By
Yvonne Halpaus
Industry in Europe has brought to the attention
of the European Commission that they support the self-certification of safe
products with the CE-Mark, and their opinion that Third Party (Notified Body)
Certification not become mandatory but be used on a voluntary basis.
Industry also
agreed that unsafe products are being brought to the market by criminally
acting manufacturers, who falsify Declarations of Conformity, which is
undermining the credibility of the Declarations of Conformity. Industry
recommends that future emphasis is to be placed on better market surveillance
by the European Governments and penalties for 1) unsafe products and 2) misuse
of the CE-mark, to serve as a source of funding for increased market
surveillance.
Consumer organizations and government market
surveillance authorities agree that significant numbers of dangerous products
still circulate throughout Europe although considerable progress has been made.
Findings in earlier reports show that 37,600
items of equipment tested in Switzerland showed 1,100 cases of CE Conformity
problems. Of 3,962 items that were
subjected to rigorous measurements, a high proportion of the devices were found
defective (976 altogether) and that none of these met the EMC specified
requirements. In 23 cases a sales ban was imposed and legal proceedings were
launched. Two other Member States also revealed problems when testing against
the EMC & Machinery Directive: 33% failed the EMC tests, 47% did not meet
the Machinery Directive formal rules and 89% had technical non-conformities.
These negative findings were not the
result of regular surveillance mechanisms, 58% was based on examinations
triggered by accidents, 33.3% following inspection of equipment installation,
8.5% based on complaints from competing manufacturers and 0.2% following visits
to trade fairs.
Many EU States and other organizations involved
in market surveillance explained their present strategies and experiences to
discover non-compliance but in the end they all agreed that the priority should
be given to:
1) intensified
cross-border co-operation between market surveillance authorities;
2) a
vital need for a relevant and well managed information system;
3) consistency
for all aspects of administration both within and between different national
systems;
4) the
need for clear guidelines on market surveillance principles to be applied by
applicant countries;
5) the
need for special alertness and rapid action in relation to non-compliant
products which particularly impact seasonally on consumers and to the growing
problem of “grey imports” from third countries.
Country
by Country Market Surveillance activity
Government officials from different
European Countries have reported the following experience with monitoring for
accurate CE-Marked goods:
United
Kingdom
The UK Health and Safety Executive (HSE) is
responsible for market surveillance for products used in the marketplace.
Priorities are based on the basic risk and established accident and ill-health
data. Internal specialists are used to target particular products and
suppliers.
The HSE support the local authorities consisting
of 202 offices called “Trading Standards Departments”. Their responsibilities
include the Toys, Low Voltage, Electro-Magnetic Compatibility, Machinery,
Simple Pressure vessel, Recreational Craft and Personal Protective Equipment
Directives. Local Authorities communicate with each other through the TSLink, a
closed Intranet System, that is frequently used to transmit information about
non-compliant products to ensure rapid enforcement action. Principal sectors
covered are: Machinery, Electrical Equipment, Lifts, Pressure Equipment and
“ATEX” equipment, designed for use in the workplace.
The success of this surveillance regime results
in lower British rates of fatalities and injury (1.3 compared to the 4.6 for
the EU average) and is lower than in the USA.
France
Market Surveillance is considered an
indispensable condition for effective application of the New Approach
Directives (CE-Marking).
Market Surveillance is a job to be done by the
public authorities. In the course of the market surveillance recourse to advice
from appropriate authorities or testing by competent laboratories should be
available. This is important in all countries because infringements against the
directives may give rise to legal penalties and in several countries, including
France, and they may be criminal offences.
The Directives give the enforcement authorities
the tools to carry out market surveillance. These include: first and foremost
the EC conformity declaration, certificates issued following EC-type
examinations or approval of the manufacturer’s quality system and the
manufacturers technical documentation. Checking this documentation is the easiest
and least costly method of market surveillance. But the Authorities must also
check that the conformity evaluating procedures are actually producing safe
products. Also taken into account should be occupational, domestic and sports
accident data. Trade Unions and consumer associations have a key role to play
in this feedback.
