Placing products on the single European market: a product safety guide for the UK
- C Pickup
- Mar 20, 2023
- 27 min read
Updated: May 6, 2024
For all Your UKCA Requirements go to the following link
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
international ISO or IEC standards, so there is also a European or ‘EN’
wrapper around the ISO/IEC),
• the front page of the standard describes the status and origin of the EN,
• the Scope of a standard is fundamental as here the products to which the
standard applies, and in some cases does not apply, are detailed,
• a section listing other Standards referenced within. These are of two types:
"normative" references which form a legal part of the Standard, and
"informative" references which are for information and do not form part of
the Standard,
• a section Defining terms used in the standard, and sometimes the
products,
• a Hazard Analysis section, usually ISO 12100 is used,
• a section listing the Safety Requirements for each hazard,
• a section indicating measures for product Verification against the
requirements,
• a section outlining what the Instructions for Use should contain,
• and it may be accompanied by a number of Annexes. These may be
Normative (which directly support the Safety Requirements), or
Informative, including
• usually in Annex Z, the origin, status, and extent to which the standard
supports product legislation, including which essential requirements, and
so for which it may give a presumption of conformity (if listed without
qualification in the OJEU).
In many cases transposed harmonised standards define the state of the art
for either a product or safety feature. For example:
BS EN ISO 13857 Safety of machinery - Safety distances to prevent hazard
zones being reached by upper and lower limbs which was prepared under a
mandate given to CEN by the European Commission and the European Free
Trade Association (more information on the process of developing standards
is available). This standard provides one means of conforming to Essential
Requirements of the New Approach Directive 2006/42/EC on machinery, by
defining the safe minimum distances through different sized holes in guards to
prevent access to dangerous parts.
Nevertheless, the use of even this standard remains voluntary, fundamental
as it is for defining safety distances. All a product designer /manufacturer has
to do is meet the objectives of the essential requirements of the relevant
product legislation and show this in his technical file. The standard shows one
way this can be done, and if followed gives a presumption of conformity.
However, in certain circumstances, and where justified, even fundamental
standards such as this need not be followed, provided the designer and
manufacturer can show compliance with the essential requirements in their
technical file by another equally effective method so the level of risk reduction
is at least as good as if the standard had been used. For example, the
physical nature of a product may ergonomically constrain access to
dangerous parts even though the safety distance is less than that defined in
BS EN ISO 13857, and so it may be justified in particular circumstances to not
follow the standard in full.
The use of any standard by a designer or manufacturer is voluntary. But
where compliance with any standard is declared without qualification on the
Declaration of Conformity for the product, that manufacturer is bound to fully
meet all requirements of those standards for his product.
Standards are not usually applied retrospectively to products first placed on
the market before the standard is published and may only define the ‘state of
the art’ at the time they were developed and published. European standards,
like most others, are therefore subject to periodic review (normally the
process starts 5 years after the date of publishing by CEN etc), and so their
provisions may change over time. Standards should normally be referenced to
a dated version. Where a standard is referenced undated, for example on a
Declaration of Conformity or in a technical file, the market surveillance
authorities can assume that the manufacturer is referring to the latest version
of that standard prevailing at the time the product was placed on the market.
Designers and manufacturers should therefore keep aware of the current
status of standards relevant to their product and ensure that product
documentation is similarly kept under review and updated as necessary.
Technical Documentation
Manufacturers of new products subject to European product safety legislation
must collect and be able to assemble comprehensive information covering the design, construction, conformity assessment and use of the product to
demonstrate how their product complies with all applicable product legislation.
This is known as a technical documentation or a technical file in some cases.
It should be in one or more of the official Community languages and kept
available for at least the time period specified in the relevant product
legislation (eg for machinery this means for at least 10 years since last
production of the product range).
The technical documentation must be complied for each product that a
manufacturer or importer places on the single European market (or one file for
a series of identical products) as required by the relevant European product
safety legislation. It should demonstrate with appropriately detailed
documentation, calculations and drawings, how the product complies with all
relevant product legislation, and so is safe and compliant during all phases of
its life. Systematically assembling the technical file may also help manufacturers when undertaking the conformity assessment process for a
particular product. If a product is submitted for type-examination, a copy of the technical documentation must be provided to the Notified Body at the same time.
