{
  "url": "https://openlegislation.uk/eu-decision-2019-417/annex/division-2/division-6/division-6.3",
  "json_url": "https://openlegislation.uk/eu-decision-2019-417/annex/division-2/division-6/division-6.3.json",
  "legislation": "eudn/2019/417",
  "legislation_title": "Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2019-417",
  "path": "annex/division/2/division/6/division/6.3",
  "kind": "division",
  "number": "6.3",
  "heading": "Sensitivity analysis",
  "text": "The factors used to calculate the risk of an injury scenario, namely the severity of the injury and the probability, often have to be estimated. This creates uncertainty. Probability in particular can be difficult to estimate, since the behaviour of consumers, for example, can be difficult to predict. Does a person perform a certain action often or only occasionally?\nIt is therefore important to consider the level of uncertainty of the two factors and to make a sensitivity analysis. The purpose of this analysis is to establish how much the risk level varies when the estimated factors vary. The example provided on the table below only shows the variation of probability, since the severity of the injury is usually predicted with more certainty.\nA practical way of performing the sensitivity analysis is to repeat the risk assessment for a certain scenario, but to use a different probability for one or more steps in the scenario. For example, a candle containing seeds could cause a fire, because the seeds can catch fire and generate high flames. Furniture or curtains can catch fire and persons not in the room could inhale toxic fumes and suffer fatal poisoning:\nInjury scenario\nInjury type and location\nSeverity of injury\nProbability of injury\nResulting probability\nRisk\nSeeds or beans catch fire generating high flames. Furniture or curtains catch fire. Persons are not in room, but inhale toxic fumes.\nFatal poisoning\n4\nSeeds or beans catch fire: 90 % (0,9)\nPeople not in the room for some time: 30 % (0,3)\nFurniture or curtains catch fire: 50 % (0,5) (depends on surface on which candle is placed)\nPersons inhale toxic fumes: 5 % (0,05)\n0 00675 > 1/1 000\nSerious\nThe probability levels for the steps in the scenario were estimated as shown in the table.\nThe overall probability is 0,00675, which corresponds to > 1/1 000 in table 4. This leads to the conclusion of ‘serious risk’. Note that the exact probability is closer to 1/100 than to 1/1 000, which already gives some confidence in the risk level because it is a little deeper in the serious risk area of table 4 than the > 1/1 000 row suggests.\nSuppose we are uncertain about the 5 % probability that persons inhale the toxic fumes. We could put it at a much lower 0,1 % (0 001 = 1 in a thousand). If we recalculate with that assumption, the overall probability is 0,000135, which translates into > 1/10 000. Nevertheless, the risk is still serious. Even if for some reason the probability were to be a factor of 10 lower, the risk would still be high. Therefore, although the probability may vary 10- or 100-fold, we still find a serious or high risk (the latter being quite close to ‘serious’). Thus, this sensitivity analysis lets us confidently assess the risk as serious.\nIn general, however, risk assessment should be based on ‘reasonable worst cases’: not too pessimistic on every factor, but certainly not too optimistic.\nTable 1\nConsumers\nConsumers\nDescription\nVery vulnerable consumers\nVery young children: 0 to 36 months\nOthers: Persons with extensive and complex disabilities\nVulnerable consumers\nYoung children: Children older than 36 months and younger than 8 years.\nOlder children: Children 8 to 14 years\nOthers: Persons with reduced physical, sensory or mental capabilities (e.g. partially disabled, elderly, including those over 65, with some reduction in their physical and mental capabilities), or lack of experience and knowledge\nOther consumers\nConsumers other than very vulnerable or vulnerable consumers\nTable 2\nHazards, typical injury scenarios and typical injuries\nNB: This table is for guidance only; the typical injury scenarios should be adapted when preparing a risk assessment. There is specific risk assessment guidance for chemicals, cosmetics and possibly others. It is highly recommended to use this specific guidance when assessing such products. See section 3.2.