Review and revision of directive 92/59/EEC (General Product Safety) - Discussion paper

June 1999

Health and Consumer Protection Directorate-General has conducted in 1998 a preliminary assessment of the application and functioning of the General Product Safety Directive, including consultations with national competent authorities.

Three meetings of a Consumer Safety Working Party have been partly devoted to this subject. Preliminary working papers were presented by the Commission at these meetings, in order to stimulate the discussion.

The present paper is still preliminary and takes into account progress of the reflection so far. It is intended to facilitate and concentrate the reflection on certain priority issues, without prejudice to the contents of the formal Commission proposal for the revision of the Directive. It is in particular intended for launching more complete consultation of stakeholders.

This note presents, for discussion, results of a preliminary review of the General Product Safety Directive (GPSD) and some preliminary reflections on issues to be considered for its possible amendment, in view of a proposal for its revision, which is due, according to the Commission work programme, before the end of 1999.

The review and revision of the Directive are required by its Article 16. According to that article, the Commission should have presented a report and appropriate proposals already in 1998. However, it was decided to postpone presentation of such proposals in order to acquire more experience, ensure a better preparation and, in particular, complete a study on the implementation of the Directive.

The overall preliminary conclusion from the assessment made so far, is that the Directive does not need a major reshaping, but only reinforcement, clarification and improvement on particular aspects. However, some of those aspects are of the utmost importance in relation to the objectives of the Directive and the corresponding amendments are therefore necessary. Moreover, the revision of the Directive would offer the opportunity to clarify the text on other points where there is some uncertainty of interpretation, thus ensuring greater coherence and legal certainty.

In the light of the above, it is felt that the best approach for the preparatory work is, in this specific case, to concentrate on the aspects where the experience has shown that some weaknesses exist or improvements are desirable, and to assess the needs, possibilities and justifications for amendments addressing the relevant issues.

Moreover, given the wide scope and objectives of this Directive and the limited aims of the revision exercise, it seems that an overall, systematic, detailed and quantified appraisal of the functioning of the Directive and of its amendments, including their cost-benefit analysis, would not be an appropriate analytical approach in this case. A more qualitative assessment would suffice in this case and be more in line with the need to ensure a reasonable use of resources.

Council Directive 92/59/EEC on general product safety (GPSD) was adopted on 29 June 1992 and was to be applied by the Member States at the latest by 29 June 1994.

All Member States have by now adopted measures to implement the Directive.

The Directive was based on Article 100A (now Article 95) and was adopted, before the entry into force of the Maastricht Treaty, in co-operation with the European Parliament.

The Directive regulates the safety of consumer products and aims at ensuring that products placed on the market are safe.

The overall motivation of this Directive was to harmonise the measures of the Member States aimed at imposing general obligations to market only safe products, in order to ensure both a consistent, high level of protection of consumer health and safety through the EC and the proper functioning of the internal market.

According to the preamble of the Directive, a broadly based, legislative framework of a horizontal nature is needed in order to cover products not covered by specific, sectoral Community legislation and also to "cover lacunae in existing of forthcoming specific legislation".

Therefore, the Directive is intended as a complement to sectoral Community legislation:

• It covers products which are not subject to sectoral legislation;
• It also covers, products that are subject to sectoral legislation (existing and forthcoming) for the categories of risks, safety aspects, and administrative and control requirements, which are not addressed in such sectoral legislation.

However, the preamble of the Directive clarifies that, when there are rules of the total harmonisation type which lay down obligations regarding product safety, further obligations on the marketing of the products covered by such rules should not be imposed on economic operators. This is in general the case of products covered by the "new approach" Directives. Moreover, Article 1 states that "where specific rules of Community law contain provisions governing only certain aspects of product safety or categories of risks for the products concerned, those are the provisions which shall apply to the products concerned with regard to the relevant safety aspects or risks".

In summary, Directive 92/59/EEC includes the following main provisions:

• Obligation for producers to place only safe products on the market.

The products covered are those intended for consumers or likely to be used by consumers, supplied in the course of a commercial activity.

Are included new, used and reconditioned products, with the exception of antiques and products sold in view of their reconditioning, provided that the supplier informs the consumer.

A generic definition of "safe product" is provided.

