Dutch Regulatory Litigation

MAAK Advocaten represents international manufacturers, importers, distributors, online marketplaces and other foreign businesses in Dutch proceedings and enforcement matters before the Dutch market surveillance authorities. Depending on the product and the applicable legislation, this may involve the Netherlands Labour Authority (NLA), the Netherlands Food and Consumer Product Safety Authority (NVWA), the Human Environment and Transport Inspectorate (ILT), and the Radiocommunications Agency Netherlands (RDI). We assist clients throughout investigations, inspections, administrative enforcement proceedings, objections, appeals and strategic discussions with the competent authorities to protect their commercial interests in the Netherlands. We act decisively, on behalf of your organisation, and always aim for the outcome that best fits your commercial interests, reputation and position in the chain.

MAAK Advocaten in Amsterdam supports your organisation with written warnings, an order subject to a penalty (last onder dwangsom), administrative fines (bestuurlijke boetes), product recalls, sales bans, the seizure or destruction of products, publication of infringements (“naming and shaming”), intensified supervision or re-inspections, the withdrawal of permits or other corrective measures.

What is regulatory litigation under Dutch administrative law?

Regulatory litigation is the legal practice in which an organisation mounts a defence against enforcement actions by regulators, such as sanction decisions, fines, sales bans and penalty payments (dwangsommen), or in which a regulator is deployed strategically to tackle unfair competition. Regulatory litigation therefore has both a defensive and an offensive dimension. Under the Dutch General Administrative Law Act (Algemene wet bestuursrecht, Awb), your organisation has the right to lodge an objection (bezwaar) against decisions by regulators and subsequently to appeal (beroep) to the administrative court (bestuursrechter). The objection period is six weeks from the date of the decision, after which an appeal before the district court usually takes three to twelve months.

Regulatory litigation is an increasingly prominent area of law in the manufacturing industry. Regulators such as the Netherlands Food and Consumer Product Safety Authority (NVWA), the Dutch Authority for Digital Infrastructure (RDI) and the Human Environment and Transport Inspectorate (ILT) are intensifying their enforcement, partly as a result of European market surveillance coordination under the Market Surveillance Regulation (EU 2019/1020). Research by the European Commission shows that more than 30% of products offered through online platforms do not comply with the applicable safety regulation. That increases the enforcement pressure on every link in the chain. Therefore, it is essential that your organisation has specialised legal support as soon as a regulator takes action.

How do our regulatory litigation specialists in Amsterdam help you?

Our regulatory litigation lawyers offer your organisation full support in every phase of an enforcement process, from the first inspection to a final court ruling. Below you will find an overview of our services.

Enforcement and supervision

• Assistance with enforcement actions: immediate action on inspections, sanction decisions, sales bans, penalty payments and other enforcement measures by national and international regulators.
• Objection and appeal: the timely filing of an objection against regulators’ decisions and the conduct of administrative proceedings, including a request for interim relief (voorlopige voorziening) to suspend the enforcement measure pending the proceedings.
• Contact with regulators: we take over contact with the regulator entirely, monitor the statutory deadlines and position your organisation in a strategically sound way.
• Proactive compliance advice: identifying enforcement risks early and building a defensible compliance position before a regulator takes action.
• European and international enforcement: acting in proceedings before European institutions and cross-border enforcement actions, including RAPEX/Safety Gate notifications and the follow-up of EU market surveillance coordination (Joint Actions).

Product recalls and corrective measures

• Product recalls and market withdrawals: legal guidance on voluntary and imposed recalls, market withdrawals and corrective measures, from strategy and risk analysis to execution and external communication.
• Notification and information duties: advice on the notification duty for unsafe products under the General Product Safety Regulation (GPSR) and sector-specific regulation, including guidance on the notification to the competent authorities.
• Damage limitation and reputation management: strategic advice during recalls to limit financial loss, liability and reputational damage as far as possible.

Product liability in the chain

• Liability claims: assistance with claims from consumers, business customers and other chain parties under product liability and the law of liability.
• Allocation of liability in the chain: advice on the allocation of liability between manufacturer, importer, distributor and other chain parties for non-conforming or unsafe products.
• Technical documentation as a defence: assessment of technical files, declarations of conformity and test results as support for the defence against liability claims.
• Preventive liability advice: early identification of liability risks in product design, production processes and the supply chain, and advice on contractual and technical measures to control those risks.

Would you like to know how best to prepare your organisation for an enforcement process? Contact our regulatory litigation specialists without obligation for a free introductory meeting.

Which Dutch regulators does MAAK know from the inside?

