«COMMISSION COMMISSION DECISION of 14 December 2004 laying down guidelines for the notification of dangerous consumer products to the competent ...»
28.12.2004 Official Journal of the European Union L 381/63
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) put forward, possibly in the form of a guide, simple and
THE COMMISSION OF THE EUROPEAN COMMUNITIES,clear criteria for determining the special conditions, particularly those concerning isolated circumstances or products, for which notification is not relevant.
Having regard to the Treaty establishing the European Community, The obligation to inform the authorities about dangerous (3) products is an important element for improved market Having regard to Directive 2001/95/EC of the European surveillance as it enables the competent authorities to Parliament and of the Council of 3 December 2001 on monitor whether the companies have taken appropriate general product safety (1), and in particular the second subparmeasures to address the risks posed by a product already agraph of Article 5(3) thereof, placed on the market and to order or take additional measures if necessary for avoiding risks.
After consulting the Committee set up by Article 15 of Directive 2001/95/EC, In order to prevent a disproportionate
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
The GPSD mandates the Commission, assisted by the GPSD Committee of Member States, to draw up a guide defining simple and clear criteria to facilitate the effective application of this obligation. In addition the guide is to simplify the work of economic operators and the competent authorities by defining the particular conditions, especially isolated circumstances or products, for which notification is not appropriate. The guide should also define the content and lay out of the standard form for notifications by producers and distributors to the authorities.
(a) clarify from the operational point of view the scope of producers’ and distributors’ obligations in such a way that only the information relevant for risk management is notified and that any information overload is prevented;
(b) make reference to relevant criteria for applying the concept of ‘dangerous products’;
(c) provide criteria for identifying the ‘isolated circumstances or products’ for which notification is not relevant;
(d) define the content of notifications, in particular the information and data required, and the form to be used;
1.3. To whom the guidelines are addressed These guidelines are addressed to the Member States. They should be used to guide producers and distributors of consumers’ products as well as the national authorities designated as contact points to receive information from producers and distributors, in order to ensure the effective and consistent application of the notification requirement in question.
‘Isolated’ circumstances or products are excluded from the obligation to notify.
Producers and distributors could give the authorities preliminary information about a potential product risk as soon as they are aware of it. With this information the authorities may be able to help producers and distributors to carry out their notification duty correctly. In addition, they are encouraged to contact their national authorities if they have a doubt as to whether a product risk exists.
2.2. Reason and objectives for the provision on notification The obligation to inform the authorities about dangerous products is an important element for improved market surveillance and risk management.
Producers and distributors, within the limits of their respective activities, are responsible in the first instance for preventing risks from dangerous products. However, producers and distributors may not have taken (or may not be in a position to take) all the necessary measures. Moreover, other products of the same type may pose risks similar to those related to the products considered.
The purpose of the notification procedure is to enable the competent authorities to monitor whether the companies have taken appropriate measures to address the risks posed by a product already placed on the market and to order or take additional measures if necessary to prevent risks. The notification also allows the competent authorities to assess whether they should check other similar products on the market. Therefore, competent authorities must receive adequate information to enable them to assess whether an economic operator has taken adequate measures with regard to a dangerous product. In this respect it should be noted that the GPSD entitles the competent authorities to request additional information if they feel unable to assess whether a company has taken adequate measures with regard to a dangerous product.
It should be noted that separate requirements for the notification of dangerous food products are established by EU food law (Regulation (EC) No 178/2002 of the European Parliament and of the Council (1)).
If Community sectoral legislation on product safety establishes notification obligations with the same objectives that excludes the applicability of the GPSD obligation to the categories of products covered by the sectoral requirements.
For further information on the relationship between the notification procedures and their purposes, please see the Guidance Document on the Relationship between the GPSD and certain Sector Directives (2). This document will be further developed, in particular if in light of experience any overlapping or uncertainty appears concerning the application of Article 5(3) of the GPSD and relevant sectoral information or notification requirements in specific Community legislation.
In addition, it is worth noting that these guidelines are not relevant for, and do not interfere with the application of requirements concerning ‘safeguard clauses’ or other notification procedures established by vertical Community legislation on product safety.
— the product is within the scope of Article 2(a) of the Directive: a product intended for or likely to be used by consumers (including in the context of providing a service and second-hand products);
— Article 5 of the Directive is applicable (that is, no specific similar obligation is established by other Community legislation, cf. Article 1(2)(b) GPSD);
— the producer or distributor has evidence (from monitoring the safety of products on the market, from testing, from quality control or from other sources) that the product is dangerous as defined by the GPSD (it does not satisfy the general safety requirement, taking into account the safety criteria of the GPSD) or does not satisfy the safety requirements of the relevant Community sectoral legislation applicable to the product considered;
— the risks are therefore such that the product may not remain on the market and producers (and distributors) have the obligation to take appropriate preventive and corrective action (modifying the product, warnings, withdrawal, recalling, etc. depending on the specific circumstances).
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:
(i) the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
(ii) the effect on other products, where it is reasonably foreseeable that it will be used with other products;
(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.
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.
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 (1). 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 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.
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.