle monografie Clorpropamide, Oxprenololo cloridrato e Acqua… Leggi tutto
D Lgs  22 maggio 1999 n 194
Apr 17, 2019 33

D.Lgs. 22 maggio 1999 n.194

Decreto legislativo 22 maggio 1999 n.194 Attuazione della direttiva 96/74/CE relativa alle denominazioni del settore tessile. GU n. 146 del 24 giugno 1999 Entrata in vigore del decreto: 9-7-1999 .... Testo consolidato con le modifiche/abrogazioni di cui: 31/01/2005 DECRETO 1 dicembre 2004, (in G.U.… Leggi tutto
Legge 26 novembre 1973 n  883
Apr 17, 2019 37

Legge 26 novembre 1973 n. 883

Legge 26 novembre 1973 n. 883 Disciplina delle denominazioni e della etichettatura dei prodotti tessili. GU n. 7 del 8 gennaio 1974 ________ Testo consolidato contenente modifiche/abrogazioni di cui: 31/08/1977 LEGGE 8 agosto 1977, n. 632 (in G.U. 31/08/1977, n.236) 18/10/1986 LEGGE 4 ottobre 1986,… Leggi tutto
Regolamento  UE  n  1007 2011 Tessile
Apr 17, 2019 46

Tessile e abbigliamento: quadro normativo

Tessile e abbigliamento: quadro normativo ID 8196 | 17.04.2019 Il settore del tessile e abbigliamento è disciplinato dal Regolamento UE n.1007/2011 che stabilisce norme su:- le denominazioni delle fibre tessili, le modalità di etichettatura dei prodotti tessili, nonché le menzioni figuranti su… Leggi tutto
Apr 17, 2019 45

Regolamento (UE) n. 1007/2011

Regolamento (UE) n. 1007/2011 Regolamento (UE) n. 1007/2011 del Parlamento europeo e del Consiglio, del 27 settembre 2011 , relativo alle denominazioni delle fibre tessili e all'etichettatura e al contrassegno della composizione fibrosa dei prodotti tessili e che abroga la direttiva 73/44/CEE del… Leggi tutto
Apr 09, 2019 182

Decreto 7 febbraio 2019 n. 30

Decreto 7 febbraio 2019 n. 30 Regolamento recante aggiornamento al decreto del Ministro della sanita' 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire a contatto con le sostanze alimentari o con sostanze d'uso personale (GU n.84 del… Leggi tutto
Apr 08, 2019 59

Regolamento (CE) n. 1334/2008

Regolamento (CE) n. 1334/2008 Regolamento (CE) n. 1334/2008 del Parlamento europeo e del Consiglio, del 16 dicembre 2008 , relativo agli aromi e ad alcuni ingredienti alimentari con proprietà aromatizzanti destinati a essere utilizzati negli e sugli alimenti e che modifica il regolamento (CEE) n.… Leggi tutto
Apr 08, 2019 60

Regolamento (CE) n. 1333/2008

Regolamento (CE) n. 1333/2008 Regolamento (CE) n. 1333/2008 del parlamento europeo e del Consiglio del 16 dicembre 2008 relativo agli additivi alimentariGU L 354/16 del 31.12.2008Testo consolidato con le modifiche apportate dal 2008 al 2018 Leggi tutto
Legge 31 dicembre 1962 n  1860
Apr 04, 2019 124

Legge 31 dicembre 1962 n. 1860

Legge 31 dicembre 1962 n. 1860 Impiego pacifico dell'energia nucleare. (GU n.27 del 30-1-1963) Testo consolidato 2019 con le modifiche di: 09/05/1966DECRETO DEL PRESIDENTE DELLA REPUBBLICA 30 dicembre 1965, n. 1704 (in G.U. 09/05/1966, n.112) 04/12/1974La Corte costituzionale, con sentenza 21… Leggi tutto

Più letti Chemicals

Mar 02, 2019 16646

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