Anyone ever make a "Declaration of Conformity"?

[K3mHtH]

Hey everyone,
So I've been building little synthesizers as a hobby recently and shipped one to Spain. Unfortunately it got stopped in Spain by their customs and they are now asking for:

-DECLARATION OF CONFORMITY OF THE MANUFACTURER OR ANY OTHER TECHNICAL DOCUMENTATION ISSUED BY THE MANUFACTURER THAT GUARANTEES WITH WHICH MATERIALS AND / OR SUBSTANCES THE PRODUCT IS MANUFACTURED.

This stuff is all new to me. The instrument is powered by 16VAC wallwart (the wallwart is CE approved) and all electronics inside are ROHS compliant, all lead-free solder and as far as I know every component is lead-free and ROHS.

What exactly are they wanting me to send? Is this even a document I can write myself?

[Jeroen3]

They are asking you for a document from your company with your signature that your product is CE compliant.

[picburner]

Here you can find the instructions and documentation to provide.
At the bottom of the page it says that it should also be written in the language of the importing country (in addition to English).

[selcuk]

I'm curious. Was there a visible CE logo on the equipment packaging or the equipment itself?

[SiliconWizard]

"Unfortunately", you can't sell products in the EU without a declaration of conformity (CE), even if you just do that as a "hobby". It's pretty much the same deal with the FCC in Canada, AFAIK.
There are exceptions to that, like if you make strictly "custom" gear for professional customers who will only use it in-house, with some subtleties too. But I doubt your devices can really be considered that in your case.

It looks like in this particular case, they are only asking for the list of materials and not strictly a declaration of conformity, so your best bet would be here to strictly reply with what they ask.
You'll have to write a technical document listing all materials and references for the assembly process proving it's 100% RoHS.

Note that writing a "declaration of conformity" will take you less time than this actually, as it doesn't contain any technical details. But it's a much more, legally-binding document that I would avoid sending to authorities at this point, unless you really have to.

After that, you'll have to figure out how to go from there, as selling products as just a "hobby" may get you in more trouble than you think if anything goes wrong. And the declarations of conformity won't be the main concern. Just my 2 cents.

[wilhe_jo]

They are asking you for a document from your company with your signature that your product is CE compliant.

To make it more precise: they want to know if all applicable directives got applied.

You already mentioned RoHS (EN63000)

The next one is the low voltage directive (EN62368-1)

And finally, you need to care about EMC... But you did ICES-003 emission-testing for Canada (comparable to EN55032) already, right? So it's most likely your're "just" missing EN55035.... That's the immunity part...

First step is requesting the DoC. But I'm sure, they'll ask for your technical file next... So you better prepare some test-data or other evidence that everything is fine (in your case, the safety part might be easy to proof if you get good cert).

Providing a CE marked wall wart will be too little.

Btw, actually, the one importing (receiver) is the one that needs to provide everything. The DoC can be signed by the mfg outside the EU (preferred), but the one sitting in the EU is the one that gets in trouble if he can't provide a DoC and technical file.

The same's true for all that Chinese garbage... The moment market surveillance requests the legal requirements, 99% of the online shops will vanish. And this is true for almost any region I know.

Regards

[Smokey]

Can't you still self certify CE in some cases?

[PGPG]

Can't you still self certify CE in some cases?

I think in most directives it is such that device can get presumption of being in accordance with the directive provided that you (yourself) can proof (in made for these reason documentation) that it meets the requirements of the relevant standard(s) harmonized with this directive. Your task is to find right standard(s) among tens harmonized. If there is no right standard you have to use certified body (or how it is named) to get the paper that the device is in accordance with the directive.
The problem is that (specially EMC) standards call for making tests for which you need million dolar lab.

So it's most likely your're "just" missing EN55035.... That's the immunity part...

This is going out of thread subject, but in my opinion immunity requirement is the best example of excessive bureaucracy in Europe. These simply should be quality parameter and poor quality devices should just lose on the market. Immunity testing takes long time as you need to see if device exposed to the field of subsequent frequencies still works good.

