Chapter 1Regulations for New Machinery

Contents1.0 Background to the Regulations

1.1 The Supply of Machinery (Safety) Regulations 19921.1.1 Documentation1.1.2 Technical file1.1.3 Declaration of conformity1.1.4 Declaration of incorporation1.1.5 CE marking1.1.6 Enforcement

1.2 The Low Voltage Directive (LVD)1.2.1 Documentation1.2.2 Technical documentation1.2.3 Declaration of conformity1.2.4 Key standards1.2.5 Enforcement

1.3 The Electromagnetic Compatibility (EMC) Regulation1.3.1 Protection requirements1.3.2 Conformity assessment requirements1.3.2.1 The standards route1.3.2.2 The technical construction file route1.3.2.3 The EC type examination certificate route1.3.3 Key standards1.3.4 Enforcement1.3.5 Conclusion

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1.4 Schedule 4 machinery

1.5 Routes to CE marking4

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51.0 Background to the Regulations

The Single European Act of 1985 committed all EU member states tothe implementation of the four freedoms defined in the 1956 Treaty ofRome: the freedom of movement of goods, services, finance andpeople. To achieve this, legislation relating to these freedoms clearlyneeded to be the same in all member states. To this end, numerousEuropean Directives, issued from Brussels, have been implementedinto law across Europe by means of regulations, including thosefeatured in this guide.

The regulations are not intended to be technically detailed, but to bestraightforward in their requirements, listing the potential hazards frommachinery and requiring that these be protected against. They laydown Essential Health and Safety Requirements (EHSRs), whichequipment covered by the regulations must meet and, mostimportantly, they call upon member states to give freedom ofmovement within the European Economic Area (EEA) to equipmentthat complies.

This chapter deals with The Supply of Machinery (Safety)Regulations, Low Voltage Directive (LVD) and EMC Regulation.Choosing which directive to apply to which product is not toodifficult; here are a few examples:

An electric fireIt has no moving parts so it is not a machine. It has apredominantly resistive load, which is not affected by emissionsand does not generate electromagnetic interference. Thisequipment must meet the requirements of the LVD and itspaperwork must contain a statement indicating that it is EMC-benign.

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A toasterThis has moving parts, but the primary dangers are electrical(the springs ejecting the toast are not powerful enough to inflictsevere injuries). Again, its heaters are resistive, so it can betreated in the same way as the electric fire.

A power press This is clearly a machine, so it will be covered by theMachinery Regulations. If it has complex control systems thatcan generate or be affected by electromagnetic emissions, itmust also meet the EMC requirements.

A computer terminalThis does have moving parts, but these are low power andcause no hazard to health and safety. It has complexelectronic controls and usually a mains supply, so both the LVDand the EMC Regulations will apply.

A child’s battery-powered computer gameThis would generally be outside the voltage limits of the LVD,but would fall under the EMC Regulation. If an auxiliary supplyor charger is used, the LVD will apply. More specificinformation on the type of equipment covered can of course befound under the specific regulation.

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1.1 The Supply of Machinery (Safety) Regulations 1992

The Supply of Machinery (Safety) Regulations (Statutory Instrument[S.I.] 3073/1992) came into force on 1 January 1993, with a 2 yeartransitional period to enable industry to get up to speed. Since 1January 1995, therefore, most machinery supplied within the EEA hashad to satisfy the wide-ranging Essential Health and SafetyRequirements (EHSRs) for the design and construction of machines,as specified in Schedule 3 of the Regulations. This also applies toimports from countries outside the EEA and in-house machinerywhere manufacturers put their own machinery into service.

Evidence that the machine complies with the regulations must beprovided in the form of relevant technical documentation, prepared by“the responsible person”. The machine must also be CE marked,though in most cases this can be done via self-certification.Machinery listed in Schedule 4 of these Regulations requires specialtreatment; this is covered later in this chapter (see under “Schedule 4machinery”).

The regulations start by defining a machine as:

An assembly of linked parts, at least one of whichmoves under power

An assembly of machines linked together to achievethe same end

Interchangeable equipment.

These wide-ranging statements cover most assemblies.

