Product Liability & Safety 2024 Comparisons

Product safety laws in the Netherlands are mainly based on European legislation. There are separate product safety regimes for medical devices, pharmaceuticals and food. In addition, harmonised legislation applies for sector-specific products, such as cosmetics, toys, radio equipment and motor vehicles. For consumer products that fall outside the scope of the sector-specific regime, the European General Product Safety Directive 2001/95/EC (GPSD) applies.

European legislation is implemented within the Dutch Commodities Act (“Warenwet”), the Commodities Act Decree on General Product Safety (“Warenwetbesluit algemene productveiligheid”) and sector-specific Product Safety decrees, such as those applicable for cosmetics products, toys and machinery, etc. For food, the Dutch Commodities Act applies, as well as specific Commodities Act decrees.

Since 2021, Market Surveillance Regulation (EU) 2019/1020 (“Verordening Markttoezicht”) has applied for non-food consumer products subject to the “Union harmonisation legislation” shown in Annex I of the Regulation, in so far as there are no specific provisions with the same objective in the Union harmonisation legislation that more specifically regulate particular aspects of market surveillance and enforcement.

The current applicable GPSD has been replaced by the new European General Product Safety Regulation (EU) 2023/988 of 10 May 2023 (“the Regulation”). The Regulation aims to ensure an even higher level of consumer protection and improve the functioning of the internal European market with regards to products intended for consumers. The Regulation must be complied with for all non-food consumer products put on the market from 13 December 2024.

Sector-specific directives and regulations with the same objective remain in place. The new Regulation will only apply to those aspects and risks or categories of risks of products which are not covered by those sector-specific regulations.

There are several Regulatory Authorities in the Netherlands that are designated to supervise on product safety, as follows.

• NVWA: The Netherlands Food and Consumer Product Safety Authority (“Nederlandse Voedsel- en Warenautoriteit”) is the main designated responsible authority for consumer products (including food).

• RDI: The Dutch Authority for Digital Infrastructure (“Rijksinspectie Digitale Infrastructuur”) is the supervising Authority for products relating to telecom, radio equipment and 5G, and is responsible for obtaining and allocating frequency space and monitoring its use. The work of the agency covers the entire field of wireless and wired communication.

• ILT: The Dutch Human Environment and Transport Inspectorate (“Inspectie Leefomgeving en Transport”) is responsible for transport, infrastructure, environment and living. Its task is to ensure that businesses, organisations and government agencies comply with laws and regulations regarding sustainable living, environment, physical safety, and the housing association sector.

• “Nederlandse Arbeidsinspectie”: The Netherlands Labour Authority oversees machinery and tools at work to ensure compliance with laws and regulations with respect to working conditions.

• IGJ: The Health and Youth Care Inspectorate (“Inspectie Gezondheidszorg en Jeugd”) handles safety on medical devices and medication.
• ACM: The Netherlands Authority for Consumers and Markets (“Autoriteit Consument & Markt”) is the authority for fair sales of products to consumers to prevent misleading practices. 

Scope of Power

The scope of power of the abovementioned Authorities is similar. They are authorised, among other things, to request information, carry out inspections and investigations, impose fines, and order corrective measures, etc. 

Producers are obliged to place only safe products on the market and to monitor those products. If they become aware, or should be aware, of a safety risk, they need to perform a risk assessment and then take appropriate corrective measures. The corrective measures depend on the product, the nature and severity of the risk in question and (potential) damages, as well as the group of people for whom the product is intended (children or adults, for example). In case of a serious risk, a product recall might be required.

Notification

Based on the current applicable GPSD, where producers and distributors know or ought to know, on the basis of the information in their possession and as professionals, that a product they have placed on the market poses risks to the consumer that are incompatible with general safety requirements, they must immediately inform the competent authorities, giving details, in particular, of action taken to prevent risks to the consumer.

However, the flow of information must remain manageable. The guidelines of the Commission Decision of 14 December 2004 (2004/905/EC) (“the Guidelines”) therefore include criteria for non-notification. Producers and distributors do not need to issue a notification, for example, on products for which the manufacturer has been able to take immediate corrective action and for all items concerned, if the defect is limited to well-identified items or batches of items, and if the manufacturer has withdrawn the items in question.

