Status of the debate on amendments to the General Product Safety Directive

United Kingdom
STATUS OF THE DEBATE ON AMENDMENTS TO THE
GENERAL PRODUCT SAFETY DIRECTIVE

Directive 92/59/EEC on general product safety (the GPS Directive) became mandatory on 29 June 1994. It is a measure based on consumer protection1 which aims at ensuring that all consumer products are safe. This directive is a horizontal directive applying to all consumer products which fills in the gaps between, and supplements, the vertical sectoral regulatory directives. It requires national enforcement by competent authorities, backed by criminal sanctions.

The central provisions of the GPS Directive which relate to producers (and similar less onerous provisions relate to distributors) are that they shall:-

  1. place only safe products on the market2 ;
  2. provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against these risks;
  3. adopt measures commensurate with the characteristics of the products which they supply, to enable them to be informed of risks which products might present; and
  4. take appropriate action including, if necessary, withdrawing products from the market.3

There is no proposal to change these obligations on producers, other than to clarify one issue in relation to the post-marketing obligation to recall (obligation 4 above, discussed below).

The Directive also imposes regulatory obligations on member states, notably relating to market surveillance, notification amongst the member states and the Commission of measures taken to restrict the placing of products on the market, and emergency procedures in relation to products which present serious and immediate risk.

The former Directorate-General XXIV of the European Commission (Consumer Affairs and Food) has during 1999 been considering with a Working Group of member states possible revisions to the GPS Directive. Several drafts of changes have evolved. Meetings have also been held with stakeholders, including representatives of consumers and industry. The new Directorate-General for Health and Consumer Protection (SANCOM) is expected in early 2000 to forward a draft proposal to the Council of Ministers, thereby initiating the legislative mechanism to adopt an amending Directive. As with all draft proposals at this stage, it is recognised that certain proposals and particular wording may cause greater difficulties than others. The purpose of this article is to examine the more difficult policy changes.

The Commission has been criticised for proceeding with proposed changes to the Directive in advance of public consideration of the results of studies on the implementation and effects of the Directive. A study commissioned from Louvain-la-Neuve University is expected to be published shortly and others may follow. Stakeholders have criticised the depth and consultation of the Louvain study as superficial.

Coverage

Given the nature of a legislative system which includes both horizontal and vertical directives, and the fact that many of the vertical directives were created before this horizontal directive was mooted, problems inevitably arise over the inter-relation between the horizontal provisions and the various vertical directives. No problem arises with products which are not subject (at least for the present) to sectoral directives: the GPS provisions apply in their entirety to such products. Where a product is subject to a vertical directive, it has always been the position that the provisions of that sectoral directive apply in their entirety4 but there has been confusion as to the extent to which there might also apply, first, those of the four obligations relating to producer/distributors outlined above which are not covered by the sectoral provisions and, secondly, those provisions of the GPS Directive impose obligations on regulators. The sort of problems which usually arise are, first, uncertainty over the extent to which producers may be subject to the post-marketing information system and recall obligation (obligations 3 and 4 above), since sectoral directives rarely include post-marketing provisions nor, in particular, a positive obligation to take appropriate action or recall products, secondly, whether distributors are subject to any obligations (since sectoral directives do not usually impose any obligations on distributors) and, thirdly, whether a product will be subject to the rapid alert mechanisms under the GPS Directive or any other regulatory mechanisms which might exist (and sometimes do not) under sectoral directives, and similarly whether the relevant competent authorities are those that exist under sectoral directives or the GPS Directive.

Further obligations proposed for the GPS Directive might also apply in a confusing way, such as notification (discussed below): post-marketing vigilance systems and reporting are for some sectors being developed over time by use of Commission guidelines and industry practice (such as for medical devices). This incremental system is proving flexible and effective as the experience and resources of industry and competent authorities develop. Yet a GPS notification obligation would lead to considerable confusion on the extent of the overlap between the vertical and horizonal mechanisms.

Sectoral legislation and sectoral competent authorities have been created in situations where the particular nature and circumstances of use of products require particular measures and specialist knowledge and experience. The nature of the legislation and regulatory mechanisms relating to the safety of medicinal products, for example, differs from that which is appropriate for chairs, medical devices, machinery, consumer electronics and so on. It is argued that the only policy solution which makes sense is, therefore, for all aspects of the regulation of products for which sectoral legislation exists to be governed by that sectoral legislation. As a matter of policy, therefore, it would follow that products which fall under sectoral regulatory legislation, at least of the "total harmonisation" type should be subject only to that legislation and not to any of the provisions of the GPS Directive.

