Substitution of hazardous chemicals: training on decision support tools to assess hazard and sustainability of chemicals and alternatives

Transcription

1 Substitution of hazardous chemicals: training on decision support tools to assess hazard and sustainability of chemicals and alternatives April the 12 th 2018 Ruth Moeller- Clémence Varret REACH&CLP Helpdesk Luxembourg 1

2 Agenda Substitution of hazardous chemicals 1. Introduction to substitution and international initiatives 2. Information sources: where to find regulatory and hazard information on chemicals? 3. Overview on tools that can be used to assess and compare chemicals and how to check the completeness and accuracy of your SDS 4. Practical exercise using tools (column model, COSHH) with safety data sheets brought by participants 5. Questions and closing of the event 2

3 1. Substitution of hazardous chemicals -Introduction 3

4 Substitution - a growing policy issue Substitution feeds into current governments strategies to reduce risks of chemicals on human health and the environment, Increasingly included as part of policy and regulatory measures for the management of chemicals of concern, Also feeds into industry s approach to sustainable development, The SVHC Roadmap a commitment of the EU Commission 2010: have all relevant currently known SVHCs included in the candidate list by 2020 REACH Authorisation obligation and substitution of the most severe hazardous substances

5 Substitution - a growing policy issue Towards a non-toxic environment strategy The 7th Environment Action Programme (7th EAP), adopted in 2013 by the European Parliament and the Council, mandated the European Commission to develop by 2018 "a Union strategy for a non-toxic environment that is conducive to innovation and the development of sustainable substitutes including non-chemical solutions." Study report: overview of the state of play and identifies gaps and deficits in the current EU chemicals policy and legislative framework, in relation to the following aspects: Substitution, including grouping of chemicals and measures to support substitution Chemicals in products (articles) and non-toxic material cycles The improved protection of children and vulnerable groups from harmful exposure to chemicals (plus appendix) Very persistent chemicals Policy means, innovation and competitiveness Programme on the development on new, non-/less toxic substances Early warning systems for examining a non-toxic environment that is free of exposures to minimise and eliminate all exposures to hazardous substances (plus appendix)

6 Substitution of hazardous chemicals Working Definition The replacement or reduction of hazardous substances in products and processes by less hazardous or non-hazardous substances, or achieving an equivalent functionality via technological or organisational measures. Lissner, Lohse (2003): Substitution of Hazardous chemicals in products and processes. Report compiled for Directorate General for Environment of the European Commission Substituting chemicals goes beyond finding a drop-in chemical alternative and can include systems, materials, or process changes. Pay attention to Risk Shift and Regrettable substitution 25/04/2018 6

7 Substitution of hazardous chemicals Risk Reduction Risk = Exposure / Hazard Hazard replace or reduce hazardous substances in products and processes Exposure reduce or eliminate emissions by setting technical or organisational barriers Substitution is a (preferred) way of eliminating or reducing the risk from chemicals to health, safety and the environment 25/04/2018 7

8 Substitution of hazardous chemicals a principle implemented in OSH 8

9 Motivation? Chemical Inventory Setting Criteria for transition to safer alternatives List of chemicals to be substituted Identification of possible candidates Prioritisation of candidates Identification of alternatives Screening of alternatives short listing Assessment of alternatives Decision and Implementation 9

10 What affects substitution and alternative assessment? Technical functionality Health and environmental risks Guarantee and liability regulations Economy Availability of the substitute Company decision Safety aspects Qualification of employees Societal pressure Communication Legislation and standardisation 10

11 Substitution - a growing policy issue Criteria Art. 57 REACH Substances to be included in REACH Annex XIV a) Carcinogenicity category 1A or 1B b) Germ cell mutagenicity category 1A or 1B c) Reproductive toxicity category 1A or 1B d) Persistent, Bioaccumulative, Toxic (PBT) e) very Persistent, very Bioaccumulative (vpvb) f) Equivalent level of concern (ELoC) (e.g. Endocrine disruptors, respiratory sensitisers) ECHA s approach on prioritisation of SVHC on the Candidate List for Annex XIV inclusion is based on Art. 58(3) criteria (PBT, vpvb, wide-dispersive use, high volumes) A risk-based approach can be used by companies to prioritise substitution efforts. 11

