{
  "url": "https://openlegislation.uk/eu-decision-2004-905/annex/annex-II",
  "json_url": "https://openlegislation.uk/eu-decision-2004-905/annex/annex-II.json",
  "legislation": "eudn/2004/905",
  "legislation_title": "Commission Decision of 14 December 2004 laying down guidelines for the notification of dangerous consumer products to the competent authorities of the Member States by producers and distributors, in accordance with Article 5(3) of Directive 2001/95/EC of the European Parliament and of the Council (notified under document number C(2004) 4772) (Text with EEA relevance) (2004/905/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2004-905",
  "path": "annex/annex/II",
  "kind": "appendix",
  "number": "ANNEX II",
  "heading": "Methodological framework for facilitating consistent risk estimation and evaluation",
  "text": "The following text is based on the framework developed for the RAPEX Guidelines and is presented here in order to assist companies in assessing the level of a risk and deciding whether a notification to the authorities is necessary. The guidelines in this Annex II are not exhaustive and do not attempt to take into account all possible factors. The companies should judge each individual case on its merits taking into account the criteria set out in these guidelines as well as their own experience and practice, other relevant considerations and appropriate methods.\nA consumer product may present one or more intrinsic hazards. The hazard may be of various types (chemical, mechanical, electrical, heat, radiation, etc.). The hazard represents the intrinsic potential of the product to damage the health and safety of users under certain conditions.\nThe severity of each type of hazard may be given a rating, based on qualitative and sometimes quantitative criteria related to the type of damage that it is liable to produce.\nIt may happen that not all individual products present the hazard in question, but only some of the items placed on the market. The hazard may in particular be related to a defect that appears only in some of the products of a certain type (brand, model, etc.) placed on the market. In such cases the probability of the defect/hazard being present in the product should be considered.\nThe potential of a hazard to materialise as an actual negative effect on health/safety will depend on the degree to which the consumer is exposed to it when using the product as intended or as could reasonably be expected during its lifetime. In addition the exposure to certain hazards may in some cases involve more than one person at a time. Finally when determining the level of the risk presented by a product by combining the severity of the hazard with the exposure, consideration should be given also to the ability of the exposed consumer to prevent or react to the hazardous situation. This will depend on the evidence of the hazard, the warnings given and the vulnerability of the consumer who may be exposed to it.\nTaking into account the above considerations, the following conceptual approach may assist businesses when deciding whether a specific hazardous situation caused by a consumer product requires a notification to the competent authorities.\nIt is recommended that assessments be carried out by a small team who have knowledge and experience of the product and its hazards. Assessors may have to make subjective judgements if objective data are not available and it is hoped this procedure will help them to make consistent and reasoned judgements about actual or potential risks.\nThe assessor should analyse the information collected and use the risk assessment table as follows:\n1.. As a first step, use Table A to determine the gravity of the outcome of a hazard, depending on both its severity and the probability of it occurring under the conditions of use considered, and of the possible health/safety effect related to the intrinsic hazardous characteristics of the product.\n2.. As a second step, use Table B to further assess the gravity of the outcome depending on the type of consumer and, for non-vulnerable adults, whether the product has adequate warnings and safeguards and whether the hazard is sufficiently obvious to make it possible to grade the risk level qualitatively.\nTable A — Risk estimation: severity and probability of health/safety damage\nIn Table A the two main factors affecting the risk estimation, namely the severity and probability of health/safety damage, are combined. The following definitions of severity and probability have been drawn up to assist in the selection of appropriate values.\nSeverity of injury\nThe assessment of severity is based on consideration of the potential health/safety consequences of the hazards presented by the product considered. A grading should be established specifically for each type of hazard.\nThe assessment of severity should also take into account the number of people who could be affected by a dangerous product. This means that the risk from a product which could pose a risk to more than one person at a time (e.g. fire or gas poisoning from a gas appliance) should be classified as more severe than a hazard which can only affect one person.\nThe initial risk estimation should refer to the risk to any person exposed to the product and should not be influenced by the size of the population at risk. However, it may be legitimate for the companies to take account of the total number of people exposed to a product in deciding on the type of action to be taken.\nFor many hazards it is possible to envisage unlikely circumstances that could lead to very serious injury, e.g. tripping over a cable, falling and banging one’s head, leading to death, although a less serious outcome is more likely. The assessment of the severity of the hazard should be based on reasonable evidence that the effects selected for characterising the hazard could occur during foreseeable use. This could be the worst-case experience involving similar products.