Chapter 1. Regulations for New Machinery. Contents 1.0 Background to the Regulations

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1 Chapter 1 Contents 1.0 Background to the Regulations 1.1 The Supply of Machinery (Safety) Regulations Documentation Technical file Declaration of conformity Declaration of incorporation CE marking Enforcement The Low Voltage Directive (LVD) Documentation Technical documentation Declaration of conformity Key standards Enforcement 1.3 The Electromagnetic Compatibility (EMC) Regulation Protection requirements Conformity assessment requirements The standards route The technical construction file route The EC type examination certificate route Key standards Enforcement Conclusion

2 4 1.4 Schedule 4 machinery 1.5 Routes to CE marking

3 2 1.0 Background to the Regulations The Single European Act of 1985 committed all EU member states to the implementation of the four freedoms defined in the 1956 Treaty of Rome: the freedom of movement of goods, services, finance and people. To achieve this, legislation relating to these freedoms clearly needed to be the same in all member states. To this end, numerous European Directives, issued from Brussels, have been implemented into law across Europe by means of regulations, including those featured in this guide. 5 The regulations are not intended to be technically detailed, but to be straightforward in their requirements, listing the potential hazards from machinery and requiring that these be protected against. They lay down Essential Health and Safety Requirements (EHSRs), which equipment covered by the regulations must meet and, most importantly, they call upon member states to give freedom of movement within the European Economic Area (EEA) to equipment that 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 too difficult; here are a few examples: An electric fire It has no moving parts so it is not a machine. It has a predominantly resistive load, which is not affected by emissions and does not generate electromagnetic interference. This equipment must meet the requirements of the LVD and its paperwork must contain a statement indicating that it is EMCbenign.

4 6 A toaster This has moving parts, but the primary dangers are electrical (the springs ejecting the toast are not powerful enough to inflict severe injuries). Again, its heaters are resistive, so it can be treated in the same way as the electric fire. A power press This is clearly a machine, so it will be covered by the Machinery Regulations. If it has complex control systems that can generate or be affected by electromagnetic emissions, it must also meet the EMC requirements. A computer terminal This does have moving parts, but these are low power and cause no hazard to health and safety. It has complex electronic controls and usually a mains supply, so both the LVD and the EMC Regulations will apply. 3 A child s battery-powered computer game This would generally be outside the voltage limits of the LVD, but would fall under the EMC Regulation. If an auxiliary supply or charger is used, the LVD will apply. More specific information on the type of equipment covered can of course be found under the specific regulation.

5 4 1.1 The Supply of Machinery (Safety) Regulations The Supply of Machinery (Safety) Regulations (Statutory Instrument [S.I.] 3073/1992) came into force on 1 January 1993, with a 2 year transitional period to enable industry to get up to speed. Since 1 January 1995, therefore, most machinery supplied within the EEA has had to satisfy the wide-ranging Essential Health and Safety Requirements (EHSRs) for the design and construction of machines, as specified in Schedule 3 of the Regulations. This also applies to imports from countries outside the EEA and in-house machinery where manufacturers put their own machinery into service. Evidence that the machine complies with the regulations must be provided 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 special treatment; this is covered later in this chapter (see under Schedule 4 machinery ). The regulations start by defining a machine as: An assembly of linked parts, at least one of which moves under power An assembly of machines linked together to achieve the same end Interchangeable equipment. These wide-ranging statements cover most assemblies.

6 8 The EHSRs are divided into 6 groups. Group 1 can be regarded as mandatory for all machines. Groups 2 to 6 are additional requirements for certain categories of machine. Group 1 This 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. Other sections explain safety integration, lighting, handling and the need for materials and products used in the construction of the machine to be safe. 5 Controls (Section 1.2 of the Regulations) This section defines how controls should be identified. Starting, stopping, emergency stopping, mode selection, power supply 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 in manufacture and machine operation, and also provides an introduction to guarding. The requirements of guards (Section 1.4 of the Regulations) This section defines the various types of guard: fixed, movable type A and B guards, adjustable, etc.