Product entering the market from third countries
should be checked because of unfamiliarity with European regulations and
imports from third countries where production costs are low tend to have
quality consequences. It is easier and
more effective to check at the point of entry before they are dispersed through
multiple distribution channels. In France, customs has been appointed as an enforcement
authority in their own right.
Emphasis is on the co-operation between Customs
and Inspectorate for Health protection. The Inspectorate of Health covers three
main areas: 1) Food; 2) Non-food, including following directives: Low Voltage,
Toys, Machines (for consumers), Personal Protective Equipment, Gas appliances.
3) Veterinary affairs.
They consist of 1 General Inspectorate and 5
Regionals. All are responsible for enforcement activities, including sample
testing in their laboratories and a toll-free number for members of the public.
They hold the following powers: Inspection, Powers of entry into manufacturers
and supplier premises, sampling and testing, investigation of producer
activities, suspension of sale of unsafe goods, advising the Ministry of Public
Health to publish warnings and on prosecutions to be handled by the Public
Prosecutor.
On October 27, 1997 an “Agreement on product
safety” between Customs and the Inspectorate for Health Protection in the
Netherlands went into effect. Together they determine which categories of
products should be given specific attention during a certain period.
These categories are red-profiled and all
customs declarations fitting these categories are faxed to the Inspectorate who
decides within 3 hours if checks are necessary, or to allow free movement, or
to indicate that checks are necessary, which means that the products are
suspended for 3 days at the importers premises. If everything checks out the
products are brought into the free movements of goods, if there is any serious
doubt, they can hold them longer. If products are found in non-compliance they
can take legal measure including: written warning, seizure, public prosecution.
Rotterdam and Amsterdam locations are staffed to handle these faxes 24 hours
per day.
Producers, importers and traders are responsible
for the safety, read “CE-marking” of these products and are expected to make
sure that all products meet legal requirements.
Containers are scanned at the rate of 1 every 15
minutes looking for undocumented and improperly documented imports.
Portugal
Responsibility
for market surveillance and enforcement rests with the Ministry of Economy and
Consumer Affairs called IGAE, and they have 5 regional directorates. IGAE
expect to become the exclusive Competent Authority for enforcement in the
future. The Directorate General of Industry, Portuguese Institute of Quality
& Consumer, is responsible for implementing directives. Other agencies that
play a role are: Rapex System and Ehlass, Safety Commission of products and
services.
Labeling
requirements are considered the most problematic; most often found are
non-conforming logotypes and the use of English language only.
For example:
CE-marked
decorative lamps, rocket shape, glass section filled with water and wax. They were
breaking, exploding and leaking wax. Country of Origin was China and other
unknown. When tested they did not meet electrical standard EN-60598 for impact
and resistance. The same lamp found under a different name, certified by 2
Notified Bodies (1 for LVD and 1 for EMC). The technical file supplied by the
distributor only contained a Declaration of Conformity and test reports with
models and serial numbers that did not match. Total lack of efficient design,
process and document control, and traceability. The distributor was held
responsible.
Enforcement
results to be released on monthly basis identifying dangerous and
non-conforming products.
Iceland
A Central
Authority, Loggildingarstofa leads the sectoral surveillance authorities and
inspection bodies. All inspection bodies must be accredited to EN 45000 and
follow the methods and procedures set out in an inspection manual published by
the sectoral authorities.
General law on
official market control passed in 1999 it emphasizes that duplication between
regulatory authorities should be avoided.
Hungary (Not
yet an EU member State)
The Hungarian
legal system is inserting the practical implementation of the European New
Approach Directives. The objective is free movement of products and services in
Hungary. Free movement means having the obligation to introduce and operate a
market surveillance system. This system was started December 1999.