The current wording of the draft amendment partially reflects this new policy approach. Yet there is still scope for continued confusion, since the aspects of safety which are not covered by sectoral legislation would be covered by GPS. The current approach clarifies almost nothing since it could be argued that the statement that "only the safety requirements of New Approach Directives shall apply" means that non-safety requirements of those Directives do not apply!

Curiously, however, whilst the wording specifies the exemption of products which are subject to "new approach" directives, it inconsistently omits other products which should be included, notably medicinal products, agrochemicals, cosmetics, tobacco and motor vehicles5. The total exclusion from the GPS Directive of products which are subject to sectoral regulation will require consequential amendment of the sectoral directives so as to provide for appropriate6 post-marketing obligations on producers and competent authorities. However, such a solution will have a number of advantages. First, there will be less confusion than currently exists given the complex inter-relation between the GPS Directive and vertical directives, and given the confusing result that the extent to which the GPS obligations apply varies as between different vertical sectors. It will be far clearer to have all the relevant provisions within a vertical directive. Secondly, this will enable solutions to be adopted which are appropriate for the particular sector.

For example, it was recognised that a safety problem arose with top-handled chainsaws which were CE marked under the Machinery Directive but migrated to consumer use. There was confusion about whether the relevant obligations and regulators were those which arose under the Machinery Directive or the GPS Directive. It was and is accepted that the Machinery Directive is the appropriate mechanism but this legal result needs to be clarified.

Service products

The Commission has for some years wished to introduce provisions dealing with liability for services, so far without success. In the context of the regulation of products, it had been hoped that the GPS Directive would apply to all products which might be used by consumers, but the insistence by some Member States on including the fifth recital into the GPS Directive effectively disapplied it in relation to production equipment, capital goods and other products used exclusively in the context of a trade or business. The safety of such work products is already provided for under the Directives dealing with health and safety in the workplace7. It is currently proposed that products used to provide a service should be included in the GPS Directive. Examples put forward by the Commission are sports equipment in a fitness centre, childcare articles in a nursery, playground equipment in a kid-club, a professional hairdryer used by hairdressers, and a sunbed used in a beauty centre.

Consumers are also concerned with product migration, that is where some users or secondary users choose to use for personal use products intended by their producers for industrial or professional use. In response, industry argues that it is unfair for producers to be subject to regulatory and ultimately criminal sanctions in such circumstances, where the migration may be not only unintended by them but also unforeseeable. Bearing in mind that producers are subject to the lesser obligations in relation to paying compensation to injured consumers of reasonable expectation for strict product liability8 and reasonable foreseeability under negligence/fault liability9 , the imposition of a higher test under regulatory and criminal law may well be contrary to the principle of proportionality.

Product migration may also present insuperable problems for the design and labelling of products. Products intended for either professional or consumer use may need to be designed or labelled in a particular way to take account of the level of knowledge and skill of the intended user. A requirement to provide for both potential users at the same time may be impossible to achieve.

Examples of lack of safety due to product migration are lacking in the current debate. It would assist in taking the debate forward, on a practical basis of addressing evidence of need, if actual examples could be given.

As a small point, the current draft provides that such products would be subject to the GPS Directive "under normal or reasonably foreseeable conditions of use". It should be clarified that it is the use of the product by the consumer which must be normal or reasonably foreseeable.

A sectoral approach to defining safety

The Directive currently provides that where a product is not subject to specific Community provisions governing its safety, it should be deemed safe when it conforms to any specific rules of national law which conform to the EC Treaty10. It is now proposed that these deeming provisions should also apply where the product conforms to voluntary national standards which conform to Community harmonised standards, in respect of the safety aspects covered. The Commission would be given a power to mandate the European standardisation bodies (CEN, CENELEC and ETSI) to produce product-specific standards. The Commission would also be given the power to adopt recommendations which set guidelines for risk assessment, aimed at facilitating effective and consistent application of the definition of what is a safe product, in consultation with the Commission's Advisory Committee.

All of these proposals are viewed as being constructive amendments. They underline the trends both towards greater clarity of regulatory obligations and greater product-specific requirements and consistency of application. There is, however, some concern about the nature of standards in the GPS context.