7 6 Other hazards (Section 1.5 of the Regulations) This section looks at other relevant issues not included in the above, and lists 15 topics which may need addressing, such as supply voltage, fire, explosion, vibration and radiation. The Low Voltage and EMC Regulations must also be met in order to comply with parts of this section. 9 Maintenance (Section 1.6 of the Regulations) This section details what is required when designing a machine to enable it to be maintained safely. Warnings (Section 1.7 of the Regulations) Details, markings and instructions. Group 2 This group is concerned with machines for making foodstuffs, woodworking equipment and hand-held machinery. Group 3 This group details the requirements to offset the hazards arising from the mobility of machinery. Group 4 This group details the requirements to offset hazards arising from lifting operations (i.e. lifting machinery, not passenger lifts). Group 5 This group deals solely with machinery intended for use underground.

8 10 Group 6 This group is concerned with machinery designed to lift or move people Documentation The regulations require manufacturers or their authorised representative to certify that their equipment conforms to the relevant standards. 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 will require a declaration of incorporation Technical file The technical file will need to include the following information: 7 Overall drawings, used to identify the machine or assembly Control circuit drawings, safety circuits Drawings, calculations; test results necessary to check conformity with the EHSRs, LVD, EMC Directive and any other validation tests List of the EHSRs taken into account when designing the machine List of the harmonised standards, plus other standards and technical specifications used to achieve the overall design of the machine A description of the methods used to eliminate hazards presented by the machine, plus risk assessment data If required, a test report or certificate issued by a competent body

9 8 If the machine is built to a harmonised standard, any technical report giving the results of tests carried out by the manufacturer or a competent body A copy of the instructions For series-manufacture, the internal measures implemented to ensure the machine continues to conform to the regulations, proof of QA Declaration of conformity The declaration of conformity will need to include the following information: 11 Name and address of the responsible person If the responsible person is not the manufacturer, the full address of the manufacturer Description of the machine, type and serial number All regulations with which the machine complies, plus any statement of conformity with the EHSRs If appropriate, the name and address of the approved body and number of EC type examination certificate If appropriate, the name and address of the approved body to which the technical file has been forwarded If appropriate, the name and address of the approved body that has drawn up the certificate of adequacy A list of harmonised standards used A list of national standards used Identification of the signatory.

10 Declaration of incorporation The declaration of incorporation will need to include the following information: Name and address of the responsible person A description of the machine If appropriate, the name and address of the approved body and number of EC type examination certificate If appropriate, the name and address of the approved body to which the technical file has been forwarded If appropriate, the name and address of the approved body that has 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 until the machinery into which it will be incorporated has been shown to conform with the provisions of the directive Identification of the signatory CE marking Once the declaration of conformity has been issued, the responsible person must affix the CE mark to the machinery. The CE mark must be distinct, visible, legible and indelible. Machinery that bears the CE mark and is accompanied by the relevant documentation can be presumed to conform with the provisions of the machinery directive. Anyone who supplies a machine that does not bear the CE mark is required to provide full information as to why not, if requested to do so by an enforcement authority. It is an offence to fail to provide this information if requested.

11 Enforcement In Great Britain, the Health and Safety Executive (HSE) is responsible for enforcing the regulations regarding machinery and safety components for use at work. Machinery and safety components for private use are the responsibility of the local trading standards authority. 13

12 The Low Voltage Directive (LVD) 11 The Low Voltage Directive (LVD) was adopted in 1973 under EEC directive 73\23\EEC. This was an old approach directive and did not require a CE mark to be affixed. In 1994 the directive was changed to incorporate the CE Marking Directive, becoming law in the UK as S.I. 1994\3260. The regulation is officially known as The Electrical Equipment (Safety) Regulations It is similar to the Machinery Regulations in that its primary aim is freedom of movement for goods throughout the EEA. All electrical equipment is covered by this regulation, with just a few 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 and regulations. If the product is covered by other directives, it must of course meet the requirements of these directives before it can be CE marked and placed on the market. The LVD affects manufacturers, importers representatives, suppliers of second-hand equipment, equipment hire companies and even

