What is REACH?

The REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) was published in 2006. The list of SVHC’s (Substances of Very High Concern) currently consists of 224 chemicals demonstrated to cause cancer, birth defects, and to have other toxic impacts. The regulation was considered largely not applicable to most electrotechnical products, even though many of the 224 chemicals are commonly used in electrotechnical products.

REACH requires reporting and safe handling information of SVHC’s above 0.1% by weight. Unlike RoHS, which prevents the legal importation and sale of products above the relevant thresholds, REACH is a reporting requirement. Unlike RoHS, which requires a request of documentation by “a reasoned request from a competent national authority”, REACH documentation must be available to practically anyone requesting it, including any customer who asks.

The applicability to electrotechnical products has changed due to a European Court of Justice ruling and subsequent official Guidance published in December, 2015. Until recently, the weight of SVHC’s was calculated as a percentage of weight of a completed product, such as a circuit board or television. The threshold was rarely reached in practice. The recent ruling now changes the definition of “article”, and the SVHC is measured as a percentage of the weight of an article such as a lithium battery.

REACH documentation provided to a customer must include the names chemicals present above the threshold, and where they occur in the product. Safe handling information must be included under circumstances specified in the Regulation.

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RoHS Certification and Compliance

RoHS Compliance

Restriction of Hazardous Substances (RoHS) is a group of international environmental laws requiring the re-design of many electronic devices. We at Lead Free Design are cost-effective experts at RoHS Compliance.

We analyze your electronic products, provide RoHS compliant documents, and maintain them for you, all at a fraction of the cost of doing it in-house. For Europe RoHS, China RoHS, California RoHS, Korea RoHS, Japan RoHS and other RoHS directives.

RoHS Conversion

If analysis shows non-compliant parts in your product, we recommend substitute parts; if there are no direct replacements, we offer re-design of the affected sub-assembly; under special circumstances making redesign impractical, we can convert existing leaded parts into lead-free compliant parts.

Medical RoHS Conversion

We are specialists in Medical RoHS conversions. To ensure FDA compliance, medical devices require special methods and in-depth documentation during a RoHS conversion.  We protect your existing FDA certification and 510K with full verification and validation procedures.  And we analyze your supply chain using predictive life cycle tools.

  • EU RoHS
  • China RoHS
  • Japan RoHS
  • Australia RoHS
  • Sony Green
  • Mitsubishi Sumitomo
  • Korea RoHS
  • California RoHS

For China RoHS

After extensive product analysis, we provide detailed labeling instructions and camera-ready artwork specific to each of your products.

We supply the all important certified Supporting Documentation package, in Chinese, detailing the material content of the components of your product.  Without it, you will not survive a marking inspection or audit.

For all RoHS laws, including China RoHS

We maintain your RoHS certification, through design revisions, vendor changes and part substitutions. And we do it at a fraction of the cost of doing it in-house.  That way, your engineers are designing your next products, and your RoHS documentation is always current and on hand.  With relationships in 3500 component companies, we have over 50 component and material engineers maintaining your data and certifications.

And we defend our certification with RoHS Audit Protection. We provide the due diligence you need to survive an audit.  Our RoHS engineers are world class experts.

Additional Services 

In addition to our standard services, our experienced engineers are ready to provide these optional services:

  • Review of your design, procurement and manufacturing processes, with recommendations to ease compliance and ensure compatibility.
  • Review and testing of the actual physical parts using Underwriters Laboratories (UL).
  • Redesign of your products to meet requirements in a cost effective way.  For medical devices, we have an experienced FDA medical device engineering team on staff.

How It Works

  • You provide us your Bill of Materials (BOM) and Assembly drawings for each product.
  • We scrub your BOM through engineering review.
  • We research the MCD (Material Composition Declaration) sheets and IPC 1752 documents on each component.
  • For custom parts, our engineers determine material composition in a variety of ways tailored to the nature of each component.
  • We store relevant elements that make up each component.
  • We analyze your product at the assembly, component and material levels.
  • We generate the required compliance documents with proof of compliance.
  • We report accurate BOM, compliance letters and supporting documentation in one, indexed printed and electronic PDF document for each product.
  • We update your documentation whenever you make any changes to the product that may affect your certification, whether it is due to a part change, vendor change or assembly processes change.
  • We stand by you to defend our processes, testing and documentation if you are audited.
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Medical Devices No Longer Exempt

Medical devices are no longer exempt from the RoHS and REACH Directives.

