Placing products on the single European market: a product safety guide for the UK
Updated: May 8
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Introduction
UK businesses wishing to supply goods into the single European market,
comprising the EU and EEA member states, and Switzerland, must meet EU
single market rules for product conformity and in many cases show this by CE
marking. This guide describes the common requirements for industrial
products that must be met, primarily from a product safety perspective.
However, other non-safety product legislation may also apply to a particular
product and must also be met in full for product compliance (eg environmental provisions). Furthermore, this guide is not a substitute for the provisions of the relevant European legislation or other detailed guidance such as the EU Blue Guide or the RAPEX guidelines.
Key examples of relevant European product legislation and topic guidance are
listed. All are freely available using the legislation’s reference via the
Commission’s europa.eu website.
Placing industrial products on the single European market
European product legislation is concerned with: the health and safety of
people (and in many cases domestic animals), as well as the safety of
property; the protection of the environment; correct product function; and
other matters of public interest protection. Although this guide mentions some
other legislation (eg on electromagnetic compatibility), its emphasis is on the
health and safety of industrial products by design and construction.
New products may not be placed on the single European market unless they
fully meet the requirements of all product legislation relevant to the product.
CE marking, which is a sign of compliance for many goods regulated under
the New Approach, is required in most cases, as well as product labelling
indicating the relevant economic operator(s). Manufacturers may only affix the
CE marking when all of the requirements of all CE marking legislation
applicable to the product have been met. Where CE marking is not required
by any product legislation applicable to the product it must not be affixed (eg
industrial scaffolding towers): in these cases, manufacturers must meet all
applicable national requirements for the particular product for the market(s) it
is made available, and recognised standards may assist in helping meet
these.
It is the responsibility of economic operators, but particularly the
manufacturer, to establish which, and all, legislation is applicable to their
product, and apply it/ensure it has been applied before making a product
available for the first time on the single European market. Enforcement of any
non-compliance will be subject to the national provisions of each member
state of the market on which a product is made available. National market
surveillance authorities have general obligations, which are summarised by
European Regulation 765/2008 on market surveillance, to deal with noncompliance, taking account of the principle of proportionality, in particular where products present risk.
Compliant products accompanied by appropriate ‘Information for Use’, and in
many cases EC Declarations (of Conformity, Incorporation or Performance) in
the language of the market for which they are intended, then have a right of
free movement within the single European market, without further barrier to
trade.
Manufacturers, importers (who place goods on the single European market for
the first time from a third country) and distributors who subsequently make
goods available (which have already been placed on the market by
manufacturers or importers), are collectively known as economic operators
and have specific duties as described by the specific product legislation. With
the recent alignment of much European product legislation to the New
Legislative Framework (NLF) these duties are common for much product
legislation, as too are the definitions of terms like manufacturer, importer,
distributor, placing and making available on the market, and many others (see
EC Decision 768/2008 for further details of these obligations and definitions).
Certain legislation, like the Machinery Directive 2006/42/EC, have yet to be
fully ‘aligned’ according to the NLF, but expect to be on revision in the next
few years. A number of specific guides have been published by the European
Commission on the application of certain legislation like that for lifts,
machinery, pressure, ATEX and electrical equipment, and electro-magnetic
compatibility. These freely available guides explain further the specific
application of the legislation they cover, in particular the safety objectives or
essential requirements that such products must meet by design and
construction, and the procedures concerning third party verification when
required for specific products.
CE marking
Most new products placed on the European market and regulated by the New
Approach must be CE marked. This will include products which are "new" to
the single European market, that is second-hand products from outside
Europe and which are put into service or placed on the market in Europe for
the first time, some existing products which are so substantially modified as to be considered "new", and users who make certain products (eg machinery)
for their own use.
CE marking is the responsibility of the person/company who places the
product on the single European market for the first time, or in some cases (eg
machinery) where it may not have been placed on the market, the person who
puts it into service for the first time. This duty primarily rests with the
manufacturer, aspects of which may be performed by the manufacturer's
authorised representative (must be agreed in writing between the parties). But
it can also apply to those who import and place products on the single market
for the first time (particularly where goods are not yet compliant, eg without
CE marking, etc), and those who rebrand products made by another to supply
under their own brand name.
