Low Voltage Equipment

(also see A Primer for Garage Doors)

Overview of the CE Marking Process for the Low Voltage Directive

This overview references key websites relating to the Low Voltage Directive (2006/95/EC), an updated list of standards for the Low Voltage Directive, and instructions on how to certify for the Low Voltage 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 Low Voltage Directive.

PHASE 1: Does the Low Voltage 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. The Commission requires the manufacturer to determine the applicability of directives to any given product. The purpose of the Low Voltage Directive is to ensure the safety of people, domestic animals, and property by protecting them against hazards arising from electrical equipment and protecting them against hazards caused by external influences such as mechanical or chemical dangers or risks to health caused by noise, vibrations, or ergonomic factors.

All electrical equipment designed for use with a voltage rating between 50 and 1000 volts for alternating current or between 75 and 1500 volts for direct current are covered by the Low Voltage Directive. Voltage ratings refer to the voltage of the electrical input or output, not to voltages which may appear inside the equipment.

Generally speaking, products that must comply with the Low Voltage Directive are electrical consumer products or capital goods that are designed to operate within those voltage limits. Examples are: electrical appliances and hand-held electrically driven tools; lighting equipment including ballasts; switch gear and control gear; electric wiring; appliance couplers and cord sets; electrical installation equipment; and cable management systems.

The Low Voltage Directive does not apply to battery-operated equipment that is outside the voltage rating. However, the Low Voltage Directive does apply to accompanying battery-chargers and equipment with integrated power supply units within the voltage ranges. The directive also covers battery-operated equipment with supply voltage rating under 50 volts AC and 75 volts DC, with accompanying power supply units (e.g. Notebooks).

Additionally, the Low Voltage Directive applies to products for which the European Commission has mandated a Low Voltage Harmonized Standard. For the list of Low Voltage Harmonized Standards, please consult the website http://www.newapproach.org and click on “Directives and Standards.” Then click on the box entitled “References Harmonized Standards” in the column marked Low Voltage Equipment.

Annex II of the Directive lists the following equipment as being outside the scope of the Directive:

Electrical equipment for use in a potentially explosive atmosphere;

Electrical equipment for radiology and medical purposes;

Electrical parts for goods and passenger lifts (elevators);

Electricity meters;

Plugs and socket outlets for domestic use;

Electric fence controllers;

Radio-electric interference; and,

Specialized electrical equipment for use on ships, aircraft or railways which complies with the safety provisions drawn up by international bodies in which the Member States participate.

The products listed in Annex II above are excluded from the Low Voltage Directive because they are regulated under national laws, international agreements, or other New Approach Directives.

For information on whether components need to be certified for the Low Voltage Directive, please read the NIST booklet entitled, “A Guide to the EU Low Voltage Directive” found at http://ts.nist.gov/europe.

PHASE 2: CE Marking Requirements for the Low Voltage Directive

The essential requirements of the Low Voltage Directive are contained in Annex I of the Directive. The essential requirements describe the safety objectives of the directive in terms of general conditions, protection against hazards arising from electrical equipment, and protection against hazards that may be caused by external influences on the electrical equipment. Compliance with these requirements is mandatory. In some cases, components must also be CE-marked to comply with the requirements of the Low Voltage Directive. (For information on whether components need to be certified for the Low Voltage Directive, please read the NIST booklet entitled, “A Guide to the EU Low Voltage Directive” found at http://ts.nist.gov/europe.)

A manufacturer can self-certify to the requirements of the Low Voltage Directive by conforming to the European standards that apply to its product. The manufacturer must get a test result either in house or from a lab, which proves product conformance to the appropriate European harmonized low voltage standard(s). The list of these standards can be found on the European Commission’s website: http://www.newapproach.org by clicking on “View Standards” under the Low Voltage Directive. Compliance with the harmonized standards provides assurance to the manufacturer that the product complies with the essential requirements of this directive.

If a manufacturer chooses not to use European standards, the firm has to have its product tested and certified at a “competent body” lab, which is a European Union (EU)-affiliate lab associated with an EU notified body. Such labs are deemed competent to test and certify products to the requirements of the Low Voltage Directive. Notified bodies are entities designated by EU Member States to oversee the testing and certification process for CE marking directives. For a list of labs that can do the required testing for CE marking requirements for the Low Voltage Directive, see the Testing/Certifying Labs link on the sidebar of this page and throughout this website.