It looks like in this particular case, they are only asking for the list of materials and not strictly a declaration of conformity, so your best bet would be here to strictly reply with what they ask.
You'll have to write a technical document listing all materials and references for the assembly process proving it's 100% RoHS.

It seems so to me too.
When ordering assembled PCB from contract manufacturer we always ask to provide with it the declaration of RoHS conformity of assembled PCBs (so he declares that he used RoHS compliant elements and assembled them using RoHS compliant technology).
Since 2006 I also collect for each element I use the element manufacturer declaration of it being RoHS compliant. For many of elements such declaration is in datasheet. Some manufacturers have at their homepage the signed declaration that all their products are RoHS compliant and for some manufacturers you can find at their www such separate declaration for each product. I have also some declarations I asked for and got directly being written for me (but it was the case at the far beginning (so 2006) when contract manufacturers and sometimes element manufacturers were surprised what I am asking them about ).
These are not my rules and I don't like it that when beginning in 1988 I spend 90% time designing and 10% on bureaucracy and now the proportions are reversed.

[jonpaul]

As always governments steal our money and waste it on useless paperwork.

j

[K3mHtH]

Okay, thanks for all of the replies so far - I admit to being a bit overwhelmed here, but willing to do this if it means I can sell my products in the EU.

Do all small businesses and one-person shops jump through all of these hoops themselves? Or is there consultants that can be hired to guide someone's product through these steps?

To make it more precise: they want to know if all applicable directives got applied.

You already mentioned RoHS (EN63000)

The next one is the low voltage directive (EN62368-1)

And finally, you need to care about EMC... But you did ICES-003 emission-testing for Canada (comparable to EN55032) already, right? So it's most likely your're "just" missing EN55035.... That's the immunity part...

For low-voltage directive, is that not for devices between 50-1000VAC? My unit runs on 16VAC.

EMC, I have not done any emissions testing in Canada. I also have not done any immunity testing. While my product is an analog synthesizer, there is also a microcontroller onboard so presumably those tests would apply here. Are these tests required for all products regardless of quantities produced and quantities imported into the EU?

[Siwastaja]

Declaration of Conformity is only required and relevant when a manufacturer or importer places a product on the market (see e.g. https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm )

Now what "placing a product on the market", or what "a product" exactly mean is up to debate but basically if you are selling things to consumers so that anyone can buy this is definitely placing products on the market even if you manage to only sell one.

So is the customs right? Did you sell the thing? If it's a true actual prototype e.g. sold to a company as a consultant job then it is not placing a product on the market. Or if you are giving a gift to your friend then it's not placing a product on the market. No declaration of conformity is needed in such cases, if customs say otherwise they are lying and you should appeal against it.

You could also try to lie to them that this is a personal gift not a product being sold, it's up to you to decide.

If you are truly selling, then you need to satisfy the legal requirements to sell in EU. Which brings us to the usual point:

As always governments steal our money and waste it on useless paperwork.

always ignroe jonpaul. There might be a lot to criticize in EU, but the CE declaration of conformity process is historically simple regarding amount of paperwork. It's a self-declaration process with really minimum amount of boilerplate, the declaration itself is like one page, you can find examples by buying similar product in EU and seeing the declaration on the manual. Or just google for examples.

The product of course needs to comply to legal requirements but this is so everywhere and for very good reasons, our society would collapse if anyone could sell any shit which nukes other devices dead with EMC or kills their users or burns down your house, or poisons your kids.

Conceptually CE is easy - you need to sign a simple document where you list the standards your product satisfies and you personally guarantee this is the case. Rest of the documentation is for your own sake, if your product ever causes any trouble then you are being asked for more documentation how you verified it is conformant to requirements, but there are no formal requirements of how this documentation must look like, minimizing unnecessary paperwork.

You should be working with a consultation house which discussed with you about your products and quickly suggest standard(s) you need to comply with (always some sort of EMC). Then you go to EMC test lab to prove the design is compliant. Then you prepare paperwork which is enough for you to be ready to take the personal responsibility by signing it. The better job you do the better position you are in if any problems arise.

Selling "just a few" to consumers is quite difficult. With companies you can of course do prototypes and work as consultant, it's not placing products on a market. But if you sell on Ebay to general public then it's placing product on the market.