Notification

It is proposed to introduce an obligation on producers and distributors to inform the competent authorities as soon as they become aware that a product that they supply or have supplied is dangerous. Specific requirements for this information would be suggested in a new Annex II to the Directive. It is also proposed that producers and distributors should collaborate with the competent authorities' requests on action taken in order to avoid risks.

The Commission notes that the notification requirement is believed by the US Consumer Products Safety Commission to be a particularly useful mechanism in practice. They are also concerned that unsafe products are removed from the US market but remain on the EU market because the authorities are unaware of the situation. Industry responds that it is unclear whether any EU state currently has national legislation requiring notification collaboration and, if this is lacking, there would be no jurisdiction to introduce a harmonising measure.

The current wording of the notification obligation has improved from an earlier proposal that all risks, or changes in risk, potentially associated with the product should be notified. This would have given rise to an enormous and disproportionate number of unnecessary and costly notifications. The current proposal is limited to the conclusion that a product is dangerous, and the definition of "dangerous" is linked in with that of whether the product is "safe" as defined in Article 2(b).

Nevertheless, industry considers that the notification provision gives rise to serious difficulties. In particular, there is difficulty over definition of the appropriate trigger for notification. It is quite possible that the Article 2(b) test would operate a trigger which would still give rise to an excessive and unnecessary volume of costly notifications, in which case it would be disproportionate. This would be a matter on which it would be relevant to consider empirical evidence, which is currently entirely lacking. Industry therefore believes that it would be appropriate to carry out detailed Cost Compliance Assessments on the effect of adopting different triggers both for the notification obligation and all of the other relevant mechanisms provided for by the Directive: obligation to remove an unsafe product from the market; recall; banning export; notification to a competent authority; enforcement action by a competent authority (particularly prosecution, removal from the market and mandatory recall); competent authority notification of other member states; and rapid alert mechanism.

There is also a question over the proportionality of the need for a notification mechanism. As can be seen from the totality of the responses to the Commission's Green Paper on the Product Liability Directive, there is an absence of evidence that the very large number of consumer products which are not currently regulated by product-specific sectoral regulation gives rise to frequent or serious safety issues. Where safety issues are recognised post-marketing, manufacturers are currently under a GPS obligation and a product liability duty to take appropriate action, whether by redesign, relabelling, withdrawing the product from the market etc. If there were a notification obligation, this might either lead to a large number of unnecessary notifications where producers and distributors wished to seek protection by making pre-emptive notifications where products were not necessarily dangerous, or alternatively might act as a disincentive for producers and distributors to notify, since that might give rise to further regulatory action, particularly prosecution. In this connection, industry is concerned about the increasing trend towards empowering consumer organisations rather than regulators to obtain access to regulatory information and to institute court proceedings. Industry believes that regulators are in a far better position to take decisions which are informed, consistent and proportionate.

Collaboration: delay

It is also proposed that producers and distributors should "collaborate with the competent authorities, according to the requests of the latter, on action taken in order to avoid risks posed by products which they supply or have supplied". In those countries which contain responsible, experienced and responsive competent authorities, a practice has grown of industry voluntarily informing and collaborating with competent authorities on these matters. Industry is, however, concerned that the introduction of a permanent mechanism requiring consultation to take place between producers/distributors and competent authorities in every case as a pre-condition of instituting appropriate post-marketing action would have a number of adverse consequences in many, if not most, post-marketing situations.

Aspects of design, production or labelling are frequently improved in the post-marketing situation: indeed, many product sectors operate on an incremental basis of improvement. The introduction of an improvement does not mean to say that the previous product was dangerous, although the proposed changes in the Directive might introduce an undesirable element of uncertainty about this. Would it be justified to report all changes in product design, production, labelling and distribution? Industry and member states consider that this would be very costly and disproportionate for both of them. But all these aspects might be reportable as "action taken".

Moreover, product changes, including recalls, are sometimes not associated with safety aspects but producers may believe they have to notify many changes in order to avoid the risk of prosecution. Industry agrees that blanket notification requirement would place a huge drag on innovation and argues that there is no evidence of a need to introduce such a wide-ranging mechanism which could merely impede industry's development. Moreover, in situations in which urgent action needs genuinely to be taken, an obligation to brief and consult with the authorities before instituting urgent action would merely delay the process, to the significant safety detriment of consumers. Even if the obligation did not expressly require collaboration before taking voluntary action, many operators would feel obliged to delay action until approval by the authorities so as to avoid potential sanctions.