If you haven’t converted to RoHS and documented REACH completely, you have exposure. And that puts your existing FDA approval at risk.

If your company is having component issues because your suppliers are switching to RoHS (lead free) compliant parts, you are definitely not alone.

What has changed?

As component suppliers are moving towards “lead free only” and discontinuing your leaded parts, you will be faced with redesign issues.

China RoHS and Medical devices

China RoHS required product marking for all electronic products beginning on March 1, 2007, including medical equipment. And unless you have supporting documentation down to the material level on all sub-assemblies, you will not survive a marking audit.

We can help

We are experts at Medical RoHS analysis and conversions

We help keep your staff focused on future products, not redesign work, by collaborating with them to convert your existing products to be RoHS compliant, while maintaining your FDA approval status.

And we do it cost-effectively. RoHS compliance is a major focus of Lead Free Design.

Why use Lead Free Design?

We have engineering and manufacturing specialists with experience in FDA compliance, electrical and electronic design, mechanical design, plastics engineering, metallurgy, hydraulics and pneumatics. Though some engineering firms have RoHS experience, we have the FDA Medical Device expertise you require.

During the conversion process, we work closely with your team (design, verification, documentation, supply chain, testing, manufacturing), so that your RoHS documentation is always up to date and available, leaving your engineers to focus your next generation of products.

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Waiting Until You Get Caught

We’ve helped clients in emergency situations, and then followed with lower cost, lower stress planning for compliance going forward.

Stuff happens. But this a problematic strategy to follow consciously.

  • The timeframe to get compliance documents from suppliers is usually too long. Especially if you are not a major customer of theirs.
  • Without the time needed to get compliance docs from suppliers, much more lab testing is needed, greatly increasing the cost.
  • Lab upcharges for expediting testing can be 50% or higher.
  • Depending on the Directive or Regulation, some EU courts have ruled that “a reasonable time for transmission” of compliance documentation is three days – the time it takes for Fedex to deliver the documents.
  • Squeezing the schedule too hard invites errors.
  • CE “Market Surveillance” means once you’re caught in one EU country (“member state”), national authorities are obligated to inform the other member states. This rapidly causes import problems in all EU member states.
  • Once you’re caught, authorities tend to look at your documentation very closely. For this and future shipments.

In other words, please don’t let this happen to you.

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What is WEEE Recast?

Waste Electrical and Electronic Equipment Directive 2002/96/EC (WEEE) set collection, recycling and recovery targets for electrical goods and is part of a legislative initiative to solve the problem of huge amounts of toxic e-waste. It was replaced by DIRECTIVE 2012/19/EU, called WEEE Recast. The WEEE Directive requires each member state to transpose the Directive into its own regulations. In effect, this creates a different implementation in each country, including varying requirements for registering and reporting.

What is included

WEEE applies to Electrical and Electronic Equipment (EEE). Unlike RoHS 2, the definition of EEE stays the same: “equipment which is dependent on electric currents or electromagnetic fields in order to work properly”.

WEEE Directive In Plain English

There are not enough landfills for trash in many parts of Europe; electronics tend to leach chemicals into groundwater when put in a landfill. WEEE is designed ensure that recycling happens more and more. Retail stores are obligated to take electronics back from consumers at no charge. Business to business commerce is a little different. Producers that sell Electrical and Electronic Equipment (EEE) are obligated to register in each member state where their EEE is sold. They are also obligated to recycle EEE that they sold. In a nutshell, you’re the “Producer” if your name is on the product label.

There are three steps:

  1. Register in each country (member state)
  2. Report total weight sold in that member state
  3. Arrange for shipping to a recycler

Registration is different for each country. Reporting is different for each country: some annual, some quarterly, some monthly, each may have different categories of reporting. Each member state has it’s own billing calculation for total products imported by weight.

There are several ways to accomplish recycling in each member state, including the Producer joining a compliance scheme as a member, arranging to have relevant products recycled, and in some cases shipping the product to the recycler.

Lead Free Design has the experience to assist you in WEEE compliance customized for your requirements and distribution system.

