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Harmonised European Standards - produced by CEN and CENELEC in support of the relevant EU Directives

In accordance with the "New Approach" the structure of EC Directives was modified so that they were to state the legal requirements to be achieved in the form of Essential Health and Safety Requirements (EHSRs) and the detailed technical requirements were removed. It was anticipated that many organisations would have difficulty in interpreting these EHSRs - particularly small and medium firms, which means most firms in the market. The solution was to ask the European standards bodies CEN and CENELEC to prepare standards in support of these Directives - known as "Harmonised Standards". The philosophy was that Europe's best experts would gather together in a Technical Committee and produce standards that was their approach to meeting the EHSRs for a particular series of risks.

A "Harmonised Standard" is a standard that is in support of one or more Directives, has been produced by CEN or CENELEC and when the reference has been published in the Official Journal of the EC (OJ) and at least one national standards body has published it, provides a presumption of conformity with the EHSRs covered by the standard. These standards - produced under a mandate from Member States through the Commission - give the technical measures to meet the EHSRs. In other words the:-

• Directives would state the legal objectives (EHSRs) to be met, and
• Harmonised Standards would identify the technical means to meet these legal objectives.

Harmonised Standards are one way of meeting the ESRs and are never intended to be mandatory, however compliance with them does give a presumption of conformity with the EhSRs covered by the relevant Harmonised Standard(s).

Every New Approach Directive has a programme of standards associated with it and details of work in progress and published can be obtained from the Commission's New Approach programme website and the CEN and CENELEC websites. CEN and CENELEC do not publish or sell standards and the English versions of the standards (BS EN …) can be obtained from the British Standards Institute (BSI). All three organisations also produce a range of helpful guides on the standardisation process and for specific Directives.

Before you use any of the Harmonised Standards it is important to understand how they are made because each step of the procedure could be important to you and your interests:-

1. The first stage is the adoption of a work item (WI) in the programme of a Technical Committee (TC) at CEN or CENELEC**. This is normally done at the Plenary meeting after the circulation of a proposal.
2. The creation of a Working Group (WG) to produce the standard - or the assignation of the Work Item to an existing WG. Members of the WG are nominated through the shadow TC of their National Standards Body (NSB) - BSI in the case of the UK.
3. The production of the draft standard leading to the CEN/CENELEC Enquiry - the draft standard is assigned an EN number and sent to the NSB for comment. The Enquiry period is normally 6 months.
4. The draft standard is revised by the WG accepting or rejecting the comments received.
5. The revised draft standard is then sent to the Formal Vote. The NSBs vote yes or no on a weighted majority basis. NSBs can appeal at this stage on matters affecting safety if they disagree with a positive vote.
6. If the vote is yes the standard is ratified by CEN/CENELEC and sent to the NSB for publication.
7. At the same time the CEN/CENELEC Secretariat send details of the ratified standard to the Commission for inclusion in the Official Journal (OJ). It is from this stage that Member States can raise an objection to the inclusion of the reference to the standard in the OJ.
8. The standard becomes an "Harmonised Standard" when reference to it is published in the OJ and published by at least one NSB of CEN or CENELEC.

Clearly the finished Harmonised Standard is the best source of information but you can get a lot of useful information from the Enquiry version although you should be aware that this version may be subject to change during the revision process. The Enquiry version can be obtained from the shadow TC/WG at BSI.

NB. It is always important to know what standards are being produced in connection with your sector because you may wish to take part in the preparation of the standard in the WG (3) or through the BSI shadow group, comment on the draft standard at the Enquiry (3) and finally influence the vote at the Formal Vote stage (5). You can get details of the standards programme for the New Approach programme and CEN and CENELEC websites and from the shadow TCs and WGs via the BSI website.

NB. The most up to date list of Harmonised Standards are available from the list published by the Commission on their website. This can be conveniently accessed via the Commission's New Approach programme website under the relevant Directive. Be warned that some standards listed in the OJ do not deal with all the relevant EHSRs or are restricted to one EHSR or have a restriction on their use. Therefore, it is important to read the actual listing in the OJ before you use a standard. You should be aware that there is always a delay between the standard being ratified and its publication in the OJ. If you have a particular problem with the listing of a standard the best thing to do is to contact CEN or CENELEC and ask for the current position.

NB. Each published standard contains a foreword (and for CEN standards) an annex that identifies the directive that it supports and the EHSRs covered - so that you can check the EHSRs that you are covering.

