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CE conformity - importing electrical products into EU
Post 1 of 11
This Topic responds to Mark's topic but is too lengthy to post there.  
 
Mark, because of the 1998 Agreement between EU and Australia as to cross-conformity, CE is something that passes my desk nearly every day for the container loads of electrical equipment my company imports for Australian shops. We use CE conformity certificates, or more precisely, the underlying CE technical lab docs to fast track C-Tick approval for our products in Australia. We also export CE conforming mobile phones to EU.
 
As to CE conformity for EU and its 3 EFTH member states, there is really no such thing as a "CE certificate", although we often use that term for brevity. It's a "legal process" rather than a one-off bit of approval paper (where the key point is that the EU importer must hold a highly technical CE conformity File in most circumstances).
 
Speaking broadly, the legal process is:-
 
One, the manufacturer must design/produce the product to conform with EU Directives and EN Standards.
 
Two, an approved lab must examine / test the product for conformity (I'll come back to the difference between Notified Body labs and approved labs and those masses of non-recognised Chinese labs later). CE conformity for your product includes testing for safety under what is known as the "EU Low Voltage Directive", being equipment which uses between 50 and 1,000v AC or 75-1,500 DC, and also tests for electromagnetic compatibility (EMC). Those two Safety and EMC Reports typically run into 30 pages each. Other tests also apply before you even consider the somewhat separate RoHS issue.
 
Three, the manufacturer must draw a Declaration of Conformity as laid out in EU law and place this in a file together with the technical documents from the test lab (known as a Technical File). This file must prove in rigid technical terms that the product is CE compliant.    
 
Four, that file must be held on EU territory for at least 5 years after the product ceases to be manufactured or sold in the EU.
 
Five, in the case of a non-EU manufacturer, that file must be held by an EU based Authorised Representative of the manufacturer – the file must at all times be kept on EU territory.
 
Six, any relevant authority from any EU member state can demand to see the file at any time. You must instantly produce it upon demand and it must prove CE compliance in a highly technical way.  
 
Seven, where the manufacturer has no Authorised Representative holding that file, the importer must hold it and instantly produce it upon demand by any one of all sorts of relevant authorities in EU.
 
Eight, and this is important for you. Under EU law, the importer is deemed to declare that the imported product bearing a CE label does in fact conform with all CE related laws (at least in your case where the manufacturer does not have an Authorised Rep holding the file). In that case, EU law in effect deems you, the importer, to be the manufacturer. You must prove from your file, held in your office on EU territory, that the product does comply when the authorities knock on your door.
 
You can't pass the buck off to the Chinese manufacturer who stuck the CE label on the product and/or try to rely on a Technical File provided by one of the hordes of non-authorised Chinese labs.
 
It is your very own CE label – you, as importer, are the one person self-declaring that the imported product bearing the CE label conforms by your act of placing the product on the EU market (in this instance where the manufacturer does not have an EU Authorised Rep holding the file).
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The very act of importing/distributing a product bearing a CE label in EU or its EFTH member states is a self made declaration that the product conforms – so your technical file needs to be watertight when the authorities knock on your door to examine it.
 
Nine, all above is set out in "EU Directives" and in "EN Standards" for each prescribed product (of which electrical products are near top of the dangerous list because non-compliant design can kill people).
 
Ten, those laws have real teeth. Both criminal and civil sanctions are at play. Civil awards of up to 70 million Euro have been made in EU for non-compliant products.
 
Mark, the good news is you have hardly anything to worry about if the German conformity certificate you mentioned was issued by a Notified Body laboratory. The certificate will state whether or not they are a Notified Body. In cases of a certificate of conformity issued by a Notified Body lab, the EU authorities will essentially leave you alone. That's because Notified Boby labs (unlike others) are actually directly appointed by various EU governments to test for CE conformity.
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In other cases of non-recognised labs doing the testing (particularly Chinese labs) and the manufacturer then issuing a Declaration of Conformity based on those tests, you are in strife.  
 
