Regulations

EU Directives and Legislation

The purpose of this section is to act as a guide for anyone concerned with machine safety especially guarding and protective systems in the European Union. It is intended for designers and users of industrial equipment.

In order to promote the concept of an open market within the European Economic Area (EEA) (which comprises all EU Member States plus three other countries) all member states are obliged to enact legislation that defines essential safety requirements for machinery and its use.

Machinery that does not meet these requirements cannot be supplied into or within EEA countries.

There are several European Directives that can apply to the safety of industrial machinery and equipment but the two that are of the most direct relevance are:

1.	The Machinery Directive
2.	The Use of Work Equipment by Workers at Work Directive

These two Directives are directly related as the Essential Health and Safety Requirements (EHSRs) from the Machinery Directive can be used to confirm the safety of equipment in the Use of Work Equipment Directive.

This section deals with aspects of both directives and it is strongly recommended that anyone concerned with the design, supply, purchase or use of industrial equipment within or into the EEA and also certain other European countries should familiarize themselves with their requirements. Most suppliers and users of machinery will simply not be allowed to supply or operate machinery in these countries unless they conform to these directives.

There are other European Directives that may have relevance to machinery. Most of them are fairly specialized in their application and are therefore left outside the scope of this section but it is important to note that, where relevant, their requirements must also be met. Examples are: The EMC Directive 2004/108/EC and the ATEX Directive 94/9/EC.

The EU Machinery Directive

The Machinery Directive covers the supply of new machinery and other equipment including safety components. It is an offense to supply machinery within the EU unless the provisions and requirements of the Directive are met.

The broadest definition of “machinery” given within the Directive is a follows: an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application.

Detailed information and guidance on the definition and all other aspects of the Machinery Directive can be found at the official EU website:

http://ec.europa.eu/enterprise/sectors/mechanical/machinery/index_en.htm

The current Machinery Directive (2006/42/EC) replaced the former version (98/37/EC) at the end of 2009. It clarifies and amends but does not introduce any radical changes to its Essential Health and Safety Requirements (EHSRs). It does introduce some changes to take account of changes in technology and methods. It extends its scope to cover some extra types of equipment (e.g. construction site hoists). There is now an explicit requirement for a risk assessment for the determination of which EHSRs are applicable and there are changes made to the conformity assessment procedures for Annex IV equipment.

The key provisions of the original Directive (98/37/EC) came into force for machinery on January 1, 1995 and for Safety Components on January 1, 1997.

The provisions of the current Directive (2006/42/EC) became applicable on December 29, 2009. It is the responsibility of the manufacturer or his authorized representative to ensure that equipment supplied is in conformity with the Directive. This includes:

Figure 1: CE Marking Affixed to Machine

• Ensuring that the applicable EHSRs contained in Annex I of the Directive are fulfilled
  
• A technical file is prepared
  
• Appropriate conformity assessment is carried out
  
• An "EC Declaration of Conformity" is given
  
• CE Marking is affixed where applicable
  
• Instructions for safe use are provided
  

Essential Health and Safety Requirements

Annex 1 of the Directive gives a list of Essential Health and Safety Requirements (referred to as EHSRs) to which machinery must comply where relevant. The purpose of this list is to ensure that the machinery is safe and is designed and constructed so that it can be used, adjusted and maintained throughout all phases of its life without putting persons at risk. The following text provides a quick overview of some typical requirements but it is important to consider all of the EHSRs given in Annex 1.

A risk assessment must be carried out to determine which EHSRs are applicable to the equipment under consideration.

The EHSRs in Annex 1 provides a hierarchy of measures for eliminating the risk:

Figure 2: Machine Must Meet EHSRs

(1) Inherently Safe Design—Where possible the design itself will prevent any hazards.

Where this is not possible (2) Additional Protective Measures, e.g., Guards with interlocked access points, non-material barriers such as light curtains, sensing mats etc., should be used.

Any residual risk which cannot be dealt with by the above methods must be contained by (3) Personal Protective Equipment and/or Training. The machine supplier must specify what is appropriate.

Suitable materials should be used for construction and operation. Adequate lighting and handling facilities should be provided. Controls and control systems must be safe and reliable. Machines must not be capable of starting up unexpectedly and should usually have one or more emergency stop devices fitted. Consideration

must be given to complex installations where processes upstream or downstream can affect the safety of a machine. Failure of a power supply or control circuit must not lead to a dangerous situation. Machines must be stable and capable of withstanding foreseeable stresses. They must have no exposed edges or surfaces likely to cause injury.

