SDS Section 12: Ecological information

The section that stops being about people

Sections 1 to 11 are written for the person holding the container. Section 12 is written for what happens after the container fails — its subject is the drain, the soil under the yard and the sewage works downstream.

UN GHS Annex 4 states the purpose at A4.3.12.1: to enable evaluation of the environmental impact of the substance or mixture if it were released to the environment, and to assist in handling spills, evaluating waste treatment practices, control of release, accidental release measures and transport. Four of those five uses live in other sections of the same sheet. Section 12 is the evidence they rest on.

Mandatory in the EU, unenforced in the US

Section 12 is the first of four — 12 to 15 — where the two regimes part company completely.

Under REACH Annex II as amended by Regulation (EU) 2020/878, section 12 is fully mandatory. Part A of the Annex is blunt: the safety data sheet shall not contain blank subsections. All seven subsections must be answered, and sheets not complying with the amended Annex could only continue to be provided until 31 December 2022.

Under OSHA’s Hazard Communication Standard the heading is compulsory and the content is not. Note 1 to § 1910.1200(g)(2) requires an SDS to include headings for sections 12 to 15, in the prescribed order, to align with the GHS. Note 2 then states that OSHA will not be enforcing information requirements in sections 12 through 15, as these areas are not under its jurisdiction. Appendix D agrees: those sections may be included, but are not mandatory.

The reason is jurisdictional, not scientific. HazCom’s hazard classes are physical hazards, health hazards, simple asphyxiants, combustible dust and hazards not otherwise classified — there is no environmental class in the standard, and aquatic toxicity belongs to the EPA. In the EU it is classified: CLP produces Aquatic Acute 1 and Aquatic Chronic 1 to 3, and with them the aquatic hazard statements H400, H410, H411 and H412. The same data that changes an EU label changes nothing on a US one.

Hence the rule of thumb: a US-origin sheet with a thin section 12 is not necessarily a bad sheet; an EU one is defective.

Four properties, asked in a deliberate order

Toxicity, persistence and degradability, bioaccumulative potential, mobility in soil. All three texts ask for the same four, and the sequence is an argument rather than a list.

Toxicity asks how much harm a given concentration does. Subsection 12.1 wants acute and chronic aquatic data for fish, crustaceans, algae and other aquatic plants, plus soil micro- and macroorganisms, birds, bees and plants where available. Where the material inhibits microorganisms, the possible impact on sewage treatment plants must be mentioned: that plant stands between a factory drain and a river.

Persistence and degradability asks how long the harm lasts. Degradation may be biological, oxidative or hydrolytic, and a quoted half-life must say whether it refers to mineralisation or to primary degradation — the difference between the molecule being gone and it having become something the sheet has not described.

Bioaccumulative potential asks whether concentration rises up a food chain, answered with the octanol-water partition coefficient (Kow) and the bioconcentration factor (BCF). Mobility in soil asks where the material goes: to groundwater, or away from the point of release, evidenced by adsorption and leaching studies, with Koc predictable from Kow.

Read in order they answer one question: how bad, for how long, concentrating where, and travelling how far.

A number without its conditions is not data

Annex 4 A4.3.12.2 sets the reporting standard, and it is the part most often ignored: species, media, units, test duration and test conditions shall be clearly indicated. A figure with no species and no exposure period cannot be compared with another laboratory’s, cannot be checked against a classification cut-off, and is useless to whoever decides how the waste is treated.

Both texts also deal with the gap where testing was never done. Subsections 12.1, 12.2 and 12.3 each require the supplier to consider whether reliable and relevant model information can be provided instead — and Annex 4 attaches the limit in a one-line NOTE under A4.3.12.8: where real data on the substance or mixture is available, that data takes precedence over models and predictions. Modelled values are a fallback, not an equivalent.

Mixtures are not answered in bulk

A4.3.12.3 is explicit that bioaccumulation, persistence and degradability are substance-specific. For a mixture the information should be given for each relevant ingredient — each one that had to be listed in section 3. A single line covering the formulation as a whole cannot answer 12.2 or 12.3, because the constituents degrade at different rates.

12.5 and 12.6 — the two subsections only the EU has

PBT and vPvB

Subsection 12.5 requires, where a chemical safety report is required, the results of the PBT and vPvB assessment as set out in that report. It is not a restatement of the aquatic classification: PBT and vPvB status is assessed against Annex XIII to REACH and judges behaviour over time rather than potency — which is why a substance can be PBT without a dramatic acute figure, or acutely toxic to fish without being PBT.

Endocrine disrupting properties — new in 2020/878

Subsection 12.6 did not exist before Commission Regulation (EU) 2020/878. It requires information on adverse effects on the environment caused by endocrine disrupting properties, where available, for the substances identified as having endocrine disrupting properties in subsection 2.3, given as brief summaries of the information derived from applying the assessment criteria in REACH itself and in Commission Delegated Regulation (EU) 2017/2100 and Commission Regulation (EU) 2018/605.

Two things follow. First, 12.6 is downstream of subsection 2.3: if 2.3 declares no such substance there is nothing to summarise, and if it declares one, an empty 12.6 contradicts the same document three pages earlier. Second, this is the environmental half of the finding only — the human-health half belongs in section 11.

Neither of the other texts has followed. In Annex 4, endocrine disrupting potential remains one example among several under “other adverse effects” at A4.3.12.9; the US text does not mention it at all.

How section 12 connects to the rest of the sheet

• The environmental precautions in section 6 — keep away from drains, surface and ground water — are the instruction the toxicity and mobility data here justify.
• Waste treatment in section 13 is a use A4.3.12.1 names outright: degradability and inhibition of sewage microorganisms decide whether a stream can go to an ordinary plant.
• Section 2 carries both label consequences: the aquatic classification in 2.1 and 2.2, and the PBT, vPvB and endocrine declaration in 2.3 that 12.5 and 12.6 support.
• Section 3 fixes which ingredients need their own ecological answer, and carries the M-factor — the multiplier deciding how heavily an aquatic-toxic constituent weighs in a mixture’s classification.
• The partition coefficient in section 9 is the same log Kow that 12.3 and 12.4 build on. Where the two quote different values, one is wrong.
• Union environmental provisions are listed in section 15; section 12 is the technical basis for why they apply.

What a good section 12 looks like

Three tests, all answerable by reading:

1. Can every number be compared with another laboratory’s? Species, medium, duration, endpoint and test conditions attached to each value. A figure standing alone is decoration.
2. Does each answer say what kind of answer it is? “No data available”, “evaluated and does not meet the classification criteria”, and a modelled estimate are three different statements; a compliant sheet never blurs them.
3. Do 12.5 and 12.6 agree with 2.3? The declaration is made in section 2 and evidenced in section 12. If one is populated and the other silent, the sheet has not been reviewed as a whole.