Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

2.3. Some useful tips

Seek information

As can be seen from the above examples, each of the above steps of a risk assessment requires anticipation of what might happen and how likely it is to happen, since the product under consideration will normally not have caused an accident, and thus the risk will not have materialised (yet). Previous experience with similar products will help in this exercise, as will any other information about the product, such as design, mechanical stability, chemical composition, operation, instructions for use, including possible risk management advice, type of consumers it is intended for (and those for which it is not), test reports, accident statistics, the EU Injury Database (IDB)(1), information about consumer complaints, about the behaviour of different consumers when they are using the product, and about product recalls. Product requirements laid down in legislation, in product standards or in checklists (such as in ISO 14121: Safety of machinery – Risk assessment) can also be useful sources of information.

Nevertheless, the products to be assessed may be quite specific and thus these sources may not contain the information required. The information collected may also be incomplete, inconsistent, or not fully plausible. This may be the case in particular for accident statistics, when only the product category is registered. The absence of an accident history, a small number of accidents or low severity of accidents should not be taken as a presumption of low risk. Product-specific statistics also have to be viewed with great care, since the product may have changed over time, be it in design or composition. The information must always be critically assessed.

Feedback from expert colleagues can be particularly useful, since they can draw from their real-life experience and provide suggestions that are not immediately obvious when assessing a product risk. They may also give advice when assessing the risk for different types of consumers, including vulnerable consumers such as children (see table 1), since the latter may handle a product differently. They may also help to assess the risk for different injuries that a product may cause, and the way in which those injuries emerge through the use of the product. They can also judge whether an injury scenario is ‘totally unperceived’, too unlikely, and then guide the risk assessor towards more realistic assumptions.

Thus, feedback from experienced colleagues, although not an obligation, can be helpful in several aspects. A risk assessor from an authority could seek advice from colleagues in that same authority, in other authorities, in industry, in other countries, in scientific groupings, and elsewhere. Conversely, any risk assessor in industry could use his contacts with authorities and others when a new or improved product is to be assessed before it is placed on the market.

New information obtained should of course be used to update any existing risk assessment.

Make a sensitivity analysis of your risk assessment

If all information searches and queries to expert colleagues do not provide the required, very specific data, a so-called sensitivity analysis might help. In this analysis a lower and a higher value than previously chosen is assumed for each parameter of the risk assessment, and taken through the entire risk assessment procedure. The resulting risk levels will show how sensitive the risk level reacts to the input of lower and higher values. In this way the range in which the real risk of the product will be can be estimated.

If the most likely value of each parameter can be estimated, then those most likely values should be taken through the procedure, and the resulting risk level will be the most likely risk.

An example of a sensitivity analysis is illustrated in section 6 below.

Let others check your risk assessment

Feedback from colleagues will also help when finalising the risk assessment. They will be able to provide advice on the assumptions and estimations made during the three steps above. They will feed in their experience and thus help to generate a more robust, more solid, more transparent and ultimately more acceptable risk assessment. It is therefore recommended that, ideally, advice be sought from expert colleagues, possibly in the form of a group discussion, before concluding a risk assessment. These groups, of perhaps 3 to 5 members, should include a combination of expertise appropriate to the product under assessment: engineers, chemists, (micro-)biologists, statisticians, product safety managers, and others. Group discussion will be particularly useful when a product is new on the market and has never been assessed before.

Risk assessments should be solid and realistic. However, since they require a number of assumptions, different risk assessors may come to different conclusions in view of the data and other evidence they have been able to find or because of their diverging experience. It is thus necessary for risk assessors to talk to one another in order to reach agreement or, at least, consensus. The step-by-step risk assessment described in these guidelines, however, should make such discussions more productive. Each step in a risk assessment must be clearly described in detail. Thus, any point of disagreement can be quickly identified, and consensus can more easily be reached. This will make risk assessments more acceptable.

Document your risk assessment

It is important to document your risk assessment, describing the product and all the parameters that you chose while developing it, such as test results, the type(s) of consumers you chose for your injury scenario(s), and the probabilities with the underlying data and assumptions. This will enable you to demonstrate unambiguously how you estimated the level of risk, and it will also help you to update your assessment while keeping track of all changes.