Acting effectively before a regulator requires more than procedural knowledge. It also requires insight into the specific enforcement practice, the working methods and the priorities of the inspectorate concerned. Our specialists work daily with the relevant regulators in the manufacturing industry and know their methods, their legal frameworks and their weak points. Below is an overview of the authorities with which MAAK regularly engages:

Our regulatory litigation lawyers have experience with enforcement procedures at all of these authorities. That breadth is, however, no coincidence: it flows directly from our specialised focus on the manufacturing industry and supply chain, sectors in which several regulators can play a role at the same time.

How does an enforcement procedure before a Dutch regulator work?

An enforcement procedure usually runs in three phases: the inspection and investigation phase, the decision-making phase and the objection and appeal phase. Each phase offers legal opportunities to strengthen the position of your organisation. As soon as an enforcement action arises, acting quickly is essential. Our specialists immediately analyse the legal position of your organisation and anticipate the regulator’s strategy.

The procedure runs through the following steps:

1. Inspection and investigation: the regulator announces an inspection or acts unannounced. We advise your organisation immediately on cooperation, rights and obligations during the investigation.
2. Intention to sanction: the regulator communicates its intention to enforce. Under article 4:8 Awb, your organisation has the right to submit a statement of views (zienswijze). We draft that statement and ensure all legal and technical arguments are put forward in time and forcefully.
3. Primary decision: the regulator imposes a sanction, namely a fine, a penalty payment, a sales ban or an order subject to administrative coercion (last onder bestuursdwang). We lodge an objection within the statutory period of six weeks and, where necessary, request interim relief from the administrative court to suspend the measure.
4. Objection phase: we defend your position in the objection procedure, including any hearing before the regulator. Statistically, in around 30 to 40% of administrative objection procedures the primary decision is revised in whole or in part.
5. Appeal and higher appeal: if the objection procedure does not lead to the desired result, we litigate before the district court and, if necessary, before the Trade and Industry Appeals Tribunal (College van Beroep voor het bedrijfsleven, CBb) or the Administrative Jurisdiction Division of the Council of State.

The close cooperation between our compliance specialists and experienced litigation lawyers enables us to handle both the substantive regulatory questions and the procedural aspects in one team, for a consistent, effective and high-quality approach to your legal challenge.

When can you also deploy a Dutch regulator offensively?

Regulators are not only a party to defend against. They can, however, also be a strategic instrument. When a competitor structurally fails to comply with the applicable regulation and thereby gains an unfair competitive advantage, the targeted involvement of a regulator can restore the level playing field. This offensive use of regulatory enforcement is particularly relevant for manufacturers, importers and distributors in the manufacturing industry, where non-compliance with product regulation causes direct competitive harm.

An example from our practice illustrates this well. An importer of industrial machinery established that a foreign competitor was placing products on the Dutch market that structurally failed to meet the Machinery Directive and the associated safety standards. As a result, the competitor could charge lower prices. Our specialists guided the importer in drawing up a detailed complaint to the RDI, including technical substantiation and a file with market analysis and product tests. The regulator acted, the products were removed from the market and the level playing field was restored.

MAAK guides organisations in this offensive use of regulatory enforcement, namely from the first analysis through to the follow-up of the enforcement action. Our work includes:

• Complaints and notifications: filing well-substantiated notifications with relevant regulators, such as the NVWA, RDI or ILT, about structural non-compliance by competitors, including the necessary legal and factual documentation.
• File building and evidence gathering: identifying, collecting and structuring evidence of rule violations by competitors, from product tests and technical documentation to market analyses.
• Strategic positioning: careful weighing of the timing, manner and basis of a notification, with an eye to your commercial interests, ongoing client relationships and the prevention of unintended side effects.
• Follow-up and monitoring: tracking progress after a notification, maintaining contact with the regulator and, where desired, sharpening or expanding the approach if enforcement fails to materialise or falls short.

What makes our regulatory litigation approach in the Netherlands distinctive?

Our approach to regulatory litigation is assertive and decisive. Where possible, we seek constructive consultation with regulators. Where necessary, we litigate energetically. Throughout, one goal is central: protecting the position and reputation of your organisation. What makes MAAK Advocaten distinctive as a regulatory litigation lawyer, however, is the integrated approach we uniquely offer in this field:

• Sector and regulatory knowledge: our specialists advise daily on product regulation, CE marking, supply chain compliance, REACH, RoHS, the Machinery Directive and dozens of other regulations. Consequently, we understand not only the enforcement process but also its technical and commercial context. That difference is felt in the quality of the defence.
• Compliance and litigation in one team: the close cooperation between our compliance specialists and our litigation lawyers ensures that substantive regulatory questions and procedural aspects are handled in a consistent team. That prevents translation errors and strengthens your position.
• Proven track record in complex cases: MAAK has a proven track record in complex enforcement cases, across various regulators and in cross-border contexts. We combine that experience with a personal approach: you always have direct contact with an experienced lawyer.
• Proactive approach: we not only respond to legal questions, but actively think along with your organisation. We monitor European enforcement developments closely and anticipate new regulation, so that your organisation builds a defensible position early.
• International network: our firm has a solid international and European network. For cross-border enforcement actions or proceedings before European institutions, we engage with the right local and international partners.