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The EHSRs are divided into 6 groups. Group 1 can be regardedas mandatory for all machines. Groups 2 to 6 are additionalrequirements for certain categories of machine.

Group 1This group is divided into 7 parts, each part having several sections:

General remarks (Section 1.1 of the Regulations)This section defines people and objects around the machine,such as the exposed person, danger zone and operator. Othersections explain safety integration, lighting, handling and theneed for materials and products used in the construction of themachine to be safe.

Controls (Section 1.2 of the Regulations) This section defines how controls should be identified.Starting, stopping, emergency stopping, mode selection, powersupply properties and, of course, software are also defined.

Protection against mechanical hazards(Section 1.3 of the Regulations)

This section deals with most mechanical problems inmanufacture and machine operation, and also provides anintroduction to guarding.

The requirements of guards (Section 1.4 of the Regulations)This section defines the various types of guard: fixed, movabletype A and B guards, adjustable, etc.

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Other hazards (Section 1.5 of the Regulations)This section looks at other relevant issues not included in theabove, and lists 15 topics which may need addressing, such assupply voltage, fire, explosion, vibration and radiation. TheLow Voltage and EMC Regulations must also be met in orderto comply with parts of this section.

Maintenance (Section 1.6 of the Regulations)This section details what is required when designing a machineto enable it to be maintained safely.

Warnings (Section 1.7 of the Regulations)Details, markings and instructions.

Group 2This group is concerned with machines for making foodstuffs,woodworking equipment and hand-held machinery.

Group 3This group details the requirements to offset the hazards arising fromthe mobility of machinery.

Group 4This group details the requirements to offset hazards arising fromlifting operations (i.e. lifting machinery, not passenger lifts).

Group 5This group deals solely with machinery intended for use underground.

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Group 6This group is concerned with machinery designed to lift or movepeople.

1.1.1 DocumentationThe regulations require manufacturers or their authorisedrepresentative to certify that their equipment conforms to the relevantstandards. A technical file has to be drawn up for all machinery.Stand-alone machinery will also require a declaration of conformity.Machinery that is to be incorporated as part of another machine willrequire a declaration of incorporation.

1.1.2 Technical fileThe technical file will need to include the following information:

Overall drawings, used to identify the machine or assembly

Control circuit drawings, safety circuits

Drawings, calculations; test results necessary to check conformitywith the EHSRs, LVD, EMC Directive and any other validationtests

List of the EHSRs taken into account when designing themachine

List of the harmonised standards, plus other standards andtechnical specifications used to achieve the overall design of themachine

A description of the methods used to eliminate hazards presentedby the machine, plus risk assessment data

If required, a test report or certificate issued by a competent body

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If the machine is built to a harmonised standard, any technicalreport giving the results of tests carried out by the manufactureror a competent body

A copy of the instructions

For series-manufacture, the internal measures implemented toensure the machine continues to conform to the regulations, proofof QA.

1.1.3 Declaration of conformityThe declaration of conformity will need to include the followinginformation:

Name and address of the responsible person

If the responsible person is not the manufacturer, the full addressof the manufacturer

Description of the machine, type and serial number

All regulations with which the machine complies, plus anystatement of conformity with the EHSRs

If appropriate, the name and address of the approved body andnumber of EC type examination certificate

If appropriate, the name and address of the approved body towhich the technical file has been forwarded

If appropriate, the name and address of the approved body thathas drawn up the certificate of adequacy

A list of harmonised standards used

A list of national standards used

Identification of the signatory.

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1.1.4 Declaration of incorporationThe declaration of incorporation will need to include the followinginformation:

Name and address of the responsible person

A description of the machine

If appropriate, the name and address of the approved body andnumber of EC type examination certificate

If appropriate, the name and address of the approved body towhich the technical file has been forwarded

If appropriate, the name and address of the approved body thathas drawn up the certificate of adequacy

A list of harmonised standards used

A list of national standards used

A statement that the machinery must not be put into service untilthe machinery into which it will be incorporated has been shownto conform with the provisions of the directive

Identification of the signatory.

