Fredrik Gronkvist explains what CE marking is, which products are covered, how to make your products compliant and how much it costs
This post is by Fredrik Gronkvist, the co-founder of Chinaimportal.com, in Hong Kong. They provide free online courses for importers who want to learn more about manufacturing in Asia, product regulations and shipping.
What is CE marking? What kind of products need CE marking? And who is actually responsible for making sure the product gets CE marked?
These are questions I see in my inbox on a daily basis.
CE marking is misunderstood, but not necessarily as complicated as you might think.
In this article, I will explain what every importer and online seller must know about CE marking, what it takes to make a product compliant and how much it’ll cost you.
What is CE marking?
CE is a compliance mark, that signals to the consumer that the product is compliant with all applicable safety standards and directives.
Some of these directives regulate electrical safety, while others regulate radio communication standards, toy safety or eye protection in sunglass lenses. I wrote about the regulations in detail in Complying with EU Product and Labeling Regulations: A Complete Guide.
The CE mark itself is not a standard or directive, but only a signal that the product is safe for the consumer to use. This is also why the CE mark is found on everything from bicycles and power banks, to watches and toys.
They may be regulated by completely different standards, yet they all have the same compliance mark.
But, a product isn’t magically compliant simply because it carries the CE mark.
In addition to the printed CE mark itself, the following requirements must be met:
The product must be technically compliant. For example, a power supply must be designed according to strict safety criteria, and toys must not contain lead or other regulated substances. If the product is not made to comply with these rules, it doesn’t matter how many CE marks it has, as the CE mark itself cannot make the product compliant.
The importer must issue a set of documents for each product, this includes:
- Declaration of Conformity
- Design drawings
- PCB design (for electronics)
- Bill of materials
- Risk assessment
- List of applicable EN standards / directives
- Packaging layout file
- Test reports
Third party lab testing is not mandatory for most products. Yet, it’s the only way to be sure that the product is compliant.
As an importer, you should get the product lab tested before the goods are shipped.
Should the products fail lab testing, you can’t make them compliant. Instead, the supplier must remake the entire order.
Which products must be CE marked?
The CE mark is, for example, applicable to the following product categories:
- Quartz watches
- Protection equipment (such as safety helmets and gloves)
- Medical devices
A product that is not covered by a specific CE marking directive doesn’t need to be CE marked.
Why do I need to make sure that my products are CE marked?
When importing from countries outside the EU, such as China, it’s always the importer’s responsibility to ensure that the products are fully compliant with all applicable EU regulations.
If you import non-compliant products, customs (or other authorities) have the right to seize and destroy your products – without compensating you.
Here are a few scenarios that could occur if you don’t follow the CE marking process properly:
- Customs have the right to fine importers that cannot provide a technical file. This means you need to have your documents in order, even if it’s only a matter of providing documents you created yourself.
- Consumer product safety authorities have the right to collect and test product samples. They can issue a recall if the product fails testing. We have seen this recently with hoverboards and other risky products. To avoid this happening, make sure you always get your products lab tested.
- Customs can seize any product without a CE mark, that should carry one.
In short, you need to make sure that you cover all requirements from technical compliance, to documentation and labeling.
Will my suppliers make sure that the product is compliant?
Many importers want to take shortcuts, and that’s when things go wrong.
No, you cannot use your suppliers “CE certificate”. It doesn’t work like that, because there is no such thing as a “CE certificate”. Yet, many importers take their supplier’s advice, and act like these regulations don’t exist.
The truth is that many non-EU suppliers don’t know what CE marking really is (beyond printing a logo at least).
In addition, many suppliers cannot even make compliant products. Hence, you must do background checks to find out if they have experience making products that comply with all of the relevant CE marking directives for your product.
How do I make sure my product is compliant?
In order to make a product compliant, you must fulfill these requirements:
- Make sure the product is technically compliant. This requires two steps:
- Confirm which EU directives apply to the product, and learn the specifics in each one. Which substances are banned? How should the product be designed to comply?
- Submit a sample for third party compliance testing. It’s the only way to be sure.
- Issue the documentation
- Create the label files
The last two parts are actually really simple!
How much does it cost to make your products “CE compliant”?
The CE mark itself doesn’t have to cost anything. Go on Google.com, search for CE marking and send the file to your supplier. Done.
The documentation can be more tricky. You can buy templates online for less than $100 but you’ll have to fill them in yourself.
If you want a consultant to issue all the documents for you, the cost is normally between $5000 and $8000.
Finally, there’s lab testing.
Lab testing is, as I said earlier, not mandatory for most products. Yet, it is the only way you can be sure that your product is compliant.
A lab test can cost anything from $300 to $4000, depending on:
- The number of products your testing
- The number of applicable regulations (often more than one)
- The complexity of the testing process (for example, electrical safety checks tend to cost more than a chemical analysis)
So, all in all, CE marking can cost you less than a Ryanair flight, or more than your entire business is worth! It all comes down to how much of the process you manage on your own.
Why does the EU have to make everything so terribly complicated?
I know what many of you think. Why does the EU have to overregulate everything?
Before you draw a conclusion, I want you to consider the following:
1. Clearly defined regulations save you money in the long run
In the United States, product regulations are not as well defined as in the EU. Instead, it’s up to you as an importer to assess what steps you should take to ensure that your product is safe.
As a small business, this means that you must pay thousands of dollars to consultants and lawyers. At least. Because, if something goes wrong, you will be sued for millions. It doesn’t matter that there aren’t any national electrical safety standards.
At least the EU sets clear, and relatively easy to follow, guidelines. This is also why EU regulations are being adopted by Singapore, Korea, India and so many other countries around the world.
2. Safety standards are put in place for a reason
Non-compliant electronics can be bought from various Asian wholesale websites. Hence, many of could explode, and even kill people. Power banks and other products are not safe by default, but must be designed and assembled in the right way.
3. Product safety is here to stay
International trade is here to stay. Product regulations, and the authorities themselves, are working hard to catch up with the modern reality of manufacturing and trade.
CE marking was not designed for the crowdfunding, Alibaba and Amazon era. Yet, don’t think for a second that the authorities will just accept that, and allow our markets to become flooded with toxic toys and exploding phone chargers.
However, it’s not HMRC or the German Customs Authority that is taking the lead. It’s Amazon.
They are becoming ruthless in their drive to ensure that only safe, and compliant, products are sold on the platform. Unscrupulous traders are increasingly finding themselves permanently suspended, and their products kept as far away from Amazon as possible.
This post was by Fredrik Gronkvist the co-founder of Chinaimportal.com, in Hong Kong. They provide free online courses for importers that want to learn more about manufacturing in Asia, product regulations and shipping. Visit Chinaimportal.com to find out more.