A good business move isn’t necessarily easy, especially when the move is overseas. CE marking, which is legally required to sell equipment in the European Union’s 27 member states, Norway, Liechtenstein and Iceland, fits that description. “CE” is an acronym for the French words “Conformite Europeenne” and signifies that a product meets European health and safety requirements. The challenge is identifying and meeting the directives (laws) that apply to your product.
“There is no easy way for U.S. exporters to understand and go through the process of CE marking,” describes the U.S. Department of Commerce.
But it’s often a requirement.
There is no comprehensive list of products that require CE marking, yet it’s a manufacturer’s responsibility to determine if a product requires the marking. Before a manufacturer can affix the CE marking to a product, it must go through a conformity assessment process. The European Commission’s “New Approach Directives” (for sectors such as machinery, electrical products and medical devices) contain the legal requirements to which a product must conform. Export.gov describes that to determine if a product needs CE marking, a manufacturer must look at each directive that is related to the product. Some products require conformance to more than one directive. For example, the Safety of Machinery directive, the Electromagnetic Compatibility directive, and the Low Voltage Equipment directive may apply to one product.
Some directives allow manufacturers to assess their own products and self-certify. That’s the case with all three directives in the preceding example. GSE like pushback tractors and stairs can be self-certified, says Peter Holmgren, a former electronic engineer who’s now in charge of the GSE certifications done by SMP in Sweden. Without deep knowledge of the directives and how they should be interpreted, manufacturers have a tough job, he says. “The directives don’t tell you how the requirements should be fulfilled,” he says. “For that, you need the standards.”
Han Zuyderwijk, whose company (Alura Group in The Netherlands) helps develop CE certification self-help systems, says it’s important to understand the relationship between the directives and the harmonized European standards (EN standards), which are not obligatory. However, he says by complying with the relevant EN standards, products are presumed to comply with the applicable directives. “Because the EN standards provide far more detailed design specifications than the directives, they are much easier to apply and they are a great help in self-certification,” he says, adding that they also change as technology advances.
Directives for “high-risk products” require assessment from independent certification bodies, known as “notified bodies” within the European Economic Area. For example, machines that lift people more than 3 meters above ground require examination by a notified body unless the machines are built according to EN standards, which Holmgren says is rare. In this example, if a manufacturer deviates from the standards, self-certification is not allowed. A notified body can accept deviations as long as the product is safe or safer than if it were built according to the standard, he says, adding that using a notified body can benefit marketing.
After a manufacturer has passed a conformity assessment, the CE marking must be affixed to the product, a “declaration of conformity” signed by a manufacturer official must be included with each shipment, and the exporter must maintain a “technical file” containing the paperwork that proves conformity to the CE marking directives.
A product with the CE marking, sometimes called a “trade passport,” can travel freely throughout the EU, which the U.S. Department of Commerce describes as one of the most hospitable climates for U.S. investment.
Recently, two GSE manufacturers took the steps necessary to put the CE marking on their products and are glad they did.
Breaking the ice in Europe
Looking to export equipment worldwide, Ground Support Specialist (GSS) LLC chief manager Rudy Yates sought the CE marking as an option package for the company’s international aircraft deicers, and in early March, GSS’s first truck shipped to Europe. The process began at the end of the summer in 2008.
For consultation and product assessment, GSS contracted SMP — The Swedish Machinery Testing Institute, which was founded as a government agency and is today a share holding company owned by the Swedish government. SMP was recommended by JBT AeroTech, which markets and sells GSS trucks outside the United States.
“If you are not familiar with the regulations,” Holmgren says, “it’s easy to miss something or needlessly spend money on an expensive solution because a standard is misunderstood.”
The CE marking test methods usually differ from those required in the United States. For example, GSS had to do noise and vibration tests that they otherwise would not have had to do.
Despite the extra testing and product documentation, Yates believes any company that takes the extra steps to put the CE marking on its products is better off.
“The process was rewarding because it allowed us to look at our equipment in a different light,” he says.
To grow his business, Yates hopes to add the CE marking to other ground support and industrial equipment at a later date.
A mark of customer confidence
For AERO Specialties Inc., the decision to put the CE marking on its products was customer-driven.
“We received quote requests asking if our equipment had the CE marking,” says Bob McMichael, AERO Specialties vice president of sales and marketing.
Requests from throughout Europe, especially from Romania, combined with what looked like a growing European business aviation market prompted AERO Specialties to follow the necessary requirements to put the CE marking on everything it manufactures. Tow bars and heads from AERO Specialties all have an engraved CE mark (and there’s no extra charge assessed). CE versions of lavatory and potable water carts as well as oxygen and nitrogen carts involve different build processes and come with an additional CE fee. For example, all carts include a battery and a charger, but chargers work on different voltage systems in different countries.
