Romanian business counsel · Product safety and supplier contracts

A customer reports that a product sold by your Romanian business may be unsafe. The immediate decisions concern affected stock, consumer protection, authority notification and evidence. Your supply contract then determines which costs you may be able to recover from another party.

This guide is for retailers, distributors and importers managing consumer-product safety concerns in Romania. Food, medicines and other excluded or specially regulated categories need their own framework. “Before a recall” means preparing the response, not postponing a recall or notification that is already required.

Is this a customer dispute or a product-safety incident?

A poor-quality item, late delivery and a potentially dangerous product raise different questions. A request for a refund does not exclude a safety issue: read what happened, how the product was used and whether injury, overheating, breakage, choking or another hazard is reported.

Preserve the original message, photographs, product identifiers, purchase details and the first response. Separate reported facts from verified findings. A technical specialist should assess the hazard and possible causes; counsel should identify the applicable duties and the response required from your company. Do not require multiple complaints or a completed laboratory report before considering measures justified by the information already available.

Which product-safety rules apply in Romania?

Regulation (EU) 2023/988 on general product safety, known as the GPSR, applies from 13 December 2024. Article 2 defines its scope and its relationship with product-specific EU safety rules. Identify that relationship before relying on an obligation assigned to manufacturers, importers or distributors. Consult the consolidated GPSR text for the amendments incorporated into the regulation.

For products subject to EU harmonisation legislation, Article 2 excludes specified parts of the GPSR, including Chapter III, Section 1. Consequently, Articles 9–18 are not a universal checklist for every product carrying a CE mark. For many CE-marked products, sector-specific legislation is the primary source of operator obligations. The legal classification and covered risks, rather than the CE mark alone, determine the relationship between the regimes; other GPSR provisions can remain relevant. The European Commission’s general product-safety standards page is a useful starting point for the technical framework.

Depending on the product category and issue, competence may belong to the National Authority for Consumer Protection (ANPC) or another Romanian market-surveillance authority designated under the applicable legislation. Harmonised products are not automatically outside ANPC’s remit. For example, ANCOM’s radio-equipment surveillance guidance identifies responsibilities for both ANCOM and ANPC. The Romanian medicines and medical-devices agency (ANMDMR) has a specialist market-surveillance role for medical devices.

A consumer complaint to ANPC, a business notification and a formal enforcement measure are separate procedural events. Article 44 GPSR requires Member States to establish effective, proportionate and dissuasive penalties. For an inspection or sanction, verify the Romanian provision in force, the authority’s competence, the alleged breach and the applicable challenge deadline; the GPSR does not supply a single Romanian fine schedule.

Does being “only the retailer” remove responsibility?

No. Under the applicable framework, a retailer may be a distributor with its own duties. A Romanian company placing a product from a third country on the EU market may be an importer. Under Article 13 GPSR, placing a product on the market under your own name or trademark can bring manufacturer obligations; substantial modification has its own conditions.

Where Article 12 GPSR applies: paragraph (3) requires a distributor to withhold a product it considers or has reason to believe is dangerous or fails the specified requirements until it is brought into conformity. Paragraph (4) addresses a product already made available: the distributor must immediately inform the manufacturer or importer, ensure appropriate corrective measures and ensure immediate notification of the relevant market-surveillance authorities through the Safety Business Gateway. The authority-notification duty is in Article 12(4)(c).

That provision also covers the identification and safety-information requirements expressly listed there. A failure in those requirements is not, by itself, proof of a physical hazard. Determine the non-compliance and appropriate corrective measures; do not assume every missing label requires a consumer recall.

The Commission’s Safety Business Gateway guidelines explain that, for the distributor route, the manufacturer or importer may submit the information, but the distributor must do so if they have not. Retain evidence of the actual submission and its scope. An email asking the supplier to “handle compliance” does not demonstrate that notification occurred.

What if the manufacturer is outside the EU?

