Hi, welcome to this presentation on the RoHS compliant meaning: Everything you wanted to know about RoHS.
We will try to address as much information as possible so here are the different topics we’re going to cover:
If you have specific questions you can also send us an email at contact@getenviropass.com, especially if it’s you have something very specific to your products or anything like that.
So before starting: who is Enviropass? Enviropass is a consulting company dedicated to the field of product environmental compliance. We do RoHS consulting, of course, we also cover REACH, WEEE, California Prop. 65, Conflict Minerals, POP, ELV… Everything related to product environmental requirements!
We are specialized in electronic electrical devices, but we also cover other products.
You can follow us on LinkedIn and you will have access to the most recent news in this field, so you can follow the Enviropass page on LinkedIn and we also have a YouTube channel. By the way, this presentation will be on the Youtube channel, so you could share it with your colleagues and other presentations are on this channel as well, so you are welcome to join. Also, we have prepared an online course on product environmental compliance which covers RoHS compliant meaning, REACH, and all other requirements. So, it’s an introduction to product environmental compliance. The price is very decent. It’s an around forty Canadian dollars online course of about three hours. Feel free to register and to get a road map and a broader point of view of what may apply to your products. Why do the different requirements exist and how do they apply to your products?
I am Aury. I am a certified environmental auditor. I’ve been doing this kind of business for over ten years now. Any questions? You can email me at contact@getenviropass.com.
This is not an exhaustive presentation, but it will describe the situation concerning RoHS, right now, at this time.
News for RoHS2 was the CE Marking. When you CE mark a product or if you see a CE mark on an electronic device, this means that the product is RoHS compliant. If it’s in the scope, so it’s a kind of signature so if you see mark your product, you are saying among all those other things that your product is RoHS compliant. It better be true.
Are you in the scope? That’s the question and you need to look at article 2 of RoHS and you will see the reference to Annex I where you have product categories. You will see whether or not you fall into this product categories and typically you will because the last category is ‘any electronic equipment. If you don’t find your product is in the different categories, like for example, medical devices or monitoring instrument, if you don’t see your product there, well you will eventually fall in the last category. RoHS would apply to you except, if your products are solely for military purposes, for example, aerospace or automotive, because you have another regulation for automotive devices. Automotive products which is the ELV regulation for End of Life Vehicles. Or, unless you manufacture batteries because there is a battery directive. Or packaging which is out of the scope of RoHS. It’s under the packaging directive. Other than that, you have a few other exemptions that are listed in article 2 of the directive.
Also, it’s important to pay attention to article 3, because under article 3, we see some definitions:
Here’s the list under annex I of the scope so you see:
All that is is in the scope right now, even the last one: other EEE, which is for electrical electronic equipment. So since last year, even if you are under the older part of it, what you are in the scope.
Very good question ok a large-scale tool needs to be very large I mean very. larger than a fridge. If you look at the FAQ of the RoHS compliant meaning, it has to be bigger than a container, like a truck container. And it has to be installed by professionals only. Also, there is some weight threshold. So, you need to exceed the weight threshold. Look at the FAQ from the European Commission. If you don’t have it. I can send it to you. You will see they give you some guidelines. We also provide opinion letters. We have some customers that were on the fence, not sure whether or not their products are excluded. We will verify that for you.
Some categories were excluded. The last category was excluded last year on July 23rd which was category 11. So right now, other than few exemptions or some medical devices, most of them would fall in the scope.
Now, what is the certification? How do you get your products certified? We are going to discuss this at the end or throughout this presentation. But what you need to get at the end of your product assessment is a Declaration of Conformity which we will be part of your DOC, i.e. Declaration of Conformity.
The Declaration of Conformity should contain the wording that is indicated in Annex VI of the RoHS directive. For example, you need to have some specific details that are listed here. You need to specify that this declaration is issued under the sole responsibility of the manufacturer. For example, refer exactly to your product. What type of product? And very important, indicate the standards that you use to prepare your technical file and your Declaration of Conformity. And typically, that should be the IEC 63000. We’re going to discuss that later. Also, the exemptions. We will see that your product can be RoHS compliant without any exemption. It can also be proven as compliant with some exemptions, for complex products like yours. You would typically have at least a couple of exemptions that allow lead above the threshold for some specific applications. Let’s say, for ceramic of some capacitors you will need Lead above the regular threshold. We’re going to discuss it with the RoHS compliant meaning, which is the main question.
