On 1 July 2006, the EU implemented Directive 2002/95/EC restricting the use of lead, cadmium, hexavalent chromium, mercury, polybrominated biphenyls (PBB) and polybrominated diphenylethers (PBDE) for electronic and electrical equipment sold in the EU. This legislation led to enormous changes in the technology with which electronic and electrical equipment was produced.
It also led to dramatic changes in the supply chains for electronic and electrical equipment producers. Key among these changes was the requirement for compliant parts to be used in the manufacture of electronic and electrical equipment. OEMs queried and supply chains confirmed, the parts that they were supplying were/were not compliant. Non-compliant parts and components were excluded. Since implementation, stories about non-compliance crept out: cables were not compliant, parts previously confirmed as being compliant were found to be out of compliance – surely minor slips in the supply chain?
The ROHS recast or ROHS 2.0 will be implemented in the EU under Directive 2011/65/EU on 2 January 2013. This legislation brings about a number of significant changes to the original legislation. Critically, ROHS 2.0 is aligned with the new legislative framework meaning that ROHS 2.0 contains specific requirements regarding CE marking and conformity assessment among other obligations. This means that from 1 January 2013, a CE mark that is displayed on any electronic and electrical equipment placed on the EU market complies with all aspects relevant legislative aspects (such as electrical safety, interference with radio waves and ROHS). ROHS 2.0 also brings some new product categories into scope including medical devices (July 2014 to July 2016 depending on the type of medical device), monitoring and control instruments and industrial monitoring and control instruments (from July 2017). Finally, there is a new ‘open’ scope category that covers all electronic and electrical equipment not covered by the other categories (from July 2019).
The substances that are restricted by the legislation remains unchanged, however, the EU Commission are planning to review the use of HBCDD, DEHP, BBP and DBP in electronic and electrical equipment. As in the original Directive, these substances will be considered at the homogeneous material level. The procedures around exemptions have been clarified and the validity of an exemption will be determined on a case-by-case basis. The maximum validity period for products in Categories 1-7 and 10 and 11 is five years and for Categories 8 and 9 seven years.
The conformity assessment that must be applied to electronic and electrical equipment is ‘internal production control’. Following careful assessment of all relevant documentation, the manufacturer must declare that the product satisfies the requirements of the legislative instruments that apply to it. A Declaration of Conformity must be issued and the associated technical documentation prepared. This documentation should comprise (as a minimum):
- General description of the product
- Conceptual design and manufacturing drawings and schemes (and explanations)
- Harmonised standards that were applied and/or relevant technical specifications
- Test reports.
It must be possible for an inspector to confirm the product’s conformity from reviewing the technical documentation. It is up to the manufacturer to determine the level of information required, but this should be dependent on the risk associated with the presence of restricted substances. Testing by the manufacturer should be on an ad-hoc basis and related to lack of data or perception of risk. Determining this information as well as the reliability of the supply chain and the technology being considered may be guided by the standard EN 50581 and are the responsibility of the manufacturer. The EU Declaration of Conformity must be identified as such and signed by an officer of the company/authorised representative.
ROHS 2.0 significantly changes the way in which compliance with the restrictions of materials in electronic and electrical equipment are implemented. Previous approaches will not meet the more rigorous requirements of ROHS 2.0 and companies should prepare appropriate policies and programmes to ensure they can meet the