By affixing CE marking you take on responsibility for the conformity of the
product. CE marking is a visible sign that the product complies with all
relevant product supply requirements, and its presence together with the
Declaration of Conformity and/or Performance gives the product to which it is
affixed a presumption of conformity with relevant product legislation. However,
the CE mark is not a quality mark, nor a guarantee that the product actually
meets all of the requirements of relevant EU product safety law.
CE marking is the final stage of the conformity assessment process as
specified in the relevant legislation for the product. If CE marking is required
you must:
• use the initials "CE" in the prescribed form (see the mark below)
• ensure it is of a minimum size - at least 5mm tall (unless this is not possible for very small products)
• maintain the proportions shown whatever the size,
• attach it to the product visibly, legibly and indelibly,
• where possible position next to the name of the manufacturer, importer etc.
Conformity assessment
This is the process by which persons can legally place safe and compliant
products onto the single market (or in some cases, machinery, put into use)
for the first time. Conformity assessment is a common feature of the product
legislation concerned with safety, and is concerned with:
• assessing the risks presented by a product throughout its lifecycle,
• meeting health, safety and other objectives by design and construction,
• taking account of the current best practice to ensure compliance for that
product, known as meeting the ‘state of the art’,
• in some cases, the supply legislation will require the use of third parties
who have been notified by an EU member state to the EU Commission
(usually referred to as ‘Notified Bodies’) to verify compliance,
• collecting and retaining information about the design, testing and
construction process and the means by which the product complies with
the essential requirements of all relevant product safety directives in a
technical file which, in most cases, must be kept for at least 10 years after
the last product of the product series has been produced,
• declaring the product's conformity with all relevant product safety
legislation by means of a document (the Declaration of Conformity), which
in many cases must accompany the product down the supply chain to the
end user,
• and the preparation and provision of comprehensive product User
Instructions, in the language of the end user.
Depending on the applicable legislation and the nature of the product and risk,
conformity assessment ranges from self-assessment of the product, to self assessment with third party type-examination by a conformity assessment
body and/or full assessment by a third-party conformity assessment body
(quality assurance). Full details of the procedures are given, normally within
the Annexes, of each piece of applicable legislation. Manufacturers and their
authorised representatives need to find out what these procedures are for any
of their products destined for the single market. Information generated and
obtained during the conformity assessment procedure must be retained as
part of the product's technical file.
Where a third party is required for conformity assessment (eg under the Gas
Appliances Regulation 2016/426/EU) the economic operator responsible for
product compliance must select an appropriate EU Notified Body to assist.
However, whilst the Notified Body will undertake and assessment of the
product and the manufacturer's quality system, and may issue an EU Type Examination Certificate, the duty to meet the relevant conformity assessment
procedure always remains with the relevant economic operator. It is the
economic operator’s responsibility to declare the product's conformity with all
relevant product legislation and correctly affix CE marking, before placing the
product on the market.
Although most larger member states have several Notified Bodies within their
territory, and manufacturers will often for convenience use one of their
national Notified Bodies, they can choose to use any valid accredited Notified
Body in any member state that is permitted to examine that particular product
type. But they are not entitled to ‘play off’ one Notified Body against another.
In applying for assessment by a Notified Body the applicant must declare that
an application for the same product has not been made to another Notified
Body. Manufacturers are advised to check that the proposed Notified Body is
valid for the product type and conformity assessment module (see below for
details on NANDO website).
If a Notified Body issues an EU Type-Examination Certificate for a product
submitted to them for conformity assessment this must be retained by the
economic operator and included in the technical file. There is sometimes
confusion as to what the EU Type-examination certificate means. It is a
document indicating that in the Notified Bodies' judgement the product meets
the requirements of particular product legislation. It is not a Declaration of
Conformity, although details of any Notified Body issuing such a certificate
should be included on the Declaration of Conformity, as well as the Type examination reference number.
EU Type-examination certificates normally have to be renewed after 5 years
even if no changes have been made to the product. Where changes are made
to a product for which a Type-Examination certificate has been issued the
manufacturer is obliged to inform the Notified Body of those changes in case
re-assessment is required, which may give rise to a new Type-examination
Certificate if the product is found in conformity.
Where the use of a Notified Body is not required for conformity assessment,
this is often referred to as ‘self-certification’ (internal control of production. This applies to many products that are not considered of high or special risk, or to all products in scope of certain legislation. However, your company may still not have the expertise to conduct the compliance process, this is were the CE Marking can help by reducing your costs and ensure conformity by outsourcing the compliance to a dedicated expert.
