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Basic approaches in RISK ASSESSMENT. István Murányi Hungarian Cosmetic and Home Care Association. What is Risk Assessment?. RISK. DANGER. Danger (hazard) versus Risk. Danger Exposure or vulnerability to harm or risk. Risk The probability of a danger to occur.

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Basic approaches in RISK ASSESSMENT

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## Basic approaches in RISK ASSESSMENT

István Murányi

Hungarian Cosmetic and

Home Care Association

RISK

DANGER

### 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

### 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

### 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.)

### 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

### 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.

Tier approach !

### 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.

### 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.

### Warming upExample of a household product

Hard surface cleaner, spray, consumer use

### Dermal exposure of the surfactant

Calculation MOE (Margin Of Exposure)

MOE = NOAEL (No observable adverse effect level ) / Exposure

Generally speaking objective is MOE > 100

Dermal

Inhalation

### 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

### Risk Management MeasuresRMMs

Dermal exposure of spray painting during car body repair

Spraying paint

Filling paint

Cleaning spray gun

### 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

### 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.

### 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.

### 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/cm2/h)

Dermal Exposure per body part (µg/cm2/h)

### 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

### 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

• http://echa.europa.eu

Guidance on information requirements and chemical safety assessment

• https://www.ecetoc-tra.org (needs membership)

• 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)