Selling your product in the EU; what kind of regulatory requirements do I need? - Page 1
Forum section: electronics / projects

author: guscrown
author_rank: Regular Contributor
timestamp: July 08, 2015, 02:31:57 am
content: Hey everyone, I've been doing Product Design (I'm an EE) for a few years now, and I've always only handle the EMC portion of the regulatory requirements. But now I'm also in charge of Safety and I'm at a lost a bit here with the European Union.I already did my EMC testing and I certified not only for the FCC but also CE, so I think with that regards I covered (I haven't done the Declaration of Conformity, though, I simply hold a test report and certificate from the test lab). From the safety side, I hold a certificate from TUV, one of the testing standards that was used on my product was EN 60950-1:2006/A12:2011, and I believe this covers at least the safety portion, but I am not really sure.Does anybody have experience bringing your Product to the EU? What are the requirements for selling it? My basic understanding of things is that CE is completely mandatory, but Safety (in my case the TUV marking) is compulsory. Is this correct?Could I be missing something else that I might need? The product is a Point of Sale Terminal, and since I purchase my power supply separately, and its certifications are handle by the vendor, my product falls under the Low Voltage Directive.

author: babysitter
author_rank: Frequent Contributor
timestamp: July 08, 2015, 05:39:49 am
content: You might consider downloading a german manual with the declaration of conformity to a similar product.EMC and electrical safety test under "european" conditions done by a accredited lab I would consider sensible.You rather comply to RoHS, too.The DoC has to be done by yourself and you simply list the standards you think you adhere to.Another greenish thing is that you need to take part in the "electronic waste business", which means you are required to register as e product manufacturer and take back your products, in fact you can expect that you will sometimes get the chance to get a container full of e-scrap to properly dispose of. But there are companies that will do the waste processing for you.Parts of those tasks you can/must "outsource"to a eu representative.

author: AndyC_772
author_rank: Super Contributor
timestamp: July 08, 2015, 06:22:43 am
content: The CE mark indicates compliance with 'all applicable Directives', including EMC and safety.You've done EMC testing and have a report, so that goes in the product's Technical File as evidence of compliance. Any changes you make to the product throughout its life should be documented in that file, especially if they could affect its EMC performance.60950 is a safety standard applicable to a lot of general industrial electronics, and if you have a certificate from TUV, then that goes in the technical file too. There's no separate mark that you need to apply in respect of safety.You should, however, apply the crossed-out wheelie bin mark, indicating compliance with the WEEE directive. This mark, along with the black bar that goes under it, indicates that the product was placed on the market after the date when WEEE compliance became mandatory. As a producer, you're obligated to take back not just your own products at end-of-life, but any other product which is directly replaced by one of yours. Normally companies meet this obligation by signing up to a take-back scheme with a registered recycler, and pointing customers in their direction.Your product should also be RoHS compliant, and usually it's the CEM who ends up having to deal with this. You specify the lead free versions of all the components on your BoM, and they do the rest. Do be aware that RoHS doesn't just apply to lead; some common metal finishes and cable insulation materials contain other banned substances. Be sure to require RoHS compliance from all the manufacturers of parts that go into your product, not just the PCB assembler.Then there's also ErP, and the Batteries Directive. Last time I checked, these applied to products made in higher volume than the products I've tended to work on, so I don't claim any great expertise. ErP is all about energy usage, and sets limits on how much power your product can require when it's in standby mode (if applicable). BD compliance may require your product's battery - if it has one - to be easy to remove so it can be properly recycled when it's flat.Finally, you should make a Declaration of Conformity in the product's manual. This is a certification that the product is compliant, and it names you as the party solely responsible for that compliance.

author: guscrown
author_rank: Regular Contributor
timestamp: July 08, 2015, 02:38:01 pm
content: Quote from: AndyC_772 on July 08, 2015, 06:22:43 amThanks for this incredible answer.

author: LDM
author_rank: Contributor
timestamp: July 09, 2015, 11:36:49 am
content: Just note that the volume requirement is for all units combined for the product sold in the EU. If the product is in the list of those covered by 2005/32/CE, you need to meet ErP requiremetns for standby mode, even if you only make one of them.

