New EU Regulatory Framework may include ROHS

The European Union (EU) has adopted three new regulations that aim to modernize the “New Approach” or NRF (New Regulatory Framework) for EU directives. These regulations were adopted in 2008, and the regulation that most affects manufacturers of electrical equipment is 768/2008; “a common framework for the marketing of products.” The other two regulations are 764/2008 and 765/2008, and all three come into force on January 1, 2010. These new regulations specify the format for any new directives adopted by the EU, for which CE marking is required.

Currently, the ROHS directive is not a CE mark directive, but the EC’s (European Commission’s) proposals to amend ROHS include changes that make ROHS a “new approach” directive requiring CE marking of products. Therefore, RoHS could be the first directive to adopt the NRF approach.

Main aims of the NRF
The main aims of these new regulations are to:
• Provide more effective market surveillance. Market surveillance is currently variable across the EU with some Member States being very vigilant, but others doing almost nothing. Minimum market surveillance obligations will be imposed on all EU States.
• Harmonize rules for notified bodies and make greater efforts to ensure that these organizations provide a high quality service.
• Make the CE mark a community trade mark, so there will be additional legal measures that can be employed against those that abuse its use.
• Introduce common definitions and procedures, which will harmonize CE mark legislation

EU Regulation 768/2008
Many of the obligations of this regulation are mirrored in the EC’s proposals for the recast ROHS directive, because it is proposed to be a CE mark directive. These types of generic obligations will become familiar when directives such as EMC, LVD, machinery, ATEX are amended and these obligations are included.

The NLF approach
All “economic operators” are responsible for compliance. Economic operators are; manufacturers, importers, distributors and authorized representatives operating on behalf of manufacturers or importers. This is different from previous approaches, where only manufacturers and/or importers were responsible for compliance. Under the NLF (New Legal Framework), distributors will have legal responsibilities.

The conformity assessment procedure is defined with several alternative options provided, described as “modules.” Each new directive would specify which option is to be used. This will be based on various factors, but in particular will depend on the risk to safety by consumers from non-compliant products. Therefore, self-declaration (module A) has been selected for ROHS as the risk is minimal, whereas notified bodies must be used for approval under the medical devices directive, as the potential for harm is high. The regulation also provides measures to prevent compliance from being too much of a burden.

Annexes
Annex I provides definitions of terms that would be used by all future EU directives. These include placing on the market, manufacturer, importer, distributor, technical specification, and harmonized standard. Annex I also specifies the obligations of manufacturers, importers and distributors (these are reflected in the recast ROHS proposals).

The main approach used for CE mark directives is the assessment of products against harmonized standards, and this will continue. There is a presumption that a product complies with the directive if it complies with an appropriate harmonized standard.

The modules provided in Annex II specify the requirements for demonstration of compliance. All products that need to comply with CE mark directives shall have declarations of conformity “DoC” (as they are currently required) and the format is given in Annex III. Only one declaration is required for each product and this must list all applicable directives and the current versions of standards that apply and were used for conformity assessment. DoCs must be continuously updated (as directives and standards change) and translated into the language required by the States where products are placed on the market.

The table below summarizes the main obligations of manufacturers that are located in the EU, product importers into the EU, and distributors within the EU.

Notified compliance assessment bodies (Notified Bodies)
These are required for assessing products where this is required by the CE directive. It will not be necessary to use a Notified Body for demonstrating compliance with ROHS. There are various requirements concerning notified compliance assessment bodies (who test products) and notifying bodies (who approve notified bodies). Where a notified body is used, their identification number will need to be printed with the CE mark on products.

Conclusion
768/2008 and the NLF will not immediately affect manufacturers, but changes to all CE mark directives will eventually be made. The result will be that the compliance approach requirements of all CE mark directives will essentially be the same, distributors and authorized representatives will have clear responsibilities, and enforcement should be more effective and carried out by all EU States. There are currently some apparent inconsistencies and conflicting requirements between the NLF approach and the approach required by existing directives (examples: DoC formats, name of manufacturer requirement, etc.) and these will need to be resolved.