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Overview on Human Safety and Safe Use of Machinery, Machinery Directive, Safeguard
Establishment Strategies and Techniques

Anamaria DAVID - 1441694


Erasmus student. Safety in Food Chain programe, University of Natural Resources and Life
Sciences, Vienna, Austria.
Food Quality Management, Faculty of Food Science and Technology, University of
Agricultural Sciences and Veterinary Medicine, Cluj-Napoca, Romania.

Abstract
Machinery safety is an important issue that every company is dealing with everyday, starting
with the equipment manufacturing companies and finishing with workers working with
machinery. The aim of this study is to introduce machinery safety and provide short
information about the directives and regultations regarding safe use of machinery. Because is
a moral obligation to avoid harming anyone, there are legislative acts that require the safety of
the machines, and providing economic reasons for reducing accidents to zero. Safety of the
machinery should be taken into consideration from the early design stage and must not be
forgotten trough all stages in the life of a machine: design, manufacture, installation,
adjustment, operation, maintenance and eventual scrapping.(Schneider Electric Safe
Machinery Handbook, 2009) A risk assesment should be carried out in order to be able to
design a safe machinery taking into account all European Dirrectives and EC standards. This
study is a quick overview which relies on Machinery Directive (2006/42/EC) and also on the
set of harmonised standards which are based on this directive. Directive 2006/42/EC is a
critical one for manufacturing and using the machinery, and without respecting this law, the
machineries are not allowed to be on the European market.

Keywords: Human safety, machinery, directive, work, equipment, risk.

Introduction
This overview research is based on principles establised in european law instruments relevant
for the protection of every workers safety and health. It is meant to provide a short preview
on safety and health in the use of machinery in the workplace as it is stated in the European
standards and directives. In the beging of this study will be presented the legal framework for
safe use of machinery, risk assesment, as well as the general obligations, responsibilities and
duties of the designers, manufacturing companies, employers and employees, and presenting

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the technical requirements and specific measures that should be taken in order to protect
workers safety and health.

2. Legal framework
The most important law regarding machinery in Europe is the Directive 2006/42/EC of the
European Parliament and the Council (Machinery Directive EN60204) which harmonizes the
legislation of the member countries and where are stated all the requirements that member
states should ensure. Based on this directive there is a list of standards, which have the role to
provide the readers with an overall framework and guidance for decisions during the entire
lifecycle of machinery and to enable them to maintain machines safe for their intended use.
There are 3 types of standards each one for a specific matter regarding machinery. The entire
list of standards can be found at http://ec.europa.eu/growth/single-market/europeanstandards/harmonised-standards/machinery/index_en.htm. Depending on the activity of the
company (machinery manufacturer or company using machinery) there are also national
regulations which have to be implemented and respected. The European legislation that
contains conditions for the placing on the EU internal market machines consists of Directive
2006/42/EC which was subsequently amended by Directive 2009/127/EC. This amendment to
the Machinery Directive it is supposed to contribute to the protection of the environment and
human health. (Directive 2009/127/EC of the European Parliament and of the Council
amending Directive 2006/42/EC with regard to machinery for pesticide application, 21
October 2009). Another important legislative act is Directive 2009/104/EC, on the use of
work equipment, recoded version of Directive 89/655/EEC (UWED) and its successive
amendments. This applies since the term "work equipment" includes machinery (and any
parts of machinery, tools or installation used at work) and contains minimum requirements
concerning the characteristics required such as to ensure adequate protection and maintenance
of health state of workers. All European Union countries enact their own form of legislation
to implement these Directives. A harmonized European (EN) Standard is listed in the Official
Journal of the European Union (OJ) under the Machinery Directive, these standards are being
however not legally required, but their use is strongly recommended since proving conformity
by alternative methods can be an extremely complex issue. These standards support the
Machinery Directive and are produced by CEN (the European Committee for Standardization)
in cooperation with ISO, and CENELEC (the European Committee for Electrotechnical
Standardization) in cooperation with IEC. So if a manufacturer wishes to put his machinery
on the european market he should prove that all the essential health and safety requirements
were respected. Industrial security has grown in importance in recent years - as such, the
current Directive 2006/42/EC provides a detailed list of safety components, part of these
logical components to ensure safety functions, emergency stop devices, devices to prevent
slips/falls from height, speed limitation devices, mechanical shock absorbing devices and
optoelectronic components for security. Low Voltage Directive (LVD) Low Voltage Directive
(LVD) 2006/95/EC deals with electrical powered equipment designed to operate at a nominal
voltage between 50 to 1000VAC and between 75 to 1500VDC. In general, standard
equipment falling under the LVD are household (EN60335 standards), IT equipment (SR
EN60950-1) and measuring and control equipment for laboratories (SR EN61010-1). The
main differences between LVD and the new Machinery Directive refers to moving parts and
the risk of injury associated classification. These risks are more serious and rigurous treated
by MD than LVD Directive. As regards the main risks, the new Machinery Directive
removes the "gray area" that exists between the two European Directives. Now there are