author: splin
author_rank: Frequent Contributor
timestamp: July 10, 2015, 01:15:17 am
content: What about boards or modules which aren't end products in their own right? Eg. those 1$ buck regulators on Ebay? Do they have to meet RoHS and WEE? (Not that anyone is likely to chase small Chinese vendors to slap their wrists).What about very small volume products such as a Voltage reference board where somebody decides to sell the half dozen extra boards they designed and built because they had to buy a minimum number of blank PCBs/components and wants to offset some of the costs?I know the Raspberry Pi was delayed as it fell foul of the CE certification early on, but that was intended to be sold in large volumes to end users.

author: babysitter
author_rank: Frequent Contributor
timestamp: July 10, 2015, 05:14:02 am
content: Splin: No mercy, at least the german customs already look at CE marking and product safety, while I (as a ham who is considered qualified to operate junk) got some questionable stuff (e.g. old test equipment) thru, a friend who regularly used to order stuff from hobbyking (RC gear) had a few of his orders shredded due to it.If you are a seller of low quantities in the EU, you have to meet RoHS and register as a small volume e-waste producer (and preferrably engage one of the e-waste processing outsourcers.) You still need to declare conformity to CE.There are very specific rules about sub-assemblies, like who is likely to operate it and depending on the instructions manual (that you might have to ship in the language of the country you sell to.) Components, OTOH, are a bit easier - maybe you are sometimes better off if you pot it (maybe removable potting?)

author: splin
author_rank: Frequent Contributor
timestamp: July 10, 2015, 12:15:42 pm
content: Quote from: babysitter on July 10, 2015, 05:14:02 amI've seen this mentioned elsewhere on these forums (fora?) about German customs. Is this particular to Germany or has anybody else had similar problems with customs?QuoteI wonder who is enforcing this apart perhaps from customs - and presumably then only for imports from outside the EU? Has anybody ever heard of anyone being prosecuted or forced to withhdraw sales of components or equipment which wasn't RoHS compliant or didn't meet EMI standards? There must be vast quantities of cheap goods coming in from China which don't go through the big retailers who are likely to ensure they meet the relevant standards.As to RoHS is there likely to be any significant production of components or equipment worldwide which is non-compliant anyway (apart from specialist areas such as military or certain industrial uses)?Is it complaints driven such that action is only taken when somebody (perhaps a rival supplier) alleges that non-compliant goods are being sold? I realize that trading standards or similar bodies may investigate sales of hazardous goods with potentially serious electrical or fire risks, but I'd be surprised if there were many Government funded bodies with the resources to routinely check for compliance of goods.QuoteErrm not sure what you mean by that - why would potting a product change anything other than making it more difficult for someone to determine what it contains?

author: Neilm
author_rank: Super Contributor
timestamp: July 10, 2015, 06:33:06 pm
content: Quote from: splin on July 10, 2015, 12:15:42 pmI believe that Apple got their wrists slapped shortly after RoHS came in due to contamination of the solder used. I do know that if there is a complaint due to EMI, this can be investigated and traced. Generally it is due to installations rather than ordinary commercial products. In the UK customs might stop something they think is dodgy, but the final responsibility rests with Trading Standards

author: acbern
author_rank: Frequent Contributor
timestamp: December 29, 2015, 09:18:51 am
content: In another thread a pretty interesting question came up, which should better be placed here:It was related to some small electrical test equipment, newley designed, and operated at low voltages (5V range). Take e.g. as example Dave's current amplifier.Generally CE marking needs to be applied if the product is in one of the designated product categories which are e.g. listed herehttp://www.ce-marking.org/what-product.htmlOf these only "Measuring Instruments" looks at first glance as if it will apply - "Low Voltage Electrical Equipment" actually covers 50-1500V (so,essentially anything mains powered), not battery powered devices or powered from other DC voltages (such as an external lab PSU).But measuring instruments actually covers a narrow range of devices mainly for liquid measure and so - seehttps://www.element14.com/community/servlet/JiveServlet/previewBody/51607-102-1-264611/CE%20Mark%20-%20Measuring%20instruments.pdfandhttp://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/measuring-instruments/index_en.htmSo it looks as if battery powered or low voltage DC (again, e.g. Lab PSU or USB connector, or a USB type battery) powered (test) equipment would not need CE marking because it neither falls into the low voltage directive nor into the measuring instruments list. It also looks as if this is not limited to test equipment, anything not on the list and below rated voltage.And for FCC, test gear is excempt anyway IIRC.

