1. General principles for classifying substances and mixtures Workshop on GPA Risk Assessment and REACH/GHS Implementation in practice Kiev 30-31 May 2011 Eva Sandberg ECHA - International Relations

2. Content GHS and Basis facts about CLP Harmonisation of Classification and Labelling (CLH) C&L notifications Guidance and Support by ECHA http://echa.europa.eu

3. GHS - Global Context Rio, 1992 Chapter 19 of UNCED Agenda 21 Development by IOMC up to 2001 UN ECOSOC adopted July 2003, rev 3 2009 WSSD, Johannesburg 2002 – operational by 2008 A Global Initiative

4. GHS - Context GHS is not legally binding but agreed to implement at WSSD (World Summit on Sustainable Development) GHS provides common basis for classification and hazard communication for transport and supply and use GHS includes a “building block” approach to facilitate implementation => freedom to take up hazard classes and/or categories GHS will not be completely “harmonised” at first Increased harmonisation and improvement over time Living document, updates every 2 years

5. Why do we need GHS? GHSDanger (Skull & Cross Bones) 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

6. European Union Objective of EU Chemicals Legislation (REACH and CLP) High level of protection to health and environment Prevention of barriers to single European market 27 Member States 4 Candidate countries 23 languages

7. CLP Regulation Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging Entry into force on 20 January 2009 –Transitional period 2010 – 2015; both classification systems to be used –Substances 1 Dec 2010 –Mixtures 1 June 2015 Replaces –Directive 67/548/EEC (Dangerous Substances Dir., DSD) –Directive 1999/45/EC (Dangerous Preparations Dir., DPD) both by 1 June 2015 –REACH, Title XI (Classification & Labelling)

8. CLP Regulation: Scope and main features Regulation on classification, labelling and packaging of substances and mixtures (CLP) Scope Substances and mixtures including plant protection products and biocides (no tonnage thresholds ) Main features Self-classification based on available information Common rules within the EU on classification & labelling Harmonised classification for some properties (CMR, resp. sensitizers) Classification and labelling Inventory

9. Regulation- Principles Applies the general principles of the GHS Introduces the GHS criteria for data interpretation, classification and labelling Uses the GHS Building Block Approach and a few other options to adapt the system to EU needs Ensures consistency with transport rules Keeps the scope as close as possible to the previous EU system

10. Different classification criteria and concentration limits Explosives (criteria) Acute toxicity (criteria: new cut-off limits) Reproductive toxicity (concentration limits for mixtures) Skin corrosion/irritation (criteria for irritation) Serious eye damage/eye irritation (criteria for eye irritation) New classification criteria

11. New hazard pictograms Physical hazards Health hazards Environmental hazards ExplosiveOxidisingFlammable Gases under pressure Acute Toxicity Category 1-3 Serious Health hazard Corrosive Hazardous to the environment

12. http://echa.europa.eu

13. New classification criteria Example: Acute toxicity ! No Pictogram Very toxic < 25 Toxic > 25 - 200 Harmful > 200 - 2000 EU GHS Category 1 < 5 Category 2 > 5 - < 50 Category 3 > 50 - < 300 Category 4 > 300 - < 2,000 Category 5 - option > 2,000 - < 5,000 2000 - 5000200 - 300

14. ECHA’s role under CLP Manage proposals for harmonised C&L (CLH) Develop and manage the C&L inventory Handle requests for use of alternative names ECHA Forum co-ordinates enforcement activities Receive MS reports on control & enforcement Provide guidance and support C&L awareness Carry out a study on communication of safe use

15. Main roles and obligations of suppliers Classify: –before placing on the market –if REACH requires classification; e.g. on-site isolated intermediate Ensure appropriate labelling and packaging before placing on the market –Downstream users may use classification from supplier, provided no change of composition –Distributors: no obligation to classify; may use classification from supplier Cooperate with others in the supply chain for meeting requirements

16. Main Industry Responsibilities under CLP If a harmonised classification is available, this shall be used Suppliers placing a substance or a mixture on the market, shall label and package them in accordance with the classification (Group of) manufacturers or importers placing a substance on the market shall notify the Agency