Time Limit

“Immediately” is interpreted as acting without undue delay. According to the Guidelines, this means as soon as the relevant information has become available, and, in all cases, within 10 days of the manufacturer or distributor having reportable information, even while investigations are continuing, indicating the existence of a dangerous product. When there is a serious risk, companies are required to inform the authorities immediately, and in no case later than three days after they have obtained notifiable information. In an emergency situation, such as when immediate action is taken by a company, the company should inform the authorities immediately and by the most expedient means.

Notification Process

Although notification can be carried out in person, the authorities in the Netherlands prefer electronic notification via the Product Safety Business Alert Gateway set up by the European Commission.

This application offers the advantage of simultaneously notifying all competent authorities in the affected Member States.

Formal Requirements

A template form for notifying authorities about dangerous products by manufacturers or distributors can be found in Annex I of the Commission Decision of 14 December 2004 (2004/905/EC). The notification should include details of the notifier, the product involved, the safety risk at hand and conclusions of the risk assessment, the jurisdictions where the product was put on the market, details of the supply chain (including the numbers sold) and the corrective measures taken to prevent or limit the risk.

The authorities have recourse to various interventions in case of non-compliance. These depend on the type of violation (serious, medium or light). The more serious the violation in terms of product safety, or in the case of repeat violations, the heavier the penalty. Interventions include the following:

•       an official warning;

•       corrective measures;

•       an administrative fine or criminal penalty;

•       closure or shutdown of activities;

•       suspension of accreditation; and

•       criminal prosecution.

For non or late notification of a product safety issue, an administrative fine of EUR795 applies, or EUR1,590 for companies with more than 50 employees. These amounts also apply for putting unsafe products on the market. They may also may vary slightly, depending on product type. One can also be criminally prosecuted for non or late notification, leading to six months’ imprisonment, community service or a criminal penalty of EUR25,750 (category 4).

Failure to cooperate with the authorities is regarded as a serious offence. It can lead to three months’ imprisonment or a criminal fine of EUR5,150 (category 2).

In exceptional circumstances involving intent or gross negligence, large companies can be subject to an administrative fine related to annual turnover. This fine is capped at EUR900,000 per violation. According to the NVWA’s intervention policy, in principle, a maximum of five violations will be fined per inspection. As a consequence, a total maximum fine of EUR4.5 million can be imposed.

In the Fipronil case, where millions of eggs were unlawfully infected with Fipronil, two board members were sentenced to one year of imprisonment by the Court of Overijssel. These board members neglected food safety, resulting in health risks, environmental damage, and significant economic loss (District Court Overijssel 12 April 2021, ECLI:NL:RBOVE:2021:1508).

In the Netherlands, the causes of action for product liability are based on the Dutch Civil Code (DCC):

Strict Liability

Article 6:185 of the DCC includes the lex specialis. Based on this article, a manufacturer can be held liable for damages resulting from a defective product. This strict liability is only applicable to cases involving death, personal injury or property damage caused by the defective product to another item intended for private use or consumption. The injured party must have primarily obtained the product for their own private use or consumption. For this kind of property damage, a threshold of EUR500 applies. Articles 6:185 to 6:193 of the DCC align with European Product Liability Directive 85/374, incorporating its provisions into Dutch law.

Fault-based Liability (Tort)

Article 6:162 of the DCC is the lex generalis. It provides a general legal basis through which a manufacturer may be held liable for damages caused by a defective product. Fault on the part of the defendant needs to be established. This article imposes no limitations on the type of damages that can be pursued, and is therefore often utilised by companies. Consumers may also resort to these legal grounds when the long or short stop has expired, which is applicable for the strict liability regime.

Contractual Liability

Article 6:74 of the DCC is the legal basis for addressing breaches of contract related to defective products. Strict liability (Article 6:185 of the DCC) cannot be contractually excluded towards the consumer. This means that, even if a contract attempts to waive strict liability, these attempts would be legally invalid.

