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REACH: Once an Article, Always an Article Webinar Overview

Posted by TUV Rheinland on Apr 16, 2018 12:40:15 PM
TUV Rheinland

In September of 2015, the European Court of Justice (ECJ) ruled that the original definition of an ‘Article’ stands true, meaning “Once an Article, Always an Article.” The new guidance document on defining and determining substances in articles under REACH from the ECHA is having a major impact on both the supply chain and OEMs of products. In our recent webinar, TÜV Rheinland discussed the impact, how to define articles, and how using a risk-based approach is the best path forward to demonstrate compliance. 

Every six months, the European Union votes on which substances are added to the list of Substances of Very High Concern (SVHCs). Currently, there are 174 SVHCs on the candidate list. However, it is becoming more and more difficult for manufacturers to determine what is in their product.

What You Need to Know

What is a Substance?
A substance is a chemical element and its compound in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

What is a Preparation?
A preparation is a mixture or solution of 2 or more chemical substances.
What is an Article?
An article is 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. 
What is the Impact to OEMs, Contract Manufacturers, and Suppliers?
OEMs, CMs, and Suppliers must provide:
  • Data Traceability
  • Documentation Control
  • Calculation of Data
  • Reporting of Data
  • Quality of Data
  • Risk Assessment
  • Due-Diligence

Substances of Very High Concern (SVHC)

Article 32(4): duty of actors in the supply chain for articles containing identified Substances of Very High Concern (SVHC) to communicate sufficient information to allow safe use down the supply chain (substance is present in quantities 0.1% by weight of Article).

Substances of Very High Concern Are:

  • PBT Substances 
  • vPvB Substances
  • CMR cat. 1, 2 substance
  • And...Substances of equivalent concern with scientific evidence of probable serious effects

Currently, it can be quite difficult to determine the level of compliance on suppliers of articles. As a result, the Forum for Exchange of Information on Enforcement has started a pilot project to help negate this issue. The purpose of this pilot project is to raise the awareness of the legal obligations for importers, subsequently raising the level of compliance among producers under Articles 7 and 33 of the REACH regulation. This project aims to target the reasons for non-compliance and inevitably establish better enforcement methods in the future for substances of very high concern. 

Performing a REACH Risk-Based Assessment:

Determine Type of Article:

Is the article a...

  • Solid material
  • Complex article
  • Substance released during normal use
  • Preparation
  • Chemical substance (with CAS#)
  • Example: Ball-Point Pen - a preparation (ink) is encased within several articles (the pen casings). The preparation is intended to be released during normal use (onto the paper).

Determine Type of Material:

  • Alloys
    • XRF analysis of alloys to detect Cadmium
    • Follow-up chemical analysis if Cadmium is present
  • Polymers and other materials
    • Hard plastics
    • Soft plastics
    • Textiles
    • Paints, coatings, adhesives, etc...
    • Corrugated paper-board

Chemicals Eliminated from Testing in Electro-Technical Products During Risk Assessment:

  • Pesticides
  • Biocides
  • Herbicides
  • Lead oxides found in gun-powder
  • Refractory ceramic fibers
  • Various other substances


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Topics: RoHS/REACH, Green Product Mark