Why manufacturers need to re-think product compliance strategy for RoHS2
RoHS2 is not just business as usual. Under RoHS2, manufacturers are required to produce technical documentation which enables assessment of RoHS conformity for the product, and includes a conformity risk assessment, and “the technical documentation shall, wherever applicable, include test reports”. In particular, if the RoHS2 technical documentation for a product does not include test reports for certain parts, then the manufacturer is required to explain why test reports are not applicable for these parts.
ENVIRON’s presentations at the TechAmerica roadshows will help manufacturers navigate through these new requirements. ENVIRON will explain that the product conformity risk assessment should include assessment of the materials risk and the supplier risk for the parts in the product. This risk assessment determines the level of internal production control which is required and sets the criteria to identify which suppliers are required only to provide self-declarations and which suppliers must also provide test reports. As part of the internal production control, the purchasing department should only buy parts from suppliers who comply with the documentation requirements and regular quality assurance checks should be carried out on a significant sample of test reports. Manufacturers who wish to benefit from this approach need a systematic approach to gathering and analysing declarations and test reports from suppliers. However, supplier declarations continue to be provided in many different formats and often include disclaimers. Systematic analysis and roll-up of supplier parts data to the product level requires all declarations data to be in the same format.
The business impact of non-compliance under RoHS2 is much higher. Manufacturers and importers are required to take immediate action for non-compliant equipment including product withdrawal or recall if appropriate, and inform Member States where non-compliant equipment was sold. Another fundamental change is that distributors have legal responsibilities under RoH2. Distributors must act with due care and are not allowed to sell equipment if they have ‘reason to believe’. Distributors must ensure that immediate action for non-compliant product is taken and must also inform Member States.
The background for these increased compliance obligations on manufacturers, importers and distributors comes from the European Commission’s research in 2008 which found that up to 44% of equipment inspected in Member States was non-compliant to RoHS. Enforcement action published by Sweden last month found that 20% of electronic products were non-compliant to the RoHS substance restrictions for lead. The Swedish Chemicals Agency (www.kemi.se) used XRF to scan 129 products electronic products purchased in toy stores and consumer electronics stores. Products that failed the scan were sent for further laboratory analysis and manufacturers were asked if the use of lead in their products was covered by a RoHS exemption. The remaining 27 non-compliant products were reported to the police. The Dutch VROM Inspectorate carried out similar enforcement action in 2009 to investigate 450 products from 47 importers and also found that about 20% of electronic products were non-compliant.
Manufacturers face considerable challenges under RoHS2, starting with the need to educate their suppliers to provide valid RoHS declarations. Many large component suppliers are still providing declarations which claim RoHS exemptions that the European Commission deleted last September when it published Decision 2010/571/EU. For example, a number of suppliers are still claiming RoHS exemption 5. A valid supplier declaration must reference to the new list of RoHS exemptions contained in 2010/571/EU. The list of valid RoHS exemptions in 2010/571/EU will change every 6 months as certain exemptions expire – the same timeframe that new SVHCs are added to the REACH Candidate List. Manufacturers need to continually review whether their products are still RoHS and REACH compliant. Manufacturers who require their suppliers to publish declarations into centralised web databases have an advantage because all supplier data can be updated automatically as the list of regulated substances and exemptions changes.
Another significant compliance risk facing manufacturers is the number of suppliers who are still using the out-of-date 1752 v1.1 PDF forms and XML files to provide their declarations. IPC stopped supporting the 1752 v1.1 standard in 2008 and emphasises at www.ipc.org/175x that the old PDF forms are out-of-date. (The forms still use the obsolete RoHS exemptions list published 12 October 2006 and the out-of-date JIG-101 list published May 2005, which does not include the REACH Candidate List substance). Instead, all companies in the supply chain should use the new IPC 1752A standard to communicate their materials declarations data. This standard is kept up-to-date on all regulatory changes as they occur. Due to the frequency of the updates, the IPC-1752A standard is not supported by a PDF form. Instead, IPC publishes a list of software companies who have developed IPC 1752A declaration tools at www.ipc.org/2-18b-committee.
For further information about the industry-led substance declarations web database for RoHS, REACH, Batteries and Packaging compliance, please visit www.BOMcheck.net. For further information and registration details for the TechAmerica 2011 International Environmental Compliance Roadshow, please visit www.techamerica.org/environment2011.
A leading international consultancy, ENVIRON (www.ENVIRONcorp.com) partners with clients to assess and manage the potential environmental, energy, and health issues associated with their activities and products. Decision makers rely on us as they strive to reduce or eliminate health and environmental impacts throughout their business life cycles - from acquisition to ongoing operations to restructuring or divestiture. Whether responding to existing challenges or seeking strategies to prevent future liabilities, clients around the world benefit from our blend of universally high technical skills and knowledge of local requirements and practices.
ENVIRON UK Ltd
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