How to read an eSDS? Yvonne Jansma NVvA – January 26th, 2012 C t t Content • Introduction IHS • eSDS within REACH regulation • Set up of the eSDS • Exposure E pos re Scenario information • eSDS in the workplace • Conclusion Copyright © 2010 IHS Inc. All Rights Reserved. 2 The Leading Source of Critical Information • IHS provides content, content software and expert analysis that supports an organization’s ability to advance critical decisions with speed and confidence. 55 000 customer organizations in • We serve 55,000 180+ countries around the world • We are > 5.000 people, speaking 50 languages, helping our customers address challenges in six key areas areas… Copyright © 2010 IHS Inc. All Rights Reserved. 3 Th eSDS The SDS within ithi th the REACH regulation l ti Copyright © 2010 IHS Inc. All Rights Reserved. 4 E Exposure A Assessmentt Required when : • If substance is manufactured / imported >10 tpa AND Classified as dangerous according 67/548/EEC OR • Persistent, Bioaccumulative and Toxic (PBT) OR very Persistent and very Bioaccumulative (vPvB) acc. to REACH Result is communication to DU as Annex to SDS (Art. 31 (7) of REACH regulation*) g ) (*): Regulation (EC) No 1907/2006 Copyright © 2010 IHS Inc. All Rights Reserved. 5 El Elements t off the th eSDS SDS Extended SDS SDS (section 1 to 16) Copyright © 2010 IHS Inc. All Rights Reserved. ANNEX (Exposure Scenario) 6 SDS REACH information SDS: i f ti in i section ti 1 REACH Registration Number (RRN): ¾Listed for substance SDS in section 1 (14 digits for substance ID + 4 digits for legal entity). ¾No RRN for mixtures. mixtures See section 3 for RRN of ingredients. Only 14 digits will be displayed. Uses/Uses ad advised ised against against: ¾ It is important that the use of the substance in the workplace is among the “identified uses”. ¾The identified uses are described in the Annex of the SDS. If not described/different: ÆThere is an issue Copyright © 2010 IHS Inc. All Rights Reserved. ¾If the use of the substance is described as “uses advised against” 7 ÆThere is a – bigger - issue! SDS REACH information SDS: i f ti in i section ti 8 PNEC: Predicted No Effect Concentration (environment) Copyright © 2010 IHS Inc. All Rights Reserved. DNEL: D DNEL Derived i dN No Eff Effectt L Levell (h (health): lth) • DNELS for oral/dermal/inhalation • DNELS for consumers/workers g term/short term • DNELS for long • DNELS normally lower as MAC (ACGIH acrylonitrile = 4,3 mg/m3) 8 E Exposure S Scenarios… i Wh Whatt format? f t? • In 2010 ECHA Proposed 4 Templates – related to … • • • • …uses of substances carried out by workers …uses of substances carried out by consumers …service life of substances in articles (handling by workers) …service life of substances in articles (handled by consumers) • 4 Sections each… • + optionally… Copyright © 2010 IHS Inc. All Rights Reserved. E Exposure S Scenario: i section ti 1 (Titl (Title)) USE DESCRIPTORS CONTRIBUTING SCENARIO (environment and health) Copyright © 2010 IHS Inc. All Rights Reserved. 10 U D Use Descriptors i t Objective: Pre-defined categories/phrases to help suppliers and users to structure their communication with each other. Categories: • SU: Sector of UseÆ describes in which sector of the economy the substance is used. • • • • This includes mixing or re-packing of substances at formulator’s level as well as industrial, professional and consumer end-uses. (SU18: Manufacture of furniture) PC: chemical Product CategoryÆ describes in which types of chemical products (= substances as such or in mixtures) the substance is finally contained when it is supplied pp to end-uses. ((PC25: Metal working g fluids)) PROC: Process CategoryÆ describes the application techniques or process types defined from the occupational perspective (PROC07: Industrial spraying) ERC: Environmental Release CategoryÆ describes the broad conditions of use from the environmental perspective. perspective (ERC01: Manufacture of substance) AC: Article Category Ædescribes the type of article into which the substance has eventually been processed. (AC7: Metal Articles) Copyright © 2010 IHS Inc. All Rights Reserved. 