One of the concerns companies face when obliged to prepare a Safety Data Sheet (SDS) is, understandably, the protection of confidential business information regarding the product’s composition. When reviewing SDSs from different suppliers, it becomes clear that the amount of information disclosed in Section 3 varies significantly – from cases where not a single substance is listed, to those where the entire composition with exact concentrations is disclosed.
However, this is not merely a matter of the supplier’s or the SDS author’s preference – to a large extent, what we see in this section of the document depends on the type and nature of the product and the substances it contains.
The provisions of Regulation (EU) 2020/878 strictly regulate the minimum requirements for listing substances in Section 3 of the SDS. This means that there is a certain mandatory minimum of information that must be provided in this part of the document. However, this minimum is not the same for all products – it depends on the CLP classification of the mixture, but most importantly on the classification of its components.
Put simply, the more hazardous a substance is (the more severe its classification), the lower its concentration at which disclosure in the SDS becomes mandatory. For example, carcinogenic substances must be listed at lower concentrations compared to substances classified only as skin irritants. If a given substance is present in the product below the regulatory disclosure threshold, it may be omitted. For substances not classified as hazardous, there is no obligation to list them in the SDS at all, unless required under other provisions (for example, due to the existence of occupational exposure limits). As a result, there may be cases where no components are listed in Section 3 of the SDS – this does not mean the SDS is incorrect, but rather that the present substances are at low concentrations or are not classified under CLP.
At the other end of the spectrum, there are cases where the entire product composition is disclosed in the SDS, again as required by law. Such situations raise the greatest doubts and concerns among companies, as they expose trade secrets. It is important to note, however, that the SDS does not require disclosure of exact concentrations – even where significant information must be provided, there remains the possibility to protect the product’s formulation. Using concentration ranges is acceptable, though they should be applied with “moderation” so as not to create inconsistencies in the document or hinder its interpretation by the user.
In the European Union, there is a mechanism under Article 24 of the CLP Regulation which, in theory, allows hiding the name and identification number of a specific substance (known as the Use of an Alternative Chemical Name). In practice, however, it is rarely applied, since it may only cover certain substances. Additionally, its use requires submitting an application (which must be approved by the European Chemicals Agency) and paying an administrative fee.
Permission to use an Alternative Chemical Name may also be revoked, for instance, if the classification of the substance changes in a way that no longer meets the necessary conditions for its use.
As mentioned earlier, the requirements described above represent the regulatory minimum. However, nothing prevents suppliers from listing additional substances in the SDS even if not required by law. Some suppliers choose this approach, for example, when the disclosed substances highlight a desirable technological feature of the product, or conversely, to demonstrate that the product does not contain “undesired” substances.
The regulations do not set out specific rules for providing such additional information. It is not prohibited, and the decision on how far beyond the required minimum to go rests solely with the SDS supplier. Typically, however, companies choose to limit Section 3.2 to the absolute minimum.
Due to regulatory requirements, the diversity of products, and varying approaches of suppliers, Safety Data Sheets can differ significantly in terms of the level of composition disclosed. Without access to the full formulation, it may not always be possible to assess the correctness of the SDS. Therefore, when reviewing documentation, it is useful to follow the general principle that the more hazardous the product, the more information about its composition should be expected from the Safety Data Sheet.