6-7/5/20101

Belgrade, 6-7 May 2010

RISK ASSESSMENT - METHODOLOGY RAG - RISK ASSESSMENT GUIDELINES FOR

NON-FOOD CONSUMER PRODUCTS

Prof. Maurizio Mensi Academy of Economy and Finance

ITALY

6-7/5/20102

OVERVIEW OF THE PRESENTATION

1. The new RAG - Risk Assessment Guidelines - Comm. Dec. 16/12/2009

2. Main features - Risk – Combination of hazard and probability

3. Basic notions: hazard, product hazard and risk

4. Risk assessment, step by step5. The product, the consumer, the injury

scenario (severity and probability) 6. Determination of risk7. From risk to action

6-7/5/20103

THE NEW RISK ASSESSMENT GUIDELINES

Commission Decision of 16 Dec. 2009Public Internet Consultation (15 July-!5 Oct. 2008) – 25 questions - 68 replies received

Some interesting statements It is reasonably foreseeable that consumers

do not read the instructions Some never do, most have a look at them

after meeting a problem Only old engineers and lawyers read all Products should be used safely without

instructions for a basic use Dangerous misuses should be prevented by

the design, not by instruction

6-7/5/20104

THE NEW RAG (2)

Better convergence of terminology needed New RAGs do not erase national

perceptions of risk, but provide more transparency

“Measuring risk […] is an empirical scientific activity, judging safety –judging the acceptability of risks – is a normative, political activity”, W. Lowrence, 1976

6-7/5/20105

THE NEW RAG (3)

Divergent risk assessments of the same consumer product from:

1. Different authorities2. Authorities and manufacturers Different perceptions of risks Application of previous Guidelines not always

clearWho developed the new Guidelines ? Commission expert Working Group 21 experts nominated by Member States

6-7/5/20106

MAIN FEATURES

More clarity Elements of a risk assessment clearly

separated Step-by-step instructions Standard tables for each step Computer progamme planned

6-7/5/20107

MAIN FEATURES (2)

More transparency and communication Documentation of each step obligatory Outside world can better accept/discuss

the assessmentMore flexibility Any risk scenario allowed: severity of

injury and its probability provide for balance

6-7/5/20108

SERIOUS RISK

Before an authority of a MS decides to submit a RAPEX notification, it always performs the appropriate risk assessment in order to assess whether a product to be notified poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met

6-7/5/20109

SERIOUS RISK (2)

RISK ASSESSMENT METHODAppendix 5 to the Guidelines sets out the risk assessment method to be used by MS authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary

ASSESSING AUTHORITYThe risk assessment is always performed by an authority of a MS that either carried out the investigation and took appropriate measures or monitored voluntary action taken with regard to a dangerous product by a producer or a distributor

6-7/5/201010

ASSESS THE RISK

This risk can be assessed in different ways

How to quantify risks has been under permanent development

The purpose of RAG is to improve the situation and, to provide a transparent and practicable method for appropriate use by MS competent authorities when they assess the risks of non-food consumer products

6-7/5/201011

ASSESS THE RISK (2)

RAG do not set out to replace other guidelines that may address very specific products or may be specifically provided for in legislation (chemicals, cosmetics, pharmaceuticals or medical devices)

RAG are not to be used by manufacturers just to avoid serious risks when designing and manufacturing products

Consumer products have to be safe and RAG aim at helping authorities to identify serious risks when, despite the best efforts of the manufacturer, a product is not safe

6-7/5/201012

RISK ASSESSMENT

Risk – Combination of hazard and probabilityRisk is generally understood as something that threatens the health or even the lives of people, or that may cause considerable material damageNevertheless, people take risks while being aware of the possible damage, because the damage does not always happen Notion of Hazard, Product hazard Risk, Risk Assessment, Risk level, Risk Management

6-7/5/201013

RISK ASSESSMENT (2)

Risk is the combination of the severity of possible damage to the consumer and the probability that this damage should occur

THREE STEPS1. Anticipate an injury scenario in which the intrinsic

product hazard harms the consumer - Determine how severe the consumer’s injury is