• Obligation for producers to provide consumers with the relevant information to assess the risks associated with a product.
• Obligation for producers to adopt measures to be informed of risks posed by the products which they supply, and take action to prevent those risks, including withdrawal of products when necessary.
• Obligation for distributors not to supply products which they know or should have presumed to be dangerous, and to collaborate in the monitoring of the safety of products they supply and in action to avoid the risks.
• Definition of criteria for assessing product safety and deciding under which conditions a product should be deemed to be safe.
• Obligation for the Member States to take measures in order to make producers and distributors comply with their obligations. This includes in particular establishing or designating market surveillance authorities empowered to adopt a range of control and enforcement measures and to impose sanctions in the event of failure to comply with the obligations of the Directive.
• Obligation for the Member States to notify the Commission of the measures they take restricting the marketing of products or imposing their withdrawal from the market.

The Commission examines the reasons for the measures and informs all Member States when it concludes that a measure is justified.

• Establishment of a rapid exchange of information system (RAPEX) for rapid exchange of information on products posing a "serious and immediate" risk, when a Member State adopts or decides to adopt measures to prevent, restrict or impose specific conditions on the marketing or use of such products. Details of the functioning of the system are set out in an annex to the Directive.
• Establishment of a procedure under which the Commission may adopt temporary, emergency, Community-wide measures concerning products which pose serious and immediate risks, subject to a number of substantive and procedural conditions.
• Setting of an "Emergencies Committee" in charge of assisting the Commission on matters related to RAPEX and acting as a regulatory "3b" committee in the procedure for adoption of Community emergency measures.
• Obligation for Commission's and Member States' officials not to disclose confidential information obtained for the purposes of the Directive, except for information relating to the safety of a product which must be made public in order to protect the health and safety of persons.

Article 16 of Directive 92/59/EEC states:

"Four years from the date referred to in Article 17 (1), on the basis of a Commission report on the experience acquired, together with appropriate proposals, the Council shall decide whether to adjust this Directive, in particular with a view to extending its scope as laid down in Article 1 (1) and Article 2 (a), and whether the provisions of Title V should be amended."

Reference is therefore made, in view of the Directive revision, to its scope (Articles 1 (1) and 2 (a) and to Title V (Emergency situations and action at Community level).

Article 1 (1) says, "the purpose of this Directive is to ensure that products placed on the market are safe".

This article is relevant for defining the directive's scope in that it limits it to products, therefore excluding services.

Article 2 (a) states, i.a.: "products shall mean any product intended for consumers or likely to be used by consumers, supplied whether for consideration or not in the course of a commercial activity and whether new, used or reconditioned. ..."

Here also, services are not mentioned. Moreover, the scope is restricted to products intended or likely to be used by consumers, therefore excluding products for professional use or use in any trade or industry activities.

In order to comply with the requirements of Article 16 of the General Product Safety Directive, an assessment of the implementation and the functioning of the Directive is in progress

Work made so far, in particular consultations with the Member States, leads to preliminary indications on the needs and possibilities for modification of the Directive.

Later on, a report on the implementation of the Directive will be presented, based on results of a study on the subject, presently in progress.

At this stage, it appears that the following issues should be considered in relation to the Directive's revision:

• Scope of the Directive
• Emergency situations and action at Community level

which are explicitly mentioned in Article 16 of the GPSD, and

• Conformity assessment criteria and product safety standards
• Market surveillance
• Application of the "precautionary principle"
• Regime applicable to export to third countries of "dangerous" products
• Safeguard clause

for which the experience with the application of the GPSD has shown significant weaknesses in the present provisions, and finally

• Obligations of producers and distributors
• Confidentiality requirements
• Committee
• Relationship with other Community legislation

which are issues on which the review of the Directive offers an opportunity to introduce useful improvements and clarifications.

Two issues in particular were debated by the Council and EP concerning the scope of the GPSD:

• Its possible extension to cover services
• The possible coverage of products other than those intended or likely to be used by consumers, i.e. products for professional, trade or industrial use.

No Community horizontal regulatory framework exists by now for services.

A proposal for a Directive on the liability of service providers was presented by the Commission in 1990. The proposal was subject to a difficult debate, in particular in the EP and was finally withdrawn by the Commission in 1994. When withdrawing that proposal, the Commission announced in a communication a revision of its approach in this field, highlighting in particular the opportunity to focus Community initiatives on well chosen priority sectors.

Services represent a major element of the European economy. The opening of market for services is increasing their relevance for the internal market both on the side of demand and of supply. Finally consumer health and safety aspects are very relevant in several service sectors.

