NIST SP 951
A Guide to EU Standards and Conformity Assessment
Technically speaking, the use of a Harmonized Standard is voluntary. That is, a manufacturer can elect to use a Harmonized Standard (like the ones above), or elect to use a non-Harmonized Standard (an American Standard, for example) to meet essential requirements. When using a Harmonized Standard, however, the manufacturer is presumed in conformity with the law. On the contrary, using a standard that is not a Harmonized Standard will impose additional responsibilities. The use of anything but a Harmonized Standard places a burden of proof upon the manufacturer that the product meets essential requirements. This proof may be provided by the manufacturer's Technical File, by the employment of a third party (consultant, testing house, etc.), or by a combination of the two. (The directive will prescribe conformity assessment procedures that are commensurate with the risk of injury associated with the product.)
Harmonized Standards and the Presumption of Conformity
Presumption of conformity is a legal concept surrounding Harmonized Standards that denotes the relationship between the legislative and standardization processes. The European Commission (the lawmaking body) and the European Standards Bodies collaborate to produce Harmonized Standards. They enter into a contractual relationship, with the Commission providing financial support when needed. The contract (or mandate) stipulates that the standards body will produce a standard that will provide a technical solution, or a technical interpretation, of an essential health and safety requirement. When the standard is completed and the conditions of the Commission's mandate are met, the Commission publishes the notice of its completion in the Official Journal of the European Communities. Once the notice is published, the standard takes on the presumption of conformity mantle. A manufacturer, therefore, using a Harmonized Standard in the design and/or production of the product, is presumed to be in conformity with the essential requirements of the law.
The Role of Standards in the Marketplace
There is a vast body of European Standards (ENs) that is not mandated by the Commission; and these standards are not necessarily directed toward essential requirements. In theory, their use is voluntary, just as the use of harmonized standards is voluntary. These standards may or may not address health or safety aspects of products. They may define other characteristics, such as durability, appearance, quality levels, or even cultural preferences. They may be test methods, or measurement guides.
The use of a European standard in the European marketplace, however, has definite advantages. Chief among them is recognition. A standard that does not emanate from one of the European Standards Bodies is not always recognized by insurers, lending institutions, retailers, developers, conformity assessment bodies, and consumers, and may hinder acceptance of the product in the marketplace, particularly when a European Standard already exists for the same product.
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