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 Market
Surveillance Developments in Europe
Lars Ettarp and Heidi Lund
New initiatives create confidence in the internal market.
The free movement of goods and the removal of technical barriers
to trade are key elements of the EU's single-market program and
the European system for conformity assessment, which is referred
to as the New Approach. In a single European market, goods should
be able to cross borders without national reinspection or retesting.
The function of the EU's single-market program depends on
the vigilance of manufacturers in ensuring that products meet essential
health and safety requirements, and on the product monitoring performed
by national authorities once the products are on the market. This
monitoring, called market surveillance, is critical for maintaining
consumer and business confidence in the present conformity assessment
system.
Market surveillance should not merely be regarded as an
obligation resulting from European Commission (EC) rules, but also
as a means of ensuring compliance with current regulations. In the
nonharmonized area, it ought, therefore, to be the actual need for
surveillance that is decisive rather than the fact that this area
is not regulated at the EC level. In practice, it is the nonharmonized
area where substantial efforts are needed.
The new system, however, has become a real challenge for
the enforcement community. There have been major differences among
member states in how market surveillance is carried out. Some countries
do not have a market surveillance organization while others carry
out passive market surveillance, reacting only after crises occur.
Some member states, however, actively plan and monitor product compliance.
In order to make market surveillance effective, authorities ought
to have the necessary resources and power to carry out their surveillance
activities.
Given the current situation, it is no surprise that more
and more voices in the regulatory community have been requesting
the development of unambiguous rules for market surveillance. As
a result, many steps have been taken to ensure that market surveillance
will become more effective and consistent. The improvements, essential
to the success of the New Approach, are ongoing.
Cornerstones of the European Conformity Assessment Structure
The New Approach to a single European market was unveiled
in 1985 in the White Book. The book described a resolution that
was adopted by the EC in 1985 for the development of a series of
directives to govern the quality, testing, and inspection of products.1
These directives set out the essential requirements that ensure
the protection of health and the environment. These requirements
must be fulfilled before a product can be put on the European market.
The directives also indicate to what extent the manufacturer
must arrange for products to be tested or inspected by a competent
third party. The most simple method for demonstrating that a product
fulfills the essential requirements is a supplier's declaration,
a statement from the manufacturer that a product or service was
made in accordance with the requirements. Along with this statement,
a technical file for the purpose of market surveillance is also
often required. For potentially dangerous products, however, the
declaration is often not sufficient and third-party involvement
is required.
Detailed, harmonized technical standards are drawn up by
the European standardization bodies: the European Committee for
Standardization (CEN), the European Committee for Electrotechnical
Standardization (CENELEC), and the European Telecommunication Standardization
Institute (ETSI).
Compliance with these standards is voluntary, although a
product manufactured in accordance with them is presumed to fulfill
the basic requirements and will enjoy free movement throughout the
EU. The manufacturer can choose not to comply with the standards,
but must still be able to show that the product fulfills the essential
requirements of the applicable directives. For product types that
do not have harmonized specifications, mutual recognition of test,
inspection, and certification results based on the EN 45000 series
of standards can be applied.
Market surveillance, the method for enforcing the function
of the European conformity assessment system, is based on requirements
given in the New Approach directives. These requirements are very
general, leaving most of the practical details of surveillance methods
to the discretion of the member states.
The CE mark, the external symbol that a product fulfills
the applicable requirements of the directives, has become the central
object for control of the market surveillance strategies of the
member states.
However, since CE marking was adopted in 1993, lack of confidence
in the EU conformity assessment structure has become a major issue.
According to government reports, many CE-marked product groups have
failed to meet essential requirements. Some CE-marked products actually
have been shown to be dangerous. Also, some products that have been
on the market were sold without CE marking. For example, yearly
market surveillance statistics of toys have revealed a large number
of noncompliant products on the market.
Another reason for lack of consumer confidence in the CE
mark is that consumers are often unsure of what the mark means,
especially with the proliferation of commercial marks, which serve
a different purpose.
So the New Approach to conformity assessment presents an
enforcement challenge. If the enforcement is not consistent and
effective, businesses are put at risk by low consumer confidence,
and consumers are put at risk by unsafe products. The regulatory
community has been taking steps to improve enforcement.
Market Surveillance Is on the European Agenda
In June 1997, the European Council endorsed the Single Market
Action Plan, presented by the EC June 4. The plan outlined how the
functioning of the single market was to have been improved by 1999.
