Safety of Machinery

Overview of the CE Marking Process for the Safety of Machinery Directive

This overview references key websites relating to the Safety of Machinery Directive, an updated list of standards for Safety of Machinery Directive, and instructions on how to certify for the Safety of Machinery Directive. This document also provides information on where standards can be purchased, and presents a list of labs around the country that can do CE marking testing for the Safety of Machinery Directive.

PHASE 1: Does the Safety of Machinery Directive Apply to Your Product?

As a manufacturer, you need to secure copies of the directives and judge whether they apply to your product. The European Commission does not publish a list of products to which their laws apply. They require the manufacturer to determine the applicability of directives to any given product. The Safety of Machinery Directive (98/37/EC) is very broad in scope, covering any equipment that has moving parts (excluding manually operated equipment).

In some cases, a product might be covered by more than one directive. For example, a machine would probably be covered by the Machinery, EMC, and Low Voltage Directives. A manufacturer must meet the CE marking requirements for all the directives that apply to the company’s product. To view the machinery directive, go to the European Commission’s website at http://www.newapproach.org and click on “Directives and Standards.” Then click on the Safety of Machinery Directive.

The purpose of the Machinery Directive is to integrate safety into the design, production, adjustment, maintenance, assembly and dismantling of machines, and thereby reduce, as far as possible, the chance of accidents and harm to persons at risk. Article I defines machinery as “an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material.” Also covered by the machinery directive are assemblies of machines that function as an integral whole, interchangeable equipment modifying the function of a machine, and “safety components.” A safety component fulfills a safety function when in use, and would endanger the safety or health of exposed persons if it failed or malfunctioned.

The Machinery Directive is very broad in scope, covering any equipment which has moving parts (excluding manually operated equipment) joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material. Safety components (such as emergency stopping devices or safety belts and restraining devices in the event of overturning) that protect workers from hazards are also covered by the Machinery Directive. The Machinery Directive also covers mobile machines, machines intended for use underground, and machine lifts.

Article I, paragraph 3 lists products that are excluded from coverage by the Machinery Directive. Some examples from the list of 18 entries are: Machinery powered manually (unless used for lifting or lowering loads); special equipment for use in fairgrounds and/or amusement parks; steam boilers, tanks and pressure vessels; firearms; radioactive sources forming part of a machine; and seagoing vessels and mobile offshore units together with equipment on board such vessels or units.

The products listed in Article I, paragraph 3 are usually covered by another CE marking directive or possibly by member state regulations.

For more information on the CE marking and the EU Machinery Directive, see the booklets published by the National Institute of Standards and Technology (NIST) entitled, “NIST GCR 814 – A Guide to the EU Machinery Directive,” and “NIST SP 951 – A Guide to EU Standards and Conformity Assessment,” which are available on the website http://ts.nist.gov/europe.

PHASE 2: Check to see if Your Product is Listed in Annex IV of the Safety of Machinery Directive

Machines listed in Annex IV cannot be self-certified because the European Union has decided these machines are too dangerous. There are 17 machines listed in Annex IV (mostly saws, presses, injection or compression molding machines, lifts, and machinery for work underground) along with five safety components.

A manufacturer has two options to certify machinery listed in Annex IV of the directive: (1) Submit an example of the machine to an EU-affiliate lab for an EC type-examination (in which the manufacturer submits a representative model or “type” to see if that machine satisfies the provisions of the directive that apply to it); or, (2) conform to the European standards applicable to the firm's product, compile a technical file, and submit the report to an EU notified body for review and approval.

Option (1): If a manufacturer chooses to get an EC type-examination, the lab it uses must be affiliated with a notified body because notified bodies are the only entities authorized to issue a certificate for the CE marking. Annex VI of the Machinery Directive has detailed information about what is entailed in a type-examination of a machine. For a list of labs that can do testing and certification for the Machinery Directive, see the link Testing/Certifying Labs on the sidebar on this page and throughout this website. This list is not an endorsement for any laboratory. There are other labs, not listed on our link, that can do testing for this Directive.

Option (2): If a manufacturer chooses to conform to the European standards, consult the list of standards for the “Safety of Machinery” Directive at the European Commission’s website at http://www.newapproach.org and click on “Directives and Standards” to see which standards apply to the machine and then order the appropriate standards. Some sources for ordering standards are listed on the Consultants/Ordering Standards link on the sidebar of this page and throughout this website. Once a manufacturer obtains the standards, it needs to conform to the standards, draw up a technical file (see PHASE 7) providing evidence that the manufacturer has met the European standards, and then send the technical file to a notified body for verification that the standards were correctly applied. The notified body will draw up a certificate of adequacy for the file. The risk involved in option 2 is that the notified body might reject the technical file, which would cause the manufacturer to lose time and money. The advantage of option 2 over option 1 is that it is usually less costly than option 1 because there is no expense for the lab test.