TLDR: In essence CE is manufacturer/importer giving their word the product is legal. No registration, no certification (except in some special cases, OP's synthesizer isn't one) of any kind needed. You just sign a small piece of paper (which you only deliver when asked) and take responsibility of your product being legal, which it needs to be anyway.

[guenthert]

Can it be sold as a kit (IKEA style, i.e. no soldering, not Heathkit style, which might be too challenging for the targeted customers)?

[wilhe_jo]

Can it be sold as a kit (IKEA style, i.e. no soldering, not Heathkit style, which might be too challenging for the targeted customers)?

Strictly forget about this approach!
This is a "German" idea! I don't know why this rumor still exists and why it only lives in Germany...
Clearly, all guides to the directives say, if you sell a kit, an assembled kit has to fulfill the requirements.
Hence, you need the same testing as a ready-to-use product!

Declaration of Conformity is only required and relevant when a manufacturer or importer places a product on the market (see e.g. https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm )

Now what "placing a product on the market", or what "a product" exactly mean is up to debate but basically if you are selling things to consumers so that anyone can buy this is definitely placing products on the market even if you manage to only sell one.

No! There's absolutely nothing to debate about!

There are the guides to the directives (EMCD, LVD, RED) and the Blue Guide.
Everthing is clearly defined!

If you are truly selling, then you need to satisfy the legal requirements to sell in EU.

Ähm....

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52016XC0726(02)

2.3.   PLACING ON THE MARKET

...
Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question after the stage of manufacture has taken place (51). This transfer could be for payment or free of charge. It does not require the physical handover of the product.
...

So declaring as a gift does not help!

You should be working with a consultation house which discussed with you about your products and quickly suggest standard(s) you need to comply with (always some sort of EMC). Then you go to EMC test lab to prove the design is compliant. Then you prepare paperwork which is enough for you to be ready to take the personal responsibility by signing it. The better job you do the better position you are in if any problems arise.

I'm doing such consulting work. From my experience, and what I get from test-houses, this is the "only" way to get through the requirements of the CE-scheme in a economical way.

You can do all the necessary and voluntary requirements of the US and EU in one go.
With CA and EU, and CA+US+EU, I'm not totally sure, because of some oddities in the ICES docs...
If you ignored US/CA and just want the EU testing... it's going to get prohibitively expensive.
With some planing, I can see ways to do the testing for world-wide selling for 5-10k...
But this highly depends on the product!

Do all small businesses and one-person shops jump through all of these hoops themselves? Or is there consultants that can be hired to guide someone's product through these steps?

Too many ignore these facts... I see a huge potential for a big debate in the very near future.
In fact, the scrap-selling stores will vanish the moment the rules are enforced.
The problem is, however, over the last decades, nobody cared... so everyone is used to the wild-west situation we have.
So the moment, somebody realizes, that enforcing existing law is easier and more effective compared to getting protective tariffs, we'll see unhappy people...

But this is the same with US and CA....

For low-voltage directive, is that not for devices between 50-1000VAC? My unit runs on 16VAC.

Well, does your product include the wall-wart?

If it does, then I'd be careful.

EMC, I have not done any emissions testing in Canada. I also have not done any immunity testing. While my product is an analog synthesizer, there is also a microcontroller onboard so presumably those tests would apply here. Are these tests required for all products regardless of quantities produced and quantities imported into the EU?

Well, any product in the US and CA needs EMC as well.

The US has "FCC15" (47 CFR 15) and CA has ICES-Gen + the applicable parts.


Regards

[PGPG]

For low-voltage directive, is that not for devices between 50-1000VAC? My unit runs on 16VAC.

It is about safety and I can't say that I'm sure of anything.
About 20 years ago someone entered me into a IEEE EMC-PSTC discussion list (those time closed list) where are people working with safety (consultants, lab workers, people working in standard commitees...). I think now it is probably some kind of forum and anyone can someway enter it.
When I have written there that I am reading 60950-1 (not actual now) for the third time and understand nothing I got answer: "Welcome in the club."

