Manufacturing compliance

As the European Union (EU) expands and becomes an ever more attractive export destination, new players have to keep compliance top of mind. The CE mark indicates that a product complies with all the requirements set out in the EU’s New Approach Directives, and without it, exporting certain products to Europe simply isn’t possible. Make sure your products make the grade

By Julie Demers

On May 1, 2004, 10 new countries joined the European Union (EU), creating the world’s single biggest trading block — 500 million customers and a lot of opportunities for business. Small and medium-sized companies that want to capitalize on this have to make sure they take care of the details, and that includes compliance issues.

In 1985, the European Commission adopted the New Approach to Technical Harmonisation and Standardisation. The New Approach made compliance with certain essential requirements mandatory, along with the use of a visual symbol, the CE mark, indicating that the product meets safety requirements. The CE mark therefore signifies European compliance. The marking system was devised by the European Commission to promote the free movement of goods among member states of the EU.

The idea was not, as in the past, to set out highly detailed technical specifications, but rather to establish general or essential requirements, for health and safety, the environment and consumer protection. The European Commission also specifies terms of use for the CE mark in its various directives. Non-EU manufacturers must have the CE marking for their products to sell them in European countries.

Not all products are subject to this policy, only those included in the 20 or so families of products listed in the New Approach directives. The CE marking can’t be affixed to products that aren’t covered by these directives. Items subject to the New Approach directives essentially consist of all manufactured products.

To meet these requirements, manufacturers use harmonized standards that are updated on a regular basis. “The Directives set out the essential requirements, while the standards establish the methods for meeting the requirements,” notes Jean Thibodeau, engineer and manager of industrial information and technology at Quebec’s Centre de recherche industrielle (CRIQ). According to Thibodeau, tracking down and identifying harmonized standards applicable to a particular product can lead to problems with CE marking. “It’s a painstaking process,” he says.

A product could be covered by several New Approach directives, because there may well be various types of risks associated with the product. For example, a network-powered machine with electronic controls will be covered by the Machines Directive for its mechanical hazards, by the Electromagnetic Compatibility Directive for the risk of electromagnetic disturbances it may generate or may be affected by, and the Low-Voltage Directive for its electrical hazards.

CE marking, Thibodeau notes, isn’t necessarily synonymous with quality. First and foremost, it represents a safety indicator for users. It also means that there is complete traceability.

“The manufacturer is required to have in its possession references to all the components used to make the product, all the warranties, the documents associated with subcontracting, mechanical drawings, and so forth,” specifies Thibodeau. Theoretically, he says, Europeans want product designers to have CE marking requirements in mind from the very outset.

CE marking is intended primarily for national authorities that monitor product safety (customs, government competition, consumer and fraud prevention branches). These authorities are empowered to request the declaration of compliance and technical documentation if ever they wish to check the validity of the marking. If a product is generally subject to a directive and is distributed in Europe without the CE marking or if the CE mark is affixed to the product before the appropriate measures have been taken, the manufacturer could be subject to administrative or even criminal sanctions.

For manufacturers considering exporting a product subject to the Directives, the process may appear extremely daunting, especially compared to the comparable U.S. process. “But it is not any more complicated,” says Thibodeau, “just more comprehensive.” The requirements are similar to those in place in Canada and the U.S., but the material the manufacturer has to supply is far more exhaustive.

In the U.S., the term “certification” means that testing is performed by a third party. Canadian manufacturers have to pay annual fees to use the CSA logo (with a small “C” for Canada and a small “US” for the United States). The presence of this symbol on a product means that a testing laboratory accredited by the Canadian Standards Association (CSA) evaluates a sample product each year, in addition to carrying out a multitude of tests according to an established procedure.

The CSA thereby determines that the product meets relevant national standards, whereas in the case of CE marking, the manufacturer in most cases is required to oversee the various steps that lead to affixing this symbol of compliance.

The evaluation of compliance is generally a two-phased process carried out during the design and manufacture of the product, and involves several major steps. The first step is to check the directives to verify whether the manufactured or exported product is subject to the CE marking process.

The second step is to comply with the requirements laid out in the directives, especially any safety-related requirements. The directives make reference to harmonized European standards and, if no such standards exist, to national standards.

The third step entails assessing the conformity of the product with the essential requirements. This system differs from Canada’s in that it’s largely done under the auspices of the manufacturer and testing laboratories or certification bodies. There are specific modules that determine what assessments need to be made by either the manufacturer or a “notified body.”

Notified bodies are organizations designated by European states to assess the conformity of products to essential requirements. They are independent organizations with technical and organizational expertise that are nominated by the European states to the European Commission.

When the conformity assessment procedure demonstrates that a product fulfills the requirements of the applicable directives, the manufacturer affixes the CE mark to the product. Only when conformity to the safety directives has been confirmed, the manufacturer can then affix visual proof of conformity, or the CE mark, to the product, the fourth step in the process.

The fifth step is for the manufacturer to attest to this conformity by drawing up a Declaration of Conformity and technical documentation for the product. The manufacturer or its authorized representative in any country within the European Economic Area (EEA) is responsible for drafting this declaration, even if a third party was used for the conformity assessment.

The declaration must be written in one of the official languages of the EEA. However, it’s generally recommended that it be drafted in the language of the target country for obvious commercial reasons and to facilitate the relationship with administrative departments responsible for carrying out controls. The manufacturer is generally also required to draw up technical documentation on the product. This includes administrative information on the company as well as other information with which to check product compliance (descriptions of products and manufacturing processes, plans, and so forth).

The higher the risk associated with a product, the greater the number of requirements will apply under harmonized standards. It all depends on the product. It can take from a few weeks to 18 months to obtain CE marking, and the cost can vary from $1,000 to $25,000. Thibodeau believes it’s vital to start thinking about CE marking early in the design phase, even for small companies. Thinking ahead will not only reduce costs but ease the entire process for the manufacturer. And once a product has the CE marking, it can move freely on the European market without any further formality, national safety standard or new test being imposed. 

Julie Demers (jdemers2000@hotmail.com) is associate French editor of CMA Management magazine.

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