Every country's technical culture and technical practice is reflected in its standards and legal provisions and these vary greatly from country to country.
Consequently, each European country has its own complex body of legislation - consisting of laws, regulations, technical rules drawn up by private standardization committees and inspection and licensing procedures. These requirements often form an obstacle to free trade.
· General Scheme
· List of Directives
· Modules
In order to achieve the free circulation of goods, EU authorities developed a new approach to technical legislation, its mechanism and procedures.
Legislation takes place through directives issued under Article 100b of the EEC treaty. All EU states are bound to turn the objectives of directives issued by the EU into national law. Consequently, the EU member states' laws aim for the same goal.
The purpose of the directives is to set binding requirements in the health and safety field and other requirements for the common good. These are labeled "essential requirements".The main concern behind the new legislative approach is to ensure that:
1. Only products which are safe in respect to health, the environment and consumer protection will be allowed to circulate.
2. Any product marketed legally in one country of the EU can also be sold in all the other countries.
The manufacturer demonstrates that the product conforms fully to the requirements of the Community directive through the CE marking on the product. If the directive permits, the CE marking can also be shown on the packaging or on accompanying documentation. CE-marking is not a test-mark: it shows that the manufacturer declares his product to comply with all relevant directives.
Various modules are in place for demonstrating conformity to the essential requirements, which may require the intervention of several agents such as the producer, the importer and the distributor. In addition, demonstrating conformity may require the service of independent bodies such as third-party inspection, testing and certification bodies which should be officially authorized or "notified" under the supervision of a recognized accreditation bodies.
Since non-compliance of a product with the applicable directives presents several risks we recommend third-party inspection.
For further details please contact your LT office.
EU directives provide essential health and safety requirements and establish procedures for assessing product compliance. Detailed specifications for fulfilling the essential requirements of each directive are provided through harmonized European standards prepared by regional standardization bodies.
Consequently, producers, importers and distributors of affected products are required to demonstrate product compliance with health and safety requirements as laid down in the "essential requirements" established in each directive.
The directives that form the base of the "New Approach", cover either broad categories of products (horizontal directives) or only specific categories of products (vertical directives).
Machinery |
98/37/EC |
Electromagnetic Compatibility |
89/336/EEC |
Low Voltage |
73/23/EEC, 93/68/EEC |
Medical Devices |
93/42/EEC |
Medical Devices Active Implantable |
90/385/EEC |
Medical Devices Invitro Diagnostic |
98/79/EC |
R & TTE |
99/5/EEC |
Pressure Equipment |
97/23/EC |
Simple Pressure Equipment |
87/404/EEC |
Toy Safety |
88/378/EEC, 93/68/EEC |
Personal Protective Equipment |
89/686/EEC, 96/58/EC |
Packaging and Packaging Waste |
94/62/EEC | |