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clearly defined six categories of electrical machines which are excluded from the scope of the
Machinery Directive and which fall under the LVD: electrical household appliances, audio/
video equipment, IT equipment, office equipment, control devices and low voltage switchgear
and motors plants. SR EN 60204-1 standard is the most useful for assessing the conformity of
industrial machinery punch of view of electrical safety.

3. Risk assessment
In order for a machine or other equipment to be made safe, it is necessary to assess the risks
that can result from its use. Risk assessment for machinery is characterized in BS EN ISO
14121-1. Risk assessment is the first step in preventing work accidents and occupational
diseases and consists in identifying existing hazards to workplaces and risk quantification.
Risk assessment is a systematic examination of the risks of all components of the work
process: work equipment and materials, work environment, workers, the workload. Follow-up
the evaluation results: existance of risks on workplaces, what risks can be eliminated, what
protective measures have to be taken to prevent and control to keep the risks that can not be
removed or reduced, ensuring management thereof. In order to assess the risks there are some
steps that have to taken into account, like identifying the restraints of the machinery: what are
the speeds, the loads, the substances that might be involved, what is the expected life of the
machinery and its application, identifying the hazards: what parts of the machinery could
cause harm to a person, considering the possibillity of entrapping, crushing, cutting from
tools, sharp edges. Examples of typical hazards are presented more detailled in BS EN ISO
14121-1. After hazards have been identified it has to be determined who might be harmed by
these risks, taking into consideration who gets in contact with the machine, what are the
reasons for interacting with the machine, covering also the possibillity of using the machine
by people who are untrained, and other persons who might be present on the workplace, not
only machine operators, but cleaners, security staff, visitors and members of the
public.(Schneider Electric Safe Machinery Handbook, 2009) Further the risks should be
prioritised according to their gravity, the so called risk estimation as it is described in BS
EN ISO 14121-1. It is hard to estimate the potential harm, given the possibility that every
accident can be fatal. All possible repercusions should be considered, not only the worst
scenario. In general, it is recomended thatif there are risks that have the posibility to be
reduced, to be diminished. The risk reduction requirements can be found in BS EN ISO
12100-2. The concept of 'danger zone' makes possible localization of spaces in which people
can be exposed to hazards. For example, if there are risks involving contact with moving parts
of work equipment, dangerous area is restricted to the vicinity of dangerous parts of
machinery. For other risks, such as risk of being hit by objects ejected from the work
equipment or risk caused by exposure to noise or dangerous substances used or ejected from
the equipment, hazardous area may include significant areas where the environment
equipment is working. One of the most effective methods of risk prevention is the design of
machinery so as to avoid the need for people to enter the danger areas. This part will be
discussed below in Safe design and safeguarding.

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4. Safe design and safeguarding