Whether the firm chooses the route of self-certification or third party testing and certification at an EU-affiliate lab, the company must compile a technical file showing the steps it took and the standards it used to meet the CE marking requirements in the directive.

For more information on CE marking and the Low Voltage Directive, please consult the guides published by the National Institute of Standards and Technology (NIST) entitled, “NIST SP 951– A Guide to EU Standards and Conformity Assessment” and “NIST GCR 813 – A Guide to the EU Low Voltage Directive” at http://ts.nist.gov/europe.

PHASE 3: Identify the European Standards for the Low Voltage Directive That Apply to Your Product

The Low Voltage Directive sets down rules for the use of standards for gaining the CE marking. Article 5 states that application of European “harmonized” standards (developed by a European standards-setting body, approved by Member States, and transformed into national law) will give the presumption of conformity for CE marking requirements for the Low Voltage Directive. If there are no harmonized standards for the manufacturer’s product, then Member State authorities should recognize international standards, such as those developed by the International Electrotechnical Commission (IEC). In the absence of harmonized European or international standards, Member State authorities should observe national standards in effect in the Member State of manufacture; or, from the U.S. exporter’s point of view, Member State authorities should recognize national standards used by a U.S. company in the Member State receiving that product.

Manufacturers are not required to use harmonized European standards, but if they do not, then they bear the burden of proof that they have met the requirements of the directive. Article 8 cautions the manufacturer: “In the event of a challenge, the manufacturer or importer may submit a report, drawn up by a body, which is notified....” In other words, in the event of a challenge, a manufacturer using standards that do not carry a presumption of conformity might be well advised to enlist the aid of a notified body or one of the United States branches.

If a company chooses to use the European harmonized standards, its technical staff should go through the list of standards (For the list of standards, go to http://www.newapproach.org and click on “Directives and Standards”) and identify the standards that apply to their product, and order those standards from a designated outlet, some of which are listed on the Consultants/Ordering Standards link on the sidebar of this page and throughout this website.

In general, the standards for the Low Voltage Directive can be divided into seven major categories: safety of households and similar electrical appliances; safety of machinery; safety of handheld electrical tools; safety of information technology equipment; safety of household electronic appliances; luminaires; and safety requirements for electrical equipment for measurement, control, and laboratory use.

The National Institute of Standards and Technology (NIST) has written excellent guides on several CE marking directives, including the Low Voltage Directive. These guides can be accessed at http://ts.nist.gov/europe.

PHASE 4: Conform to the Appropriate Standards

Once the company has ordered and received the appropriate European standards (possibly from the list under the Consultants/Ordering Standards link), its engineering or technical department can apply the standards to the design and production phase of its product. The standards contain all the detailed information, diagrams, and tests necessary to meet the requirements of the Low Voltage Directive. The directive is general in scope, stating that people, property, and animals must be protected from hazards arising from electrical equipment and from hazards caused by external influences such as mechanical dangers, chemical dangers, and risks to health caused by noise, vibrations, or ergonomic factors. The details and specifics of what is actually required to meet the requirements of the Directive are found in the European standards.

PHASE 5: Get a Lab Test to Prove Conformance to the Low Voltage Standards

Once a company has applied the standards for the Low Voltage Directive, it will need a lab result to prove that the standards have been met. For a list of labs that can do testing and certification for the Low Voltage 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 the Low Voltage Directive.

If you have used European standards, you can self-certify for the Low Voltage Directive. Indicate to the lab that you only need a test result verifying the European standards you have used. The lab charges more for assessing the product, applying the standards, and producing a test result than it will for producing only a test result showing conformance to European standards. As long as the manufacturer has conformed to European standards, it can get a test result from any lab that has the equipment to test to the standard. The manufacturer can go to an EU-affiliate lab or an independent lab. In fact, if the company has the equipment to test to European standards, it can do the testing in-house.

After a product has successfully passed the tests, the manufacturer needs to obtain a certificate from the lab showing the product has met standards for the Low Voltage Directive. This certificate will form the core of the company’s technical file (see PHASE 7).

