Manufacturers exporting products to Europe should determine whether their products must be certified with a CE marking that indicates compliance with the European Union's health, safety and regulatory requirements.
The CE marking, “Conformité Européenne," is required for many products exported to Europe. The good news for exporters is that CE certification covers all of the European Economic Area (EEA), which includes 28 EU countries, as well as Iceland, Lichtenstein, and Norway.
“Often the CE marking is described as a trade passport because it enables the free movement of products within the European market," says Han Zuyderwijk, a CE marking expert and president of The Alura Group, based in The Netherlands.
For American exporters, products that meet U.S. testing and certification requirements still have to be separately certified for compliance with EU standards. It also is important to remember that the CE marking is an indicator, but not proof, of a product's compliance with European Union regulations. “If your product comes under the scope of a directive requiring CE marking, you must ensure the product complies with the applicable requirements, and affix the CE mark before placing it in the market in the EEA," says Zuyderwijk.
Does My Product Require Certification?
Determining whether CE marking is required for your products can be a complex undertaking. Products requiring certification range from electronics and hot-water boilers to medical devices and toys. Figuring out which products require certification requires knowledge and expertise about more than two dozen EU directives. For U.S. exporters, this means developing in-house expertise or working with a third party that understands and monitors CE marking requirements.
Under what is called the “New Approach directives," the EU has provided mandates to various European standards organizations to develop technical guidelines that meet the essential health and safety requirements of CE marking regulations. “For higher-risk products," adds Zuyderwijk, “the EU Commission still requires a third party to ensure that a product is safe to be put into service in the EU."
—Han Zuyderwijk, president, The Alura Group
Some products must conform with more than one directive. Electronic equipment, for example, might be covered under three separate directives. To expedite the process, the New Approach directives detail the compliance requirements for specific products to meet CE specifications.
While some directives mandate third-party certification, many of the CE marking requirements allow manufacturers to self-certify their products.
Technical details for products covered by the New Approach directives can found by consulting with one of three regional European standards organizations: CEN, CENELEC and ETSI. There are also government-appointed product certification labs, called “notified bodies," that provide testing and product approvals. Another good place for learning more about CE marking requirements is on the EU's website.
CE Marking Compliance
Products that require third party certification must be tested in a laboratory associated with an officially recognized notified body. Some testing labs in the United States are affiliated with European labs, and are qualified to do the testing and certifying in the U.S.
For products that conform to the CE marking directives, manufacturers can affix the “CE marking" to their products. All shipments of CE-certified products into the EEA must be accompanied by a declaration of conformity. In addition, the seller must maintain a technical file that proves it meets the certification requirements.
The European system differs from the U.S., where certification is done by a third party and the government acts as an enforcer. In the EEA, says Zuyderwijk, the manufacturer and distributor of a product are responsible for that product within the European market for 10 years after the last unit is sold. “The EU," he adds, “does not rely on pre-market control. Rather, it uses a system of ongoing market surveillance."
Market surveillance is done at the national level because there is no central enforcement authority in the EU. That means U.S. exporters are responsible for products they sell as CE-certified, and are subject to the national laws of each country within the EEA in the event of a problem. “This a big incentive to make sure your product is safe and compliant," says Zuyderwijk. “You are responsible for products placed in the market under your brand name."
U.S. exporters are also responsible for any components in their products that bear the CE marking. For example, Zuyderwijk says, power adapters sourced from China are an example of products that bear the CE marking, but sometimes do not comply with the certification requirements. “Just because it says it is CE-certified, don't assume the product is compliant," he says.
If a product is non-compliant, both the manufacturer and the distributor can be held liable for prosecution in the event of a problem. Moreover, non-compliant exports may be blocked or held at customs. If the product is already in the European market, national authorities can force the manufacturer to withdraw or recall the product, says Zuyderwijk.
While the certification process can be daunting, it is intended to protect buyers by requiring sellers to ensure the safety of their products. But investing in self-certification or third party certification also ensures compliance with EU regulations, and gives a U.S. exporter access to the entire European market. “If you prepare yourself and take the necessary steps to properly certify your products," Zuyderwijk says, “it's almost impossible to fail."
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