In November, the European Parliament voted to adopt the latest proposed amendments to the Restriction of Hazardous Substances (RoHS) Directive. A review of their impact on the electronics supply chain would not be complete without stating that until the approval of the recast is finalized; published in the Official Journal of the European Union and enacted into the laws of all EU Member States, it is not a done deal.
That said, let’s look at some examples of what we believe will be approved and their impact on OEMs.
1. Change: Scope
Without prejudice to Article 4(3) and 4(4), Member States shall provide that electrical and electronic equipment that was outside the scope of Directive 2002/95/EC, but which would be in non-compliance with this Directive, may nevertheless continue to be made available on the market until eight years after the entry into force of this Directive.
The addition of Category 11, “Other electrical and electronic equipment not covered by any of the categories” would add additional products meeting the definition of Electrical and Electronic Equipment, EEE, which are not specifically identified as exempted or out of scope. This can be viewed as a catch all bucket, which greatly simplifies the RoHS decision tree in regards to product scope. The change also supports the argument made by many EU Member States that the category list is meant to be indicative and that they have very wide latitude when determining what is or is not in scope.
2. Change: Categories
Addition of Category 8, Medical Devices and Category 9, Monitoring and Control instruments including industrial and control instruments to Annex I.
Medical devices have three years from the date of entry into force of the new directive to obtain compliance. This is not a significant amount of time given the typical design, qualification, and regulatory approval cycles required to bring a new product to market or to possibly redesign an existing product and submit the product for regulatory certification. The good news is that some progressive companies have had plans in place to react to the addition. The bad news is that many manufacturers and their suppliers may not meet the deadline, resulting in lost market share.
3. Change: Exempted Products
The Directive does not apply to photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications.
The exclusion of photovoltaic panels sets the stage for a new element to be added to the criteria for justification of an exemption. That is the socioeconomic benefits derived from a product versus the environmental impact resulting from the unrestricted use of hazardous substances.
The use of photovoltaic panels and the healthy development of this product sector is clearly a major economic goal of many member states. If you search for the scientifically sound, objective data that was used to arrive at this decision you will not find any published data to justify the conclusion.
This decision is likely to add to the debate of what is better for the environment — lead/tin (PbSn) or tin/silver/copper (SAC) — which some argue was not scientifically based.
4. Change: CE Marking — Declaration of Conformity
–Article 7 Obligation of Manufacturers: (selected examples):
Manufacturers draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out.
Where compliance of EEE with the applicable requirements has been demonstrated by that procedure, manufacturers draw up an EC declaration of conformity and affix the CE marking on the finished product.
Manufacturers keep the technical documentation and the EC declaration of conformity for ten years after the EEE has been placed on the market.
Manufacturers ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonized standards or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account.
–Article 13 EC Declaration of conformity
The EC declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated. It shall be translated into the language or languages required by the Member State on the market of which the product is placed or made available.
For many OEMs, the addition of the CE marking will not have an impact. Many products are already required to add CE Marking in order to be in compliance with the EU Low Voltage Directive or other directives referenced in the CE Marking Directive.
The significant changes are driven by the requirements to file a formal declaration of conformity. OEMs must make the declaration available for 10 years and be able to provide evidence that the OEM can produce objective data to demonstrate that their business and technical processes are in control and that they have sufficient checks in place to demonstrate their ongoing product compliance.
The existing RoHS Directive makes the “assumption” that by putting a product on the market that the product is in compliance and it is “assumed” that the manufacturer of the product has taken reasonable steps to ensure that it was in compliance as first put on the market. It was also “assumed” that the supplier has controls in place to ensure that the product remains in compliance.
The recast of the RoHS Directive, if approved by the EU Commission, as agreed to by the European Parliament, will move away from making “assumptions” to a more stringent process, which can be best described as “trust through verification.”
The goal of the European Commission’s current president is to have the recast approved prior to the expiration of his term on December 31, 2010, which is likely to happen.
The new RoHS directive would be published in the Official Journal of the European Union no later that 20 days after approval by the Commission. Member states will have 18 months to enact the changes into the member state law. If the timetable happens as forecasted, the new RoHS Directive would impact OEMs as early as July 2012.
A link to the recast document can be obtained at RoHS RECAST.
About the author: Kenneth Stanvick is senior VP and co-founder, of Design Chain Associates, LLC, San Francisco, California.