There are also further proportionality and consistency issues. Such levels of detailed notification and collaboration as are proposed for consumer products which are not thought serious enough for sectoral legislation are not required for most products which are subject to sectoral legislation. It is argued that this would be inconsistent between product sectors.

Confidentiality

This leads on to the current proposal that all information available to the authorities should be available to the public on request except that, as now, information covered by "professional secrecy in duly justified cases" should remain confidential. However, it is proposed that protection of professional secrecy may be applied in no case when it compromises the effectiveness of market surveillance activities11. Consumers support these provisions but industry strongly objects to their scope. Consumers wish to see transparency, as a mechanism for confidence in decisions, whereas industry stresses the need for confidence in the decision-making process, involving independent expert determinations based on full information.

Industry has no objection to sharing information on product safety with the appropriate authorities where this is appropriate and proportionate and where information which is of commercial value can be kept confidential. The continued ability of EU industry to remain competitive and innovative and to maintain employment is fundamentally based on the protection of appropriate confidential information. Industry points out that it is inconsistent for the European Commission to propose a major breach of this principle while supporting it in the context of promoting the competitiveness of European industry, and such a stance is thoroughly naive.

It is not in consumers' interests to have access to huge amounts of detailed scientific and statistical information but no jobs. The public must have confidence in the decision-making process but whilst it is possible to recognise the principle of openness, it is debatable to what extent consumers should have access to information which would lead to a business becoming uncompetitive simply so that the validity of the decision could be open to third party scrutiny in the absence of any formal mechanism for such scrutiny. The current policy trend on the achievement of decisions about which consumers may have confidence essentially involves ensuring that mechanisms are in place for the generation of relevant safety information and for their scrutiny by expert scientific committees. Industry argues that the policy is to encourage confidence in the excellence and objectivity of the scientific committees, rather than permit their credibility and conclusions to be undermined and double-guessed by less well-informed individuals.

The Commission had originally provided that information covered by professional secrecy should, in duly justified cases, remain confidential. In answer to industry's points, the Commission in December 1999 proposed that professional secrecy could not be applied in any case where it compromised the effectiveness of market surveillance activities, or prevented the information of consumers on the risks and characteristics of products which have been found or are suspected to be dangerous, and on the measures taken concerning those products, as far as necessary to protect consumer health and safety. Industry argues that the "as far as necessary" proviso introduces major uncertainty and that the first two of the above three situations (market surveillance, suspected dangerous products) would in practice lead to revealing extensive commercial information to the public authorities and hence to competitors in the EU and elsewhere. The Commission has promised to reconsider this issue.

Confidentiality also arises in another context. The Commission proposes to create a Regulatory Product Safety Committee and an Advisory Product Safety Committee, as well as amending the procedure for decisions at Community level. These proposals would merely develop current provisions and practice and are uncontroversial in themselves. Both consumers and industry have expressed a desire to become more involved in these decision functions, which may well be acceptable in theory but may also give rise to difficult issues of access to confidential information.

Recall

As discussed above, the original Directive provides that producers must take appropriate action post-marketing, including where appropriate withdrawing a product from the market. There has been an unresolved dispute about whether the current wording requires the recall of products which have already been sold12 as well as withdrawing from the market unsold products. The current proposal is to make clear that, if necessary, a producer must recall products already supplied to consumers and/or withdraw them from distributional channels and/or adequately and effectively warn consumers. These provisions are relatively uncontentious13 since such obligations have long been thought to exist as a matter of product liability law and what is proposed is precisely what responsible manufacturers have been doing for some decades.

However, there is a related proposal that member states' existing obligation to organise the withdrawal of a dangerous product from the market should now be extended to recalling products already supplied to consumers. Some member states (notably UK) have implemented the existing provision as a power to suspend the sale or supply of dangerous products, and the Commission has accepted that this is acceptable implementation. However, the new proposals would require powers to order or carry out mandatory recalls from consumers, which would involve quite new legislation and a new approach to the climate of product safety. British industry at least is against the change, which it regards as unnecessary, since many recalls are already carried out voluntarily and effectively.