**NB. In order to respond to the global market there is an increasing trend for standards to be actually written at the "International Standards Organisation" (ISO) and the "International Electro Technical Committee" (IEC). The standard will still appear in the CEN and CENELEC programme as a potential Harmonised Standard and will be processed in parallel as a CEN/CENELEC standard. You can find out the current status via the CEN/CENELEC or BSI "shadow Committee".

How to find the Harmonised Standard that you want

Although there are some 3500 standards in the programme supporting the "New Approach" directives finding the standard that you want is very straightforward. The Commission has a New Approach programme website that gives comprehensive details of the Mandated programmes for each directive and lists the directives and links into the associated programme of standards. The standards are identified by the topic area covered by the TC and lists all of the WIs by title. These titles are very descriptive and easily navigated. Each WI gives the current status of the standards (see above) and you can see the current stage up to and including its ratification.

How to use the Harmonised Standards developed in support of the Machinery Directive 98/37/EC

The programme of machinery standards follows all the requirements described above but has a format developed to deal with the very diverse nature of the topics covered in the mandate. The standards are divided into three categories, namely:-

A-type standards - These deal with the basic methodology and philosophy needed to undertake the mandatory risk based approach required in Schedule 3. There are two standards in this category and they should be regarded as essential reading for every designer seeking to design a safe machine:-

• BS EN ISO 12100:2003 Parts 1 and 2 Safety of Machinery (this is the updated and revised version of BS EN 292)
• BS EN 1050 Safety of machinery - Principles of risk assessment.

B-type standards - These deal with a variety of topics that are common to the design of most machines. These enable a designer to obtain information about a wide range of risks of hazards and the means to deal with the risk reduction process. There are some 130 standards in this category and they can be divided into broad categories:-

Safety devices, electrical safety, fire and control systems 9including a guide to control systems - look under CEN/TC 114 and CENELEC/TC 44X.

• Ergonomics - look under CEN/TC 122.
• Noise - look under CEN/TC 211. Includes a guide on how to deal with noise.
• Mechanical vibration and shock - look under CEN/TC 231. Included a guide on how to deal with vibration.
• Explosion - look under CEN/TC 305.
• Lasers - look under CEN/TC 123.
• Conveyor belts - look under CEN/TC 188.
• Eye protection - look under CEN/TC 85.

C-type standards - These deal with a specific machine or class of machines and give a presumption of conformity for the EHSRs covered in the standard. There are some 40 TCs dealing with a wide range of machines from hand-held portable tools, to complete paper making plants and most industrial sectors in-between. There is a programme of some 700 standards - with about 60% ratified. The best way of finding if there is a standard for you is to go to the New Approach machinery programme website and look for the TC dealing with the product sector that you want. The standards will be listed by machine. You can also check that the standards are listed in the OJ. You can also get information from the CEN and New Approach programme websites.

It is not possible in this website to describe in detail how to use some 800 standards. However, the following rules will enable you to use the standards in the most efficient way:-

• If you intend to use a C-type standard you should always carry out a separate hazard identification and risk assessment for your machine or product using BS EN ISO 12100:2003 292 Part 1 & 2 and BS EN 1050. You should then compare your list of hazards with the list of hazards in clause 4 of the standard. This is to check that your machine is the same as the one that the WG who wrote the standard had in mind. If the list is not identical you will have to deal with them yourself - see the Risk Assessment section.
• Be aware that most C-type standards do not deal with all of the relevant EHSRs identified during the risk assessment. Clause 4 will list all of the hazards identified by the WG. The Scope will then list those hazards/risks not dealt with. In most cases this will include noise, vibration and hazardous substances but you should always check what is excluded. To comply with the EHSRs not covered in the standard - see the Risk Assessment section.
• If you cannot find a C-type standard for your machine or product or the C-type standard does not fully deal with all of the ESRs you should proceed as follows:-

You can obtain valuable information on the practical application of the above principles from BS PD 5304:2000 "Code of Practice for Safety of Machinery" This is an updated version of BS 5304:1988 one of the seminal sources for the current standards programme.

NB. This procedure alone will not comply with the full requirements of the Machinery Regulations and there will still be the need to complete the technical file, provide information for use and carry out the relevant conformity assessment procedures.

British Standards

All CEN and CENELEC standards - in particular Harmonised European Standards in support of New Approach Directives - are published by BSI (the British Standards Institution) and can be purchased via the BSI website. BSI also publish ISO and IEC standards. These can also be purchased via the BSI website.

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