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CLP/GHS for REACH practitioners

CLP/GHS for REACH practitioners. REACH update session ECTIC, University of Hull, 11 th December 2009 Janet Murfin. Background to CLP/GHS. GHS – Global Harmonised System UN-driven worldwide classification system Merging three main systems, EU, USA, Canada

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CLP/GHS for REACH practitioners

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  1. CLP/GHS for REACH practitioners REACH update session ECTIC, University of Hull, 11th December 2009 Janet Murfin

  2. Background to CLP/GHS • GHS – Global Harmonised System • UN-driven worldwide classification system • Merging three main systems, EU, USA, Canada • CLP – Classification, Labelling & Packaging Regulation • EU’s method of implementing GHS • First major political unit to implement • Will eventually replace CHIP and ADR (ADR further ahead than CHIP) • EU Regulation, like REACH ETCIC REACH meeting, 11th December 2009

  3. How will CLP affect REACH practitioners? • need to include CLP classifications in 2010 Registrations within IUCLID • reclassifications coming into force on 1st Dec 2010 from 1st ATP to CLP may bring forward REACH deadline • CLP/ REACH will interact with each other ETCIC REACH meeting, 11th December 2009

  4. Why do REACH practitioners need to understand CLP? • you need to understand CLP because of the effects it may have on REACH, and vice versa • Also, if no-one in your organisation is leading on CLP, you may become the company expert by default ETCIC REACH meeting, 11th December 2009

  5. When will CLP be implemented? • now! published 20th January 2009 • substances to be reclassified for CLP by 1st Dec 2010 • mixtures (formerly preparations) to be reclassified by 1st June 2015 • dual classification of substances from 2010 to 2015 (label CLP, MSDS CLP & CHIP) • CLP Notification to ECHA by early 2011 (separate to REACH, wider notification scope) • CLP takes over MSDS and labelling requirements from REACH (sensible) ETCIC REACH meeting, 11th December 2009

  6. CLP and CHIP timelines • 5 year dual classification period for substances (CLP label, CHIP & CLP MSDS) • New CLP notification in 2010 ETCIC REACH meeting, 11th December 2009

  7. CLP / REACH implementation • First REACH registration coincides with substance CLP reclassification deadline ETCIC REACH meeting, 11th December 2009

  8. A word on CLP notification • Wider scope than REACH, notification required for any substance made or moved within EU. There will be no minimum amount (unlike REACH 1 tonne de minimis for most chemicals), so • R&D chemicals will be included –unclear if R&D confidentiality will be an issue • Registration includes basic information like REACH pre-registration • Software packages for CLP registration due out in Spring 2010 (according to ECHA) – rumours that REACH-IT may be tweaked for CLP use ETCIC REACH meeting, 11th December 2009

  9. Actual CLP reclassification is comparatively easy.. • as long as you are not writing manual MSDSs (yes, this still happens!) • and provided your classification software package is being updated to include CLP/GHS • although there is a “quickie” manual reclassification method in Annex VII of CLP, the capacity for error is HUGE ETCIC REACH meeting, 11th December 2009

  10. .. the real difficulty is understanding what the new system means • It’s like a whole new language of risk assessment • Think of it as having to learn a foreign language • And the symbols will change too, some completely, others in minor ways  ETCIC REACH meeting, 11th December 2009

  11. Effect on CSRs and authors • Chemical Safety Reports take the chemical hazard classification as their starting point – it describes the hazardous properties of a substance in a systematic manner • If you are writing a CSR, or helping with technical aspects of it, you will need to learn this new language ETCIC REACH meeting, 11th December 2009

  12. Many things will change from CHIP – ideas… • new concepts such as target organ, and single or repeat dose, for human health hazard classes • new physico-chemical hazards - self-reactive substances and self-heating substances • new abbreviations, such as STOT – Specific Target Organ Toxicity ETCIC REACH meeting, 11th December 2009

  13. Low level health hazard ….how labels may look (a).. Chronic health hazard Compressedgas ETCIC REACH meeting, 11th December 2009

  14. …. product labels (b).. • St Andrews Cross (Harmful) removed • descriptive words replaced by “Signal Word” • Toxic becomes Danger • Harmful becomes Warning • Risk Phrases become Hazard Phrases • Safety Phrases now Precautionary Phrases ETCIC REACH meeting, 11th December 2009

  15. … and how you classify chemicals… • instead of “preparations”, now “mixtures”. (can contain substances, or other mixtures). • some thresholds have been changed, some hazard classes have no equivalent • generally more hazard classes in both health and environment ETCIC REACH meeting, 11th December 2009

