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Guidance on Labelling and Packaging in Accordance with Regulation (EC) No 1272/2008

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2 1 GUIDANCE Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 Version 4.2 March 2021 Guidance on Labelling and Packaging 2 Version 4.2 – March 2021 Legal Notice This document aims to assist users in complying with their obligations under the CLP Regulation. However, users are reminded that the text of the CLP Regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. Usage of the information remains under the sole responsibility of the user. The European Chemicals Agency does not accept any liability with regard to the use that may be made of the information contained in this document. Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 Reference: ECHA-21-G-02-EN Catalogue Number: ED-03-21-082-EN-N ISBN: 978-92-9481-834-8 DOI: 10.2823/697587 Publication date: March 2021 Language: EN © European Chemicals Agency, 2021 If you have questions or comments in relation to this document please, send them (quote the reference and issue date) using the information request form. The information request form can be accessed via the Contact ECHA page at: https://echa.europa.eu/contact European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Guidance on Labelling and Packaging Version 4.2 – March 2021 3 Document History Version Changes Date Version 1.0 First edition April 2011 (originally unnumbered) Version 2.0 Full revision of the guidance addressing the content and structure. September Main changes in the guidance document include the following: 2016 • Alignment with the 4th Adaptation to Technical Progress (ATP) to the CLP Regulation (Commission Regulation (EU) No 487/2013) bringing the CLP in line with the 4th revised edition of the UN Globally Harmonised System (GHS); • Addressing the provisions of the 5th ATP to the CLP Regulation (Commission Regulation (EU) No 944/2013) amending precautionary statement P210 to fully align it with the changes arising from the 5th Revision of the UN GHS; • Addition of new section 3.5.1 on child-resistant fastening (CRF) and tactile warnings of danger (TWD); • Addition of new section 3.5.2 including information on additional safety measures for liquid laundry detergents in soluble capsules adopted by the Commission through Regulation (EU) No 1297/2014; • Addition of new sections 4.2.1 and 4.2.2 clarifying the provisions of CLP Article 18(3) with regard to product identifiers for substances and mixtures; • Re-organisation of information in section 4.3 by inclusion of new sections 4.3.1, 4.3.2, 4.3.3; • Addition of new section 4.3.4 describing the issue of blank pictograms; • Re-organisation and clarification of information on supplemental labelling in section 4.8 by inclusion of new sections 4.8.1 and 4.8.2; • Inclusion of clarification on the issue of “readability” and “minimum letter size” in section 5.2; • Re-organisation and update of the text in section 5.3 to reflect the provisions of CLP Article 29 and sections 1.5.1 and 1.5.2 of Annex I to CLP; • Inclusion of information on general and specific requirements for fold-out labels in section 5.3.1.1; • Section 6: Update of the labels and the text in examples in line with the provisions of the 4th and 5th ATPs to CLP; • Deletion of Example 6.6 (Single language label of a plant protection product for supply & use in form of a fold-out booklet); • Inclusion of new Example 6 (fold-out label for a mixture supplied to the general public); Guidance on Labelling and Packaging 4 Version 4.2 – March 2021 • Addition of section 6.1 separating the examples of labels on packagings that are small or difficult to label; • Addition of a new section 6.1 describing labelling of two- component products; • Clarification and extension of the text in section 7.2; • Section 7.3: Update of the precautionary statements in selection tables according to the provisions of the 4th and 5th ATPs to CLP; • Section 7.4: Update of the practical examples in line with the provisions of the 4th and 5th ATPs to CLP; • Deletion of the outdated references to past deadlines and to the DSD and DPD provisions thorough the whole document; • Alignment of the document with the latest ECHA corporate image requirements. Version 3.0 Full revision of the guidance. Main changes in the guidance July 2017 document include the following: • Alignment with the 8th Adaptation to Technical Progress (ATP) to the CLP Regulation (Commission Regulation (EU) 2016/918); • Addition of a new section 5.4.2 clarifying the issue of packaging used for consolidation of supply packaging during transport; • Update of the precautionary statements according to the provisions of 8th ATP (section 6, section 7.3 and section 7.4). Version 4.0 Full revision of the guidance. Main changes in the guidance March 2019 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; • Addition of a new section 6.2 describing the labelling of multi-component products with label examples; • Deletion of the outdated paragraph “Limited derogation for re-labelling and re-packaging” in Section 2.4 and deletion of outdated section 3.4 on the “Differences between CLP and DSD/DPD labelling rules”; • Editorial changes and reformatting of the document; • “Preamble” renamed “Preface” and moved before the table of contents; • Update of broken and outdated hyperlinks; • Renumbering of sections, tables and figures. Version 4.1 Update via fast track to implement the amendment of the legal text May 2020 Guidance on Labelling and Packaging Version 4.2 – March 2021 5 due to Commission Delegated Regulation 2020/11 of 29 October 2019. In particular: • Clarification of labelling requirements with regards to the UFI code in standard situations (in section 4.8.1.1); • Clarification of labelling requirements with regards to the UFI code in particular cases of fold-out labels, tie-on tags or outer packaging (section 5.3.1); • Minor changes and clarification in the labelling examples concerning mixtures (section 6). Version 4.2 Update to implement the amendment of the legal text due to March 2021 Commission Delegated Regulation 2020/1677 and Commission Delegated Regulation 2020/1676 of 31 August 2020 (the “workability amendments”) and limited to: • Clarification of exemption from labelling requirements for bespoke paints (new section 5.3.3); • New example of application of the labelling requirements for a bespoke paint (new section 6.3); Minor changes and clarification in the rest of the document. Preface This document describes specific provisions for the labelling and packaging of chemical substances and mixtures under Titles III and IV of the Regulation (EC) No 1272/20081 (the CLP Regulation or “CLP”). The aim of this document is to assist manufacturers, importers, downstream users and distributors of substances and mixtures in the effective application of the CLP Regulation. This guidance includes relevant amendments from the 2nd, 4th, 5th and 8th Adaptations to Technical Progress (ATPs) to the CLP Regulation, as well as the changes brought about by the ATP to the CLP Regulation related to labelling and packaging of liquid laundry detergents in a soluble packaging for single use (Regulation (EU) No 1297/2014). This document also includes relevant changes introduced by Commission Regulation (EU) 2017/542, which amends the CLP Regulation by adding Annex VIII on harmonised information relating to emergency health response. All current ECHA guidance documents are available on the ECHA website at: https://echa.europa.eu/support/guidance. 1 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006; OJ L 353 31.12.2008, p. 1 (http://eur-lex.europa.eu/legal- content/en/TXT/?uri=CELEX%3A02008R1272-20150601) Guidance on Labelling and Packaging 6 Version 4.2 – March 2021 Table of Contents PREFACE ............................................................................................................................ 5 1. INTRODUCTION ....................................................................................................... 10 1.1 Who should read this document?................................................................................ 10 1.2 What is in this document? ............................................................................................. 10 2. GENERAL OVERVIEW ............................................................................................. 11 2.1 Legal background .............................................................................................................. 11 2.2 Scope of labelling and packaging under the CLP Regulation .......................... 12 2.3 Derogations from labelling requirements for special cases ............................. 13 2.4 Timelines for classification, labelling, packaging and updating of CLP hazard labels ............................................................................................................................... 13 3. REQUIREMENTS OF LABELLING AND PACKAGING IN ACCORDANCE WITH THE CLP REGULATION ................................................................................... 14 3.1 General labelling
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