Slide background
Slide background




Guidance on harmonised information relating to emergency health response

ID 7875 | | Visite: 3992 | Documenti Chemicals ECHAPermalink: https://www.certifico.com/id/7875

Guidance on harmonised information 5 0

Guidance on harmonised information relating to emergency health response - Annex VIII to CLP / April 2022

ID 7875 | Update 17.05.2022 | Version 5.0 Aprile 2022

This document provides guidance on the provisions of Article 45 and Annex VIII to CLP. These concern the obligation to submit certain information on hazardous mixtures placed on the market, for emergency response reasons.

Document History
______

Version 5.0 April 2022

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.

Version 4.0 March 2021

Update to implement the amendment of the legal text due to Commission Delegated Regulation 2020/1677 and Commission Delegated Regulation 2020/1676 of 31 August 2020 (the “workability amendments”). In particular:
- Added in section 3.1.1.4 reference to articles with integral substance or mixture intended to be released.
- Added in section 3.3 clarification about the borderline between mixture and substance.
- Added new section 3.3.1.3.1 to address the exemption for bespoke paints.
- Added in section 3.4 a clarification about mixture with end use not subject to notification requirements.
- Added in section 4.1 an introduction on the new workability solutions.
- Added in section 4.2.1 a clarification of the UFI concept applied to Interchangeable Component Groups, Standard Formulas and Fuels.
- Added in section 4.2.7 clarification about the need to update the UFI in case of notifications concerning Standard Formulas, fuels or containing Interchangeable Component Groups.
______

Version 3.0 May 2020

Update to implement the amendment of the legal text due to Commission Delegated Regulation 2020/11 of 29 October 2019.
In particular:
- Removed reference to Generic Product Identifier “Fragrances” throughout the document.
- Added in section 3.1.1 new subsection on import/manufacturing of combination of mixture and article.
- Added example 11 in section 4.2.3. In addition, clarified labelling and SDS requirements in case of multiple UFIs in the notes to the examples.
- Amended section 4.2.8 on labelling requirements and UFI placement and aligned with Guidance on Labelling and Packaging.
- Clarified in section 4.2.8.2 that exemption to labelling requirements applies to mixture used at industrial site.
- Added contact point in section 5.1.2, in addition to submitter details.
- Clarified and further developed pH requirements in section 5.2.3.
- Amended section 5.3.3 with regards to requirements for identification of MiMs when composition is not fully known. Clarified that for MiM not requiring an SDS, the compositional information is not mandatory.
______

Version 3.0 December 2019 Draft

This document provides guidance on the provisions of Article 45 and Annex VIII to CLP. These concern the obligation to submit certain information on hazardous mixtures placed on the market, for emergency response reasons.
______

Version 2.0 July 2019

This document provides guidance on the provisions of Article 45 and Annex VIII to CLP. These concern the obligation to submit certain information on hazardous mixtures placed on the market, for emergency response reasons.

Document History

- Restructured sections 3.1.1 and 3.1.2 to present separately activities leading to obligations under Art.45 and Art.4(10).
- Moved example 6 to section 3.1.2 and new figure added.
- Updated table 1 to include obligations for distributors. Removed column on “Obligations along the supply chain”.
In addition:
- Revised section 6.3 to reflect the updated terminology referring to the submission tool provided by ECHA.
- Revised section 6.4 to reflect the updated list of features provided by the ECHA submission tool.
Comment Date
- Replacement of “deadline” by “date of applicability” with reference to the timeline to meet the obligations.
- Updated the additional support section.
- Editorial changes and typos corrected
______

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
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 the obligation to submit information according to Annex VIII
3.1.1.1 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?
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 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
4.2.3.1 UFI and mixtures in a mixture
4.2.3.2 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
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

Revision

Rev. Date Object Author
5.0 April 2022 Update ECHA
4.0 March 2021 Update ECHA
3.0 May 2020 Update ECHA
2.0 July 2019 Update ECHA
1.0 February 2019 Update ECHA

______

Collegati:

Tags: Chemicals Regolamento CLP Abbonati Chemicals Guida ECHA

Articoli correlati

Ultimi archiviati Chemicals

Parametri microbiologici acque   Escherichia coli
Gen 26, 2023 59

Parametri microbiologici acque - Escherichia coli

Parametri microbiologici acque - Escherichia coli ID 18842 | 26.01.2023 / In allegato I batteri coliformi totali che sono capaci di fermentare il lattosio a 44-45°C sono conosciuti come coliformi fecali o termotolleranti, il genere è Escherichia, ma alcuni tipi di Citrobacter, Klebsiella ed… Leggi tutto
Parametri microbiologici acque   Enterococchi
Gen 26, 2023 72