As it was mentioned before, the safe use of the machinery starts with its design, inherently
safe design measures are presented in BS EN 12100-2, clause 4. Safe design and safeguarding
are designers responsability. Of course, they cannot deisgn a safe machinery right from the
begining without a risk assessment process carried out not only by the designers but also by
an entire team formed from: designers, engineers, workers, managers. Usually the best way to
design a safe machinery is to improve an existing one. As it was stated before for a proper
designing of the machinery there have to be identified the hazards that can occur. Hazards can
differ from machine to machine, some of them can be specific for a precise industry, includes
the material with which the machinery works and also takes into account who is dealing with
the machine. Typical categories of hazards dealing with machineries include: mechanical
hazards (cutting, shearing, trapping, impact, friction, hit by mobile machinery), electrical
hazards, thermal hazards, noise and vibration hazards, radiation hazards, exposure to
hazardeous materials and substances, ergonomic hazards, visibility, slips, trips and falls
hazards, work environment hazards. Experience shows that protective measures built into the
design are more likely to remain effective even where well designed safeguarding fails or is
vulnerable to error or the failure to follow safe use information. (Best Practice Guidelines for
the Safe Use of Machinery, 2013) Where improving safe design is not aplicable, the other
accepted method is safeguarding. This measure can include, for example, fixed guarding,
interlocked guarding, presence sensing to prevent unexpected start-up, etc. Safe design of
machinery has become an increasingly serious problem treated in the past decade, and the
new Machinery Directive provides a detailed list of 17 security components specified in
Annex V. The current Machinery Directive specifies only five security components in Section
B of Annex IV. For a clearer picture regarding the new list of safety components, here are
presented some of them: logical components to ensure safety functions; emergency stop
devices; doors/ gates with lock; devices to prevent slips/ falls from height; speed-limiting
equipment; devices to absorb shocks; security optoelectronic components. Safeguards should
block peaple to get in contact with specific hazards, or at least to reduce the risks to a
minimum level. Usualy, safeguards are defined as a physical barrier between the workers
and the dangerous parts of machinery or plant( Best Practice Guidelines for the Safe Use of
Machinery, 2013) The most common categories of guards are: fixed guards, interlocked
guards, adjustable guards and self-adjusting guards. Depending on the hazard that can occur
and the possibility to avoid it one or more types of these guards can be used. In industry the
most used type of guards are the fixed ones because they are simplier and effective. Behind
the advantages that these guards provide, they also have their limitations (disadvatages) for
example: it could interfere with visibility (fixed ones), can only be applicable for specific
operations and others, but of course when taking into consideration designing safeguards the
main objective should be the safety of the people involved with the machinery.
5. General responsabilities of employers
Regarding the employers, first of all they should ensure that all the machineries that are used
in their company are according to the law. They should buy only new machineries from
certified suppliers, and each equipment should be marked with CE mark, proving that all

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Essential Health and Safety requirements from all the directives are met. They are allowed to
buy also second-hand machinery, but first they have to perform a risk assessment to prove
that the equipment is safe and suitable for use. Furthermore, employers togher with workers
and managment of the company should provide the OSH policy, which should be
communicated to all persons from the company. Also, the employer should provide that safe
and conformity of the machinery is kept during all stages, hiring specialist for maintance of
the equipment and training the workers who get in contact with the machinery. Employers
should hire only trained personnel to work with the machinery, training them and assuring
good working conditions, to avoid any danger that could arise from improper using of the
machinery. Directive 89/391/EEC on safety and health of workers at work is known as the
'Framework Directive', as it establishes the basic obligations of employers and workers on
safety and health at work and provides the framework for a series of specific directives
dealing with specific aspects of health and safety hazards.
6. Workers responsabillities
Because workers are an important part of the use of the machinery they should always follow
safe working methods as instructed by their employers. Workers should take all prudent steps
to eliminate or to reduce the risks to minimum levels, for themselves and for others resulting
from their use of machinery at work. Furthermore they should have the right to be consulted
before decisions are taken on issues relevant to safety in the use of machinery at the
workplace and to be involved in risk assessment and the implementation and review of risk
control measures and have the time and resources to do so. (Ocupational health and safety
risks in the healthcare sector, 2013)
7. Cooperation
Because in the safety and health in the use of machinery are envolved many participants, they
should colaborate. The competent authority, designers, manufacturers and suppliers of
machinery, employers and workers and their representatives should cooperate in a
constructive manner to ensure that the all the requirements for safety and health in the use of
machinery are met. Starting with the designers and continuing with suppliers, employers and
employees all should respect their obligations for a safe use of the machinery during its whole
life cycle, and also to colaborate for future improvements of the equipment.
8. Steps in marking a machinery with CE mark
CE marking is a critical indicator of a machinery's compliance with EU legislation and ensure
free movement of it on the European market. By applying the CE marking on the machinery,
the manufacturer declares on its own responsibility that the product complies with all legal
requirements on obtaining the CE marking and therefore ensuring the conformity of the
product for sale on the European Economic Area (EEA: the 27 EU Member States, Iceland,
Norway and Liechtenstein) and Turkey. These conditions are valid also for machineries
manufactured in third countries, which will be sold in the EEA and Turkey. First step is to
identify the directives and harmonised set of standards applicable for machinery. These
legislative acts are preseted above in Legal framework chapter. Second step is verifying the

