Topic outline


    Risk assessment

    The risk assessment must take into account all aspects that affect the safe use of the product, such as:

    • intended purpose of use
    • foreseeable uses and conditions of use
    • hazards and risks associated with the use of the product
    • potential misuse (way or purpose for which the manufacturer did not intend the product to be used)
    • the user group and its specific characteristics that involve risks, such as children

    The Consumer Safety Act does not lay down detailed requirements for the characteristics of a product.

    The safety assessment of a product can be based on national and international standards, recommendations from the European Commission or guidelines from the supervisory authority, or you can use a testing facility. For example, in the absence of a product-specific standard, the applicable parts of standards made for other similar product groups can be used in relation to risks. 

    For example, Tukes has applied the standard for soother holders when assessing the safety of childcare goods that were not described as a soother holder, but their intended use was the same. The childcare product in question is a ribbon that can be used to attach a sipper cup to a highchair so that the child cannot throw the cup on the floor. The standard for soother holders does not apply to such a strap in principle, but since the purpose and way of use is very similar, it was estimated that a strap of a considerable length creates a risk of strangulation like that of a soother holder with too long chain. 

    The operator is responsible for product safety and risk assessment. It has a duty to know its products and the risks associated with them. Risk assessment is part of product design. 

    Eliminating risks 

    Operators cannot choose whether to eliminate risks with technical solutions or statutory markings. Risks must be primarily minimised with technical solutions. Instructions and warnings are a secondary method. 

    Products that are an important part of consumers’ daily lives can be accepted with some controlled risks. There are products that pose risks to the user, but the danger is not particularly severe or difficult to foresee if they are:

    • properly designed and manufactured
    • appropriately labelled and have instructions and
    • carefully used by the appropriate user group 

    An axe is a good example of a product with a high potential for serious accidents. Yet it is a necessary and useful tool in some circumstances. Many manufacturers have developed the product – for example, in how the blade is attached to the handle to prevent it from detaching in any circumstances. The handle is also shaped so that one can grip it firmly. A knife must also be sharp to serve its purpose, and a candle has a flame for a reason. 

    Usually, risks are unacceptable in products that are not essential or less important in everyday life, such as decorative items. In the case of such products, the residual risk cannot be eliminated with user instructions and warnings; the product must be designed and manufactured to be safe.

    For example, in the case of a decorative oil lamp, a warning text alone is insufficient; the legislation requires a technical solution that prevents children from accessing the oil contained in the lamp.

    When a product poses a risk

    If an operator becomes aware that a consumer product poses a risk, it must immediately take measures to eliminate the risk and inform the authorities. 

    The operator should be prepared by having an action plan in advance for dealing with a dangers caused by a product. The plan can be part of a quality management system. At its simplest, the operators should have a written plan or policy on how to handle product complaints, and how to react to potentially dangerous products.

    Quality system/Management system

    Although a business distributing general consumer goods is not required to have a quality system, its use can be of considerable benefit to the business. In practice, a quality system means a system of high-quality management.

    Modern quality thinking usually concerns a management rather than a quality system, because experience has shown that establishing a separate quality organisation does not always serve its purpose in a business. The best system is one where quality starts from management, and which engages all stages of the processes in high-quality and the continuous development of operations.

    There are several ready-made models and tools that assist in the deployment of a quality system, such as the ISO 9000 series of standards on the management of organisational operations in terms of quality management and quality assurance.

    If a product does not fulfil the legal requirements and poses a risk to health, safety or the environment, the operator must:

    • Stop selling the product immediately and, if necessary, remove the product from the market, i.e. all stages of the distribution chain.
    • Notify Tukes immediately about the product that poses risks and the measures taken concerning the product. The business can submit the notification with the form available on the Tukes website or send the notification to the Tukes registry.
    • Submit a notification on the product posing a risk and on the relevant measures taken to competent authorities in EU or EEA countries in which the product has been sold. The notification can be made through the Product Safety Business Alert Gateway system.
    • recall products posing a severe risk from consumers and other end users. The distributors and consumers who have already purchased the products, as well as other end users, must be informed of the recall.

    A serious risk requires both quick action and follow-up by the operator, including in cases in which the effects do not appear immediately. Timely and adequate measures are the operators responsibility, even if it has submitted a notification to the authorities. The operator must take the necessary measures on its own initiative.

    Taking foreseeable misuse into account

    The operator must assess which instructions the consumer needs to use the consumer product safely. Risks in consumer products must be eliminated primarily by product design, and the instructions for use are only a secondary means of reducing risks.

    The user instructions and warnings must consider the possibility of misuse. This is a situation in which a consumer product is unintentionally but foreseeably misused. Different misuse situations should already be considered in the product design, and before making the product available. All imaginable but unlikely ways of misuse do not need to be acknowledged.

    When thinking of ways of misuse, one should pay attention to the following:

    • Is it possible to misuse the consumer product because it has the same characteristics as another consumer product?
    • Is it likely that the consumer product will be misused because it lacks some features that another consumer product with a similar intended use has?
    • Who are the potential users of the product? Pay special attention to specific groups such as children and elderly people.
    •  Can the product be confused with a product used for another purpose?
    •  Does the product’s use differ in any way from the way in which similar products are usually used?