# Reagents and high-purity lab chemicals: Regulation

Labels, safety sheets and drug-precursor rules on every pack

Source page: https://www.materialinsights.org/chemicals/lab_reagents/regulation/

What this tab covers How it is regulated and what could disrupt supply: hazard classification, rules in the EU, US and India, anti-dumping duties and other trade measures, and supply-risk notes.

#### Hazards

| Classification | UN number | Key risks |
|---|---|---|
| varies by product; all packs need GHS labels and SDS | varies; limited and excepted quantities common | Mislabelled or contaminated reagents give wrong test results; diversion of precursor chemicals. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **EU** | CLP labelling; REACH (most reagents below 1 t/yr per substance or registered by the bulk maker); drug precursor rules (Reg. 273/2004) | labelling and customer checks |
| **Global** | ISO 17034 and ISO 17025 for reference materials; pharmacopoeia (USP, EP) grades | accreditation is a barrier to entry |
| **Global** | Chemical Weapons Convention and dual-use export controls | licences for some scheduled reagents |

#### India

| Rule | Effect |
|---|---|
| **NDPS (Regulation of Controlled Substances) Order 2013 for precursors such as acetic anhydride and potassium permanganate (indicative)** | licensing and reporting for sales |
| **Medical Devices Rules 2017 for in-vitro diagnostic reagents (CDSCO)** | licensing of diagnostic kits |
| **Indian Pharmacopoeia (IP) reagent specifications** | grades used in pharma QC |

#### Trade measures

- No major anti-dumping measure on lab reagents found in the sources used

#### Supply risk

Low for most products; some reagents depend on a single by-product or a few qualified makers (acetonitrile, certain standards and enzymes).

## Other sections

- [Summary](https://www.materialinsights.org/chemicals/lab_reagents/index.md)
- [Overview](https://www.materialinsights.org/chemicals/lab_reagents/overview/index.md)
- [Correlation](https://www.materialinsights.org/chemicals/lab_reagents/correlation/index.md)
- [Production route](https://www.materialinsights.org/chemicals/lab_reagents/routes/index.md)
- [Production](https://www.materialinsights.org/chemicals/lab_reagents/production/index.md)
- [Feedstocks](https://www.materialinsights.org/chemicals/lab_reagents/feedstocks/index.md)
- [Cycles](https://www.materialinsights.org/chemicals/lab_reagents/cycles/index.md)
- [Trading](https://www.materialinsights.org/chemicals/lab_reagents/trading/index.md)
- [Movement](https://www.materialinsights.org/chemicals/lab_reagents/movement/index.md)
- [Characteristics](https://www.materialinsights.org/chemicals/lab_reagents/characteristics/index.md)
- [Emissions](https://www.materialinsights.org/chemicals/lab_reagents/emissions/index.md)
- [Relationships](https://www.materialinsights.org/chemicals/lab_reagents/links/index.md)