12 Work in progress Increasingly, practitioners are asking for support, Guidance is being developed: Frameworks for AA: arrangement of analyses and decisions that can be used to assess alternatives, Tools for AA: approaches for evaluating a chemical, material, process, product, and/or technology for the purpose of attribute analysis within an alternatives assessment; And others See an OECD meta review of existing tools and frameworks at: doclanguage=en 12

13 ECHA strategy to Substitution of Hazardous Chemicals

14 ECHA strategy to Substitution of Hazardous Chemicals 14

15 ECHA strategy to Substitution of Hazardous Chemicals Whats next?

16 OECD Ad Hoc Group on Substitution of Harmful Chemicals Established in maingoal: Furthering tools and approaches to support decision making for the substitution of chemicals of concern. Co-chaired by the U.S. Environmental Protection Agency and the European Chemicals Agency - OECD Substitution and Alternatives Assessment Toolbox(SAAToolbox)

17 Information sources: where to find regulatory and hazard information on chemicals? 17

18 Early warnings - Regulatory Risk Management activities encourage substitution Regulatory Scrutiny a cascade of actions Preceding regulatory risk management processes Regulatory risk management processes Outcome Early warning Serious warning Comply

19 ECHA s Substances of potential concern website section Simplified presentation of the link of regulatory activities and processes 19

20 Regulatory Scrutiny a cascade of actions CLH = Harmonised Classifiation and Labelling (acc. CLP) Registry of CLH intention until outcome Copyright European Chemicals Agency

21 Copyright European Chemicals Agency (ECHA) Source: ECHA guidance "Chemical safety in your business"

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24 Regulatory Scrutiny a cascade of actions Early warning Serious warning Comply

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26 Where to find information on substances Besides ECHA website you may consult the OECD sources

27 SAAToolbox: OECD Substitution and Alternatives Assessment Toolbox

28 OECD Substitution and Alternatives Assessment Toolbox Brings together practical resources on chemical substitution and alternatives assessments, Launched in January Updated on an ongoing basis

29 SAAToolbox Tool Selector 29

30 SAAToolbox Tool Selector 30

31 SAAToolbox Tool Selector

32 SAAToolbox

33 SAAToolbox

34 SAAToolbox

35 3. Overview on tools that can be used to assess and compare chemicals and how to check the completeness and accuracy of your SDS 35

36 Hazard or Risk? Hazard: anything that can cause harm Risk: Probability that a hazard can cause harm Expressed in severity and probability 36

37 How to prioritize the substitution effort? Probability of occurrence exposure (for selected unit of time or activity) Frequent Likely to occur repeatedly Probable Likely to occur several times Catastrophic Death or permanent total disability Critical Disability in excess of 3 months Severity Marginal Minor injury, lost workday accident Negligible First aid or minor medical treatment High High Serious Medium High High Serious Medium Occasional Likely to occur sometime Remote not likely to occur Improbable Very unlikely High Serious Medium Low Serious Medium Medium Low Medium Low Low Low Severity: High (operation not permissible); Serious (High Priority remedial action); Medium (Take remedial action at appropriate time); Low (Risk acceptable) 37

38 TRGS 600 (Annex I): substitution flow chart Annex I 38

39 SUBSPORT Substitution Support Portal 39

40 Before you start: assess the quality & reliability of the SDS? (1) Information about the content of the substance/mixture: CAS/EC number for substance and trade name of substance/mixture Information about impurities 40

41 Before you start: assess the quality & reliability of the SDS? (2) Hazard information (H statements) : In section 2 and 3 of the SDS: classification according to the CLP Regulation (EC) n 1272/2008 Double check with information available on ECHA website (infocard, C&L inventory, etc) Source: ECHA infocard for formaldehyde 41