Guards or protection devices must be used to protect risks such as moving parts. These must be of robust construction and difficult to bypass. Fixed guards must be mounted by methods that can only be removed with tools. Movable guards should be interlocked. Adjustable guards should be readily adjustable without the use of tools.

Electrical and other energy supply hazards must be prevented. There must be minimal risk of injury from temperature, explosion, noise, vibration, dust, gases or radiation. There must be proper provisions for maintenance and servicing. Sufficient indication and warning devices must be provided. Machinery shall be provided with instructions for safe installation, use, adjustment etc.

The Machinery Directive—Conformity Assessment and Standards

A harmonized European (EN) Standard that is listed in the Official Journal of the European Union (OJ) under the Machinery Directive, and whose date of cessation of presumption of conformity has not expired, confers a presumption of conformity with certain of the EHSRs. (Many recent standards listed in the OJ include a cross-reference identifying the EHSRs that is covered by the standard).

Therefore, where equipment complies with such current harmonized European standards, the task of demonstrating conformity with the EHSRs is greatly simplified, and the manufacturer also benefits from the increased legal certainty. These standards are not legally required, however, 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.

A thorough, documented risk assessment must be conducted to ensure that all potential machine hazards are addressed. It is the responsibility of the machine manufacturer to ensure that all EHSRs are satisfied, even those that are not addressed by harmonized EN Standards.

Technical File

The manufacturer or his authorized representative must prepare a Technical File to provide evidence of conformity with the EHSRs. This file should include all relevant information such as test results, drawings, specifications, etc.

It is not essential that all the information is permanently available as hard copy but it must be possible to make the entire Technical File available for inspection on request from a competent authority (a body appointed by an EU country to monitor the conformity of machinery).

At the minimum, the following documentation must be included in a Technical File:

Figure 3: Document Assessment Results

1.	Overall drawings of the equipment including control circuit drawings.
2.	Detailed drawings, calculation notes, test results, etc. required for checking the conformity of the machinery with the EHSRs.
3.	Risk assessment documentation, including a list of the essential health and safety requirements which apply to the machinery and a description of the protective measures implemented.
4.	A list of the standards and other technical specifications used, indicating the essential health and safety requirements covered.
5.	A description of methods adopted to eliminate hazards presented by the machinery.
6.	If relevant, any technical reports or certificates obtained from a test facility or other body.
7.	If conformity is declared with a Harmonized European Standard, any technical report giving test results for it.
8.	A copy of the instructions for the machinery.
9.	Where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery.
10.	Where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery.
11.	A copy of the EC declaration of conformity.

For series manufacture, details of internal measures (quality systems, for example) to ensure all machinery produced remains in conformity:

• The manufacturer must carry out necessary research or tests on components, fittings or the completed machinery to determine whether by its design and construction it is capable of being erected and put into service safely.
  
• The technical file need not exist as a permanent single file, but it must be possible to assemble it to make it available in a reasonable time. It must be available for ten years following production of the last unit.
  

The technical file does not need to include detailed plans or any other specific information regarding sub-assemblies used for the manufacture of the machinery, unless they are essential to verify conformity with the EHSRs.

Conformity Assessment

Certain types of equipment are subject to special measures. This equipment is listed in Annex IV of the Directive and includes dangerous machines such as some woodworking machines, presses, injection molding machines, underground equipment, vehicle servicing lifts, etc.

Annex IV also includes certain safety components such as Protective devices designed to detect the presence of persons (e.g. light curtains) and logic units for ensuring safety functions.

Figure 4: Conformity Assessments

For Annex IV machines that are not in full conformity with the relevant Harmonized European Standards the manufacturer or his authorized representative must apply one of the following procedures:

1.	EC Type Examination. A Technical File must be prepared and an example of the machine must submitted to a notified body (test house) for EC type examination. If it passes, the machine will be given an EC type examination certificate. The validity of the certificate must be reviewed every five years with the Notified Body.
2.	Full Quality Assurance. A Technical File must be prepared and the manufacturer must operate an approved quality system for design, manufacture, final inspection and testing. The quality system must ensure conformity of the machinery with the provisions of this Directive. The quality system must be periodically audited by a Notified Body.

Figure 5: Notified Body Examinations

For machines that are not included in Annex IV or machines that are included in Annex IV but are in full conformity with the relevant Harmonized European Standards, the manufacturer or his authorized representative also has the option prepare the Technical and self assess and declare the conformity of the equipment. There must be internal checks to ensure that the manufactured equipment remains in conformity.

