The European Chemicals Agency (ECHA) updated the long-awaited guidance on the requirement for substances in articles by including new examples and scenarios to clarify the obligation on communication and notification of substances of very high concern (SVHC) in articles that are in line with the 2015 judgment of the Court of Justice of the European Union (CJEU) in 2015 on the definition of articles.
The EU REACH Regulation defines an article as 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. On September 10, 2015, CJEU ruled that the obligation on SVHC in an article as set in Article 7 and 33 under REACH applies to ‘each article in an entire article’ (each component in an entire article) rather than to the ‘entire article’.
Under Article 7(2) ‘Notification of substances in articles’, an article producer or article importer shall notify ECHA if an SVHC on the Candidate List is present in an article with a concentration of more than 0.1% by weight, and the total quantity of the SVHC in all articles produced or imported, exceeds 1 metric ton per producer or importer per year.
Under Article 33 ‘Duty to communicate information on substances in articles’, the supplier of an article (including producer, importer, distributor and retailer) containing an SVHC on the Candidate List in a concentration of more than 0.1% by weight, shall provide the recipient of the article with sufficient information, available to the supplier, to allow the safe use of the article, including, as a minimum, the name of the SVHC.
In response to the ruling, ECHA published a “quick update” of the guidance in December 2015 to correct the parts that are not consistent with the court’s judgment. However, useful and practical guidance on how to comply with the notification and communication obligations under REACH was not available in the quick update until the recent comprehensive updated version in June 2017.
Some of the important updates in the latest version of the guidance are listed below:
Newly added definition of complex object
‘Complex object’ is defined as any object made up of more than one article by joining or assembling the articles together in various ways. Examples of simple complex objects are a pair of scissors (mechanically assembled) and a block of sticky notes (joined together using a substance/mixture).
Some objects are called ‘very complex articles’ which are further combinations of simpler complex objects. Examples are sofas, bicycles, mobile phones, computers, card and aircraft.
New illustrative examples and scenarios on the requirements for SVHCs in articles, for example:
- Articles A and B are joined together by mixture M (e.g. adhesive) to make complex object C
- Article A contains Candidate List substance X > 0.1% w/w
- Article B contains Candidate List substance Y > 0.1% w/w
- Mixture M contains Candidate List substance Z and Z is > 0.1% w/w in complex object C
Communication and notification obligations:
The EU producer of complex object C purchases articles A and B from another EU supplier to produce complex object C:
- An EU producer or importer of articles A and B has to communicate and notify presence of X in article A and Y in article B
- The EU producer of complex object C has to notify presence of Z in complex object C
- The EU producer of complex object C has to communicate presence of X in article A, Y in article B and Z in complex object C
- An EU importer of complex object C has to communicate and notify presence of X in article A, Y in article B and Z in complex object C
New examples and scenarios illustrating how to determine the concentration of a SVHC (w/w) in articles
|Scenario||Calculation of concentration of a SVHC (w/w)||Description/Example(s)|
|I. Article made from a SVHC as such or in a mixture||Weight of SVHC in the article divided by the total weight of the article||Example: plastic article (e.g. injection molded chair, plastic print for a t-shirt)|
|II. SVHC as such, or in a mixture used for joining two or more articles (complex object)||Weight of SVHC in the complex object divided by the total weight of the complex object||Example: block of sticky notes, unpainted bicycle frame formed by welding together multiple steel tubes|
|III. SVHC in coatings on coated article or complex object||Weight of SVHC in the coated article or complex object by the total weight of the article or complex object respectively||Examples of coating mixtures: paint, lacquer, varnish, functional coating
Examples of coated articles: painted bent strip of steel, painted zipper sliders
|IV. Very complex objects||The calculation rules set out for scenarios I to III above apply for each article or simpler complex object.||Examples: sofa, bicycle, mobile phone, car and aircraft.|
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This article was last updated on January 27, 2020.