1. Basic approaches in RISK ASSESSMENT István Murányi Hungarian Cosmetic and Home Care Association

3. What is Risk Assessment? DANGER RISK

4. Danger (hazard) versus Risk Danger Exposure or vulnerability to harm or risk. Risk The probability of a danger to occur. Risk = Probability (exposure)x seriousness of aftermath R = W K

5. Objective: Reduce risk Step 1 Identify the hazards Step 2 Decide who might be harmed and how Step 3 Evaluate the risks and decide on precautions Step 4 Record your findings and implement them Step 5 Review your assessment and update if necessary

6. Step 1 Identify the hazards You need to find those sources, which mean danger and possibly can cause harm. Basicly you can - identify the known dangers (e.g. from legislation, literature, experience, etc.) - investigate the unknown dangers (e.g. experiments, statistics, extrapolations, etc.)

7. Step 2 Decide who might be harmed and how Practically it is estimation of exposure Identify and investigate all possible effects of risk sources onto human health and environment Exposure assessment

8. Step 3 Evaluate the risks and decide on precautions and risk management measures (RMMs) Estimation of probability and seriousness of risks to happen in a certain circumstances, with given conditions. This process is based on quantative, semi- quantitave (empiric or theoretical) estimation taking hazards, exposure routes into consideration.

9. Tier approach !

11. Step 4 Record your findings and implement them If you’ve gone over Step 3, you need to know: -Hazard sources, exposure routes and their quantitative and qualitative nature. -Dos and don’t dos -RMMs Put these in a set of rules and make ensure to be followed.

12. Step 5 Review your risk assessment and update if necessary Very important! Two ways: -If it turns out that with the given conditions and RMMs it is not possible to control the risk = you need to start over and adjust accordingly. -Initial conditions and other factors might change by time. You need to start over.

13. Risk Assessment as a Component of Risk Management

14. Warming up Example of a household product Hard surface cleaner, spray, consumer use

15. Dermal exposure of the surfactant Calculation MOE (Margin Of Exposure) MOE = NOAEL (No observable adverse effect level ) / Exposure Generally speaking objective is MOE > 100

16. Outcome Dermal Inhalation

17. Environmental Exposure Standard Emission Table (%) Aggregated Emissions (AE, %) in whole supply chain (soil, water, air) AE is converted into quantitative data (PEC, Predicted Environmental Concentration PNEC (Predicted No Effect Concentration) Aim: PEC/PNEC is lower than 1

18. Environmental Exposure Standard emission table

19. Risk Management Measures RMMs Exposur e routes Exposure to human health: Inhalation: accidantely possible, but exposure is under tox limit Recommendation: Do not inhalate! Dermal accidantely possible, but exposure is under tox limit Recommendation: Wear protective gloves in case of irritation! Oral: not accepted, no RMM is needed Exposure to environment: Exposure: diffuse Possible routes depend on application Application 1: to surface water via sewage system (drains) Application 2: community waste, to air or soil depending on local waste treatment RMMs Human Environmental

20. Spraying paint Filling paint Cleaning spray gun Dermal exposure of spray painting during car body repair

21. Sampling techniques General idea placing collection medium against the skin or clothes and subsequently analysing it for its chemical content 1 Patch methods The traditional patch size is 10 x 10 cm. Usually only one or two patches are attached under the clothing layer to measure actual exposure. After the sampling and analysis, the measured amount is related to the surface area of the corresponding body part. Materials may include surgical gauze, alpha-cellulose paper, charcoal, cotton gauze, polyurethane, and polypropylene

22. Sampling techniques 2 Whole-body methods Lightweight disposable overalls, cotton overalls, and the like are used as samplers. The actual exposure and efficiency of protective clothing can be measured with underclothing as a monitor. The normal clothing of workers has also been used as monitors.

23. Sampling techniques 3 Glove method Use of absorbent gloves, usually cotton liners, to measure the exposure of hands. They can be used in place of, underneath, or on the top of the protective gloves. Gloves are easy to use in the field, and they efficiently collect residues that would otherwise be absorbed into the skin during the sampling period. Gloves should not become saturated, and they should be replaced if soaked.

24. Xylene in spray painting NOAEL (?) = 180 mg/kg/day =3 mg/kg/h =3000 µg/kg/h For 60 kg bodyweight = 180000 µg/h – 10 (µg/cm 2 /h) Dermal Exposure per body part (µg/cm 2 /h) BodypartDermal Exposure MOE (NOAEL/Exp) Hands25 Chest + forehead0.250 Back + Back of head0.250 Forearms0.617 Thighs0.520

25. Legal background Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals REACH Major changes Chemical Safety Assessment (CSA) Chemical Safety Report (CSR) Exposure Scenarios (ES) PBT/vPvB

26. Overview of CSA process

27. CMR only? No – PBT/vPvB! REACH Annex XIII. For what? REACH: separate PBT/vPvB assessment (including of course CMRs)! Substance may -fulfill Annex XIII criteria - characterise the potential emissions -If not - monitoring data on a case-by-case basis -If further verterbal experiments are needed – test proposal

29. Useful links http://echa.europa.eu Guidance on information requirements and chemical safety assessment https://www.ecetoc-tra.org (needs membership)https://www.ecetoc-tra.org http://ecb.jrc.ec.europa.eu/euses/ (European Union System for the Evaulation of Substances) http://ecb.jrc.ec.europa.eu/tgdoc/ (Technical Guidance Document – repealed by REACH, but principle still applies)