The booklet written by the National Institute of Standards and Technology (NIST) entitled, “A Guide to the EU Machinery Directive” at the website http://ts.nist.gov/europe has an excellent section on Annex IV of the machinery directive.

PHASE 3: Overview of CE Marking Requirements for the Safety of Machinery Directive

For most machinery, manufacturers can self-certify compliance with the directive by meeting the “essential health and safety requirements” outlined in Annex I of the Directive. However, machinery listed in Annex IV of the Directive, primarily saws, presses, and safety components, have been deemed exceptionally hazardous and must be tested and approved by a lab affiliated with a European Union notified body (See PHASE 2).

For more information on CE marking and the EU Machinery Directive, see the booklets published by the National Institute of Standards and Technology (NIST) entitled, “NIST GCR 814 – A Guide to the EU Machinery Directive,” and “NIST SP 951 – A Guide to EU Standards and Conformity Assessment,” which are available on the website http://ts.nist.gov/europe.

Annex I of the Machinery Directive contains the descriptions of the “essential health and safety requirements (EHSRs) relating to the design and construction of machinery and safety components.” There are about 100 EHSRs listed. The first part of Annex I applies to general machinery. Examples of EHSRs described for general machinery are: lighting, materials and products, design of machinery to facilitate its handling, control devices, starting, stopping, emergency stop, mode selection, stability, software, failure of power supply, special requirements for guards, etc. The EHSRs are fairly detailed and give manufacturers guidance on what actions must be taken to satisfy the requirements. The purpose of the EHSRs is to eliminate or reduce dangers caused by operating the machine. A manufacturer can self-certify compliance with the Machinery Directive by meeting the EHSRs that apply to its product and recording the solutions to these problems in a technical file (see PHASE 6). As long as the manufacturer’s machine is not listed in Annex IV of the Directive, the company can use any group of standards it wants–European, international, or U.S.–to meet these applicable EHSRs. For machines listed in Annex IV, please refer to PHASE 2.

Besides general machinery, there are several separate categories of machinery covered in Annex I. These categories include: Certain categories of machinery (agri-foodstuffs machinery, portable hand-held and/or hand-guided machinery, and machinery for working wood and analogous materials); mobile machinery; lifts for people; and machinery for work underground. Lifts for people, machinery for work underground, and some machines for woodworking are listed in Annex IV and need to be type-certified by a notified body. The other types of machines listed in this paragraph can be self-certified by meeting the applicable EHSRs of the directive and recording these solutions in a technical file.

Although a manufacturer whose machine does not appear in Annex IV of the machinery directive can self-certify and does not need to use a lab, the manufacturer can still employ a lab if the manufacturer has questions on how to meet a particular EHSR or if the company wants help setting up a quality control system to ensure that machines being produced subsequently will meet CE marking requirements. A lab performing testing on a machine that is not listed in Annex IV of the machine directive does not have to be affiliated with a European notified body.

Note: Operating instructions are covered in Annex I, article 1.7.3. The article states that operating instructions must be in the language of the user when the machine is put into service. The translation can be done either by the manufacturer, his authorized representative, or by the person introducing the machinery into the language area in question.

PHASE 4: Identify the European Standards for the Machinery Directive That Apply to Your Product

Refer to the European Commission's website at http://www.newapproach.org to get a complete listing of European standards for the Machinery Directive. The Consultants/Ordering Standards link on the sidebar of this page and throughout the Trade Information Center's CE marking website lists some sources for ordering standards. The European Union has developed about 500 standards for this directive. A large group of standards covers specific types of machinery (such as earthmoving machinery, rubber and plastics machinery, packaging machinery, agricultural and forestry machinery, pumps, and many more). Another group of standards sets rules for characteristics of machines such as acoustics, ergonomics and noise emissions, and another small group of standards covers the general principles of machine safety.

The European Committee for Standardization (CEN) develops the standards for the machinery directive. Use of European standards is not required for a U.S. company to self-certify to the essential requirements of the machine directive. A company can use U.S., international, or European standards to meet the essential requirements of the directive.

European standards do have to be used to meet CE marking requirements for machines listed in Annex IV. The machines in Annex IV cannot be self-certified because the European Union has deemed them too dangerous. There are 17 machines listed in Annex IV (mostly saws, presses, injection or compression molding machines, lifts, and machinery for work underground) along with five safety components.

