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EU Directives and Standards

What are European Directives?

A European Directive, as it pertains to product safety, is not an engineering standard, code of construction or technical specification. A European Directive is a legislative Directive (Law) applicable to all European Member States. It outlines the Essential Safety Requirements (ESR’s = Minimum Requirements) related to a product within the scope of the individual Directives. In other words, European Community (EC) directives define the “essential requirements”, e.g., protection of health and safety, that products must meet when they are placed on the market.

It is possible that multiple European Directives apply to one product, especially if mechanical and electrical features are applied to it. For example, a Fuel Cell or a Boiler falls within the scope of several European Directives due to the mechanical concerns related to fluids, temperature, pressure, etc., as well as electrical/electronic control and safety systems. Hence the Pressure Equipment Directive (PED; 97/23/EC), Low Voltage Directive (LVD; 73/23/EEC), Directive for Potentially Explosive Atmospheres (94/9/EC) may apply as part of the conformity requirements.

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What are European Standards

The term “European Standards” is often used in reference to Harmonized European Norms. Harmonized norms are developed to enable compliance with the essential requirements of specific European Directives. It is a rather complex list, which is constantly being updated, and cannot be considered complete.

Harmonized standards” are European standards, adopted by CEN, CENELEC or ETSI, following a mandate issued by the European Commission after consultation with Member States. They are developed through an open and transparent process, built on consensus between all interested parties.

Compliance with harmonized standards, of which the reference numbers have been published in the Official Journal and which have been transposed into national standards, provides presumption of conformity to the corresponding essential requirements of a specific EC directives. Compliance with harmonized standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. In a number of cases compliance with harmonized standards also increases the options for conformity assessment procedures.

For instance, as related to pressure equipment, many companies question whether the ASME code meets the requirements of the PED (Pressure Equipment Directive 97/23/EC). Although, the ASME Code of Construction does not meet all provisions of the PED, in many cases, it is possible to compliment the ASME Code with requirements and testing procedures as stipulated in harmonized European Norms. Hence, the ASME code is applied as a basis for design, complimented by additional essential requirements per directive and European standards / requirements.

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Non-European Standards vs. European Standards

At ECE we refer to the process of complimenting non-European codes (e.g. ASME PV&B Code) with European harmonized standards as “Building Bridges between Continents.” This approach enables companies, whenever possible, to continue business activities on the basis of their existing practices. The strategy can also help avoid quality deficiencies and failures to achieve the desired approval.

The European member states expend a great deal of consideration towards the development of European Codes and Requirements with respect to the commissioning and operation of equipment within the EU community. The goal is a uniform understanding of safety levels relative to workers’ protection, environmental safety, and safety of animals. We emphasize that discussions related to safety, and therefore the suitability of a given code, standard or procedure, may be sufficient only if the technical aspects are considered.

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European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR)

The European Agreement concerning the International Carriage of Dangerous Goods by Road, or ADR, governs transnational transport of hazardous materials. The most recent revision in effect as of January 1, 2009. (http://www.unece.org/trans/danger/publi/adr/adr2009/English/Foreword.pdf)

The agreement itself is brief and simple, and its most important article is Article 2. This article states that with the exception of certain exceptionally dangerous materials, hazardous materials may, in general, be transported internationally in wheeled vehicles, provided that two sets of conditions be met:
– Annex A regulates the merchandise involved, notably their packaging and labels.
– Annex B regulates the construction, equipment and use of vehicles for the transport of hazardous materials.

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