The plan called for simplification and better enforcement
of legislation, the removal of obstacles to market integration by
better product control, and, more symbolically, the creation of
a true single market for consumers.
By 1997, it had thus become evident that the existing requirements
for market surveillance were too general to create a coherent structure
and to guarantee safety for citizens and profit for industry. For
example, the Eurobarometer survey in 1997 showed that 64% of Europeans
thought that consumer protection standards differed among member
states.
But 1997 became a turning point in market surveillance.
In October, the first European Conference on Market Surveillance
was organized by the EC, the Swedish government, and the Swedish
Board for Accreditation and Conformity Assessment (SWEDAC). That
year, market surveillance also gained a permanent forum for discussion
in the EC's Senior Officials Group for Standardization (SOGS).
At that time, it was apparent that cooperation between member
states was essential for improvement, but it could only be stated
that discussion and development of criteria for market surveillance
were more or less not taking place at all.
Since 1997, market surveillance questions have remained
at the top of the New Approach agenda. The New Guide to the Implementation
of Directives, based on the New and Global Approach, contains
a voluminous chapter on market surveillance and will further specify
the enforcement obligations of the member states.
European industry is also becoming more outspoken on the
need for improving market surveillance. In some cases, industry
has refused to accept higher product standards if surveillance is
not drastically improved.
In 1998, the Mutual Joint Visit Programme was launched by
the directorate general for enterprise in the Commission. The aim
of the program is to form expert teams of enforcement professionals
from different member states in key regulatory areas. The teams
will visit member states to assess their market surveillance systems.
The first visits took place in April 1999, and a final meeting was
organized in Brussels in September 1999. A continuation of the program
is planned for 2000.
Many other improvements are under way in the European market
surveillance community. New European working groups for market surveillance
have been established in the areas of low voltage, EMC, and legal
metrology. A Nordic reference group for market surveillance has
been formed, and a pilot study has been carried out to determine
contact points and actions for intensified Nordic cooperation.2
Further, in November 1999, a Nordic Conference on Market Surveillance
was organized by the governments of the Nordic countries in cooperation
with SWEDAC in Stockholm. The candidate countries were also invited
to this event. The many activities involving market surveillance
manifest the emphasis now placed on enforcement in the European
Community.
Calendar of Events
Market surveillance has finally become an integrated part
of the European conformity assessment policy. Enforcement organizations
now exist in most of the member states and enormous pressure is
being placed on all of them to make the enforcement organizations
more effective.
Several factors may affect the success of the single market.
The enlargement of the EU to include Central and Eastern European
candidate countries may place more pressure on the market, creating
an increased need for market surveillance.
Another factor is the effect of mutual recognition agreements
(MRAs) on conformity assessment between EU and non-EU countries.
These agreements will probably create new challenges.
For example, the MRA with Canada and the United States specifies
that restrictions on the market entrance of products should be communicated
to the authorities in the country of origin, requiring that the
market surveillance authorities inform not only the EC but also
the manufacturing country. Identifying contact points for this communication
may be difficult.
Other agreements, such as those between the EU and Australia
and New Zealand, do not have provisions for market surveillance
at all. The lack of rules may cause ambiguity when problems arise.
For example, how should a market surveillance authority respond
when it finds that an assessment of a conformity assessment body
(CAB) is incorrect? Who should be informed of noncompliance: the
designated authority or the EC? Who should take actions against
a CAB or a manufacturer in a third country? The fact that MRAs cover
only particular market sectors may also affect surveillance. The
authorities must be observant that a CAB is competent to make assessments
of all directives needed. The focus on improving enforcement structures
in the EU will be accelerated when the confidence-building period
of the MRAs is over.
With improving market surveillance as a central goal of
conformity assessment policy, a challenging period of work is to
be expected in Europe in the coming years.
References
- Council resolution on a new approach to technical harmonization
and standards, 85/C 136/01.
- Swedish Board for Accreditation and Conformity Assessment,
Market Surveillance in the Nordic Countries. An overview of contact
points and coordinated surveillance projects carried out by sectoral
authorities, SWEDAC DOC 99:1.
Lars Ettarp is director general of the Swedish Board for Accreditation
and Conformity Assessment (SWEDAC). Heidi Lund is special adviser
on market surveillance at SWEDAC.
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