Notified Bodies

A network of notified bodies that communicate with each other and work to common criteria exists throughout the EU. Notified Bodies are appointed by governments (not by industry) and details of organizations with notified body status can be obtained from: http://ec.europa.eu/enterprise/sectors/mechanical/machinery/index_en.htm

EC Declaration of Conformity Procedure

The CE Marking must be applied to all machines supplied. The machines should also be supplied with an EC Declaration of Conformity.

Figure 6: CE Mark

The CE Mark indicates that the machine conforms to all applicable European Directives and that the appropriate conformity assessment procedures have been completed. It is an offense to apply the CE Mark for the Machinery Directive unless the machine satisfies the relevant EHSRs.

The EC Declaration of Conformity must contain the following information:

• Business name and full address of the manufacturer and, where appropriate, the authorized representative;
  
• Name and address of the person authorized to compile the technical file, who must be established in the Community (in the case of a manufacturer outside the EU this may be the “Authorized Representative”);
  
• Description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;
  
• A sentence expressly declaring that the machinery fulfills all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies;
  
• Where appropriate, a reference to the harmonized standards used;
  
• Where appropriate, the reference to other technical standards and specifications used;
  
• (For an Annex IV machines) where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX and the number of the EC type-examination certificate;
  
• (For an Annex IV machines) where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X;
  
• The place and date of the declaration;
  
• The identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or the authorized representative.
  

EC Declaration of Incorporation for Partly Completed Machinery

Where the equipment is supplied for assembly with other items to form a complete machine at a later date, a DECLARATION OF INCORPORATION should be issued with it. The CE mark should not be applied. The declaration should state that the equipment must not be put into service until the machine into which it has been incorporated has been declared in conformity. A Technical File must be prepared and the partly completed machinery must be supplied with information containing a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety.

This option is not available for equipment which can function independently or which modifies the function of a machine.

The Declaration of Incorporation must contain the following information:

• Business name and full address of the manufacturer of the partly completed machinery and, where appropriate, the authorized representative;
  
• Name and address of the person authorized to compile the relevant technical documentation, who must be established in the Community (in the case of a manufacturer outside the EU this may be the “Authorized Representative”);
  
• Description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;
  
• A sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives;
  
• An undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;
  
• A statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive, where appropriate;
  
• The place and date of the declaration;
  
• The identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or the authorized representative.
  

Machinery Supplied from Outside the EU—
Authorized Representatives

If a manufacturer based outside the EU (or EEA) exports machinery into the EU they will need to appoint an Authorized Representative.

An Authorized Representative means any natural or legal person established in the European Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with the Machinery Directive.

Figure 7: Overview of Procedures for the Machinery Directive

It is important to study the Directive (2006/42/EC) for full details.

The EU Use of Work Equipment Directive (U.W.E. Directive)

Whereas the Machinery Directive is aimed at suppliers, this Directive (89/655/EEC as amended by 95/63/EC, 2001/45/EC and 2007/30/EC) is aimed at users of machinery. It covers all industrial sectors and it places general duties on employers together with minimum requirements for the safety of work equipment. All EU countries are enacting their own forms of legislation to implement this Directive.

For example it is implementation in the UK under the name of The Provision and Use of Work Equipment Regulations (often abbreviated to P.U.W.E.R.). The form of implementation may vary between countries but the effect of the Directive is retained.

The articles of the Directive give details of which types of equipment and workplaces are covered by the Directive.

They also place general duties on employers such as instituting safe systems of working and providing suitable and safe equipment that must be properly maintained. Machine operators must be given proper information and training for the safe use of the machine.

New machinery (and second hand machinery from outside the EU) provided after January 1, 1993 should satisfy any relevant product directives, e.g., The Machinery Directive (subject to transitional arrangements). Second hand equipment from within the EU provided for the first time in the workplace must immediately provide minimum requirements given in an annex of the U.W.E. Directive.

Figure 8: Directive Covers Use of Equipment

Note: Existing or second-hand machinery which is significantly overhauled or modified will be classified as new equipment, so the work carried out on it must ensure compliance with the Machinery Directive (even if it is for a company's own use).

Suitability of work equipment is an important requirement of the directive and it highlights the employer’s responsibility to carry out a proper process of risk assessment.

It is a requirement that machinery must be properly maintained. This will normally mean that there must be a routine and planned preventive maintenance schedule. It is recommended that a log is compiled and kept up to date. This is especially important in cases where the maintenance and inspection of equipment contributes to the continuing safety integrity of a protective device or system.

The Annex of the U.W.E. Directive gives general minimum requirements applicable to work equipment.

If the equipment conforms to relevant product directives, e.g., The Machinery Directive, they will automatically comply with the corresponding machine design requirements given in the minimum requirements of the Annex.