The content depends on the relevant product safety legislation applicable to
the product, but generally should include:
• information concerning the products design assessment and construction,
including which essential requirements are relevant, and how these
essential requirements have been met (which may include references to
technical standards applied),
• the conformity assessment procedure applied to the product,
• a copy of the Declaration of Conformity and Declaration of Performance (if
relevant), and any other Declarations of Conformity or Incorporation
relevant to the product or its subassemblies/component parts)
• a copy of the User Instructions,
• details of relevant research and test reports,
• and where a series of products are made, details of the quality systems to
assure the safety of those products with the original specification (and any
changes made).
It used to be that, the technical documentation did not have to be permanently available in material form, nor located within the territory of the
EU/EEA/Switzerland, However since the 16th July 2021 at technical files should be stored in any one of the members states at the manufacturers address or with their Authorised Representative or other economic operator that reside in one of the member states. See Market Surveillance Regulation EU 2019/1020
What is the EU Market Surveillance Regulation?
The Market Surveillance Regulation was adopted by the European Commission to ensure the safety of products sold within the European Union. It is part of the Goods package and aims to ensure that products placed on the EU single market are compliant with EU legislation.
The need for extra efforts to keep unsafe products off the EU market is largely due to challenges posed by increasingly popular e-commerce and online trade. Until now, consumers have been considered the importers of the products they buy online. Importers are legally responsible for ensuring that products comply with EU safety standards, yet most end-users have been unaware of whether the products they buy online are certified as safe or not.
The Market Surveillance Regulation closes this loophole by strengthening controls on products sold in the EU in three main ways:
All non-EU manufacturers must have an ‘economic operator’ in the EU
Strengthened market surveillance of products
Stricter controls at the EU border
What is an economic operator?
An economic operator can be one of the following:
· a manufacturer
· an importer into the EU (if the manufacturer is not established in the EU)
· an authorised representative
· a fulfillment service provider (person or company responsible for warehousing, packaging, addressing and/or dispatching products)
Under the Market Surveillance Regulation, suppliers must have an economic operator established within the European Union to sell their products in the EU. Stricter controls, strengthened market surveillance and possible penalties will enforce the responsibilities of economic operators, which include:
Ensuring the availability of conformity documentation
Cooperating with market surveillance authorities
Informing authorities when there is reason to believe that a product presents a risk
Who will be affected by the Market Surveillance Regulation?
The new regulation will affect manufacturers based outside of the EU, consumers in the EU and fulfillment service providers. It will have the greatest impact on online sales where the business is based outside of the EU and the consumer is in the EU. By strengthening compliance checks for products, consumers can be assured that the products they order online will meet the EU harmonised standards for health and safety.
How to prepare for the enforcement of the Market Surveillance Regulation?
If your business is established outside of the European Union and you want to sell your products in the EU either directly, online, or through a fulfillment service provider, you will need an EU economic operator to do so. This applies for all products that fall under EU harmonisation legislation, including (but not limited to):
· ATEX products
· EMC equipment
· Machinery
· Radio equipment
· Pressure equipment
· Electrical and electronic equipment
The CE Marking Certification Experts can take on the role of economic operator as an EU Authorised Representative. If you are interested in our AR service or have more questions about the Market Surveillance Regulation, contact us today
Instructions
New products must be accompanied by information, most often in the form of an Instruction Manual. All European product safety legislation require
information to be made available to end users to enable the safe use of
products. Others, such as installers, may also need information to enable the
product to be safely installed before use. User instructions should be
comprehensive, easy to understand, and in a language easily understood by
the end user (except certain parts for specialist maintenance activity where
this will not be undertaken by the user). Other information provided on the
product such as warnings, which may be given in pictorial form, should be
explained in the user instructions. User instructions essential for safety should
normally be provided in a printed form.