2. Determine the probability of the consumer being injured in practice by the intrinsic product hazard

3. Combine the hazard (in terms of severity of the injury) with the probability (in terms of a fraction) to obtain the risk

6-7/5/201014

RISK ASSESSMENT (3)

Some useful tips1. Seek information2. Make a sensitivity analysis of your risk

assessment3. Let others check your risk assessment4. Document your risk assessment5. Several hazards, several injuries – but

only one risk

6-7/5/201015

RISK ASSESSMENT (4) In conclusion, risk is a balanced combination

of both the hazard and the probability of the injury that the hazard can cause - Risk describes neither the hazard, nor the probability, but both at the same time

Can risks cumulate ? Several injury scenarios leading to several

risks can be developed for virtually every product

Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury

Risks are not simply cumulated Risk management depends on many factors,

not only on the number of risks that a product may present at one and the same time

6-7/5/201016

RISK ASSESSMENT (5)

Compliance with limit values in legislation and standardsA product is presumed not to be safe where it fails to comply with established limit valuesNon-compliance with limit values does not automatically mean that the product presents a “serious risk”

Specific risk assessment guidelines in specific cases

6-7/5/201017

BUILDING A RISK ASSESSMENT STEP BY STEP

THE PRODUCTThe product should be clearly identified (the product name, the brand, the model name, the type number, a possible production lot number, any certificate that may come with the product)

A risk assessment should always consider the entire life time of a product and its packaging

6-7/5/201018

BUILDING A RISK ASSESSMENT STEP BY STEP (2)

THE PRODUCT HAZARDHazard is the intrinsic property of the product that may cause an injury to the consumer who uses the productIt can appear in different forms: mechanical, choking, suffocation, electrical, thermal, chemical or microbiological hazard, etc.

Hazard identification by tests and standards

Products may still present a risk even though they do not cause injuries

6-7/5/201019

BUILDING A RISK ASSESSMENT STEP BY STEP (3)

THE CONSUMER The abilities and behaviour of the consumer

using the product may greatly influence the level of risk

It is of prime importance to have a clear idea of the type of consumer pictured in the injury scenario

Consideration should also be given to people who are not actually using the product, but who may be in the vicinity of the user

A product that is normally safe for an average adult may not be safe for vulnerable consumers

6-7/5/201020

BUILDING A RISK ASSESSMENT STEP BY STEP (4)

INJURY SCENARIO: STEPS LEADING TO INJURY

Most injury scenarios consist of the following three main steps:

1. the product has a “defect” or can lead to a “dangerous situation” during its foreseeable lifetime

2. the “defect” or “dangerous situation” results in an accident

3. the accident results in an injurySEVERITY OF INJURY: different degrees of severity

6-7/5/201021

BUILDING A RISK ASSESSMENT STEP BY STEP (5)

Probability of injury: the probability that injury scenario may indeed materialise during the expected lifetime of the productIt is not easy to estimate

Determination of risk

6-7/5/201022

FROM RISK TO ACTION

Once the risk assessment is complete it will normally be used to decide whether action needs to be taken to reduce the risk and thus prevent harm to a consumer’s health

Measures to reduce the risk may include withdrawal from the market or recall

Lower levels of risk normally lead to less rigorous measures

Nevertheless, there is no automatic link from risk to action

6-7/5/201023

HOW TO PREPARE A RISK ASSESSMENT

1. Describe the product and its hazard2. Identify the type of consumer you want to include

in your injury scenario with the hazardous product3. Describe an injury scenario in which the product

hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected

4. Determine the severity of the injury5. Determine the probability of the injury scenario6. Determine the risk level7. Check whether the risk level is plausible8. Develop several injury scenarios to identify the

highest risk of the product9. Document and pass on your risk assessment

6-7/5/201024

Author l Prof. Maurizio MensiAcademy of Economy and Finance

(SSEF)Ministry of Economy and FinanceRome - ITALY___________________

mamensi@tin.it

Tel/Fax: +39 06 68135539Mobile: +39 335 5623327