  16. … but some things will stay the same • the HSE will still be the Competent Authority for the UK, during the dual classification period and beyond into full CLP/GHS • at least we don’t have the uncertainty we went through over whether HSE or EA would be the REACH Competent Authority ETCIC REACH meeting, 11th December 2009

  17. Spot the difference – CHIP label ETCIC REACH meeting, 11th December 2009

  18. Chloroform label - CLP/GHS ETCIC REACH meeting, 11th December 2009

  19. Handover from CHIP is starting • Process of replacing CHIP with CLP/GHS started • CHIP3 replaced (April 2009) by CHIP4 • Approved Supply List (harmonised classifications) replaced by Table 3-2 of Part 3 of Annex VI of CLP regulations • new v6 Approved Classification and Labelling guide for CHIP4 from HSE (free download!) • Classifications the same as ASL except sodium hypochlorite >5% free Chlorine becomes R50 ETCIC REACH meeting, 11th December 2009

  20. Immediate CLP consequences - COMAH • If you have Sodium Hypochlorite with greater than 5% free chlorine, we recommend you check your COMAH calculation, as it is now COMAH-liable • several sites (bleach manufacturers, larger distributors, cleaning chemical formulators) have been seriously affected by this, including going into COMAH, or moving from Lower Tier to Top Tier. ETCIC REACH meeting, 11th December 2009

  21. Translating classifications from CHIP to CLP/GHS will involve changing: • Product labels • MSDSs (remember the dual classification system for substance MSDSs for 5 years from 2010 to 2015) • Transport labels (minor changes compared to product labels) • COSHH assessments (will need to be rewritten) • COMAH liability, if substances or mixtures change classification • REACH registrations (you must include CLP classification as well as CHIP for 2010 registration, and if there is a change in substance classification, this may even bring forward your registration date) ETCIC REACH meeting, 11th December 2009

  22. Staff will need training if they: • Handle chemicals in their work • Use MSDSs • Are responsible for packaging and transport • Classify chemicals and write MSDSs • Are involved in REACH registration (or other registrations such as pesticides or biocides) • Carry out COSHH assessments and risk assessments involving hazardous chemicals • Are involved in managing any of these activities ETCIC REACH meeting, 11th December 2009

  23. Other CLP changes • new labels for product containers and transport (may need software upgrade, new printer, or fresh set of labels if printed for you) • new MSDSs (software upgrade required) • New COSHH risk assessments CLP/GHS won’t simply be a matter for the Product Safety specialists, it affects many departments ETCIC REACH meeting, 11th December 2009

  24. But CLP is changing already • Already had first update (ATP) to CLP regs, published 25th Sept 09 • Contains 30th and 31st ATP for Dangerous Substance Directive, held back while CLP enacted (previously would have been brought in via Approved Supply List) • Makes changes to harmonised classifications contained in CLP, but they are only mandatory from 1st December 2010 ETCIC REACH meeting, 11th December 2009

  25. If you want to know more about CLP… CLP regulations 1355 1st ATP to CLP regulations 439 Introductory Guidance on the CLP regulations 117 Guidance on the Application of the CLP Criteria 528 CHIP4 regulations 53 Approved Classification and Labelling Guide v6 66 Total number of pages relevant to UK business 2,558 ETCIC REACH meeting, 11th December 2009

  26. How CLP affects REACH - 1 … Bob Warner of Chemwise, and Mark Selby of Denehurst Chemical Safety, both want me to remind the 2010 REACH registrants in the audience that: you HAVE to include the CLP/GHS classification (as well as CHIP4) in your IUCLID5 submission, otherwise you won’t meet the Completeness Checks ETCIC REACH meeting, 11th December 2009

  27. Why are the completeness checks in REACH so important? • Your dossier won’t be assessed, so you’ll have to withdraw substance from market until it is resubmitted (if that happens) • This error is preventable – check that your lead registrant is including CLP classification • “Incomplete dossiers” was the main reason for removal of Pesticides from the market – only 26% of 1991 products still on market today ETCIC REACH meeting, 11th December 2009

  28. CLP bringing REACH deadline forward - A • Existing CLP Harmonised Classifications are the same as CHIP3, except sodium hypochlorite • But 1st ATP to CLP has new (and amended) Harmonised Classifications coming into effect on 1/12/2010, ie same date as first REACH registration deadline • 1st ATP to CLP therefore has the potential to change your REACH registration date i.e. bring it forward ETCIC REACH meeting, 11th December 2009