If you look at the directive itself and article 4 you will have the reference to an annex. Annex II. Annex II gives a list of substances with the threshold. This is the list of substances. Six substances with the threshold of 1000 ppm part per million which is equivalent to 0.1% for heavy metals: lead mercury cadmium hexavalent chromium. Except for cadmium which is only 100 ppm so 10 times lower concentration, i.e. 0.01 percent per material. There are also two brominated compounds PBB and PBDE. They are used in plastics, typically in PVC plastics, maybe rubber, and other types of plastics. The threshold is the same as all the other substances. 1000 ppm, 0.1% except for cadmium.
Now, since 2015, four other substances have been added to this list. If you look at the original version of the directive 2011, you won’t see these four phthalates, four additional substances that are the BBP, DBP, DEHP, and DIBP. The threshold is the same 0.1% and this applies since 2019, since last year, for most product categories, except two exclusions for medical devices. If you manufacture medical devices, you’re still in a grace period until next year July 22nd. By the way, most of the time, the regulatory changes for RoHS apply in July, and monitoring control instruments are also excluded for the phthalates. Not for the first 6 substances, i.e for lead, mercury, cadmium, etc. but only for the four phthalates. You can still use them as much as you want, until next year. So, you just have one year to correct the situation, to make sure that your product will still pass next year. This means that the product that is compliant today is not necessarily compliant next year. So you need to keep your technical file up to date to make sure that you will remain compliant.
For lead, you would find them in particular in PVC plastics. You will say PVC is a pet peeve in terms of environmental compliance because you may have many additives. When we say lead it’s not only pure lead. Usually, it’s not. Lead and lead compounds like lead monoxide for example. You will see lead in glasses and screens, in the glass of fuses, in solder. Be careful, because if you verify all your BOM (bill of materials) that’s very good but you also need to include your consumables like solder, paste, paint that may not be RoHS compliant. As discussed, you also have lead in ceramics and there are a couple of exemptions for lead and ceramics, for example.
What about mercury? Mercury. You will find it in this place. Interestingly enough, infuse also. In batteries, even if it’s out of the RoHS scope. For the Battery directive.
Cadmium. Interestingly enough, cadmium is used in plastics. You know, if you have a color like a pigment, a color from yellow to red, it may contain cadmium. There are many replacements, other colorants but the industry used to use Cadmium. Same thing for PVC cables. They may contain Cadmium. Also, in connectors, because we would use Cadmium as a finish, or a coating, connectors for their physical properties. It’s it’s useful. It’s interesting to get Cadmium.
Hexavalent chromium. So, it’s not every type of chromium just the hexavalent form of it, used for example as a finish. Normally, it’s replaced by a trivalent form of chromium but the trivalent is slightly more expensive. Some companies that are not familiar with the rules or sell only for let’s say for aerospace industries may still use hexavalent chromium and so we need to make sure that you have a trivalent chromium part, not a hexavalent chromium one.
Again, for cadmium or mercury, it’s not only the pure form of cadmium or mercury but every compound.
PBB and PBDEs are families and are used as flame retardants. You expect them in plastics.
The four new phthalates we just discussed, DEHP, BBP, DBP, and DIBP are individuals that are typically found in PVC plastics. They are found in all the type of plastics, possibly and also in rubbers.
Lead is very well known. You know if you have too much lead in your water. It’s neurotoxic. Other substances are also a carcinogen, mutagen, reprotoxic and that’s why we try with RoHS, to reduce the amount, the usage of these substances. The level as discussed is 0.1 percent for all of them except cadmium at 0.01 percent.
The percentage applies at the homogeneous material level. This is a very important key concept. Key information. Because, let’s say someone tells you: okay, my product is RoHS compliant and below 0.1%. Is it 0.1% of the whole device? No, it’s for every material within the device, within a component. That’s the most important information you will need to remember from this presentation that it applies at the homogenous material level. What does it mean?
A homogenous material is defined in the directive as a material of uniform composition throughout or material consisting of a combination of materials that cannot be destroyed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding, or abrasive processes. What does it mean? It means, let’s say you have a resistor, quite a simple part. You will still have different homogeneous materials, for example, the connecting lead, the end cap, ceramic substrate, carbon field. Maybe you have five different materials in this resistor, so this means every single material needs to meet the requirement of 0.1 percent for the ten substances and 0.01 for Cadmium.
What about a LED simple part? Same thing. Different materials maybe five, five-ish, different homogeneous materials in it. A ceramic capacitor? Different materials. Up to a dozen of materials. A cable? Same thing. Don’t forget screws, mechanical parts, custom parts. All of these needs to be RoHS compliant. We find a lot of cadmium in some finishes of screws. Some finishes, like for example zinc finish, may contain cadmium above the threshold, depending on the type of finish that is used. So, you need to make sure that the whole assembly, the whole product, is RoHS. There is no de minimis. Nothing can be excluded, except batteries and packaging because they have other restrictions in their regulations or directives, that are stricter. It’s more demanding, so there are no possible exemptions. For example, what do you do when you have an assembly, a sub-assembly like this one? You may have 30 different components, maybe 150 homogeneous materials.
