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Placing products on the single European market: a product safety guide for the UK

Updated: May 8

For all Your UKCA Requirements go to the following link


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 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


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


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


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


• 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


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