Mixture components identified on SDS
Substances contained in mixtures classified for CLP are required to be identified on the SDS under Section 3.2:
- If the mixture is classified for CLP, its component substances must be identified if they meet one or more of the following criteria, and if more than one criterion applies the lowest limit must be used:
- substance is present at or above the generic cut off limits in the table below, or if there are other cut off limits for that substance (related to Specific Concentration Limits, or M-factors, see ECHA SDS guidance for more details at https://echa.europa.eu/documents/10162/23036412/sds_en.pdf/01c29e23-2cbe-49c0-aca7-72f22e101e20)
- if the substance is a sensitiser at EUH208 level (0.1 – 1% sensitiser class 1 or 1B, 0.01 – 0.1% sensitiser class 1A; or 10% of the specific concentration limit, if one exists for sensitisation )
- if the substance holds a Workplace Exposure Limit (there is some debate about whether at cut-off limit of 1% applies, or whether this is at any concentration)
- if a substance has been Authorised for specific uses, and is present at or above 0.1%.
- substances which are on the SVHC candidate list, but which have not been authorised, and which are present at or above 0.1% in the mixture
- substances which are PBT or vPvB and are present at or above 0.1% in the mixture
This can also be downloaded as a pdf: Generic limits for including a component substance on a mixture SDS .
If the mixture is not classified for CLP, its component substances must be identified if they meet one or more of the following criteria:
- hazardous to health or the environment, at or above 1% w/w (or 0.2% v/v for gaseous mixtures)
- substances with a Workplace Exposure Limit, at or above 1% w/w (or 0.2% v/v for gaseous mixtures)
- substances which are PBT or vPvB,at or above 0.1% w/w
- substances which are on the SVHC candidate list, whether or not they have not been authorised, present at or above 0.1% w/w
Note that not all of the component substances required to be identified on an SDS are required to be identified on the CLP label, see: https://ttenvironmenta.wpengine.com/clp-knowledgebase/mixture-components-identified-on-clp-label/
Information required on SDS for each component substance
The information which is required for each component substance is:
- substance name
- identification number(s)
- CLP hazard classification of the substance
- either the actual % w/w of the component, or a % w/w range (or, for gaseous mixtures, % v/v)
- Its REACH registration number, if it has been registered (the last 4 digits may be omitted)
- Its Authorisation number, if it has been Authorised
- M-factor(s) for any substance classified Aquatic acute tox. 1 H400 and/or Aquatic chronic tox. 1 H410 (this is a “nice to have” rather than mandatory)
The CLP hazard classification of the substance is required to enable downstream formulators to calculate the effect of the substance in mixtures they make from the original mixture. It is also possible that a substance may be classified more severely than a published classification (such as a Harmonised Classification or REACH registration classification) might indicate, e.g. due to impurities.
Using percentage ranges on the SDS
The use of percentage ranges is widespread in order to give a degree of confidentiality to commercially important formulations. However, where you are using percentage ranges, the overall classification of the mixture must reflect the maximum effects of the component(s).
For example, say you have a component in a mixture which is classified as Cat 2 H310, May be fatal in contact with skin, with no other components which are hazardous to health. If you put a range of 20 – 30% on the SDS, you would have to classify the product as Cat 2 H310, as the threshold for classification is 25%. If the actual figure is 22.8% w/w, and you want the mixture to be classified as Cat 3, H311, Toxic in contact with skin, you would have to change the range so that it stops at 24.9%, e.g. 15 – 24% w/w.
Note that substances which have a Workplace Exposure Limit are also required to include those limits under Section 8 of the SDS.