Consumers who are directly affected by the product defect and who claim to have suffered damages as a result of the defective product can bring a claim for product liability on the basis of Article 6:185 and Article 6:162 of the DCC. On behalf of a group of consumers, representative bodies, such as foundations and associations, can bring a collective product liability claim. Companies can rely on contractual liability and fault-based liability (Article 6:162 of the DCC).

Two important limitation periods apply for a product liability claim against the manufacturer based on Article 6:185 of the DCC, as follows:

• short-stop term: this is three years from the day on which the injured person became aware, or reasonably should have become aware, of the damage, the defect and the identity of the manufacturer; this short term can easily be suspended by sending a letter to the defendant in which all rights are reserved; and
• long-stop term: this is 10 years from the date on which the manufacturer put the product that caused the damage into circulation; unless the injured person initiated legal proceedings within these 10 years, the right to claim damages expires.

A different limitation period applies for a fault-based liability claim based on tort: a five-year term applies from the day on which the injured person became aware, or reasonably should have become aware, of the damage and the identity of the manufacturer. This term can also easily be suspended by sending a letter to the defendant reserving all rights. No long-stop term applies for a claim based on tort.

European Legislation

For product liability, international jurisdiction is, in principle, governed by European Council Regulation EU No 1215/2012, commonly referred to as the Brussels I Recast. One can be sued in court in another member state if the place where a harmful event occurred, or could occur, falls within the competence of that court. The place where the product in question was manufactured and the place where the initial damage occurred are referred to Handlungsort and the Erfolgsort, respectively. Depending on the specifics of the case, there could be some special jurisdiction rules (eg, for liability insurers).

Lugano Convention 88/592/EEC governs the jurisdiction and the enforcement of judgments in civil and commercial matters, specifically between EU member states and Switzerland, Norway and Iceland.

The Convention on Choice of Court Agreements, established in The Hague in 2005 (2014/887/EU), is applicable to the exclusive choice of court agreements in commercial transactions involving parties from EU member states, as well as from other nations such as the United Kingdom.

DCCP

Where no international treaty is applicable, the Dutch Code of Civil Procedure (DCCP) determines international jurisdiction. The main rule according to Article 2 of the DCCP is that the Dutch court has jurisdiction if the defendant is domiciled or habitually resident in the Netherlands. The court may also have jurisdiction if jurisdiction has been agreed upon in a contract or if the contract that is the subject of the proceedings had to be performed in the Netherlands (Article 8 of the DCCP). However, if it is truly impossible for the claimant to start legal proceedings outside the Netherlands, the Dutch court may also assume jurisdiction, according to the forum of necessity doctrine (Article 9 of the DCCP).

Due to the complexity of the above-mentioned legislation, careful legal analysis must be carried out to ensure that the claim is brought before the competent court.

There are no pre-action procedures and requirements in the Netherlands for filing a lawsuit for product liability claims. The only exception is for collective action (Article 3:305a of the DCC). Failure to comply with these pre-action requirements can result in the claim becoming inadmissible. For more detailed information, please see 2.16. Existence of Class Actions, Representative Proceedings or Co-ordinated Proceedings in Product Liability Claims.

Except for the statutory retention period for technical files, etc, there are no further rules for the preservation of documents or other evidence. For an individual’s own position, it would likely be advisable to preserve a number of products and documents relating to product compliance.

There are no such rules in the Netherlands other than on the basis of Article 843a of the DCCP, which provides the Dutch version of a disclosure proceeding. However, before a party can be ordered to disclose specific documents, it must meet strict conditions.

New Product Liability Directive

This situation may change with the upcoming new Product Liability Directive (“new PLD”). EU institutions informally agreed on the proposal at the end of 2023 and the new PLD will replace the existing EU General Product Liability Directive, introducing a fresh disclosure regime. According to the new PLD, claimants only need to provide “facts and evidence to support the plausibility of the claim for compensation” to obtain disclosure. When determining whether the disclosure is proportionate, the national courts will consider the legitimate interests of all parties in relation to the protection of confidential information and trade secrets.