If the proposals were to be introduced, there is one important respect in which regulators and others should exercise care about their exercise. In certain circumstances, it may be appropriate and proportionate to institute a recall of products in the distribution chain. That should not necessarily mean, however, that a recall of products sold would be appropriate or proportionate. A "consumer recall" might be expected to have a low response rate, as many do, perhaps because products have been discarded or consumers choose to ignore the warning not to use them or the request to return them. It may also involve disproportionate expense. Accordingly, it should be recognised that withdrawal from the distribution chain, withdrawal from the market, warning consumers against use and requesting consumers to return or dispose of products, are in fact all individual options (amongst a number of others) which need to be considered individually in deciding on appropriate and proportionate action.

Precautionary action? Compensation

There is also significant concern that the competent authorities in some member states have or may develop a habit of notifying other member states prematurely when they think that there might be a problem with a product, when the position still needs to be debated and established with the producer. Some member states shoot from the hip and publish information prematurely about possible risks. Industry believes that the GPS Directive should make clear that competent authorities should not communicate to the public potential concerns until they have been fully justified.

As an appropriate mechanism to protect industry against improper regulatory action in a wider context, industry proposes that an obligation should be included that authorities should pay compensation to traders where harm has been caused to them as a result of publication of unsubstantiated allegations. This may be available under national law but takes time to establish: by the time a reference to the courts, particularly the European Court, have been made, the business may be irrevocably damaged. There is also some uncertainty about whether the Commission is subject to a compensation mechanism.

Export

The proposal is being continued that products which are dangerous under EU rules should be banned from export outside the EU. The Commission argues that a product which is dangerous in Europe is dangerous anywhere and there is a moral obligation not to export it which should be enacted. Against this, industry argues that different countries have different regulatory rules, both in their general systems and detailed requirements, and different moral or cost-benefit judgments. It is morally unjustified for the EU to seek to impose on others its judgments on legal regulation or on cost-benefit. Other countries sometimes adopt regulation or cost-benefit standards which are higher than EU as well as lower: they are free to make their own decisions. Some EU businesses manufacture products significantly or exclusively for export. Industry points out that the proposals would therefore have an adverse economic impact on EU business.

Member States' obligations and powers

A major motivation behind many of the proposed amendments is to produce a level playing field for enforcement and the flow of information between competent authorities, so as to achieve consistent results. In general, the more northern States have appropriate mechanisms, personnel, budgets and experience over consumer product safety, whereas Italy and Greece and, until some recent improvement, Spain and Portugal, are in a less favourable position. Both consumers and industry support measures aimed at producing consistency in all these respects. There are therefore various proposals to define more precisely the obligations and powers of the member states which, at least in their current form, are uncontroversial. Indeed, many support speedy action on this point and would be dismayed if less important points held up the passing of appropriate amendments.

The need for an appeal mechanism

An important amendment which could be included is that of provision for an appeal mechanism against regulatory action. Such a mechanism is provided under the national law of a number of member states and should be included within the Directive. Several possibilities should be mandated. First, there should be a mandatory right of appeal from the judgments of criminal courts. Secondly, there should be provision for judicial review of administrative decisions where appropriate procedures have not been followed (ultra vires) or where regulatory authorities have taken decisions which no reasonable authority would have taken. Thirdly, there should be provision for review of the scientific and substantial aspects of decisions by regulatory authorities by similar expert bodies. The need for this third mechanism has been demonstrated by experience of judicial reviews in a number of product sectors, whereby not only has the legal process been shown to be slow (including perhaps 2 years spent on a reference to the European Court) but also that courts do not regard themselves as competent to review the decisions of regulatory and scientific bodies within a central margin of discretion, thereby leaving a serious lacuna in relation to independent, expert reconsideration of the information.

Precautionary principle?

Previous draft proposals from the Commission have included a requirement for observation of the "precautionary principle" by producers and authorities. Consumers strongly support the principle. It has been objected that this principle has not been defined and is, in any event, inconsistent with the definition of what constitutes a safe product. The latest proposal does not include the words "precautionary principle" but does include an obligation on competent authorities to take due account of the need to "guarantee a high level of consumer health and safety protection even in case of scientific uncertainty or unavailability of sufficient data and knowledge".

The Commission is considering how to define the principle but has found it very difficult to do so. A paper on this is expected to be published in February, after which the Commission may seek to reintroduce further wording.