How do you make sure that all of these materials meet the requirements? Are you going to test 150 x 10 substances? That should be 1’500 tests. It will cost you an arm and a leg.
There is another option. We’re going to discuss that. Especially for complex products like yours. Maybe your BOM contains 150 components, maybe over. Maybe over 1000 homogeneous materials! What are you going to do with that? And even if you would take the test. Let’s say you cut, you dismantle this assembly and you will find a way of getting every tiny single homogeneous material. let’s say you analyze them.
Then you will have destroyed your product. First of all, it may be costly. The testing itself will be very costly and you would just have a picture of the compliance of this product. You won’t get any commitment from your suppliers. So, let’s say this supplier has a new batch. Let’s say you change a supplier. Let’s say you change a source. What do you do? You don’t have a guarantee that the new source is RoHS compliant. Are you going to do another test? That’s not reasonable. There is another option.
On top of it, there are exemptions. So let’s look at the exemptions. You can access the exemptions from our website at https://getenviropass.com/europe-rohs/. If you go on the website. Maybe I can share that with you. So you would go on enviropass.ca and you will have access if you go under services, RoHS, EU RoHS. Then you would have access to the exemption lists. So let’s download the general exemption list. You need to get up-to-date exemptions because the exemptions are updated regularly. They are reviewed and have expiration dates, so if you look for example the very popular exemption 6a-1 – lead in steel alloys, you can have lead in steal alloys above the threshold. So, feel free to download these documents. If you want to look at them, there are also some general specific exemptions to medical devices. So medical devices benefit from general exemptions plus specific exemptions. Control instruments: same thing. You have 40-ish general exemptions plus specific exemptions. You may benefit from medical device exemptions. I give you an example. You go to the dentist, take a radio. Well, you need lead to protect the dentist from radiation. So, there is an exclusion for some shields in lead. Now if I go back to a presentation here. So, we will keep you up to date if you follow us on LinkedIn. That’s probably the best way to keep updated.
Let’s say an exemption expires. What do you do? You need to contact your suppliers for their exemption and ask them: do they have the new exemption or are they able to update their statement and provide a statement without this exemption? Maybe you would have to find a new source. 6-(c) is an exemption that is very popular for the copper alloy containing lead up to 4%. Not above, but up to 4% of this specific copper. You will need to list this exemption in your technical file. Some exemptions have expired, for example, the 7-c(III). We had the lead in dielectric ceramic in capacitors for low voltage. It’s no longer possible to benefit from this exemption. So, let’s say you collected the declaration of conformity a couple of years ago. It’s no longer valid. If the supplier claimed this exemption it has been removed. Some exemptions are split. This should be reflected in your declaration of conformity.
So, the homogenous material level is very important information and the exemption status is another very important key concept under RoHS. If you understand these two key concepts, you can navigate through them quite easily.
Here is an exemption that is very popular: 6-a with steel alloy with the lead up to 0.35 percent. It has been replaced last year by 6- a(I). So, the beginning is the same but they added a new restriction and in that hot-dip galvanized steel components containing up to 0.2% lead by weight. Every five years, by default, these exemptions are revised, but it could happen any time. It’s by default every five years. They are reviewed and eventually changed so your technical documentation should reflect these details on the exemptions. You should actually.
If you look at the regulation under article seven, the directive says that the manufacturer must draw up technical documentation and carry out internal procedures. So, you need to have procedures in place to explain:
These RoHS procedures must be in place for series production to remain in conformity because the regulation changes all the time, your design changes, etc. So, let’s say you find a new source. You find a new part etc. it should be reflected in your procedures, in your technical documentation. You need to keep the information for 10 years. So let’s say you change the model. You have to keep the file to be able to demonstrate compliance for the last ten years.
Question. We got a question about the machine’s power tools. Well unless they would be a large-scale tool, they would fall under RoHS. They may benefit from specific exemptions if they are monitoring instruments. But if they are just machine-like power tools typically general exemptions would apply for the whole product, unless it’s considered as a large-scale tool. In that case, you would be excluded from the law. If it’s not that big let’s say it’s as big as a table. if it’s an assembly line or part of the assembly line, it would still be in the scope unless it cannot be dismantled. It can be work solely.
