Guide
Assess whether your product meets the general safety requirement
How to carry out a product safety risk assessment to determine whether your product meets the general safety requirement under the General Product Safety Regulations 2005. Covers the OPSS PRISM methodology, designated standards, documenting your assessment, and building a due diligence defence.
Before placing a consumer product on the GB market, you must satisfy yourself that it meets the general safety requirement. This means the product presents no risk, or only minimum risks compatible with its use, under normal or reasonably foreseeable conditions.
A structured risk assessment is the primary way to demonstrate this. It also forms the foundation of any due diligence defence if enforcement action is taken against you. Without a documented assessment, you will find it difficult to show that you took all reasonable steps to supply safe products.
This guide sets out a step-by-step process for assessing product safety, based on the methodology used by the Office for Product Safety and Standards (OPSS).
What the law considers a safe product
The General Product Safety Regulations 2005 set out specific criteria for assessing whether a product is safe. Your risk assessment must address each of these factors.
Step-by-step risk assessment process
Follow these steps to assess your product against the general safety requirement. The OPSS Product Risk Assessment Methodology (PRISM) provides a structured framework for evaluating risk as a function of likelihood and severity of harm.
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1. Identify intended users and foreseeable use
Define the intended user group for your product, including age range, skill level, and any relevant physical characteristics. Consider vulnerable users, particularly children and elderly people. Document all reasonably foreseeable uses, including predictable misuse. A product aimed at the general public requires broader consideration than one designed for trained professionals.
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2. Identify all foreseeable hazards
Systematically identify every hazard the product could present. Consider physical hazards (sharp edges, entrapment, choking), chemical hazards (toxic substances, skin irritation), electrical hazards (shock, overheating), thermal hazards (burns, fire risk), and mechanical hazards (moving parts, instability). Also consider hazards arising from the product's interaction with other products where combined use is foreseeable.
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3. Assess risk using likelihood and severity
For each identified hazard, assess the risk using the PRISM methodology. Estimate the likelihood of harm occurring (from remote to very likely) and the severity of the potential injury (from minor to fatal). Combine these to determine the overall risk level. OPSS classifies risk as serious, high, medium, or low. Products presenting a serious risk require immediate corrective action.
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4. Check applicable designated standards
Search the GOV.UK designated standards database for standards that apply to your product type. Compliance with a designated standard creates a presumption that your product meets the safety requirements covered by that standard. Note which standards apply and which risks they address.
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5. Test against relevant standards
Arrange testing of your product against each applicable designated standard. Use a UKAS-accredited test laboratory where possible, as this provides the strongest evidence of compliance. Retain all test reports, certificates, and supporting documentation. Where no designated standard exists, test against relevant codes of practice or assess against the current state of the art.
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6. Document your assessment and retain records
Record the full risk assessment in writing. Include the product description, identified users, all hazards, risk ratings, applicable standards, test results, and your overall conclusion on safety. Date and sign the assessment. Retain this documentation for at least 10 years from the date the last product is placed on the market.
Using designated standards
Designated standards are your most efficient route to demonstrating product safety. Compliance with the relevant designated standard creates a legal presumption that your product is safe for the risks that standard covers.
Presumption of conformity is powerful but limited. If your product complies with all applicable designated standards, it is presumed to meet the general safety requirement for the risks those standards address. However, if your product presents hazards not covered by any designated standard, you must still assess and mitigate those risks separately.
Documenting your assessment for due diligence
Your risk assessment is the cornerstone of a due diligence defence. If enforcement action is taken, you will need to demonstrate that you had effective systems in place and that they were actively used. A paper system that was never followed will not protect you.
Ensure your documentation covers:
- Design review records showing safety was considered from the outset
- Hazard identification worksheets with dates and participants
- Test reports and certificates from accredited laboratories
- Standards compliance matrix mapping each standard to the risks it covers
- Supplier verification records if components are sourced from third parties
- Ongoing monitoring evidence including complaint logs, sample testing, and post-market surveillance
What to do next
- If your assessment shows the product is safe: retain the documentation and proceed to place the product on the market. Continue monitoring through post-market surveillance, complaint tracking, and periodic sample testing.
- If your assessment identifies unacceptable risks: redesign or modify the product to eliminate or reduce the risk before placing it on the market. Repeat the assessment after changes.
- If you discover a safety issue after placing the product on the market: notify OPSS or your local Trading Standards immediately and take corrective action. See the product safety compliance checklist to verify your ongoing obligations.