However, there is nothing to stop an economic operator approaching a Notified Body, or another organisation, to assist with his product assessment, but if a Notified Body is used when not required by the legislation then it is only as a
‘consultant’ and no Type-Examination Certificate must be issued and the
number of the Notified Body must not be quoted on the Declaration of
Conformity. This option is at the economic operator's own election and cost
and does not relieve the economic operator of his fundamental duty to declare conformity of, and take responsibility for, the product.
Essential requirements
All product legislation requires conformity with essential requirements,
sometimes known as safety objectives. These requirements are usually listed
in Annex I of the legislation and tailored to the specific characteristics of the
product types in scope for the objectives of the legislation. Standards,
especially those harmonised to the legislation (see later), often assist in
describing or ‘benchmarking’ the ‘state of the art’ for products in scope.
Designers and manufacturers must meet the common minimum requirement
of all the relevant essential requirements when placing their products on the
market, to the ‘state of the art’, although they can choose to go beyond these
minimums if they wish.
In the main, essential requirements set objectives to be reached rather
specifying the precise method of compliance. This allows designers and
manufacturers to choose the most appropriate ways to meet those objectives
for their particular product, which they must show through technical
documentation/file for the product.
Where a corresponding hazard/feature exists for the product the objectives of
all relevant essential requirements must be met, in so far as the product is
used under the conditions foreseen by the manufacturer, who must also take
account of foreseeable abnormal situations. While each essential requirement
is mandatory, taking account of the state of the art, it may not be possible to
meet the objectives set by them. In these cases, the product must, as far as
possible, be designed and constructed with the purpose of approaching their
objectives. Although the precise means by which an objective is met is left to
the product designer/manufacturer, over time the possibilities and standards
for meeting those objectives may change as the ‘state of the art’ for
compliance improves.
The notion of the ‘state of the art’ is not defined, however it includes both a
technical and economic aspect. It is a dynamic concept reflecting what can be
done at reasonable cost using generally available technology at the time. But
it is not an excuse for the lowest common achievable safety level, nor
necessarily what all manufacturers of a particular product currently do for
safety. The state of the art can change over time as new technologies appear,
especially as new/improved methods of safety evolve, such that what was
previously the state of the art may some years later no longer be so. Further
discussion of this concept in the context of the Machinery Directive’s Essential
Health and Safety Requirements (EHSRs) as listed at Annex I of 2006/42/EC
may be found at paragraph 161 of the European Commission Guide to the
Machinery Directive.
Some product legislation (eg the Machinery Directive 2006/42/EC) indicates
the order of preference in which risks must be managed, following long
standing principles of:
• firstly, risk avoidance or reduction, by design
• secondly, protection against risks that cannot be eliminated
• thirdly, warning of any residual risks that remain
Where a hazard can be avoided or reduced by design, that method should be
employed in first preference when meeting any applicable essential
requirements. But in many cases hazards persist, perhaps because they are a
fundamental part of the product (eg the blade of a circular saw), and so
physical methods of protection must be employed to meet the objectives of
the essential requirement. However, it is not always possible to protect
against all risks (eg part of the blade of a circular saw necessarily remains
unguarded) and manufacturers will have to warn users of any residual risks.
The job of the product designer is to consider all relevant essential
requirements and seek the best methods of meeting their objectives, to the
state of the art, taking account of the fundamental hierarchy of safety outlined
above.
Some "total" product safety legislation has a comprehensive list of essential
requirements dealing with all aspects of health and safety (eg the EHSRs for
machinery), whereas other product legislation only covers a restricted range
of issues (eg the essential requirements of the EMC Directive only deal with
issues of electromagnetic compatibility). Note that although the objectives of
Annex I of the Low Voltage Directive (2014/35/EU) principally concern
electrical matters it is nevertheless a ‘total’ safety Directive even though nonelectrical hazards are not further detailed (however many standards
supporting LVD include requirements for non-electrical hazards that are
expressed by the equipment they cover).
Essential requirements from more than one piece of product legislation may
apply to a particular product. For example, most machinery is electrically
powered so both the Machinery and EMC Directives will apply, and the
designer and manufacturer must take account of and simultaneously meet the
requirements of both Directives' essential requirements. However, for ‘total
safety Directives’ that cover all risks, only one can be applied to any product.
