Han Zuyderwijk (we’ll give you a free Supplier Screening if you can properly pronounce his last name) is the founder of cemarking.net, the leading online resource for information on product certification. In this interview, Han explains what CE, RoHS and FCC really means – and why European and American importers should care!
Han, please tell us a bit about what you do and how you got started.
Hi, my name is Han Zuyderwijk. My last name is really a tongue-breaker, so everyone calls me just Han. Han is short for Johannes: in English you’d say “John”. I am Dutch. Yeah, a real cheese head…
I’m a lawyer by education. I graduated from the University of Leiden in the Netherlands. I started out as a CE consultant for a small consulting company. Later, I was asked to help the Eastern European countries that applied for membership of the European Union to prepare their systems of technical regulation and standardization to match the EU’s system.
After a few years I left the consulting company to start my own consulting business. I founded the website www.CEmarking.net, which has been one of the oldest and most trusted online sources of information about CE marking. The page has consistently ranked on the first page of Google, ever since we started.
Currently, I divide my time between running CEmarking.net and an EU funded project in Russia, which aims to bring the systems of technical regulation and standardization between Russia and the EU closer to each other, and to remove trade barriers. I have been working in Russia since the reform of the system started, and therefore I can say that I am one of the few experts in this field. My experience with working with small and medium sized companies helps me to explain the bureaucrats what we are doing it for.
Many of our readers are small businesses importing from China. To say that they are confused by the product certification regulations in Europe and America is an understatement. What is exactly is the difference between a CE certified product and a non-CE certified product?
Your question is a great question, because it allows me to explain one of the biggest misconceptions about CE: CE certification is not a correct term to describe the obligation to fulfill the CE rules. The term ‘certification’ implies that a person takes his/her product and goes to a third party in order to have the product certified against certain rules. In many cases, that is not what happens in CE. Approximately 90% of the products do not have to be certified by a third party at all.
There may be testing involved, but the manufacturer can subcontract these tests to qualified labs, or, if the required test equipment is available, do it him/herself. It is important to note that in CE, the manufacturer always bears the responsibility* for the compliance of a product, even when a third party is involved in the conformity assessment. In other words, there is no other person or body to hide behind.
By affixing the CE mark to a product, the manufacturer indicates that the product complies with the applicable CE requirements, AND that he can prove this through technical documentation. Not all types of product require CE. Food, for example. If a product is covered by the 25 or so CE marking directives or regulations, they must comply with the CE requirements and they must bear the CE mark when placed on the market in the European Economic Area. However, when a product is not covered by those directives or regulations, it is not allowed to bear the CE marking.
*This is only valid for EU based manufacturers and doesn’t apply to foreign (Non-EU) manufacturers. The importer is always responsible for ensuring CE mark compliance when importing products from countries outside of the European Union, including China.
Not all products are required to be compliant with the CE directive. Can you give us a few examples of products that are required to be compliant with CE?
Sure! Medical devices, toys, machinery, electrical equipment, electronic equipment, pressure equipment, personal protective equipment, and construction products are a few. But there are more.
Certain products are quite hard to fit into one of the product categories you mentioned above. Let’s say I want to import one of those products that doesn’t really “fit in”. Is there any general “rule of thumb” that can help me determine whether a product must be in compliance with CE or any other certification standard?
No, not a general rule of thumb. In the end you really need to check the different directives and regulations. Everything with moving parts and a propulsion, everything which contains electronics or active components, everything with the purpose of treating or alleviating a disease, and everything that is intended to be used by children in play, all these things are likely to be covered by CE requirements.
Apart from CE, there are more product certification requirements that must be taken into consideration such as RoHS. What is the difference between CE and RoHS?
CE is the general name for a methodology of regulating products*, and RoHS is just a regulation for one particular product aspect. RoHS is about the prevention of the use of certain heavy metals in electronics. RoHS originally was not considered to be within the set of CE documents, but the last couple of years it is.
*There are several sub directives included in the CE directive, such as EN71 and Low Voltage Directive. Starting in january 2013, RoHS is also included in the CE directive.
CE is a European standard. What standards are in general required in the United States?
UL is quite important. It applies to all kinds of electrical material and also some mechanical equipment. FCC is similar to EMC in the EU. FDA covers medical devices and pharmaceuticals. In the US, the system of regulating the market is very different from the system in the EU. I dare to state that the European system is more flexible, and it adapts faster to new technologies.
Some importers are unaware of these regulations and even more assumes that product certification compliance is the foreign suppliers issue. However, the importer is legally responsible to ensure compliance with product certification standards. What can happen to those businesses that import products that are in non-compliance with the market regulations?
You are quite correct. It is impossible for the inspection authorities in the EU member states to enforce compliance on non-EU based manufacturers. That is why, the same responsibilities are also put on the importers. That means that in case the manufacturer does not fulfill its CE responsibilities, the importer is responsible and can be prosecuted if he places the non-compliant products on the market. Even when he is not aware that the products do not comply!
Importers should realize this, because it leads perhaps to unwanted liability. Also, a lot of products, particularly from the Far East, do not comply with EU and US certification standards. It is not my personal opinion, but is statistically established that a significant higher percentage of products coming from the Far East are stopped at the borders for reasons of non-compliance or because of incidents in the market.
The penalties are defined in the legislation of the EU Member States, but authorities have a big range of measures, such as fines and prison sentences, to the (more effective) prohibition of sales, forced withdrawal and recall. I have witnessed a recall of a medical device from the market, and I can tell you that not many small companies have the resources to survive the costs, as well as the loss of reputation.
Do you think that the EU and US will become even stricter and enforce product certification compliance even more in the future?
For certain products, yes for sure. In the EU there is no policy to make things stricter just to show off. However, some product groups have proven to require stricter control, because manufacturers and importers are not following the rules enough. Also, in the EU societies there is a lot more attention for sustainability of products. We have seen a surge in “green” regulations, such as RoHS, WEEE, Ecodesign, energy efficiency labeling etc.
Apart from your own site www.CEmarking.net, which is a great resource on this topic, is there any other website you can recommend for finding information regarding product certification requirements?
I would say the website of the European Commission, because everything is there. However, it is a huge and complex site. It is not always easy to find the information you are looking for there. Actually, that is exactly the reason why we started our website. There are many nice websites from individual consulting companies, or certification bodies. Those can be really useful when you already know what directives and standards apply.