Other questions if the design changes do we need to get revised conformity? Well, a very good question the quick answer is yes: you will need to make sure that your technical file is up to date. So what I suggest, recommend, is any time you purchase a new part, any time you consider a new part, verify whether or not it’s RoHS compatible. Any time you find a new subcontractor for a new design, verify with your contractual arrangements that they will provide you RoHS compliant parts, so you won’t have any bad surprises.
So, you have two sources of possible information to build your technical file, to do your assessment. One is analytical testing meaning chemically testing every homogeneous material and the other option is the documentary review and for complex products like the power tools for example go with the documentary review, meaning you will gather the information from your suppliers. If you go down to the supply chain, at the end of the day, you will go to a smelter, for example of aluminum bars, just one homogeneous material, very easy to test, to do chemical testing. So why don’t you benefit from the test that has already been done by your suppliers or the supplier of your suppliers? Then you would gather their documents. You don’t need chemical testing from them. That’s not what you want. You don’t want a test report, because a test report is just for a sample.
What you want is a commitment from your suppliers, whether a certificate of compliance or a commitment from them. And you need to make sure that this certificate of compliance is up to date, is comprehensive, covers your part, covers the information about the exemptions. Very important. So, analytical testing is not that difficult if you have just one homogenous material. Then, you could use x-ray fluorescence, send it to a lab. They will test. In this example with the x-ray gun, it would test copper and verify the heavy metals especially lead in copper. This is possible. Now if you have multiple homogeneous materials, as discussed, it will be harder. Very hard also if you want to test the phthalates or the PBB, PBDEs. You need to go into all the more costly testing. So definitely, use the documentary approach by default. First, don’t do these testing or your complex products but ask your supply chain, your suppliers, to provide you with certificates of compliance. You would typically use the standard IEC 63’000 or that’s the same European 50581. This standard has been designed for complex products. So, the European Union is aware that it’s impossible to test all of these substances, but they will recommend the documentary approach.
In essence, your technical file should demonstrate what the is the products RoHS compliant meaning.
I see a question do we need a certificate of compliance for a component that is by design not containing regulated chemicals such as known still grade or natural materials, such as wood cotton. No, the answer is no. If you are sure. Now, what it the RoHS compliant meaning of an aluminum part? You have the aluminum alloy. You can verify the aluminum alloy material content and you can verify yourself. Make sure this part does not contain any RoHS substances. Let’s say on your drawing sheet, you specify exactly the alloys, the specification the military or the ASTM alloy, then you can archive this drawing as proof of compliance. But if you have a finish, the same thing. You need to specify exactly the finish of the drawing. Some drawings say: All these parts must be RoHS compliant. It’s not sufficient in my opinion. From my standpoint, I’m telling you it’s not sufficient to demonstrate compliance if it only says all these parties Europe RoHS compliant. What is the exemption status? If it only says RoHS, are we talking about the EU, China? We’re going to see that there are different rules regulations so it’s important to pay attention to that. So the answer again is yes if you are sure if you know exactly every material in your product.
The IEC 63 000 says the technical documentation should be used for complex products since its introduction. It says that it’s impractical for manufacturers of complex products to undertake their testing of all materials. Instead, manufacturers work with their suppliers to manage to comply and compile technical documentation as evidence of compliance. That’s the idea. This approach is well recognized by both the industry and enforcement authorities. What does it mean? That you will never do XRF analysis or any chemical testing? No. The answer is no. But only as a last resort, you would do it. You would target specific materials that you have not received any confirmation from the supplier, and you are stuck with this material because you don’t have any alternative source. It’s a kind of monopoly. You cannot find other sources. What do you do? What your supplier should have done, aka the testing, You would do it and you will hope that it would pass but what do you do? You will have a testing program. You would do it every month, maybe every week, every year. It depends. Just make sure that it’s still compliant.
So, the idea is:
Well, that’s it about RoHS. I wanted to this is. The gist, in a nutshell.
You have other regulations worldwide. The RoHS compliant meaning differs from a country to another.
China. It has different marking, different thresholds, different rules. Some similarities but different rules. So, if you export your product to China, and you say: I am EU RoHS. Very good. But you need to make sure that you have a table. For China, it will help you but the rules are slightly different and there are other regulations everywhere now in the world even in California, California RoHS, in New Jersey, in the United Arab Emirates (UAE RoHS) with some similarities but the obligation to have an audit from a local agency. Taiwan RoHS same thing depending on your product. Turkey RoHS, you need to register every year in Turkey and provide your certificate of compliance. Russia and some neighboring countries just have issued a RoHS-like regulation and also it has to go with the local agency. Ukraine has a RoHS regulation. New Jersey. Brazil is drafting one and all the countries as well.