But this situation is covered, for example medical devices which are also
machines. Although medical machinery is out of the scope of the Machinery
Directive, the EHSRs of the Machinery Directive are ‘called up’ by the Medical
Devices Directive and Regulations, in so far as those EHSRs are relevant to
that medical device. Similarly, the essential requirements of the Low Voltage
Directive are brought into the Machinery Directive via EHSR 1.5.1, so any
Standard developed for the Low Voltage Directive may be support the design
of machinery, especially the electrical system.
Standards and their use
The use of Standards in complying with European product safety legislation is
not compulsory, but they can be very useful when designing products, and
may simplify the conformity assessment process. Some European standards
(those which are harmonised) have a special legal status and define minimum
acceptable levels for health and safety by supporting the essential
requirements of the legislation they support. For products in scope, if followed
in full, they can provide a ‘presumption of conformity’ with the relevant
legislation's essential requirements, potentially reducing the burden of
demonstrating product conformity (through the technical file).
Standards may deal with broad general principles, aspects of safety common
to many products, or be product specific, and can exist at many levels and
include:
• International standards (prefixed by "ISO" or "EN", sometimes by both)
• National standards (eg British Standards prefixed by "BS", German by
“DIN”, etc)
• industrial/sector
• even in-house
Standards have been defined as "an agreed, repeatable way of doing
something" (BSI). Normally they are published documents containing
technical information to guide or define practice in a consistent way and are
usually used by designers and manufacturers of products. They are also used
by customers when specifying products, and authorities when checking
product compliance, particularly where the use of a standard is declared in the Declaration of Conformity or the technical file.
Normally, the use of standards is voluntary and they do not impose legal
responsibilities. However, in some cases legislation may ‘call-up’ a specific
standard effectively giving it legal force (eg under the Construction Products
Regulation (EU/305/2011) products covered by its harmonised standards
must meet certain minimum requirements of those standards concerning the
Declaration of Performance). Manufacturers who declare compliance with a
standard effectively bind themselves and their product to the requirements of
the standard.
The British Standards Institute (BSI) is the UK's National Standards Body, and
publishes in English all National, European and many International standards.
In many cases standards are double prefixed "BS EN" which means this is the
UK version in English of a European standard (in some cases the prefix may
be "BS EN ISO" where an international standard has been adopted by Europe
as a European standard). The UK, through BSI as a member of CEN,
CENELEC, ISO and IEC, continues to contribute to the preparation of
International and European standards, as well as British Standards in areas
where there are none at or proposed at European or International level.
In the field of European product safety transposed harmonised standards are
a group of standards with special status. Their status is confirmed by their
listing in the Official Journal of the European Union (OJEU), although usually
an indication of the status of any particular standard is given in the standard,
and any limits on its coverage, at Annex Z. Although their use remains
voluntary, if a transposed harmonised standard is followed in full by a product
designer it can confer a presumption of conformity with one or more essential
(health and safety) requirements, provided the product is within scope of the
standard and the standard supports the relevant product safety legislation –
and without qualification, eg as detailed by Annex Z, and fundamentally by
any modification to the listing in the OJEU (usually a complete de-listing or
restriction of an existing standard’s presumption of conformity following due
process and publication of a Commission Decision in the OJEU).
This means in effect that by following the requirements of a currently
transposed harmonised standard a designer knows that his product will
comply with the parts of the legislation applying to his product. The use of
such standards can save designers much time in assessing risks and
adopting strategies for safety, particularly where the standard deals with all
essential requirements relating to a particular product.
Standards are subject to review and revision, and normally the presumption of
conformity they can provide is only valid for the latest version of the standard
(manufacturers should check the listing in the OJEU against the relevant
legislation).
In the machinery sector, standards dealing with a particular type of product
are often referred to as "C" standards (eg BS EN 1493 Vehicle Lifts). Those
dealing with common safety issues (eg BS EN 574 Two-hand control devices)
are often referred to as "B" standards, and those dealing with the fundamental
principles for safety (eg BS EN ISO 12100 Safety of machinery - General
principles for design - Risk assessment and risk reduction) as "A" standards.
European standards typically follow a similar style and format and knowing
something of the structure can help reading and understanding them. The
following is typical of a CEN machine specific "C" standard supporting the
Machinery Directive as published by BSI:
• the European standard (EN) will be inside a BSI "wrapper" with a National
forward. Inside that will be an unaltered copy of the EN as published by
CEN or CENELEC (some EN standards are similarly based on