Short searching I got links:
https://www.mail-archive.com/emc-pstc@listserv.ieee.org/maillist.html
https://www.mail-archive.com/emc-pstc@listserv.ieee.org/

According to my understanding with LVD the problem can arise if the AC230 adapter is sold together with your device (or has your name on it). If yes than it can be concluded that your product (what customer gets from you) is not powered from AC16 but from AC230.

If your product not uses RF field than you are more happy with LVD because if uses than you fall under RED directive and RED directive says that product that fall under it have to fulfill LVD requirements  irrespective of voltage it is powered.

The product of course needs to comply to legal requirements

You describe in some way optimistic view on CE (I'd like things to be such as you write it, but I'm afraid they are not).
One of legal requirements is that until you don't have documentation proving that your product fulfill all directives under which it falls you are not allowed to issue CE declaration then until you not issue CE declaration you are not allowed to mark your product with CE mark, then until you not mark your product with CE you are not allowed to put it on the market. Dot.
Market surveillance authorities have the right to carry out inspections and, as part of these inspections ask you for this documentation.
Once when I wanted to test my device lab couldn't find a date for me because all the local LED lighting manufacturers had taken all the available dates. Customer reported that he can't see TV when he switch LED light on and someone decided that all LED light manufacturers have to be controlled.

As I understand first post in this thread one of market surveillance authorities just asked to get such documentation regarding only RoHS directive (at the beginning).

[LaserSteve]

Make sure you can say it is free of "Conflict Materials" and "ROHS" banned materials, and your part vendors and board assemblers  have sent you the certs on this. Probably something in there about the labor being used was not suspect to slavery, are legally in your country, and are not sexually trafficked,  if its like the USA.

You have landed on the desk of a Mark One, Mod Zero admin type who is bored.

Steve

[K3mHtH]

Thank you again for all of this information.

In the short term, I have this one instrument stuck at customs in Spain where they are asking for the documentation I listed in the first post.

I feel like I could 'attempt' to make a document that shows ROHS compliance and what the instrument is made with, based on the parts that are in it. This would just be me guessing and attempting to make a document that looks legit and hoping it fools spanish customs.

It also seems like a lot of work to collate a proper Declaration of Conformity to legally back that up, if they ask for it. I've screwed myself in several ways here, the instrument has no CE markings on it, just the wallwart and I have not even received any declaration of conformity for the wallwart from the chinese manufacturer that I had manufacture it (these were custom, through alibaba).

At this point, I think I'd prefer to just have Spain ship my instrument back and then take my time to properly hire a consultant who can guide me through the process of getting this legal to sell in CA, US and EU, including EMC testing, etc.

[Siwastaja]

No! There's absolutely nothing to debate about!

Of course there is;

So declaring as a gift does not help!

So you seriously claim a grandfather who makes a wooden toy for his grandchild is "placing a product on market" and this toy must comply to CE requirements (relevant standards of children's toys)? I claim bullshit, bullshit and again bullshit.

True gifts are true gifts, not "manufactured products" at all so the whole document you refer to is irrelevant. Of course "declaring" as gift when actually doing business does not work, which I made clear.

You describe in some way optimistic view on CE (I'd like things to be such as you write it, but I'm afraid they are not).
One of legal requirements is that until you don't have documentation proving that your product fulfill all directives under which it falls you are not allowed to issue CE declaration then until you not issue CE declaration you are not allowed to mark your product with CE mark, then until you not mark your product with CE you are not allowed to put it on the market. Dot.

The point is, there is no requirement of a certain form of this documentation. You document it in the form and degree you trust will be sufficient if authorities have a reason to ask for this documentation. Your responsibility is to prove the product is compliant. Period. Therefore I would not complain about "unnecessary paperwork". It is very necessary paperwork.

Having gone through this process, I highly recommend hiring consultant company because they can work out the list of required standards and highlight the parts that are relevant by just spending a few hours; even technically capable engineers (inexperienced in standards) would have to spend maybe weeks to understand all the legal requirements and document them to a satisfactory degree. Therefore even if you consider your own time cheap and consultant time say 10 times, even 20 times more expensive, it's still worth it. A few thousand gets you pretty far for CE and you can then concentrate on the actual product design.

