For manufacturers outside the EU the responsibility for demonstrating compliance with EU Directives and Regulations rests with the first person placing the product on the market, or taking it into service. For non-EU manufacturers this may be the importer, distributor or the user. Alternatively, the manufacturer may appoint an authorised representative to perform this function. Doing so has the advantage that a person who understands all the requirements for EU compliance becomes responsible for making sure that the equipment is fully compliant.
A CE marking is a specific mark, usually of a minimum of 5mm high that must be fixed to a product, literature or to its packaging, prior to its sale in the European Union. There are special provisions for CE marking products that are small, or to which it is not possible to affix the mark. If the services of a Notified Body have been used then other marks are also added.
Declaration of Incorporation
Under the Machinery Safety Directive, where the machine is only partially completed, e.g. if the machine forms part of a larger assembly and the manufacturer is not supplying the complete assembly, it may not be possible to claim compliance with the directive for the machine as some safety features, such as guards or lights may not have been installed. In this case it is the responsibility of the machine assembler, or integrator, to ensure the final assembly is safe. The manufacturer of the partially completed machine only issues a Declaration of Incorporation and does not affix the CE marking for this directive. If another directive, such as the EMC directive, is also complied with then compliance with this directive is indicated by affixing the CE marking onto the partially completed machine. Thus there could be a Declaration of Incorporation in compliance with the Machinery Safety Directive and a Declaration of Conformity in compliance with the EMC directive.
Declarations of Conformity
The preparation and issuing of these is a prerequisite for any product that requires CE marking for sale and use within the European Union. This procedure confirms that the manufacturer believes that the manufactured product meets the Essential Requirements of all applicable Directives.
DoCs must be kept on file for issue in the EU. Manufacturers may also provide copies with each product or shipment, and for machines a DoC or Declaration of Incorporation (for machines intended to be incorporated with other machines) is required for each machine.
In general terms, an EC or EU Type-Examination is a process by which a notified body must ensure that a product is compliant with the relevant legislation. For example, the Machinery Directive states that: an ‘EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery …. satisfies the provisions of this Directive.’. A technical file, in a form specified within the Machinery Directive, must be drawn up in order for the EC type-examination to take place.
It must be recognised that although the laws and regulations established by the European Commission are applicable to the EU they also apply to the other countries in Europe that previously formed the European Free Trade Area (EFTA). These are Iceland, Norway and Liechtenstein. These countries and the EU member states now form the European Economic Area (EEA). Switzerland is not a member of the EEA and therefore does not participate in these rules.
Everywhere on our website where we refer to the European Union it includes the additional three countries that, together with the EU, make up the EEA.
European Union Directives and Regulations
The establishment of the Single European Act in 1986 followed by the Single European Market required the preparation of a wide range of directives and regulations for product performance. This was to ensure that there was a common approach across the whole of the EU to product safety and environmental performance. Prior to this, directives had been prepared for the specific performance of different products, but with the advent of the Single Market there was a requirement for a simpler “New Approach” to ensuring product compliance.
The European Union operates on a treaty basis. It has no legal standing as an entity in its own right and cannot make laws. However, the provisions of the treaties establishing the EU are such that all directives and regulations must be transposed by the member states into their own legal system. This requirement is achieved in different ways by implementing national laws, decrees or regulations themselves in accordance with the legal requirements of each member state. Each member state appoints an authority within its own legal jurisdiction. These organisations are referred to as the national “competent authority” for the implementation of a directive.
Please see the Directives and Regulations page for further details about achieving compliance with the major EU Directives and Regulations which apply to manufacturing. If you have any further questions, do not hesitate to contact us.
For the majority of products that require CE marking a ‘harmonised’ standard may exist. The use of the standards is the simplest and lowest risk route to compliance. There are several levels of standards that exist and their use appears below in order of preference:
- A European harmonised standard (EN) published in the Official Journal of the European Union (OJEU)
- An IEC standard that has been published where an EN standard does not exist
- A national European Union standard where neither of the above exists
- A Code of Practice where all of the above do not exist
Note however that there are significant differences between US and European standards and US standards which are not listed in the OJEU cannot be used.
Depending on the type of product you wish to sell, there may be no harmonised standard, in which case there are several methods to ensure compliance. Please contact us for further details.
Within the scope of the Machinery Safety Directive, for products that are considered to offer a higher level of risk to the user the approach to demonstrating compliance may involve the services of a third party body that has been appointed specifically to examine the product design and performance or possibly the manufacturer’s quality assurance system. These bodies are appointed by the EU Member State’s government and their appointment is notified to the EU Commission, hence they are referred to as Notified Bodies. The EU has also established a number of Mutual Recognition Agreements (MRA) where the requirements for product certification can be met by EU Notified Bodies established in third countries. These perform the same functions as Notified Bodies in the EU Member States and other EEA countries.
Within the scope of the Low Voltage Directive, no high risk products are identified and therefore there are no requirements for third party examination by Notified Bodies. Notified bodies have been appointed for the LVD but their role is only to examine products on behalf of national authorities and prepare safety reports for LVD competent authorities or organisations responsible for the monitor of compliance of products with the requirements of the LVD.
Under the terms of the Cosmetics Regulations, the Responsible Person is either the EU importer or a ‘person’ designated by the importer. If the latter, the importer must designate the Responsible Person in writing. A distributor can be the Responsible Person, if he or she places the product on the market under his/her name or he or she modifies the product in such a way that the regulatory requirements may be affected.
Self Declaration Approach
The EU’s general approach has been to prepare a range of directives and regulations that are applicable to specific types of products. In particular the directives require that products that are deemed to comply with the directives must meet a set of essential requirements. These are generally referred to as the Essential Health and Safety Requirements (EHSR). How compliance with these is demonstrated is dependent on the type of product and in particular the attendant risk to the user. To simplify the compliance demonstration process the vast majority of products are designed to meet the applicable EHSRs and then are declared as such by the manufacturer or the person selling the product in the EU. This process is often referred to as the self declaration approach. Compliance with the EHSRs of a directive may be determined by assessing the performance of the equipment against the requirements of all appropriate harmonised standards. A list of harmonised standards for each directive is published in the Official Journal of the European Communities.