GPSR risk assessment: how to write the internal risk analysis (with example)
Article 9(2) of the GPSR requires manufacturers to carry out an internal risk analysis and draw up technical documentation before placing a product on the market. The documentation must contain at least a general description of the product, its essential safety characteristics, an analysis of possible risks and the solutions adopted to eliminate or mitigate them, and — where relevant — the European standards or other elements used. It must be kept up to date and available for 10 years.
A practical method
- Describe the product: what it is, materials, dimensions, intended use, who uses it.
- Think about foreseeable misuse: a toddler grabbing a necklace, a candle left burning, a mug used in a microwave.
- List hazards: mechanical (small parts, sharp edges, cords), chemical (nickel, lead, dyes, resins), thermal (fire, burns), electrical, suffocation, tipping over.
- Rate each hazard for severity (minor → very serious) and probability (very unlikely → likely), giving a risk level.
- Record the measures you take: design changes, safer materials, pull tests, lab tests, warnings, packaging.
- Re-rate the residual risk and write a conclusion.
Worked example: beaded bracelet
| Hazard | Who | Risk before | Measures | Residual |
|---|---|---|---|---|
| Beads detach and are swallowed | Children under 3 in the home | High | Double-knotted, crimped stringing; pull test; age warning | Low |
| Nickel release from clasp | Users with nickel allergy | Medium | Stainless 316L clasp; supplier REACH declaration | Low |
Severity and probability follow the logic of the EU's RAPEX risk-assessment guidelines, simplified for small producers.
Common mistakes
- Copy-pasting a generic template that does not mention your actual product.
- Listing warnings but no design measures.
- Forgetting children who are not the intended users but can reach the product.
- Not dating or versioning the document.
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