Product Risk Level Table

A risk assessment is a structured process that manufacturers must carry out pursuant to Article 9(2) of Regulation (EU) 2023/988 (GPSR). It involves identifying the hazards that a product may pose under reasonably foreseeable conditions of use and evaluating the level of risk of harm. The assessment covers factors including probability of harm, severity of potential injury, the vulnerability of the user population, and the nature of the hazard (chemical, mechanical, electrical, etc.).

A GPSR risk assessment considers four core factors: (1) Probability of harm — the likelihood that a hazardous event will occur; (2) Severity of potential harm — ranging from minor temporary injury through to permanent damage or death; (3) Number of persons at risk — the exposure or prevalence factor; (4) Level of safety awareness of the user — with heightened weight given to vulnerable groups such as children, elderly persons, and persons with disabilities. These factors combine to produce four risk tiers: Critical, High, Medium, and Low.

A risk assessment must be updated whenever a material change occurs — including changes to product design, manufacturing process, raw material suppliers, or target markets. Updates are also required when a new Safety Gate notification is published for a comparable product, or following a serious safety incident. GPSR requires the assessment to be treated as a living document, subject to review at least annually even in the absence of specific changes.

A risk assessment may be performed internally by qualified technical staff or externally by compliance consultants, Notified Bodies, or technical inspection organisations. For high-risk products — including toys, childcare articles, and electrical equipment — an independent third-party assessment is strongly recommended. GPSR requires only that the assessment is conducted by a competent and impartial person; it does not mandate an external body.

Applicable standards depend on the product category: the EN 71 series for toys (harmonised standards under Article 10); EN 14682 for cords and drawstrings on children's clothing; EN 62368 for audio, video, and information technology equipment; EN 12520 / EN 12521 for domestic seating and tables. Compliance with harmonised standards creates a presumption of conformity with GPSR safety requirements, though this presumption can be rebutted by market surveillance authorities.

Yes. GPSR mandates a risk assessment for all consumer products — including those manufactured under harmonised standards. For low-risk products such as household accessories or textile accessories, the assessment may be shorter and simpler in format, but it cannot be omitted entirely. Missing documentation is identified as a standalone non-compliance finding during market surveillance inspections and can result in enforcement action.

Safety Gate (the EU product safety notification portal that replaced RAPEX) publishes details of products withdrawn from the market or subject to voluntary recall. Manufacturers should review Safety Gate regularly for comparable products or materials before finalising or updating their risk assessment. A new notification for a similar product or material must be addressed directly in the manufacturer's own assessment — potentially requiring design modifications or changes to warning labelling.

In the event of a recall or market surveillance authority intervention, the manufacturer must immediately update the risk assessment to document the hazards identified by the authorities, record the corrective actions taken, and revise the assessment accordingly. Under Article 35 of GPSR, a Safety Gate notification must be filed within 3 business days. An inadequate or outdated risk assessment constitutes an independent compliance failure and may result in additional sanctions.