13 12 people who let accommodation containing electrical equipment. The regulation says that all electrical equipment must be safe and that there should be no risk in using it, other than residual risks that have been reduced to a minimum. If practical, the equipment itself should carry a warning against these risks. If this is not practical, the warning should be contained within the operating instructions, for example: Unplug the toaster before attempting to remove a slice of bread which is stuck and cannot be ejected normally. The general advice is that equipment must be constructed in accordance with good engineering practice. This advice is also given in the Machinery Regulations. Equipment manufactured in accordance with harmonised standards is considered safe in this respect. 15 Equipment must be safe when connected to the electrical supply system. This can be achieved by protecting against electric shock through insulation and earthing. Other means that can achieve the same level of safety may also be used. Again, the standards are the best route to compliance. The equipment must meet the principle elements of the regulation s safety objectives. These are explained in three parts: General conditions These detail the essential characteristics to be observed and recognised to ensure that equipment will be used safely and for the application for which it was intended. These will be marked on the equipment or, if this is not possible, in the instructions or packaging.

14 16 Protection against hazards arising from the equipment People and domestic animals must be protected against danger or injury, which may be caused by electrical contact, either directly or indirectly. The same applies to non-electrical dangers, whether apparent or revealed by experience. It must be impossible for potentially dangerous temperatures, arcs or radiation (EMC) to be produced. The installation should be suitable for the foreseeable conditions of use. Protection against external influences The product must meet the expected mechanical requirements, so that exposed persons cannot be affected or endangered. Non-mechanical phenomena must also be considered. This again includes EMC, as well as the effects of chemicals, heat and ultra-violet radiation, to name just a few. It must be impossible for a foreseeable overload condition to present a hazard to exposed persons Documentation The manufacturer, importer, or other person responsible for placing the equipment on to the EEA market must complete the appropriate documentation. As in the case of the Machinery Regulations, this must 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 Technical documentation This documentation should enable the enforcement authorities to endorse the product as conforming with the requirements of the regulations. It should contain the following information:

15 14 A general description of the equipment Basic design drawings of the product, including drawings of subsystems and assemblies; these could be photographs, assembly drawings and/or control circuit diagrams, and should carry details of the product type to which they relate, along with the year of manufacture Information to enable both the drawings and the operation of the equipment to be understood (this should be available from the instructions for use) A list of the standards applied Details of any design calculations and information on any tests or examinations carried out Results of any test reports Declaration of conformity The document must contain the following information: The name and address of the manufacturer or authorised representative 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 the manufacturer 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 external competent body, but, in the case of large production items, it is considered the best route to ensure compliance.

16 Key standards The key standards written to support the LVD are listed below and are available through the British Standards Institution (BSI). EN Safety of machinery. Electrical equipment of machines. Specification for general requirements. EN , Part 1: General requirements Safety of household appliances and similar electrical goods. Please note there are 60 sub-sections to this standard, giving detailed requirements for specific equipment. A list is available from the DTI. 15 EN , Part 1: General requirements Low voltage switchgear and controlgear. EN , Part 1: General requirements and tests Luminaries EN , Part 1: General requirements Automatic electrical controls for household use, and similar Enforcement The local authority trading standards departments are primarily responsible for enforcing the 1994 Regulations, but the HSE may also make arrangements to enforce the regulations with regard to electrical equipment either used at work or made available for use in non-domestic premises.

17 16 A more detailed description of the contents of the regulations is given in a booklet entitled Electrical Equipment (implementing the LVD). This is available from the DTI, together with a full list of the standards applicable to the LVD. 19