Member states are allowed to issue legislation regarding the use of work equipment that goes beyond the minimum requirements of the U.W.E. Directive.

Detailed information on the Use of Work Equipment Directive can be found at the official EU website:

U.S. Regulations

This section introduces some of the industrial machine guarding safety regulations in the U.S. This is only a starting point; readers must further investigate the requirements for their specific applications and take measures to ensure that their designs, uses and maintenance procedures and practices meet their own needs as well as national and local codes and regulations.

There are many organizations that promote industrial safety in the United States. These include:

1.	Corporations, which use established requirements as well as establish their own internal requirements;
2.	The Occupational Safety and Health Administration (OSHA);
3.	Industrial organizations like the National Fire Protection Association (NFPA), the Robotics Industries Association (RIA), the Association of Manufacturing Technology (AMT) and the suppliers of safety products and solutions such as Rockwell Automation.

Occupational Safety and Health Administration

In the United States, one of the main drivers of industrial safety is the Occupational Safety and Health Administration (OSHA). OSHA was established in 1970 by an Act of the U.S. Congress. The purpose of this act is to provide safe and healthful working conditions and to preserve human resources. The act authorizes the Secretary of Labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce. This Act shall apply with respect to employment performed in a workplace in a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, Guam, the Trust Territory of the Pacific Islands, Wake Island, Outer Continental Shelf Lands defined in the Outer Continental Shelf Lands Act, Johnston Island, and the Canal Zone.

Article 5 of the Act sets the basic requirements. Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees; and shall comply with occupational safety and health standards promulgated under this Act.

Article 5 also states that each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to this Act which are applicable to his own actions and conduct.

The OSHA Act places the responsibility on both the employer and the employee. This is quite divergent from Machinery Directive, which requires suppliers to place machines on the market that are free from hazards. In the U.S., a supplier can sell a machine without any safeguarding. The user must add the safeguarding to make the machine safe. Although this was a common practice when the Act was approved, the trend is for suppliers to provide machines with the safeguarding, as designing safety into a machine is far more cost effective than adding the safeguarding after the machine is designed and built. Standards are now attempting to get the supplier and user to communicate requirements for safeguarding so that machines are made not only safe but more productive.

The Secretary of Labor has the authority to promulgate as an occupational safety or health standard any national consensus standard, and any established Federal standard, unless the promulgation of such a standard would not result in improved safety or health for specifically designated employees.

OSHA accomplishes this task by publishing regulations in Title 29 of the Code of Federal Regulation (29 CFR). Standards pertaining to industrial machinery are published by OSHA in Part 1910 of 29 CFR. They are freely available on the OSAH website at www.osha.gov. Unlike most standards, which are voluntary, the OSHA standards are laws.

Some of the important parts as they pertain to machine safety are as follows:

A	General
B	Adoption and Extension of Established Federal Standards
C	General Safety and Health Provisions
H	Hazardous Materials
I	Personal Protective Equipment
J	General Environmental Controls—includes Lockout/Tagout
O	Machinery and Machine Guarding
R	Special industries
S	Electrical

Some OSHA standards reference voluntary standards. The legal effect of incorporation by reference is that the material is treated as if it were published in full in the Federal Register. When a national consensus standard is incorporated by reference in one of the subparts, that standard is considered the law. For example, NFPA 70, a voluntary standard known as the US National Electric Code, is referenced in Subpart S. This makes the requirements in the NFPA70 standard mandatory.

The 29 CFR 1910.147, in Subpart J, covers the control of hazardous energy. This is commonly known as the Lockout/Tagout standard. The equivalent voluntary standard is ANSI Z244.1. Essentially, this standard requires power to the machine to be locked out when undergoing service or maintenance. The purpose is to prevent the unexpected energization or startup of the machine which would result in injury to employees.

Employers must establish a program and utilize procedures for affixing appropriate lockout devices or tagout devices to energy isolating devices, and to otherwise disable machines or equipment to prevent unexpected energization, start up or release of stored energy in order to prevent injury to employees.

Minor tool changes and adjustments, and other minor servicing activities, which take place during normal production operations, are not covered by this standard if they are routine, repetitive, and integral to the use of the equipment for production, provided that the work is performed using alternative measures which provide effective protection. Alternative measures are safeguarding devices like light curtains, safety mats, gate interlocks and other similar devices connected to a safety system. The challenge to the machine designer and user is to determine what is “minor” and what is “routine, repetitive and integral.”

Subpart O covers “Machinery and Machine Guarding.” This subpart lists the general requirements for all machines as well as requirements for some specific machines. When OSHA was formed in 1970, it adopted many existing ANSI standards. For example B11.1 for mechanical power presses was adopted as 1910.217.