WEEE vs. WEEE Recast

We are in a transition period until August 15, 2018. In addition to new recovery targets, the number of categories changes from ten to the following six:

  1. Temperature exchange equipment
  2. Screens, monitors, and equipment containing screens having a surface greater than 100 cm2
  3. Lamps
  4. Large equipment (any external dimension greater than 50cm) including, but not limited to: Household appliances; IT and telecommunication equipment; consumer equipment; luminaires; equipment reproducing sound or images, musical equipment; electrical and electronic tools; toys, leisure and sports equipment; medical devices; monitoring and control instruments; automatic dispensers; equipment for the generation of electric currents. This category does not include equipment included in categories 1 to 3.
  5. Small equipment (no external dimension more than 50cm), including the same type of products as large equipment, except for Small IT equipment, which is treated as a separate category.
  6. Small IT and telecommunication equipment (no external dimension more than 50 cm)

Exclusions to WEEE requirements are now backed up by clear definitions, of particular interest are definitions for the “Large Scale” equipment exclusions.

Exclusions of interest are:

  • equipment designed to be sent into space
  • large scale industrial tools
  • large-scale fixed installations
  • equipment specifically redesigned for R&D and are only available on a business to business basis
  • medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices.
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What is RoHS?

Originally, RoHS (“Restriction of Hazardous Substances”) was the term applied only to EU RoHS.  It is now a generic term for any country’s environmental safety directive having to do (primarily) with reductions in six common hazardous materials routinely found in electronic information products.

EU RoHS

The original EU Restriction of Hazardous Substances Directive (EU RoHS) 2002/95/EC became European Law in February 2003. This directive restricts the use of six hazardous materials in the manufacture of various types of electronic and electrical equipment. Often called RoHS 2, DIRECTIVE 2011/65/EU went into effect January 2, 2013.

There are two important differences between RoHS 1 and RoHS 2:

  • RoHS 1 required Certificates of Compliance for the product, a kind of honor system. RoHS 2 added the requirement to have Technical Documentation that demonstrates compliance for every component in the product. This Technical Documentation must be produced for any “a reasoned request from a competent national authority”.
  • RoHS 2 is now part of CE, which in practice means enforcement is higher, and penalties greater than under RoHS 1. RoHS marking is no longer valid, as it is part of CE.

RoHS currently restricts the use of the following six substances in electrical and electronic equipment:

  • Lead
  • Mercury
  • Cadmium
  • Chromium VI (Also known as hexavalent chromium)
  • PBB
  • PBDE

PBB and PBDE are flame retardants used in some plastics.

These four phthalates will become restricted in 2019 and 2021, depending on product category:

  • DEHP
  • BBP
  • DBP
  • DIBP

While the environmental concerns vs. the economic impact continue, these banned substances can cause very serious health problems.

The maximum concentrations are 0.1% (except for Cadmium which is limited to 0.01%) by weight of homogeneous material. This means that the limits do not apply to the weight of the finished product, or even to a component, but to any single substance that could (theoretically) be separated mechanically – e.g. . the sheath on a cable, the tinning on a component lead etc).

As an example, a radio comprises a case, screws, washers, a circuit board, speakers etc. A circuit board comprises a bare PCB, ICs, resistors, switches etc. A switch comprises a case, a lever, a spring, contacts, pins etc. The contact might comprise a copper strip with a surface coating.

Everything that can be identified as a different material must meet the limit. So if it turns out that the switch’s contact coating was gold with 2300 ppm cadmium then the entire radio would fail the requirements of the directive.

Note that batteries are not included within the scope of EU RoHS, therefore Ni-Cd batteries are permitted despite the Cadmium. This is not true for China RoHS (more below).

RoHS applies to these products in the EU whether made there or imported.

For EU RoHS, many exemptions apply.  This is not true for China RoHS.

China RoHS

China RoHS requires stringent marking, and China-approved testing prior to product entry into China.

On November 6, 2006, China’s Ministry of Information signed three standards into law:

  • Marking: labeling and information disclosure
  • Levels: maximum concentration value
  • Testing: testing methods

EU RoHS compared to China RoHS:

  • EU RoHS compliance does not equal China RoHS compliance.
  • EU RoHS has no Marking requirements.  China RoHS Marking requirements are stringent.
  • Many components with EU RoHS certificates will still have hazardous materials which must be disclosed.
  • EU RoHS exempts many components from compliance.
  • China RoHS currently has no RoHS exemptions.

 

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Straight Answers: China RoHS

(Q:) OK, I’ve read everything I can about this new China RoHS “law”.  Give me the salient points.