For which organisations do our regulatory litigation lawyers in Amsterdam work?

Our regulatory litigation specialists in Amsterdam work for a broad group of organisations active in the manufacturing industry and international supply chains. They include, among others:

• Manufacturers of consumer products, electronics, machinery, medical devices and other regulated products
• Importers and distributors placing products on the European and Dutch market
• (Online) platforms responsible for the products on their platform under the Market Surveillance Regulation
• Fulfilment businesses and logistics service providers involved in the distribution of regulated products
• Suppliers and OEM manufacturers confronted with enforcement actions against their customers
• Government bodies and (semi-)public organisations involved in market surveillance

Consequently, we offer tailored legal support, focused on your specific position in the chain, your sector and the regulators relevant to you. Contact our regulatory litigation lawyers for a no-obligation discussion of your situation.

Which regulation is relevant to regulatory litigation in the Dutch manufacturing industry?

Regulatory litigation in the manufacturing industry is closely interwoven with European product law and the associated national enforcement frameworks. Our specialists are, namely, active daily in the field of the following regulation and supervisory frameworks:

• Market Surveillance Regulation (EU 2019/1020): the European regulation governing market surveillance coordination and strengthening the powers of national regulators.
• General Product Safety Regulation (EU 2023/988, GPSR): the revised product safety regulation in force since 13 December 2024, which governs the notification duty for unsafe products.
• Machinery Directive and Machinery Regulation (EU 2023/1230): regulation for machinery and assemblies, with particular attention to safety and conformity assessment requirements.
• Low Voltage Directive (LVD), EMC Directive and Radio Equipment Directive (RED): regulation for electrical, electronic and radio equipment, relevant to enforcement by the RDI.
• REACH and RoHS regulation: European regulations for hazardous substances in products, enforced by the NVWA and Customs.
• Product Liability Directive (PLD, revised in 2024): the renewed directive governing the liability of producers and importers for defective products.
• General Administrative Law Act (Awb): the Dutch procedural framework for objection, appeal and interim relief in enforcement procedures.

Ultimately, knowledge of this regulation is essential not only for compliance, but also for an effective defence in enforcement procedures. It is precisely that combination that distinguishes our regulatory litigation specialists from generalist administrative-law lawyers.

Practical example: in a full civil trial (bodemprocedure), the central question was whether a company was obliged under the REACH Regulation to contribute to a competitor’s registration and research costs. On behalf of the defendants, MAAK Advocaten argued that there was a valid opt-out with its own registration dossier and that, therefore, no cost-sharing obligation existed. The court fully followed this defence: there was no breach of the REACH rules or unlawful conduct, the claims were dismissed and the counterparty was ordered to pay the legal costs (ECLI:NL:RBAMS:2025:6489).

Why is speed so important during a Dutch enforcement action?

Speed is decisive during an enforcement action by a regulator. The statutory objection period is six weeks from the date of the decision. If this period is exceeded, the decision becomes irrevocable and virtually all legal remedies lapse. Moreover, requests for interim relief, intended to suspend a sales ban or a penalty payment pending the proceedings, must be filed in time with the administrative court. However, even before the primary decision there are essential moments: the statement-of-views procedure offers the first, and sometimes most effective, chance to prevent or limit a sanction decision.

As soon as an enforcement action arises or even threatens, we therefore strongly advise you to contact our regulatory litigation specialists immediately. We analyse your legal position at once, assess the tenability of the inspectorate’s position and determine together with you the most effective approach, from constructive consultation to formal proceedings. Throughout, we always keep an eye on the wider business interests: your market position, ongoing client relationships and reputation.

Why do organisations choose MAAK as their regulatory litigation lawyer in Amsterdam?

MAAK Advocaten is located on the Kraanspoor in Amsterdam, a place that symbolises the dynamic Dutch manufacturing industry. From Amsterdam, our specialists guide organisations throughout the Netherlands and Europe in regulatory litigation and enforcement procedures, namely because we combine characteristics that few other firms offer:

• Specialised focus: we are lawyers for the manufacturing industry. Regulatory litigation is therefore not a sideline but a core practice, directly connected to our compliance and contract-law practice.
• Integrated services: our pillars, including product and supply chain compliance, market access, contracting and litigation, together form an integral service. That means that in an enforcement procedure we also oversee the wider legal context and advise strategically within it.
• Personal contact: you always have direct contact with an experienced lawyer, no juniors or outsourced files. We distinguish ourselves through clear communication, concrete advice and an accessible approach.
• International network of experts: for cross-border enforcement actions or European procedures, we have the right international partners to represent your interests effectively outside the Netherlands too.

