European Commission Considering eCompliance System

by on Jun.16, 2014, under Europe, Regulation

The European Commission is contemplating developing an “eCompliance System” and has published a “Preliminary Reflections on eCompliance” paper on how it would work.  Following is a summary of this report that was distributed at the May 2014 meeting of the Group of Notified Bodies under the EMC Directive (EUANB) in Amsterdam.

As products become more complex while product cycles become shorter, the Commission believes it is necessary to explore how compliance with Union harmonisation legislation can be demonstrated/controlled electronically (“eCompliance” concept) instead of the traditional paper-based approach.

The primary objective is to maintain protection of the public interest, while reducing the administrative burden for manufacturers (especially SMEs), Notified Bodies, and authorities.

In an eCompliance context, the process of demonstrating compliance would become more interactive: manufacturers and other operators, Notified Bodies (if involved in the conformity assessment procedure) and authorities would share information and provide real-time feedback to each other.

This may lead to a situation where the border between conformity assessment (ex-ante control) and market surveillance (ex-post control) would not be so clearly defined – authorities may have the opportunity to monitor a product before it is placed on the market.

Various tools (e.g. e-labelling, digital market surveillance, electronic declarations of conformity, etc.) could function in all official Union languages and improve communication:

  • Between authorities and manufacturers
  • Between authorities and Accreditation/Notified Bodies and between Accreditation/Notified Bodies themselves
  • Between authorities

Commercial secrets and confidentiality aspects would be protected by a system of access authorizations.

In order to avoid the proliferation of IT tools, the Commission would examine whether the eCompliance System should be part of the Information and Communication System on Market Surveillance (ICSMS).

Planning for an eCompliance System in Europe is still very preliminary, with many questions to be answered and stakeholders to be consulted.  Subscribe to Compliance Today to be kept apprised on further developments in this area.

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First Blood Diamonds. Now Blood Electronics?

by on Sep.20, 2010, under Regulation

To product safety and electromagnetic compatibility compliance, add another regulatory hurdle for electronics manufacturers.  To assure “conflict minerals” are not imported from the Democratic Republic of Congo and neighboring conflict areas, Securities and Exchange Commission (SEC) registered companies will have to start documenting the source and purpose of Congo-related raw materials.

The affected minerals include:

  • Tin (cassiterite)
  • Coltan (columbite-tantalie)
  • Tungsten (wolf-ramite)
  • Gold
  • Any other mineral the U.S. Secretary of State wants to add

From coltan, tantalum is extracted and used to manufacture electronic capacitors.  It can be found in video game systems, cell phones, digital cameras, CD players, computers and pacemakers. Tungsten is used to make cell phones vibrate and the biggest use of tin worldwide is in electronics on circuit boards.

The exact timing of when compliance to this Title XV provision of the recently-passed Dodd-Frank Wall Street Reform and Consumer Protection Act isn’t known, although the act stipulates that regulations must be finalized by April 2011.  Prior to that, there will be a public comment period.  In the meantime, the SEC is soliciting unofficial public comment here.

National security applications have up to a two-year exemption.

Do you think this new data collection requirement is justified, or is it just a political move that adds an unnecessary regulatory hurdle?

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