The precise contents of information to be provided with a product depends on
the relevant product legislation, but can be summarised as sufficient detail
about the product regarding:
• intended use, and ways the product should not be used
• the manner of installation
• correct use to ensure health and safety, and
• safe maintenance, including cleaning, unblocking, and any inspection and
testing
Some legislation specifies the content of Instructions for users and others
such as installers in significant detail. For example, the Machinery Directive,
where essential health and safety requirement (EHSR) 1.7 specifies detailed
information requirements for all types of products covered, and EHSRs 2.1.2
etc supplement this for specific types of machinery (eg cleaning instructions
for machinery processing foodstuffs to avoid cross contamination in the
processed product). Others, such as the Low Voltage Directive, are less
specific, although, where possible key information is required on the electrical
component itself, so it can be used safely in the manner intended.
Instructions should cover not only intended use of a product, but take account
of reasonably foreseeable misuse, warning of ways the product should not be
used. Where the product is intended to be used by non-professionals,
instructions should be worded and laid out taking account of the level of
general education and understanding that can be expected of such users.
Short quick start guides may be a useful additional approach.
In some cases, the results of product testing should be provided in the User
Instructions. For all machinery information on airborne noise emissions must
be provided, and in the case of hand-held and hand-guided machinery,
information concerning vibrations transmitted must also be provided. Where
machinery is likely to emit non-ionising radiation information concerning the
radiation emitted for the operator and exposed persons should be provided.
Sales literature describing the performance characteristics of machinery must
contain the same information on emissions as is contained in the instructions.
Where the on-going safety of a product depends on it remaining within certain
parameters (eg below a certain force limit for a powered door/gate, the
stopping time of a braking system, trip current of electrical equipment), this
information should be specified within the maintenance, inspection or
examination/testing sections of the instructions.
In the case of partly completed machinery (PCM, as defined by Article 2g of
the Machinery Directive 2006/42/EC) assembly instructions must be provided
instead. Assembly instructions must contain a description of the conditions
which must be met with a view to the correct incorporation of the partly
completed machinery into the final machinery, so as not to compromise safety and health (eg relevant data on safety performance/reliability so the required safety performance of the machinery is achieved when the PCM is
incorporated).
Instructions, and warnings given on products must be in the official
Community language or languages of the member state(s) in which the
product is first placed on the market and/or first put into service. This may
require dedicated language versions for each member state the product is
marketed in, or, as is often seen, multi-language instructions / warnings
including all languages of all the members states on which the product is
placed on the market. Where pictorial warnings are given on the product
these, along with the meanings of any warning devices, should be explained
in the Instruction Manual.
Exceptionally, parts of the machinery maintenance instructions intended for
use only by specialised maintenance personnel mandated by the
manufacturer may be supplied in the one official Community language which
the specialised maintenance personnel understand. However, the other
general parts of the user instructions must be supplied in the language of the
end user.
A copy of the original Instruction Manual should be included as part of the
technical documentation/file for a product, along with any translations made
into other Community languages.
EU Declarations
Most new products must be supplied to end users with a certificate called an
EU Declaration of Conformity which must relate to the particular product
placed on the market. Products in scope of the Construction Products
Regulation (EU/305/2011) and a relevant standard must also be accompanied
by a Declaration of Performance. There is also a Declaration of Incorporation,
which is only currently relevant for partly completed machinery as defined by
the Machinery Directive.
A Declaration of Conformity, Performance or Incorporation is a formal
declaration by a manufacturer, or the manufacturer's representative, that the
product to which it applies meets all relevant requirements of all product
safety legislation applicable to that product. It is a sign that the particular
product has been designed and constructed for compliance with relevant
essential requirements and has been through the appropriate conformity
assessment processes. The precise requirements are specified in each piece
of product legislation, but essentially Declarations of Conformity should
include the following key information:
• the name and address of the organisation taking responsibility for the
product
• a description of the product plus identification of type and serial number
• list which product safety Directives it complies with
• may include details of relevant standards used
• and be dated and signed by a representative of the organisation placing it
on the single European market.
Such Declarations are not quality certificates, nor a guarantee for safety.
However, when properly drawn up along with CE marking on the product,
conformity of the product with the product legislation quoted on the
Declaration may be presumed by economic operators in the distribution chain
and by the end user, provided there are no obvious or known defects, and
permit free movement throughout the European single market. However, this
presumption of conformity is rebuttable if it can be shown that the product is
not in fact in conformity with all aspects of any applicable product legislation.