Several hazards, several injuries – but only one risk

When several hazards, several injury scenarios or differing severities of injuries or probabilities have been identified, each of those should be carried through the entire risk assessment procedure in order to determine the risk for each. As a result, the product may have several risk levels. The overall risk of the product is then the highest risk level identified, because action on the highest risk level is normally the most effective way of risk reduction. Only in special cases may a less-than-highest risk be considered particularly important, since it may require specific risk management measures.

As an example of several risks, a hammer may have a weak head and a weak grip, each of which may break when the hammer is used, and the consumer may be injured. If the relevant scenarios lead to different risk levels, the highest risk should be reported as ‘the risk’ of the hammer.

It could be argued that

• the apparently most significant hazard should be decisive, since it would lead to the most severe injuries. In the above example of the hammer, this could be the hammer head breaking, since pieces of the broken head could fly into one’s eye, possibly blinding the user. The hammer grip breaking, on the other hand, would never split into small pieces that could do as much damage to the eyes.

  However, this would be a hazard assessment, not a risk assessment. A risk assessment also looks at the probability of an injury actually happening. Thus, the ‘most significant hazard’ might cause an injury that is much less likely than a lesser hazard, and therefore present a lower risk. Conversely, a scenario leading to a less severe injury may be much more likely than a scenario resulting in death, and the less severe injury may therefore present a higher risk;

• the highest probability for an injury scenario to happen should be the decisive factor for ‘the risk’ of the product. In the above example of the hammer, if the hammer grip is very weak, the most likely injury scenario would be from the grip breaking, and that should therefore be decisive.

However, this would not consider the seriousness of eye injuries that the hammer head breaking could cause. Looking at probability alone would not therefore give the whole picture.

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. Taking the highest risk as ‘the risk’ of the product will ensure the most effective product safety (apart from specific risks requiring specific risk management, as mentioned above).

Can risks cumulate?

Several injury scenarios leading to several risks can be developed for virtually every product. For example, an angle grinder may present the risk of an electric shock, because electrical wires may be too exposed, and the risk of fire, because the machine may overheat and ignite during normal use. If both risks are considered to be ‘high’, do they add up to the grinder posing an overall ‘serious risk’?

Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury. The overall likelihood of an injury is therefore greater. This does not mean that the overall risk is automatically higher, however:

• The overall probability is not calculated by simply adding up probabilities. More complex calculations are necessary, and these always result in a probability that is lower than the sum of all probabilities.

• There is difference of a factor of 10 between two succeeding probability levels (table 4). This means that a lot of different scenarios of the same level would be needed to result in higher overall probability (and possibly risk).

• Probability values are estimations which may not be totally accurate, as they often err on the ‘safe’ side in order to ensure a high level of protection. It is therefore more useful to look at a more accurate estimation of the probability of a scenario leading to the highest risk than to add up rough estimations of probabilities of all sorts of scenarios.

• With a little effort hundreds of injury scenarios could be developed. If risks were simply added together, the overall risk would depend on the number of injury scenarios generated and could increase ‘endlessly’. This does not make sense.

Thus, risks are not simply cumulated. However, if more than one relevant risk exists, action to manage the risks may need to be taken more rapidly or may need to be more pronounced. For example, with two risks, a product may need to be immediately taken off the market and recalled, whereas, with a single risk, halting sales could be sufficient.

Risk management depends on many factors, not only on the number of risks that a product may present at one and the same time. Thus, consideration is given below to the link between risk and risk management (section 4).

Compliance with limit values in legislation and standards

In market surveillance, consumer products are often tested against limit values or requirements laid down in legislation and in product safety standards. A product that complies with the limit value(s) or requirement(s)(2) is presumed to be safe in terms of the safety characteristics covered by those value(s) or requirement(s). This assumption can be made because the risks of a product from its intended and reasonably foreseeable use are taken into account when establishing the limit value(s) or requirement(s). Manufacturers thus need their products to comply with these values or requirements, because they then only have to look at risks with their products that are not be covered by those limit value(s) or requirement(s).

