ROHS Compliance

We were besieged with customer requests for the materials composition of our products. It was an overwhelming and onerous task. We were concerned because as a small company we couldn’t provide it for all 9800 products and stay in business. Glenn Tanzman was recommended and he made sense of it all for us and developed a cost effective compliance plan that we were quickly able to implement with his help. We were so pleased we signed up for Tanzco’s quarterly update service.

-- Jay Weiner, EFC Wesco

YOU SHOULD START TO PREPARE FOR ROHS2 NOW

The revised version of European directive Restriction of Hazardous Substances Directive (RoHS) was published on July 21, 2011 and will come into force 18 months from the date of publication (Jan 2013).  Companies along the value chain should start preparing for that to assure continuous RoHS compliance.

RoHS is a European Directive regarding “Restriction of Hazardous Substances” (2002/95/EC), effective since July 1, 2006. This directive restricts the use of six hazardous materials in the manufacture of various types of Electronic and Electrical Equipment (EEE). A recent European Commission (EC) impact assessment study showed that almost half of the EEE currently placed on the EU market is not fully RoHS compliant. As a consequence, more stringent market surveillance may be expected. ROHS2 makes it easier to enforce the Directive by requiring CE marking and a Declaration of Conformity with each shipment.

The recast of RoHS (Directive 768/2008/EC) , commonly referred to as RoHS2 will become a CE Marking Directive), which means manufacturers will have to perform conformity tests based on and Regulation 765/2008/EC. Furthermore, this helps clarify the expectation for what is to be included in a technical file that you should have for each product to demonstrate that they are ROHS compliant. The TIF (Technical Information File) must include:

  • A general description of the product
  • A bill of materials (BOM)
  • Requirements for design and manufacture
  • A robust risk assessment of the product and internal processes
  • A conformity assessment of products and processes.
  • Examinations carried out (material assessments, suppliers Certificates of Compliance, etc.)
  • Test reports or the rationale for not testing

The technical file and Declarations of Conformity must be available for 10 years after the product is “put onto market”.

Other key elements of the ROHS2 include:

  • No additional substances were added but 4 substances were prioritized for review including DEHP
  • Category 8 Medical Devices will in scope as of 2014 (in-vitro devices in 2016)
  • Category 9 Monitoring and Control Instumentation will be in scope as of 2014 (some in 2017)
  • Category 11 All EEE not covered before will be in scope as of 2019
  • Definition of EEE revised to include any product dependant on electricity for at least one intended function
  • All current and future exemptions will have sunset dates, normally 4 years.

A Declaration of Conformity must now accompany each shipment into the EU. Manufacturers will share RoHS compliance responsibility with retailers and importers. Therefore, manufacturers should rethink and redesign products to comply with the new requirements, while importers and retailers should find the support to assess technical documentation presented by manufacturers. Distributor now are responsible for reporting any non-compliant products to the member states.

Once the revised Directive is effective EU manufacturers, importers, retailers and authorized representatives will have to make sure that they are placing compliant products on the market. Independent RoHS consulting companies like Tanzco can assist companies along the value chain preparing for RoHS2 and other related requirements. Tanzco RoHS experts have a deep understanding of the RoHS legislation backed up with the ability to help you redesign your products to make them compliant.

Current Issues

The Impact of RoHS CE Mark on Manufacturing