Free movement of goods in Europe: plans for improving the New Approach

Following the consultation on the New Approach in 2002, the European Commission has adopted a Communication setting out its plans for improving the New Approach regime. New Approach Directives concern the free movement of goods and currently cover more than 20 industrial sectors, including electrical equipment, radio/telecoms equipment, machinery, medical devices, toys, pressure equipment, gas fires and building materials.

Summary of Recommendations

The Communication identifies the need to:

• improve the control of Notified Bodies to ensure that they do their work to the highest standards;
• facilitate the co-operation and exchange of information between Notified Bodies so that they provide a common level of service;
• increase transparency between Member States as to how they appoint Notified Bodies, how they manage market surveillance and how they manage the collective withdrawal of (non-conforming) products from the market;
• promote the understanding of the CE marking so that consumers understand what it represents;
• propose common amendments to the New Approach system, including introducing a legal basis for administrative co-operation between Member States, simplifying the safeguard clause procedure and introducing the Rapid Exchange of Information (RAPEX) procedure for industrial products which present a serious and immediate risk to users.

New Approach

The New Approach system came into being in 1985. The "New Approach" refers to a new way of drafting directives for the free movement of goods so that they were simpler by defining within them mandatory essential product requirements to ensure a high level of public protection while leaving the choice of technical solution to interested parties (users, manufacturers etc). The Approach is generally regarded as successful but after 20 years operation, areas where the Approach needed improvement are becoming apparent and it was felt that the system was in need of review.

Main issues

The Communication raises two important issues: the inadequacy of some Member States' measures for market surveillance and enforcement and the interaction of the General Product Safety Directive (GPSD) and New Approach Directives. The latter issue is one on which there is likely to be further activity and a need to follow developments and discussions. The Commission states that it considers that the enforcement provisions of the revised GPSD apply to consumer products covered by New Approach legislation, eg the RAPEX procedure. It is expected that the emphasis in changes to the New Approach will be on the post-marketing systems.

Inconsistency of the quality of Notified Bodies between the bodies and the level of enforcement between Member States were also identified as problem areas. Lack of cooperation between the various bodies and regulators and consistency of approach is considered by many to be a problem. Hence, many of the Commission's recommendations relate to these areas. Certain recommendations, for example the on-line database of Notified Bodies on the Europa web site, will make life easier for industry. The Commission's plans to incorporate into the Directives further common definitions such as "manufacturer" will hopefully help industry to apply the Directives to their particular circumstances of supply. The plan to work on the conformity assessment procedures to iron out the problems associated with the dual application of Directives may be welcomed by many in industry, but industry may wish to contribute to the discussions since the Commission is still proposing more recourse to Module H (Full Quality Assurance) or one of its variants despite a majority of the respondents to the consultation disagreeing with that as a solution.

CE conformity marking

In relation to the CE conformity marking, the Commission has decided to clarify and promote the meaning of the marking by means of an information campaign but it also intends to introduce enforcement and protection measures, including sanctions, and clarify its relation to voluntary product marks. It does not exclude the possibility to propose a clearer legal text in order to exclude ambiguities and to strengthen the position of the CE marking. The various mark issuing bodies will be interested in keeping an eye on developments in this area.

Simplification of the Safeguard Clause

The legal framework will be revised to simplify and shorten the Safeguard Clause procedure (which Member States must follow if they restrict or forbid the placing on the market and putting into service of products they ascertain are non-compliant or to have them withdrawn from the market), following positive support from consultees. This is surprising since the proposals appeared to give manufacturers and suppliers less protection in terms of putting their case in the event of enforcement action. Industry may wish to take part in discussions on this aspect in order to find some middle ground and ensure that simplification of the procedure does not entail reduction of their rights to be consulted if they refute the justification of the action. More information or guidance is needed to determine what enforcement actions require the triggering of the Safeguard Clause as there is a disparity between Member States as to what constitutes an action requiring notification under the Safeguard Clause.

RAPEX Procedure

Following positive support from consultation responses, the Commission will be putting forward proposals to include in New Approach Directives provisions for an information exchange concerning industrial products which present a serious risk to users, similar to the RAPEX procedure in the General Product Safety Directive 2001/95/EC applicable to consumer products. The RAPEX procedure requires notification by Member States of measures taken against a product or product batch which presents a serious risk to the health and safety of consumers. Industry should note that the Commission may choose to also incorporate the provision that the information available to the authorities on risks to health and safety posed by products should also be available to the public and therefore any problems that do arise may become more widely-known.

Implications and further information

As most of the actions necessary to achieve these aims fall under the direct responsibility of Member States, the Commission has opted not to come up with legislative proposals before full discussion with the European Parliament and the Council. Some of the areas proposed for change could have a serious impact on industry and companies should consider how their operations might be affected and enter into the discussions. It will be especially important considering the enlarged region it will relate to following EU enlargement in May 2004.

The Communication can be found in document COM(2003)240 final on the Europa website (under official documents, legislation in preparation).

For advice on the implications of these decisions or for further information, please contact:

Christopher Hodges
CMS Cameron McKenna
T: +44 (0) 20 7367 2738
[email protected]

Natalie Wood
CMS Cameron McKenna
T: +44 (0) 20 7367 2523
[email protected]