1. WWW.THEREACHCENTRE.COM WWW.PTKLTD.COM WWW.THEREACHCENTRE.COM INTRODUCTION TO CLP: CLASSIFICATION, LABELLING AND PACKAGING REGULATION (1272/2008)

2. WWW.THEREACHCENTRE.COM CLP Regulation 1272/2008 Came into force in January 2009 Will ultimately replace the current classification and labelling requirements of the Dangerous Substances Directive (67/548/EC) and Dangerous Preparations Directive (1999/45/EC) Progressive transition until June 2015 Has implications for REACH and 20 pieces of downstream legislation (e.g. worker safety, consumer products, Sevesco II)

3. WWW.THEREACHCENTRE.COM Current/old system The current EU system on classification, packaging and labelling of chemicals has been developed over the last 40 years and is set out in three key instruments the Dangerous Substances Directive (67/548/EEC) the Dangerous Preparations Directive (1999/45/EC) REACH Annex II ((EC) 1907/2006); originally the Safety Data Sheet Directive (91/155/EEC) Dangerous/non-dangerous, R-phrases, S-phrases Well understood, effective

4. WWW.THEREACHCENTRE.COM Why do we need CLP? EU together with ~ 150 other counties have agreed to implement GHS by end of 2008 CLP is the EU implementation of GHS (global harmonised system of classification & labelling)

5. WWW.THEREACHCENTRE.COM Why do we need GHS? GHS was an outcome of the 1992 Rio world summit and was developed by IOMC by 2001 Classification of the hazards of chemicals is the cornerstone of chemical risk management Many different systems have been developed over time (e.g. EU, Japan, USA, Canada) Increased globalisation of markets made these differences increasing impractical and differences not only in systems but in actual classification undermine the integrity of all systems

6. WWW.THEREACHCENTRE.COM Why is the GHS Important? GHS/CLPDanger (Skull & Crossbones) TransportLiquid: slightly toxic; solid: not classified EUHarmful (St Andrew’s Cross) USToxic CANToxic AustraliaHarmful IndiaNon-toxic JapanToxic MalaysiaHarmful ThailandHarmful New ZealandHazardous ChinaNot Dangerous KoreaToxic Substance - oral toxicity LD 50 = 257 mg/kg

7. WWW.THEREACHCENTRE.COM Why is the GHS Important?

8. WWW.THEREACHCENTRE.COM What is GHS? The Globally Harmonized System of Classification and Labelling of Chemicals Aims to create a common and coherent approach to: defining and classifying chemical hazards communicating information on labels and safety data sheets. Provides the underlying infrastructure for comprehensive national chemical safety programs.

9. WWW.THEREACHCENTRE.COM GHS – STATUS WORLDWIDE EARLY 2010 ACTIVITIES PREPARATION IMPLEMENTATION

10. WWW.THEREACHCENTRE.COM What is CLP? New EU Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP) Implements GHS in the EU Entry into force 20 January 2009

11. WWW.THEREACHCENTRE.COM What is CLP? Scope: –substances and mixtures including C&L of Plant Protection Products and Biocides –certain specific articles (explosive articles) Although it is the EU implementation of GHS it is not exactly the same of GHS It scope is broader than GHS e.g. –Rules for packaging (child resistant fastenings) –Classification and labelling inventory –EU specific hazard statements (e.g ozone depletor) –Translation tables (Annex VII) –Harmonised classifications (Annex VI) –Amends REACH

12. WWW.THEREACHCENTRE.COM What is CLP? It takes up all GHS Hazard classes but not all GHS hazard categories (that are not part of the current EU system) for example: –Flammable category 4 –Acute toxicity category 5 –Acute aquatic toxicity categories 2 or 3 –Skin corrosion/irritation category 3 –Aspiration hazard category 2

13. WWW.THEREACHCENTRE.COM Health Hazards: e.g. acute oral toxicity (mg / kg) Example - Acute toxicity GHS 12 300505 345 No Symbol 2.000 5.000 EU T+TXn 252002.000 Not contained in CLP

