EU General Product Safety Regulation incident and recall triage workflow

Confirm the legal scope at intake. The GPSR is the baseline for consumer products and products likely to be used by consumers, but Article 2 excludes specified categories and limits the GPSR where product-specific EU safety law regulates the same risk. A harmonised product may also have a separate vigilance or incident regime, so record the applicable instrument and do not assume that one submission satisfies every reporting duty.

Open a case as soon as the signal alleges a safety issue, accident, or dangerous product. Record the product exactly as it is sold: name, brand, type, model, batch or serial number, barcode, packaging description, images, listing URL, marketplace offer identifier, countries where it was made available, and the economic operators in the supply chain.

Classify the notifier role before anyone submits through the Safety Business Gateway. Submissions are reserved for economic operators and online marketplace providers concerned by the product; the Commission manual says third-party submissions are prohibited. For accidents, importers and distributors inform the manufacturer without undue delay, the manufacturer submits or instructs one of them to submit, and a responsible person that knows of the accident ensures submission when the manufacturer is outside the EU.

The triage owner should separate three questions: what is the defect or safety issue, how the issue can lead to harm, and what evidence supports the risk level. Under Article 3, risk combines the probability that a hazard causes harm with the severity of that harm; serious risk is the category that requires rapid authority intervention, even when effects are not immediate. The Safety Business Gateway form captures a safety description, risk category, risk level, and available laboratory, visual-test, certificate, or risk-assessment material.

Do not delay notification solely because the team has not completed a formal risk assessment. The Safety Business Gateway manual states that determining the risk level is not required for notifying a dangerous product; if the notifier cannot assess the level, the form allows an Unknown risk level. Market surveillance authorities can reach a different conclusion from the notifier's grading.

Article 20 applies when an occurrence associated with use of the product resulted in death or serious adverse effects on an individual's health and safety, whether permanent or temporary, including injuries, other bodily damage, illness, or chronic health effects. The manufacturer must ensure notification through the Safety Business Gateway to the authority in the Member State where the accident occurred, without undue delay from when it knows of the accident.

A case that does not meet Article 20 can still involve a dangerous product. Apply the role-specific notification duties in Articles 9 to 12 and 22 separately. Submit the available core facts without treating an unfinished risk grade as a reason to delay, then keep the Case ID, submission number, submitted copy, translation status, authority correspondence, and later updates in the evidence record.

Once the product is treated as dangerous or potentially dangerous, assign a corrective-action owner and decide which measure removes the risk or, where that is not possible, mitigates it. A withdrawal prevents a product in the supply chain from being made available on the market. A recall aims to return a product that has already been made available to consumers.

A single case may need more than one action. For example, the team may withdraw unsold inventory, recall units already with consumers, warn consumers about safe use while replacement parts are prepared, and ask marketplaces to remove or disable offers. Keep each action separate with scope, duration, responsible company, start date if available, results, and the consumer-facing message.

When recall information is provided in writing, GPSR Article 36 requires a recall notice that consumers can easily understand in the language of each Member State where the product was made available. The notice should help consumers identify the product, understand the hazard, stop using it, obtain the remedy, and contact the business for more information.

Avoid phrasing that lowers perceived risk. The GPSR and the recall-notice template warn against words such as voluntary, precautionary, discretionary, in rare situations, in specific situations, or statements that there have been no reported accidents. The notice should be accessible and, online, essential identification information shown in pictures should also be available as machine-readable text.

For online sales, involve marketplace contacts early. Providers of online marketplaces must register with the Safety Gate Portal, keep product-safety internal processes, process product-safety notices, cooperate with authorities and economic operators, publish recall information on their interfaces, directly notify affected consumers who bought through their interfaces, and report certain dangerous products or accidents through the Safety Business Gateway.

Move the case from triage to monitored corrective action only after the file shows the product identity, risk rationale, notification status, corrective measures, consumer communications, marketplace actions, and open follow-up items. GPSR does not set a universal return-rate or response-rate threshold for closure; the residual risk, new incidents, remedy backlog, distribution reach, authority position, and ability to resume contact should drive any close or escalation decision.

Regulation (EU) 2023/988 and the cited implementing and delegated regulations are binding. The Safety Business Gateway user manual supplies operational form guidance, including the Unknown risk option and case references, but it does not change the legal notification triggers. Sorena's intake, evidence, and closure fields are workflow recommendations.