Proposal for a new EU Directive on General Product Safety, 2000

					Register/Notify your MDD-Medical Devices and IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking Specialists based in London/UK. Click here to get FREE Guide Now!

Proposal (in 2000)
for a new EU Directive on
General Product Safety

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general product safety
(presented by the Commission)

EXPLANATORY MEMORANDUM
1. Introduction
2. Reasons, objectives and main elements of the proposal
3. Subsidiarity
4. Economic aspects and impact on SMEs
5. Consultations
6. Contents of the proposal

THE PROPOSAL
1. Taking into account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-
The General Product Safety Directive was adopted in 1992 as part of the programme aimed at establishing by 31 December 1992, the internal market. The aims and motivations of the General Product Safety Directive, which remain unchanged, fall within the fundamental competencies of the European Community.
All the amendments proposed in the revised text are aimed at reinforcing the effectiveness of the Directive and ensuring a more consistent implementation of its provisions.
The absence of efficient market surveillance in one Member State can have negative consequences at European level for the functioning of the Internal Market, for business competitiveness and consumers protection. The experience has shown certain weakness and lacunae in Community product safety legislation and its enforcement. This situation calls for improved Community provisions aimed at guaranteeing the protection of consumers and the proper functioning of the market.
The modifications envisaged are compatible with the need to respect the prerogative of Member States in deciding their own internal institutional and administrative arrangements and business regimes.

THE IMPACT ON BUSINESS
2. Who will be affected by the proposal-
The proposal will not significantly modify the implications for business compared with the present Directive. All business sectors and all sizes of businesses related to the production, distribution and trade of consumer products are interested. The proposed Directive will also apply to business which use or supply products in the provision of services to consumers.
The proposal has a similar impact over the entire Community. It is not aimed at any particular region.
3. What will business have to do to comply with the proposal-
The main new additional obligations for business will be:
Obligations for producers:
to effectively warn consumers of the risks posed by those products already supplied to them, and when necessary and as a last resort recall such products in order to avoid such risks.
Obligations for distributors:
to collaborate in tracing of the products they supply and to co-operate in any risk avoidance action;
Obligations for producers and distributors:
to inform the competent authorities if they conclude that a product which they supply is dangerous. Specific information requirements are provided in Annex I.
to collaborate, in accordance with the requests of competent authorities, in taking action to avoid any risks posed by the products they supply.
not to export to non-Member States dangerous products subject to a Community decision prohibiting them from being placed on the Community market or which have been withdrawn from the market or recalled from the consumers.
However, it should be noted that the increased costs associated with the new obligations for SMEs will solely occur when a product in found not to comply with the safety requirements of the Directive.
4. What economic effects is the proposal likely to have-
This proposal will facilitate an effective and consistent framework for ensuring protection of consumer health and safety, and an equal treatment of producers, importers and distributors.
Certain provisions of the proposal will improve businesses' competitiveness. At present businesses which do not respect their obligations to protect consumer health and safety, have an unfair advantage over those that do. More effective market surveillance will reduce such unfair competition between businesses within the internal market and also in the context of the globalisation of World trade. Business could also gain a marketing advantage in terms of the increased safety that their product offers.
The new "status" that the proposal will give to European standards, will help provide clear references points for business in defining a safe product. This in turn, will assist businesses and particularly SMEs in penetrating the internal market as the manufacturing and technical standards that need to be attained will cover a wider range of products. Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring them equal opportunities.