In order to support their arguments and position, the parties are allowed to present expert evidence. In addition, the court can appoint an expert, either upon request of one of the parties or upon its own authority. The court-appointed expert is regarded as fully independent. The expert is not permitted to have a role in the decision-making process alongside the judge.

Burden of Proof

The burden of proof lies with the claimant. The injured party needs to prove the damage, the defect and the causal link between the damage suffered and the defect (Article 6:188 of the DCC). The same applies for a tort claim, based on Article 6:162 of the DCC, although proof of an attributable unlawful act is also required.

Res Ipsa Loquitur

For incidental production failure of one particular product, defectiveness can be assumed under this doctrine.

Batch Liability

In the Boston Scientific case of 5 March 2015 (ECLI:EU:C:2015:148) involving pacemakers and defibrillators implanted in patients, the European Court of Justice introduced the principle of “batch liability”: “Where it is found that such products belonging to the same group, or forming part of the same production series, have a potential defect, products within that batch may be classified as defective without needing to prove the defect in the particular product in question”. In the same judgement, the Court ruled that compensation of damages includes the costs relating to replacing the defective product, provided that such replacement is required to overcome the defect in the product in question.

Batch liability is adopted in the new PLD.

Civil Court

Product liability claims in the Netherlands are normally brought before one of the eleven District Courts. For claims with a maximum quantum of EUR25,000, the cantonal court is competent. The relative jurisdiction of a specific court depends on factors such as where the harmful event occurred or where the defendant is domiciled.

Judges

Cases are decided by judges. The Dutch legal system is not familiar with juries.

Parties are allowed to appeal within three months at the Court of Appeal. One can also appeal at the Supreme Court, for which a term of three months also applies. Shorter terms apply for interlocutory proceedings.

According to Article 6:185 of the DCC, the following statutory defences regarding strict liability are available to the manufacturer:

• they did not put the product on the market;
• with regard to the circumstances, it is likely that the defect that caused the damage did not exist at the time the product was put on the market, or that the defect occurred afterwards;
• the product was neither manufactured by the manufacturer for sale or any form of distribution for economic purpose, nor manufactured or distributed by them in the course of their professional practice or business;
• the defect was due to compliance of the product with mandatory regulations issued by the public authorities;
• the state of scientific and technical knowledge at the time the product was put on the market was not such that the existence of a defect could be discovered (“state-of-the-art defense”); and
• in the case of a component, that the defect was attributable to the design of the product in which the component was fitted, or to the instructions given by the producer of the parts.

According to Article 6:186 of the DCC, a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, particularly in terms of:

• its presentation;
• the use that could reasonably be expected to be made of the product; and
• the time when the product was put on the market.

These circumstances are not limitative. Non-compliance with product safety requirements will be taken into account when considering a defect.

On the other hand, full compliance with safety requirements does not automatically mean a product is not defective.

The proposal of the new Product Liability Directive states: “In order to reflect the relevance of product safety and market surveillance legislation for determining the level of safety that the public at large is entitled to expect, it should be clarified that safety requirements, including safety-relevant cybersecurity requirements, and interventions by regulatory authorities, such as issuing product recalls, or by economic operators themselves, should also be taken into account in that assessment. Such interventions should, however, not of themselves create a presumption of defectiveness”.

Court Fees

In the event of litigation, court fees are due by both parties. A fixed schedule applies, and the amount depends on the quantum of the claim. The minimum amount for companies is EUR688, and the maximum is EUR9,825.

Recoverable Costs

These include fixed court fees, expert fees, costs for hearing witnesses, bailiff fees and disbursements, and fixed expenses for having the judgment executed are recoverable costs for the successful party. Attorneys’ fees will only be compensated according to a fixed liquidation schedule. In reality, these fees are much lower than the actual attorneys’ fees incurred.

“Deelgeschil”

A product defect can cause personal injury. In personal injury cases, one could start a deelgeschil, in which the court is asked to rule a judgment on a particular issue of the case, such as liability, causation or quantum. A condition for admissibility of a deelgechil is that the judgment assists parties in reaching an out-of-court settlement. Contrary to normal litigation, in a deelgeschil the liable party will be ordered to pay for the actual attorneys’ fees of the personal injury claimant.

