Articles under the REACH Regulation and the Requirement to Provide a Safety Data Sheet
In the daily operations of many companies, a common question arises: is a Safety Data Sheet (SDS) required for a given product?
The answer depends primarily on whether the product in question is a substance, a mixture, or an article. In this article, we explain what qualifies as an article under REACH, for which products an SDS is required, and what the supplier’s obligations are.
REACH regulation and the definition of an article
According to the REACH Regulation (EC) No 1907/2006, an article is defined as an object which during production is given a specific shape, surface or design which determines its function to a greater degree than its chemical composition.
Of course, all objects around us have a chemical composition. In some cases, the composition may be just as important to the function of the product as its final shape or form. Therefore, distinguishing between an article and a chemical mixture is not always straightforward and requires careful product assessment. The European Chemicals Agency (ECHA) provides guidance documents to help companies make this assessment (e.g. the "Guidance on requirements for substances in articles", available here: [Guidance]).
Examples of products classified as articles:
-
Car tyre
-
Battery
-
Metal alloy casting
Examples of products classified as mixtures:
-
Soy candles
-
Glitter
-
3D printer filament
Article, substance, mixture – the key difference
When determining whether a product is a substance, mixture, or article under the REACH Regulation, it is worth referring to the legal definitions. We already provided the definition of an article; below are the definitions of a substance and a mixture. In particular, note that the REACH definition of a substance may differ significantly from the intuitive chemical understanding:
-
Substance – means a chemical element and its compounds in the natural state or 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.
This means that, somewhat counterintuitively, a substance under REACH may consist of more than one component (hence terms such as multi-constituent substances or UVCB substances).
-
Mixture – means a mixture or solution composed of two or more substances.
This distinction is crucial for determining whether a Safety Data Sheet is required and also affects other obligations, such as the PCN notification requirement.
Is a Safety Data Sheet required for articles?
In principle: NO.
According to Article 31 of the REACH Regulation, a Safety Data Sheet (SDS) is required for hazardous substances and mixtures, but not for articles.
However, a supplier of an article may still have information obligations, such as those under Article 33 of the REACH Regulation concerning SVHC substances. In such cases, since there is no prescribed format for communicating this information, suppliers sometimes choose to prepare an SDS for their product even though it is not formally required.
Additionally, dangerous goods transport regulations may sometimes lead companies to prepare an SDS for an article. This is the case, for example, with lithium-ion batteries, which are articles under REACH but are still subject to transport regulations.
Which products actually require an SDS?
| Product | Is an SDS required? |
|---|---|
| Car tyre | ❌ No |
| Scented soy candle | ✅ Yes (mixture) |
| 3D printer filament | ✅ Yes (mixture) |
| Lithium-ion battery | ❌ No (but the carrier may request it) |
Summary - articles and safety data sheets
An article is not the same as a substance or a mixture – which means that in most cases, it does not require a Safety Data Sheet.However, there are situations where the supplier should still provide hazard information or use alternative communication methods, especially when the article contains SVHC substances. The key to making the right decision is a proper understanding of the product classification and the application of relevant legal requirements.
Need help determining whether your product requires an SDS?
Contact us – we’ll help you classify your product correctly and fulfil all your legal obligations.
Contact
ANY QUESTIONS?
Contact us