\nHazard group\nHazard(product property)\nTypical injury scenario\nTypical injury\nSize, shape and surface\nProduct is obstacle\nPerson trips over product and falls; or person bumps into product\nBruising; fracture, concussion\nProduct is impermeable to air\nProduct covers mouth and/or nose of a person (typically a child), or covers internal airway\nSuffocation\nProduct is or contains small part\nPerson (child) swallows small part; the part gets stuck in larynx and blocks airways\nChoking, internal airway obstruction\nPossible to bite off small part from product\nPerson (child) swallows small part; the part gets stuck in the digestive tract\nDigestive tract obstruction\nSharp corner or point\nPerson bumps into sharp corner or is hit by moving sharp object; this causes a puncture or penetration injury\nPuncture; blinding, foreign body in eye; hearing, foreign body in ear\nSharp edge\nPerson touches sharp edge; this lacerates the skin or cuts through tissues\nLaceration, cut; amputation\nSlippery surface\nPerson walks on surface, slips and falls\nBruising; fracture, concussion\nRough surface\nPerson slides along rough surface; this causes friction and/or abrasion\nAbrasion\nGap or opening between parts\nPerson puts a limb or body in opening and finger, arm, neck, head, body or clothing is trapped; injury occurs due to gravity or movement\nCrushing, fracture, amputation, strangulation\nPotential energy\nLow mechanical stability\nProduct tips; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces\nBruising; dislocation; sprain; fracture, concussion; crushing; electric shock; burns\nLow mechanical strength\nProduct collapses by overloading; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces\nBruising; dislocation; fracture, concussion; crushing; electric shock; burns\nHigh position of user\nPerson at high position on the product loses balance, has no support to hold on to and falls from height\nBruising; dislocation; fracture, concussion; crushing\nElastic element or spring\nElastic element or spring under tension is suddenly released; person in the line of movement is hit by the product\nBruising; dislocation; fracture, concussion; crushing\nPressurised liquid or gas, or vacuum\nLiquid or gas under pressure is suddenly released; person in the vicinity is hit; or implosion of the product produces flying objects\nDislocation; fracture, concussion; crushing; cuts (see also under fire and explosion)\nKinetic Energy\nMoving product\nPerson in the line of movement of the product is hit by the product or run over\nBruising; sprain; fracture, concussion; crushing\nParts moving against one another\nPerson puts a body part between the moving parts while they move together; the body part gets trapped and put under pressure (crushed)\nBruising; dislocation; fracture; crushing\nParts moving past one another\nPerson puts a body part between the moving parts while they move close by (scissor movement); the body part gets trapped between the moving parts and put under pressure (shearing)\nLaceration, cut; amputation\nRotating parts\nA body part, hair or clothing of a person is entangled by the rotating part; this causes a pulling force\nBruising; fracture; laceration (skin of the head); strangulation\nRotating parts close to one another\nA body part, hair or clothing of a person is drawn in by the rotating parts; this causes a pulling force and pressure on the body part\nCrushing, fracture, amputation, strangulation\nAcceleration\nPerson on the accelerating product loses balance, has no support to hold on to and falls with some speed\nDislocation; fracture, concussion; crushing\nFlying objects\nPerson is hit by the flying object and depending on the energy sustains injuries\nBruising; dislocation; fracture, concussion; crushing\nVibration\nPerson holding the product loses balance and falls; or prolonged contact with vibrating product causes neurological disorders, osteoarticular disorder, trauma of the spine, vascular disorder\nBruising; dislocation; fracture; crushing\nNoise\nPerson is exposed to noise from the product. Tinnitus and hearing loss may occur depending on sound level and distance\nHearing injury\nElectrical Energy\nHigh/low voltage\nPerson touches part of the product that is at high voltage; the person receives an electric shock and may be electrocuted\nElectric shock\nHeat production\nProduct becomes hot; a person touching it may sustain burns; or the product may emit molten particles, steam, etc., that hits a person\nBurn, scald\nLive parts too close\nElectric arc or sparks occur between the live parts. This may cause a fire and intense radiation\nEye injury; burn, scald\nExtreme temperatures\nOpen flames\nA person near the flames may sustain burns, possibly after clothing catches fire\nBurn, scald\nHot surfaces\nPerson does not recognise the hot surface and touches it; the person sustains burns\nBurn\nHot liquids\nPerson handling a container of liquid spills some of it; the liquid falls on the skin and causes scalds\nScald\nHot gases\nPerson breathes in the hot gases emitted from a product; this causes lung burn; or prolonged exposure to hot air causes dehydration\nBurn\nCold surfaces\nPerson does not recognise the cold surface and touches it; the person sustains frostbite\nBurn\nRadiation\nUltraviolet radiation, laser\nSkin or eyes of a person are exposed to radiation emitted by the product\nBurn, scald; neurological