1.1.5 CE marking Once the declaration of conformity has been issued, the responsibleperson must affix the CE mark to the machinery. The CE mark mustbe distinct, visible, legible and indelible. Machinery that bears the CEmark and is accompanied by the relevant documentation can bepresumed to conform with the provisions of the machinery directive.Anyone who supplies a machine that does not bear the CE mark isrequired to provide full information as to why not, if requested to doso by an enforcement authority. It is an offence to fail to provide thisinformation if requested.

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1.1.6 EnforcementIn Great Britain, the Health and Safety Executive (HSE) is responsiblefor enforcing the regulations regarding machinery and safetycomponents for use at work. Machinery and safety components forprivate use are the responsibility of the local trading standardsauthority.

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1.2 The Low Voltage Directive (LVD)

The Low Voltage Directive (LVD) was adopted in 1973 under EECdirective 73\23\EEC. This was an “old approach directive” and did notrequire a CE mark to be affixed. In 1994 the directive was changedto incorporate the CE Marking Directive, becoming law in the UK asS.I. 1994\3260. The regulation is officially known as The ElectricalEquipment (Safety) Regulations 1994. It is similar to the MachineryRegulations in that its primary aim is freedom of movement for goodsthroughout the EEA.

All electrical equipment is covered by this regulation, with just afew exceptions, listed as follows:

Equipment for use in an explosive atmosphere

Equipment for radiology or medical purposes

Parts for goods and passenger lifts

Electricity supply meters

Plugs and sockets for domestic use

Fence controllers

Specialist equipment for use on aircraft or on seagoing ships

Equipment to be exported outside the EEA.

Most of these exceptions are covered by other legislation andregulations. If the product is covered by other directives, it must ofcourse meet the requirements of these directives before it can be CEmarked and placed on the market.

The LVD affects manufacturers, importers’ representatives, suppliersof second-hand equipment, equipment hire companies and even

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people who let accommodation containing electrical equipment. Theregulation says that all electrical equipment must be safe and thatthere should be no risk in using it, other than residual risks that havebeen reduced to a minimum. If practical, the equipment itself shouldcarry a warning against these risks. If this is not practical, the warningshould be contained within the operating instructions, for example:“Unplug the toaster before attempting to remove a slice of breadwhich is stuck and cannot be ejected normally”.

The general advice is that equipment must be constructed inaccordance with good engineering practice. This advice is also givenin the Machinery Regulations. Equipment manufactured inaccordance with harmonised standards is considered safe in thisrespect.

Equipment must be safe when connected to the electrical supplysystem. This can be achieved by protecting against electric shockthrough insulation and earthing. Other means that can achieve thesame level of safety may also be used. Again, the standards are thebest route to compliance. The equipment must meet the principleelements of the regulation’s safety objectives. These are explained inthree parts:

General conditionsThese detail the essential characteristics to be observed andrecognised to ensure that equipment will be used safely and forthe application for which it was intended. These will be markedon the equipment or, if this is not possible, in the instructions orpackaging.

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Protection against hazards arising from the equipmentPeople and domestic animals must be protected againstdanger or injury, which may be caused by electrical contact,either directly or indirectly. The same applies to non-electricaldangers, whether apparent or revealed by experience. It mustbe impossible for potentially dangerous temperatures, arcs orradiation (EMC) to be produced. The installation should besuitable for the foreseeable conditions of use.

Protection against external influencesThe product must meet the expected mechanical requirements,so that exposed persons cannot be affected or endangered.Non-mechanical phenomena must also be considered. Thisagain includes EMC, as well as the effects of chemicals, heatand ultra-violet radiation, to name just a few. It must beimpossible for a foreseeable overload condition to present ahazard to exposed persons.

1.2.1 DocumentationThe manufacturer, importer, or other person responsible for placingthe equipment on to the EEA market must complete the appropriatedocumentation. As in the case of the Machinery Regulations, thismust include a declaration of conformity (sent with the product),together with a technical file, which in this directive is known as“Technical Documentation”. The product must also carry the CE mark.

