REACH in articles / products (Scope)
Article definition
According to REACH, an article refers to an object which, during production, is given a special shape, surface or design that determines its function to a greater degree than its chemical composition does.
Examples include toys, textiles, packaging, furniture, etc.
It should be kept in mind that a product could made up of different articles. For instance: a computer is made up of hundreds of different articles (cables, screen, keyboard pieces, etc.), each of them fulfilling the definition of article, as explained above.
Substances / mixtures definition
Substance refers to a chemical element and its compounds in the natural state or as 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.
Mixture refers to a mixture or solution composed of two or more substances.
Examples of mixtures include paints, cleaning agents, glues, etc.
To be considered that, for instance, a rubber roll for roof insulation is considered an article (since it has been given a special shape for its function). However, if this same rubber material were presented in the form of pellets, it would, then, be considered a mixture or substance (depending on the composition).
Intended release of substances from articles
A release of substances from articles is “intended” if it fulfils an accessory function (differentiated from the main function of the product), which is deliberately planned and would not be achieved if the substance were not released.
An intended release of a substance from an article must furthermore occur under normal or reasonably foreseeable conditions of use[1]. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article’s life cycle is not an intended release.
Example: Pantyhose with lotion – the main function is to provide clothing and the function of the lotion (skincare) is only an accessory function, which would not be achieved if the lotion were not released.
Another example: Scented rubber, whereby the fragrance substances need to be released in order for the article to be smelled, but the main function of the article is to erase.
Combination of an article and a substance / mixture
If the release of a substance from an object fulfils the main function of the object, the release is not classed as an “intended release” for the purpose of REACH. In this case, the object usually would be considered a combination of an article (functioning as a container or a carrier material) and a substance/mixture, and not as an article with intended release of a substance/mixture.
Examples: Writing materials, spray can with paint, wet cleaning wipe.
Packaging
According to REACH, packaging is considered an article independent of its content, and may be subject to separate registration, authorisation and/or restriction requirements. Manufacturers and importers should gather all available information on packaging in order to verify if it contains any substance which may be released under normal or reasonably foreseeable conditions of use and, therefore, be subject to registration; or any substance considered as SVHC (Substance of Very High Concern) on the candidate list or authorisation list according to Annex XIV; or included in the restriction list according to Annex XVII.
[1] Reasonably foreseeable conditions of use mean conditions of use that can be anticipated as likely to occur because of the function and physical form of the article (even though they are not normal conditions of use).
It is explicitly not a “normal condition of use” if the user of an article uses an article in a situation or manner that the supplier of the article has clearly recommended to avoid in writing, e.g. in the instructions or on the label of the article.