17. Hazard communication: Labelling Content of the label –Labelling elements –Product ID, hazard pictograms, signal words, hazard and precautionary statements, supplemental info, (supplier ID, quantity) –Use of languages –Derogations; use of alternative name for substances in mixtures –Updating information on labels

18. What are the time lines? NEW! 3 2 1 1) CLP entered into force 20 Jan. 2009. 2) Substances have to be classified & labelled according CLP from 1 Dec. 2010 + Notification to C&L inventory 1 month after placing a substance on the market. 3) Mixtures to be classified & labelled according CLP criteria by 1 June 2015 2009 2015

19. Transitional provisions: Substances * Applied in practice in the Safety Data Sheet (SDS ) CLP = Regulation (EC) No 1272/2008 DSD = Directive 67/548/EEC

20. Transitional provisions: Mixtures * Applied in practice in the Safety Data Sheet (SDS) CLP = Regulation (EC) No 1272/2008 DPD = Directive 1999/45/EC

21. Harmonisation of Classification

22. C&L Harmonisation (CLH) Agreement at EU level on classification List of harmonised C&L (Annex VI, C&L Inventory) Suppliers obliged to classify & label accordingly

23. C&L Harmonisation - Scope Which types of substances? –Carcinogenic, Mutagenic, Toxic to Reproduction, Respiratory Sensitizers (CMRs) –Other hazard classes on case-by-case basis –Pesticidal & biocidal active substances (all properties) How many? –Estimated 100 proposals per year

24. Harmonisation of classification & labelling Harmonised classification and labelling of substances For specific hazard classes or categories –CMRs, respiratory sensitizers, others case-by-case if justified; specific active substances Procedure to include a substance into Annex VI – started by public authorities or industry actor, decision by European Commission

25. C&L Harmonisation – procedure Right of initiative –Member State Competent Authorities –Industry (Manufacturers, Importers, Downstream Users)  ECHA: Scientific opinion by Risk Assessment Committee (RAC)  European Commission decision via Comitology

26. CLH: Notification of intention MSCAs & industry are requested to notify intentions to propose harmonised C&L –Web-form available ECHA checks substance ID ECHA consults MSCAs ECHA publishes Register of Intentions –Allows parties concerned to provide information to dossier submitter –Allows parties concerned to prepare for commenting http://echa.europa.eu/chem_data/reg_int_tables/reg_int_curr_int_en.asp

27. C&L Inventory and Industry Notification

28. What is the C&L inventory? Publicly available database containing information on C&L of substances on the market in EU –Substances with harmonised C&L –Substances self-classified by manufacturers and importers Linked to the obligation of (groups of) manufacturers and importers of substances to notify the C&L To be established and maintained by ECHA Public part of the Inventory will be available in 2011.

29. The purposes of the C&L Inventory http://echa.europa.eu It is a source of basic information on classified substances and on non-classified substances subject to registration which are placed on the market; It reveals disagreement on the classification and labelling of the same substance and the need for discussion, evaluation or for harmonisation of a particular C&L of a substance; It is a tool for hazard communication and risk management, e.g. when Member State Competent Authorities assess the need for potential authorisations and restrictions of hazardous substances under REACH.

30. Inventory notification Deadline for C&L notification – General rule: Within one month of placing on the market But Substances on the market on 1 December 2010 had to be notified by 3 January 2011 (EoB ) – Exemption: No notification is required if the same information has already been submitted in a registration dossier Update is needed if a notifier becomes aware of new information due to which C&L of the substance is changed

31. C&L Notification – Who? “Any manufacturer or importer, or group of manufacturers or importers … who place on the market a substance … shall notify to the Agency …” (CLP, Art. 40(1)) Group of Manufacturers / Importers –Corporate company with different legal entities –Several companies with no specific links –SIEF –Joint Submission … that agree on a common C&L for the same substance C&L for a same substance should be agreed (Art. 41)