\nOverall probability\nThis refers to the probability of negative health/safety effects to a person exposed to the hazard. It does not take into account the total number of people at risk. Where the guide refers to the probability of a product being defective, this should not be applied if it is possible to identify each one of the defective samples. In this situation, the users of the defective products are exposed to the full risk and the users of the other products to no risk.\nThe overall probability is the combination of all the contributing probabilities such as:\nthe probability of the product being or becoming defective (if all products carry the defect then this probability would be 100 %);\nthe probability of the negative effect materialising for a normal user who has an exposure corresponding to the intended or reasonably expected use of the defective product.\nThese two probabilities are combined in the following table to give an overall probability which is entered into Table A.\nOverall probability of health/safety damage\nProbability of hazardous product\n1 %\n10 %\n100 %(All)\nProbability of health/safety damage from regular exposure to hazardous product\nHazard is always present and health/safety damage is likely to occur in foreseeable use\nMedium\nHigh\nVery high\nHazard may occur under one improbable or two possible conditions\nLow\nMedium\nHigh\nHazard only occurs if several improbable conditions are met\nVery low\nLow\nMedium\nCombining the severity and overall probability in Table A gives an estimation of the gravity of the risk. The accuracy of this assessment will depend upon the quality of the information available to the company. However, this assessment needs to be modified to take account of society’s perception of the acceptability of the risk. Society accepts much higher risks in some circumstances such as motoring, than in others, such as children’s toys. Table B is used to input this factor.\nTable B — Grading of risk: type of person, knowledge of the risk and precautions\nSociety accepts higher risks in some circumstances than in others. It is considered that the main factors affecting the level of risk are the vulnerability of the type of person affected and for non-vulnerable adults, the knowledge of the risk and the possibility of taking precautions against it.\nVulnerable people\nThe type of person using a product should be taken into account. If the product is likely to be used by vulnerable people, the level of risk which should be notified should be set at a lower level. Two categories of vulnerable people are proposed below, with examples:\nVery vulnerable\nVulnerable\nBlind\nPartially sighted\nSeverely disabled\nPartially disabled\nVery old\nElderly\nVery young (<3 years)\nYoung (3-11years)\nNormal adults\nThe adjustment of the seriousness of risk for non-vulnerable adults should only apply if the hazard is obvious and necessary for the function of the product. For non-vulnerable adults, the level of risk should be dependent on whether the hazard is obvious and whether the manufacturer has taken adequate care to make the product safe and to provide safeguards and warnings, especially if the hazard is not obvious. For example, if a product has adequate warnings and safeguards and the hazard is obvious, a high gravity of outcome may not be serious in terms of grading the risk (Table B), although some action may be needed to improve the safety of the product. Conversely, if the product does not have adequate safeguards and warnings, and the hazard is not obvious, a moderate gravity of outcome is serious in terms of grading the risk (Table B).\nRisk Assessment of consumer products for the GPSD\nThis procedure is proposed to assist companies when deciding whether a specific hazardous situation caused by a consumer product requires notification to the authorities\nTable A is used to determine the gravity of the outcome of a hazard, depending on the severity and probability of the possible health/safety damage (see tables in notes)\nTable B is used to determine the rating of the gravity of risk depending on the type of user and, for non-vulnerable adults, whether the product has adequate warnings and safeguards and whether the hazard is sufficiently obvious\nExample (indicated by the arrows above)\nA chain saw user has suffered a badly cut hand and it is found that the chain saw has an inadequately designed guard which allowed the user's hand to slip forward and touch the chain. The company’s assessor makes the following risk assessment.\nTable A — The assessment of probability is High because the hazard is present on all products and may occur under certain conditions. The assessment of severity is Serious so the overall gravity rating is High.\nTable B — The chain saw is for use by non-vulnerable adults, presents an obvious hazard but with inadequate guards.\nThe High gravity is therefore intolerable so a serious risk exists.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "As an example, for certain mechanical risks the following definitions of the severity classifications may be proposed, with typical corresponding injuries: SlightSeriousVery serious< 2 % incapacityusually reversible and not requiring hospital treatment.2-15 % incapacityusually irreversible requiring hospital treatment> 15 % incapacity usually irreversibleMinor cutsSerious cutsSerious injury to internal organsFracturesLoss of limbsLoss of finger or toeLoss of sightDamage to sightLoss of hearingDamage to hearing"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2004/905/annex/annex/II",
    "retrieved_at": "2026-11-01T15:18:03.290347+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."
}