Assent Compliance Inc.

A Product is a sum of its parts


Courtesy of Assent Compliance Inc.

On September 10,2015, The Court of Justice of the European Union (GEU) clarified a longstanding conflict with respect to the definition of 'complex articles' or 'once an article, always an article.' This preliminary ruling' has a significant impact to the entire supply chain as it now requires responsible parties to disseminate the chemical content in their products to a much deeper level.

Introduction to Directive 2015/863
The REACH Regulation (EC) No 1907/20062 released almost a decade ago is an incredibly complicated and expansive law impacting almost every product produced or imported into the European Economic Area5. In addition to many other requirements, there is a provision that 'articles' containing a Substance of Very High Concern (SVHC)4 greater than 0.1 percent weight/weight (w/w) create various regulatory requirements, including communication of their presence within the supply chain.

The interpretation of the definition of an article has been clouded by disagreement, especially from a number of European Union (EU) Member States plus Norway who disagree5  with the European Chemical Agency’s (ECHA) Guidance on Requirements for Substances in Articles6.

This diverging opinion has caused angst among the industry due to the uncertainty of how they manage their compliance programs. This uncertainty arises when a company faces different enforcement practices from one Member State to the next, impacting the free movement of their products.

This whitepaper will focus on the impact of this ruling without providing an in-depth analysis of the REACH Regulation and its various requirements. The Assent Compliance Blog7 and website provide8 further clarification for those who want to know more about the regulation.

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