DEFINITIONS
Definitions are described in Article 3 of the REACH Regulation, but some key ones are described below.
A substance : defined chemical with EC number or registration number
Impurities : unwanted by-products or residual starting materials that do not enhance the substance. These will not need registration in their own right if they do not contribute to the nature of the substance (typical accepted maximum limit of 20% impurities).
Mixed substances : multi-component substances that are synthesised in such a way that two or more key chemical components form, such as mixed isomers. These need special pre-registration and cannot be bulk-uploaded and must be pre-registered individually.
Polymers : at least three repeating unit of monomer unit with no single constituent at > 50% by weight composition. Therefore, there it needs good molecular weight spread as well as number of units. Post-reacted polymers are still polymers, but the substance reacted with them will need registration.
Unknown Variable Chemicals (or of Biological origin) (UVCB) : poorly defined substances or biological extracts and derivatives that need special consideration for registration. These include reaction products, but where there is no clear understanding of the actual constituents or the proportions of such constituents. Some biological materials may be exempt.
Mixtures or preparation : one or more substances added together after synthesis, such as solution in solvent or blended product. The mixture does not need registration, but all components must be registered and if importing, it is necessary to determine the components in the preparation from the supplier.
If importing mixtures, remember that the tonnage band that triggers registration is the quantity of the specific component of the mixture; for example, if importing 10 tonnes of a cleaning fluid with 60% water, 30% surfactant and < 10% fragrances, colourants, preservatives etc, registration will only need to consider the 3 tonnes of surfactant. Those less than a tonne do not need registration and water is exempt.
Article : a material that is supplied primarily to fulfil a function based on its size or shape and dried paint providing a water proof coloured surface is considered part of the article it has coated. Polymer supplied as bead to make plastic cups are ‘chemical’ (polymer), but the finished cup is an article.
Even though the definition is easier to work out when the logic is understood, there are many grey areas, such as metals, where it is necessary for suppliers to make their own decision, record that decision in case of later questioning, and then do what is appropriate in terms of hazard assessment and communication.
The metal industry is one where there is confusion, with the best example being that a lump of iron is a chemical if the user melts and makes steel from it, but is an article if used to hold a door open as a doorstop. The function and use of the material is key.
Chemicals delivered by articles, such as pens, printing cartridges, wet-wipes etc. are considered as chemical for purposes of registration. These are delivered by ‘speciality containers’ even though the container is an article (eg. pen case). This can also apply to some chemicals in serviceable parts of machinery (eg lubricants) or screen wash in imported cars.
Substances deliberately released from an article : the object has a primary physical form, but secondary chemical nature. Examples include toys with special smells (eg toy banana smelling like a banana) where the scent is a chemical released and will need registration.
Foreseeable release : chemicals expected to be released from an article during normal use by wearing and during re-working, such as metal dust from grinding, polymers from tyres etc. These do not need registration by importers of the article.
No foreseeable release : chemicals are considered to be bound tightly in the matrix of the article, such as plasticisers in plastics where there is no evidence of leaching or loss from the article. This is an important point when the chemical is hazardous
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