I trust the above helps a little.  I've gone to a fair bit of trouble to try to explain those complex CE related laws because you wisely said your aim is to stay out of prison.  
[em1]
30 Jun 2008 02:28
Post 2 of 11

In Reply to [Aussie]

Hi Aussie,

I would just like to thank you for taking the trouble to reply to me in such detail, you have certainly given me food for thought.

I have examined the conformity certificate issued by my supplier a little closer and the test lab are indeed a "Notified Body" like you mentioned in your earlier posts.

I will ask my supplier about the "Authorised Rep" within the EU and see what they come back with.

Once again my thanks for your valuable help.

Regards,

Mark

01 Jul 2008 02:06
Post 3 of 11
cooncat
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Hi there Mark and all, I have been reading the entries with great interest. I am in a similar position in importing e-bikes into the Uk and of course asking the Chinese companies for CE documentation. It is as most say, a bit of a minefield. Most of the Chinese companies either tell mo OK No problem? (Hmm right) Or they send me copies of an EMC conformity certificate stamped by a Chinese test facilility. Then tell me they already supply the EU so it is all OK. But it isn't. I have been in contact with a CE body in the Netherlands and they have looked at the certificates for me, they tell me no, these are not acceptable, primarily because they are not authorized by a responsible party in Europe to act as an authorized representative. Which of course the Chinese documentation are not. The authorized representation also includes the keeping up to date of the technical files and carrying the responsibility for all questions regarding European CE marking certification. Again the chinese certificates fall short in that as well.

When I have questioned these suppliers they become quite affronted, they state "This is not a problem, we do this already, no other buyer has questioned this so much, what is your problem" LOL Charming. Either they don't export to Europe at all and are totally unaware of the requirements. Or if they do I assume so far they have been overlooked? Like the previous posts state, if it has German authentication it probably is ok but of course better check it is all above board. The EU regulations state it is the Producers responsibility to obtain the required certification, but you may well lose out if they are pulled up at customs. At the very least you will lose your money. There is the fact that they one or two can come into the country, clearly stated as SAMPLES and has to be supported with documentation that these are for inspection only, and will not be resold or passed on etc. It seems to be the fact that indeed as previous posts state, the knowledge of proper CE certification is minimal in China. There are some companies who are certified properly, with the amount of companies making various products there it is usually a case of hunting down the supplier who already has it all signed off and proper, which is the route I have taken.

Good luck anyway,
03 Jul 2008 05:48
Post 4 of 11



Thanks Cooncat for sharing your valuable info, which continuing from above, raises another point.
Eleven
Tips on checking if a CE Certificate is fake 
 
The CE Certificate of Conformity should preferably be issued by  a Notified Body lab (you won't find any of these in China). These particular labs are directly appointed by Governments of EU member states to test products for CE conformity. The certificate will be issued on the letterhead of the Notified Body (complete with its address and phone number which will likely be in Europe) and should show: 
 
1. Registration Number of the certificate.
 
 
2. Certificate Holder (who should be your supplier).
 
 
3. Product Designation and Description (model number etc).
 
 
4. Sort of lab tests done on the product and the file number of the Test Reports.
 
 
5. Finally, the certificate should designate a CE number which must be marked on the product and the certificate will be signed by the director of the Notified Body.
 
 
6. Attached to the certificate should be a list of the EN Standards which the product complies with and the name of the testing lab plus dates of its test reports. 
 
Start your check by telephoning the Notified Body using the phone number on the certificate - check whether they issued a certificate the same as the one in your hand. If the certificate is real, you are about 50% there.   
 