ROLE OF NOTIFIED
BODIES in Market Surveillance
The European
Coordination of Notified Bodies for Machinery and Safety Components has
raised the issue of how to ensure that Notified Bodies and
the Authorities, responsible for market surveillance, interpret the new
approach directive criteria in the same manner.
Notified bodies are commercial organizations
that enter into business agreements with manufacturers to test their products,
they are also responsible to the public authority that notified them.
Questions raised: Does that mean that Notified
Bodies have an obligation to make the test results available to enforcement
agencies or should they be requested from the manufacturer? Opinions are
varied, but in France, Notified Bodies are obliged to participate in meetings
with enforcement authorities for information exchange purposes.
In the majority
of CE Type examinations Notified Bodies and Conformity Assessment Bodies have
been able to develop a common view. However, specific cases do exist where
national practices die hard. The problem of harmonization can exist in 1)
procedures applicable to type examination testing and 2) in divergences of
interpretation by national Authorities.
Networking of technical interpretations given by
permanent committees and Notified Body Co-ordination Group could be considered
a superior tool which will require substantial financing to implement.
This also raises the question of rights and
obligations of the Notified Body which finds itself involved in a protection
clause. If the authorities in charge of market surveillance find a product that
they suspect to be in non-compliance, Notified Bodies have the duty to
cooperate with the authorities, taking into account their general obligation of
confidentiality.
A need
exists for two clarifications:
-
Authorities performing the surveillance do not
systematically inform the Notified Body involved when they identify a possible
problem. Notified Bodies are usually
informed by the manufacturer who asks them to defend their position.
Surveillance Authorities may request “Certificates and decisions” from the
Notified Body.
-
The meaning of “relevant information”.
Is it: answer to
motivated questions related to specific issues? Or answers to any question
related to the conformity assessment procedure? Or communication of the full
conformity assessment report (based on testing, inspections and/or system
certification?).
There is the additional question of market
surveillance activities, which may or may not be implemented by Notified
Bodies.
Notified Bodies can be involved in three types
of surveillances, conflicts of interest should be avoided. Problem is that the
main source of expertise is within Notified Bodies
Type
I Market Surveillance by a
certification body is a relationship between a manufacturer and a Notified Body
in purely commercial context.
Type
II Market Surveillance
performed by a Notified Body within the context of a product conformity
assessment for a manufacturer legally obliged to do so before the
product is taken to market. This is also a contractual relationship between a
manufacturer and a Notified Body.
Type
III Market surveillance
performed by a Member State after the product has been put on the market
and the Authorities ask the Notified Body to act as an expert.
A proposed
solution is to clearly define the manufacturer’s responsibility to have a post
marketing surveillance system similar to the one defined in the Medical Device
Directive. There is a view that if non-conformity is of serious nature not just
one product but the entire production should be taken off the market.
Regional
organizations involved in the Market
Surveillance
Central and East European Countries - Trapex (CEEC-Trapex)
Trapex is a
rapid information system about dangerous products in the EU Member States.
Based on the experience of this system a similar system was formed in Bulgaria,
Estonia, Hungary, Latvia, Lithuania, Poland, Romania, and Slovakia in 1999. Only the non-food product network has been
operating. One category stands out, electrical appliances: 28 notifications
were sent out, also 3 textile products and 3 toys for a total of 43 notices.
The Low Voltage Directive was implemented
December 1998, in the participating CEEC countries, which created a focus on
electrical domestic appliances. The majority of dangerous products came from
the Far East countries. These were not simply of poor quality but actually
jeopardized lives, health and safety of consumers.
Measures taken included: sales ban, retailers to
buy the goods back, fines and confiscation.
Major problem: prohibited products re-appear
under a new brand name.
Created in 1998
responsible for the coordination of market surveillance cooperation between the
Nordic Countries. They met 4 times between 1998-2000 and have issued a report
highlighting market surveillance cooperation in different product sectors.