No Cure, No Pay

According to the Rules of Professional Conduct for lawyers (“de Gedragsregels voor advocaten”), lawyers are prohibited from making “no cure, no pay” arrangements. An exception is made for personal injury claims (based on a pilot, which is recently extended for another two years), but this is strictly regulated. Certain conditions need to be met, and the Dean of the Bar where the lawyer practices needs to be notified. Fixed or capped fees are permitted.

Third-party Funding

Third-party funding for court litigation is allowed in the Netherlands. The European Collective Redress Directive 2020/1828 includes provisions regulating third-party litigation funding for collective actions on behalf of consumers. These are incorporated in the WAMCA (see 2.16 Existence of Class Actions, Representative Proceedings or Co-ordinated Proceedings in Product Liability Claims).

Previously, the so-called Claim Code 2019 served as a code of conduct for claim vehicles with principles governing the relationship between a claim vehicle and a third-party funder.

On 13 September 2022, the European Parliament adopted a resolution (2020/2130(INL) including a proposal for a new directive on the regulation of third-party litigation funding (2023/C 125/01). This proposal is still under consideration.

Legal Aid

Individuals who have insufficient financial means to secure legal representation might be eligible for legal aid under the conditions outlined in the Legal Aid Act.

Two causes of collective action are available under Dutch law, as follows.

WCAM Procedure

The Dutch Act on the Collective Settlement of Mass Damage (WCAM), as laid down in Article 7:907 of the DCC, provides for a collective settlement to be approved as binding by the Amsterdam Court of Appeal, after which it can be enforced.

WAMCA

On 1 January 2020, the Dutch Collective Redress Act (WAMCA) came into force. A claim vehicle can initiate a collective damages action on an opt-out basis. The WAMCA is characterised by the following:

• it only applies to actions that relate to events that occurred on or after 15 November 2016;
• strict admissibility requirements apply for the claim vehicle;
• the so-called “scope rule” requires a claim to have sufficiently close connection to the Dutch jurisdiction before it can be brought under the WAMCA;
• collective claims must be registered in the Central Register, which is publicly accessible;
• if there are several claim vehicles for the same event, the Court will appoint an Exclusive Representative from among the claimants who shall act for the interests of all parties in the litigation;
• the Court classifies the individual claimants into groups for the purpose of damage awards, which is known as damage scheduling; and
• a final judgment on a collective action binds all people residing in the Netherlands who have not opted out, and on all non-Dutch residents who opted in.

Product Liability

Currently, there are two WAMCA class actions pending in the Netherlands:

District Court of Amsterdam 14 February 2024 (ECLI:NL:RBAMS:2024:745) – Allergan

On 12 December 2022, on behalf of thousands of women, the Foundation Bureau Clara Wichmann issued a WAMCA class action against Allergan, an American medical device manufacturer of breast implants. The women claim the breast implants to be defective, as a result of which they have suffered damages. On 14 February 2024, the Court of Amsterdam ruled that Bureau Clara Wichmann is admissible in its claim. As a consequence, the case will now be dealt with on its merits.

District Court of Midden-Nederland (ECLI:NL:RBMNE:2023:4132) – Bayer

On 3 April 2023, a WAMCA class action was issued by the Foundation Essure Claims (and others) against medical device manufacturer Bayer. The case concerns permanently implanted birth control devices for women (female sterilisation). The Foundation is holding Bayer liable for these allegedly defective products to which numerous attribute a variety of complaints. A first hearing on the preliminary issues is expected in September or October 2024.

Please refer to 2.16 Existence of Class Actions, Representative Proceedings or Co-ordinated Proceedings in Product Liability Claims,in addition to:

Supreme Court 16 July 2021 (ECLI:NL:HR:2021:1172) – Long-stop term metal-on-metal hip implant

Metal-on-metal hip implants consist of various components, such as the ball, the stem and the cup. These components can be put on the market at different dates. During surgery, they are put together in order to replace the patient’s original hip. When does the long-stop term of 10 years start for a hip implant? According to the Supreme Court, every component can be regarded as a separate product. The start of the long-stop term depends on when the particular component was put on the market.