disorders; eye injury; skin cancer, mutation\nHigh intensity electromagnetic field (EMF) source; low frequency or high frequency (microwave)\nPerson is close to the electromagnetic field (EMF) source, body (central nervous system) is exposed\nNeurological (brain) damage, leukaemia (children)\nFire and explosion\nFlammable sub stances\nPerson is near the flammable substance; an ignition source sets the substance on fire; this causes injuries to the person\nBurn\nExplosive mixtures\nPerson is near the explosive mixture; an ignition source causes an explosion; the person is hit by the shock wave, burning material and/or flames\nBurn, scald; eye injury, foreign body in eye; hearing injury, foreign body in ear\nIgnition sources\nThe ignition source causes a fire; a person is injured by flames, or intoxicated by gases from the house fire\nBurn; poisoning\nOverheating\nProduct overheats; fire, explosion\nBurn, scald; eye injury, foreign body in eye; hearing injury, foreign body in ear\nToxicity\nToxic solid or fluid\nPerson ingests substance from product,\ne.g. by putting it in mouth, and/or substance gets on skin\nAcute poisoning; irritation, dermatitis\nPerson breathes in solid or fluid, for example vomited material (pulmonary aspiration)\nAcute poisoning in lungs (aspiration pneumonia); infection\nToxic gas, vapour or dust\nPerson inhales substance from product; and/or substance gets on skin\nAcute poisoning in lungs; irritation, dermatitis\nSensitising substance\nPerson ingests substance from product,\ne.g. by putting it in mouth; and/or substance gets on skin; and/or person inhales gas, vapour or dust\nSensitisation; allergic reaction\nIrritating or corrosive solid or fluid\nPerson ingests substance from product,\ne.g. by putting it in mouth, and/or substance gets on skin or in eyes\nIrritation, dermatitis; skin burn; eye injury, foreign body in eye\nIrritating or corrosive gas or vapour\nPerson inhales substance from product, and/or substance gets on skin or in eyes\nIrritation, dermatitis; skin burn; acute poisoning or corrosive effect in lungs or in eyes\nCMR substance\nPerson ingests substance from product, e.g. by putting it in mouth, and/or substance gets onto skin; and/or person inhales substance as gas, vapour or dust\nCancer, mutation, reproductive toxicity\nMicrobiological contamination\nMicrobiological contamination\nPerson gets into contact with contaminated product by ingestion, inhalation or skin contact\nInfection, local or systemic\nProduct operating hazards\nUnhealthy posture\nDesign causes unhealthy posture of person when operating the product\nStrain; musculoskeletal disorder\nOverexertion\nDesign requires use of considerable force when operating the product\nSprain or strain; musculoskeletal disorder\nAnatomical unsuitability\nDesign is not adapted to human anatomy, which makes it difficult or impossible to operate\nSprain or strain\nIgnoring personal protection\nDesign makes it difficult for a person wearing protection to handle or operate the product\nVarious injuries\nInadvertent (de)activation\nPerson can easily (de)activate product, which leads to unwanted operation\nVarious injuries\nOperational inadequacy\nDesign provokes faulty operation by a person; or product with a protective function does not provide expected protection\nVarious injuries\nFailure to stop\nPerson wants to stop the product, but it continues to operate in situation where this is unwanted\nVarious injuries\nUnexpected start\nProduct shuts down during a power failure, but resumes operation in a hazardous way\nVarious injuries\nInability to stop\nIn an emergency situation, person is not able to stop operation of the product\nVarious injuries\nInadequately fitting parts\nPerson tries to fit a part, needs too much force to fit, product breaks; or part is too loosely fitted and becomes loose during use\nSprain or strain; laceration, cut; bruising; entrapment\nMissing or incorrectly fitted protection\nHazardous parts are reachable for a per son\nVarious injuries\nInsufficient warning instructions, signs and symbols\nUser does not notice warning instructions signs and/or does not understand symbols\nVarious injuries\nInsufficient warning signals\nUser does not see or hear warning signal (optical or audio), causing dangerous operation\nVarious injuries\nTable 4\nRisk level from the combination of the severity of injury and probability\nProbability of damage during foreseeable lifetime of the product\nSeverity of injury\n1\n2\n3\n4\nHigh\nLow\n>50 %\nH\nS\nS\nS\n> 1/10\nM\nS\nS\nS\n> 1/100\nM\nS\nS\nS\n> 1/1 000\nL\nH\nS\nS\n> 1/10 000\nL\nM\nH\nS\n> 1/100 000\nL\nL\nM\nH\n> 1/1 000 000\nL\nL\nL\nM\n< 1/1 000 000\nL\nL\nL\nL",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2019/417/annex/division/2/division/6/division/6.3",
    "retrieved_at": "2026-11-01T15:12:47.956200+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}