Is your organisation facing an enforcement action, an intended sanction decision or a product recall? Or would you like the enforcement risks for your organisation mapped out proactively? Contact our regulatory litigation specialists in Amsterdam today on +31 (0)20 210 31 38 or send an email to mail@maak-law.com. We aim to answer your message within one working day and offer a free introductory meeting.

Frequently asked questions about regulatory litigation in the Netherlands

What is regulatory litigation?

Regulatory litigation is the legal practice in which an organisation mounts a defence against enforcement actions by regulators, such as sanction decisions, fines, sales bans and penalty payments, or in which a regulator is deployed strategically to tackle unfair competition. Under the Dutch General Administrative Law Act (Awb), your organisation has the right to lodge an objection and then to appeal to the administrative court.

How long does an objection procedure before the NVWA or another Dutch regulator take?

The statutory objection period is six weeks from the date of the decision. The objection procedure itself usually takes six to twelve weeks. If an appeal is lodged with the administrative court, an appeal procedure before the district court usually takes three to twelve months. Where there is urgency, it is possible to request interim relief to suspend an enforcement measure pending the proceedings.

Can a sales ban or penalty payment be suspended pending the proceedings?

Yes, a sales ban or penalty payment can be suspended through a request for interim relief before the administrative court, under article 8:81 of the General Administrative Law Act (Awb). The court assesses whether the interest in suspension outweighs the regulator’s enforcement interest. Speed is essential here: we advise contacting us immediately once an enforcement decision has been received.

Which regulators fall under regulatory litigation in the Dutch manufacturing industry?

The most relevant regulators in the manufacturing industry are the Netherlands Food and Consumer Product Safety Authority (NVWA) for product safety and consumer protection, the Dutch Authority for Digital Infrastructure (RDI) for electronics and radio equipment, the Human Environment and Transport Inspectorate (ILT) for transport and hazardous substances, the Netherlands Labour Authority (NLA) for occupational safety and machinery, and Customs for import control and trade restrictions. In addition, the European Commission plays a role through market surveillance coordination and RAPEX/Safety Gate.

What does a regulatory litigation lawyer at MAAK Advocaten cost?

MAAK Advocaten offers a free introductory meeting to discuss your situation and the possible approach. The costs of a regulatory litigation process depend on the complexity of the case, the regulator involved and the desired approach, from a statement of views to a full appeal procedure. Contact us on +31 (0)20 210 31 38 or mail@maak-law.com for a no-obligation discussion.

What should I do if the NVWA or RDI announces an inspection?

Contact a specialised regulatory litigation lawyer immediately. During an inspection, your organisation has rights and obligations about which you should be well informed in advance. We advise your organisation on the scope of the duty to cooperate, guide contact with the inspectorate and ensure that your legal position is protected from the outset. Early legal support considerably increases the chance of a favourable outcome.

Can a regulator also be deployed offensively against a competitor?

Yes, regulators can also be deployed strategically when a competitor structurally fails to comply with the applicable regulation and thereby gains an unfair competitive advantage. MAAK guides organisations in filing well-substantiated notifications with regulators such as the NVWA, RDI or ILT, including file building, evidence gathering and follow-up of the enforcement action. This offensive use of regulatory enforcement is particularly effective in the manufacturing industry.

How does MAAK Advocaten differ from other administrative-law lawyers in regulatory litigation?

MAAK Advocaten combines in-depth knowledge of product regulation and supply chain compliance with sharp procedural skills, specifically for the manufacturing industry. Consequently, our specialists understand not only the enforcement process but also its technical and commercial context. Compliance specialists and litigation lawyers work together in one team, so that substantive regulatory questions and procedural aspects are handled consistently. That sets MAAK apart from generalist administrative-law lawyers.

Related expertise

Regulatory litigation at MAAK Advocaten never stands alone. Our approach is integrated: the knowledge and experience from our other practice areas directly strengthen the quality of your defence in enforcement procedures. The following areas of expertise are closely connected to regulatory litigation:

• Product and Supply Chain Compliance: preventive guidance on product regulation, CE marking, REACH, RoHS and supply chain due diligence, so that enforcement risks are minimised early.
• Market access: legal and administrative support in challenging regulatory barriers that delay or prevent access to the European and international market.
• Litigation and proceedings: civil proceedings in commercial disputes, product liability, international arbitration and urgent summary proceedings that coincide with or arise from enforcement processes.