Echa chapter 7a guidance – echa r7a pdf

Guidance on labelling and packaging in accordance with Regulation (EC) 1272/2008 .0 (public) – March 2017 1 2 The objectives of this Guidance are to address the REACH information requirements related .11 of the Guidance on IR&CSA following amendment of Annex XIII to REACH (according to Commission Regulation (EU) No 253/2011 of 15 March 2011, OJ L 69 7 16.0 (Public) – August 2016 3 1 NOTE 2 3 Please note that the present document is a proposed amendment to specific extracts 4 only of the Guidance on IR&CSA, Chapter R. This document was prepared by the ECHA Secretariat for the purpose of this consultation and includes only the parts open for the current consultation, i. ISBN: 978-92-9495-970-6, pages 610, PDF-Datei, DOI: 10.

356 Chapter

0 – Public – February 2016 1 by guidance on the process of judging the available data in terms of . download full PDF document (02/03/2021) .4 Clarification on ‘‘Only Representative’’ added November 2008 Version 1. ase note that the present document is a pro.Version 2 The chapter on RMMs (earlier R.Guidance on information requirements and chemical safety assessment Chapter R. 7 R7-1 to Chapter R.Guidance documents aim at facilitating the implementation of the legislation in ECHA’s remit by describing good practice on how to fulfil the obligations. Endpoint specific guidance 6.Three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R7a, R7b and R7c) have been developed in order to provide advice to . 9 the parts open for the current consultation, i.how to establish the validity of a (Q)SAR model, how to establish the adequacy of a (Q)SAR model result for regulatory purposes, how to document and justify the regulatory use of a .

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1) was shortened, moved to Chapter R.(5) Addition in chapter 1.0) of Chapter R.European Chemicals Agency: Guidance on information requirements and chemical safety assessment.11: PBT/vPvB assessment Version 4. • Update of Figure 7. Practical Guide 2: How to report weight of evidence.7A – ENDPOINT SPECIFIC GUIDANCE 3 PREFACE This document describes the information requirements under REACH with regard to substance .0 (Public) – October 2015 1 • the classification and labelling of the substance for acute toxicity . • Clarification in chapter 7.7a: Endpoint specific guidance Version 2.0–December 2023 • Update of Section R.Guidance on harmonised information relating to emergency health response Version 5.7a: Endpoint specific guidance.0 – December 2023 Preface This document describes the information requirements under the REACH Regulation with .2 on “Assessment of substances containing multiple constituents, impurities and/or

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Main changes in the guidance document included the following: • References to the updated Chapter R.

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15-4 November 2009 Version 2 A new chapter R.This document describes the information requirements under the REACH Regulation with regard to substance properties, exposure, use and risk management .0 – December 2021 1 PREFACE 2 3 4 Three appendices . the parent guidance which is applicable in case of the absence of nanospecific advice in this appendix.• Addition of a new chapter 7.Bundesanstalt für Arbeitsschutz und Arbeitsmedizin – Three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R7a, R7b and R7c) have been developed in order to provide advice to registrants for use when preparing REACH registration dossiers that cover nanoforms.0 – Public – June 2016 NOTE Please note that the present document is a proposed amendment to specific extracts only of the Guidance on IR&CSA, Chapter R.12 on uncertainities. Reference name: Guidance on labelling and packaging Description: This document provides guidance on how to label and package substances and mixtures in accordance with the CLP Regulation. sub-sections R.3 ³Available information onECHA has withdrawn the following practical guides, as their content has been integrated in the Practical guide on how to use alternatives to animal testing to fulfil your information requirements under REACH: Practical Guide 1: How to report in vitro data.7a of IR&CSA Guidance. 8 This document was prepared by the ECHA Secretariat for the purpose of this consultation and includes only.Guidance on information requirements and chemical safety assessment Extracts from: Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a – .15-1 on consumer mixture and article categories that can be assessed with the ECETOC TRA was introduced April 2010 Draft Version 6.“Physicochemical properties” within Chapter R. : 10 – Section 2. Clarification on ‘‘Only Representative’’ added : September 2008 . It implements the EU’s groundbreaking chemicals legislation, benefiting human health, the . November 2009 Version 2 The introduction has been updated November 2009 Version 2 The chapter on RMMs (earlier R. April 2010 Version 2 A new Appendix R.Please note that the present document is a proposed amendment to specific extracts only of the Guidance on IR&CSA, Chapter R.3 with explanatory text on the transitional provisions in Commission Regulation (EU) 2015/830; (7) Deletion of original chapter 2 (and renumbering of chapter 3 and its subchapters) containing out of date information, no

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11 were added and the corresponding text updated;

Guidance for Annex V

This guidance describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of .1 Corrigendum to: – Add reference to the CLP Regulation (Regulation (EC) No 1272/2008 of 16 December 2008) in the title and in the chapters’ titles.13 was deleted.The guidance documents were drafted and discussed within the REACH Implementation Projects (RIPs) led by the European Commission services, involving stakeholders from Member States, industry and non-governmental organisations.This document was prepared by the 5 ECHA Secretariat for the purpose of this consultation and includes only the parts .provisions of 8th ATP (section 6, section 7. The advice provided in this .7a: Endpoint specific guidance Draft Version 6.and does not supersede the applicability of the general principles given in Chapter R.0 November 20120 – December 2023 DOCUMENT HISTORY Version Comment Date Version 1 First edition June 2007 Version 1. They are developed .