  29. CLP bringing REACH deadline forward - B • Example: AEEA moving from non-harmonised to harmonised classification on 1st December 2010 • Check all 2013/2018 substances in 1st ATP to see whether classification altered, and if so whether this brings REACH registration forward • Your SIEF administrator/ Lead Registrant should be able confirm registration date • It may also show if you have incorrectly classified substances for REACH – example, Company K ETCIC REACH meeting, 11th December 2009

  30. CMR Risk Phrases for Category 1 and Category 2 • Carcinogenic • T, R45 (may cause cancer) • T, R49 (may cause cancer by inhalation) • Mutagenic • T, R46 (may cause heritable genetic damage) • Toxic to Reproduction • T, R60 (may impair fertility) • T, R61 (may cause harm to the unborn child) ETCIC REACH meeting, 11th December 2009

  31. Reminder – not just CMRs • Don’t forget to check your 2013/2018 REACH registrations for Very Toxic to the Aquatic Environment, N R50/53 – due in 2010 if >100 tonnes • Fortunately this doesn’t apply to Sodium Hypochlorite Cl>5%, as that is only R50 – REACH deadline remains the same ETCIC REACH meeting, 11th December 2009

  32. CLP and REACH interactions • CLP changing substance classification • REACH changing substance classifications • Effect of reclassification on other regulations ETCIC REACH meeting, 11th December 2009

  33. CLP is not just a change in labels and (M)SDSs…. Very important – substance and mixture classifications may change • There is NOT a 1:1 translation between CHIP and CLP for all substances • CLP is not just adding new labels or changing the risk language – some substances and many preparations may change category ETCIC REACH meeting, 11th December 2009

  34. Poster shows threshold differences- (free download from Merck) ETCIC REACH meeting, 11th December 2009

  35. Example of REACH changes to CLP • A fragrance undergoing testing for REACH by a Trade Organisation has been found to be R50/53. • This in turn will affect the MSDS under CLP • Other regulations will be affected – in this case site will go into Top Tier COMAH ETCIC REACH meeting, 11th December 2009

  36. Reclassification as more hazardous – impact on other regulations • COMAH - bring sites into COMAH, or from Lower Tier to Top Tier • EPR – take Low Impact (Standard) Permits up to Bespoke Permit level • COSHH – will need to be reassessed in light of new classification, probably increase controls on handling/ lead to substitution if very hazardous These are major changes, involving significant time, hassle and costs for the chemical industry ETCIC REACH meeting, 11th December 2009

  37. While we’re discussing COMAH.. • The COMAH regulations will need to be updated to include the CLP/GHS classifications (presumably will be a dual-classification at first) • Although HSE/ EU will try to ensure thresholds are equivalent, so no new COMAH entrants, this may not be possible where substances change to more hazardous classifications (eg sodium hypochlorite under CHIP4) Top Tip - be prepared to control inventory to avoid COMAH, or go into Lower or Top Tier ETCIC REACH meeting, 11th December 2009

  38. Summary: CLP and REACH • CLP/GHS change from CHIP4 is a major change for chemical businesses in itself • CLP/GHS will actively involve far more businesses in the chemicals supply chain than REACH • Implementation is simultaneous with REACH, and they will interact with each other • Impact on other major chemical regs (COMAH, EPR, COSHH) directly from CLP/GHS, and indirectly from interactions with REACH ETCIC REACH meeting, 11th December 2009

  39. REACH practitioners involvement with CLP • Even if no direct involvement with CLP (other people/ departments doing reclassification), you still have two vital roles to play: • Liaison with CLP practitioners • Liaison with senior managers ETCIC REACH meeting, 11th December 2009

  40. Liaison with CLP practitioners • ensure you understand the CLP system • check your REACH 2010 substances have new CLP classification, not just CHIP • you may be able to help them with CLP notification, particularly if REACH-IT is the mechanism to be used ETCIC REACH meeting, 11th December 2009

  41. Liaison with senior management • Together with CLP practitioner, keep senior management informed of changes in classification which might affect other chemical regulations, in particular COMAH, and also COSHH • Remember – you are keeping your business alive, now and in the future ETCIC REACH meeting, 11th December 2009

  42. Thank you very much • Any questions? • Presentation available on request • Contact tel 01422 24 22 22 • Emailjanet@ttenvironmental.co.uk • www.ttenvironmental.co.uk ETCIC REACH meeting, 11th December 2009

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