author: ltz2000
author_rank: Regular Contributor
timestamp: December 29, 2015, 01:33:41 pm
content: Quote from: acbern on December 29, 2015, 09:18:51 amYou forgot the EMC Directive which doesn't care about the supply voltage. And there are also some general safety requirements.

author: grumpydoc
author_rank: Super Contributor
timestamp: December 29, 2015, 01:53:49 pm
content: Quote from: ltz2000 on December 29, 2015, 01:33:41 pmThe general safety directive does not, in itself require a CE mark to be placed.Looks as though you are correct about EMC (but no different to FCC regs?)

author: acbern
author_rank: Frequent Contributor
timestamp: December 29, 2015, 05:12:44 pm
content: Quote from: ltz2000 on December 29, 2015, 01:33:41 pmWell, I was only referring to the CE mark requirement, not any requirement to EMC (any specific you were referring to?). In other words, while EMC requirements may be applicable, I still believe the CE mark seems not to be.Quote from: grumpydoc on December 29, 2015, 01:53:49 pmFCC regs make an exception for digital devices used for industrial (and other) test equipment (ndand also for some others). That seems to be a unique FCC rule (different to CE).

author: janoc
author_rank: Super Contributor
timestamp: December 29, 2015, 05:38:21 pm
content: Quote from: splin on July 10, 2015, 12:15:42 pmThis is very much German thing. The directive applies to the entire EU, but only Germans decided to implement and enforce it in such crazy heavy handed way. If you search the forums, you will see this discussed several times in the past - the last one was the discussion of the Dave's uCurrents being blocked at the German customs.I have never had issues like that in France, Denmark or Slovakia (countries where I regularly reside or did reside not so long time ago).However, all this applies only for stuff arriving from theoutsideof EU. I don't think they are as strict with goods that are coming from another EU country (presumably the checks having been done there already).

author: dom0
author_rank: Super Contributor
timestamp: December 29, 2015, 05:52:52 pm
content: Quote from: janoc on December 29, 2015, 05:38:21 pmNot a German Zoll thing per se, it depends on the point of entry and the office handling it. Some are reportedly very strict about everything, some not so much. Never had any issues with Hannover, for example.#1111 = 15

author: ltz2000
author_rank: Regular Contributor
timestamp: December 29, 2015, 06:14:22 pm
content: Quote from: acbern on December 29, 2015, 05:12:44 pmAn ice hockey helmet is obviously not covered by the Low Voltage Directive, but the CE mark is still required because directives other than the LVD also exists.A computer mouse for example is not under the LVD but there is still a CE mark.

author: ciccio
author_rank: Frequent Contributor
timestamp: December 29, 2015, 06:21:02 pm
content: Quote from: splin on July 10, 2015, 12:15:42 pmYears ago I worked for a Pro Audio manufacturer in Italy.They had a problem in Germany when a rival manufacturer made a complaint to one government agency (sorry but I don't remember which one) about one of the products I designed (an active speaker system).They said that they were not compliant to the applicable IEC standard.Our distributor in Germany was give a short time to prove compliance, and they were faced with a recall from the market.Usually we applied the CE mark after in-house tests (we had a lab equipped with all the necessary tools) so we sent our CE technical file to our distributor, but it got a request to have the product tested by a German test body.We sent the product to a VDE recognised lab, paid a lot of money, and got a VDE approval.Our distributor was happy, but our accountant was not....Sorry but I cannot be more specific. I do not work anymore for that Company, but I still have a non-disclosure agreement.Best regards

author: acbern
author_rank: Frequent Contributor
timestamp: December 29, 2015, 09:19:28 pm
content: One thing is what customs staff does. This, in some cases, in Germeny is insane. Actually, they do npt even obey the law (e.g. when refusing old test gear that is net CE marked). I actually have never had an issue. It strongly depends on where you are, and I think onle some, not sufficiently trained, overdo it.However, the other thing is, what is required by EU legislation. Thats my main topic here.