The European Parliament has recently invited the Commission, in its Resolution on a Consumer Policy Action Plan 1999-2001 to lay down mandatory regulations on the liability of service providers in certain services.

Therefore, Community action in the field of service safety should indeed be considered. However, the difficult discussion on the proposal on liability of service providers has demonstrated the need for careful preparation of any proposal in this sensitive area.

As a consequence, a systematic evaluation of the justifications, needs and priorities for Community action on service safety is presently being launched.

In this context, a proposal to include services in the scope of the GPSD seems premature at this stage.

Moreover, several provisions of the Directive would not be adapted to services (p.ex. the market surveillance measures, the "safeguard clause", the rapid exchange of information provisions etc), whereas others would require a re-definition which poses difficult problems (p.ex. transposal to services of the concept of safe products).

In conclusion, both for reasons of timing and substance, it seems more appropriate to deal with service safety under separate, specific initiatives, to be developed rapidly.

The Commission proposal for a Directive on General Product Safety, presented in 1989 included in its scope all products, covering therefore also products intended for use by workers or professionals in trade and industry.

The discussions on that aspect of the proposal led the Council to conclude that the scope should be restricted to Consumer products for the following reasons:

• The safety of a product used by a service supplier, vis-à-vis the consumers being supplied the service, depended on the intrinsic characteristics of the product, but also on the way in which it was used by the service supplier. It was considered impossible to deal separately with these two aspects.
• The safety of a product in relation to the service supplier himself or its personnel (workers, professionals) had to be considered in conjunction with the legislation applicable to worker's protection. Whereas certain safety aspects of some of these products are subject to sectoral Community legislation (machinery, safety of "low voltage" electrical equipment...), a wide horizontal regulatory framework might impinge on aspects of workers' safety which are normally dealt with in relation to requirements applicable to industrial or trade installations, facilities or equipment including safety measure at work, training, etc.

In consideration of the above, the possible complications or extending the scope of the Directive were considered high and the added value of such an extension low.

These conclusions seem still valid as far as products intended for use by workers or professionals without direct potential impact on consumer safety are concerned.

However, products are sometimes supplied to consumers or put at their disposal for use in the course of a service. Moreover, certain equipment or products used by service providers have a direct relevance for consumer safety, independently from the professional skills, organisation etc of the provider, i.e. even when used as intended.

In such cases, it is the intrinsic characteristics of products that matter directly, for consumer safety. When such products are not also supplied to consumers outside the services in question, there might be uncertainty, under the present formulation, whether they are covered by the GPSD.

In some cases the service supplier acts as a producer. In some other cases the service supplier has little influence on the safety for consumers of a product used in supplying the service. There is no justification for excluding these products from the scope of the Directive.

Therefore, it would be useful to clarify the interpretation of the Directive on this particular aspect.

Finally, the Directive applies to products intended for consumers or likely to be used by consumers. Certain products, which were originally not intended for consumers have "migrated" from professional sectors to the broader consumer market. Since these products are by now "likely to be used by consumers", it should be clear that they are covered by the GPSD.

Laser pens had been developed originally for professional use and allowed on the market as intended for professionals. However, the same technology has been used to develop and market products intended for consumers, which do not comply with the general safety requirement of the Directive. It has taken a certain time to clarify the situation and enforce requirements appropriate for the new utilisation of the technology in question. It should be clearer to all interested parties that when a product or technology "migrates" from the professional sector to the general consumer market, the safety requirements applied must be adapted accordingly.

This is the second issue explicitly mentioned in Article 16 in view of the Directives revision.

Title V includes two provisions: the establishment of a rapid exchange of information system and the setting of a procedure for taking at Community level temporary emergency measures. Both provisions refer to products posing "serious and immediate risks".

These provisions were subject to lengthy negotiations before the adoption of the Directive and the fact that Title V is mentioned in Article 16 reflects generic concerns at that time which were expressed by some Member States, in particular on the Community emergency measures.

In the absence of clear indications from the Council at the time of the adoption of the Directive on issues to be considered for the revision in this area, a preliminary review of the needs for amendment should be based on the experience made so far.

Title V provisions apply to "serious and immediate risks".