18 The Electromagnetic Compatibility (EMC) Regulation 17 This regulation was adopted into UK law under S.I. 1992/2372 and came fully into force on 1 January All apparatus liable to cause or be affected by electromagnetic disturbance must comply with the regulation. The term apparatus is defined as an electrical or electronic appliance or system consisting of a finished product, having an intrinsic function which is intended for the end user, and is supplied or intended for supply or taken into service as a single commercial unit. The vast majority of products that are electrically powered or controlled, including machinery, will be covered by this regulation. Those that are not covered include: Apparatus for export outside the EEA Spare parts, defined as a component or combination of components intended for use in replacing parts of electrical or electronic apparatus Second-hand apparatus, unless it has been subject to further manufacture (equipment that has been substantially refurbished could be included under this); please note that second-hand equipment imported from outside the EEA since 1 January 1996 must comply with the regulation Electromagnetically benign equipment; this is defined as equipment with inherent qualities unlikely to cause or be affected by emissions Equipment used in a sealed electromagnetic environment Medical equipment covered by other legislation.

19 18 It is an offence for anyone to supply to an end user apparatus that 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 apparatus that does not conform to the protection requirements Protection requirements These are essential requirements which state that equipment shall be constructed so that the electromagnetic disturbance it generates does not exceed the level at which radio and telecommunications equipment will suffer interference, or at which other relevant apparatus will be prevented from operating as intended. Equipment must also have a level of intrinsic immunity to enable it to operate correctly when installed, maintained and used for the purpose intended Conformity assessment requirements There are three routes that can be used to show conformity with the regulation: The standards route The technical construction file (TCF) route The EC type examination route.

20 The standards route This is a self-certification route for all apparatus other than radiocommunication transmitting equipment. The manufacturer must certify compliance with the appropriate harmonised standards. The equipment must be CE marked and issued with a declaration of conformity giving the following details: The name and address of the responsible person and the details of the manufacturer (these may be one and the same) The signature of the responsible person and the identity of the 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 the protection requirements of the EMC Directive The technical construction file (TCF) route This route is for equipment other than radiocommunication transmitting equipment. It can be used where there are no harmonised standards to refer to, or where the manufacturer chooses to take this route. 19 The TCF must include a report or certificate issued by a competent body, authorised by the DTI. In this case the equipment must be CE marked and issued with a declaration of conformity containing the information listed below:

21 20 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 the competent 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 the protection requirements of the EMC Directive. The TCF must uniquely identify the equipment, including the manufacturer and model number. It must also identify the intended function of the equipment and any limitations on its location and environment for use. Relevant drawings and circuit diagrams, together with assembly diagrams, parts lists and installation instructions must also be included. The manufacturer is required to write a brief technical rationale that should include the special features and component specifications adopted to address the problems of EMC. The rationale must also include details of any theoretical modelling of the equipment s performance, plus details of the quality control procedures in place to ensure continued compliance for series-manufacture. 23 Finally, the TCF should list the EMC tests that were performed and the results obtained, together with a rationale for the tests that were performed and their adequacy in ensuring compliance. This list should be accompanied by a report or certificate from the competent body, including their comments on the rationale and procedures used.

22 The EC type examination certificate route This is reserved for radiocommunication transmission equipment and is not relevant to manufacturers of machinery. As with the TCF route, it requires external certification Key standards It is worth repeating that the only sure way to claim compliance is either to go to the expense of full and detailed testing, or to have the technical file approved by a competent body and supply the equipment with a certificate. There are several sources of help listed in the DTI s Guide to the EMC Regulations. The key standards supporting EMC are: 21 EN (Part 1) Electromagnetic compatibility. Generic emission standard (residential, commercial and light industry) EN (Part 2) Electromagnetic compatibility. Generic emission standard (industrial environment) EN (Part 1) Electromagnetic compatibility. Generic immunity standard (residential, commercial and light industry) EN (Part 2) Electromagnetic compatibility. Generic immunity standard (industrial environment) IEC 1000 Good EMC practice for installers. These are available from the BSI.