Whilst industry views the current wording as an improvement on the suggestion that if any scientific uncertainty emerges in the post-marketing situation, the authorities should err on the side of caution and take the product off the market, the currently suggested wording is effectively meaningless since it provides no test for action which is different from that of pre-marketing safety. Indeed, it is difficult to see any justification why the tests of safety to be applied pre-marketing and post-marketing should be different. Provided that these words are not interpreted as making any difference to the substantive test, but that the "having due regard" provision is merely a reminder to member states to include a particular consideration in their process of considering post-marketing safety, the current proposal is probably of little significance.

It has also been objected that there is no jurisdiction to introduce the precautionary principle since the EC Treaty only mandates this in relation to environmental legislation (Article 174).

Enforcement: consistency and speed

No formal mechanism for exchanges of information between member states and the Commission currently applies save after a state has taken enforcement action or in an emergency situation. Informal communication mechanisms currently exist between national enforcement authorities and it is proposed that these should be formalised into a European Product Safety Network, which would facilitate the exchange of information on risk assessment, dangerous products, test methods, joint surveillance and testing programmes and general co-ordination. These provisions are uncontroversial and generally supported since they ultimately contribute to consistency of decisions on product safety and enforcement across the Community.

Industry is concerned that all the proposals for reform of the GPS Directive should be tested against the possibility of individual member states using them for their own purposes, in order to provide barriers to trade favouring national producers. For example, a state might object to the safety of a particular brands of electrical cookers on the basis that they are alleged to harm kitchen woodwork where that state does not produce cookers but does produce woodwork.

Various recent events have dented confidence in the ability of Community mechanisms to produce swift and reliable decisions. One example is the recent and undistinguished history relating to phthalates. Following safety concerns raised by a minority of member states, discussion lasted over 2½ years and a decision was ultimately taken banning phthalates in circumstances where most member states and observers believe that there is no convincing scientific basis for the decision. Similarly, France has invoked the safeguard clause in relation to certain medical devices (breast implants and condoms) and refused to accept British beef, in circumstances where others believe there is no scientific evidence for the French position. In order to restore confidence in the Community and its mechanisms, there is a need for a mechanism for high-level scientific review of safety information that reaches a conclusion that is reliable, swift, binding and enforceable on recalcitrant member states.

Emergency measures: rapid alert

The GPS Directive currently provides for emergency action to be taken where there is a "serious and immediate risk" presented by a product or batch to the health and safety of consumers14. It is proposed, however, that the "serious and immediate risk" test should be dropped in favour of a test currently formulated as "products posing a risk which requires immediate or rapid intervention"15 or "a risk which requires rapid intervention"16. The Commission's study into the Article 8 RAPEX system has indicated that there is confusion over a definition of what is "a serious and immediate risk" and, hence, a problem over consistency. However, the alternative wordings currently put forward are even less clear, circular and beg the question of the conclusion.

Industry strongly believes that the "serious and immediate risk" test is correct and should be reinstated, subject to reconsideration in the light of serious study and a Cost Impact Assessment, mentioned above. There is a need to provide for a test which is proportionate and forms a consistent matrix with the other tests in the Directive.

Christopher Hodges           20 January 2000 Partner, CMS Cameron McKenna, London
Member, Working Party on the GPS Directive, Confederation of British Industry
UNICE representative at the Commission's Stakeholders meetings on the GPS Directive
Chair, Legal Affairs Committee, Association of British Health-Industries



1 EC Treaty, former Article 100a.
2 GPS Directive, Article 3.1.
3 GPS Directive, Article 4.1.
4 GPS Directive Article 1.2.
5 Consideration should also be given to exclusion of other forthcoming directives, such as that for biocides.
6 It is entirely possible, as already occurs as between different sectors - for example compare medicinal products and medical devices - that what is appropriate will vary between sectors.
7 Particularly Directive 89/655/EEC as amended by 95/63/EC.
8 Directive 85/374/EEC, Article 6.1(b).
9 National provisions.
10 GPS Directive, Article 4.1.
11 Proposed Article 15.
12 See C Hodges, M Tyler and H Abbott Product Safety Sweet & Maxwell 1996, page 136.
13 although some might question whether there is jurisdiction under the EC Treaty for the Community to legislate in relation to products which are no longer on the market.
14 GPS Directive, Article 8.
15 New Article 6.2.
16 New Article 10 triggering an obligation on member states to inform others through the rapid information system of action adopted or proposed; and new Article 11 empowering the Commission to act.