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requirements of the product by the manufacturer. He has the responsability to assure that the
machinery was manufactured according to the legislation and complies with all the Essential
Health and Safety requirements from all the directives that apply to it. Than, a Notified Body
conducts an evaluation/inspection to check if the machinery complies with all regulations in
cause and as a part of this step is evaluation of risks, which has to be satissfied if the legal
requirements from the Directives have been respected. Fith step is drafting and providing the
mandatory tachnical documenation. Manufacturer has to provide the technical documentation
required by the Directive for assessing the conformity of the product with the relevant
requirements, and to estimate risks. Together with the declaration of conformity, the technical
documentation must be presented to the relevant national authorities. The final step is
applying CE mark on the machinery. The CE marking is affixed by the manufacturer or his
authorized representative in the EEA. It must be applied directly on the machinery or its data
plate, in a visible, legible and indelible way, according to the legal format. If a Notified Body
was involved in the production or control phase, its identification number must also be
mentioned. The manufacturer is responsible for issuing and signing a " CE Declaration of
Conformity" as proof that the product meets the all the requirements. (Guide to Application of
the Machinery Directive 2006/42/EC, 2010).
9. Conformity Assessment Procedures and Market supervision
Currently, a manufacturer can certify the compliance of the machinery manufactured, this
requirement is stated in the new Machinery Directive. Annex IV of this Directive provides a
list of categories of machinery that must conform to certain conformity assessment
procedures. According to the new Directive, manufacturers have the choice of several types of
procedures, namely:
- If the machine is designed in accordance with harmonized standards and meet the
requirements of the Directive, the manufacturer can certify it;
- For machines listed in Annex IV, the manufacturer has the choice between a call to an
assessment by a Notified Body (NB) or appeal the approval of its own quality assurance
system by a Notified Body;
It is important to note that under the new directive, EU members should constantly and
periodically evaluate their Notified Bodies. If an NO does not meet the accreditation criteria,
the Member State may withdraw its accreditation. Another way of quality assurance system
approval for machinery manufacturers listed in Annex IV, as it is indicated in Annex X, adds
certification options for those manufacturers which will allow the period of time necessary for
the introduction of machinery into the EU market to decrease.
In the new Machinery Directive, EU Member States have clearly defined their responsibilities
with regard to market surveillance. These measures and requirements are inspired from
General Product Safety Directive 2001/95/EC, which refers to the security and health of
consumers. These laws use a systemic approach for the market surveillance process with the
clear purpose of encouraging cooperation between the EU authorities and to ensure a high
level of consumer protection. Duties include cooperation with authorities for market

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surveillance and privacy and transparency as essential requirements. Such a framework of


rules has on one hand been designed to help manufacturers remain competitive in the market
and on the other to maintain the neutrality of EU Member States in the conformity assessment
process.

Conclusion
Directive 2006/42/EC is a revision of the Machinery Directive whose first version was
adopted in 1989. The new MD is applicable since 29 December 2009. The Directive has a
double objective to harmonize security and safe requirements for using the machineries, while
ensuring the free movement of them on the EU market. According to the regulations all
machineries that are put on the European Market should be affixed with CE mark and should
met all the requirements from the specific directives and set of harmonised standards. The
safe of machinery has to be taken into account right from the start, from the designing stage,
designers and manufacturers should follow the european legislation in order to provide safe
machinery. All the requirements that they have to accomplish are stated in the Directives and
European Standards than have been shortly presented above. For the safe use of the
machinery are responsible also all persons who get in contact with it, also the employers,
workers, maintanace personell and others. Each one has its own responsability and obligation
to ensure a safe use of the machinery. Todaay, taking into account all the legislative acts that
have been issued for the safe of the machinery the risks of accidents have been reduced to
minimum level, but even so, it is not eliminated. This is why, there is always place for
improvements considering the improvment of the machinery design and perfoming new
actions to increase the safe use of machinery.

References
2003. Global strategy on occupational safety and health, conclusions adopted by the
International Labour Conference (Geneva)
2001. ISO 14122, Safety of machinery Permanent means of access to machinery.
2006. Directive 2006/42/EC of the European Parliament and of the Council
2002. ISO 14120, Safety of machinery Guards General requirements for the design and
construction of fixed and movable guards.
2009. Schneider Electric. Safe use of Machinery Handbook.
2010. ISO 12100, Safety of machinery General principles for design Risk assessment and
risk reduction.

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2010. European Commission, Enterprise and Industry. Guide to application of the Machinery
Directive 2006/42/EC (second edition).
2013. European Union Programme for Employment and Social Solidarity Progress.
Occupational health and safety risks in the healthcare sector. Guide to prevention and good
practice.
2013. Ministry of Business, Innovation and Employment of Australia, Best Practice
Guidelines for the Safe Use of Machinery.

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