author: Aeternam
author_rank: Unknown
timestamp: December 30, 2015, 07:40:12 am
content: OT, contact a chamber of commerce in the country you want to sell your appliance in. They should be well versed in the legal mumbo jumbo, and if not they'll at least be able to point you in the direction of some other administration that does know what hoops you need to jump through.Germany:http://www.dihk.de/enFrance:http://www.cci.fr/#

author: janoc
author_rank: Super Contributor
timestamp: December 30, 2015, 09:28:19 pm
content: Quote from: dom0 on December 29, 2015, 05:52:52 pmWell, the inconsistent enforcement is yet another thing, but the German implementation of the WEEE directive is by far the strictest and the most bureaucratic in EU. Keep in mind that EU only adopts a directive, however the enforcement is driven by an actual translation of that into national law - which is different from country to country.The same with their enforcement of the CE mark rules on imports. It is more often the "Papieren muessen in Ordnung sein!" than the actual spirit of the directive that is being enforced.

author: tooki
author_rank: Super Contributor
timestamp: December 31, 2015, 12:19:58 am
content: Quote from: Neilm on July 10, 2015, 06:33:06 pmDo you have a source for this? A cursory Google search only comes up with your own statements here on eevblog.Beyond that, all I could find was Apple deliberately retiring some products in the EU ahead of RoHS, and a time where Apple violated California state law by forgetting the CA hazardous materials warning on product packaging, because the phthalates in the headphone wire require such a warning. (This was egged on by Greenpeace, which loves to use Apple's brand recognition to create drama where none existed.)

author: AndyC_772
author_rank: Super Contributor
timestamp: December 31, 2015, 08:38:20 am
content: To be fair to Apple, the hard vacuum of space probably contains something "known" to the state of California to require some kind of warning label.https://en.wikipedia.org/wiki/California_Proposition_65_%281986%29#/media/File:Disneyland_Prop_65_Warning_crop.jpg

author: SeanB
author_rank: Super Contributor
timestamp: December 31, 2015, 09:07:44 am
content: Probably those high energy protons that have 10 occupying a cubic kilometer. Or the nasty radiation from high energy electrons. You do know that everything causes cancer in large enough doses fed for a long enough time. Plain water is deadly in ton lots dropped on you, along with ton lots of sugar or salt. i think even politicians have been known to cause cancer, though that could just be a side effect.

author: tooki
author_rank: Super Contributor
timestamp: December 31, 2015, 04:17:15 pm
content: Quote from: AndyC_772 on December 31, 2015, 08:38:20 amOh, absolutely!!!!Quote from: SeanB on December 31, 2015, 09:07:44 am

author: RobertBG
author_rank: Regular Contributor
timestamp: January 01, 2016, 01:51:41 am
content: If all of this hasn't scared you yet I wont mention the headaches you'll experience after approvalHopefully you have a good distributor to work worth because that can make all the difference.I import quite a bit of stuff into the EU and I originally was going to go through Germany but we choose to use Bulgaria as our entrance and distribution point.I had hoped to avoid some of the corruption issues associated with BG by going in through Germany but i quickly realized it's cheaper than dealing with someone who misinterprets the regulations or applies them as they feel without reason.Fortunately once in the EU and legal things will get easier,choose your entry point wisely because it can make or break things.I have been told that Germany is so tough because they rather things be made there and I cant blame them,thankfully there's other entry points to the EUI understand if you dont want to get into details but in the EU (at least in BG) all POS systems are tied into a central database for VAT reasons.Just something to think about if you havent already.Lastly,if and when you're ready,if you're looking for a distributor in and around Bulgaria,Greece and Cyprus send me a PM.I'm always looking for products that are new to the EU and if it's not something I work with I'd be more then happy to point you in the right direction.