Court of Appeal Arnhem-Leeuwarden 15 June 2021 (ECLI:NL:GHARL:2021:5818), confirmed by the Supreme Court 11 November 2022 (ECLI:NL:HR:2022:1602) – Seroxat

As a minor in 2001, the claimant was prescribed the antidepressant Seroxat. Fifteen years later, they held the manufacturer liable for failing to properly warn them about the suicide risk linked to the drug. At the time, they used the medication for five months and attempted suicide several times. Unlike the Midden-Nederland Court, the Court of Appeal rejected liability. According to the Court of Appeal, the manufacturer did comply with its duty of care in properly warning users about this risk. Moreover, in terms of a conditio sine qua non, a causal link between the damages and the use of the product or the alleged failure to warn was not established. The judgment was upheld by the Supreme Court.

District Court of Rotterdam 28 June 2023 (ECLI:NL:RBROT:2023:5214) – Biomet metal-on-metal hip implants

Following the extensive report of the Court-appointed experts, the Court was of the opinion that the metal-on-metal hip implants could not be regarded as defective in the relevant (2004–2009) period, when they were considered to be “state of the art”. Liability was rejected.

District Court of Rotterdam 27 September 2023 (ECLI:NL:RBROT:2023:8987) – PFAS

This judgment is worth mentioning as it concerns PFAS, or manufactured chemicals used in consumer goods. In the judgement, the District Court of Rotterdam held manufacturer Chemours (a Dutch company previously known as DuPont) liable towards four Dutch Municipalities for environmental damage caused by PFAS from 1984 to 1998. This judgement could open the door for product liability claims from local residents against Chemours. In September 2023, around 3,600 people had already collectively filed a criminal complaint against Chemours and, in the meantime, the Public Prosecutor’s Office opened a criminal investigation against Chemours and its directors.

New Product Safety Regulation 2023/988

The European Product Safety Directive and the Food Imitating Product Directive are being replaced by new General Product Safety Regulation 2023/988. This increases the protection of EU consumers against dangerous non-food products sold both online and offline. The Regulation will be applicable by businesses and national market-surveillance authorities from 13 December 2024.

Compared with the current Directive, the main changes under the Regulation are as follows:

• a product includes software (and artificial intelligence);
• for all non-food consumer products, a responsible person needs to be established in the EU, and can be the fulfilment service provider;
• specific requirements for providers of online marketplaces will be introduced;
• manufacturers will be required to immediately report accidents with their products to the authorities in the event of severe injury or fatalities;
• specific rules will apply on how to handle product-safety recalls and a mandatory recall notice template must be used; and
• a Consumer Safety Network will be set up and a modernised Safety Gate will be the platform where all information comes together.

Revision of the EU Product Liability Directive

On 28 September 2022, the European Commission issued a proposal for a new Product Liability Directive. In December 2023, the EU reached a provisional agreement on the text of the new directive. 

The main proposed changes under the new directive compared to the current directive, are as follows:

• the definition of a product should be expanded to include software;
• damages should include medically recognised damage to psychological health and the destruction or irreversible corruption of data;
• the threshold for property damage should be deleted;
• any person that substantially modifies the product outside the manufacturer’s control and makes it available on the market thereafter will be considered a manufacturer;
• a disclosure obligation should be introduced;
• the burden of proof is eased for consumers; and
• the whole supply chain is exposed to strict liability.

The revised Directive, if accepted, will substantially improve the position of consumers, and all the more so due to European Collective Redress Directive 2020/1828, which became effective from 25 June 2023. As a result, consumers are more likely to issue a (collective) product liability claim, with an improved chance of success.

As the Netherlands is already familiar with class actions due to the popularity of the WAMCA, it will likely remain a leading forum for class actions. The class-action framework is well established, the court is geared up, extensive expertise is available, and the duration of the litigation process is attractive compared to other European countries.

Please refer to 3.1. Trends in Product Liability and Product Safety Policy.