Parametri microbiologici acque - Enterococchi

Parametri microbiologici acque - Enterococchi ID 18841 | 26.01.2023 / In allegato Gli Enterococchi intestinali sono un sottogruppo di un più ampio gruppo di organismi definiti come Streptococchi fecali, che comprendono specie del genere Streptococcus. Sono batteri Gram-positivi, anaerobi… Leggi tutto
Valutazione del rischio e valore guida acque   Tallio
Gen 26, 2023 49

Valutazione del rischio e valore guida acque - Tallio

Valutazione del rischio e valore guida acque - Tallio ID 18840 | 26.01.2023 / In allegato Assorbimento e distribuzione Il tallio è rapidamente assorbito e si distribuisce rapidamente (circa 1 ora dopo l’esposizione) in tutto il corpo sia negli animali da laboratorio che negli uomini,… Leggi tutto
Valutazione del rischio e valore guida acque   Nichel
Gen 26, 2023 41

Valutazione del rischio e valore guida acque - Nichel

Valutazione del rischio e valore guida acque - Nichel ID 18839 | 26.01.2023 / In allegato Assorbimento e distribuzione In seguito ad esposizione per via orale la biodisponibilità del nichel può variare dall’1% al 40%. I fattori che ne determinano la biodisponibilità sono la solubilità del composto… Leggi tutto
Valutazione del rischio e valore guida acque   Fluoro
Gen 26, 2023 49

Valutazione del rischio e valore guida acque - Fluoro

Valutazione del rischio e valore guida acque - Fluoro ID 18838 | 26.01.2023 / In allegato Assorbimento e distribuzione Dopo l’assunzione per via orale, i composti del fluoro solubili in acqua sono rapidamente e quasi completamente assorbiti nel tratto gastro intestinale. Anche il fluoro presente… Leggi tutto
Valutazione del rischio e valore guida acque   Cromo
Gen 26, 2023 46

Valutazione del rischio e valore guida acque - Cromo

Valutazione del rischio e valore guida acque - Cromo ID 18837 | 26.01.2023 / In allegato Assorbimento e distribuzione I composti del cromo trivalente, Cr(III), presentano in generale un basso assorbimento per via orale. Nell’uomo l’assorbimento orale stimato è dello 0.4 %. L’assorbimento e la… Leggi tutto
Valutazione del rischio e valore guida acque   Boro
Gen 26, 2023 48

Valutazione del rischio e valore guida acque - Boro

Valutazione del rischio e valore guida acque - Boro ID 18836 | 26.01.2023 / In allegato Assorbimento e distribuzione I composti del boro sono rapidamente assorbiti nel tratto gastro-intestinale e distribuiti nell’organismo, come dimostrano gli aumentati livelli di boro nei tessuti e nei fluidi… Leggi tutto
Valutazione del rischio e valore guida acque   Arsenico
Gen 26, 2023 48

Valutazione del rischio e valore guida acque - Arsenico

Valutazione del rischio e valore guida acque - Arsenico ID 18835 | 26.01.2023 / In allegato L'arsenico ha uno spiccato effetto neurotossico, letale ad alte dosi. A dosi più basse, l’esposizione prolungata ad arsenico determina a sua volta una varietà di effetti avversi a carico di vari apparati,… Leggi tutto
Valutazione del rischio e valore guida acque   Amianto
Gen 26, 2023 37

Valutazione del rischio e valore guida acque - Amianto

Valutazione del rischio e valore guida acque - Amianto ID 18833 | 26.01.2023 / In allegato Con il termine di amianto o asbesto1 , si indicano una serie di minerali naturali a morfologia fibrosa appartenenti alla classe mineralogica dei silicati. Nella composizione chimica dei silicati entra… Leggi tutto
Scheda informativa dei parametri emergenti   Tallio
Gen 26, 2023 41

Scheda informativa dei parametri emergenti - Tallio

Scheda informativa dei parametri emergenti - Tallio ID 18832 | 26.01.2023 / In allegato Il tallio (simbolo Tl) è un elemento chimico appartenente al III gruppo del sistema periodico degli elementi, con numero atomico 81 e peso atomico 204.383. Il tallio è un metallo tenero e malleabile; esposto… Leggi tutto

Più letti Chemicals

Regolamento  CE  n  178 2002
Ott 24, 2022 74461

Regolamento (CE) N. 178/2002

Regolamento (CE) n. 178/2002 Regolamento (CE) n. 178/2002 del Parlamento europeo e del Consiglio del 28 gennaio 2002 che stabilisce i principi e i requisiti generali della legislazione alimentare, istituisce l'Autorità europea per la sicurezza alimentare e fissa procedure nel campo della sicurezza… Leggi tutto