Last reviewed 27 January 2016
Gordon Tranter outlines the position of EU harmonised legislation, its relevance to the product user and the changes that have taken and will take place.
The “New Approach” to technical harmonisation and standards was a key part of the development of the European Single Market, in that it removed technical barriers to trade. In 2006, however, the European Commission concluded that this EU process of creating harmonised product standards was not as effective as it should be. It therefore introduced the “New Legislative Framework” (NLF)” in 2008. The NLF is a package of measures that aim to improve market surveillance, clarify the use of CE marking and establish a common legal framework for industrial products.
The New Approach framework
The New Approach was based on legislative harmonisation by the adoption of specified directives that set essential health, safety and environmental requirements. These “Essential Requirements” are mandatory for products put on the market in order to enjoy free movement throughout the territory of the EU.
The technical specifications needed for the production and placing on the market of products conforming to the Essential Requirements are established by but not set out in the directives. Instead, three European Standards Organisations — CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute) — produce Harmonised Standards, which must take into account the current stage of technology. Once a reference to a new standard has been published by the European Commission as a Decision in the Official Journal of the European Union, it becomes a Harmonised Standard. Harmonised Standards are then transposed into identical national standards by the National Standards Bodies in Member States, whereupon they enable manufacturers and service providers to demonstrate that products, services, or processes comply with the relevant Essential Requirements.
These Harmonised Standards are not mandatory: they have the status of voluntary standards. However, products manufactured in conformity with Harmonised Standards are presumed to conform to the Essential Requirements established by the New Approach Directives. Some product Directives directives specify that an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for “CE” marking.
If a producer does not manufacture its product in conformity with the relevant Harmonised Standards, it must prove that the product conforms to the Essential Requirements. This provides manufacturers with a significant degree of flexibility and allows them to choose and adapt their product to meet the Essential Requirements.
Before a product can be placed on the market, its manufacturer, which has gone through this mandatory conformity assessment process, must:
label the product with the CE mark
provide a Declaration of Conformity, a document issued by the manufacturer stating that the item is compliant with all applicable EU product directives
provide user instructions for the country in which it will be used.
Health and safety legislation
End-users are not defined in the EU harmonisation legislation and are not subject to its obligations. However, Directive 2009/104/EC concerning the minimum safety and health requirements for the use of work equipment by workers at work requires that work equipment complies with the provisions of any relevant Community directive. This has been implemented in the UK by the Provision and Use of Work Equipment Regulations 1998 (PUWER).
PUWER requires employers to ensure that an item of work equipment has been designed and constructed in compliance with any Essential Requirements set out in any of the directives listed in Schedule schedule 1 to PUWER. The schedule lists 20 directives including those that deal with machinery, personal protective equipment, electrical equipment, gas appliances, equipment and protective systems intended for use in potentially explosive atmospheres, electromagnetic compatibility, construction products, and simple pressure vessels.
PUWER therefore requires that new work equipment for use at work in the UK must be “CE” marked, come with a Declaration of Conformity and be provided with instructions in English.
The CE mark
The CE mark is not a quality mark, such as the British Standards Institution’s Kite Mark. It is a manufacturer's declaration that the product complies with the essential requirements of relevant European product safety law. In practice, the presence of “CE” marking is not necessarily a guarantee that the product meets all of the requirements of EU product safety law. This is particularly so for products imported from outside the EU. There is a very similar CE logo where the CE stands for Chinese Export or China Export, which has nothing to do with European conformity.
Employers should ensure that any new products are given reasonable checks for obvious defects. In addition they should ensure that user instructions have been supplied and that these are in English. Not only should work equipment comply with any of the relevant EC Directives but it should also comply with current health and safety legislation. In addition, the user should not rely on the CE marking alone; a risk assessment of its suitability for the intended use is still needed.
It should be remembered that CE marking covers only the specific categories of apparatus and equipment covered by the product safety directives. On the other hand, PUWER must be applied to all apparatus, equipment and installations used in the workplace. Consequently, there are certain categories of equipment (eg hand-powered machines) within the scope of PUWER that do not require CE marking.
The Personal Protective Equipment at Work Regulations 1992 require employers to ensure that any personal protective equipment (PPE) for use at work covered by PPEWR bears CE marking and complies with the Personal Protective Equipment Regulations 2002 (PPER). The latter concern the design or manufacture of PPE with regard to health and safety and implements the Personal Protective Equipment Directive 89/686/EEC in the UK.
The Control of Substances Hazardous to Health Regulations 2002 (COSHH) also require that personal protective equipment provided by an employer in accordance with COSHH complies with all provisions in the PPER.
The New Legislative Framework
The NLF was adopted in July 2008 and entered into force 1 January 2010.
reinforces the application and enforcement of internal market legislation
improves market surveillance rules
sets clear and transparent rules for the accreditation of conformity assessment bodies
includes stronger and clearer rules on the requirements for the notification of conformity assessment bodies
clarifies the meaning of CE marking and enhances its credibility
establishes a common legal framework for industrial products in the form of a toolbox of measures for use in future legislation.
The package of measures consists of:
Regulation (EC) No. 765/2008 on accreditation and market surveillance
Decision 768/2008/EC on establishing a common framework for the marketing of products
Regulation (EC) No. 764/2008 to strengthen the internal market for a wide range of other products not subject to EU harmonisation.
Establishing a common framework for the marketing of products
A main objective of the NLF is to bring make product harmonisation legislation consistent. Decision 768/2008/EC, the provisions of which are being incorporated into existing Directives when they are revised, is now the template for product harmonisation legislation.
In February 2014, an “Alignment Package” that aligned nine directives with the NLF was adopted. The new directives are:
Low Voltage Directive, 2014/35/EU
Electromagnetic Compatibility Directive, 2014/30/EU
ATEX Directive, 2014/34/EU
Lifts Directive, 2014/33/EU
Simple Pressure Vessels Directive, 2014/29/EU
Measuring Instruments Directive, 2014/32/EU
Non-automatic Weighing Instruments Directive, 2014/31/EU
Civil Explosives Directive, 2014/28/EU
Pressure Equipment Directive, 2014/68/EU.
These recast Directives must be transposed by Member States into their national law by April 2016. The Department for Business, Innovation and Skills has already consulted on their implementation in the UK, except for the Civil Explosives Directive on which the Health and Safety Executive carried out the corresponding consultation.
Legislation aligned with the NLF has also been adopted in the areas of toy safety (2009/48/EU), restriction of hazardous substances in electrical and electronic equipment (2011/65/EU), pyrotechnic articles (Directive 2013/29/EU), recreational craft (2013/53/EU), radio equipment (2014/53/EU), and marine equipment (2014/90/EU). Further aligning proposals are pending on medical devices, gas appliances, cableways, and PPE.
Realignment of the Personal Protective Equipment Directive
A proposal for the realignment of the Personal Protective Equipment (PPE) Directive 89/686/EEC has been issued. It will be reissued as a regulation and consequently will not have to be transposed into each Member State’s national law. It is intended that the regulation will come into force in 2016 with a transitional period leading to full enforcement of the regulation at the end of 2018. Among the changes in the regulation will be new definitions of PPE categories, reclassification of some type of equipment, and updated conformity assessment procedures.
Although European harmonised product safety legislation applies directly to manufacturers, importers and suppliers and not directly to end users, it is of significance to the end user. Purchasers need to be aware of the requirements under PUWER, PPEWR and COSHH to ensure work equipment and PPE is CE marked. It must be emphasised that CE marking should not be the only assessment of the suitability of the product. It should be examined for defects and its suitability for the task included in the risk assessment.