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.

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.

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.

EU REACH Enforcement Project Launched

REACH is now being aggressively enforced via the SCIP database and Market Surveillance Regulation. If you are selling into the EU and do not have compliance data available, you have very real exposure.

The Forum for Exchange of Information on Enforcement (Forum) is a network of authorities responsible for the enforcement of the REACH, CLP and PIC regulations in the EU, Norway, Iceland and Liechtenstein.

The Forum has announced the first EU wide project focused on articles, beginning in October, 2017. Electronic products have been considered articles since the fall of 2015.

Until now, enforcement action has focused on the upstream, such as chemical registrations, Safety Data Sheets and their quality. Widespread evidence of non-compliance has been discovered by certain Market Surveillance Authorities (MSAs) and campaign groups. The European Chemicals Agency (ECHA) also points out that it has received fewer notifications than it would have expected.

While these obligations apply to all SVHCs, there will be a particular focus on the following substances:

  • brominated flame retardants (HBCDD used in expanded polystyrene foam but also as in encapsulants – note that this is restricted in the EU as a POP)
  • phosphorous flame retardants (TXP used in PVC and other polymers)
  • phthalates (used to soften plastics and rubbers)
  • short-chain chloroparaffins (SCCP) (another plasticizer and flame retardant, also now banned in the EU as a POP)
  • aprotic polar solvents (dimethylformamide and N-methyl pyrrolidone, used in some electrolytic capacitors)
  • perfluorinated substances (PFOS which is most likely to found in textile and leather goods)
  • phenolic benzotriazoles (e.g. the four UV stabilizers on the candidate list which might be found in polymers, sealants, adhesives, etc.)

These requirements fall primarily on those who make, import or distribute articles (hardware products, components etc.). Such companies should be aware they may be contacted by their national MSA – particularly if they are in the consumer market or the articles they deal with have a high risk of containing SVHCs. Other target areas include electronics, building materials and “interior articles”.