That’s the question we all wonder: what if you get caught? Let’s say your product is not RoHS compliant. There are different powers of enforcement:
There is a website called Safety Gate Rapex which is managed by the European Commission. On this website, you will see some consumer products that are not RoHS compliant. Only consumer products but professional industry products are also targeted. There are not on Rapex but they are also targeted. This is one example. For this USB cable. Just this year, by Sweden. Another example here, plastic contains SCCP. This is not regulated under RoHS but REACH.
Other regulations, like REACH, POP that applies in the European Union. So let’s say you are RoHS compliant. That’s very good but you also need to comply with every product environmental requirement in Europe. Lead also was above the threshold for this multimeter and it has been withdrawn from the market, not complying. This mouse, same thing. This adapter had cadmium above the threshold, with no exemption. Was withdrawn from the market by Slovenia. You see, it is Slovenia that found it, but it is withdrawn from the whole European market. Same thing here and the European Union is aware that many products don’t pass and they have readily issued a new regulation last year to increase surveillance for RoHS, REACH, the battery directive, and the packaging directive. This means that we expect more surveillance next year. They are supposed to send every member state to the European Union. Would have to send a report to Brussels to say how it goes if it’s improving, how many like a percentage of products that didn’t pass, etc.
A question: Can a once-provided product return to the market if changes are done to correct the situation? Yes. As long as you update your technical file, you demonstrate that you have corrected the situation. You would be able to go back, to return the product. However, it’s very costly, in terms of image, especially for your customer’s products. Blocked on the border, you have to pay every day. It’s stuck at the border plus if you have a recall notice, it’s super expensive. But the answer is yes, you are not withdrawn from the market forever. Thankfully.
Before I let you go, the future is maybe the true RoHS3, with the addition of any of these substances not before 2023: The TBBP-A and MCCPs have been recommended already. The other substances are still under investigation, so far we don’t know maybe we will stay with ten substances, twelve, maybe more maybe it will be a RoHS recast number three third version or maybe it will just be an amendment of the current RoHS regulation. Also, the exemptions are continuously revised so this is for sure.
Do you have examples? I’m not sure about the question. If you are talking about some chemical testing it can go from let’s say it’s one homogeneous material for the lead only that $200 so it may go from 200 to thousands of dollars per homogeneous material. If you do so it’s way better to do the used IEC 63’000 approach documentary approach and then you would gather the information from your suppliers. You benefit from the tests they did but you ask them for a certificate of compliance. Make sure it contains exemption status all the information and purpose will help you with these so if you send us the BOM, we would verify. We will contact your suppliers and make sure that the documents are up to date we’ll do the risk assessment. I will verify all of that for you on your behalf, for a very tiny portion of the price.
Was about the penalties. If your code at the border is not too expensive, talking about dozens of thousands of dollars. Not too expensive. What is expensive is that it damages your image and the recalls are very expensive because you have to pay for every part going back to Canada or to the US and modify the design, modify the product. In that terms, it’s very expensive.
In this sense, how do face these amendments well? We have developed at Enviropass as a form. It’s free. You can use it at your best convenience so if you would go under the website product compliance form and you would open the form. It’s an Excel form and in this form, you would have details so if you are not too sure what type of information you need to gather, send this form to your suppliers, ask them to fill in the form, as long as it’s well filled in with the exemption details, if it’s RoHS without exemption, with exemptions or not compliant, you have different tabs. So, one for EU REACH. We may discuss it in the original coming webinar. Prop 65, battery, packaging and you will keep archived this document. Other proofs are the certificates of compliance may be along with other details depending on the part.
Let’s say your product was compliant last year and some exemptions have changed, have been updated, you didn’t know you were now aware. Well, unfortunately, your product is no longer valid this year and the surveillance Authority may ask for your technical file. First of all your declaration of Conformity, if you’re a declaration of conformity does not contain the exemption status, they will ask for more details, a technical file that’s why I highly recommend having the exemption status directly on the technology on the Declaration of Conformity.
A constellation of many regulations. You see RoHS it’s about the restriction of substances and products that you have so many other regulations which are a mix of restriction of substances in product or declaration of substances in products. If you want to get more, to know more about these different regulations I highly encourage you to go on the online course, which is managed by the Heroxx Compliance Academii platform, so you would go. You would register and get more details on these different regulations. It’s an introduction. It will give you a broad image, a broad picture and that was it for today. So if you have any other questions, feel free to post them. We still have 3 minutes left so I can answer right away or send it by email. You can send it by email at contact@getenviropass.com I will also send you this presentation so that you can keep it in your records. This YouTube Live will also be available so you can share it with your colleagues.
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