1.2.2 Technical documentationThis documentation should enable the enforcement authorities toendorse the product as conforming with the requirements of theregulations. It should contain the following information:

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A general description of the equipment

Basic design drawings of the product, including drawings of sub-systems and assemblies; these could be photographs, assemblydrawings and/or control circuit diagrams, and should carry detailsof the product type to which they relate, along with the year ofmanufacture

Information to enable both the drawings and the operation of theequipment to be understood (this should be available from theinstructions for use)

A list of the standards applied

Details of any design calculations and information on any tests orexaminations carried out

Results of any test reports.

1.2.3 Declaration of conformityThe document must contain the following information:

The name and address of the manufacturer or authorisedrepresentative in the community

A description of the product

A list of the standards applied

The identity of the signatory, with details of their relationship with,or position in, the supply organisation

The address of the signatory, if different from that of themanufacturer

The last two digits of the year in which the CE mark was affixed.

It is not strictly necessary to have the product certified by an externalcompetent body, but, in the case of large production items, it isconsidered the best route to ensure compliance.

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1.2.4 Key standardsThe key standards written to support the LVD are listed below andare available through the British Standards Institution (BSI).

EN 60204-1 Safety of machinery.Electrical equipment of machines.Specification for general requirements.

EN 60335-1, Part 1: General requirementsSafety of household appliances and similar electrical goods.Please note there are 60 sub-sections to this standard, givingdetailed requirements for specific equipment. A list isavailable from the DTI.

EN 60947-1, Part 1: General requirementsLow voltage switchgear and controlgear.

EN 60598-1, Part 1: General requirements and testsLuminaries

EN 60730-1, Part 1: General requirementsAutomatic electrical controls for household use, and similar.

1.2.5 EnforcementThe local authority trading standards departments are primarilyresponsible for enforcing the 1994 Regulations, but the HSE may alsomake arrangements to enforce the regulations with regard toelectrical equipment either used at work or made available for use innon-domestic premises.

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A more detailed description of the contents of the regulations is givenin a booklet entitled “Electrical Equipment (implementing the LVD)”.This is available from the DTI, together with a full list of the standardsapplicable to the LVD.

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1.3 The Electromagnetic Compatibility (EMC) Regulation

This regulation was adopted into UK law under S.I. 1992/2372 andcame fully into force on 1 January 1996. All apparatus liable to causeor be affected by electromagnetic disturbance must comply with theregulation. The term “apparatus” is defined as “an electrical orelectronic appliance or system consisting of a finished product,having an intrinsic function which is intended for the end user, and issupplied or intended for supply or taken into service as a singlecommercial unit”.

The vast majority of products that are electrically powered orcontrolled, including machinery, will be covered by thisregulation. Those that are not covered include:

Apparatus for export outside the EEA

Spare parts, defined as a component or combination ofcomponents intended for use in replacing parts of electrical orelectronic apparatus

Second-hand apparatus, unless it has been subject to furthermanufacture (equipment that has been substantially refurbishedcould be included under this); please note that second-handequipment imported from outside the EEA since 1 January 1996must comply with the regulation

Electromagnetically benign equipment; this is defined asequipment with inherent qualities unlikely to cause or be affectedby emissions

Equipment used in a sealed electromagnetic environment

Medical equipment covered by other legislation.

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It is an offence for anyone to supply to an end user apparatusthat does not meet the following requirements:

The essential protection requirements

The conformity assessment requirements

The affixing of a CE mark

The issuing of an EC declaration of conformity.

It is also an offence for anyone to take into service apparatusthat does not conform to the protection requirements.

1.3.1 Protection requirementsThese are essential requirements which state that equipment shall beconstructed so that the electromagnetic disturbance it generates doesnot exceed the level at which radio and telecommunicationsequipment will suffer interference, or at which other relevantapparatus will be prevented from operating as intended. Equipmentmust also have a level of intrinsic immunity to enable it to operatecorrectly when installed, maintained and used for the purposeintended.

1.3.2 Conformity assessment requirementsThere are three routes that can be used to show conformity with theregulation:

The standards route

The technical construction file (TCF) route

The EC type examination route.

