EU REACh - Article Definition and Declaration Responsibilities

Question:

What is an Article? and what are my declaration responsibilities under the REACH regulation given the “once an article always an article” ruling?

Answer:

The definition of an article from the REACH regulation is as follows: 'an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition'.

An updated understanding of the how the concept of an article is to be applied was established by the European Court of Justice’s "Once An Article, Always An Article" ruling, which means that when a product first meets the above definition, the part within the product is considered an article from that point onwards.

REACH requires notification to ECHA (under Article 7) if:
SVHC(s) are contained in a product at or above 0.1% w/w within an article

  • Imported in volumes of 1 ton or more per year
  • The SVHC presents an exposure risk to humans or the environment during normal or reasonably foreseeable use of the product
  • The substance is not already registered for that use

REACH also requires communication to downstream users of the safe use of a product/substance (under Article 33) if:

  • The product contains one or more SVHCs at or above 0.1% w/w within the article
  • Must be provided as soon as an SVHC is added to the list
    Note: It should also be provided when a customer begins purchasing the product so they are aware of any safety concerns

Reference: https://echa.europa.eu/documents/10162/23036412/articles_en.pdf

 

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