Directives

The concepts ‘directives’ and ‘standards’ appear in practice to cause quite some confusion. A directive is a ‘law’ that obliges the member states to incorporate it into their national legislation; thus, a directive must be complied with. A ‘standard’ does not have legal status, but a voluntary character. Certain (harmonised) European standards give the manufacturer the so-called ‘presumption of conformity’ with the stipulations of the directive. For more on this, see our information page ‘Standards’.

Given below are brief summary descriptions of frequently-encountered directives; only the texts of the directives themselves are legally valid.

Machinery Directive
The Machinery Directive has, since 1 January 1995, been applicable to machinery which was put on the market or taken into service after that date. The Machinery Directive makes fundamental requirements in respect of health, safety and the environment. In practice, this means that the following must be demonstrably present: a technical dossier, a user manual and risk analyses that have been carried out.

Machinery Directive 

Low Voltage Directive
The Low Voltage Directive has been applicable since 1973 to electrical equipment intended for a nominal alternating current (AC voltage) of between 50 V and 1,000 V, and a nominal direct current (DC voltage) of between 75 V and 1,500V. The directive was drawn up to ensure that design and construction (methods) offer the operator simple protection against: electrical charge or shock, excessive temperatures, fire hazard and radiation hazard. In practice, this means that the following must be demonstrably present: a technical dossier and risk analyses that have been carried out.

Low Voltage Directive

EMC Directive
The EMC Directive is applicable to equipment that can cause electromagnetic interference or the operation of which can be affected by such interference. In this directive, ‘equipment’ is to be understood as: all electronic appliances, as well as equipment and installations that contain electrical and/or electronic components. As a result of the broad definition, in principle all electrically-powered products come under the EMC Directive, thus industrial products too. This directive requires of electronic components that they have been demonstrably exhaustively tested (with certificates from competent authorities). The EMC Directive does not require a risk analysis of the complete installation; it is sufficient to have a Declaration per component (included by the supplier of that component) in the technical dossier.

EMC Directive

Work Equipment Directive
The Work Equipment Directive obliges the employer to make an inventory of the risks associated with the use of the work equipment that is available, or is put at the disposal of, his employees, and what measures are to be taken so that one can work safely with the work equipment. The Directive requires, furthermore, that this work equipment must be electrically safe, which can be tested by means of the standard NEN 3140.

Work Equipment Directive 

ATEX 95 Directive
The ATEX 95 Directive, also called “CE atex”, describes regulations for equipment (electrical and non-electrical) and protective systems in places (“zones”) where the danger of dust- or gas explosion can occur. Explosion-proof material that complies with the regulations of ATEX 95 must be marked with the “Epsilon x” logo in a regular hexagon. There is no requirement for a yellow background here. For that material, the supplier must provide a CE declaration of conformity.

ATEX 95 Directive

ATEX 137 Directive
The ATEX 137 Directive, also known as the “Occupational Health and Safety Atex”, describes minimum regulations for improving the protection of the health of employees who may be endangered by explosive atmospheres. All businesses where an explosive atmosphere can arise through the use of hazardous substances must comply with this directive. With effect from 1 July 2006, all businesses must fulfil the obligations deriving from this directive.

In the Working Conditions Decree, a paragraph on ‘explosive atmospheres’ has been applicable since July 2003; this is aimed at preventing gas and dust explosions. The Working Conditions Decree makes it mandatory to take a structured approach to explosion hazards.

ATEX 137 Directive

Pressure Equipment Directive
The Pressure Equipment Directive (97/23/EC) is applicable to the design, the construction and the conformity assessment of pressure equipment and assemblies for which the maximum allowable pressure PS amounts to more than 0.5 bar. By pressure is to be understood: the pressure as related to the atmospheric pressure; that is to say, the overpressure. A vacuum or negative pressure is therefore indicated by a negative value.
For the application of this directive, the following is to be understood by:

  • “pressure equipment” or “pressure devices”: pressure vessels, industrial piping, safety accessories and pressure accessories. In so far as is applicable, pressure equipment also includes elements that are attached to pressurised components, such as flanges, nozzles, couplings, lifting lugs, etc.
  • “assemblies”: various pieces of pressure equipment which a manufacturer has assembled to constitute an integrated and functional whole.
    In the directive, pressure equipment is classified according to increasing risk, in categories from I to IV. Determinative for this classification are the type, the material in the pressure equipment, the maximum allowable pressure (design pressure) and the volume or the diameter of the pressure equipment.

Pressure Equipment Directive

Medical Devices Directive
The Medical Devices Directive details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device. However, in most cases, the use of an EU Notified Body is required to assess compliance with the Directive before the CE mark can be applied to a device.

A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices can also include certain electronic radiation emitting devices with medical applications, including ultrasound devices and x-ray machines.

Medical Device Directive

Toy Safety Directive
This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age. (hereinafter referred to as toys).

Toys have to be safe for children to play with. Ensuring that toys marketed in the EU do not put children at risk is a priority. EU legislation aims to ensure that toys meet safety requirements that are amongst the strictest in the world, especially in relation to the use of chemicals in toys.

There are two possible conformity assessments allowing toys to be sold in the EU. The manufacturer has to demonstrate the compliance of a toy by: self-verification by using the European harmonised Standards third party verification through a notified body. All toys sold in the EU must carry a CE marking. This is the manufacturer’s declaration that the toy satisfies the essential safety requirements.

Toy Safety Directive 

Construction Products Regulation
Construction Products Regulation 305/2011 is a law states that all construction products which are sold within European Union must bear the CE marking. The CE marking indicates that the product was designed in accordance with the specifications in the corresponding harmonized European standards.

Construction products include a wide range of products, such as bricks, cement, timber, concrete, steel, as well as complex structure, such as facades. So, construction product means any product or kit which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works.

If your construction product fall into the scope of European harmonised Standards, next step will be to test the product and check its conformity, as well as Factory Production Control that includes quality control of procedures. After all required testing and controls the manufacturer should compile Technical Documentation and draw up Declaration of Performance (DoP). Based on those documents the CE marking can be affixed, and only after that the product can be sold within European Economic Area.

Construction Products

General Product Safety Directive
In fact, whilst safety usually does form part of the CE marking requirements, not all Directives and Regulations have safety requirements. Also, not all products can be CE marked! Only those that are covered by one of the current 25 CE Marking Directives or Regulations.

The General Product Safety Directive (GPSD) (2001/95/EC) sets out safety requirements for all consumer products being placed on the European market, but unlike other European Directives, the GPSD is not a CE marking Directive. The act of placing the product on the market is the only act required to illustrate that product has been assessed and found to comply with the general safety requirements.

The General Product Safety Directive sets out to ensure that all products placed on the market are safe. To comply the GPSD, a manufacturer shall undertake and document an assessment that covers the risks and risk categories associated with the product. The recommended method of undertaking such an assessment is through the application of voluntary European Harmonised Standards.

The Directive is purely self-assessment with no requirement to involve a third party. Manufacturers are not required to complete a Declaration or Certificate and they do not need to affix any conformity markings (other than the information identified to be supplied for the safe use of the product). Whilst you do not need to involve a third party, you can do so at your choice.

General Product Safety Directive

The most up-to-date directive statuses

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