Safety Data Sheets
Hazard Communication Hazard Communication
Overview Introduction Regulatory Requirements Suppliers Duties SDS and CLP Annex II changes (453/2010) Recipients Duties Summary and Guidance
Introduction Familiar tool for hazard communication Suppliers of hazardous substances or mixtures must provide Overlap of REACH and CLP SDS
General Requirements Enable users to take necessary measures to protect human health & worker safety protect the environment by providing appropriate information on handling, storage, transport and disposal of substances and mixtures
Regulated by REACH Title IV Information in the Supply Chain applies to all actors in the supply chain Article 31: Requirements for SDS Annex II Guide to compilation of SDS From 1 st Dec 2010 amended by Reg. (EC) No. 453/2010
SDS Format 16 sections with subsections In an official language where substance/mixture is placed on the market Consistent with registration dossier No fixed length Exposure Scenario may be attached Should include: page number (page x of y) date and revision status
Annex II SDS Format SDS Required Headings 1. Identification of the substance/mixture and of the company/undertaking 9. Physical and Chemical Properties 2. Hazard Identification 10. Stability and Reactivity 3. Composition/Information on 11. Toxicological Information Ingredients 4. First Aid Measures 12. Ecological Information 5. Fire-Fighting Measures 13. Disposal Considerations 6. Accidental Release Measures 14. Transport Information 7. Handling and Storage 15. Regulatory Information 8. Exposure Controls/Personal Protection 16. Other Information
Exposure Scenarios Applies to hazardous substances M/I > 10t/yr Describes conditions of use of substance & mixtures Sets out operational conditions & risk management measures for specific use Part of the registration requirements May be seen from 2011
Suppliers Duties Supplier must provide SDS if: substance/mixture is hazardous substance is PBT or vpvb substance is on Candidate List of substances of very high concern (SVHC) for reasons other than those above
Need to provide Supplier must provide SDS at recipients request where mixture not hazardous but contains substance which: poses human health or environmental hazard or is a PBT or vpvb or is on Candidate List of SVHC or has an occupational exposure limit (OELV)
Provide on delivery SDS must be supplied before or at time of 1 st delivery of chemical Free of charge Paper or electronically
No need to provide if: Hazardous chemicals made available to general public with sufficient information on hazards (unless requested by a DU or distributor) Radioactive substances Subject to customs supervision Non-isolated intermediates R&D not placed on market Waste Substance/Mixture used in defence
Provision not necessary Substance/Mixture in finished state for final user: Medicinal/Veterinary products Cosmetics Medical devices Food/Feeding stuffs
How CLP affects REACH Amendment to Annex II REACH to adapt it to criteria for classification & labelling as in CLP Transitional arrangements for amendment of SDSs required to follow staggered application of CLP
Reg. (EC) No. 453/2010 To facilitate new CLP requirements and GHS global SDS Format Annex I Comes into force 1 st Dec 2010 & repeals current Annex II Annex II Comes into force 1 st June 2015 & repeals Annex I
Annex I 453/2010 For substances: Existing CPL (DSD*) & new CLP classifications must appear in parallel from 1 st Dec 2010 to 1 st June 2015 in section 2 Label must be to CLP Section 15 to contain regulatory info only *Dangerous Substances Directive 67/548/EEC
SDS for Substances From 1 st Dec 2010 to 1 st Jun 2015 CLP & DSD CLP Only (as on Label)
Annex I 453/2010 For mixtures: Existing CPL (DPD*) classification must appear in section 2 from 1 st Dec 2010 to 1 st June 2015 Label must be DPD Section 15 to contain regulatory info only *Dangerous Preparations Directive 1999/45/EC
SDS for Mixtures From 1 st Dec 2010 to 1 st Jun 2015: DPD DPD (as on Label)
However. Suppliers of Mixtures can apply CLP before 1 st June 2015: Add CLP classification to Section 16 Add CLP classification to section 2 alongside DPD classification Label must be to CLP Add CLP & DPD classifications of substances in mixture in section 3
Derogations Substances placed on market before 1 st Dec 2010 SDS according to Annex I 453/2010 from 1 st Dec 2012 Mixtures placed on market before 1 st June 2015 SDS according to Annex II 453/2010 from 1 st June 2017 SDSs for mixtures provided to recipient before 1 st Dec 2010 need not comply with Annex I 453/2010 til 30 th Nov 2012
