Subsection 11.1 of the Safety Data Sheet – Information on hazard classes as defined in Regulation (EC) No 1272/2008
Subsection 11.1 of the Safety Data Sheet – Information on hazard classes as defined in Regulation (EC) No 1272/2008
Subsection 11.1 of the SDS must include information on all hazard classes affecting human health. This includes the following points:
a) Acute toxicity
b) Skin corrosion/irritation
c) Serious eye damage/eye irritation
d) Respiratory or skin sensitisation
e) Germ cell mutagenicity
f) Carcinogenicity
g) Reproductive toxicity
h) Specific target organ toxicity – single exposure
i) Specific target organ toxicity – repeated exposure
j) Aspiration hazard
If available, values for the final product should be provided. However, test results for the final mixture are rarely available, which is why SDSs typically present test results for individual components. Based on these substance-level data, and using appropriate methods, the SDS author can classify the product in accordance with the CLP Regulation.
Subsection 11.2 of the Safety Data Sheet – Information on other hazards
This part of the SDS should include information on:
- Endocrine-disrupting properties (ED)
- Toxicological data relevant to human health
How to properly compile Section 11 of the Safety Data Sheet?
🔹 The data presented in Section 11 must be consistent with the classification provided in Section 2 of the SDS and with the classification of components in Section 3. Therefore, do not include any arbitrary test results found—carefully consider their validity and assess their relevance to the classification decisions made. Avoid including irrelevant or contradictory information.
🔹 If a classification is not assigned for a given hazard class, it must be clearly explained—e.g. due to lack of data, inconclusive data, or negative test results. The explanation does not need to be extensive, but no part of Subsection 11.1 should be omitted. Ensure the SDS contains all required data.
What does this mean in practice for SDS Authors?
📌 The supplier of the safety data sheet must have access to reliable and up-to-date toxicological data—these are often obtained from the raw material supplier or scientific literature.
📌 The person preparing the SDS must be able to find, interpret, and correctly present the data, avoiding errors that could lead to incorrect classification. They should also carefully select data to avoid including contradictory or unnecessary information in Section 11 of the SDS, which could reduce the document’s clarity.
Summary
Section 11 of the Safety Data Sheet is not just a legal requirement, but a cornerstone in the assessment of hazards to human health and life. Its reliable preparation increases the value of the SDS, supports user safety, and protects the company from legal consequences.
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