14. WWW.THEREACHCENTRE.COM CLP is similar to the current EU system: It provides one single system for hazard classification and labelling It covers approximately the same hazards It often uses similar or equal classification criteria It sets up an equivalent system of hazard communication CLP is different to the current EU system: It sets criteria for both transport and supply, and use It defines different hazard classes and categories It uses partly other criteria and other cut- offs It uses a different approach for mixtures It changes some labelling elements CLP scope

15. WWW.THEREACHCENTRE.COM Language differences between CLP and DSD/DPD Replaces the term “dangerous” by the term “hazardous” Warnings (irritant, corrosive etc) replaced by signal words (warning or danger) R-factors replaced by hazard codes and statements S-factors replaced by precautionary statements Symbols replaced by pictograms

16. WWW.THEREACHCENTRE.COM New Terminology Classes Categories/Divisions/Groups Pictograms Mixtures Hazard statements Precautionary statements

17. WWW.THEREACHCENTRE.COM Indication of danger (= Signal word) EU - IRRITANT CLP – WARNING Risk Phrase (= Hazard statement) EU - Irritating to eyes CLP - Causes severe eye irritation Safety phrase (= Precautionary statement) Keep out of reach of children Do not breath dust In case of contact with eyes, rinse immediately with water and seek medical advice Changes

18. WWW.THEREACHCENTRE.COM Pictograms Symbols DSD and DPD CLP / GHS

19. WWW.THEREACHCENTRE.COM Source: Introductory Guidance on the CLP Regulation, ECHA, 2009 Risk Phrase Hazard statement Safety phrase Precautionary statement

20. WWW.THEREACHCENTRE.COM ‘Old’ C&LGHS/CLP Symbol Indication of danger Explosive Extremely/very flammable Oxidising Very toxic/toxic Corrosive Harmful/irritating Dangerous for the environment Risk phraseR## Safety phraseS## Pictogram Signal wordDanger Warning Hazard statement H### EUH### Precautionary statement P###

21. WWW.THEREACHCENTRE.COM CLP Hazard Classes and categories Physical hazards –Explosives (unstable explosives, Divisions 1.1, 1.2, 1.3, 1.4, 1.5, 1.6) –Flammable gases (Categories 1 and 2) –Flammable aerosols (Categories 1 and 2) –Oxidising gases (Category 1) –Gases under pressure –Flammable liquids (Category 1, 2, 3) –Flammable solids (Category 1, 2) –Self-reactive substances and mixtures (Type A, B, C, D, E, F, G –Pyrophoric liquids (Category 1) –Pyrophoric solids (Category 1) –Self-heating substances and mixtures (Category ! And 2) –Substances and mixtures which in contact with water emit flammable gases (Category 1, 2 and 3) –Oxidising liquids (Category 1, 2, 3) –Oxidising solids (Category 1, 2, 3) –Organic peroxides (Type A-G) –Corrosive to metal (category 1) Health Hazards –Acute toxicity (Category 1, 2, 3, 4) –Skin Corrosion/irritation (Category 1A, 1B, 1C, and 2) –Serious eye damage/eye irritation (Cat 1&2) –Respiratory or skin sensitisation (Category 1) –Germ cell mutagenicity (Category 1A, 1B, 2) –Carcinogenicity (Category 1A, 1B and 2) –Reproductive toxicity (Category 1A,1B&2) plus addition category for effects by lactation –Specific target organ toxicity (STOT)- repeated exposure (Category 1&2) –Specific target organ toxicity (STOT)- single exposure (Cat 1&2) and Cat 3 for narcotic effects and respiratory tract irritation only –Aspiration Hazard (Category 1) Environmental Hazards –Hazardous to the aquatic environment (Acute Cat 1, Chronic Cat 1,2 3&4) –Hazardous to the ozone layer

22. WWW.THEREACHCENTRE.COM Structure of the CLP Regulation Legal text containing principles and general rules 79 Recitals: principles and reasoning TITLE I - General Issues TITLE II – Hazard Classification –Chapter 1 Identification and Examination of Information –Chapter 2 Evaluation of Hazard Information and Decision on Classification TITLE III – Hazard Communication in Form of Labelling –Chapter 1 Content of the Label –Chapter 2 Application of Labels TITLE IV - Packaging TITLE V – Harmonisation of C&L of Substances and the C&L Inventory –Chapter 1 Establishing Harmonised Classification and Labelling of Substances –Chapter 2 Classification and Labelling Inventory TITLE VI – Competent Authorities and Enforcement TITLE VII – Common and Final Provisions

