Division 3.2 General safety requirement and conformity criteria

Producers and distributors must inform the competent authorities of the Member States if a product they have placed on the market poses a risk to consumers ‘that is incompatible with the general safety requirement’. Producers are obliged to place only ‘safe’ products on the market. Article 2(b) defines a safe product as one that under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons taking into account the following points in particular:

1. (i)

   the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;

2. (ii)

   the effect on other products, where it is reasonably foreseeable that it will be used with other products;

3. (iii)

   the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;

4. (iv)

   the categories of consumers at risk when using the product, in particular children and the elderly.

The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be ‘dangerous’.

Any product that does not meet this definition is regarded as dangerous (Article 2(c)). In other words, a product is ‘dangerous’ when it does not satisfy the general safety requirement (products on the market must be safe).

Article 3 GPSD describes how conformity is assessed with reference to national legislation, European standards and other reference material. Where suitable European standards do not exist, the GPSD allows other elements to be taken into account in assessing the safety of a product: national standards, codes of good practice, etc.

In addition to the above, the Directive also refers to serious risk, which is defined in Article 2(d) as ‘any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities’.

Nevertheless, the Directive recognises that the feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk do not constitute grounds for considering a product to be ‘dangerous’.

The level of risk could depend on a number of factors such as for example the type and vulnerability of the user and the extent to which the producer had taken precautions to guard against the hazard and warn the user. It is considered that these factors should also be taken into account in determining the level of risk that is regarded as dangerous and requires producers to notify the competent authorities.

A risk could be the result of a manufacturing or production error or it could result from the design of, or the materials used in, the product. A risk could also arise from a product's contents, construction, finish, packaging, warnings or instructions.

In determining whether a product is dangerous under the terms of the GPSD several issues should be analysed: the utility of the product, the nature of the risk, the population groups exposed, previous experience with similar products, etc. A safe product must have no risk or only present the minimum risk compatible with the product's use and needed in order to ensure useful operation of the product.

Producers are expected to undertake a risk assessment of their products before they are marketed. This will form both the basis of their conclusion that the product satisfies the general safety obligation and can be marketed, and also provide a reference for subsequent reassessment of further risk information and whether the product continues to satisfy the definition of ‘safe product’ or notification needs to be made.

If producers or distributors become aware of information or new evidence showing that a product may be dangerous they should determine whether such information leads to the conclusion that a product is actually dangerous.

The guidance referred to in this document was developed for the Guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC ^f1. It is presented here in order to assist producers or distributors to decide if a specific situation caused by a consumer product justifies a notification to the competent authorities. It represents a methodological framework intended to promote consistency and does not take account of all possible factors, but should facilitate consistent, reasoned, professional judgements on the risks posed by specific consumer products. However, if producers or distributors consider that they have clear evidence based on different considerations of the need for notification they must carry out the notification.

Producers or distributors should analyse the information collected and decide whether a particular hazardous situation should be notified to the authorities taking into account:

• the gravity of the outcome of a hazard, depending on the severity and probability of the possible health/safety damage. Combining the severity and probability gives an assessment of the gravity of the risk. The accuracy of this assessment will depend upon the quality of the information available to the producer or distributor.

  The severity of health/safety damage for a given hazard should be that for which there is reasonable evidence that the health/safety damage attributable to the product could occur under foreseeable use. This could be the worst case from health/safety damages that have occurred with similar products.

  The probability of health/safety damage for a normal user who has an exposure corresponding to the intended or reasonably expected use of the defective product has also to be considered as well as the probability of the product being or becoming defective.

  The decision to notify should not be influenced by the number of products on the market or by the number of people who could be affected by a dangerous product. These factors may be taken into account in deciding on the type of action to be taken to solve the problem.

• the factors which affect the level of the risk such as the type of user and, for non-vulnerable adults, whether the product has adequate warnings and safeguards and whether the hazard is sufficiently obvious.

  Society accepts higher risks in some circumstances (e.g. such as motoring), than in others (e.g. such as children's toys). It is considered that among the important 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.

  The type of person using a product should be taken into account. If the product is likely to be used by vulnerable people (such as children, the elderly) the level of risk which should be notified should be set at a lower level.

  For non-vulnerable adults the level of risk which is high enough to require notification should depend on whether the hazard is obvious and necessary for the function of the product and whether the manufacturer has taken adequate care to provide safeguards and warnings, especially if the hazard is not obvious.

Annex II gives more details on the risk estimation and evaluation assessment method developed for the Guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC. Other methods may be suitable and the choice of method may depend on the resources and information available.

Producers and distributors should be encouraged to contact the authorities if they have evidence of a potential problem in order to discuss whether a notification is appropriate. The authorities will be responsible for assisting and helping them to correctly fulfil their notification obligation.