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.
What You Need to Know
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.
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.
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:
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Determine Type of Article: Is the article a...
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Determine Type of Material:
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Chemicals Eliminated from Testing in Electro-Technical Products During Risk Assessment:
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