Common Compliance & Recall Risks for IoT Devices in the EU & UK.Sofeast commissioned some research recently on which chemical compliance incidents occurred in EU countries in the past year 22/23, the substances found, where, and the actions taken by authorities.

Let’s look at issues found in IoT Devices by market surveillance authorities. These products are usually consumer electronics and as such will use plastics, metals, electrical components, and other materials in which manufacturers sometimes use restricted and banned chemicals.

Note: we only cover chemical compliance in this article.

 

 

What are the key applicable regulations & directives?

In general, we investigated these common regulations and standards that market surveillance authorities tend to check products against:

IoT devices could have problems with all of the above because, aside from REACH, RoHS, and POPs, some children’s toys are also IoT devices these days.

 

Market surveillance on chemical substances: recalls and withdrawals from market

IoT devices only had a relatively modest number of incidents discovered in 22/23, however, this still provides some information importers can learn from:

iot devices incidents substances
These banned substances were found in the devices which were USB chargers, earbuds, and a camping shower:

  • Short-chain chlorinated paraffins (SCCPs)
  • Di-(2-ethylhexyl) phthalate (DEHP) (most comm, and often in plastics)
  • Cadmium (likely in metal parts)
  • Lead (likely in soldering)

Phthalates are plasticizers which are added to plastics to increase strength, durability, flexibility, and transparency. They’re banned or restricted because they’ve been scientifically shown to disrupt hormones and cause birth defects and are banned under RoHS.

Short-chain chlorinated paraffins have historically been used as plasticizers and fire retardants, but they are toxic carcinogens that accumulate in the body without being flushed out and cause damage to health and the environment.

Cadmium is a toxic metal which is often found in metal parts and is a common by-product of zinc production. However, it’s one of the RoHS-banned substances because it is a toxic carcinogen.

Lead is also a toxic metal and is banned in products due to its toxicity, especially the damage it does to the nervous system, cognitive development, and health in general, especially in children. It is sometimes used as a stabilizer, in solder, and is useful due to its malleability, corrosion resistance, and more.

 

Which regulations were not complied with and by whom?

iot regulations incidentsIn the several incidents involving IoT devices, most broke the RoHS regulation and some also consisted of banned POPs. The majority of the offending products were from China, with a couple of unknown origins.

What steps did the authorities take?

It should be noted that the incidents were picked up by market surveillance authorities from different Scandinavian EU countries who seem to be particularly hot on upholding these regulations:

  • Sweden 5x (RoHS & POPs)
  • Norway 1x (RoHS)

Authorities took several steps to reduce the risk posed by the devices that were in breach of regulations:

  • 2 were withdrawn from the market (in Norway and Sweden)
  • 4 had their online marketplace listings taken down (Sweden)

 

General advice to reduce such risks

Make sure you work with suppliers who are aware of the regulations in the countries where the devices are to be sold.

Ask your supplier for confirmation that every material is compliant, with testing reports if possible as evidence.

If you have a doubt, run a risk analysis (and the list of most common issues found, as laid out above, will be useful) and take action. It could mean that you select the suppliers of certain materials directly (and you ensure those are reputable manufacturers that show evidence of compliance) and/or you run some laboratory tests.

Finally, if you are still unhappy about the product’s risk profile, you may have to re-design it and choose less risky materials.

 

What can importers of IoT devices learn from this data?

As with many consumer electronics, IoT devices often contain metal, plastics, and electronic components, and all of these are prone to including banned substances like metals and phthalates because, despite their toxicity for humans and the environment, they can make manufacturing easier or improve certain functions due to their positive properties. Manufacturers in Asia who are cutting corners may still use them, as we’ve seen with some of these devices.

If your product includes plastics and metals like these IoT devices, you need to make sure you work with experienced and well-organized suppliers who give you some transparency into what they are buying. Otherwise, risks are too high and lab testing for compliance is a must.

Once again, Scandinavia can be seen to be checking incoming products for chemical compliance quite strictly.

About Renaud Anjoran

Our founder and CEO, Renaud Anjoran, is a recognised expert in quality, reliability, and supply chain issues. He is also an ASQ-Certified ‘Quality Engineer’, ‘Reliability Engineer’, and ‘Quality Manager’, and a certified ISO 9001, 13485, and 14001 Lead Auditor.

His key experiences are in electronics, textiles, plastic injection, die casting, eyewear, furniture, oil & gas, and paint.

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