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Article 33 obligations under REACH; The law of unintended consequences…or were they intentional?

By Michael Wurzman

EU importers supply articles from non-EU manufacturers to the EU market. If any of those articles contain a Substance of Very High Concern (SVHC) in a concentration above 0.1% (w/w), REACH’s Article 33 requires the importer to automatically provide available and relevant safety information about the SVHC to the recipients of the articles. If no particular information is necessary for the safe use of thearticle containing the SVHC, the importer must provide – at a minimum - the name of that SVHC to industrial or professional users of the article, as well as to distributors

In practice, what does Article 33 really mean? It means that immediately after a substance is identified as an SVHC, the importer must communicate with its downstream users, if the concentration threshold is exceeded. It also means that, proactively, manufacturers must document the substances in their articles, before any of those substances is identified as an SVHC to meet this requirement.

Now, did the EU intentionally include the “immediacy” requirement in Article 33, or was it a case of poor wording with unintended consequences for companies exporting to the EU? 

While a case can be made for “poor wording with unintended consequences,” I think it may have been intentional. Given the EU’s goal of reducing the negative and costly impacts of toxic substances on human health and the environment, the “immediacy” requirement may have been intentionally added in order to 1) force supply chains to be proactive in tracking the substances in their articles, and ,hopefully, 2) cause the early reduction or elimination of those substances that are being proposed to become SVHCs, which would further the intention of REACH and minimize the need for even more regulatory intervention.

Whether intentional or not, the understandable question from manufacturers is “how in the world can this be done?”   The answer is: use AEM’s MAP program, which was designed to make it possible.  By using a common data exchange system, such as CDX, the "secret sauce" substances can be kept confidential, but recipients of a material can be tracked along the supply chain.  Should a company have a substance in their material that is a newly-identified SVHC, it can immediately notify via the system the recipients, who can pass the information along.  And, over time, the system could be structured to allow immediate notification to all levels of a supply chain at once. 

The goal of REACH is to eliminate the usage of harmful substances, and encourage companies to be proactive in making product improvements to eliminate potential SVHCs before they need to be disclosed.  For those that cannot be easily eliminated, CDX provides for a system where the information on these substances can be disclosed extremely rapidly along the supply chains, no matter the depth, to allow companies to be able to analyze any and all products and meet their REACH Article 33 communication requirements. 

The key to making this happen is education and training, and complete supply chain participation in a common data exchange system, that can feed all internal data analysis software systems.  The actual tracking and mechanics of it are addressed in the data exchange system.  The education on what is required to make this possible can be addressed in the AEM training system designed to reach all levels of the supply chain.  The system to make this easily achievable exists and is in operation today.

Article Library

  • 2017 IMDS and Chemical Reporting Summit
  • Article 33 obligations under REACH; The law of unintended consequences…or were they intentional?
  • Reducing REACH Risk Management
  • You Can't Go it Alone
  • The REACH Data Dilemma: Part 2
  • The REACH Data Dilemma: Part 1
  • The Case for Training
  • The Importer-of- Record and REACH Obligations
  • The “H” Factor