The 1910.212 is the general OSHA standard for machines. It states that one or more methods of machine guarding shall be provided to protect the operator and other employees in the machine area from hazards such as those created by the point of operation, ingoing nip points, rotating parts, flying chips and sparks. Guards shall be affixed to the machine where possible and secured elsewhere if for any reason attachment to the machine is not possible. The guard shall be such that it does not offer an accident hazard in itself.

The “point of operation” is the area on a machine where work is actually performed upon the material being processed. The point of operation of a machine, whose operation exposes an employee to injury, shall be guarded. The guarding device shall be in conformity with any appropriate standards or, in the absence of applicable specific standards, shall be so designed and constructed as to prevent the operator from having any part of his body in the danger zone during the operating cycle.

Subpart S (1910.399) states the OSHA electrical requirements. An installation or equipment is acceptable to the Assistant Secretary of Labor, and approved within the meaning of this Subpart S if it is accepted, certified, listed, labeled, or otherwise determined to be safe by a nationally recognized testing laboratory (NRTL).

What is Equipment? A general term including material, fittings, devices, appliances, fixtures, apparatus, and the like, used as a part of, or in connection with, an electrical installation.

What is “Listed”? Equipment is “listed” if it is of a kind mentioned in a list which, (a) is published by a nationally recognized laboratory which makes periodic inspection of the production of such equipment, and (b) states such equipment meets nationally recognized standards or has been tested and found safe for use in a specified manner.

As of August 2009, the following companies are recognized by OSHA as NRTLs:
Canadian Standards Association (CSA)
Communication Certification Laboratory, Inc. (CCL)
Curtis-Straus LLC (CSL)
FM Approvals LLC (FM)
Intertek Testing Services NA, Inc. (ITSNA)
MET Laboratories, Inc. (MET)
NSF International (NSF)
National Technical Systems, Inc. (NTS)
SGS U.S. Testing Company, Inc. (SGSUS)
Southwest Research Institute (SWRI)
TÜV America, Inc. (TÜVAM)
TÜV Product Services GmbH (TÜVPSG)
TÜV Rheinland of North America, Inc. (TÜV)
Underwriters Laboratories Inc. (UL)
Wyle Laboratories, Inc. (WL)

Some states have adopted their own local OSHAs. Twenty-four states, Puerto Rico and the Virgin Islands have OSHA-approved State Plans and have adopted their own standards and enforcement policies. For the most part, these States adopt standards that are identical to Federal OSHA. However, some States have adopted different standards applicable to this topic or may have different enforcement policies.

Employers must report incident history to OSHA. OSHA compiles incident rates and transmits the information to local offices, and uses this information to prioritize inspections. The key inspection drivers are:

• Imminent Danger
  
• Catastrophes and Fatalities
  
• Employee Complaints
  
• High Hazardous Industries
  
• Local Planned Inspections
  
• Follow-up Inspections
  
• National and Local Focus Programs
  

Violations of OSHA standards can result in fines. The schedule of fines is:

• Serious: up to $7000 per violation
  
• Other than Serious: discretionary but not more than $7000
  
• Repeat: up to $70,000 per violation
  
• Willful: up to $70,000 per violation
  
• Violations resulting in death: further penalties
  
• Failure to abate: $7000/day
  

The table below shows the top 14 OSHA citations from October 2004 to September 2005.

Standard	Description
1910.147	The control of hazardous energy (lockout/tagout)
1910.1200	Hazard communication
1910.212	General requirements for all machines
1910.134	Respiratory protection
1910.305	Wiring methods, components, and equipment for general use
1910.178	Powered industrial trucks
1910.219	Mechanical power transmission
1910.303	General requirements
1910.213	Woodworking machinery
19102.215	Abrasive wheel machinery
19102.132	General requirements
1910.217	Mechanical power presses
1910.095	Occupational noise exposure
1910.023	Guarding floor and wall openings and holes
Table 1

Canada Regulations

In Canada, Industrial Safety is governed at the Provincial level. Each province has its own regulations that are maintained and enforced. For example, Ontario established the Occupational Health and Safety Act, which sets out the rights and duties of all parties in the workplace. Its main purpose is to protect workers against health and safety hazards on the job. The Act establishes procedures for dealing with workplace hazards, and it provides for enforcement of the law where compliance has not been achieved voluntarily.

Within the Act there is regulation 851, Section 7 that defines the Pre-Start Health and Safety review. This review is a requirement within Ontario for any new, rebuilt or modified piece of machinery and a report needs to be generated by a professional engineer.