23 Enforcement The local authority trading standards departments are primarily responsible for enforcing these regulations, although the Secretary of State for Trade and Industry may enforce the regulations with regard to radiocommunications transmitting equipment. In some cases the Civil Aviation Authority and Director General of Electricity Supply may be responsible for enforcement Conclusion In practice, manufacturers of large machines that are only fully assembled on site can only claim definite compliance by having the equipment assessed by a competent body. Smaller machines that can be shipped as a whole can be tested in a test house and selfcertified, but both these options can be expensive and timeconsuming. 25 Many companies are tackling the EMC requirements via selfcertification through the standards route, using good engineering practice in conjunction with components and sub-assemblies with known EMC performance. This involves simple tests using equipment that is readily available. Everyday devices such as scanners (for emissions), cell phones, AM transmitters, unsuppressed drills and spark generators (for susceptibility) can give valuable information about EMC characteristics. If the results are satisfactory, the declaration of conformity can be produced and shipped with the equipment. Manufacturers of sub-assemblies (drives, PLCs, safety relays etc.) do not need to have their products certified to the EMC Directive, as these are not regarded as apparatus, as defined in Section 1.3. Machine builders can go a long way down the road to compliance if they select products that have been tested and have known EMC

24 26 characteristics, and use them in accordance with the manufacturer s instructions regarding cable separation, earth bonding and mounting. Many manufacturers of components and sub-assemblies are prepared to provide the results of their EMC tests along with recommendations on the correct application of their product. Trading standards officers acting on complaints will in the end police these regulations. Machine builders should be able to claim compliance if they 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 variable frequency drives and switch mode power supplies Fit any required filtering. If this is the chosen route, details of the precautions taken and the tests carried out must be documented for future reference. In the unlikely event of a prosecution, the builder will have to show due diligence in attempting to adhere to the regulations. 23

25 Schedule 4 machinery 27 This section deals with more dangerous types of machinery, as per the regulations. Machinery in this section includes: Woodworking machinery Hand-fed machinery, including portable chainsaws for woodworking 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-propelled machinery, e.g. tractors Vehicles servicing lifts. This is the current list of Schedule 4 equipment (total of 15 types of machine). However, the European Parliament is constantly looking to improve and consolidate the substance of the directives. With this in mind, the official document L 207 containing Directive 98/37/EC Schedule 4 has now been modified to include more equipment. In view of the procedures required to amend legislation, the Department of Trade and Industry believes that this is unlikely to come into force before The additions will contain: Devices for lifting people, where there is a risk of falling Pyrotechnics machinery

26 28 Safety components such as photoelectric devices, pressure mats, etc., logic units for bi-manual controls, automatic movable screens for presses and moulders, rollover and falling object structures. Manufacturers of Schedule 4 machinery are required to comply with the EHSRs and, where possible, to manufacture to the harmonised standards. When the machine is ready, manufacturers must construct a technical file to the best of their ability and take one of the following routes: If the machine has been manufactured to conform fully with the harmonised standards, the technical file can be sent to an approved body, which will acknowledge its receipt If the machine has been manufactured to conform fully to the harmonised standards, the technical file can be sent to an approved body to verify that the standards have been applied correctly; the approved body will then issue a certificate of adequacy A prototype can be sent to the approved body for an EC type examination; again, a certificate will be issued If the machine manufactured does not comply fully with the harmonised standards, or there are no relevant standards for that particular machine, a prototype MUST be submitted for EC type examination.

27 1.5 Routes to CE marking 29 CE path for machines not listed in Schedule 4 Machine built to conform with harmonised standard (C standards) Machine built to EHSRs The responsible person must draw up a technical file The responsible person must draw up a declaration of conformity The responsible person must draw up a declaration of incorporation Affix the CE mark Fig. 1: Route to CE marking

28 30 CE path for machines listed in Schedule 4 Machine that does not fully conform with harmonised standards, or for which no standard exists Send a prototype for EC type examination The responsible person must draw up a declaration of conformity The responsible person must draw up a declaration of incorporation Affix the CE mark Fig. 2: Route to CE marking

29 CE path for machines and components listed in Schedule 4 31 Machine fully conforms with harmonised standards The responsible person must either Send a technical file to an approved body for acknowledgement Send a technical file to an approved body for verification and a certicate of adequacy Send a prototype for EC type examination The responsible person must draw up a declaration of conformity The responsible person must draw up a declaration of incorporation Affix the CE mark Fig. 3: Route to CE marking

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