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Standardization and the Law

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On December 22, 1917—100 years ago today—the German Institute for Standardization (Deutsches Institut für Normung, DIN) was founded. DIN develops the content of standards and coordinates the work of other bodies involved in the process. It is organized as a private non-profit organization and has entered into an agreement with the German government to be recognized as the sole German national standardization body. As such, DIN represents Germany in non-governmental international standards organizations and participates in the development of standards at a European and international level.

European Union (EU) legislation defines a standard as “a document that prescribes requirements to be fulfilled by a product, process, service, or system” (technical specification). This might sound very abstract, but we are actually surrounded by standards on a daily basis. One example of a widely-used standard in the United States is the letter paper size. The letter size is used as the standard paper size in North America, including the U.S., Canada, and parts of Mexico, and measures 8.5 x 11 inches. The equivalent standard default paper size used in most other countries is the A4 paper size which measures 210 × 297 mm (8.27 × 11.69 inches). A4 paper size sheets—a German invention—proved so popular that they were made an international standard by the International Organization for Standardization (ISO) in 1975—the ISO 216 standard.

But we encounter standards in many other circumstances. Here in the U.S. a lot of consumer products like children’s toys or clothing must be accompanied by a declaration of conformity that signifies that the products comply with the relevant standards for safety and environmental soundness, and are fit for purpose. Compliance is often also indicated by displaying a certification mark on the product itself. Children’s toys, for example, must generally be tested by a third party and comply with the federal toy safety standard that addresses various possible hazards related to their construction (sharp edges, exposed parts), materials used, electrical requirements, or presence of heavy metals such as lead.

Other areas for which standards are developed in Germany and internationally are energy generation, storage, and efficiency; logisticselectromobilitydrones; and smart cities, to name of few.

Are Standards Binding?

Standards are generally voluntary to use and are developed as needed by the market. They are developed in an open and transparent process and adopted by consensus to ensure wide acceptance. However, standards may become legally binding if they are included or referenced in contracts or legislation. Manufacturers in the EU, for example, can use “harmonized standards” and display a CE marking to indicate that their products, processes, services, or systems comply with EU legislation.

Bureau of Standards. Standardization of card colors: Kenneth Kelley judging colors of dyes. Harris & Ewing, photographer. 1936. Library of Congress Prints and Photographs Division.

European Standardization Policy

With regard to EU legislation, it is necessary to define the terms “European standards” and “harmonized standards.” European standards are those standards that are adopted by one of the three European standardization organizations (ESOs). Those three ESOs are the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI). They have been officially recognized by the EU as being responsible for developing and defining voluntary standards at the European level.

Harmonized standards are European standards that are adopted by an ESO upon a request made by the EU Commission for the application of EU harmonization legislation. The references of harmonized standards are published in the Official Journal of the EU (O.J.). A harmonized standard must be incorporated into national law by the EU Member States. Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential or other legal requirements. However, a manufacturer remains free to choose another technical solution to demonstrate compliance with the mandatory legal requirements.

By affixing the CE marking to a product, a manufacturer declares that the product is in conformity with the essential requirements set out in the applicable EU legislation. The CE marking is not awarded by the EU and does not indicate the origin of a product; the manufacturer or importer is responsible for carrying out the conformity assessment and affixing the CE marking. In some cases, EU legislation requires an independent third party (notified body) to conduct the conformity assessment and verify compliance. Also, not all EU legislation requires the affixing of the CE marking, which can be confusing for a consumer.

As the world becomes more and more globalized, standardization is a way to promote international trade and assess the quality of products and services. In fact, the World Trade Organization (WTO) encourages adopting international standards and conformity assessment systems to improve efficiency of production and facilitate the conduct of international trade in its Agreement on Technical Barriers to Trade.

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