At the beginning of 1992, the European Single Market w=
as
created. The objective was to remove barriers to trade throughout the European Economic=
Area
allowing companies free access to markets in all the different countries
without having to meet particular local requirements such as safety testing
regulations, customs tariffs or contract conditions. Potentially, manufactu=
rers
now have access to a market with a spending power even larger than
In the period up to 1992, and subsequently, the Europe=
an
Parliament has enacted a series of measures intended to put the Single Mark=
et
into practice. Some of these Directives=
have
been aimed at removing barriers of a purely customs/excise nature, others h=
ave
concentrated on transport arrangements to ensure the free movement of goods,
while a series of Directives (produced under the heading of `New Approach
Directives) are intended to provide controls on product design, with the
principal objective being to provide a `level playing field' for product sa=
fety
requirements across the European Community.
The directives cover a very wide range of product areas. One of the first t=
o be
implemented concerned the safety of children's toys. Subsequent directives =
have
included provisions for machinery, electromagnetic compatibility (EMC),
personal protective equipment, medical devices, gas appliances and commerci=
al
explosives, among others. Also relevant is the Low Voltage
Directive. Strictly speaking the LVD, which was first enacted in 1973, =
pre-dates
the New Approach directives, but subsequent amendments have given it a very
similar function and legal structure, and the amendment which introduced the
requirement to CE mark products recognised that the LVD should broadly be
treated as if it were a New Approach directive.
The primary function of the New Approach directives is= to ensure that products are sufficiently well designed and built that they wil= l be fit for the purpose for which they are sold and that reasonable precautions= are taken to protect the user against injury while the product is being used. T= he Directives recognise that different product categories require different precautions; for instance the Low Voltage Directive generally only requires that products be designed to comply w= ith the relevant international safety standards and while an independent check = that the standards have been complied with is often advisable, it is not mandato= ry and manufacturers are free to declare their products safe without the need = for independent testing. The Machinery Directive, on the other hand, requires that for certain categories of equipment a third party independent check be made by a te= st house = notified for the purpose by the Government. The most stringent requirement, which applies to certain products covered by the Personal Prote= ctive Equipment Directive and to the Gas Appliances Directive, is that not only should the product undergo an independent t= ype test, but that it also has to be manufactured using a quality management sy= stem which has been assessed to ISO9000.
Directives essentially contain two distinct sets of
requirements. The first, the protection requirements, are the parts =
of
the directive which lay down the safety requirements which must be met in o=
rder
to comply with the directive. Different directives go into different levels=
of
detail on these points, but the full requirements are never contained in the
directive itself - this is left to product
standards which are developed by multinational committees made up from =
the
national standards organisations of all countries in the EU.
The administrative requirements are the part of the directive which =
lays
down how the manufacturer (or their agent) must CE mark=
the product. The manufacturer must produce a decla=
ration
of conformity stating that the product meets the requirements of the
directives which apply to it, and the standards or other references which w=
ere
used to judge that it complies. Usually there is also a requirement to prod=
uce
and maintain a file of design and manufacturing information, known as a
technical file or technical construction file, which shows how the product =
was
designed and built to meet the requirements of the directive. The Directive=
may
lay down time limits during which the manufacturer must keep the technical
file, even after the end of a product's market life.
It should be noted that, before the product can be CE marked, it must comply
with all the directives which apply to it.
The CE mar=
k
must be affixed to (in order of preference) the product, its instruction ma=
nual
or to its packaging. Recent guidance from the European Commission indicates
that the mark must appear on the product itself unless there are good techn=
ical
reasons why it cannot. It must be at least 5 mm high. It is not intended to=
be
a mark of quality - rather it is intended to indicate to the authorities
responsible for enforcing the Directives that the product's manufacturer cl=
aims
compliance with the directives which apply to the product.
The act of fixing the mark to the product, and signing the Declaration of
Conformity, constitutes a declaration by the manufacturer that the product
meets the requirements of all the Directives which apply to it. The onus is
very much on the manufacturer to take responsibility for this actually being
true. Marking a product which is not fully in accordance with the requireme=
nts
of the applicable directives is an offence in its own right, and would also
contravene related consumer safety and trades descriptions legislation.
The purpose of the directives is not to ban any products from the Europe= an Single Market, unless the product is very poorly made or is unsafe. For most reputable manufacturers, complying with the essential protection requiremen= ts of the directives is not particularly onerous and companies which have alwa= ys taken a responsible attitude to the performance and design of their products will have few problems complying with the New Approach directives.
Where a manufacturer is based outside the EU, it is the person who is responsible for bringing the equipment across the first EU border who has l= egal responsibility for CE marking it. However, because of their intimate involvement in the safety of the product, manufacturers almost always have = some responsibilities under the CE mark directives even if they are not directly responsible for importing the goods into the EU.
Where the manufacturer has a formally app=
ointed
distributor or subsidiary ('authorised
representative') the situation is reasonably straightforward. Where a p=
iece
of equipment is imported for the use of the importer, things get more compl=
ex
and each case must be considered on the basis of the individual circumstanc=
es.
Where there may be difficulties is in the administrative requirements since
these will require a new way of working for some manufacturers and supplier=
s,
particularly small businesses. Manufacturers may well find it cost effectiv=
e to
seek outside help in the early stages of complying with the Directives in o=
rder
to save time and prevent expensive mistakes. However, it is important to be
aware that it is rarely necessary to commit to an expensive program of test=
ing
and modifications: unless the Directives which apply to the product
specifically require the involvement of a third party for product approval =
or
quality system assessment, the manufacturer can affix the mark without havi=
ng
to involve a test house, consultant, the DTI or anyone else.
As with all CE marking directives, the actual requirements for any piece= of equipment under the directive are complex and dependent on not only the des= ign but also the type of user, the intended use and sometimes even what is clai= med in the instructions or sales literature.
For further advice specific to your products, please contact us at Conformance and we will be pleased to discuss your needs. If you'd like= us to prepare a no-obligation quote for assisting you with CE marking your products, please take a look at our page which gives details of the information required in= order to be able to give you an accurate idea of the costs and procedures involve= d.
23 April 2001