23. WWW.THEREACHCENTRE.COM Structure of CLP -Annexes Annex I: Classification and labelling for substances and mixtures Annex II: Special labelling rules (EU phrases) Annex III: Hazard (H) statements (23 languages) Annex IV: Precautionary (P) statements –general; prevention; response; storage; disposal Annex V: Hazard pictograms Annex VI: Harmonised classifications –3.1 CLP; 3.2 ‘old’ Annex I of 67/548/EEC Annex VII: Translation table (DSD/DPD => CLP)

24. WWW.THEREACHCENTRE.COM Roles and obligations Manufacturers and importers: –Classify, label and package substances and mixtures according to CLP before placing on the market –Classify substances not placed on market but which are subject to registration or notification under REACH –Notify the classification and labelling elements to the classification and labelling inventory established by ECHA –Take all reasonable steps to make yourself aware of new technical/scientific information that may effect the classification of substances and mixtures you place on the market and in the event that such information becomes available review your classification –Update the label following any change to the classification and labelling –If you have information that may effect the harmonised classification you should submit proposal to the MS where the substance is placed on the market –Retain information relative to the classification and labelling under CLP for a period of 10 years after ceasing supply

25. WWW.THEREACHCENTRE.COM Roles and obligations Downstream users: –Classify, label and package substances and mixtures placed on the market according to CLP – however you may adopt the classification for a mixture derived in accordance with CLP by an actor up the supply chain provided you do not change the composition of the substance or mixture –Take all reasonable steps to make yourself aware of new technical/scientific information that may effect the classification of substances and mixtures you place on the market and in the event that such information becomes available review your classification –Update the label following any change to the classification and labelling –If you have information that may effect the harmonised classification you should submit proposal to the MS where the substance is placed on the market –Retain information relative to the classification and labelling under CLP for a period of 10 years after ceasing supply

26. WWW.THEREACHCENTRE.COM Roles and obligations Distributors (including retailers) –Label and package substances you place on the market –May adopt the classification of a substance or mixture carried out in accordance with CLP by an actor up the supply chain –Retain information relative to the classification and labelling under CLP for a period of 10 years after ceasing supply Producers of certain specific articles: –If you produce/import and place on the market an explosive article (sec 2.1 of annex1) you must classify, label and package according to CLP –Producers/importers of articles not placed on the market but which require registration or notification under REACH should classify in accordance with CLP

27. WWW.THEREACHCENTRE.COM Key deadlines 1 December 2010 - deadline for the (re)classification of substances to CLP 3 January 2011 (in practice 24 December 2010?) first deadline for the notification to the classification and labelling inventory of substances placed on the market on 1 December 2010 (notifications are due 30 days after placing on the market starting from 1 December 2010) 1 June 2015 for the (re)classification of mixtures to CLP

28. WWW.THEREACHCENTRE.COM Transitional arrangements Transitional arrangements: –CLP classifications will have to be applied to all classification of substances from 1 st December 2010 –Prior to 1 st December 2010 existing DSD classification applies but new CLP classification is optional (where CLP is used then labelling and packaging must follow CLP rules not DSD and it must be included on safety data sheet) –Upto 1 st June 2015 DSD classification must be included on safety data sheets –For preparations (mixtures) classification using DPD must be applied until 1 st June 2015 but classification under CLP is optional (where CLP is used it must be included in any safety data sheet and CLP labelling and packaging will apply)

29. WWW.THEREACHCENTRE.COM Timelines for CLP and REACH 20 Jan 2009 CLP entry into force; repeal of Annex I to DSD 1 Dec 2010* Obligation to apply CLP to substances 1 June 2015* Obligation to apply CLP to mixtures *derogation for already placed on the market: - substances until 1.12.2012 - mixtures until 1.6.2017 1 Jun 2007 REACH entry into force 1 Jun – 1 Dec 2008 Pre-registration period 1 Dec 2010 1 st Phase registration deadline 1 Jun 2013 2 nd Phase registration deadline 1 Jun 2018 3 rd Phase registration deadline

30. WWW.THEREACHCENTRE.COM C&L notification The following substances will have to be notified to the C&L Inventory: Substances subject to REACH registration (≥ 1 t/y) and placed on the market. Notification is not necessary where a manufacturer, importer or OR has already registered the substance; Substances classified as hazardous under CLP and placed on the market irrespective of the tonnage. This includes substances which are classified as hazardous under CLP, but which are exempted from registration, e.g. polymers referred to in REACH Article 6(3); Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I of CLP or as specified in Directive 1999/45/EC, which results in the classification of the mixture as hazardous, and where the mixture is placed on the market irrespective of the tonnage.

