The European Union
The European Union (EU) has roots that go back to the post-World War II era, when the European Coal and Steel Community was formed in 1951.
Many changes occured between then and now, but the EU as most people know it became a reality in the early 1990’s. Freedom of trade between the member states was critical for the success of the union as a whole. One of the main barriers to trade was the presence of different technical standards and different mandatory product certifications in each country.
THE CE MARK
To correct this problem, the idea of a unified CE mark was born. Standing for “Conformité Européen”, the CE mark must be present on products that are placed on the market in any EU member state or any European Economic Community (EEC) country. The CE mark is not a safety or certification mark as understood in North America. The CE mark is generally a self-declaratory mark, meaning that manufacturers and distributors are the ones who decide if the product meets the requirements and then place the mark on the product.
There are some notable exceptions to this rule, including machinery falling under Annex IV of the Machinery Directive (2006/42/EC from 31-Dec-09 onward), pressure vessels falling under the Simple Pressure Vessels Directive (2014/29/EU) and pressure vessels and equipment falling under the Pressure Equipment Directive (2014/68/EU). These directives require the involvement of a European Notified Body as part of the conformity assessment program.
All EU member states and EEC countries are required to accept the CE mark. While EU law allows member states to create laws and regulations that go beyond the EU Directives, they are also strongly discouraged from making laws that will create new technical barriers to trade. For machine builders and distributors, this means one mark for 25+ countries!
The European Union is sub-divided into General Directorates (DG) with specific responsibilities. The EU parliament in Brussels publishes Directives which are similar to government “Acts” in the North American system.
Machinery and related products fall under DG Industry. There are specific directives for a wide variety of subjects. These directives use “harmonized standards”, denoted by the prefix “EN”, as the basis for conformity assessment under each directive. Where the involvement of a Notified Body is required, you have a wide selection of organizations to choose from. Lists of NB’s under each directive are also available from the Directive web site.
When it comes to industrial machinery, there are a few key directives that typically apply:
- 2006/42/EC Machinery (MCD)
- 2014/35/EU Low Voltage (LVD)
- 2014/30/EU Electromagnetic Compatibility (EMC)
- 2014/34/EU Equipment explosive atmospheres (ATEX)
- 2014/68/EU Pressure Equipment (PED)
- 2014/29/EU Simple Pressure Vessels (SPV)
There are potentially hundreds of standards that can apply, and it is the responsibility of the manufacturer or the importer of record to ensure that ALL of the applicable directives and standards have been applied to the product. A list of the current harmonized standards under each directive can be found by visiting the Harmonized Standards List of Directives and Subjects page. This page provides access to the text of the directives, as well as to lists of standards harmonized under each directive.
EU law also allows that non-harmonized standards can be used to declare conformity to the Essential Requirements of each directive, however they provide a presumption of conformity when EN standards are used, making life very much simpler from the conformity assessment perspective.
Manufacturers are required to develop and maintain a Technical File for each product. The file must be maintained for 10 years following the last date of manufacture of the product, and must be available in Europe through an organization located within the EU. This could be a branch office, a distributor, a Notified Body or a lawyer.
Technical Files are confidential and need not be supplied to customers.
DECLARATIONS OF CONFORMITY
Every product must be accompanied by a Declaration of Conformity. This legal document should follow a common format and must include the manufacturer’s name, trademark and contact information, along with a list of the directives and standards used in the assessment of the product and information on any Notified Body(ies) involved in the conformity assessment of the product. Each Directive will lay out the requirements for marking and for the content of the Declaration in the Annexes to the Directive.
If you need to understand Declarations more deeply, read this article on our blog.