No matter where you market your product, you'll probably need to meet some kind of established standard to verify that your product is safe for use. In the United States, that often means having your product certified by Underwriters Laboratories, while products sold in Canada are certified by the Canadian Standards Association. In most of Europe it's the CE certification, so if your goals include a presence in the European market, you'll need to learn about it.
A Quick CE Primer
The initials CE stand for “Conformité Européenne," which is French for "European Conformity." If you put it on your product, it means you're claiming to be in compliance with the applicable European standards. The CE mark is used throughout the member states of the European Union, as well as Iceland, Lichtenstein and Norway. Together, those countries make up what's called the European Economic Area or EEA. Switzerland and Turkey aren't formally part of the EEA but do recognize CE labeling for many products. That means European union certification opens the door for your product in over 30 different countries. It's not handled the same way as UL or CSA certification, though. There's no single government body awarding CE certification. It's up to you to research the standards your product has to meet and verify that you've done it.
There Are Separate Paths
Finding your way through the system isn't necessarily straightforward. To start with, not all products fall under the CE system. Cosmetics don't require CE certification, for example, and neither do foods or pharmaceuticals. That doesn't mean you won't need to go through some sort of legal process to sell your product in Europe – you likely will – but it's not the CE process. Your product might also be exempt from CE regulation if it fits certain categories. If you ship antiques to Europe they're exempt and so are any products that'll be refurbished in Europe or are turned around and resold outside of Europe. Bear in mind that if your product falls outside of CE requirements, or Europe's broader General Product Safety Directive, you'll still need to make sure you're in compliance with each individual country's own legislation. Finally, if you do need to comply with CE certification, not all products require third-party certification. Often, you can just research the appropriate standard yourself, compile documentation to verify that your product meets the standard and submit the paperwork for approval.
Getting the Process Started
The first step in getting your product CE certified is to find out which of the EU's CE directives apply to your product. If you make toys, for example, there are three that apply: 2009/48/EC, 88/378/EEC and 93/68/EEC. A lot of electronics products would have to comply with 2004/108/EC, which covers electromagnetic compatibility, and probably also 2006/95/EC, which covers low voltage products. Sometimes several directives apply. If you manufactured a smart electronic toy with Bluetooth features, for example, you'd have to look at all of those directives to make sure you're in compliance.
Figuring Out How to Comply
Those directives are kept deliberately broad because they have to apply to a wide range of different products. You could think of them as a set of best practices, laying out general principles about how your product should be designed and built. Unfortunately, that creates some potential for costly and time-consuming disagreements about whether a product or process meets the standards laid out in the directive, so the European Commission provides a more helpful and detailed set of harmonized standards for some products and product categories. If your product is covered by one of the harmonized standards, it's a lot easier to verify that you're doing things in what the EU will recognize as "the right way."
One key detail in the directives spells out whether you'll need to have your product tested and certified by a third-party lab or testing organization. You may know these as conformity assessment bodies or CABs, but the EU uses different terminology. There, they're called "notified bodies" or NBs. If your product does require third-party certification, that doesn't mean you'll need to go through the time and expense of shipping samples or prototypes to Europe for testing. The EU has agreements in place with the United States and other countries, so a U.S.-based CAB can certify your product for sale in the EEA. You can find an American CAB by consulting Europe's NANDO database, which lists certifying bodies from all of the EEA countries as well as all the countries covered by mutual recognition agreements.
Doing the Assessment
The various directives spell out what level of verification your product needs and how to go about it. There are eight different "modules" covering different products, with requirements ranging from documenting your own production processes to full ISO 9001 certification. Once you've identified the module that applies to your product, you'll need to read through its requirements and create a plan for how you're going to incorporate those into your production process. Your existing methods might already meet with European standards or you might have to make significant changes. In either case, you'll need to document what you've done at every step of the way. You're obligated to keep that technical documentation for a full 10 years after a product goes out of production.
Declaring Your Product's Conformity
The final step in the compliance process is creating a Declaration of Conformity for every product you want to sell in Europe. This isn't the thick sheaf of technical documentation you've created along the way. You'll keep that as proof of what you've done, the same way you used to show your work in math class back in grade school. The actual declaration itself is usually just a simple one-page document that sets out the basic facts. It tells European officials who you are and what product the declaration covers. It explains which directives applied to your product and what standards you've used, where the test results are recorded and who the responsible person is at your company should there be any questions.
Marking Your Product
When you've met all the requirements for CE certification, you're legally entitled – and required – to add the CE mark to your product. Ordinarily, the CE mark should be permanent and easily seen. If your product has a plate or decal on the bottom with its part number, serial number and UL certification, for example, you might opt to put the CE logo there as well. If one or more notifying body has verified the product, their identification number has to appear on the label as well. In some specific cases, you might need to put the CE mark on your product's packaging or user documentation instead of the product itself. Sometimes it might just be impossible to mark a specific product or you can't do it without incurring excessive costs or facing significant technical challenges. In some cases, the size and shape of the product might mean you can't meet the EEA's requirements for the size and legibility of the CE logo.
The CE Symbol
The CE symbol itself has to be used in very specific ways. First, it has to be indelible so it can't be erased or altered without the alteration being obvious. Molding or stamping it right into the body of your product is one way to do that, or if it's printed it has to be resistant to smearing when it encounters water and other substances. The CE logo should be a minimum of 5 millimeters high, or about one-fifth of an inch. You'll also have to use the CE logo exactly as it's specified by European authorities, with the stylized C and E formed from half-circles. You can download high-resolution copies of the actual logo from the European Union's website in multiple formats so you don't have to reproduce it yourself from scratch.
- Your Europe: CE Marking
- CE Marking.net: Do Your Products Need CE Marking?
- National Institute of Standards and Technology: Compliance FAQs - CE Marking
- Canadian Trade Commissioner Service: Six Steps to CE Marking
- European Agency for Safety and Health at Work: Directive 2001/95 EC - Product Safety
- European Commission: Notified Bodies NANDO
- European Commission: CE Marking