42 ECHA C&L Inventory 42 Source: ECHA C&L inventory for formaldehyde

43 ECHA C&L Inventory Source: ECHA C&L inventory for formaldehyde 43

44 Different types of tools Available tools: Screening tools, comparative assessment tools, hazard-based tools or more holistic approaches, some examples: COLUMN model Green Screen for safer chemicals Green Wercs DfE Design for the environment COSHH Stoffenmanager TRGS 600 ACC prioritization tool ECETOC TRA (Targeted Risk Assessment) UBA guide for sustainable chemicals LCSP Further information: Gauthier et al. 2014: Chemical assessment state of the science: Evaluation of 32 decision-support tools used to screen and prioritize chemicals, Integr Environ Assess Manag 2015;11: , ECHA webinar on substitution. Joel Tickner and Molly Jacobs, University of Massachusetts, Lowell: The landscape of tools to support the transition to safer chemicals: lessons learned, OECD Substitution and alternatives assessment toolbox. 44

45 Column model 45

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47 Column model for Substance X See section 11 of the SDS "toxicological information" Potential data gaps data available? If not 1. Acute toxicity Yes Substance or mixture should be classified as "high risk" in the column "acute health hazards" 2. Skin corrosion/skin irritation Yes Substance or mixture should be classified as "low risk"'in the column "acute health hazards" (in terms of a "skin irritant H315") 3. Skin sensitisation yes Substance or mixture should be classified as "high risk"'in the column "acute health hazards" (in terms of a "skin sensitizer H317") 4. Germ cell mutagenicity no data available Substance or mixture should be classified as "high risk"'in the column "chronic health hazards" (in terms of a "germ cell mutagenic substance cat 2 H341") 5. Target organ toxicity after repeated exposure no data available Substance or mixture should be classified at least as "medium risk" in the column "chronic health hazards 47 (in terms of "possible organ damage H373")

48 Column model for Substance X 1 Risk 2a Acute health hazards (single exposure) very high high data gap 4 medium data gap 5 2b Chronic health hazards (repeated exposure) 3 Environmental hazards H400 Very toxic to aquatic life; H410 Very toxic to aquatic life with long lasting effects Information fromsds sections 2, 3, 9, 11, 12 H phrases: H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation H400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects low negligible H315 Causes skin irritation; H319 Causes serious eye irritation; H335 May cause respiratory irritation 48

49 Important when considering a substitute On the basis of the outcome of the risk assessment, a product must be substituted if it reduces the risk to employees. A risk exists if employees are capable of spatially and temporally encountering a hazard source (hazardous substance). The hazards inherent in hazardous substances have to first become effective (e.g. through exposure, fire, explosion) in order to become relevant risks. The columns 2, 3 and 4 constitute hazards. The columns 5 and 6 are to be interpreted as hazards becoming effective. If the potential substitute product rates better in all five columns than the product in use, the substitution problem is solved. It will mostly be the case that the potential substitute product rates better in some columns, but worse in one or two to other columns. This obliges you to assess which potential hazards in other words, which columns play a larger role in your particular situation. If, for example, sources of combustion cannot be excluded in your production processes, then the fire and explosion characteristics together with the exposure potential will have the greater weight. If your production methods result in large quantities of waste by-products, then the environmental hazards will be emphasized. 49

50 COSHH - Control of Substances Hazardous to Health Goals: Protecting employees from hazardous substances at work. Procedure: look at each substance and think about the tasks & exposure (by breathing in, exposure by skin contact, by swallowing, to the eyes or by skin puncture). Based on SDS and uses (processes, quantity used everyday, duration of the process). Result of risk assessment, in order of priority: 1. Eliminate the use of harmful product or substance and use a safer one, 2. Use a safer form of the product (paste>powder) 3. Change the process to emit less of the substance, 4. Enclose the process (the product cannot escape), 5. Extract emissions of the substance near the source, 6. Have a few workers in harm s way, 7. Provide personal protective equipment (PPE) such as gloves, coveralls and a repsirator.choosing adequate control measures. 50

51 Test substance 51

52 Test substance Test substance Test substance 52

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55 COSHH 55

56 Guide on sustainable chemicals 56

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58 Conclusion on tools Check the quality of your SDS and double check the information on your substance (ECHA website, OECD website, etc), Pay attention to data gaps, Know your uses and your quantities, Choose the tool (or combination of) depending on your requirements. 58

59 Thank you for your attention! 59