As of March 1, 2007:

All products sold into China must be labeled for restricted substance content.  As almost every electronic product has at least one of the restricted substances, the labeling works like this:

  • Figure out the Environmentally Friendly Use Period (EFUP) and mark that on the product. It looks like an “e” with a number in the middle. 10, 20, 30, 50 years are common.
  • Then, analyze all the components in your product for the 6 restricted substances, aggregate them, and mark your product with a hazardous material “x/o” chart in Chinese.
  • Finally, analyze your packaging material for recycling purposes, and mark the materials. You might also have to mark your documentation and data sheets with this same information.

(Q:) That doesn’t seem so bad.

As usual, the devil is in the details.

To do this, you need to analyze, label, and you must have supporting documents for every component in your product at the substance level.

(Q:) Wait! The Chinese RoHS spec doesn’t say that!

Very true.  All it says is that you have to indicate which of the restricted substances are in your product.  Keep reading if you want to know why you absolutely must have substance-level supporting docs…

(Q:) But, I have all these European RoHS “Certificates of Compliance”

EU RoHS certs do not demonstrate compliance for China RoHS.

(Q:) Why not?

Because most EU RoHS certificates simply say “we meet the EU RoHS spec”.  Also – and this is a biggie – EU RoHS has many exemptions.  China has *none*.  Your EU RoHS certificate might say “no lead”, but what they mean is “no lead after considering all the exemptions”.

(Q:) Fine.  My vendor says they have a “China RoHS” certificate.

Doesn’t mean much.  China doesn’t want certificates from a vendor.  They want a simple chart – from you, in Chinese, showing which restricted substances are in your product. Your entire product.   The only way to know that is to analyze all the components, track the substances, roll them up, and then create the chart and the supporting documentation.

(Q:) My products are exempt from EU RoHS.

They are not exempt from China’s marking requirement.  Everybody has to label.  And to label, you need to analyze down to the substance level.

(Q:) Fine.  We will get to it later in the year when our China sales forecast justifies the cost.

You can’t.  Products without the necessary marking don’t get into the country anymore.

(Q:) Can’t we just put an “X” in each box of the chart and label the thing?

Sure.

(Q:) Great!  Hey, why are you laughing?

Because, you will get caught.

Think about it:  China is forcing the entire world to spend lots of money analyzing and labeling products.  They also spent lots of time and money coming up with the law.  And they will be checking, if only to protect their own industries.

(Q:) How will they catch me? They can’t check everyone for compliance.

Checking is easy for them.  All they have to say is “You have these boxes marked.  Can you show why you marked them that way?”

Also, the number of entities that can set an audit into motion will astound you: OEM, buyer, importer, wholesaler, retailer or ANY local official.

Even your competitors.

If your supporting document is not a substance level report, you face sanctions and penalties.  Nasty and expensive penalties.  Same outcome if all you have is reassurances and “certificates of compliance”.  They want you to have proof.

(Q:) Fine.  What do I need to support the markings?

You need to show them a list of the individual components and sub-assemblies, and you must identify the hazardous materials in each individual sub-assembly.  In Chinese.

(Q:) But the China RoHS spec doesn’t say this!  They don’t mention supporting documentation at all!

True.  The spec is purposely ambiguous.  Practically anyone can instigate an audit, and the only way to defend an audit is to have supporting documentation.  This is not like EU RoHS.

(Q:) Isn’t there an easier (cheaper) way to do this?

China RoHS is all about substance level declaration.  If you can’t prove it, you have a serious problem.

(Q:) My engineers tell me that substance level data is not even available on all commercial components.  What do you say to that?

They are right.  Published substance level data is not available on all commercial components, especially passives.  There are still ways to get the answers.  Worst case, you can crush up the parts and measure them in a mass spectrometer.  XRF guns are an option too.

(Q:) So, in order to compile this huge phone book of supporting documents, I have to get the material content of *every* component from each of my vendors?

Yes. You must have substance level proof for every component in your product.

(Q:) And translate it into Chinese too?

The Chinese seem pretty insistent on having all the documents in Chinese.

(Q:) I don’t have this budgeted.  We don’t have the time to do this.  My Engineering manager didn’t tell me this.  You are just trying to spread FUD.

The experts have been saying this for 9 months.  Experts with nothing to sell to you.  This is not a “nice to have”.  This is a “must have”.  Most consultants offer various recommendations.  We, on the other hand, are not paid for our “advice”.  We get paid to do the work and keep you out of trouble.

(Q:) The Chinese government can’t audit everyone.  I’ll take my chances until I have more China sales.

Good luck.  As mentioned earlier, the real risk is NOT from the Chinese government.  It is from everyone else in your distribution chain, as well as the risk that your competitors can turn you in.