Annex I states:

"The system is essentially aimed at a rapid exchange of information in the event of a serious and immediate risk to the health and safety of consumers. It is impossible to lay down specific criteria as to what, precisely, constitutes an immediate and serious risk; in this regard, the national authorities will therefore judge each individual case on its merits. It should be noted that, as Article 8 of this Directive relates to immediate threats posed by a product to consumers, products involving possible long-term risks, which call for a study of possible technical changes by means of directives or standards are not concerned." (Underlining added)

The wording of these provisions and in particular the explicit exclusion of "long-term risks", represent a shortcoming of the Directive and have posed concrete problems in its implementation. In particular, there have been uncertainties on the applicability of Articles 8 and 9 to the case of risks related to long-term effects (carcinogenic, mutagenic, endocrine disruption...), but requiring immediate intervention because of the need to rapidly remove the causes of such long-term effects.

The case of phthalates containing toys, is an example of the need to ensure the applicability of the provisions of Article 9 on Community emergency measures in a case where the risks for child health are related to release of substances, whose potential adverse effects would be apparent only in the long term. Similar considerations would apply to all risks that, in spite of being related to exposure taking place in the short term, would bring serious adverse effects only at a much later stage. The same considerations apply to measures to be notified by the Member States under Article 8.

Therefore, consideration should be given to the need to cover all "serious risk requiring immediate intervention".

Various shortcomings have been noticed in applying Article 8.

In many cases action is taken in order to restrict or impose conditions on marketing of products posing serious risks requiring immediate intervention through voluntary measures, by distributors and/or manufacturers in agreement with the authorities.

Only in some cases are such measures notified under Article 8 and this represents a loss of information of high importance for consumer safety. Consideration should be given to the need to ensure that notification of such "agreed" measures be systematic.

Under the present arrangements for transmission of the information on the measures taken, the products in question and their risks, in the case of non-food products, several days are necessary for such information to reach the contact points. This can sometimes take longer when the notifications are not properly drafted.

Moreover, in four years of functioning since the entry into force of the Directive, only 182 notifications have been received, treated and sent to Member States. It is hardly believable that this corresponds to the real situation of market interventions.

In many cases, the information about the danger and description of product is unclear, or it is a lack of information about origin and manufacturer. Sometimes the Member States do not use the correct form, or the photos received by fax are useless, etc. In some cases, solving misunderstandings with the Member State notifying takes a time incompatible with the potential urgency of the matter.

The Annex to the Directive may need to be revised in order to increase the rapidity and effectiveness of the system. A clear description in the Annex of the information to be provided and its format, and of criteria for notifying under this system, could allow for introducing direct transmission without delay of such notifications to all Member States, with subsequent validation of the notification by the Commission.

Finally, the experience has shown that the follow-up given by the Member States to the notifications is limited. The objective of promoting through RAPEX a consistent, high level of protection through the EC is therefore not yet fully achieved.

In spite of the provisions in the Annex to the Directive on the information to be given to the Commission on the follow-up to notifications, on 47 notifications received, treated and sent to Member States in 1998, only 50% reactions have been forwarded.

The provisions on the follow-up to be given to notifications should be reinforced in order to ensure that products posing serious risks are adequately tackled.

Article 9 foresees the possibility of temporary emergency measures at Community level, taken by the Commission subject to several, cumulative conditions:

a. The Commission must learn about the risks from a Member State.

b. One or more Member States must have adopted restrictive measures against the product in question.

c. There must be divergence between the Member States on measures to be taken.

d. It must be impossible to deal with the risks in question under other applicable Community procedures in a manner compatible with the urgency of the case.

e. The risk can only be eliminated effectively by measure at Community level in order to safeguard consumer health and safety and the internal market.

f. The Member States must be preventatively consulted.

g. At least one Member State must request the Commission to take an emergency Community measure.

h. A type 3b Committee procedure must be applied before the Commission is allowed to adopt the measure.

Moreover, these temporary measures have a validity limited to 3 months. Prolongation of this period requires implementation of the same procedure as for the first adoption of the measure.

The multiple conditions applicable are difficult to reconcile with the very objective and justification of an emergency procedure, which is rapid intervention. Moreover, it has been difficult to reach agreement on the interpretation and fulfilment of these many conditions.

Finally, the very limited period of validity of such emergency measures discourages use of this procedure, knowing that it takes 3-4 years before a permanent Community measure can be put in place and therefore the temporary measure would have to be confirmed 12-16 times in order to bridge the gap!

In the light of the difficulties encountered, consideration should be given to reformulate the conditions for adopting Community emergency measure along the following lines:

• The products considered pose a serious risk requiring immediate intervention
• There is a need for action at Community level in order to ensure a consistent, high level of health and safety protection through the EU, and the integrity of the internal market.
• There are no specific emergency procedures applicable to the products in question under Community sectoral legislation.