1. introduction

2. reasons, objectives and main elements of the proposal 3. subsidiarity

4. economic aspects and impact on small and medium-sized enterprises
Several of the new or modified provisions introduced by the proposed revision are of an administrative nature (such as those concerning the reinforcement of market surveillance, better collaboration between Member States, improvement to the RAPEX system, etc.) and have no impact on economic operators.
Certain other amendments only aim at clarifying the present text to ensure a more effective and consistent implementation (for instance the amendments concerning the scope of the Directive, its relationships with other Directives, etc.). Also, in this case, there is no impact of the amendments on economic operators.
However, a few proposed amendments may well have economic implications for businesses:
- the obligation of producers and distributors to inform the authorities when they conclude that a product that they supply is dangerous;
- the obligation of producers and distributors to collaborate with the authorities in order to prevent risks to consumer health and safety;
- the obligation to recall dangerous products, when necessary in order to prevent risks;
- the prohibition on the export to non-EU countries of dangerous products.
All these obligations, except the last one, apply only in the case where economic operators have placed on the market a dangerous product, in breach of the fundamental obligation to market only safe products. Producers and distributors can therefore prevent or at least minimise economic consequences of these obligations by carefully assessing the risks of their products before their placing on the market, which is an obligation under the present Directive.
It is not possible to estimate how frequently there will be a need to apply these obligations: all will depend on the care taken by the relevant economic operators to supply only safe products. Equally, the economic implications of each of the provisions considered will depend on the nature and circumstances of non-compliance and therefore no meaningful estimate can be carried out beforehand.
The obligation of producers and distributors to inform the authorities when they conclude that a product that they supply is dangerous, is already applied in certain non-EU countries, in particular the US. It is equally applied to European firms operating on the markets of these non-EU countries and there is no evidence of an excessive burden.
The costs associated with the obligation to collaborate with the authorities, in particular in the case of crises, like those recently experienced in the food sector, should be seen in the context of the broader economic consequences that failure to deal rapidly and effectively with consumer risks in such cases may have. Clearly, each of these cases involves specific aspects and no a priori quantification of costs and benefits is possible.
The same applies to recall of products already supplied to consumers. The cost of a recall will vary, depending on factors such as geographical spread, number of products sold, value of the products, etc. The benefits of timely recalls in economic terms will include reduced liabilities for the producers.
Finally, there is no data on the type and number of dangerous products exported, or which might in future be exported to non-EU countries. The potential market lost by European producers, and the benefits deriving from the proposed prohibition of such exports, cannot be evaluated.
It should be borne in mind that any increased costs associated with the new obligations for SMEs will solely occur when a product is found not to comply with the safety requirements of the Directive. Therefore, the vast majority of businesses will only experience the following benefits as a result of the revision of the Directive.
First, businesses which do not respect their obligations to protect consumer health and safety, may have an unfair advantage over those that do, if enforcement is not effective. More effective market surveillance will reduce such unfair competition between businesses within the internal market and also in the context of the globalisation of trade.
Secondly, increased collaboration with market surveillance authorities could help small and medium-sized firms. Where an unsafe product is supplied by SMEs, national authorities should cooperate closely with them to ensure that appropriate actions or measures are taken to deal with the problem.
Finally, the proposal also aims to clarify the safety requirements applicable to products. The new "status" that the proposal will give to European standards, coupled with the possible use of Commission recommendations setting guidelines on risk assessment, will help provide clear references points for business in defining a safe product. This will assist businesses and particularly SMEs in placing products the internal market.
Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring them equal opportunities. Increased use of European standards should be linked to the reinforcement of market surveillance.

5. consultations
The organisations consulted about the proposal and who have outlined their main views are:

6. contents of the proposal
This proposal concerns an EEA matter and should therefore extend to the EEA.
The amendments proposed with reference to the existing text are identified by underlining.
Article 1
Article 2
Article 3 obliges producers to market only safe products. It provides criteria for assessing the conformity of a product with the general safety requirement and allows products in compliance with European standards established under certain conditions, to benefit from a presumption of conformity.
Article 4
Article 5
Article 6
Article 7 establishes the obligation for the Member States to lay down rules on penalties.
Article 8
Article 9
Articles 10
Article 11
Article 12 provides for a rapid exchange of information system among Member States and the Commission concerning products that present a serious risk which requires rapid intervention and measures taken by producers, distributors and public authorities to deal with it. Participation in this system may be open to non-EU countries.
Article 13
Article 14
Article 15
Article 16
Article 17 clarifies that the application of this Directive shall be without prejudice to Directive 85/374/EEC concerning liability for defective products.
Article 18
Article 19
Article 20
Article 21
Directive 92/59/EEC is hereby repealed with effect from 1 January 2003 without prejudice to the obligations of Member States concerning the deadlines for transposition and for application of the repealed Directive as indicated in Annex III.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.
Article 22

ANNEX I
REQUIREMENTS CONCERNING INFORMATION ON DANGEROUS PRODUCTS TO BE PROVIDED TO COMPETENT AUTHORITIES BY PRODUCERS AND DISTRIBUTORS

ANNEX II
PROCEDURES FOR THE APPLICATION OF THE COMMUNITY RAPID INFORMATION SYSTEM (RAPEX) PROVIDED FOR IN ARTICLE 13 AND GUIDELINES FOR NOTIFICATIONS REFERRED TO IN ARTICLES 12 AND 13

ANNEX III
REPEALED DIRECTIVE AND DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW AND FOR APPLICATION