New Product Category Now in Scope of EU RoHS

New Product Category Now in Scope of EU RoHS

July 22, 2019, marks a major change in the scope of the European Union (EU) Restriction of Hazardous Substances (RoHS) Directive, affecting all electrical and electronic equipment (EEE) sold in the EU. The existing 10-category list of electronic equipment subject to substance restrictions has been extended to an “open” scope by the introduction of a Category 11. 

The new category includes all EEE not already covered under an existing category of the directive, such as two-wheeled electric vehicles and e-cigarettes. However, several types of EEE are still excluded from the requirements in Article 2.4 of the directive, including large-scale fixed installations, active implantable medical devices, and research and development equipment.

The product categories are as follows: 

  1. Large household appliances
  2. Small household appliances
  3. Computing and communications equipment
  4. Consumer electronics
  5. Lighting
  6. Power tools
  7. Toys, leisure and sports equipment
  8. Medical devices and equipment (compliance deadline is July 22, 2021)
  9. Monitoring and control equipment (compliance deadline is July 22, 2021)
  10. Automatic dispensers 
  11. All other EEE 

History of the RoHS Directive

When RoHS originally came into effect on July 1, 2006, regulators acknowledged it would be difficult for companies to eliminate their use of the proposed substances immediately, given they feature heavily in EEE. Because of this, they created a list of exemptions as part of an incremental implementation timeline, during which manufacturers could identify and replace these substances in their products over time.

Initially, the directive restricted the use of six harmful chemicals over a certain threshold in EEE. These chemicals and their thresholds were: 

  • Lead (Pb) (≤ 0.1 percent).
  • Mercury (Hg) (≤ 0.1 percent).
  • Cadmium (Cd) (≤ 0.01 percent).
  • Hexavalent chromium (chromium VI, Cr+6) (≤ 0.1 percent).
  • Polybrominated biphenyls (PBB) (≤ 0.1 percent).
  • Polybrominated diphenyl ethers (PBDE) (≤ 0.1 percent).

In 2015, four more substances — all phthalates — were added to the list of restricted substances under Annex II, bringing the total number of restricted substances to 10: 

  • Bis(2-ethylhexyl) phthalate (DEHP) (≤ 0.1 percent).
  • Benzyl butyl phthalate (BBP) (≤ 0.1 percent).
  • Dibutyl phthalate (DBP) (≤ 0.1 percent).
  • Diisobutyl phthalate (DIBP) (≤ 0.1 percent).

As of July 22, 2019, all products that meet the definition of EEE under RoHS — excluding those listed in Article 2.4 — must not contain any of these 10 substances above threshold. However, restrictions on the four phthalates (DEHP, BBP, DBP and DIBP) do not apply to medical devices (including in vitro medical devices) and monitoring and control instruments (including industrial monitoring and control instruments) until July 22, 2021.

For non-compliant products that were placed on the market before the updates to RoHS, spare parts and components can be legally used for the repair, reuse, functionality updates or capacity upgrades of these items. “Placing on the market” means making that product or equipment available on the EU market for the first time, in line with the European Commission’s Blue Guide.  

Next Steps

Achieving RoHS compliance can be a difficult task, depending on the complexity of the product, the availability of alternate substances in the market, and the extent of safety and functionality testing required prior to mass production and sale. Companies now in scope of RoHS should undertake actions toward compliance immediately to avoid incurring penalties. 

To learn how Assent’s Product Compliance Suite can streamline supply chain data management, contact us at info@assentcompliance.com.

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