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0 – April 2022 GUIDANCE Guidance on harmonised information relating to emergency health response – Annex VIII to CLP Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures Version 5.0 xxxx 2012 3 1 Preface 2 3 This document describes the information requirements under REACH with regard to . Appendix R7-1 for nanomaterials applicable to Chapter R7a Endpoint . In this context, it is not relevant whether yeast has been grown in nature or via a man-made cultivation.

Guidance on Information Requirements and Chemical Safety

3 and section 7.5 : Clarification on information that needs to be submitted for updating dossiers of previously notified substances (NONS) November 2009 : Version .0 – December 2023 • R.6 on the summary of the elements relevant for a standard and refined assessment. Main changes in the guidance document include the following: • Alignment with Commission Regulation (EU) 2017/542, which amends the CLP Regulation by adding an Annex on harmonised information relating to emergency health response;

0 (Public) – June 2016 3 1 NOTE 2 3 Please note that the present document is a proposed amendment to specific extracts 4 only of the Guidance on IR&CSA, Chapter R.The European Chemicals Agency (ECHA) works for the safe use of chemicals.Die ECHA organisiert Konsultationen, um Feedback von allen interessierten Kreisen einzuholen und wissenschaftliche Informationen auf möglichst breiter Ebene für die .11 on species sensitivity distribution and it’s roel in assessment of sedmi ent toxicity; addtioi n of reference to EFSA Opinion 2015.5 on the use of the outcome of the exposure assessment for risk characterisation and link to Part E.7c: Endpoint specific guidance Version 4.

394 Chapter

• New chapter R.7a: “Endpoint specific guidance” addressing structure and content.number’’ chapters amended May 2008 Version 1. The aim of this module is to provide an introduction to the Guidance Document for conducting the chemical safety assessment and preparing the chemical . Please note that this document and .4 on “Conclusions on PBT or vPvB properties”; • Revision of Section R. The Introduction and Section R. Helsinki: European Chemicals Agency (ECHA) 2017. July 2017 Version 4.4 Guidance for identification and naming of substances under REACH and CLP Version 3.7 and information which duplicated that in R.2 ³Information requirements for aquatic bioaccumulation´.• New chapter R.into one chapter R.

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This document was prepared by the 5 ECHA Secretariat for the purpose of this consultation and includes only the parts open • Further development of chapter 7. Any updates of the guidance are drafted by ECHA and are then subject to a consultation procedure, involving stakeholders from Member States, industry and non-governmental organisations.6 and an additional Appendix R.0 – Public – February 2016 NOTE Please note that the present document is a proposed amendment to specific extracts only of the Guidance on IR&CSA, Chapter R. This document was prepared by the ECHA Secretariat for the purpose of this consultation and1 Aim of this module.6 on risk characterisation has been introduced, and all relevant texts from other parts have been moved there.Appendix R7-1 for nanomaterials applicable to Chapter R7a (Endpoint specific guidance) Draft (Public) Version 4. Helsinki: European Chemicals Agency (ECHA) . This document aims to assist users in .acceptance by the Member States competent authorities the guidance documents had been handed over to ECHA for publication and further maintenance.0 Full revision of the guidance.0 – Public – June 2016 NOTE Please note that the present document is a proposed amendment to specific extracts .1 on sample preparation.Yeast is a microorganism and consequently, as a living or dead organism it is not considered a substance, a mixture or an article under the REACH Regulation (see draft guidance on Annex V(7) and Annex V(8).7a: Endpoint specific guidance Draft Version 5.5 %µµµµ 1 0 obj >>> endobj 2 0 obj > endobj 3 0 obj >/ExtGState >/XObject >/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595. • Deletion from Appendix 16- 1 of the tables 16-21 and 16-22 describing the ERCs (reference is provided to the2 of a clarification of the scope of the updated guidance; (6) Addition of a new subchapter 1.0 (public) – May 2016 3 1 NOTE 2 3 Please note that the present document is a proposed amendment to specific extracts 4 only of the Guidance on IR&CSA, Chapter R.1 have been revised by8 -8 by meging boxes when RCR>1.