The temporary measure should be valid for a longer period (e.g. one year) and could be renewed till the entry into force of a Community permanent measure, for which the Commission would be required to present a proposal as soon as possible.

In the case of an individual product or batch of products (e.g. a product of a specified model and brand) posing a serious risk requiring immediate intervention, a Community emergency measure would normally be taken when appropriate only following a notification under the Rapex system in order to rapidly enforce a consistent level of protection through the EU. In general, it is neither usual nor practical to introduce "permanent" emergency measures for individual, specific products through Council Directives, Regulations or Decisions. Measures taken under Article 9, in such cases might therefore need to be valid without a time limit.

Art. 4 of Directive 92/59/EEC states that, unless specific relevant regulatory requirements exist at Community or national level, the safety of a product must be assessed taking into account

• National standards transposing European standards, or
• Community technical specifications, or
• National standards, or
• Codes of good practices in respect of health and safety in the sector concerned, or
• The state of the art and technology and the safety which consumers may reasonably expect.

When a product is in compliance with specific applicable regulatory requirements, it is deemed to be "safe" in the sense of the Directive. In the absence of such requirements, the above mentioned non-binding specifications have to be taken into account in vetting the product.

The Directive seems to establish a hierarchic order among the specifications mentioned in the list.

The experience has shown that the potential of the Directive for ensuring consistent high level of protection through the EU and the proper functioning of the internal market is limited by the way in which conformity assessment criteria are defined and the lack of a legal status for them.

In particular, European standards do not confer "presumption of conformity" under this Directive, at the difference of harmonised standards under the "new approach" directives.

The nature, status and practical relevance of the other documents or references mentioned in Article 4 is very unclear.

Standardisation mandates to the European standardisation bodies for producing standards under this Directive are not explicitly mentioned and publication on the OJEC of the references of standards is not foreseen.

The lack of "status" of European standards under this Directive, has weakened its credibility as an effective instrument for ensuring harmonisation, when that is felt necessary. For instance, manufacturers of childcare articles have insisted on a specific "new approach" Directive for their products, in spite of the fact that they are covered by Directive 92/59/EEC and some specific European standards exist for them and are being completed and revised.

As a consequence of the above, on the side of both industry and consumers the need for additional sectoral legislation is often felt as the Directive is not always considered sufficient for the objectives of consumer protection and the internal market.

It would clearly not be possible to introduce in the Directive itself detailed safety requirements covering in a sufficient manner all the products falling into its wide scope. Therefore, it is essential to consider how to strengthen the role of European standards and other suitable specifications as criteria for establishing conformity of product to the general safety requirement of the Directive. In this way, the GPSD could provide a framework for ensuring a sufficient degree of harmonisation of consumer safety requirements, for the product groups most relevant for consumer safety and the functioning of the internal market, with a flexible approach while avoiding a proliferation of sectoral legislation.

The GPSD does not include (and could not include given its wide scope) specific "essential requirements" for the various product categories and risks it covers as it is the case for the "new approach" directive. Therefore, any standardisation mandates in this framework would need to be sufficiently detailed in order to guide standardisation bodies in setting European standards, and provide a reference for deciding whether a standard so produced is adequate in relation to the objectives of the Directive.

A specific procedure involving the Member States and the EP, in view of the establishment of standardisation mandates under this Directive and deciding to publish their references in the Official Journal of the EC might be considered in this particular case, in order to ensure an effective and institutionally balanced approach. The procedure for publication could apply also to already existing standards of the appropriate quality.

Article 4 mentions "Community technical specifications" among the conformity assessment criteria.

The experience has shown that European standards can represent only long term solutions to needs of common references for ensuring consistent levels of safety, given the long period needed to prepare and adopt a standard.

Therefore, it would be useful to clarify the nature, use and status of other technical specifications which could be used as an interim solution, pending adoption of a standard, or when a full standard is not necessary.

Such technical specifications might confer presumption of conformity to products in compliance with them, for the aspects that they cover.

Therefore, whereas the sources of such specifications could be various (standardisation bodies, technical bodies, research institutes), a procedure should be defined for conferring to them an appropriate status under the Directive, with all the necessary guarantees of quality, transparency and participation.

Market surveillance is crucial for the effectiveness of the GPSD and, more in general, the Community legislation applicable to consumer products.

