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 Substances Explained

While there are sometimes heated discussions about the economic impact of environmental laws, it might be helpful to summarize what the ten current EU RoHS materials are, where they are commonly used, and some of their less than desirable effects on humans:

Lead

Lead is a heavy metal that occurs naturally in the environment and is produced from man-made sources. Most exposures to lead come from lead paint and emissions from industrial facilities like metal smelters. Other sources of exposure include crystal tableware, porcelain enamel and contaminated food. Lead is a suspected carcinogen, a known hormone disruptor, and can damage almost every organ and system in the human body, particularly the nervous system. Lead has been indicated as a cause of decreased mental ability, developmental delays, behavioral disorders and reproductive defects.

Lead is/was commonly used in the electrical and electronics industry in solder, lead-acid batteries, electronic components, cable sheathing, in the glass of CRTs etc. Short-term exposure to high levels of lead can cause vomiting, diarrhea, convulsions, coma or even death. Other symptoms are appetite loss, abdominal pain, constipation, fatigue, sleeplessness, irritability and headache. Continued excessive exposure, as in an industrial setting, can affect the kidneys. It is particularly dangerous for young children because it can damage nervous connections and cause blood and brain disorders

Mercury

When inorganic mercury enters the air from these human sources it is then deposited in soil and water, where micro organisms transform inorganic mercury into organic mercury compounds, such as methyl mercury. Methyl mercury can bioaccumulate in the fatty tissues of living organisms, particularly fish living in polluted waters, and the people who then eat those fish. Mercury is a recognized developmental toxin, and it is also a suspected hormone disruptor, neurotoxin, reproductive toxin and respiratory toxin.

Mercury is one of the most toxic yet widely used metals in the production of electrical and electronic applications. It is a toxic heavy metal that bioaccumulates causing brain and liver damage if ingested or inhaled. In electronics and electrical appliances, mercury is highly concentrated in batteries, some switches and thermostats, and fluorescent lamps.

Cadmium

Cadmium is a heavy metal that comes from both natural and man-made sources. Most exposures to cadmium come from pigments and bake ware, as well as electronic equipment, car parts, batteries, phosphate fertilizer, sludge applications in agriculture and contaminated food. This heavy metal is known to cause lung and prostate cancer, and is toxic to the gastrointestinal tract, the kidneys, and the respiratory, cardiovascular and hormonal systems. Cadmium components may have serious impacts on the kidneys. Cadmium is adsorbed through respiration but is also taken up with food.

Due to the long half-life in the body, cadmium can easily be accumulated in amounts that cause symptoms of poisoning. Cadmium shows a danger of cumulative effects in the environment due to its acute and chronic toxicity. Acute exposure to cadmium fumes causes flu-like symptoms of weakness, fever, headache, chills, sweating and muscular pain. The primary health risks of long term exposure are lung cancer and kidney damage. Cadmium also is believed to cause pulmonary emphysema and bone disease (osteomalacia and osteoporosis).

Chromium

Chromium and its oxides are widely used because of their high conductivity and anti corrosive properties. While some forms of chromium are non toxic, Chromium (VI) is easily absorbed in the human body and can produce various toxic effects within cells. Most chromium (VI) compounds are irritating to eyes, skin and mucous membranes. Chronic exposure to chromium (VI) compounds can cause permanent eye injury, unless properly treated. Chromium VI may also cause DNA damage.

Brominated flame retardants (PBB, PBDE)

The 3 important types of BFRs which can / could be used in electronic and electrical appliances are Polybrominated biphenyl (PBB), Polybrominated diphenyl ether (PBDE) and Tetrabromobisphenol-A (TBBPA). Flame retardants make materials, especially plastics and textiles, more flame resistant. They have been found in indoor dust and air through migration and evaporation from plastics. Combustion of halogenated case material and printed wiring boards at lower temperatures releases toxic emissions including dioxins which can lead to severe hormonal disorders.

PBDEs are highly persistent and bioaccumulative and they are suspected hormone disruptors and can cause cancer reproductive and developmental disorders. PBDEs are suspected of having particularly damaging effects on the thyroid (which controls brain development), and as a result, PBDEs may cause neurodevelopmental disorders such as learning disabilities and behavior problems. PBDEs leach from products, and have been detected in house dust, human blood and breast milk.

Phthalates (DEHP, BBP, DBP, DIBP)

Added as part of DIRECTIVE (EU) 2015/863 which was published on 31 March 2015, this restriction takes effect on 22 July 2019 except for Category 8 Medical Devices and Category 9 Monitoring & Control Instruments, which takes effect 22 July 2021. Bis (2- ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DiBP) are usually found in plasticizers in PVC, rubber or other polymers (cable/wire/tubing), in sealants and adhesives, in flexible varnish/paint/coating/ink and certain glass.

Phthalates have been demonstrated to cause endocrine disruption; children are considered to be particularly vulnerable to negative health effects.

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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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