Identify the actual importer and the EU responsible economic operator before relying on a foreign supplier’s assurances. For non-harmonised consumer products where Article 16 GPSR applies, the product must have an operator established in the EU responsible for the specified tasks. The eligible roles are identified through Article 4(2) of Regulation (EU) 2019/1020 on market surveillance: an EU manufacturer, an importer where the manufacturer is outside the EU, a duly mandated authorised representative, or a fulfilment service provider in the circumstances specified there.

These roles are not interchangeable. A distributor does not automatically become the importer, and naming a responsible person does not remove other operators’ own duties. For harmonised products, check the sector rules and the applicable requirements of Regulation 2019/1020, rather than applying Article 16 GPSR indiscriminately.

What is the difference between withdrawal and recall?

Can you trace the affected batch through the business?

Build a product-specific distribution record. Connect supplier identifiers to internal stock codes, shipment records, stores, online orders and customer contact information lawfully held. Record uncertain quantities explicitly; avoid presenting a partial stock search as a complete batch reconciliation.

Use consumer contact data to the extent necessary for safety communications and handle it under the General Data Protection Regulation (GDPR). Article 35(1) GPSR requires economic operators and, where applicable, online marketplaces collecting customer personal data to use that information for recalls and safety warnings. This supports necessary direct contact with affected customers, not unrestricted use of every item of customer data. Where processing is necessary to fulfil an applicable legal obligation, Article 6(1)(c) GDPR can provide the legal basis; that does not justify unrelated marketing or unrestricted disclosure. Keep the processing transparent, restrict access and retain the data only as justified by the applicable purpose and legal requirements.

Article 35(2) separately requires businesses with product-registration systems or loyalty programmes identifying purchases for other purposes to offer customers the option of providing separate contact details solely for safety communications.

Injury reports may include health data, which require a separate applicable condition under Article 9 GDPR as well as an Article 6 basis. Collect only necessary information, restrict access and arrange secure disclosure to advisers and authorities. Do not include identifiable medical records in a public recall notice.

When must the business notify authorities or report an accident?

The trigger and responsible actor depend on the product regime, your role and the information received. Where the relevant GPSR duties apply, notification can be immediate. A commercial approval process or dispute over reimbursement must not postpone a required submission.

The European Commission’s Safety Business Gateway is the business notification portal. The public Safety Gate portal provides information on dangerous products and alerts. These have different functions: searching public alerts does not submit your business notification.

Article 20 GPSR separately addresses accidents associated with product use. Paragraph (2) covers death or serious adverse effects on health and safety, whether permanent or temporary, including injury, illness and chronic health effects. Under paragraph (1), the manufacturer must ensure notification through the Safety Business Gateway to the competent authority of the Member State where the accident occurred, without undue delay from learning of it.

Under Article 20(3), importers and distributors that know of an accident caused by a product they placed or made available on the market must inform the manufacturer without undue delay. The manufacturer must notify under paragraph (1) or instruct the importer or one of the distributors to notify. Where the manufacturer is outside the EU, paragraph (4) requires the responsible person within Article 16(1) GPSR or Article 4(1) of Regulation 2019/1020, if aware of the accident, to ensure notification. Verify the reporting actor, timeline and authority against the product regime and facts. A separate dangerous-product notification may be required even where no accident or injury has occurred.

What must a consumer-facing recall communication contain?

Under Article 35 GPSR, affected consumers who can be identified must be notified directly and without undue delay, according to the actors’ respective obligations. Where direct contact cannot reach everyone, use appropriate additional channels to achieve the widest possible reach.

Article 36 governs written recall notices, including identification of the product and hazard, the action consumers should take, available remedies and a contact route. Use the Commission’s recall-notice template under Implementing Regulation (EU) 2024/1435. Prepare the notice in the relevant languages, including Romanian for the Romanian consumer audience.

Article 36(2)(c) requires a clear hazard description and excludes wording that reduces consumers’ perception of risk, including “precautionary” and statements that no accidents have been reported. Make the product and batch identifiable without requiring the consumer to interpret an internal stock code. Provide accessible formats: important product identifiers shown in an image should also appear as machine-readable text. Ensure the contact team can explain and implement the stated remedy.

