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

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Presentation on theme: "CLP/GHS for REACH practitioners REACH update session ECTIC, University of Hull, 11 th December 2009 Janet Murfin."— Presentation transcript:

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

2 ETCIC REACH meeting, 11th December 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

3 ETCIC REACH meeting, 11th December How will CLP affect REACH practitioners? 1.need to include CLP classifications in 2010 Registrations within IUCLID 2.reclassifications coming into force on 1 st Dec 2010 from 1 st ATP to CLP may bring forward REACH deadline 3.CLP/ REACH will interact with each other

4 ETCIC REACH meeting, 11th December 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

5 ETCIC REACH meeting, 11th December When will CLP be implemented? now! published 20 th January 2009 substances to be reclassified for CLP by 1 st Dec 2010 mixtures (formerly preparations) to be reclassified by 1 st 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)

6 ETCIC REACH meeting, 11th December CLP and CHIP timelines Now to 1/12/10 1/12/10 1/6/13 1/6/13 – 1/6/15 1/6/15 – 1/6/18 1/6/18 onward Substa- nces CLP optional CLP and CHIP both mandatory CLP implemented in full, CHIP gone MixturesN/aCHIP mandatory CLP optional 5 year dual classification period for substances (CLP label, CHIP & CLP MSDS) New CLP notification in 2010

7 ETCIC REACH meeting, 11th December CLP / REACH implementation Now to 1/12/10 1/12/10 1/6/13 1/6/13 – 1/6/15 1/6/15 – 1/6/18 1/6/18 onward REACHHigh vol/ CMR reg. Med. vol registr. Low vol. registration REACH in full Substa- nces CLP optional CLP and CHIP both mandatory CLP implemented in full, CHIP gone MixturesN/aCHIP mandatory CLP optional First REACH registration coincides with substance CLP reclassification deadline

8 ETCIC REACH meeting, 11th December 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

9 ETCIC REACH meeting, 11th December 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

10 ETCIC REACH meeting, 11th December 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  

11 ETCIC REACH meeting, 11th December 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

12 ETCIC REACH meeting, 11th December 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

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

14 ETCIC REACH meeting, 11th December …. 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

15 ETCIC REACH meeting, 11th December … 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

16 ETCIC REACH meeting, 11th December … 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

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

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

19 ETCIC REACH meeting, 11th December 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

20 ETCIC REACH meeting, 11th December 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.

21 ETCIC REACH meeting, 11th December 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)

22 ETCIC REACH meeting, 11th December 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

23 ETCIC REACH meeting, 11th December 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

24 ETCIC REACH meeting, 11th December But CLP is changing already Already had first update (ATP) to CLP regs, published 25 th Sept 09 Contains 30 th and 31 st 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 1 st December 2010

25 ETCIC REACH meeting, 11th December If you want to know more about CLP… 66Approved Classification and Labelling Guide v6 2,558 Total number of pages relevant to UK business 53CHIP4 regulations 528Guidance on the Application of the CLP Criteria 117Introductory Guidance on the CLP regulations 4391st ATP to CLP regulations 1355CLP regulations

26 ETCIC REACH meeting, 11th December 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

27 ETCIC REACH meeting, 11th December 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

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

29 ETCIC REACH meeting, 11th December CLP bringing REACH deadline forward - B Example: AEEA moving from non-harmonised to harmonised classification on 1 st December 2010 Check all 2013/2018 substances in 1 st 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

30 ETCIC REACH meeting, 11th December 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)

31 ETCIC REACH meeting, 11th December 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

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

33 ETCIC REACH meeting, 11th December 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

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

35 ETCIC REACH meeting, 11th December 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

36 ETCIC REACH meeting, 11th December 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

37 ETCIC REACH meeting, 11th December 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

38 ETCIC REACH meeting, 11th December 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

39 ETCIC REACH meeting, 11th December 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

40 ETCIC REACH meeting, 11th December 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

41 ETCIC REACH meeting, 11th December 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

42 ETCIC REACH meeting, 11th December Thank you very much Any questions? Presentation available on request Contact tel


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