Specialist in product law under Dutch and EU law

Claartje van der Marel advises, contracts and litigates as a specialist within our team of product compliance experts in the Netherlands in Amsterdam. Product regulation (productregelgeving), product compliance and product safety (productveiligheid) are her core specialisations under both Dutch and EU law.

Within the Product Compliance team of MAAK Advocaten, Claartje guides suppliers, manufacturers, distributors, importers and safety advisers through the world of product regulation, harmonised standards (geharmoniseerde normen), product liability and proceedings before Dutch supervisory authorities such as the Netherlands Food and Consumer Product Safety Authority (NVWA), the Human Environment and Transport Inspectorate (Inspectie Leefomgeving en Transport, ILT) and the Netherlands Labour Authority (Nederlandse Arbeidsinspectie, NLA). Would you like to speak with her directly? Call +31 (0)20 210 31 38 or contact our specialised attorneys in Amsterdam.

What is product compliance and what obligations does your organisation have under Dutch and EU law?

Product compliance (productregelgeving) is the legal obligation to meet all applicable European and national product rules throughout the full life cycle of a product, from design and production to market introduction and end of life. Those obligations include conformity assessment (conformiteitsbeoordeling), technical documentation (technische documentatie), CE marking, labelling requirements and post market surveillance.

Enforcement pressure is rising structurally. More than 60% of non conformity findings during market surveillance by the NVWA and the RDI trace back to incomplete technical documentation or a wrongly applied conformity assessment procedure. Therefore Claartje monitors those vulnerabilities proactively for her clients and advises them in good time about upcoming regulation, so that they do not lose market share to competitors who are compliant.

Her product compliance services under Dutch and EU law include, among others:

• Translating European and national product regulation into workable, tailored compliance frameworks
• Guidance on conformity assessment, technical documentation and declarations of conformity (conformiteitsverklaringen)
• Advice on labelling, packaging and digital product passports, including the Packaging and Packaging Waste Regulation (PPWR)
• Setting up internal product compliance management systems and recall management processes
• Post market surveillance, notification duties and guidance on corrective measures
• Legal support during product development, product changes and new market introductions

How does Claartje guide the CE marking procedure for your organisation?

CE marking is a legally required declaration of conformity through which manufacturers and importers demonstrate that their product meets all applicable European directives and regulations. Namely, it is not a quality label but a legal declaration. Incorrect use or incomplete technical documentation leads to enforcement actions, sales bans and penalty payments imposed by the NVWA or the RDI.

Claartje van der Marel advises on CE marking for a wide range of product categories and guides the full conformity assessment procedure. For example, she determines which directives and regulations apply, reviews the technical documentation for completeness and legal robustness, and advises on the correct harmonised standards per product category. Consequently, the CE marking that her clients apply is legally substantiated and able to withstand an inspection by the NVWA or RDI.

For products that fall under several directives at once, Claartje also advises on the Machinery Regulation (Machineverordening), the AI Regulation (AI Verordening) and the European Battery Regulation (Batterijenverordening). The lead time of a CE marking procedure is typically four to sixteen weeks, depending on the product category and risk profile.

How does Claartje protect your organisation against product liability under Dutch law?

Product liability (productaansprakelijkheid) is the statutory liability of a producer, importer or distributor for damage caused by a defective product. Under the revised Product Liability Directive (EU 2024/2853), damage caused by defective software, AI systems and digital services integrated into a product now also falls within this regime. Every link in the chain can be held liable, including for damage that arises long after market introduction.

Claartje applies a preventive strategy. She identifies liability risks already in the design phase, covers them contractually through supply agreements and general terms and conditions (algemene voorwaarden), and advises on the allocation of liability between manufacturer, importer and distributor. However, when a liability claim nevertheless arises, she coordinates the defence strategy, manages technical and court appointed experts, and litigates before the Dutch court or in international arbitration when required.

Her advice takes account from the outset of related questions concerning liability insurance and criminal law risks. That integration prevents your organisation from facing surprises after an incident. Do you want your liability position reviewed under Dutch law? Contact Claartje van der Marel today for a clear assessment.

When is a product recall mandatory and how does Claartje guide you through a crisis?

A product recall is mandatory as soon as a product poses a serious safety risk and corrective measures are insufficient to remove that risk. Under the General Product Safety Regulation (GPSR, EU 2023/988), a notification duty applies to the competent authorities within four working days of identifying a serious risk. The average cost of a product recall in Europe ranges from €500,000 to more than €10 million, depending on the sector and geographic scope.

Claartje van der Marel is directly deployable during a recall crisis and coordinates the entire process. For example, she handles notifications to the NVWA, the RDI and competent authorities in every country involved, guides the legal crisis communication and manages liability claims arising from the recall. Timely action is essential here: namely, the earlier Claartje is involved, the more legal room there is to limit financial damage and reputational damage. Moreover, our product recall lawyers in the Netherlands are familiar with the new EU recall obligations under the GPSR.

How does Claartje defend your organisation during enforcement actions by the NVWA, ILT or Netherlands Labour Authority?

During enforcement actions by Dutch supervisory authorities, a great deal is namely at stake: financially, but also for the reputation and market position of your organisation. Claartje van der Marel represents businesses in enforcement actions by the NVWA, the Netherlands Authority for Digital Infrastructure (RDI), the Human Environment and Transport Inspectorate (ILT) and the Netherlands Labour Authority (NLA).