Some weaknesses of the functioning of market surveillance through the EC and the needed for improvement have been identified in several occasions and were mentioned in the "Internal Market Action Plan".

Directive 92/59/EEC sets out, in its Title III, "obligations and powers of the Member States" relating to market surveillance and intervention.

Article 5 and 6 commit Member States to designate or establish the competent market surveillance authorities and to provide them with the relevant market intervention powers, including the power to apply sanctions in case of non-compliance with the Directive's requirements.

However, consideration should be given to the need to reinforce the content of Articles 5 and 6 , in particular in two respects.

First, these two Articles oblige the Member States to establish the relevant powers, but say nothing on the application of those powers or the practical operation of market surveillance. In some cases the necessary steps to appoint the competent authorities, to empower them to take the various kinds of measures foreseen etc, may have been taken, but those powers are implemented in a weak, insufficient or ineffective way.

Second, whereas as a consequence of the Treaty and Community secondary legislation, products circulate freely in the internal market, in particular, for certain categories of products, based on uniform essential requirements, harmonised standards and the CE marking, no formal requirements in view of arrangements for collaboration between market surveillance authorities are set up by Community legislation. The market is unified but the surveillance is fragmented. Structured and systematic collaboration between market surveillance authorities could lead to a much more effective and efficient surveillance, improving protection of consumer health and safety at a reduced cost for taxpayers.

However, structured collaboration between Member States' Competent Authorities in this field can only work effectively and efficiently if the market surveillance systems of the Member States, are at comparable levels of performance and proceed on the basis of equivalent principles and approaches. In the case of foodstuffs, Directives 89/397/EEC on the official control of foodstuffs and 93/99/EEC on additional measures concerning the official control of foodstuffs represent useful examples and relevant precedents in this respect.

The weaknesses of market surveillance in many circumstances have been highlighted very often. The Commission receives complaints from consumer associations concerning unsafe products that they find on the market, in spite of the requirements of Community legislation, including "new approach" Directives. Moreover, producers themselves do not trust the enforcement of Community legislation by the market surveillance authorities, when it comes to situations where they fear unfair competition by "free riders", as a recent case in the sector of lighters has demonstrated.

In addition to the existing provisions in Articles 5 and 6, consideration should be given to possible provisions related to the following elements:

• The tasks, powers, working procedures and organisation of the market surveillance authorities competent for the various sectors and aspects, to be defined in detail by the Member States should be made known to the Commission and the other Member States. Any modification should be communicated in due time.
• Adequate human, technical and financial resources should be allocated to the market surveillance, based on a review of tasks to be performed and a definition of objectives to be achieved.
• Market surveillance authorities should set up and implement structured management systems including auditing procedures, and working procedures taking into account as appropriate relevant European or international standards and best practices.
• Sectoral surveillance programs should be established, and reviewed and if necessary updated yearly. Yearly reports on surveillance activities, findings and results achieved should be drafted and be made publicly available.
• Market surveillance authorities should have and implement procedures to receive, consider, follow-up and answer complaints from consumers and other stakeholders concerning product safety or their own activities.
• Market surveillance authorities of the Member States should exchange information on their activities, including surveillance and test programs and test results, with the other Member States. Contents and procedures for such exchanges and other provisions concerning collaboration should be set out in co-operation between the Member States and the Commission.
• Market surveillance authorities might conduct joint surveillance projects. The Commission should facilitate the establishment of such projects.
• Member States should appoint market surveillance contact points, responsible for co-ordinating contacts and the application of collaboration procedures concerning market surveillance.

The above-mentioned collaboration among the Member States could take place within a European Product Safety Network as requested by the European Parliament.

Effectiveness of market surveillance activities also depends on the power of authorities to deter non-compliance by the possible application of adequate sanctions.

Finally, for certain market intervention measures, it is stated in Art. 6 that they can apply to "a product or product batch". The same is mentioned in relation to RAPEX and Community emergency measures. It might be useful to clarify that market intervention measures can also apply, where appropriate, to an entire product category including all like products presenting the same risk.

Under the General Product Safety Directive the Member States must adopt the necessary measures in order to ensure that producers and distributors comply with their obligations, in such a way that the products placed on the market are safe (Art. 5).

A generic definition of "safe product" is given and some conformity assessment criteria on mentioned.

The competent authorities have the responsibility to take the appropriate measures when they deem a product to be dangerous.

