SDS Section 15: Regulatory information

The section that describes the law, not the chemical

Every other heading on a safety data sheet describes the substance. Section 15 describes what has been done to it legislatively — which lists it appears on, which permissions it needs, which uses are closed to it, and what the recipient is supposed to do about that.

Two things follow, and they explain most of what goes wrong here. First, this section can become false while the product stays identical: a Candidate List round, an Annex XIV entry, a new Annex XVII restriction, and a sheet that was accurate on Monday is wrong on Tuesday. Second, it is jurisdiction-bound in a way no other section is. Physical properties travel; a national implementing law does not.

REACH Annex II frames the whole heading by exclusion. Section 15 carries the other regulatory information “that is not already provided in the safety data sheet” — the Annex’s own examples being ozone-depleting substances, persistent organic pollutants and the export/import regime for dangerous chemicals. If it belongs in section 1, 2 or 8, it does not belong here.

15.1 — four questions in one subsection

Which Union provisions apply

The text asks for relevant Union safety, health and environmental provisions, and offers one worked example: the Seveso category or named substance. That example matters more than it looks. Annex I to the major-accident directive is what decides whether a site holding the product is a lower-tier or an upper-tier establishment, and the operator downstream cannot make that determination without knowing which category or named entry the product falls into. It is one of the few places where a line on a safety data sheet directly sets an obligation on the reader’s building rather than on the reader’s hands.

Authorisation and restriction

This is the REACH-specific half. Where the product is the subject of specific Union provisions protecting human health or the environment — authorisations given under Title VII, restrictions under Title VIII — the sheet must mention them. Title VII is the Annex XIV route: a substance on that annex may not be placed on the market or used after its sunset date without an authorisation. Title VIII is Annex XVII: conditions and outright prohibitions attached to particular substances and particular uses.

The second sentence is the one most often skipped. Where an authorisation granted under Title VII imposes conditions or monitoring arrangements on a downstream user, Annex II says those shall be provided. An authorisation number without its conditions tells the recipient that permission exists but not what it costs them.

The Candidate List, which drives this section without being named in it

A substance identified under Article 57 and placed on the list established under Article 59(1) is a substance of very high concern. The Candidate List is not mentioned in the words of 15.1, but it is the single most common reason a section 15 goes stale, because listing sets three separate duties running at once:

• Under Article 31(1)(c), listing triggers the obligation to supply a safety data sheet at all — even for a substance that meets no classification criteria. The sheet exists because of the listing.
• Under Article 33, a supplier of an article containing a Candidate List substance above 0.1 % w/w must give the recipient enough information for safe use, as a minimum the substance name, and must answer a consumer request within 45 days.
• Under Article 9(1)(i) of the Waste Framework Directive, as inserted by Directive (EU) 2018/851, that same Article 33(1) information has had to go to ECHA — the SCIP database — since 5 January 2021.

Only the first of those is section 15’s business, but a supplier who has not noticed the listing has usually missed all three.

National provisions

The subsection closes by requiring the national laws of the relevant Member States implementing those provisions, and any other relevant national measures. A supplier selling one product into six markets does not have one section 15; it has one section 15 with six labelled national blocks, or six sheets.

A caution about the Annex’s own citations

The text of section 15 still names Council Directive 96/82/EC and Regulation (EC) No 850/2004. Both have been replaced — the first by Directive 2012/18/EU on the control of major-accident hazards, the second by Regulation (EU) 2019/1021 on persistent organic pollutants (recast) — and the ozone regulation the Annex cites has likewise been superseded, by Regulation (EU) 2024/590. Copying the Annex’s examples verbatim reproduces citations that are no longer live.

15.2 — the smallest subsection on the sheet

One sentence of regulation, one bit of information: whether the supplier has carried out a chemical safety assessment. The assessment’s output surfaces elsewhere — as DNEL and PNEC values in section 8, and as the exposure scenarios annexed to the sheet — so 15.2 is a pointer, not a summary.

Its size is exactly why it fails. It is a field with a two-word answer, sitting at the bottom of a section that OSHA does not enforce, on the second-to-last page of the document. Left blank, it reads as an omission rather than an answer, and there is no way for the reader to tell which.

What a US sheet carries here instead

OSHA’s Table D.1 prints the GHS heading unchanged and marks the section “(Non-mandatory)”; Appendix D requires the listed information for sections 1–11 and 16 only. The boundary is jurisdictional, not editorial — TSCA, EPCRA and the state right-to-know statutes are not OSHA’s to enforce.

What appears anyway, by convention: TSCA Chemical Substance Inventory status, from the list EPA compiles under TSCA section 8(b), which separates an existing chemical from a new one; EPCRA — SARA Title III — status under sections 302, 311, 312 and 313, covering extremely hazardous substances, hazardous chemical reporting and the annual toxic release inventory; and state lists, chiefly the Proposition 65 list published under California’s Safe Drinking Water and Toxic Enforcement Act of 1986. None of it is required, and none of it can be assumed present.

How section 15 connects to the rest of the sheet

• The classification in section 2 is a hazard statement; section 15 is a legal statement. A substance can be unclassified and still restricted, which is the case Article 31(1)(c) exists for.
• The identities in section 3 are what the Candidate List, Annex XIV and Annex XVII are checked against. A component named inconsistently between the two sections cannot be verified by anyone.
• The registration number and supplier details in section 1 establish who the “supplier” in 15.2 actually is.
• 15.2 points at the assessment whose numbers appear in section 8 — DNELs, PNECs and the annexed exposure scenarios.
• Waste classification in section 13 runs on the same Waste Framework Directive that carries the SCIP duty referenced above.
• The revision date and change record in section 16 are what make an Article 31(9) reissue auditable. Section 15 changes and section 16 has to show that it did.

What a good section 15 looks like

1. Does every entry say what the reader must do? 15.1 asks for advice on the action the recipient should take, not a list of regulation numbers. “Subject to Annex XVII entry 28” is a citation; “may not be placed on the market for supply to the general public” is an instruction.
2. Is 15.2 answered? Yes or no. If the field is empty, the sheet has not been finished.
3. Is it dated by something? Regulatory status has a shelf life. A section 15 that cannot be tied to a specific revision in section 16 gives the reader no way to judge how old its picture of the law is.