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The registration requirement for substances in articles (as required by Article 7 (1) of REACH) applies only if all the following conditions are met:
- the substance is intended to be released during normal and reasonable foreseeable conditions of use; and
- the total amount of the substance present in the article exceeds one tonne per producer or importer per year; and
- the substance has not yet been registered for that specific use. Pre-registrations, however, do not relieve you from the obligation to register.
If the substance has already been registered for your specific use, then you do not need to register. This registration can be done in your supply chain or any other supply chain.
In order to determine what is an article in this context, especially regarding border line cases between containers and articles, you can consult the Guidance on requirements for substances in articles
Substances that meet the criteria outlined in Article 57 of the REACH Regulation are commonly referred to as substances of very high concern (SVHCs).
You must notify SVHCs present in articles (Article 7(2)) if the following conditions are met:
- the substance has been included in the Candidate List of SVHCs for authorisation; and
- the substance is present in articles above a concentration of 0.1% weight by weight (w/w); and
- the total amount of the substance in those articles (i.e. those containing more than 0.1% (w/w) of the SVHC) exceeds one tonne per producer or importer per year; and
- the substance has not yet been registered for that specific use.
However, you do not need to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal.
You must notify SVHCs in articles at the latest six months after the SVHC has been included on the Candidate List for authorisation (Article 7(7)).
Information on a substance on the Candidate List contained in articles must be sent by the supplier of the articles to the recipients as soon as possible after the substance is included in that list (Article 33). The Candidate List will be updated continuously when substances that meet the criteria of Article 57 are identified.
You can find further information at: http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.
The Candidate List can be found at: http://echa.europa.eu/candidate-list-table.
A permanent magnet should be considered as a substance or a mixture (and not an article) under REACH. This is because its shape, surface or design are less relevant for its function than its chemical composition. As a substance or a mixture, a permanent magnet is subject to the applicable provisions of the REACH and CLP regulations (e.g. it needs to be appropriately packaged and labelled).
Permanent magnets are used in different sizes and forms. They should create a (strong) permanent magnetic field and be stable to perform their main function of attracting or repelling other magnetic objects through a magnetic force (e.g. in cupboards to keep a door closed). They should also have high magnetic coercivity (i.e. they should be difficult to demagnetise).
The materials to be used to produce permanent magnets should either be materials with permanent magnetic fields or materials with a susceptibility to be magnetised by applying an external magnetic field. The latter should also retain the imprinted magnetic pattern (high magnetic coercivity).
The magnetism is one example of a physical property that results from the chemistry of the materials an object is made of, given in the Guidance on requirements for substances in articles (subchapter 2.2). The Guidance also states that such material characteristics or properties are not to be confused with the shape, surface and design of an object.
The stability (magnetic coercivity) and the strength of the created permanent magnetic field appear to be the most important properties of a permanent magnet. Therefore, the magnetic properties of the permanent magnet, which are strongly related to its chemical composition, determine its function.
Registration of substances in articles is obligatory for article producers or importers only if the substances are intended to be released from the articles and are present in quantities of one tonne or more per year. If an article supplier finds out after 1 December 2008 that they have registration obligations for a substance intended to be released from the articles they have been producing or importing already, they cannot submit a pre-registration anymore and they have to limit their production/import to one tonne or less per year until:
- Theyhave made a registration and received a registration number; or
- Someone else registers their use of the substance.
More Q&As on pre-registration can be found at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/Pre-registration