REACh Regulation (EC) 1907/2006 is the major and very comprehensive chemical legislation for the EU.
It ensures a high level of protection of human health and the environment from chemical risks.
REACh regulates chemical substances on their own, but it also sets the rules for these substances in articles.
There are two main provisions for articles in REACh. Firstly, Annex XVII lists all substances that are banned or restricted for use in products. Secondly, there are the Substances of Very High Concern (SVHC).
Substances of Very High Concern
Substances that may have serious effects on human health and the environment can be identified as SVHC by the EU’s Chemical Agency (ECHA). These substances are identified to ban or restrict them possibly later on. In other words: they are candidates to be restricted, and therefore they are on the so-called Candidate List.
The Candidate List is expanded every six months and currently holds 241 substances (June 2024). Manufacturers or importers of articles that contain any of these SVHCs have to fulfil obligations under REACH. The obligations apply only if the weight of the SVHC is more than 0,1 % of the total weight of the article, in short 0,1 % (w/w) (weight-by-weight).
Articles and products
The REACh Regulation contains a definition of an article, but the definition does not define how products that contain several parts should be interpreted.
Does article mean ‘the product’ or ‘any part’?
This is important to know, does the (w/w) percentage apply to each part in a product separately or only to the product as a whole (the total weight of the product).
Articles incorporated as part of a product shall fulfil the REACH obligations when they contain a SVHC in a concentration above 0,1% (w/w).
On 12 February 2015, the Advocate General of the EU Court of Justice published the binding opinion that parts of a product are articles on their own and the 0,1% (w/w) limit applies to each part separately and not just to the end product consisting of more than one article.
The obligations for manufacturers or importers if an article contains a SVHC above a concentration of 0,1% weight-by-weight (w/w) are:
Notification
ECHA shall be notified if any SVHC is present in articles above 0,1% (w/w) and if the quantity of that SVHC is over 1 tonne per manufacturer/importer per year. (Unless the SVHC has already been registered at ECHA for that specific use). Companies have six months for notification after a new SVHC is added to the Candidate List.
Communication
If a SVHC is present in an article above 0,1% (w/w), then the entire supply chain shall be provided with sufficient information to allow safe use of the article including, as a minimum, the name of the SVHC.
Information
If a SVHC is present in an article above 0,1% (w/w), then (on their request) consumers shall receive sufficient information to allow safe use of the article, including, as a minimum, the name of the SVHC. The information must be provided free of charge and within 45 days.
SCIP database
The information obligation has been extended with a new obligation: the SCIP database. This new obligation is written in Directive (EU) 2018/851 and it is called the SCIP Database, for Substances of Concern In Products.
Information on products with at least one SVHC above 0,1% (w/w) has to be submitted to the SCIP database of ECHA, since 5 January 2021.
The information in the database is available to waste operators and to consumers.