The experience has shown that decisions have sometimes to be taken by the national competent authorities or the Commission, in application of the Directive, in the absence of complete, definitive and quantitative scientific knowledge about the risks posed by a product.

In such cases, risk management decisions must be taken in a situation characterised by scientific uncertainty.

Risk analysis in the case of phthalate-containing toys, at the occasions of examination of measures and requests presented in relation to articles 8 and 9 of the Directive, has been complicated by uncertainty surrounding the possible reference to the precautionary principle in this context, in the absence of explicit mention to the precautionary principle in the Directive.

With such cases in mind, consideration should be given to possible reference in the Directive to the Precautionary Principle, expressing the need for the authorities to take measures (under certain conditions), in order to prevent potentially serious risks, even in the absence of full scientific knowledge.

Introduction of a reference to the precautionary principle in the Directive would go in parallel to clarification and guidance on its interpretation and practical application, presently in progress.

The implications for producers and distributors of such reference should also be considered.

Nothing in the GPSD prevents export to third countries of products which are "dangerous" in the sense of the Directive and cannot therefore, be marketed within the EU.

The authorities of certain Member States are in particular concerned of the destination of stocks of products when they impose the withdrawal of certain products from the market because of the serious risks they pose for the health and safety of consumers.

Some Member States have introduced a ban on export of dangerous products.

Whereas the safety of products intended for industrial or professional use may depend significantly on the context in which they are used, it is in general less evident how a consumer product, dangerous in the EC, would be safe in a third country. Apart from particular cases, the conditions in which consumer products are used do not seem to differ substantially from one country to another.

It should be considered whether export of dangerous products to third countries is acceptable on ethical and political grounds.

Precedents exist of cases where the EC has banned such exports.

Council Directive 87/357/EEC on "products which appearing to be other than they are, endanger the health and safety of consumers", based on Art. 94 (ex-Art. 100), prohibits "the marketing, import and either manufacture or export" of such products.

Council Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries based on Art. 133 (ex-Art. 113), specifically submits to conditions based on EC requirements or international standards, export of such formulae, in order to protect child health in third countries. The Directive bans export of non-compliant products.

In consideration of the above, the regime applicable to exports of "dangerous" products under the GPSD should be considered.

In case a ban were introduced, it might be considered given the wide scope of the Directive, to allow for some flexibility in order to let the authorities permit export of certain products, when they are satisfied that under the specific conditions of their use in the importing countries, they are not dangerous.

Article 7 of Directive 92/59/EEC provides for notification by the Member States to the Commission of measures taken by them which restrict the placing of a product or a batch of products on the market, or require its withdrawal from the market. This requirement does not apply if the notification is due under a specific Community legislation or if the "event" (meaning the risk associated with the product in question) is limited to the territory of the Member State concerned.

The notification must include the reasons for adopting the measures. The Commission after consulting the interested parties (e.g. manufacturer, importer, distributor...), must inform all Member States in the case it considers the measures to be justified. If it considers the measures not to be justified, it must inform the Member States which initiated the action.

Article 7 is included, as the only article there, under Title IV "Notification and Exchange of Information". In fact its "information" value has been so far very limited.

Member States only learn of a measure taken by one of them many months or even years after the measure has been taken. In the case that the Commission disagrees with the measure, they are never informed about it, unless an infringement (article 169) procedure is launched by the Commission against the Member State having initiated the action.

Moreover, the administrative burden put on the Commission by this procedure is very heavy: the Commission has to consult the interested parties in all cases (in many cases such parties have in fact agreed with the measure) and adopt a formal opinion on each individual case.

The following data show that the safeguard clause as formulated now is difficult to manage: For the period 1994/98 only 29 % of Article 7 notifications have reached the last stage of the procedure.

The notification to the Commission under Article 7 might be transmitted to all Member States for information. They might include a summary of any views submitted by the parties involved under Article 14. Any further exchange of information on the matter could take place under the procedures for collaboration among market surveillance authorities. The Commission would react within a certain deadline in the case it considers the measures not to be justified. Any interested parties or Member State could bring the matter to the attention of the Commission or complain to it in case of disagreement.

Article 3 of the GPSD sets out obligations of producers and distributors.

While the existing requirements appear, in the light of experience, to be appropriate, it has come out that they are not complete and that some important aspects are missing in the present formulation of that Article.

Producers and distributors have the obligation to ensure an adequate follow-up of the safety of products they supply.