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1.3.2.1 The standards routeThis is a self-certification route for all apparatus other thanradiocommunication transmitting equipment. The manufacturer mustcertify compliance with the appropriate harmonised standards.

The equipment must be CE marked and issued with a declaration ofconformity giving the following details:

The name and address of the responsible person and thedetails of the manufacturer (these may be one and the same)

The signature of the responsible person and the identity ofthe signatory

The date of issue

The identity of the apparatus to which it relates

A list of the standards applied

A declaration stating that the equipment conforms to theprotection requirements of the EMC Directive.

1.3.2.2 The technical construction file (TCF) route This route is for equipment other than radiocommunication trans-mitting equipment. It can be used where there are no harmonisedstandards to refer to, or where the manufacturer chooses to take thisroute.

The TCF must include a report or certificate issued by a “competentbody”, authorised by the DTI. In this case the equipment must be CEmarked and issued with a declaration of conformity containing theinformation listed below:

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The name and address of the supplier or manufacturer

The identity and signature of the responsible person

The date of issue

Details and identity of the apparatus

The identity of the TCF and the name and address of thecompetent body issuing the report or certificate

The reference numbers and titles of the standards applied(if any)

A declaration stating that the equipment conforms with theprotection requirements of the EMC Directive.

The TCF must uniquely identify the equipment, including themanufacturer and model number. It must also identify the intendedfunction of the equipment and any limitations on its location andenvironment for use. Relevant drawings and circuit diagrams,together with assembly diagrams, parts lists and installationinstructions must also be included. The manufacturer is required towrite a brief technical rationale that should include the specialfeatures and component specifications adopted to address theproblems of EMC. The rationale must also include details of anytheoretical modelling of the equipment’s performance, plus details ofthe quality control procedures in place to ensure continuedcompliance for series-manufacture.

Finally, the TCF should list the EMC tests that were performed andthe results obtained, together with a rationale for the tests that wereperformed and their adequacy in ensuring compliance. This listshould be accompanied by a report or certificate from the competentbody, including their comments on the rationale and procedures used.

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1.3.2.3 The EC type examination certificate routeThis is reserved for radiocommunication transmission equipment andis not relevant to manufacturers of machinery. As with the TCF route,it requires external certification.

1.3.3 Key standardsIt is worth repeating that the only sure way to claim compliance iseither to go to the expense of full and detailed testing, or to have thetechnical file approved by a competent body and supply theequipment with a certificate. There are several sources of help listedin the DTI’s Guide to the EMC Regulations.

The key standards supporting EMC are:

EN 50081-1 (Part 1) Electromagnetic compatibility.Generic emission standard (residential, commercialand light industry)

EN 50081-2 (Part 2) Electromagnetic compatibility.Generic emission standard (industrial environment)

EN 50082-1 (Part 1) Electromagnetic compatibility.Generic immunity standard (residential, commercialand light industry)

EN 50082-2 (Part 2) Electromagnetic compatibility.Generic immunity standard (industrial environment)

IEC 1000 Good EMC practice for installers.

These are available from the BSI.

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1.3.4 EnforcementThe local authority trading standards departments are primarilyresponsible for enforcing these regulations, although the Secretary ofState for Trade and Industry may enforce the regulations with regardto radiocommunications transmitting equipment. In some cases theCivil Aviation Authority and Director General of Electricity Supply maybe responsible for enforcement.

1.3.5 ConclusionIn practice, manufacturers of large machines that are only fullyassembled on site can only claim definite compliance by having theequipment assessed by a competent body. Smaller machines thatcan be shipped as a whole can be tested in a test house and self-certified, but both these options can be expensive and time-consuming.

Many companies are tackling the EMC requirements via self-certification through the standards route, using good engineeringpractice in conjunction with components and sub-assemblies withknown EMC performance. This involves simple tests usingequipment that is readily available. Everyday devices such asscanners (for emissions), cell phones, AM transmitters, unsuppresseddrills and spark generators (for susceptibility) can give valuableinformation about EMC characteristics. If the results are satisfactory,the declaration of conformity can be produced and shipped with theequipment.