AERO Specialties hired TÜV SÜD America, a testing, inspection and certification organization, owned by TÜV SÜD in Germany, to determine the applicable directives for each product line and test against them to make certain the products measured up to the safety standards.
“There are thousands of directives,” McMichael says. “They were too confusing to try to figure out on our own.”
Most of the issues TÜV SÜD pointed out were safety-oriented and, as a result, were incorporated into all AERO Specialties carts, McMichael says. In general, he says some standards were stricter, but some — like the color of a ground wire — were just different.
AERO Specialties worked with TÜV SÜD on lavatory and potable water carts for about five months in 2006. Subsequent lines took less time because AERO Specialties knew what to expect, he says. The company makes dozens of different products and had representative products from each product line tested and then extended CE compliance across the product family line.
Many of the requirements were about labeling. Operation manuals and their content also were specified.
Making the required changes has been worthwhile, McMichael says, because the CE marking provides a big marketing benefit and has allowed AERO Specialties to attend the European Business Aviation Trade Show. Even outside the European market, he says, the CE marking has a positive effect because it demonstrates a product has been through rather strenuous and strict safety testing.
“It gives people a level of confidence in your product,” he says.
Complying with the law
There can be costly consequences if a product on the market is found to be noncompliant. European national agencies, such as customs authorities and the departments of health, industry and labor conduct market surveillance for CE marking. Penalties for noncompliance include fines and imprisonment and are determined by national law.
“It’s important to make sure that all applicable requirements are fulfilled before a machine is placed on the market,” Holmgren says. “If a machine is involved in an accident, investigators always check if the CE marking is applied and if it’s correct.”
If a workplace safety inspector even suspects that the CE marking is missing or that regulations have not been fulfilled, he can stop a machine from being used, he says. EC authorities are then contacted and use of the machine is banned in all EU countries until the manufacturer has made all the machines safe or can prove that the regulations have been fulfilled.
Asking experts for help
“It is important for U.S. manufacturers to understand all requirements and standards applicable to their product for CE marking,” says Karen Grantham, an account executive for TUV SUD America’s Eastern Region. “In addition, they must prepare the proper documentation to support compliance to the applicable requirements. That is why it is advantageous to find a partner, who is knowledgeable, capable and authorized to assist in meeting the regulations.”
The fee for a third party will depend on the complexity of the product and how much testing is required, she says.
The time spent on product inspection and re-inspection also depends on how well a manufacturer has prepared documentation, test reports and how many deviations from the standards there are, Holmgren adds.
The help of a consultant can be expensive. Zuyderwijk takes a unique approach to CE marking with self-certification services. His Web site, www.cemarking.net, which has been up and running for 10 years now, provides a wealth of information for free. Zuyderwijk says one of the biggest CE certification myths is that the CE marking requires third-party certification. In almost 90 percent of the cases, he says that’s not true and self-certification can save a lot of time and money. His e-mail course and newsletter are free, but he also offers products for sale including an eBook and an online guidance system. And he, too, does consulting, conformity assessment and testing services.
The U.S. Department of Commerce provides CE marking information as well. Bob Straetz, Office of the European Union, can be reached at 202-482-4496.
Keeping up with changes
“Manufacturers must realize that CE marking is not a one-time exercise but a commitment to continuous product improvement,” Zuyderwijk says. “They should keep themselves informed of amendments and new developments.”
In this regard, he reports one recent change for GSE manufacturers, “The European Commission decided to withdraw the presumption of conformity for Clause 5.6 of the standard EN 12312-9:2005 ‘Aircraft ground support equipment – specific requirements container/pallet loaders.’” The standard is likely to be amended soon, he says because a container loader in full compliance with the clause caused an accident that revealed the weakness of the provision.
At the end of this year, Holmgren says a new machinery directive (2006/42/EC) will result in changes for safety requirements and paperwork.
“All manufacturers with CE-marked machines, not only Annex 4 machines with an EC-type certificate, must make sure that the new requirements are fulfilled, and the certificates must be renewed,” he says.
The EU Web site, www.newapproach.org, which lists the CE marking directives and their standards, is a good place to keep updated on changes.
Making your CE marking
Zuyderwijk reminds that in the past, standards changes, product requirements and test procedures in Europe were set by individual EU member states. Companies that wanted to sell products on the European market sometimes had to deal with more than 10 different technical requirements or procedures just for one product. All the different products requirements brought many costs for the producers. With the help of the New Approach Directives, manufacturers no longer need to adapt their products to the specific requirements of different member states. (Although Holmgren points out users manuals must be translated to the local language.)
In addition, Zuyderwijk says by implementing the requirements, CE marking a product will be safer for the consumer, and damage and liability claims may also be reduced.
The CE marking process may seem difficult, especially if you haven’t gone through the process before. However, help is available to get you through it and once you have the CE marking on your product, you’ll have a mark of meeting European health and safety standards, which often becomes a mark of consumer confidence and a marketing advantage.