(Q:) Wait. My competitors can audit me?

The spec says everyone who accepts responsibility for your product – OEM, importer, wholesaler, distributor, and retailer – accepts responsibility for your labeling.  If your labeling is inadequate, wrong or unsupported, they risk the same sanctions that you do.

Kind of like passing around a phony $100 bill. The last person who gets caught with it loses the $100 and has to speak with the authorities.  That makes people very nervous.

If you knew you could be left holding the bag, wouldn’t *you* ask to see the justification for the marking?  Wouldn’t *you* delay taking possession of the product until you were convinced it was correct?

All it takes is a well placed competitor telling *your* distribution channel that they are at risk – because you don’t have supporting documentation.  And they’d be right.  The Chinese were smart.  They made everyone responsible, and therefore there are many potential enforcement agents.

Your OEM/Buyer/Importer/Wholesaler/Retailer is thinking like this.

Q:) OK, you made your point.  What is your pitch?

It is simple. The only way to comply with these laws is to know exactly what is in your product.  We analyze your product, produce certified documentation, and keep it updated.

Here is how we do it:

Under NDA, we analyze your BOM along with your assembly drawings, where more components are usually found – on a product-by-product basis.  Remember, your supporting documents need to be on a product-by-product basis too.

Then we get the material and substance list directly from the component manufacturers and analyze the substances.  If you specified custom parts, we get the information directly from the engineering specifications.

Since we know all the restricted substances and levels for all of the different RoHS laws, and we know the substances in your product, we generate evidence of compliance.

(Q:) That is going to cost a fortune!

Compared to what?  The risk of not doing it is penalties, payoffs and product sitting in quarantine. The numbers speak for themselves.  We do it for a fraction of what it will cost you to do it in-house.  Besides, aren’t your engineers supposed to be designing the next quarter’s new cash cow?

(Q:) Then what?  How do I maintain all these different RoHS documents?

As part of our annual service, we maintain them.  Important, since you will probably be changing your products all the time.

Typical example #1:

Engineering wants to change a part.  You feed it to us as part of the change review, and we tell you if it is compliant – for all the RoHS laws at the same time.  When you actually change the part, we update your documents and send them back to you.  Your supporting documentation is always up-to-date and available to anyone who may demand it.

Typical example #2:

Purchasing wants to change a part – or 20 – because the lead times are better.  Or because the price is better.  Whatever the reason, you send us the proposed changes and we quickly verify compliance (usually in a day or so).  When you actually change the parts, we update your documents and send them back to you – for all the RoHS laws – and all RoHS languages at the same time – even Australian.  You have version controlled supporting documents, specific to each product and revision.

(Q:) You keep mentioning this Australia RoHS?  I don’t want to keep paying for every new RoHS law that comes along.

Assuming the new laws are all asking for the same type of information: “what substances are in your product?” we provide coverage for new RoHS laws because we already know the answer.  We might have to translate it into Australian, though.

(Q:) What does this service cost?

It depends (but you knew we’d say that).

Mostly it depends how many products you have, how many parts in each product, and how many of those parts are custom.  Commercial off-the-shelf parts are easier – therefore cheaper – to get substance data for.  Custom parts take more time and effort.

The initial cost to get down to the material level is more expensive than to maintain the documentation.  After that, the annual cost is inexpensive.

(Q:) I already have my products marked.  But I could use some help on the supporting documentation.  Maybe quite a bit of help.

We understand.  Since you must have the supporting documentation, that’s what we do best.

(Q:) How do I get this process started if I want Lead Free Design to do it?

Email us with some general information:

The number of products, brief description of what each product does, maybe a picture or data sheet, number of commercial components for each product, the number of custom components for each product.

Or call us at (719) 785-4888.  We’ll just ask you the same questions, but sometimes it is nice to talk to a live engineer.

Ask us. We’ll tell you how much it will cost and how long it will take.

(Q:) Anything else?  This didn’t exactly make my day.

We are sympathetic.  Most of us were designing something really interesting, like FDA-approved medical devices, and Boeing jets, before these RoHS requirements showed up.

We know you want to get out of this in the least expensive, fastest way that you can.  That is our goal too.  No need to make work where there isn’t any.  Many of us have advanced business degrees too.  We feel your business pain, as well as understand your engineering problems.

We are cost effective and efficient experts at RoHS.

That makes it cheaper and easier for you.

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