Important changes: Product identifiers/registration No. in sections 1/3 Uses advised against in section 1 Label elements in section 2 Regulatory info only in section 15 Remember: Consistency between sections All sections mandatory. No blanks! No generic statements
SDS & CLP Transition Today 1 st Dec 2010 1 st Jun 2015 CPL Binding CLP Optional CLP Binding for substances CLP Binding for substances optional for mixtures & mixtures Double classification Substances Annex II REACH Annex I (453/2010) Annex II (453/2010) Mixtures Annex II REACH Annex I (453/2010) Annex II (453/2010) Existing CPL New CLP Derogation for already placed on the market : - substances until 1/12/2012 -mixtures until 1/06/2017
When to Update Without delay when major change occurs: Change in tel. no. Change in C&L (more stringent) Authorisation/restriction (granted/refused/imposed) Change in controls (more stringent) Exposure scenario becomes available Other changes: Change in OELV Availability of registration number
When to update If classifications have changed consider: impacts on safety management ie. update Sections 7, 8 and 13 consistency with information on which new or revised classification based ie. Sections 9, 11 and 12 Upon update of SDS, all recipients from preceding 12 months must get revised and dated SDS
Recipient Duties Downstream User receives SDS: Correct language 16 mandatory headings and subheadings are complete Use is covered or not advised against Consistency between classification and product identifiers on SDS & label Check dates, emergency tel no., controls etc. If No to above, contact your supplier
Recipient Duties Downstream User receives SDS: Evaluate risks to workers Use information to inform employees Make available & accessible to workers Keep records for 10 years Exposure Scenario may be attached Implement Risk Management Measures in ES within 12 months
SDS Recipients Duties Downstream User right to make uses of substances known Many identified uses in practice Identify apply and recommend appropriate measures to adequately control risks identified in the SDS
Information Flow
What if use is not covered? Contact supplier with the aim to include identified use Find an alternative supplier who has covered use Find an alternative substance Prepare own Chemical Safety Assessment
The benefits of SDSs Enhanced protection for man & environment Improved flow of communication Improved quality of information: Appropriate to uses/exposures Tailored to real needs Consistent Will help comply with other legislation Global dimension
Enforcement & Implementation
CLP Enforcement Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classifed, labelled, notified and packaged in accordance with CLP First report to ECHA: 20 th Jan 2012 FORUM coordinates projects at EU Level for both REACH and CLP
CLP Implementation Article 43: Appointment of Competent and Enforcement Authorities Health and Safety Authority- Industrial Chemicals Department of Agriculture, Fisheries & Food Pesticides & PPP Dept of Health -National Poison Information Centre ( Art 45) Chemicals Act 2008 : being amended to include CLP whose penalties & fines are up to 5,000/ 6 months prison ( summary conviction) and up to up to 3,000,000/ 2 years prison(indictment conviction) 37
Guidance and Help CLP & REACH Helpdesk Ph. 1890 289 389 CLP Helpdesk: email clp@hsa.ie CLP Webpage: www.hsa.ie/clp REACH Helpdesk email: reachright@hsa.ie REACH webpage www.reachright.ie REACH & CLP E- Bulletin
Guidance and Help ECHA Guidance Document SDS (draft) Guidance document for CLP (modules 1 and 2) Guidance document for L&P (draft module 3) Guidance document for Downstream Users Guidance on C&L Inventory incl. IT tools: http://echa.europa.eu/clp/inventory_notificatio n_en.asp Annex II Commission Regulation (EU) No 453/2010
Guidance and Help HSA CLP Helpdesk Ph. 1890 289 389/email clp@hsa.ie CLP Webpage Your Industry /Chemicals/Classification_and_Labelling/ REACH Helpdesk Ph1890 289389/emailreachright@hsa.ie REACH webpage www.reachright.ie REACH & CLP E- Bulletin Information Sheet on Safety Data Sheets Publications page on www.hsa.ie
Conclusions GHS applies NOW in Europe through CLP & REACH Know your roles and responsibilities You cannot comply without an EU legal entity Basic principles for Labels & SDS s remain the same Be prepared for Classification & Notification Hazard Communication will change and improve CLP & REACH will help you attain a Globally HazCom system Help and Guidance are available