PHASE 5: Meet the Appropriate Essential Health and Safety Requirements (EHSRs) and Establish a Quality Control System

The manufacturer's engineering and technical staff should determine which essential health and safety requirements (EHSRs) apply to its machine, and then go about meeting the requirements. Use of European, U.S., or international standards is acceptable for meeting the requirements. The manufacturer does not need to get a lab test to show EHSRs were met, though a lab could be employed if the manufacturer wanted. The manufacturer will have to establish some sort of quality control system to ensure that future products also meet the CE marking requirements. ISO 9000 is not a legally required quality control system, though it does have high market visibility and could be advantageous from a marketing point of view.

PHASE 6: Assemble a Technical File

The main purpose of having manufacturers compile a technical file is for European Community authorities to conduct market surveillance activities efficiently. Annex V, paragraphs 3 and 4, of the Machinery Directive outlines the information to be supplied in a technical file. To summarize briefly, the technical file for the machinery directive contains the operating instructions (in the language of the country where the machine is going to be used) and then, for series manufacturers, the quality control program that will be implemented to ensure that the machinery remains in conformity with the directive. A description of information manufacturers must provide for instructions is found in Annex I of the directive, under 1.7.4.–“Instructions.” For more information on how to put together a technical file, please consult the Technical File Procedures link on the sidebar of this page and throughout the Trade Information Center's CE marking website for more information.

U.S. manufacturers whose machines are not listed in Annex IV can include in their technical file any standard (U.S., international, or European) and accompanying diagrams and solutions as long as the company meets the relevant EHSRs of the directive. The company can also use test results performed in the U.S. in its technical file to show compliance to the EHSRs of the directive.

PHASE 7: Affix the CE Marking to Your Product

Annex III of the Machinery Directive (at www.newapproach.org) discusses the rules of applying CE marking. The manufacturer must have met the relevant essential health and safety requirements (EHSRs) and have compiled a technical file proving conformity before applying the CE marking. The CE marking must be visible, must be affixed so it will not come off, and must be at least 5 mm in height. See the European Commission's, "Guide to the Implementation of Directives Based on New Approach and Global Approach" to see a picture of the CE marking and a brief description of it. At the website, click on 7, CE Marking, and go to page 45 to see the picture. If your product is covered by more than one CE marking directive (such as by the Machine, EMC, and Low Voltage Directives), then it is assumed that the CE marking will not be put on the product until CE marking requirements have been met for all the directives covering the manufacturer’s product.

PHASE 8: Create the Declaration of Conformity

Annex II of the Machinery Directive describes the items a manufacturer must include in the declaration of conformity. The declaration of conformity accompanies each shipment of machinery to Europe. The EC declaration of conformity is the document on which the manufacturer, or his authorized representative established in the Community, declares that the machinery being placed on the market complies with all the “essential health and safety requirements” applying to it. The signature of a company officer is required to indicate that the manufacturer has taken responsibility for having met CE marking requirements for the Machinery Directive. Paragraph A in Annex II describes the content for the declaration of conformity for machinery. Paragraph B outlines the content of the declaration of “incorporation,” which applies to a part of a machine that is going to be incorporated into a larger unit. Finally, paragraph C addresses the contents of a declaration of conformity for safety components. The contents for all three are roughly the same. Although there is no set format for drawing up a declaration of conformity, the Commerce Department has put together a sample declaration of conformity for companies to look at and possibly model their own after. To access this sample, see the Declaration of Conformity link on the sidebar of this page and throughout the Trade Information Center's CE marking website.

PHASE 9: Keep Posted on Updates of Standards Which Might Affect Your Product

The European Committee for Standardization (CEN) has been very active in issuing new and updated standards for the Machinery Directive. U.S. manufacturers can keep updated on EU standards by consulting the European Commission’s website at http://www.newapproach.org. The use of European standards is voluntary, but use of European standards does give a presumption of conformity for the directive and is especially important for getting a type-examination certificate for a machine listed in Annex IV of the directive.

More Information is Available:

If you need more information on getting the CE mark for the Safety of Machinery Directive, call either of the Department of Commerce EU specialists: Bob Straetz at 202-482-4496 in the Office of EU Affairs, or Sylvia Mohr at 011 32 2 508 2675.

Consult the U.S. Commercial Service website at http://www.buyusa.gov/europeanunion

Duquesne University Center for International Regulatory Assistance, partially funded by the U.S. Small Business Administration and the Market Development Cooperator Program of the U.S. Department of Commerce, has information on the CE mark at http://www.duq.edu/about/centers-and-institutes/international-regulatory-assistance