1 Large number of public-sector actors are involved in policy making
Low level of awareness about how well the system as a whole is operating
In the Netherlands alone, a large number of public-sector actors are involved in policy- making in relation to, and the practical implementation of, the CE system: six ministers, five national inspectorates and a number of 'autonomous administrative authorities' (government agencies). These actors all have a role to play in the CE system and each of them reports individually to parliament on the way in which they have discharged their responsibility. In many cases, these reports cover a broader range of topics than the system of CE marking alone. As a result, parliament is unable to form a general picture of how well the system as a whole is operating and of areas in which improvements could be made, both by the Netherlands and by the EU.
2 Complexity of the regulations
Incompatibility with standards
The fact that products bearing a CE marking are sold on the European market despite failing to comply with EU requirements is the result of certain weaknesses in the regulation of CE marking. In general terms, there is an inherent tension in the way in which the system is designed: the economic interests of the economic operators (such as their desire to increase their market share and maximise their profits) are not automatically compatible with the need to safeguard public interests, as is the intended purpose of the system of CE marking. In addition to this intrinsic inconsistency, we also uncovered a number of specific problems in the 'conformity assessment procedure' followed by manufacturers, which may explain why products are sold on the European market that do not comply with EU requirements. We found, for example, that the complexity of the regulations may lead to confusion, that not all innovative products are compatible with harmonised EU standards, and that it is not always easy to guarantee the conformity of products produced as part of a series.
3 Divided resources
Insufficient market surveillance
There is a single European market, but every member state decides for itself how its system of market surveillance should operate. As a result, market surveillance in some member states is stricter than in others. Similarly, the market surveillance authorities in the various member states are not equally active in their use of European databases such as the Rapid Alert System for Dangerous Non-Food Products (RAPEX) and the Information and Communication System on Market Surveillance (ICSMS). These discrepancies have an impact on the system as a whole: the European market is a chain and the strength of market surveillance is as strong as the weakest link.
The situation in the Netherlands is that five national inspectorates are responsible for overseeing compliance with the regulations on CE marking. Only a very small proportion of their budgets and staff capacity is available for monitoring compliance with the CE regulations.
4 No role for end-users
Low level of assurance about compliance with regulations
The legislation on CE marking does not make provision for end-users such as consumers and professional users to play a certain role, nor does it impose any obligations on end- users. End-users must be assured that the products they buy in shops or use for their work do indeed satisfy EU requirements in relation to safety and sustainability, for example. This need not be a problem if the system is watertight. However, as we have already pointed out, the system is not fully watertight.
5 Data and information systems are underused
Inability to identify precise size of the market
Like the market surveillance authorities in other European countries, the Dutch inspectorates face a number of challenges: the trade in products is both dynamic and international, and a huge number of products reach the market every week. Despite our conviction that this situation requires a detailed, well-founded risk assessment, market surveillance authorities find it difficult to assess the precise size of the market and the number of players they are required to supervise. We also found that the exchange of data and inspection findings among market surveillance authorities, both in the same country and internationally, was not up to standard.
Background
Everyone in Europe handles or encounters products bearing a CE more or less on a daily basis - at home, in a shop or at work. CE markings are found for example on electrical appliances such as washing machines and smartphones, on toys, on packets of sticking plaster, on supermarket scales, on roadside petrol pumps, on ladders used by window-cleaners and on bread-slicers used by bakers.
Every year in the European Union (EU), dozens of products bearing a CE marking are taken off the market and/or recalled on the grounds that they pose a serious risk to the health and safety of consumers and professional users.
One of the most infamous examples of the recent past has involved breast implants known as PIP (Poly Implant Prothèse) implants. These were found to have been filled with an industrial-grade silicone gel that formed a public health risk. A large number of telephone chargers and toys have also been removed from the market during the past few years on the grounds of constituting a risk to health and/or safety. Remarkably, many of the products withdrawn from the market or recalled carried a CE marking. This is striking in that, by affixing a CE marking on a product, the manufacturer affirms that the product in question complies with the relevant EU requirements on safety, health and environmental protection.
These various incidents (among other reasons) prompted us to ask how it is possible that these products, which clearly do not comply with EU requirements, are nonetheless traded on the European market bearing a CE marking, and what the government is doing to prevent and remedy this problem.
The system of CE markings is part of a broader package of EU measures designed to pave the way for a single European market. The CE system is not just a European system. It is also a mixed public-private system in which both private-sector parties (such as manufac- turers) and public-sector parties (such as market surveillance authorities) have their own responsibilities and need to interact with each other.
Objectives
This audit seeks to answer the following question:
How is it possible that products that do not comply with EU rules on CE marking are nonetheless sold on the European market, and what is the government doing in order to prevent and remedy this situation?
Operation of the CE system in the Netherlands
The CE system is a European system. The EU adopted the CE marking system as part of a raft of measures designed to pave the way for the creation of a single European market. The operation of the system is subject to the democratic control of the European Parliament and the member states. As an EU member state, the Netherlands has its own responsibilities. These include organising market surveillance and accreditation. We focused on the role played by the Netherlands in the CE system.
As we do not have a mandate in other member states, we are unable to examine how the system is organised both at a European level and in other EU member states. We therefore hope that the supreme audit institutions in other EU member states will undertake similar audits in order to obtain a broader picture of the operation of the CE system in Europe.
We were also unable to perform any audit activities at the EU itself. We did, however, examine a number of EU studies, as well as the member-state declaration submitted by the Netherlands to the EU.