For one-off artist projects or actual gifts, I would say don't worry, no one's going to sue you if the product is not actually harmful.

[wilhe_jo]

so the whole document you refer to is irrelevant.

Read the document. The blue guide is the bible for CE marking. Your example is totally different to the TO's problem

Again. There are guides to the CE directives and the blue guide. Together, they answer pretty much every question I came across the last 10+ years.

Yes, those docs are long.
And yes, I support your observation re. the value of good consultancy. But I think, this is quite a general thing. You can do your tax statements on your own, but a tax consultant is way cheaper when counting the hours needed to follow all changes in the laws....

However, the topic of gifts is a pretty difficult one.
It's kind of similar to selling kits or commercial samples.
Those routes to overcum customs troubles were way overstretched.

Don't get me wrong. There is a good reason to have this option for a customs declaration, and I do not think, that the EU "law" should be executed the way it is written for most non-commercial use-cases. However, I'm rather deeply involved in standardisation and the problem are those massive numbers of people that think they are smart because they "trick" the system.
It is absolutely impossible to have some algorithm (that's what happened with the TO, I think) or some customs guy judge whether a shipment contains something with commercial interest, or not. If you have a massive number of "black sheep's", all the honest ones get punished. That's how it's always goes... Sadly...

73

[SiliconWizard]

Regarding "kits", indeed, in most cases they need to be CE marked as well. The fully assembled kit is what must be considered for compliance - not the individual parts.

Actually, strictly speaking, kits are a bit more of a hassle, as you must provide assembly instructions and make reasonably sure the intended audience will be able to assemble the kit such that the resulting device will be compliant. That means giving clear instructions, intended for a specific audience that should be clearly stated in the manual (for instance, some age restriction, or otherwise mentioning some specific skills required, or excluding some mental illnesses, etc).

There are a few exclusions (like lab equipment for research intended strictly for professionals, and - probably for "legacy" reasons - radio amateur equipment, IIRC).

Also, as I hinted earlier, if you sell "products" as a "hobby", in your personal name and not behind a company, keep in mind you'll be *personally* responsible. Which is not the safest way of doing business. So if you're serious about selling stuff and don't have a company yet, that's the first thing you should consider, IMHO.

[Smokey]

Here is another question. 
Did you do the existing electronics design with any EMC compliance in mind?  How confident are you that it's anywhere near the required levels of conducted and radiated emissions levels? 
If the answer is no, then maybe prepare for a board redesign (or two) if you didn't get super lucky. 

[RoGeorge]

...
You could also try to lie to them that this is a personal gift not a product being sold, it's up to you to decide.

If you are truly selling, then you need to satisfy the legal requirements to sell in EU. Which brings us to the usual point:

As always governments steal our money and waste it on useless paperwork.

always ignroe jonpaul.
...

Should I take advice about whom to ignore, from somebody listing "try to lie" as an option to the useless paperwork?

The point is, talk about the topic, not about the users, please.  If you disagree with what jonpaul wrote, it's fine to argue against that post, but not by trying to diminish the user who posted.

Govs do steal and/or waste our money, we have had even a prime minister put to jail.  And by suggesting to lie to the paperwork, you yourself somehow admit the paperwork might be useless in certain situations.  So, after all, jonpaul was right.  Anyway, I won't insist about governments stealing money or not, or about paperwork being useless or not,

"always ignore Siwastaja".

See?!  Not nice.

[ebastler]

Again. There are guides to the CE directives and the blue guide. Together, they answer pretty much every question I came across the last 10+ years.

And yet, if you take the Blue Guide's definition of "placing on the market" literally, it does seem to include the situation of a grandfather making a toy for his grandchild. You quoted it yourself:

2.3.   PLACING ON THE MARKET
...
Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question after the stage of manufacture has taken place (51). This transfer could be for payment or free of charge. It does not require the physical handover of the product.
...

As soon as you build something that is not strictly for your own use, but give it to someone else, that is apparently considered "placing on the market". No matter whether it's a one-off, whether it's for monetary or any other consideration... That just does not make sense.