32. C&L Notification - What and When? Which substances? (CLP, Art. 39) –Substances subject to registration under REACH and placed on the market –Other substances meeting classification criteria and placed on the market on their own or in a mixture above concentration limit → Note! No tonnage trigger! Exemptions –No notification is required, if the same information has already been submitted as part of a registration dossier Deadline for C&L notification –Within 1 month after placing on market on or after 1/12 2010 –First deadline: 3 January 2011

33. How to prepare for notification (I) 1.List the substances and mixtures you manufacture or import 2. Clarify if any are exempted from CLP (cf. Art 1) 3.Check if any are subject to REACH registration 4.Collect all information on your substances’ identity and composition 5.Name your substances in line with the guidance on SID 6.Check if your substances are listed in Annex VI to CLP 7.Gather all available and reliable information on the hazardous properties of your substance if the C&L is not harmonised

34. How to prepare for notification (II) 8.Classify your substances by comparing the available information with the classification criteria 9.Prepare a scientific justification if you specify a M-factor or set a specific concentration limit (SCL) 10.Decide if you want to establish or join a group of manufacturers and/or importers 11.Create your C&L notification in the appropriate format 12.Create your REACH-IT account (if not done already) and submit your notification

35. Absence of classification http://echa.europa.eu Data lacking: if you do not have relevant data or other adequate and reliable information that can be compared with the classification criteria; Inconclusive: if the available data or other information is not reliable (e.g. data of poor quality) or if the information / data does not suggest the same conclusion. The available data/information can not be regarded as a firm basis for classification; Conclusive although insufficient for classification: sufficient adequate and reliable information / data is available, but classification is not warranted. NB the classification waivers, see Data Submission Manual 12!

36. Classification & Labelling http://echa.europa.eu By 3 Jan. deadline: –More than 3 million notifications (3 114 835 ) –submitted by ca. 6 600 companies (covering ~15 000 companies) –107 000 distinct substances Since 3 Jan 2011 - Notifications have continued ** –More than 70 000 additional notifications –1576 additional distinct substances –560 additional submitting companies ** until 22/02/11

37. Guidance and support

38. CLP guidance to industry & CAs Module 1: Basic guidance on procedures Module 2: Detailed guidance on classification & labelling –Part 1: Physico-chemical properties –Part 2: Human health properties –Part 3: Environmental properties –Part 4: General and specific issues http://echa.europa.eu/clp/clp_help_en.asp Guidance for Classification, labelling and packaging (April 2011) http://guidance.echa.europa.eu/guidance_en.htm http://guidance.echa.europa.eu/guidance_en.htm FAQs section at the ECHA web page

39. Guide available for C&L notification All relevant guides and manuals are available on the CLP section of ECHA web site: –“Practical steps” guide No 7 –Industry User Manual Part 6 on dossier submission updated –Industry User Manual Part 12 on C&L notification using IUCLID –Industry User Manual Part 15 on managing groups –Industry User Manual Part 16 on on-line C&L notification –Other CLP guidance http://echa.europa.eu

40. Further guidance activities in 2011 Reproductive toxicity: setting of specific concentration limits based on potency Other health hazards: setting of (higher) specific concentration limits Aquatic hazard: following the 2 nd ATP, update of the guidance chapters on the long-term aquatic hazard and related Annexes Publication of these updates expected for end 2011 Planned: update of the guidance chapter on sensitisation

41. Further information CLP Regulation –http://ec.europa.eu/enterprise/sectors/chemicals/documents/clas sification/index_en.htm#h2-clp-regulation-(ec)-no-1272/2008http://ec.europa.eu/enterprise/sectors/chemicals/documents/clas sification/index_en.htm#h2-clp-regulation-(ec)-no-1272/2008 ECHA Guidance –http://guidance.echa.europa.eu/docs/guidance_document/clp_en.htmhttp://guidance.echa.europa.eu/docs/guidance_document/clp_en.htm ECHA Helpdesk –http://echa.europa.eu/help/echahelp_en.asphttp://echa.europa.eu/help/echahelp_en.asp

42. Thank You for Your attention http://echa.europa.eu These slides represent the opinion of the author and do not constitute the official position of ECHA