Next step is to somehow check whether the product you are buying is (a) made by the same Manufacturer as stated on the CE certificate and (b) is the same product as stated on the certificate and (c) that factory quality control systems are in place to ensure that ongoing production is the same high quality as the sample which passed the CE lab tests. Sometimes this can be done by email correspondence. But often, I have to send a professional Inspector to the factory to check that all is in order.
03 Jul 2008 14:36
Post 5 of 11
pgms_cav
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Quoting from [Aussie]:




Thanks Cooncat for sharing your info.
.
Tips on checking if a CE Certificate is fake 
 
The CE Certificate of Conformity should preferably be issued by  a Notified Body lab (you won't find any of these in China). These particular labs are directly appointed by Governments of EU member states to test products for CE conformity. The certificate will be issued on the letterhead of the Notified Body (complete with its address and phone number which will likely be in Europe) and should show: 
 
1. Registration Number of the certificate.
 
 
2. Certificate Holder (who should be your supplier).
 
 
3. Product Designation and Description (model number etc).
 
 
4. Sort of lab tests done on the product and the file number of the Test Reports.
 
 
5. Finally, the certificate should designate a CE number which must be marked on the product and the certificate will be signed by the director of the Notified Body.
 
 
6. Attached to the certificate should be a list of the EN Standards which the product complies with and the name of the testing lab plus dates of its test reports. 
 
Start your check by telephoning the Notified Body using the phone number on the certificate - check whether they issued a certificate the same as the one in your hand. If the certificate is real, you are about 50% there.   
 
Next step is to somehow check whether the product you are buying is (a) made by the same Manufacturer as stated on the CE certificate and (b) is the same product as stated on the certificate and (c) that factory quality control systems are in place to ensure that ongoing production is the same high quality as the sample which passed the CE lab tests. Sometimes this can be done by email correspondence. But often, I have to send a professional Inspector to the factory to check that all is in order.


[em20] two thumbs up for this article, its fortunate we are still in the process of testing the sent samples to us by a factory from china and they sent us CE certificate, of course, conducted by a Chinase Laboratory, and now we know its not authentic, good work guys
06 Jul 2008 22:05
Post 6 of 11
Arnoud
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A very comprehensive post. I've learned so much. Thank you. Perhaps to make things complete, would the date on the CE matter a lot? As in, does the product need to be retested every so many years? In other words, how long is the CE valid for?










16 Jul 2008 20:43
Post 7 of 11
Darn good questions Arnoud, so let's add them to our numbered list.

Twelve

Tested CE Sample versus ongoing factory production

In background, as we touched on earlier, the "CE Certificate of conformity" is of itself worthless. Only the underlying Technical Construction File holding the lab reports etc (and which must be held on EU territority) gives right to place the CE label on a product sold in EU. So, in answer to your first question, the date on the CE certificate does not matter (except if EN Standards relating to the product are amended/updated or if fresh EU Directives are issued, as often occurs).   

The lab tests of course relate to only the tested sample and who's to say the subsequent mass production will be the same as the sample and what laws are in place in this respect?  Or, how does an importer know if the mass produced product is the same and what is the importer's legal duty to ensure that the imported products are the same as the tested sampe? 

First, the manufacturer has a duty in law to place the CE label on only products which are materially the same as the tested sample. Any small change to the product or manufacturing process must be recorded in the TC File. If the foreign manufacturer has an "Authorised Representative" holding the File on EU territory, then the importer is effectively in the clear.   

Second, if the manufacturer does not have have an Authorised Rep holding the File in EU, then by law the importer must BOTH hold the File and ensure that the imported product is exactly the same as described in the File design drawings and lab tests.  

Most mainland China suppliers who send you a CE Certificate of conformity, do not have an Authorised Representative holding the File which then or course places the importer in the sizzling hot seat.

In the latter case, even if you hold the File, how do you ensure that the imported product is the same as the tested product? The short answer is that you can't (unless you routinely send technically qualified experts to the factory to audit its quality control systems in respect of manufacturing exactly only the same as the initially approved sample. In answer to your second question, this is not a case of getting samples retested. It's a case of monitoring the factory's quality control systems.  

more ...

