General Overview of EU Directives
The European Union (EU), formerly known as the European Community (EC), is replacing individual national regulations of member countries with a series of Directives. These Directives are legislative instruments that oblige member states to introduce them into their existing laws. Once compliance with all applicable Directives has been verified for a product, that product can be legally placed on the market of any EU member country.
The EU is comprised of 27 full member states: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands, and the United Kingdom.
In addition, the European Economic Area (EEA) has been formally recognized since January 1994. The EEA is comprised of the EU countries and Iceland, Liechtenstein and Norway. These member countries have adopted EU legislation in all but a few areas. Compliance with the applicable Directives will allow a product to have free market access in the 30-country internal market of the EEA.
In the future, this market is expected to expand based on enlargement discussions underway. Under this enlargement process, Croatia, Iceland and Turkey (known as candidate countries) have accession negotiations underway. The former Yugoslav Republic of Macedonia is also a candidate country, but without accession negotiations underway. Potential candidate countries include Albania, Bosnia and Herzegovina, Montenegro and Serbia including Kosovo.
How Directives Work
Directives harmonize a variety of existing practices, preserve the different legal traditions and settle constraints for further developments. Directives are published in the Official Journal (OJ) of the European Economic Community (EEC). Each Directive is characterized by its title, its date of adoption and its date of publication in the Official Journal.
Within the text of each Directive is the date on which the Directive becomes effective -- the date when compliance with the Directive is mandatory. In addition, Directives also identify an implementation date. This date identifies when use of the Directive can begin.
During the time period from the implementation date to the effective date, the manufacturer is normally allowed the option of meeting either the Directive or the national requirements that existed prior to implementation of the Directive. This time period is known as the transition period.
Old and New Approach Directives
In 1985, after the advent of the Global Approach, the EC established a uniform marking system known as the CE Marking system. CE requirements are specified in the "New Approach" Directives. Directives written prior to the Global Approach, which did not take the CE Marking into account, are known as "Old Approach" Directives.
The CE Marking is applied to products that comply with all applicable Directives, one or more of which must be a "New Approach" Directive. If more than one relevant "New Approach" Directive is in its transition period, application of the CE Marking implies compliance with only those Directives that the manufacturer has chosen to apply.
Application of the CE Marking verifies compliance with both design and production quality requirements. This is different from the requirements of the "Old Approach" Directives, which only dealt with design requirements.
For hazardous locations equipment, the original version of the Potentially Explosive Atmospheres Directive (76/11/EEC, along with 79/196/EEC and all of its amendments) -- under which certification is no longer available -- was an example of an "Old Approach" Directive. The revised Potentially Explosive Atmospheres Directive or ATEX Directive (94/9/EC) -- now mandatory for all such certifications -- is an example of a "New Approach" Directive.
Essential Requirements and European Norm (EN) Standards
Each Directive provides a set of essential requirements that relate to product safety and call for a minimum level of protection against injury to persons or damage to property. However, they do not identify specific design criteria.
Because essential requirements are general in nature, the European Union is continually developing harmonized standards known as European Norm (EN) standards. These EN standards are issued by the European Committee for Standardization (CEN) or jointly by CEN and the European Committee for Electrotechnical Standardization (CENELEC). Each EN standard defines criteria for meeting essential requirements.