The guidance in every enforcement action is the same: have your position assessed as quickly as possible and thereby limit reputational damage. Therefore Claartje acts on behalf of your organisation across all forms of administrative enforcement under Dutch law:

• Written warnings: an immediate assessment of legal robustness and a substantive response that prevents further escalation
• Order for incremental penalty payments (last onder dwangsom): analysis of the lawfulness, monitoring of the grace period, and objection or appeal where necessary
• Administrative fines (bestuurlijke boetes): review of the legal basis, challenge of the amount and proceedings before the administrative court for unjustified fines
• Product recalls: guidance through the full recall procedure and limitation of liability and reputational damage
• Sales bans (verkoopverboden): suspension of the ban in summary proceedings (kort geding) while the proceedings on the merits (bodemprocedure) are pending
• Seizure or destruction of products: safeguarding your rights and claiming the return of goods or compensation for unlawful seizure
• Publication of infringements (“naming and shaming”): acting to prevent or limit publication and, where needed, claiming rectification
• Intensified supervision and re inspections: preparation support and monitoring that the authority stays within its powers
• Withdrawal of permits or other corrective measures: objection and appeal, if necessary with an interim measure to suspend the measure

Besides defence during enforcement actions, Claartje also guides your organisation in deploying supervisory authorities offensively. For example, when a competitor structurally fails to comply with product regulation and thereby gains an unfair advantage, targeted involvement of the NVWA or ILT can restore the level playing field.

How does Claartje help organisations navigate harmonised standards?

Harmonised standards (geharmoniseerde normen) are technical specifications drawn up by European standardisation bodies such as CEN, CENELEC and ETSI that, once a manufacturer applies them, provide a presumption of conformity with the essential requirements of the applicable directive or regulation. In practice, however, those standards are complex, extensive and not always unambiguous in their application to a specific product.

Claartje van der Marel guides manufacturers and importers in identifying the correct harmonised standards per product category, the legal interpretation of the standard requirements and the question of how far deviation from a harmonised standard is permissible. Additionally, she advises on the situation where no harmonised standard is available and a manufacturer must demonstrate conformity in another way. Those situations namely require a carefully substantiated risk analysis that holds up during an enforcement action or a product liability claim under Dutch law.

When does a breach of contract occur in the manufacturing chain and what are your options under Dutch law?

A breach of contract (wanprestatie) in the manufacturing industry almost always touches both contract law and product regulation at the same time. A supplier who fails to deliver CE documentation, a customer who files claims for non conformity (non-conformiteit) or a distributor who unilaterally stops performing its contractual obligations: Claartje advises your organisation on the most effective legal route.

In the event of a breach of contract, she immediately analyses which option is most promising, namely claiming performance, dissolving the agreement (ontbinding) in accordance with Article 6:265 of the Dutch Civil Code (Burgerlijk Wetboek) or claiming damages. Where the matter is urgent, she starts summary proceedings (kort geding) before the preliminary relief judge. For a final resolution of the dispute, she litigates before the Dutch court, on appeal (hoger beroep) or in international arbitration.

How does Claartje draft contracts that strengthen your compliance position?

Drafting an agreement (overeenkomst opstellen) in the manufacturing industry requires knowledge of both contract law and the product regulation that applies to your products. Therefore Claartje drafts contracts that are not only commercially watertight, but that also clearly allocate compliance responsibilities across the chain and limit your liability risk under Dutch law.

In concrete terms, she reviews or drafts: supplier contracts with compliance obligations, distribution agreements with product liability provisions, general terms and conditions with legally sound exemption clauses (exoneraties) and ESG chain contracts with due diligence obligations in line with the CSRD and the CSDDD. Additionally, she advises on the termination of long term agreements in the production chain and the compliance consequences of a termination. She also supports clients on adjacent topics such as greenwashing and ESG advice under Dutch law.

What does legal advice on product compliance cost under Dutch law?

The cost of product compliance advice and proceedings depends on the complexity of the matter and the scope of the work. As a rule, Claartje van der Marel works at MAAK Advocaten on an hourly rate. Additionally, MAAK offers the LAAP approach (Law As A Product) at a fixed price per defined legal product, such as a CE marking review, a liability analysis or a compliance scan of your supply chain. Consequently, your organisation knows in advance exactly what it costs.

Claartje always discusses the costs transparently beforehand. She weighs what proactive compliance guidance saves against the cost of an enforcement action, a product recall or a liability procedure. A free introductory conversation is always possible. Call +31 (0)20 210 31 38 or send an email to claartje.vandermarel@maakadvocaten.nl.

Why do organisations choose Claartje van der Marel as their product compliance attorney in Amsterdam?

Claartje van der Marel is the product compliance attorney for organisations that need someone who does not only analyse product regulation legally, but who also translates it practically into steps your organisation can take right away. Her combination of liability law expertise and broad knowledge of European product regulation makes her approach both in depth and pragmatic. Clients value her decisiveness, her clear communication and her dedication on complex files.

She is active in the manufacturing industry in the broad sense: automotive, mechanical engineering, life sciences, construction products, electronics and chemicals and consumer products. Moreover, Claartje lectures on current developments in product regulation, which underlines her position as a substantive expert in the field. Whether it concerns CE marking for a new product, guidance on a product liability claim, defence during an NVWA enforcement action, crisis management during a product recall or the drafting of supplier contracts with compliance clauses: our specialised attorneys in Amsterdam are ready to help.

Do you have a question about product compliance, liability law or product regulation under Dutch and EU law? Contact Claartje van der Marel for a free and non binding conversation. She responds within one working day and gives you a clear and pragmatic assessment of your position and the approach that best suits your situation.