If a manufacturer chooses not to use European standards, then it cannot self-certify. It will have to take its product to an EU-affiliate lab where they will do testing and certification for the CE marking requirements for the Low Voltage Directive. In this case, the lab will generally charge quite a bit more than if the manufacturer had applied European standards and used a lab (either EU-affiliate, independent, or in-house) just to produce a test result. When choosing a lab to test and certify a product on which non-European standards were applied, make sure the lab is connected to a notified body, since a notified body is the only organization that can issue a certificate for the CE marking.

PHASE 6: Set Up a Quality Control System

The manufacturer must set up a quality control system to ensure that the manufacturing process will ensure compliance of the manufactured products with the technical file and with the requirements of the directive that apply to the product. The quality control system can be designed by the manufacturer. It does not have to be ISO 9000, though ISO 9000 is widely recognized and could be advantageous for marketing purposes.

PHASE 7: Assemble a Technical File

The manufacturer is required to compile a technical file that must contain the following:

A general description of the electrical equipment;

Conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.;

Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment;

A list of the standards applied in full or in part, and descriptions of the solutions adopted to satisfy the safety aspects where standards have not been applied;

Results of design calculations made, examinations carried out, etc.; and,

Test reports (from the manufacturer or a third party).

The manufacturer or its authorized representative must keep a copy of the declaration of conformity (see PHASE 9) with the technical documentation. Also, the manufacturer must set up a quality control system to ensure that products manufactured in the future comply to CE marking requirements. The use of ISO 9000 is not legally required as a quality control system, though ISO 9000 does have high name recognition. A company can set up its own quality control system. See the Technical File Procedures link on the sidebar of this page and throughout this website for more information.

PHASE 8: Affix the CE Marking to Your Product

See the European Commission's, "Guide to the Implementation of Directives Based on New Approach and Global Approach" that contains a picture of the CE marking and a brief description of it. Click on 7, CE Marking and go to page 45 to see the picture. The CE marking must be indelibly affixed to a product. It does not have to be branded onto a product but it must be affixed so that it will not come off. The two letters (CE) must have the same vertical dimension, which may not be less than 5 millimeters in height. Once the manufacturer has met the requirements for the CE marking directives that apply to it, then the manufacturer makes up the CE marking and attaches it to each product. If your product is covered by more than one CE marking directive (such as by the Machine, Electromagnetic Compatibility, 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 the manufacturer’s product falls under.

PHASE 9: Create the Declaration of Conformity

The declaration of conformity is the document showing that the manufacturer, or his authorized representative, has met CE marking requirements for the product being placed on the EU market, in this case the Low Voltage Directive. The declaration of conformity must accompany each shipment to show EU customs authorities that the imported product meets CE marking requirements. The declaration of conformity then goes to the customer who keeps it on file in case EU authorities have questions about the compliance and origin of the product. A U.S. company official from the manufacturer, or the authorized representative, must sign the declaration of conformity to show that the firm is backing its claim of meeting CE marking requirements.

For a sample declaration of conformity, please see the Declaration of Conformity Example link on the sidebar on this page and throughout this website. There is no standard format for the declaration of conformity. However, the declaration of conformity must include the following pieces of information:

Name and address of the manufacturer or his authorized representative;

Description of the product (including model and serial number);

All relevant CE marking directives the product complies with;

Reference to the harmonized standards used, if appropriate;

Location where technical file is being kept;

Identification of the person empowered to sign on behalf of the manufacturer or his authorized representative. (And that person’s signature, indicating the company has taken responsibility for its claim of meeting CE marking requirements for the directives listed on the declaration of conformity.)

PHASE 10: Keep Posted on Updates of Standards Which Might Affect Your Product

The European Union issues new low voltage standards periodically. U.S. companies complying with the CE marking for the Low Voltage Directive should check the European Commission’s website at http://www.newapproach.org, once every 4-6 months to see if new standards have been issued that might apply to their product. These new standards usually have a lead time of a couple of years, giving companies time to conform to the new requirements, which are usually stricter than the standards they replaced. Once the new standard is implemented, the old standard no longer gives presumption of meeting CE marking requirements. A company that has not stayed current and fails to comply with a new standard is technically in violation of the CE marking requirements and could be prosecuted by EU authorities.

More Information is Available:

If you need more information on getting the CE marking for the Low Voltage 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 at the U.S. Mission to the EU, Brussels, Belgium.

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 marking at http://www.citra.duq.edu