RoHS: Obligations on B2B producers

The ROHS directive is complementary to the WEEE directive and applies to the same categories of products defined by the WEEE directive, with the exception of Category 8 medical devices and Category 9 monitoring and control equipment. From July 2006, the following substances are effectively banned from use in new electrical and electronic equipment:

  • Lead;
  • Mercury;
  • Cadmium;
  • Hexavalent chromium; and
  • Polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), which are used as flame retardants in plastics.

Trace elements of these substances are allowed, up to a maximum concentration in any individual homogenous material of 0.01% by weight for cadmium, and 0.1% by weight for the other substances. The definition of homogeneous materials has caused some confusion in the past, but has been clarified in an EC decision document published on 18 August 2005. A homogeneous material is a single substance such as a plastic, for example the PVC insulation on insulated copper wire. Components such as capacitors, transistors and semiconductor packages are not "materials" but will contain several different materials. For example, a semiconductor package will contain at least six as shown below.

Six individual homogenous materials in a semiconductor package

By placing their products on the market, producers are declaring that these comply with RoHS legislation. This is the basis for "self-declaration" which is used for several other EC directives. There are no requirements for the application of a specific mark or testing by independent third parties. However, the authorities within each Member State will carry out market surveillance and conduct checks on products. If they find that a product does not comply with RoHS legislation, the producer will be asked to show that due diligence has been used and he has taken "reasonable steps" to comply. This legal defence is used for other legislation, but what constitutes "reasonable steps" has not been defined.

To demonstrate compliance, producers have to undertake extensive and time consuming surveys of their suppliers of components and sub-assemblies. In turn, first tier suppliers require materials information from their suppliers, and so on down the supply chain. Some component manufacturers produce materials declarations for ranges of products, for example one declaration for all types of Quad Flat Pack (QFP) packages. This is reasonable because all of these components would be manufactured from the same materials and so a declaration for one part type would be identical to one for another part number in the same range.

Equipment producers often obtain a part on a regular basis from a supplier and these can, over a period of time, be from a number of batches. Separate declarations for each batch should not be necessary unless the manufacturer has made a change to the production process. However, equpment producers need to be aware that batch-to-batch variation may occur.

Where authorities find non-compliant equipment they will audit the producer's records, which should be in the form of a "technical file". These files must be kept for at least four years.

RoHS2

Directive 2011/65/EU on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (known as RoHS2) became European Law on 21 July 2011 and will take effect in EU Member States from 2 January 2013. RoHS2 brings a much wider range of equipment into scope but does not introduce any new substance restrictions. Another very important difference is that RoHS2 is a CE Marking Directive.

RoHS2 requires Manufacturers to produce technical documentation which demonstrates that their products are RoHS compliant, in line with Module A of Decision 768/2008/EC. This is a significant difference compared to the RoHS1 Directive which does not prescribe any requirements for Manufacturers to maintain compliance documentation. RoHS2 also includes obligations for all EU Member States to perform systematic market surveillance including "appropriate checks on product compliance on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples". In contrast, RoHS1 did not prescribe any enforcement procedures that Member States were required to implement.

There are many different approaches that companies can use to draw up the required technical documentation to demonstrate that their products are RoHS compliant. Many companies already have established compliance processes and quality management systems for RoHS1 compliance and for other product regulatory requirements. Each company has to decide the best approach for drawing up the RoHS2 technical documentation which makes best use of their existing compliance processes and quality management systems.

In October 2011 the European Commission issued a Mandate to CENELEC to develop a European Standard that Manufacturers can choose to follow to comply with the RoHS2 technical documentation requirements. European Standard EN 50581:2012 "Technical documentation for the evaluation of electrical and electronic products with respect to restriction of hazardous substances" was approved on 11 June 2012 by all CENELEC National Committees and, as per the Mandate, will be published in the Official Journal of the European Union as a RoHS2 Harmonised Standard. Under Article 16 (2) of the RoHS2 Directive, a Manufacturer who demonstrates compliance with EN 50581:2012 will automatically be deemed to be compliant to the RoHS2 technical documentation requirements.

Manufacturers can choose to use the EN 50581:2012 European Standard and BOMcheck to comply with the RoHS2 technical documentation requirements.

REACH and RoHS compliance declarations

REACH introduces new requirements on EU component suppliers and equipment manufacturers to provide substance declarations (Article 33) and comply with substance restrictions (Article 67) when they supply their articles (e.g. components and sub-assemblies) to the next manufacturer in the supply chain. REACH is fundamentally different to RoHS where there is no legal obligation on EU suppliers to provide information on the RoHS compliance status of their components and sub-assemblies.

Starting from October 2008 when the first Candidate List was published, Article 33 (1) of the REACH Regulation places a legal obligation on all EU suppliers to inform their manufacturing customers whether the components or assemblies they supply contain any of the REACH Candidate List substances in concentrations > 0.1% w/w. For all components or assemblies which exceed this concentration, the supplier has a legal obligation to provide information on safe use.

From June 2009, Article 67 of REACH places a legal obligation on all EU suppliers to comply with the substance restrictions listed in REACH Annex XVII when they supply components or sub-assemblies to manufacturing customers.

REACH and RoHS compliance declarations web database

Reducing REACH and RoHS compliance costs by enabling suppliers to upload their substances declarations to one location for all participating manufacturers to access

The BOMcheck substances declarations web database has been developed to help manufacturers and suppliers manage this information up the supply chain, keep up-to-date with new substances as they are added to the Candidate List and new substance restrictions added to Annex XVII. BOMcheck is an industry-wide initiative which has been developed by Siemens and thinkstep and is led by the European trade association COCIR. COCIR membership includes Siemens, Philips, GE, Agfa, Hitachi, Toshiba, IBM, Intel and Canon. The web database covers REACH, RoHS and other restricted substances legislation. Membership is free for manufacturers and costs 300 Euros per year for suppliers.