17 Jul 2008 02:16
Post 8 of 11

Thirteen

In the real world, any Chinese manufacturer worth its salt:

1. In the first place, gets the sample tested by a European "Notified Body" lab and then appoints a professional Authorised Representative to hold the Technical Construction File on EU territory. Remember that Notified Body labs are directly appointed by EU Governments to test for CE conformity while the Authorised Representative is a requirement of EU law.

2. Has ISO standard quality control systems in place in the factory complete with quality control managers. It is noteworthy that many Chinese factories have an ISO certificate hanging on the wall for marketing purposes but then completely ignore the underlying production manual.

3. Critically, appoints an internationally recognised Inspection company like SAI etc to conduct annual or bi-annual audits or surprise check-audits of its factory production process for certification that the product is being produced in accord with the initial lab tested sample. Most major Western Retailers/Importers/Distributors will not touch a Chinese product unless such certificate is routinely issued. It's not foolproof (as you see in the case of many product recalls in the West) but it's the best that most serious importers can do in order to be "seen" to discharge their duties.

That latter factory audit process is at play for compliance with all Western Standards be it UL or C-Tick, or whatever. The certificate is issued for only the tested sample. The importers/distributors/retailers must then rely on ongoing factory audits to ensure that subsequent production matches the approved sample.

Bottom line for CE ... if the manufacturer does not have an Authorised Representative holding the CE Technical Construction File on EU territory, forget it - especially for A list dangerous classifications like electrical products (even cords and power point plugs) as well as for toys, which attract the attention of EU authorities.

If the manufacturer has an EU Rep who holds the file, and if the CE Certificate of conformity was issued by a European Notified Body lab, then you are looking good.  [em1]

17 Jul 2008 02:22
Post 9 of 11
Arnoud
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what if a(nother) European customer of the manufacturer did all the testing and consequently holds the CE and Technical files... does this mean he automatically acts as the Authorized Representative? (who takes care of all factory audits)


Thanks by the way, Aussie, for your great answers...
20 Jul 2008 20:09
Post 10 of 11
Business in China
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Quoting from [Aussie]:

Thirteen

In the real world, any Chinese manufacturer worth its salt:

1. In the first place, gets the sample tested by a European "Notified Body" lab and then appoints a professional Authorised Representative to hold the Technical Construction File on EU territory. Remember that Notified Body labs are directly appointed by EU Governments to test for CE conformity while the Authorised Representative is a requirement of EU law.

2. Has ISO standard quality control systems in place in the factory complete with quality control managers. It is noteworthy that many Chinese factories have an ISO certificate hanging on the wall for marketing purposes but then completely ignore the underlying production manual.

3. Critically, appoints an internationally recognised Inspection company like SAI etc to conduct annual or bi-annual audits or surprise check-audits of its factory production process for certification that the product is being produced in accord with the initial lab tested sample. Most major Western Retailers/Importers/Distributors will not touch a Chinese product unless such certificate is routinely issued. It's not foolproof (as you see in the case of many product recalls in the West) but it's the best that most serious importers can do in order to be "seen" to discharge their duties.

That latter factory audit process is at play for compliance with all Western Standards be it UL or C-Tick, or whatever. The certificate is issued for only the tested sample. The importers/distributors/retailers must then rely on ongoing factory audits to ensure that subsequent production matches the approved sample.

Bottom line for CE ... if the manufacturer does not have an Authorised Representative holding the CE Technical Construction File on EU territory, forget it - especially for A list dangerous classifications like electrical products (even cords and power point plugs) as well as for toys, which attract the attention of EU authorities.

If the manufacturer has an EU Rep who holds the file, and if the CE Certificate of conformity was issued by a European Notified Body lab, then you are looking good.  [em1]



Great article and great Aussie, you're a teacher for most of Alibaba members online. [em20]
23 Jul 2008 00:57
Post 11 of 11
Hi there, I sure hope that Carol includes a Certifications forum in all this new electronic stuff she floated today (see the Mobile Phone forum). Somehow, we need to teach Chinese factories how to certify their products if they want serious sales to Western buyers.
02 Aug 2008 01:25
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