Section 15 – Regulatory Information: The Legal DNA of Your SDS
Why this short section contains more compliance power than most people realize
Most people reading a Safety Data Sheet focus on hazards, controls, storage, and first aid.
But Section 15, often overlooked, is where the SDS tells you how the law views your product.
This section may look administrative, but it is actually the regulatory passport of the substance or mixture.
It shows which legal frameworks apply, what restrictions exist, and what obligations you must follow across the EU and beyond.
For SHEQ managers, Section 15 is essential for staying compliant, avoiding unintentional violations, and ensuring chemicals are used responsibly.
What Section 15 Actually Covers
Under REACH Annex II, Section 15 must summarise:
- Applicable EU and national regulations
- REACH Authorisation, Annex XIV
- REACH Restrictions, Annex XVII
- SVHC Candidate List status
- Sector specific product legislation
- Global chemical inventory listings
- Chemical Safety Assessment status
Each item hides significant compliance meaning. Below we translate them into practical language.
Key Regulations You Will See in Section 15
And what they actually mean for you
Below is a selection of the regulations most often mentioned in Section 15, each with a clear explanation of what it governs and why it matters.
REACH Restrictions, Annex XVII
Annex XVII lists banned or restricted uses of substances in the EU.
Examples include:
- Limits on certain phthalates in consumer products
- Restrictions on azo dyes in textiles
- Prohibitions on methanol in windshield washer fluid
Why it matters:
If a component in your product is restricted, certain uses may be illegal or require specific control conditions.
REACH Authorisation, Annex XIV
Substances in Annex XIV cannot be used unless a company obtains an EU authorisation.
Examples include:
- Chromium VI compounds
- DEHP
- Certain aromatic amines
Why it matters:
Some uses become time limited. Downstream users must verify whether their supplier holds an authorisation that covers their specific application.
SVHC Candidate List
The Candidate List contains Substances of Very High Concern.
Examples include:
- BPA
- Lead metal
- Several PFAS substances
Why it matters:
If a mixture contains more than 0.1 percent of a Candidate List substance, companies must communicate this to downstream users and report it in the SCIP database under EU waste legislation.
Seveso III Directive
Regulates major accident hazards at industrial sites.
Why it matters:
Even if your chemical is not Seveso relevant, knowing which substances on-site are covered can change your site classification and emergency planning obligations.
VOC Legislation, Deco-Paint Directive and Industrial Emissions Directive
Controls volatile organic compounds in paints, coatings, and industrial facilities.
Why it matters:
High VOC content impacts environmental permits, process emissions, and reporting duties.
RoHS Directive
Regulates substances used in electrical and electronic equipment.
Restricted substances include:
- Lead
- Mercury
- Hexavalent chromium
- Certain flame retardants
Why it matters:
If your product ends up in electronics or cables, RoHS compliance is mandatory.
PRTR Regulation
The Pollutant Release and Transfer Register requires annual reporting of environmental emissions for certain chemicals.
Why it matters:
If your chemical appears on this list, your site may have additional reporting obligations.
Water Framework Directive
Lists priority pollutants that affect water bodies.
Why it matters:
Discharges to sewer or water systems may need special handling, treatment, or permits.
Explosives Precursors Regulation
Controls chemicals that could be misused to manufacture explosives.
Examples:
- Hydrogen peroxide above certain levels
- Nitromethane
- Acetone under specific conditions
Why it matters:
You may need to verify customer identity, maintain records, or limit concentration levels.
Drug Precursors Regulation
Controls substances used in the illegal synthesis of drugs.
Why it matters:
Storage, sales, and transport may require registration or detailed record keeping.
Ozone Depleting Substances Regulation
Regulates substances harmful to the ozone layer.
Why it matters:
These substances are banned or heavily restricted. Even trace presence can have significant compliance implications.
PIC Regulation
The Prior Informed Consent Regulation controls the export and import of certain hazardous chemicals.
Why it matters:
Companies must notify ECHA and the importing country before shipping listed chemicals.
POP Regulation
Controls Persistent Organic Pollutants that persist and bioaccumulate in the environment.
Examples include:
- Certain pesticides
- PBDE flame retardants
Why it matters:
POP substances are heavily restricted or banned in the EU.
Global Chemical Inventories
A crucial part of Section 15
Section 15 often lists the status of a substance in global chemical inventories, for example:
- US TSCA
- Canada DSL
- China IECSC
- Japan ENCS
- Korea KECI
- Australia AIIC
- Taiwan TCSI
- Philippines PICCS
- New Zealand NZIoC
Why this matters:
If a substance is not listed on a specific country’s inventory, it may be illegal to import or require a new chemical notification.
For multinational operations, this can influence procurement, supply chain choices, and logistics.
Chemical Safety Assessment (CSA)
Section 15 states whether a Chemical Safety Assessment has been carried out.
This is a REACH obligation above 10 tonnes per year per registrant.
A CSA includes:
- DNELs
- Exposure scenarios
- Environmental risk assessments
- Operational conditions and risk management measures
Why it matters:
If a CSA exists, downstream users can rely on the supplier’s assessment unless they deviate from the conditions of safe use.
Why Section 15 Matters for SHEQ Management
Section 15 tells you:
- What you are legally allowed to do
- Whether any substances are restricted or controlled
- Whether additional communication obligations exist
- Whether specific environmental or occupational rules apply
- Whether international trade is permitted
- Whether a chemical may face future restrictions
It is not a simple administrative list. It is compliance intelligence.
The NextSDS Perspective
At NextSDS, we turn Section 15 into an active compliance monitoring tool.
Our platform automatically checks each chemical component against:
- Annex XIV
- Annex XVII
- Candidate List updates
- POP, PIC, ODS, RoHS
- Global chemical inventories
- VOC or Seveso implications
- National occupational and environmental regulations
Whenever something changes, we flag it automatically.
This transforms Section 15 from static text into real time regulatory insight.
✅ Section 15 is the legal DNA of your SDS.
Understanding it helps companies stay ahead of restrictions, communicate responsibly, and maintain full chemical compliance.
👉 Discover how NextSDS can automate regulatory tracking and keep your SDSs fully aligned with the latest updates. Visit www.nextsds.com to learn more.