In this context, they may discover, or be informed, of risks related to a product. They could conclude that the product is dangerous, in the sense of the Directive, and take autonomously measures to avoid the risks in question.

The experience has shown that this happens quite often. However, the authorities are not always informed of producers'/distributors' findings and measures. This fact limits the possibility for the authorities to make the necessary checks on similar products and exchange the relevant information with the other Member States and the Commission.

Therefore, it should be considered to introduce an obligation in the Directive for producers and distributors to provide to the competent authority information on findings and measures concerning dangerous products.

The obligation of producers and distributors to ensure appropriate co-operation, within the limits of their responsibilities, to market surveillance authorities, as necessary in order to avoid risks posed by the products they supply, is not explicitly stated in the Directive.

This has led to different practices in the various Member States. A provision establishing such an obligation might be considered for inclusion in the Directive.

Producers are required, in Article 3 of the directive, to take measures in order to avoid risks of products they supply, including withdrawing such products when necessary. In some cases, recall of products already sold to consumers may be necessary in order to prevent or minimise damage to consumer health and safety. The obligation to recall products, when necessary, might be considered. The market surveillance authorities would be entitled to require producers to recall, when necessary, dangerous products.

Recall could lead to replacement, repair or refund, as appropriate according to the regime applicable.

Article 12 of Directive 92/59/EEC provides for the confidentiality of information obtained by Member States and Commission officials, for the purposes of the Directive, covered by professional secrecy. However, confidentiality requirements do not apply when disclosure of the information is necessary in order to protect the health and safety of persons.

There is uncertainty about the exact implications of the confidentiality requirements. For instance, are the authorities entitled to disclose information on potential risks, pending further verifications, in order to enable consumers to make informed choices?

Should the authorities keep secret the information they have, pending full assessment and final conclusions, even when requested by consumers to disclose what is known about the risks in question?

Under which conditions and circumstances information can be disclosed for facilitating search of products suspected to be dangerous?

Who decides what is "confidential"?

Is an information to be kept confidential just because its disclosure could damage the image of a producer?

How and how far information concerning cases "sub-judice" can be used?

It has not been possible so far to give agreed answers to these questions.

On the other hand, it is by now widely considered that, in the field of consumer health and safety, the general principle should be transparency, and secrecy should be limited to exceptional cases.

Article 12 might therefore be re-written (based on the assumption that transparency is the rule and secrecy the exception) in order to give more operational indications on how to implement the confidentiality requirements.

At present, the Directive establishes an Emergencies Committee, in charge of assisting the Commission in relation to RAPEX and the adoption of Community emergency measures.

The functions of the Committee, acting in an appropriate composition, might be differentiated in order to enable it to also assist the Commission in relation to the establishment of standardisation mandates and, as an Advisory Committee on General Product Safety, in relation to all relevant issues of application of the Directive.

By adopting Directive 92/59/EEC, the Council and EP have intended to ensure a high level of consumer health and safety protection through the EC, in respect to risks posed by consumer products. However, the safety of some consumer products is totally or partially regulated under sectoral Community legislation. Therefore, the Council and EP have introduced provisions aimed at avoiding duplication and confusion between the GPSD and such sectoral legislation. At the same time, lacunae should also be avoided, in order to be coherent with the aims of the GPSD.

The need to avoid lacunae applies both to the product safety requirements and to provisions concerning market surveillance, rapid exchange of information, emergency Community measures, which are equally important for consumer health and safety.

The present wording of the Directive on its relationship with other Community legislation is not completely clear and has led to some uncertainty in its interpretation.

The revision of the GPSD offers the opportunity to clarify this issue along the following lines:

• If a product is subject to sectoral legislation which only covers certain risks and safety aspects, the general safety requirement of the GPSD applies as far as the risks and aspects not covered are concerned.

By definition, "total safety" new approach directives cover all risks and therefore the GPSD safety requirement does not apply to products included in their scope

• Provisions concerning, RAPEX and emergency Community measures apply to all consumer products, except those covered by sectoral legislation including equivalent provisions. For the sake of legal certainty, these equivalent requirements might be explicitly listed in the Directive (as it is presently the case for rapid exchange of information systems listed in the Annex to the Directive).

In addition, the revision might clarify the issue of the applicability of the market surveillance provisions of the GPSD to consumer products covered by sectoral legislation, without prejudice to any specific market surveillance requirements in such legislation.