[artag]

As soon as you build something that is not strictly for your own use, but give it to someone else, that is apparently considered "placing on the market". No matter whether it's a one-off, whether it's for monetary or any other consideration... That just does not make sense.

And when the grandfather unknowingly uses lead paint, or fails to safely cover electrical connections, who is to blame ?
The government doesn't care too much about the personal distress but they do want to be able to say 'Look ! We passed a law to prevent this! It's not our fault!". And, sadly, they'd be right.

This is a long way from our low-voltage synthesizer with it's CE-marked power supply. But if everything were specified closely enough to catch one and not the other, there'd be even more paperwork and more bureaucrats to read it.

[SiliconWizard]

While making sure your homemade gifts are safe, especially when given to children, it's my understanding that it's not a case of "making available on the market", and so does not require CE marking.

The "Blue Guide" will tell you what you need to know: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2022.247.01.0001.01.ENG

2.2.   Making available on the market
—
A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.
—
The concept of making available refers to each individual product.

While, as some have pointed out earlier, payment per se is not a criterion; "in the course of a commercial activity" is.

Making gifts for your relatives and friends is not a commercial activity.
OTOH, selling products to people, even as just a hobby and even free of charge, is a commercial activity.

Sure there may be a gray area - that would become gray only if you try playing with regulations, really. If you send (as some have suggested before) products you make, marked as gifts, to a significant number of people that you don't even know, that's going to be a problem at some point. Also, while "free of charge" is not per se an indication of not being a commercial activity, OTOH, charging someone, while not a proof (you may just be charging the cost of the parts you used, and that's something you could do with a friend or relative too), is a sign of a commercial activity. Likewise, if you have a website advertising your products, then it would be sort of a dead giveaway you have a commercial activity, especially if people can buy from your website or from a link on it.

Lastly - there may be a part of the OP's adventure here that's not strictly related to the CE mark and making products available on the market: customs requirements. They don't seem to strictly ask for a CE mark (which may not be a direct concern of theirs), but a list of materials, in order to potentially block packages that would contain restricted substances. While the RoHS directive is part of the requirements for the CE mark, it's not the same thing.

[Siwastaja]

And yet, if you take the Blue Guide's definition of "placing on the market" literally, it does seem to include the situation of a grandfather making a toy for his grandchild. You quoted it yourself:

Maybe, maybe not - you make the classic mistake of ignoring scope of documents. I mean, for example traffic laws forbid driving over certain speeds, but on a closed track on private property this does not hold even without the law separately mentioning closed tracks because the law as a whole has a certain scope.

This is one of the most usual argumentation fallacies on online discussions where people use Google to find documents to support their statements. They don't check (or even try to apply common sense) if the document applies at all.

And this is also where the documents have the greatest shortcomings. They usually do have some kind of section trying to describe the scope, but in the end they are written by committees to convey the message to the intended audience (with less effort to underline to which audiences it is not intended). For example mentioning that something being "free of cost" does not remove the compliance requirements is obviously directed to plug loopholes, not to dramatically widen the scope of the document. (Common sense could be applied here, too: if something is mentioned as a small part of a sentence, it's effect should be fairly minor, too; like it can't dramatically change the coverage of the whole document.)

Anyway, this is more like a generic comment because SiliconWizard was able to find the clause which limits the scope. I tried to spend some 5 minutes but was not able to find it. To me it was obvious that the scope of the document must be commercial activity, not a grandfather making a wooden toy for their grandchildren, or even a guitar pedal hobbyist giving one to one of their acquaintances.

Which, after all this useless nitpicking and bullshitting as usual on this forum, leads to the main point, again:

* If truly a personal gift, appeal. Declaration of conformance applies only to commercial activity. Document how you know the recipient and why do you send him your DIY hobby guitar pedal, and you don't need a declaration of conformance because you are not putting a product in the market.
* If an actual product, do the paperwork, hire a consultant, prove the compliance. It is not unnecessary bureaucracy, it's to have safe products on the market. With the EU unified standards and self-declaration process makes placing new products on the market relatively easy. But it won't be free.

talk about the topic

Unlike your rants with zero information, my posts are at least 95% about the topic as you can easily see if you read them, but maybe I would have to use special font effects for you?