Article 37 requires the economic operator responsible for the safety recall to offer an effective, cost-free and timely remedy. As a general rule, that operator must offer a choice between at least two of repair, replacement with a safe equivalent and an adequate refund at least equal to the price paid. The limited exception for impossible or disproportionately costly remedies requires assessment under the provision’s conditions; a budget preference alone is insufficient. As an operational check, confirm that each offered option can actually be delivered through the recall process.

The remedy must not cause significant inconvenience. Consumers must not bear shipping or other return costs; for products that are not portable by their nature, the operator must arrange collection. Consumers remain entitled to a refund if repair or replacement is not completed within a reasonable time and without significant inconvenience. These logistics belong in the response plan and budget.

Are recall remedies the same as warranty or injury claims?

No. Article 37 preserves the relevant consumer sales rights. In Romania, Emergency Ordinance No. 140/2021 on consumer sales of goods provides the separate framework for conformity and remedies in the sales relationship, subject to its own conditions and time limits. Do not assume a commercial warranty period defines the limits of a product-safety recall.

Regulatory safety duties are also separate from potential civil liability for injuries or property damage caused by a defective product. Romanian Law No. 240/2004 on liability for defective products transposes Directive 85/374/EEC, as amended by Directive 1999/34/EC, and addresses that liability alongside potentially relevant contractual or non-contractual claims. Liability requires its own assessment of the defect, damage, causation and responsible parties. Recall expenditure and compensation for injury should not be treated as the same insured loss.

Directive (EU) 2024/2853 on liability for defective products sets a transposition deadline of 9 December 2026. Article 2(1), as corrected by the 7 May 2026 corrigendum, applies the directive to products placed on the market or put into service after 8 December 2026. Under Article 21, Directive 85/374/EEC is repealed with effect from 9 December 2026 but continues to apply to products placed on the market or put into service before that date. Before relying on the new regime in Romania, check whether the implementing legislation has been adopted, its effective date and the provisions applicable to the particular product and claim.

Who pays, and what should the supply agreement resolve?

Separate the immediate regulatory response from later contractual recovery. Examine the executed supply or distribution agreement, purchase orders, product specifications, insurance and notice provisions together. Responsibility for a defect and entitlement to reimbursement need evidence and an applicable contractual or legal basis.

Send contractual notices in the agreed form and within the applicable deadlines while continuing required safety measures. Review liability caps and exclusions for enforceability. Where Romanian law applies, Article 1355(1) of the Romanian Civil Code prohibits excluding or limiting liability for material damage caused intentionally or through gross negligence. Under paragraph (3), liability for harm to physical or psychological integrity or health cannot be excluded or reduced except under the conditions provided by law. The enforceability of a particular cap or exclusion depends on the clause, the parties, the type of harm and any applicable mandatory rules. An indemnity or cap does not remove mandatory duties or automatically bind an injured consumer.

The negotiation should also address incident cooperation, data access, record retention, authority communications, reimbursement timing and disputes over causation. Our guide to negotiating a Romanian distribution agreement explains how these duties fit the wider commercial relationship.

Illustrative scenario: a supplier alert reaches a Romanian retailer

Hypothetical example. This is not a client matter or a reported outcome.

How Atrium can assist with a product-safety response

Our commercial contract review services can support the analysis of supplier responsibilities, notices, indemnities and recovery provisions. For an active incident, a defined legal mandate can also cover the applicable notification route, authority correspondence and consumer-facing documents, coordinated with your technical and operational advisers.

For the first discussion, identify the product, your role, countries of sale, allegation, any injury reported and any deadline in authority correspondence. Describe the available complaint, supplier agreement, batch records, technical findings and actions already taken. Agree a secure transfer route before sending sensitive customer or medical information.

Scope and fee: Ask for a written proposal for the initial document review or incident-response work. A starting fee or fee cap should relate to specified documents and tasks; technical testing, translations, recall logistics and separate proceedings need their own allocation. No case-specific price is stated here.

Related Guides

Frequently asked questions

AI-assisted content.