Manufacturers of sub-assemblies (drives, PLCs, safety relays etc.) donot need to have their products certified to the EMC Directive, asthese are not regarded as “apparatus”, as defined in Section 1.3.Machine builders can go a long way down the road to compliance ifthey select products that have been tested and have known EMC

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characteristics, and use them in accordance with the manufacturer’sinstructions regarding cable separation, earth bonding and mounting.

Many manufacturers of components and sub-assemblies areprepared to provide the results of their EMC tests along withrecommendations on the correct application of their product. Tradingstandards officers acting on complaints will in the end police theseregulations. Machine builders should be able to claim compliance ifthey use a high-quality enclosure incorporating the correct sealing,and meet the following precautionary measures:

Use proprietary control items

Follow all the correct recommendations and procedures

Use braided earthed cables for all flexible out-of-panel wiring,with full circumference earthing (not pigtails)

Take the advice of suppliers of such products as variablefrequency drives and switch mode power supplies

Fit any required filtering.

If this is the chosen route, details of the precautions taken and thetests carried out must be documented for future reference. In theunlikely event of a prosecution, the builder will have to show “duediligence” in attempting to adhere to the regulations.

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1.4 Schedule 4 machinery

This section deals with more dangerous types of machinery, as perthe regulations. Machinery in this section includes:

Woodworking machinery

Hand-fed machinery, including portable chainsaws forwoodworking

Presses for the cold working of metal

Injection moulders which are loaded or unloaded manually

Underground machinery and engines

Household refuge trucks with compactor

Guards and detachable shafts for use on self-propelledmachinery, e.g. tractors

Vehicles servicing lifts.

This is the current list of Schedule 4 equipment (total of 15 types ofmachine). However, the European Parliament is constantly looking toimprove and consolidate the substance of the directives. With this inmind, the official document L 207 containing Directive 98/37/ECSchedule 4 has now been modified to include more equipment. Inview of the procedures required to amend legislation, the Departmentof Trade and Industry believes that this is unlikely to come into forcebefore 2003.

The additions will contain:

Devices for lifting people, where there is a risk of falling

Pyrotechnics machinery

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Safety components such as photoelectric devices, pressure mats,etc., logic units for bi-manual controls, automatic movable screensfor presses and moulders, rollover and falling object structures.

Manufacturers of Schedule 4 machinery are required to comply withthe EHSRs and, where possible, to manufacture to the harmonisedstandards. When the machine is ready, manufacturers must constructa technical file to the best of their ability and take one of the followingroutes:

If the machine has been manufactured to conform fully with theharmonised standards, the technical file can be sent to anapproved body, which will acknowledge its receipt

If the machine has been manufactured to conform fully to theharmonised standards, the technical file can be sent to anapproved body to verify that the standards have been appliedcorrectly; the approved body will then issue a certificate ofadequacy

A prototype can be sent to the approved body for an EC typeexamination; again, a certificate will be issued

If the machine manufactured does not comply fully with theharmonised standards, or there are no relevant standards for thatparticular machine, a prototype MUST be submitted for EC typeexamination.

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1.5 Routes to CE marking 29

CE path for machines not listed in Schedule 4

Machine built to EHSRs

The responsible person must draw up a technical file

The responsible personmust draw up a declaration

of incorporation

The responsible personmust draw up a declaration

of conformity

Affix the CE mark

Machine built to conformwith harmonised standard

(C standards)

Fig. 1: Route to CE marking

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Fig. 2: Route to CE marking

CE path for machines listed in Schedule 4

Machine that does not fully conformwith harmonised standards, or for

which no standard exists

Send a prototype for EC type examination

The responsible personmust draw up a declaration

of incorporation

The responsible personmust draw up a declaration

of conformity

Affix the CE mark

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Fig. 3: Route to CE marking

CE path for machines and components listed in Schedule 4

Machine fully conformswith harmonised standards

The responsible person must either

Send a technical file toan approved body

for verification and acerticate of adequacy

Send a technical file toan approved body

for acknowledgement

Send a prototypefor EC typeexamination

The responsible person mustdraw up a declaration of

conformity

The responsible person mustdraw up a declaration of

incorporation

Affix the CE mark

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