During a 1999 conference on market Surveillance
with 170 participants from the Nordic Countries, EU member States and Central
and East European countries it was concluded that:
-
Continuing support for sectoral market
surveillance cooperation will be vital.
-
Contact points and forums identified on market
surveillance must be used in communications between all attendees to build up
and maintain more efficient networks.
-
Need for in-depth dialogue between authorities,
distributors and industry.
-
Need for horizontal coordination of market
surveillance.
The senior
Labour Inspectors Committee recognized the difficulties in applying the
Machinery Directive consistently across the EU Community and formed an organization
called MACHEX.
Machex operates on a voluntary basis and
promotes consistency in the application of the Machinery Directive without
duplicating work done by the standing committee established under Article 6.2
of the Directive.
-
The network consists of 1 correspondent from
each Member Sate.
-
Information about unsafe machinery placed on the
market is exchanged quickly.
-
Action taken by one Member State may be followed
by similar action in others.
-
National laws on confidentiality to be
respected.
-
Technical file information is first requested
directly from the manufacture, if this is unsuccessful it may then be requested
through the Machex network.
-
Requests for information to be restricted to
just what is required for the purpose, instead of asking for the entire file,
which could be very large.
-
Information exchanged about actions to prohibit
or restrict the placing on the market or putting into service of machinery will
not replace the need for notifying the Commission under the safeguard clause
procedure.
European
Association for the coordination of Consumer Representation in
Standardization - ANEC
Examples of
dangerous products still circulating in Europe today:
Finland:
28.5% of 11,900 products failed to comply with the safety & marking
regulations.
Sweden:
soft toy animals, 50% were not CE-marked. The majority of those tested
did
not satisfy safety and marking requirements. Bicycle helmet models. 2/3rds were
not CE-marked
Finland:
37.5% of sunglasses lacked the CE-mark. 34% of lifejackets & personal
buoyancy
aids checked for labeling and instructions for use violated regulations. 21%
lacked CE Marking totally.
Sweden:
60 different models of baby rattles were tested, 30 did not pass the safety
requirements, and 24 of these were not
CE-marked.
UK: Consumers
Association put 18 electric household appliances through basic safety check, 6
failed the essential requirements of the Low Voltage Directive. They also found
blenders with lose-flying blades (if accidentally switched on), hair-curling
tongs with separated and exposed live parts when the handle came apart.
Co-operation between
Custom Agents and Surveillance Authorities
The
removal of internal borders in 1993 does not mean diminished importance for
European Customs. Their role has changed and now includes market surveillance.
The scope of their surveillance is based on Council Regulation 339/93/EEC,
focus is on products that are a serious and an immediate risk to health and
safety and lack of compulsory marking, label or documentation. Since January
1996 the European Commission and the Member States have enabled customs
administrations, through a well-funded program, to become efficient and perform
as one single and unique administration. Implementation includes monitoring,
studies, organization of seminars, working parties, exchange of officials,
publications of manuals, information and communication actions, IT systems and
training actions.
The five main
areas of the Customs 2002 program, the name of the partnership between Member
States customs administrations and the Commission, are:
-
the improvement of the controls effectiveness
based on good legislation and on modern management techniques such as risk
analysis and audit; in addition exchange of expertise has also an important
role to play.
-
setting standards and measuring results
-
the relation with trade
-
training
-
new developments, particularly in the fields of
computerization and equipment.
Surveillance is
producing a lot of insight into manufacturers willingness to comply with the
requirements. As a result, quite a few Directives are being amended including
the Machinery and the General Product Safety Directives. The draft of these
amendments show a tendency towards the addition of an ISO 9000 Quality
Assurance System Certification and product recall capabilities by the
manufacturer.
Yvonne
Halpaus, Partner, QNET LLC, Elk River, Minnesota. Ph: 763-441-0899, Fax:
763-441-0898. Website: http://www.ce-mark.com