Products subject to more than one Directive/Regulation should normally have
a single Declaration of Conformity declaring conformity with all of the relevant
product legislation. However, where a product bearing CE marking is
incorporated in another, such as a safety interlock in a machine, the
Declaration of Conformity for the final product need only declare conformity of
the overall final product. In this case the Declaration(s) for any component
parts should form part of the technical file for the complete product.
For some new products the full Declaration of Conformity must accompany
the product through the supply chain to the end user (eg for all products in
scope of the Machinery Directive). This is not required for electrical equipment
within scope of the Low Voltage Directive (LVD) 2014/35/EU, but key
information about the product must be supplied, although often a copy of the
Declaration is included in the User Manual. However, under LVD a
Declaration of Conformity must be drawn up by the manufacturer or the
manufacturer's authorised representative and included in the technical
documentation. Declarations must also be made available to Importers where
they place the product on the market. Some product legislation permits the
use of a ‘simplified Declaration, eg the Radio Equipment Directive
2014/53/EU, where it must accompany the product to the end user.
Declarations must also, on request, be made available by any economic
operator to any EU market surveillance authority (MSA). MSAs must presume
that products with correct CE marking and accompanied by suitable
Declaration(s) comply with the provisions of the legislation mentioned on
them, and so not restrict their free movement, unless they have evidence to
the contrary (for example by examining or testing the product).
A Declaration of Incorporation may only be issued when placing partly
completed machinery (PCMs) on the market. PCMs are drive systems and
other assemblies that are:
• almost machinery,
• cannot in themselves perform a specific application, and
• are only intended to be incorporated into or assembled with other partly
completed machinery or equipment, so forming machinery that is not
excluded from the Directive (see Articles 2g and 1(2) of the Machinery
Directive 2006/42/EC)
This is basically because partly completed machinery is not in a final state
that will allow it to operate and it needs to be incorporated with other parts, so it can work as part of the final machine. In its partly completed state it may not be able to fully conform to all of the essential health and safety requirements of the Machinery Directive. The interface where partly completed machinery will be combined with other parts will therefore require assessment and protection when the final machine is assembled.
PCMs must not be CE marked under the Machinery Directive, as they are
only intended for incorporation to form machinery to which CE marking will be
later applied. However, PCMs may need to bear CE marking under other
legislation (eg the Radio Equipment Directive) where other CE marking
legislation applies alongside the Machinery Directive. Hence the importance
of the separate Declarations of Conformity and of Incorporation to clearly
indicate on what basis CE marking is applied to PCMs.
This special legal status (PCM, as defined) cannot be used as a means of
avoiding compliance with the full conformity assessment as required by the
Machinery Directive for complete products (eg by leaving off safety items such
as guards and saying it is "partly complete"). If a product can operate as a
machine it must always be fully protected with all safeguards provided, be CE
marked and accompanied by a Declaration of Conformity.
In addition to similar particulars as required on a Declaration of Conformity
(manufacturer / authorised person details, description etc, date and signature,
etc), the Declaration of Incorporation must also clearly state:
• "that the partly completed machinery must not be put into service until the
final machinery into which it is to be incorporated has been declared in
conformity with the provisions of the directive, where appropriate"
• "an undertaking to transmit, in response to a reasoned request by the
national authorities, relevant information on the partly completed
machinery."
• "which essential health and safety requirements are applied and fulfilled…
and where appropriate, a sentence declaring the conformity of the partly
completed machinery with other relevant Directives." (Note, there is no
requirement for a PCM to fulfil any EHSRs, but it will usually be helpful if
those which are relevant to the PCM itself (eg materials used to make the
PCM, performance characteristics of any control system in the PCM,) are
covered by the technical file for the PCM, and stated on the Declaration of
Incorporation – otherwise it may be very difficult for the person
incorporating the PCM to meet his obligations under conformity
assessment).
ANNEX
Useful reference information
If you require CE Marking or UKCA Marking assistance Contact the team below
CE Marking Authority
Tomorrows Certification Today
Tel: +44 (0) 1779 841842
Tel; +44 (0) 7910 523528
www.cemarkingauthority.com
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