11 C t ib ti S Contributing Scenario i principle i i l • For industry it is assumed that operational conditions (OC) and risk management measures (RMM) ffor a substance b t are related l t d tto ttask/workplace k/ k l ((= contributing t ib ti scenario’s). Release of substance to environment is assumed to be site related. Æ An exposure p scenario on industrial spray p yp painting g may y include multiple p health contributing scenarios to describe the different tasks and various conditions under which the task is safe to be carried out, so: • conditions for mixing and filling of equipment (manually) • conditions for mixing and filling of equipment (automated) • conditions of cleaning the equipment (manually) • conditions of cleaning the equipment (automated) • etcetera This is mostly linked in the exposure scenario to only one contributing scenario for environment, for example. • Spraying/fogging by machine application Copyright © 2010 IHS Inc. All Rights Reserved. 12 Section 2: Exposure Controls Product characteristic Amount used Frequency and duration of use/ exposure Human factors not influenced by risk management RMM to prevent release of substance to the worker. worker - Process control - From source - Organisational - PPE, hygiene yg Linked to a “Health Contributing Scenario! Copyright © 2010 IHS Inc. All Rights Reserved. 13 A th example Another l Copyright © 2010 IHS Inc. All Rights Reserved. 14 Section 3: Exposure estimation and reference t its to it source Tool for exposure assessment. Like “Stoffenmanager”, “EMKG/BAUA” Compare with DNEL (workers): • Long term inhalation: 2.7 mg/m³ • Long term dermal: 1.4 mg/kg bw/day Copyright © 2010 IHS Inc. All Rights Reserved. 15 < 1 Exposure/DNEL must be (= Risk Characterization) S ti 4 Section 4: G Guidance id tto d downstream t user..... How much additional i f information ti does this give? Copyright © 2010 IHS Inc. All Rights Reserved. 16 E Exposure S Scenario: i summary • Set of conditions that describe how a substance is (safely) manufactured or used • Including Operational Conditions (OC’s) and Risk Management Measures (RMM’s) to control exposures of humans and the environment. • May cover one specific process or use or several processes or uses as appropriate • Covers the complete life-cycle of a substance Copyright © 2010 IHS Inc. All Rights Reserved. 17 W k Workers rights i ht concering i eSDS SDS • Workers (Reps) have the right to examine if the intended uses are covered by the Exposure Scenarios set out in Safety Data Sheet (SDSs) • Workers (Reps) can check if employers apply the Risk Management Measures provided for in Safety Data Sheets • Workers (Reps) can challenge proposed Risk Management Measures if they do not think that they are adequate enough Copyright © 2010 IHS Inc. All Rights Reserved. 18 Employers tasks (and Occupational Hygienist t help) to h l ) • Make sure the instructions in the SDS on safe use of chemical substances are implemented p and followed. • If the eSDS contains an Exposure Scenario of a relevant use: make sure the Risk Management Measures are implemented. • If the relevant use of the substance is NOT described as one of the identified uses in the eSDS: • Inform the manufacturer/importer of the substance on this particularly use OR • Create your own CSR on the particularly use and register this use with ECHA (if the use is > 1 tpa) • Search suppliers how did describe the relevant use • Change how the substance is used. • If the description p of a relevant use is different from the own use: • Create your own CSR on the particularly use and register this use with ECHA (if the use is > 1 tpa) • It might be possible to use “scaling” (in ES duration is 4 hours, in real duration is 8 hours) Æ ECHA guidance available available. Copyright © 2010 IHS Inc. All Rights Reserved. 19 M More information i f ti http://www.rijksoverheid.nl/docu menten-enpublicaties/brochures/2012/01/18 /reach-informatie-ten-behoevevan-het-arbobeleid-inbedrijven.html Copyright © 2010 IHS Inc. All Rights Reserved. 20