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Article 3 (3) of the REACH Regulation defines an article as an object which during production is given a specific shape, surface or design which determines its function to a greater extent than its chemical composition.
Whether an item is an article or a substance or mixture under the REACH Regulation is not always readily apparent. A detailed introduction and examples of articles can be found in the brochure issued by the REACH help desk of the German Federal Institute for Occupational Safety and Health (BAuA) and in the Guidance on requirements for substances in articles of the European Chemicals Agency (ECHA).
You are not required to register the articles themselves. As a producer or importer of an article however, you have the following duties:
As the producer or importer of an article, you may have particular duties where the article contains a substance that is intended to be released during normal use (REACH, Article 7). The duty to register applies only when the quantity of the substance concerned in the article exceeds 1 ton per year.
However, should a manufacturer or importer of a substance already have included your intended use of the substance in the article as an identified use in his own registration dossier, you as the producer of this article are not required to register the substance again (REACH, Article 7(6)).
As the producer or importer of an article, you may be subject to duties to notify ECHA (REACH, Article 7 (2)) as soon as:
The duty to notify refers only to all substances of very high concern as indicated as such on the candidate list.
Authorisation is required for all SVHCs listed in Annex XIV of the REACH Regulation.
You may have a duty to communicate information should you be a supplier of an article containing a substance indicated on the candidate list as a substance of very high concern (SVHC) in a concentration exceeding 0.1% weight by weight (w/w) (REACH, Article 33).
A distinction is drawn between the duties to communicate information to a commercial recipient and to a private consumer.
As a supplier, you must communicate all information available to you unrequested to commercial recipients.
You need communicate the information to a consumer only when requested by him to do so; you must however then provide it free of charge within 45 days.