An example of a limit value in

• legislation is the limit of 5 mg/kg benzene in toys which must not be exceeded, as per point 5 of Annex XVII, to the REACH Regulation(3), as amended by Commission Regulation (EC) No 552/2009(4);

• a standard is the small parts cylinder: small parts of a toy for children under 36 months must not fit entirely into the cylinder described in the Toys Standard(5). If they do, they present a risk.

The product is presumed not to be safe where it fails to comply with established limit values. For limit values laid down in

• legislation, such as on cosmetics or restrictions on marketing and use, the product must not be made available on the market;

• standards, the manufacturer may nevertheless try to provide evidence that his product is as safe as if it were compliant with the standard’s limit value by way of a fully fledged risk assessment on his product. However, this may require more effort, and may be impossible in cases such as the small parts cylinder referred to above, than actually manufacturing the product in compliance with the standard’s limit value.

Non-compliance with limit values does not automatically mean that the product presents a ‘serious risk’ (which is the highest risk level covered by these guidelines). Therefore, to ensure appropriate risk reduction measures, a risk assessment will be required for those parts of a product that do not comply with or are not covered by legislation or a standard.

Furthermore, some products, such as cosmetics, require a risk assessment even when they are compliant with the limit values laid down in legislation. This risk assessment should provide evidence of the safety of the whole product(6).

In conclusion, compliance with limit values in legislation or in standards provides presumption of safety, but such compliance may not be sufficient.

Specific risk assessment guidelines in specific cases

For chemicals there are specific instructions on how to prepare a risk assessment(7), and therefore they are not dealt with in detail in these guidelines. Nevertheless, they follow the same principles as for ‘normal’ consumer products:

• hazard identification and assessment – this is the same as determining the severity of the injury, as described above;

• exposure assessment – in this step, exposure is expressed as the likely dose of the chemical that the consumer may take up via oral, inhalation or dermal routes, separately or jointly, when using the product as anticipated in the injury scenario. This step is the same as determining the probability that the injury will indeed occur;

• risk characterisation – this step basically consists of comparing the dose of the chemical that the consumer is likely to take up (= exposure) with the derived no-effect level (DNEL) of that chemical. Should the exposure be sufficiently lower than the DNEL, in other words, should the risk characterisation ratio (RCR) be clearly below 1, risk is considered to be adequately controlled. This is the same as determining the risk level., Risk management measures may not be needed if the level of risk is sufficiently low.

Since a chemical may possess several hazards, risk is normally determined for the ‘leading health effect’, which is the health effect (or ‘endpoint’ such as acute toxicity, irritation, sensitisation, carcinogenicity, mutagenicity, toxicity for reproduction) considered to be the most important.

For cosmetics, there is also specific guidance(8), and there may be specific guidance for other products or purposes.

It is highly recommended to use such specific guidance, since it is tailored to the specific cases in question. Nevertheless, where the data required by the specific guidance do not exist or cannot be estimated the present guidelines may be used for a preliminary risk assessment. This risk assessment will have to be carried out with due care and attention in order to avoid any misinterpretation.

(1)

https://webgate.ec.europa.eu/idbpa/

(2)

NB: uncertainty always has to be taken into account when comparing a test result with a limit. See, for example:

• the ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation …’ http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf

• the Summary report on the ‘Preparation of a working document in support of the uniform interpretation of legislative standards and the laboratory quality standards prescribed under Directive 93/99/EEC’. http://ec.europa.eu/food/fs/scoop/9.1_sr_en.pdf

(3)

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(4)

OJ L 164, 26.6.2009, p. 7.

(5)

Standard EN 71-1:2005, section 8.2 +A6:2008.

(6)

Article 7a(1)(d) of Council Directive 76/768/EEC (OJ L 262, 27.9.1976, p. 169).

(7)

REACH Regulation and guidance documents on REACH, see http://echa.europa.eu/

European Chemicals Agency (2008). The Guidance on Information Requirements and Chemical Safety Assessment: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

(8)

Scientific Committee on Consumer Products (SCCP), The SCCP’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 6th revision, 19.12.2006: http://ec.europa.eu/enterprise/cosmetics/html/testing_guidance.htm