European Product Directives

(Sometimes referred to as EU, EC, EEC or CE Directives.)

Contrary to popular belief, the principal goal of European Product Directives is not to improve levels of safety in European products. Indeed, many nations claim that the levels of safety imposed by such directives are inferior to their previous national requirements. The directives are born from the need to facilitate a single market between the EU member states.

Prior to the implementation of such directives, many or all EU member states will have had their own regime for regulating the products in question. Each regime was based upon a national perception of related safety hazards and has evolved in isolation from the other nations. This effectively created a barrier to trade - a product acceptable to some EU member states was not acceptable to another.

The European Product Directives are intended to create a single legal structure, within which products can be sold on the EU market - without having to submit to a multitude of national assessment and approval regimes in member states.

A product that is proven to comply with the appropriate directives in one EU member state must be accepted in all member states.  A product must display the now-familiar CE marking (shown above) once this has been achieved.

As these directives are intended to overcome trade barriers, a directive has achieved its purpose once a product has been traded. Products falling within the scope of such a directive must comply at the first point of being put on the market or being put into service. Thereafter, the directive carries no bearing on the operation and maintenance of the product. Other types of European health & safety legislation or national regulations may, depending on the product, regulate these issues downstream of the point of sale.

New & Global Approach Directives
Current European Product Directives are written by the Commission incorporating two templates, known as the New Approach and the Global Approach. These lay down the way that standards are used to support the requirements of the directive, the methods used to assess conformity and where third-party certification is required.

New Approach - Harmonised Standards
Traditional legislation tended to include precise technical details and equations within the text of the legislative document. While this made assessment against the legislation easy, it has one big drawback: unforeseen developments. A new material or novel product, which was not foreseen at the time of writing the legislation, might not fit the technical requirements. If it could not comply it would be illegal, even if perfectly safe. In order to legalise the new product, the legislation would need to be updated.

The Commission's current workload of new legislation is such that amending existing directives is low priority and can take a decade. During this time there would be a danger of non-EU competitors stealing a lead in technological development. To avoid this situation, the New Approach Directives now only list essential requirements in general terms. The precise technical details of conformity are left to the manufacturer to justify. The manufacturer is not without help. For each New Approach Directive, CEN, the European Standards Organisation, is mandated to draw-up a new range of standards to provide supporting technical detail. On completion, these standards must be adopted by each member state and any conflicting national standards of their own must be removed. In doing so, the standards become harmonised across the EU.

These harmonised standards provide the manufacturer with one solution for consideration. They are the easiest solution as, in becoming harmonised, as they have already been agreed as meeting the requirements of the directive. The standards, therefore, carry a presumption of conformity: an authority may question whether the standard has been properly applied; they cannot question the suitability of the standard itself.

A manufacturer is not obliged to apply a harmonised standard. If a solution, alternative to harmonised standards is used, the manufacturer must demonstrate equivalent safety. This is difficult to do and can always be questioned by an authority. CEproof's services provide an effective solution to this problem.

Global Approach
The global approach lays down standard routes for conformity assessment. Each 'route' is called a module. There are 8 standard modules (see below) but these can be slightly altered in some directives. The European Pressure Equipment Directive (PED) is a significant example where there are many alterations to the modules. Other directives such as Machinery and Simple Pressure Vessels do not properly or explicitly define modules, although their prescribed conformity assessment procedures align closely to them.

Module Description
A  Internal Production Control
B  EC Type Examination
C  Conformity to Type
D  Production Quality Assurance
E  Quality Assurance for Final Testing
F  Product Verification
G  Unit Verification
H  Full Quality Assurance

Modules A, G & H are applied individually and module B, which covers only the design process, is applied in conjunction with one of modules C, D, E or F, which relate to the production phase.

A third party, known as a Notified Body, must verify conformity when a manufacturer applies all modules except A and C. It is clear then that these modules are only permitted for low risk products. Higher risk products are required to submit to outside verification of design (B) and/or quality audits (D, E & H) or inspection of samples of production (F) or inspection of every unit of production (G).  Each directive has its own system for categorising risk and assigning modules.

Further details of certain directives are given on this website but CEproof is able to help on a very wide range of European directives. Please contact CEproof for further details.