Safety Data Sheets (SDS) are essential documents providing information on hazards and safe use of chemical substances. One of their mandatory elements is Section 12 – Ecological Information, which contains data necessary to assess the environmental impact of chemical products.
Section 12 of the Safety Data Sheet presents information on the environmental effects of a substance or mixture. It covers aspects such as:
• toxicity to aquatic and soil organisms,
• bioaccumulation potential,
• persistence and biodegradability,
• mobility in soil.
The purpose of this section is to support environmental risk assessment related to the use and disposal of a chemical product.
According to Annex II of the REACH Regulation (Regulation 2020/878/EU), Section 12 of the Safety Data Sheet should include the following subsections:
🔹 12.1 Toxicity
Results of environmental toxicity studies – for fish, crustaceans, algae, and, if relevant, for soil micro- and macroorganisms and other environmentally significant species (e.g. birds, bees, plants). The data should reflect and support the established CLP classification of the substance.
🔹 12.2 Persistence and degradability
Information on the biodegradation of the substance or relevant constituents, and its persistence in aquatic and soil environments. The data may also describe degradation through other processes such as oxidation or hydrolysis.
🔹 12.3 Bioaccumulative potential
The section should include the log Kow and/or BCF (bioconcentration factor) values – essential for assessing long-term environmental risk.
🔹 12.4 Mobility in soil
Description of the substance's ability to migrate in the environment – including adsorption and potential for groundwater migration, leaching data, or surface tension.
🔹 12.5 Results of PBT and vPvB assessment
Information on whether the substance meets the criteria for PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent and very Bioaccumulative) substances.
🔹 12.6 Endocrine disrupting properties
A new requirement as of 2023 – available data regarding the substance’s potential to disrupt endocrine functions should be indicated.
🔹 12.7 Other adverse effects
Other known environmental impacts, such as effects on global warming, soil acidification, or ozone depletion potential.
✅ Suppliers of substances and mixtures must collect and provide up-to-date toxicological and environmental data – including data from scientific literature and databases.
✅ Information in Section 12 of the Safety Data Sheet must be consistent with the CLP classification.
✅ If data are unavailable, this must be clearly stated, along with the reason for their absence.
Values included in this section, such as LC50 or EC50, directly impact the classification of substances under the CLP Regulation. Other data are crucial for environmental risk assessments, selecting appropriate handling measures, and determining disposal methods.
A properly completed Section 12 of the Safety Data Sheet is not only a legal obligation but also a key element of environmental responsibility for companies placing chemicals on the market.