31. WWW.THEREACHCENTRE.COM Information provided Identity of notifier Other M/I covered by the notification Substance identity (as in REACH) e.g. –Identifier codes –Structure –Composition –Purity –Impurities Classification (CLP), positive or negative; and whether based on data or absence of data Specific concentration limits + M-factors Label elements Volume information is voluntary and not for publication

32. WWW.THEREACHCENTRE.COM Methods to notify 1.Using IUCLID5 2.On-line submission tool Reduced number of fields Use of defaults Link to the C&L Inventory 3.Bulk submission using XML files. Some limitations: Must have a CAS or EC # Single composition No ‘M’ factors or specific concentration limits possible

33. WWW.THEREACHCENTRE.COM C&L Inventory All C&L notifiers would receive a submission report which can be copied to group members to show compliance C&L Inventory to be publicly available on ECHA website Each notification will require up to 200 data fields to be completed so cooperation (group submissions) highly recommended Nothing in CLP asks for mixture information What was not dangerous before REACH and CLP may be hazardous now

34. WWW.THEREACHCENTRE.COM Process of classification for substances Options –Harmonised classification –Self classification Start form scratch Use translation tables

35. WWW.THEREACHCENTRE.COM Harmonised classification Substances with a harmonised classification under DSD Annex 1 have been transferred to Annex VI of CLP Annex VI includes both DSD classification (table 3.2) and translated CLP classification (table 3.1) CLP allows the Commission, member States and Manufacturers/importers to propose new entries to the Annex VI Where a substance has a harmonised classification this must be used for classification purposes Under certain circumstances M/I may apply a more severe category than this minimum classification. These circumstances are set out in section 1.2.1 of Annex VI

36. WWW.THEREACHCENTRE.COM Harmonised classification Annex VI Index NoInternational Chemical Identification EC NoCAS NoClassificationSuppl. hazard inform. Code(s) Lab ellin g Cod es Specific Conc. Limits, M- factors Classificatio n Annex I Dir 67/548/EEC Hazard Class Code(s) Hazard statement Code(s) 001-001- 00-9 hydrogen215- 605-7 1333-74- 0 Flam. Gas 1H220 F+; R12 003-001- 00-4 lithium231- 102-5 7439-93- 2 Water-react. 1 Skin Corr. 1B H260 H314 EUH014 F; R14/15 C; R34 003-002- 00-X n-hexyllithium404- 950-0 21369- 64-2 Water-react. 1 Pyr. Sol. 1 Skin Corr. 1A H260 H250 H314 EUH014 F; R14/15- 17 C; R35 004-002- 00-2 beryllium compounds with the exception of aluminium beryllium silicates, and with those specified elsewhere in this Annex --Carc. 1B Acute Tox. 2 * Acute Tox. 3 * STOT Rep. 1 Eye Irrit. 2 STOT Single 3 Skin Irrit. 2 Skin Sens. 1 Aquatic. Chronic 2 H350i H330 H301 H372 ** H319 H335 H315 H317 H411 ACarc. Cat. 2; R49 T+; R26 T; R25- 48/23 Xi; R36/37/38 R43 N; R51-53 006-003- 00-3 carbon disulphide 200- 843-6 75-15-0Flam. Liq. 2 Repr. 2 STOT Rep. 1 Eye Irrit. 2 Skin Irrit. 2 H225 H361fd H372 ** H319 H315 F; R11 Repr. Cat. 3; R62-63 T; R48/23 Xi; R36/38

37. WWW.THEREACHCENTRE.COM Self classification – Translation tables The translation tables are given in Annex VII M/I/DU may use the translation tables where the substance mixture has been classified in accordance with DSD and no other information relative to classification is available to you The translation tables covers only these hazards where there is a reasonable correlation between the two systems. Where no translation is available it will be necessary to self classify as per Annex 1 –E.g. flammable solids –Acute toxicity the classification bands overlap

38. WWW.THEREACHCENTRE.COM Annex VII – transitional tables Classification under Directive 67/548/EECPhysical state of the substance when relevant Classification and hazard statements assigned under this Regulation ClassificationHazard statement E; R2No translation possible. O; R8gasOxid. Gas 1H270 O; R8Liquid, solid No translation possible. Xn; R20VapoursAcute Tox. 4H332 T+; R27Acute Tox. 1H310 C; R34Skin Corr. 1BH314 C; R35Skin Corr. 1AH314 T+; R39/27STOT Single 1H370 R43Skin Sens. 1H317 Xn; R48/20STOT Rep. 2H373 Xn; R65Asp. Tox. 1H304 R67STOT Single 3H336 Xn; R68/20STOT Single 2H371 Carc. Cat. 1; R45Carc. 1AH350 Repr. Cat. 2; R61 Repr. Cat. 3; R62Repr. 1BH360Df N; R50Aquatic. AcuteH400 N; R50-53Aquatic. Acute Aquatic. Chronic H400 H410 N; R51-53Aquatic ChronicH411 N; R59Additional EU classificationEUH059

39. WWW.THEREACHCENTRE.COM Self classification using Annex 1 Four basic steps: –Gather available information In house information from DSD classification Information does not have to be purchased Information potentially available from SIEFs Information from ECHA website Published data can be used regardless of ownership Carry out new tests –Examine information and ensure it is adequate and reliable May require expert judgement –Evaluate available information against classification criteria specified in Annex 1 May require expert judgement Weight of evidence may be used New test may need to be commissioned –Decide on appropriate classification Special concentration limits (SCL) and M-factors may need to beset

40. WWW.THEREACHCENTRE.COM Classification of MIXTURES: Tiered approach to classification Generally use test data for the mixture, when available  Use bridging principles, if applicable  For health and environmental hazards, estimate hazards based on the known ingredient information Sometimes an additivity approach will apply in others not (sometimes even a variation within the same end-point)

41. WWW.THEREACHCENTRE.COM Classification of mixtures Bridging Principles If test data are not available for a mixture but there are available test data for a similar mixture, it is possible to classify the untested mixture using bridging principles. There are different types of bridging principles: 1.Dilution 2.Batching 3.Concentration of highly toxic mixtures 4.Interpolation within one toxicity category 5.Substantially similar mixtures

42. WWW.THEREACHCENTRE.COM Hazard Communication LabelsCLP Safety Data Sheets REACH (SDS/ MSDS)

43. WWW.THEREACHCENTRE.COM Labelling A substance or mixture contained in a package should be labelled in accordance with CLP rules if: –The substance or mixture is classified as hazardous –If in the case of a mixture it contains one or more substances classified as hazardous above concentrations referred to in part 2 of Annex II –It is an explosive article as specified in part2 of Annex 1 The size of the label is specified (Sec 1.2.1 of Annex 1) Label should be in the language of the of the member state where the substance or mixture is placed on the market (unless MS provides otherwise)

44. WWW.THEREACHCENTRE.COM CLP Label

45. WWW.THEREACHCENTRE.COM Main role for ECHA Provide industry with technical and scientific guidance and tools on how to comply with the obligations of CLP (Article 50); Provide Member State CAs with technical and scientific guidance on the operation of CLP (Article 50); Provide support to the national CLP helpdesks (Article 44); Establish and maintain the classification and labelling inventory (database) and to receive notifications to the inventory (Article 42); Receive proposals for harmonised classification of a substance from Member State CA and suppliers, and to submit an opinion on such proposals to the Commission (Article 37);

46. WWW.THEREACHCENTRE.COM Guidance documents for CLP Guidance on application of CLP developed under RIP 3.6 –Module 1 General guidance (for managers) Basics of C&L under CLP Basics of hazard assessment Links with REACH and other legislation Consequences on downstream legislation Differences between current and CLP classification systems General explanation of new items such as ATE value, bridging principles etc. The C&L inventory –Module 2 – detailed, technical guidance (for experts) Guidance published on ECHA homepage http://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm http://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm