Product Liability & Safety 2024 Comparisons

• Regulation (EU) 2023/988 of 10 May 2023 on general product safety (hereinafter, the “New Regulation”) introduces a new regime for the safety of consumer products placed on the European market. The New Regulation aims to update pre-existing rules to take account of developments in new technologies and online selling, and to strengthen the implementation of the general product safety obligation. It entered into effect on 12 July 2023 and will be applicable as from 13 December 2024. It applies mostly to non-harmonised products that were until now subject to Directive 2001/95/EC and local implementations in EU member states.

• Regulation (EU) 2019/1020 on market surveillance and compliance of products applies to harmonised products but, in order to ensure a coherent application, the New Regulation was largely inspired by Regulation (EU) 2019/1020 and shall therefore find a residual application regarding any safety measures that would not be covered by Regulation (EU) 2019/1020.
• Regulation (EU) 2019/881 on ENISA and on information and communications technology cybersecurity certification is completed by the New Regulation and shall therefore apply with respect to cybersecurity risks that could have an impact on consumer safety and thus be comprised in the safety definition.

• Code of Economic Law, Book IX contains the transposition of the requirements of Directive 2001/95/EC on general product safety and Directive 87/357/EEC on the approximation of the laws of the member states concerning products which, appearing to be other than they are, endanger the health or safety of consumers – both instruments have been replaced and repealed by the New Regulation. This general legal framework is surrounded by specific laws for certain products (such as gas or electrical appliances, playgrounds, elevators, amusement parks or fireworks) which will have to comply with all related requirements. Where specific products are subject to specific regulations, Book IX only regulates the risks that are not dealt with by such specific regulations. 

• Royal Decree of 13 December 2017 establishing the Special Consultative Commission “Consumption” (hereinafter, SCC “Consumption”) within the Central Council for the Economy and abolishing the Commission for Ecological Labelling and Advertising has a mission to provide opinions on the development of regulations and policies, advise the minister on the need to inform the public, and facilitate consultation among various stakeholders in relation to consumer safety and health. It is therefore the central consultative structure for consumer issues and consumer protection.

• Law of 31 January 2024 establishing the digital platform for consumers Consumerconnect entered into effect on 1 February 2024 and is now the Belgian Contact Point. The objective is to strengthen the position of consumers by first assisting in their search for information regarding consumer protection. It also allows the consumer to report issues to the inspection services of the Federal Public Services Economy (“FPS Economy”) and other inspection services. Lastly, it also allows consumers to submit a request for alternative dispute resolution to a qualified entity through ConsumerConnect.

The developments that follow in 1. Product Safety are without prejudice to additional sectorial legislation that applies to specific product categories, including in areas such as life sciences and healthcare. Sectorial legislation may be more restrictive and provide for supplementary regulatory requirements around the safety, the quality, the efficacy and/or the performance of regulated products that fall within its scope, and those are not discussed in this Section. Sector-specific regulations typically uphold a risk approach that is different to the risk considerations laid down in this Section, enforcement measures may vary and additional penalties may apply in the case of infringement.

EU

Under the New Regulation, the Safety Gate System replaces the old RAPEX one as follows.

• Safety Gate Rapid Alert System: EU member states must notify corrective measures taken by authorities or by an Economic Operator (EO) in relation to dangerous products presenting a serious risk to the health and safety of consumers.
• Safety Business Gateway: EOs and providers of online marketplaces shall provide market surveillance authorities and consumers with the necessary information in relation to the product in question.

In addition, the Commission will play an important role in the implementation of the New Regulation considering that it may take any appropriate measures if the risk cannot be dealt with under any other procedures and it can be eliminated in an effective manner only at EU level. New provisions have been adopted in this respect by notably allowing market surveillance authorities to carry out joint activities on product safety and conduct simultaneous co-ordinated control actions (“sweeps”). 

Regarding the surveillance system at national level, a Consumer Safety Network has just been established to ensure structured co-ordination and co-operation between the authorities of the EU member states and the Commission.

Harmonised EU sectorial legislation enables additional authorities to take action to ensure the safety of products. In life sciences and healthcare, for example, this includes the European Medicines Agency (EMA) (for medicinal products) and national market surveillance authorities (for medical devices and in vitro diagnostic medical devices).

Belgium

The main regulator is the FPS Economy, which monitors the Belgian market and ensures that the products and services supplied on the market fulfil the safety requirements.

The national contact point and authority responsible for receiving and treating notifications of dangerous non-food consumer products by manufacturers and distributors is the Safety Department within the DG Quality and Safety of the FPS Economy.

The most recent Belgian response is the creation, within the FPS Economy, of the ConsumerConnect platform. It is a central contact point where consumers can obtain information and ask questions regarding consumer protection, report issues (for example, non-receipt of an ordered product, unfair practices, product defects) to the Economic Inspection Service of the FPS Economy or another inspection service, and submit requests to a qualified entity. However, it is important to note that the recently adopted law creating the platform does not make any reference to the New Regulation. 

The SCC Consumption’s mission is to provide opinions on the development of regulations and policies, advise the minister on the need to inform the public, and facilitate consultation among various stakeholders in relation to consumer safety and health. It is therefore the central consultative structure for consumer issues and consumer protection.

Examples of additional authorities that are empowered by Belgian law to ensure the safety of products include, in life sciences and healthcare, the Federal Agency for Medicines and Health Products (FAMHP). The FAMHP’s competences are regulated by an Act of 20 July 2006 and revolve around products such as medicinal products for human and veterinary use, medical devices and in vitro diagnostic medical devices.

The Framework Introduced by the New Regulation

The New Regulation will be applicable from 13 December 2024 and will not require any transposition from the part of member states, except for certain provisions that have been left to the discretion of national laws. 

General safety requirements

EOs should be obliged to place only safe products on the market. Such a high level of safety should be primarily achieved through the design and the features of the product, taking into account the intended and foreseeable use and conditions of use of the product. The remaining risks, if any, should be alleviated by means of certain safeguards, such as warnings and instructions. This obligation already existed under Directive 2001/95/EC on general product safety but it is now further clarified. Article 6 of the New Regulation specifies the aspects that shall be taken into account when assessing whether a product is a safe product. Such an assessment will determine the risk “category” of the product. Just as it is the case now, the product will be presumed to be in conformity with this general safety requirement in two cases: the product conforms to relevant European standards or, in their absence, it conforms to national requirements.

Corrective measures

The corrective measures to be undertaken will depend on the quality of the EO. 

• Manufacturers: where a manufacturer considers or has reason to believe, on the basis of the information in that manufacturer’s possession, that a product which it has placed on the market is a dangerous product, the manufacturer shall:
1. immediately take the corrective measures necessary to bring in an effective manner the product info conformity, including a withdrawal or recall, as appropriate;
2. give details of the risk to the health and safety of consumers and of any corrective measures already taken and, if available, of the quantity of products still circulating on the member state’s market; and 
3. investigate complaints submitted, and information received on accidents, that concern the safety of products on the market and which have been alleged to be dangerous by the complainant, and shall keep an internal register of complaints and any corrective measures taken to bring the products into conformity.
• Importers: as soon as importers consider that the product could be dangerous or that manufacturers have not respected their obligations in matters of identification and information before placing the product on the market, they shall take the necessary corrective measures, including withdrawal or recall, as appropriate. Also, they shall file the complaints, as well as product recalls and any corrective measures taken to bring the product into conformity, in the manufacturer’s register or in their own internal register.
• Distributors: where distributors consider or have reasons to believe that a product is a dangerous product or that manufacturers or importers have not respected their obligations to place the products on the market, they shall take the necessary corrective measures, including withdrawal or recall, as appropriate.
• Providers of an online marketplace also have several obligations in terms of corrective actions, such as:
1. designating two single points of contact for the authorities and consumers;
2. taking the necessary measures to receive and process orders to remove content relating to dangerous products from their online interface;
3. taking account of information on dangerous products notified by the authorities; or
4. suspending the provision of their services to professionals who frequently offer products that do not comply with the regulation.

Recall of dangerous products – new requirements

The objective for remedies in the event of a recall of dangerous products is to ensure both the elimination of dangerous products from the market and the adequate remedy for the consumer. The New Regulation provides for formal requirements a recall notice under its Article 36. As a general rule, the recall notice should be available in the language spoken by the consumers from the member states in which the product has been made available on the market.

On 24 May 2024, the European Commission adopted an implementing Regulation ((EU) (2024/1435) laying down the content of this recall notice. It will enter into force on 16 June 2024 and be applicable as from 13 December 2024.

Belgian Legal Framework

Please note that the considerations that follow may be subject to amendments or updates due to the new provisions introduced by the New Regulation. 

Under Belgian law, in Book IX of the Code of Economic Law, EOs must take the necessary corrective measures and refrain from supplying products that they know (or should have known) do not meet the requirements of Book IX of the Code of Economic Law. This entails that they must share information about product risks, be able to demonstrate product traceability, and collaborate towards the prevention of product risks. 

The FPS Economy refers to the guidelines that arose from the Commission Decision of 14 December 2004 and provides the following.

Guidelines in case of supply of products directly to consumers (B2C) 

High risk or serious risk: criteria and formal requirements

High risk – product withdrawal: the EO must take the following measures:

• immediately cease the sale of the product;
• promptly and strictly follow the measures received from the supplier or from the FPS Economy to remove the Product from commerce; and
• if not contacted by the supplier, the EO is obligated to contact such supplier without delay.

Serious risk – product recall: the EO must take the following complementary measures.

• Contact all known consumers/users and inform them about:
1. the inherent risks associated with the use of the affected product; and
2. possible procedures for returning or repairing the Product, such as returning it to the point of sale or arranging for home collection.
• If not all consumers/users are known or if there is a low response rate from known customers:
1. the supplier’s notice must be prominently displayed for at least two consecutive months in a visible location for consumers/users at the point of sale. The notice should include at least a description and a photo of the product, the risks associated with its use, the possible procedures for consumers/users to return the product, and any potential reimbursement or compensation.
• If the EO has a website and/or social media account:
1. the same information must be clearly visible on the homepage of the website for at least two consecutive months; and
2. at least one message must be posted on social media platforms.
• If the EO publishes its own newsletter, the same information must be clearly communicated at least once in the newsletter.

It will be important to preserve the necessary documentation to respond to any requests from the FPS Economy and provide the requested evidence concerning notably the list of clients and the returned or repaired products.

Guidelines in case of supply not directly to consumers (B2B)

High risk or serious risk: criteria and formal requirements

High risk – product withdrawal: the EO must take the following measures immediately or no later than ten days after identifying the risk:

• Immediately cease the sale of the product.
• Take immediate measures to remove the product from commerce, including:
1. immediately halt sales by distributors and provide them with a detailed description of the product and all information regarding the associated risks;
2. provide information to distributors on actions to be taken, such as returning, repairing or destroying the product; and
3. transmit to the FPS Economy the list of customers/distributors (with their addresses) who have purchased the product in question and provide evidence that customers/distributors have been informed of the cessation of sales and the required measures to be taken.

Serious risk – product recall: the EO must take the following supplementary measures.

• Immediately or no later than five days after identifying the risk:
1. provide the FPS Economy with a description of the planned measures for recalling the product from consumers/users, along with a list of customers/distributors (including their addresses) who have purchased the product in question;
2. prepare a notice for distributors containing all necessary information, including a description and a photo of the product, the inherent risks associated with its use, the possible procedures for consumers/users to return the product to the distributor, and any potential reimbursement; and
3. immediately instruct customers (distributors) to cease the sale of the product (while awaiting the instructions for implementing the product recall).
• Immediately and no later than ten days after identifying the risk, at the distributors’ attention:
1. provide the aforementioned notice;
2. communicate the measures they should take to remove the product from the market, recall it or repair it;
3. instruct them to contact all known consumers/users and inform them of the necessary actions to be taken (product return, repair at the point of sale, repair at home, etc), as well as the practical procedures to be followed by the consumer/user; and
4. if not all consumers/users are known or if there is a low response rate from known customers, the following measures should be taken:
1. display the notice prominently and clearly visible for consumers/users at the point of sale for at least two consecutive months;
2. the same information as on the notice must be clearly visible on their website for at least two consecutive months;
3. at least one message must be disseminated via social media platforms, if available; and
4. if they publish their own newsletter, the same information must be clearly communicated at least once.

No later than three months after the launch of the recall action or cessation of sales, the EO must be able to respond to any requests from the FPS Economy and provide the requested evidence.

Any manufacturer and/or distributor must notify the Central Contact Point for Products immediately when they are aware, or ought to be aware, based on the information they have and in their capacity as professionals, that a product or service put on the market presents safety issues either because it presents risks incompatible with the general safety obligations or does not satisfy specific legal compliance requirements. 

The notification should contain at least the following information: 

• data allowing an exact identification of the product(s) or the product(s) batch concerned; 
• a complete description of the risk related to the product(s); 
• all available information allowing tracing of the product(s); and
• a description of all actions undertaken in order to avoid any risk for the users. 

The New Regulation  appears to have delegated the responsibility of establishing effective and proportionate penalties for non-compliance to the member states. It requires member states to lay down rules and measures to ensure that EOs and providers of online marketplaces fulfil their obligations and face dissuasive penalties for any infringements. Member states are required to notify the Commission of these rules and measures by 13 December 2024.

As of now, Belgian law has not made any amendments to its Code of Economic Law in relation to this specific requirement. It remains to be seen how Belgium will address this obligation and incorporate the necessary provisions into its national legislation.

Under the current legal regime, breaches of product safety legislation are subject to criminal fines up to EUR200,000 or 6% of the breaching party’s last annual turnover in Belgium, whichever is higher.

In Belgium, product liability is governed by the Law of 25 February 1991 on liability for defective products. This Law transposes the content of Directive 85/374/EEC of 25 July 1985 on liability for defective products and its amending directives into law. As from 1 January 2025, this Law will be repealed and its content will be integrated into Chapter 7 of Book 6 of the Belgian Civil Code, with no major amendments.

Product liability is also governed by general tort laws and some aspects are subject to criminal sanctions.

The Law on Liability for Defective Products

Key features of the Law include:

• manufacturers, importers and suppliers being jointly and severally liable;
• liability arising “for damage caused by a defect” in a product; and
• “product” being defined broadly as “all movable goods” but expressly excluding “primary agricultural products and game”.

Under this Law, a party can be held liable when a product is defective, without having to demonstrate any breach or negligence from that party, and if that product causes damages due to that defect to another party. 

A cause of action would require the reunion of the following three elements.

• A defect on the product: a product is deemed defective when it does not provide the safety which a person is entitled to expect, taking into account “all circumstances”, including but not limited to the product’s presentation, the use(s) to which it could be reasonably expected that the product would be put into, and the time it was put into circulation. 
• Damage to another party: consisting in a personal injury, moral and/or property damage.
• A causal link between the defect and the damage: the injured party must establish, with sufficient certainty, that in the absence of the defect, the damage would not have occurred as it did. This principle is governed by the theory of equivalence of conditions, meaning that a party will only be held liable if it is proven that the damage would not have occurred without the defect.

The liable party for defective products is primarily the producer, which can be categorised into three types: the actual producer, the apparent producer and the presumed producer. 

• The actual producer is the manufacturer of the finished product, its components, or raw materials. 
• The apparent producer includes entities presenting themselves as the manufacturer by affixing their name, brand or distinctive sign on the product, such as retailers who outsource manufacturing. 
• The “presumed” producer encompasses those who import products into the EU in the course of their economic activity with the intention of selling or transferring them to third parties.

General Tort Law

Liability under tort law requires the claimant to demonstrate a breach by the liable party of a duty of care or negligence, or the breach of a specific obligation or prohibition under the law. This cause of action can allow a claimant to seek damages against a party not qualifying as a producer under the Law on liability for defective products or in relation to products outside of the scope of this legislation (eg, immaterial products). It also allows a claimant to claim damages covering business losses. 

Criminal Law

The absence of compliance with product safety legislation, whether or not it causes harm to another party, can also be subject to criminal sanctions governed by Book XV of the Criminal Law. For instance, offences such as consciously commercialising a product not complying with product safety legislation are subject to criminal fines up to EUR200,000 or 6% of the liable party’s last annual turnover in Belgium, whichever is higher. 

The Law on liability for defective products states that the “injured person” is entitled to bring an action before the competent courts. 

The injured person is defined as any natural person, whether a consumer or a professional, suffering compensable damage under the Law due to a defective product. It is established that whether or not there is a “direct” contractual relationship with the actual, apparent or presumed producer is irrelevant in this regard.

Belgian law also provides for the possibility for several injured persons to bring a collective claim before the courts (see 2.16 Existence of Class Actions, Representative Proceedings or Co-ordinated Proceedings in Product Liability Claims).

Under the Law on liability for defective products, product liability claims must be initiated within three years from the moment when the injured person became aware, or should have reasonably become aware of the damage, the defect and the producer’s identity. 

Moreover, the window for filing claims is ten years after the producer put the specific product responsible for the damage into circulation, unless legal proceedings have been initiated against the producer in the meantime. This is commonly referred to as the ten-year statute of limitations.

Under general tort law, these terms are respectively of five years from the moment that the injured person became aware of the damage and the liable person’s identity. The claimant has 20 years to file a claim as from the day that the fact causing the damage occurred.

Belgian courts will have jurisdiction to know of a product liability claim in different cases. 

First, under Brussels 1bis Regulation (Regulation (EU) No 1215/2012 of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters), Belgian courts will have jurisdiction if: 

• the defendant is located or established on the Belgian territory; and/or
• the harmful event occurred or may occur in Belgium; and/or
• the claimant is a Belgian consumer who bases its claim on a contract with the defendant; and/or
• Belgian courts have jurisdiction based on a valid jurisdiction clause concluded between the claimant and the defendant. 

In relation to defendants located in jurisdictions outside of the EU, the Belgian Code of Private International Law provides that Belgian courts will have jurisdiction if:

• a valid jurisdiction clause was concluded between the claimant and the defendant; and/or 
• the harmful event occurred or may occur in Belgium; and/or
• the damage occurred or may occur in Belgium; and/or
• the claimant is a Belgian consumer who bases its claim on a contract with the defendant or an offer to contract was directed towards the Belgian consumer.

Prior to filing a product liability claim before courts, the injured party must send a formal notice to the producer, including details of the alleged defect and resulting harm. 

Sometimes, while not mandatory, the judge may encourage the parties to engage in mediation or settlement negotiations before initiating formal litigation, and will also take into account the attempts of the parties at settling their dispute while ruling on the case.

The common law of evidence applies to the evidence of product liability claims. The defect must be proven and cannot simply be inferred from the occurrence of the damage or the establishment of a causal link between the product and the damage. 

Businesses are required to maintain corporate documents for a definite duration but this is often required by other legislation than law on evidence as such, meaning that businesses will often dispose of evidence for their product claim due to the need to comply with other legislation. 

Moreover, the producers already need to maintain specific documentation in relation to the product and its risk assessment under product safety legislation and this documentation must be readily available following a request for information from a regulatory authority. Such documentation can of course be re-used in the framework of proceedings against another private party.

The rules regarding disclosure of documents or other evidence in product liability cases are primarily governed by the Judicial Code and the Code of Economic Law.

Under the Judicial Code, parties to a dispute have to disclose relevant documents they are aware of and which may be used as evidence during the litigation. This process is often referred to as “disclosure of documents” or “production of evidence.” Parties may request the disclosure of certain categories of documents from the other party, and in the case of a disagreement on disclosure, the court may be approached to resolve the issue.

Regarding product liability cases, the Code of Economic Law may also contain specific provisions concerning the disclosure of documents. For instance, it requires manufacturers or suppliers to disclose appropriate information in a clear and comprehensive manner regarding the product and its characteristics.

The rules governing expertise are set out in the Belgian Judicial Code. Parties involved in a product liability case may appoint their own experts to provide opinions or analysis on technical issues relevant to the case but are not allowed to render an opinion on the legal aspects of the case. 

These experts must meet certain standards of professionalism and impartiality.

In addition, the court may also appoint its own independent experts to provide opinions or conduct investigations concerning the product in question. 

The court can choose to take the expert’s report into account when ruling on a case but will not be bound by it if the parties can provide counterevidence that the expert’s findings are not accurate for instance.

In principle, the burden of proof in product liability cases lies with the claimant. The claimant must demonstrate the existence of the defect in the product, their damage as well as the causal link between the defect and that damage. 

However, this burden of proof can be reversed by law or by the judge in several circumstances. 

For instance, the claimant is not required to produce indisputable proof and can rely on the mechanism of presumptions: if the claimant brings forward several serious, precise and concordant elements of proof making the fact highly likely, while being unable to prove the fact itself, the judge can nevertheless consider the fact as proven and require the defendant to produce the opposite evidence. 

Moreover, the burden of proof will also be facilitated by the appointment of an expert witness who will provide deeper technical information allowing the claimant to evidence their claim more easily. The judge is also vested with the power to revert the burden of proof in exceptional circumstances, if imposing the burden of proof on the claimant would be obviously unreasonable (because, for instance, it would require excessive costs for the claimant).

Product liability cases are brought before civil courts (the competent court may vary depending on the quality of the claimant, consumer or business). The case will be decided by one or three judges depending on the court and no jury is involved in such proceedings. 

There is no specific threshold award of damages. However, the claimant is only entitled to compensation for damages that are certain and proven, whether or not of a patrimonial/financial nature, and to such an extent that the claimant is put in a position similar to the one the claimant would have been in had the liability event not occurred. There is no system of punitive damages under Belgian law.

An appeal against the judgment issued by the court in first instance can be filed before the relevant jurisdiction of appeal and is only possible against final judgments (not interim judgments). The deadline to lodge the appeal is one month from the date that the judgment has been served by the bailiff. In other words, there is no specific deadline to file an appeal if the judgment has not been served.

Producers of a defective product are not liable under the law if they can demonstrate any of the following: 

• they did not put the product into circulation; 
• having regard to the circumstances, it is probable that the defect which caused the damage did not exist at the time when the product was put into circulation by them or that this defect came into being afterwards; 
• the product was neither manufactured by the producer for sale or any form of distribution for economic purpose nor manufactured or distributed by the producer in the course of their business; 
• the defect is due to compliance of the product with mandatory regulations issued by the public authorities; 
• the state of scientific and technical knowledge at the time when the producer put the product into circulation was not such as to enable the existence of the defect to be discovered; or
• in the case of a manufacturer of a component, that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the manufacturer of the product.

Compliance with regulatory requirements is taken into account by judges to decide whether a product is defective or not, but it does not alone rule out the existence of such defects. The analysis and reasoning of the judge will also concern the determination of the user’s reasonable and legitimate safety expectations for a product. 

There is a parallel to be drawn between compliance with regulatory standards and building a strong product liability strategy. In complying with regulatory requirements, a product’s manufacturer is required to adhere to standards that are specific to various products aspects. Those include the product’s presentation, its intended use, as well as supply chain considerations (throughout the pre-marketing and post-marketing phases). At the same time, the Belgian and EU product liability regimes uphold the presentation of the product and the use to which it could reasonably be expected that the product would be put as criteria to determine whether a product is safe or not. As such, compliance with sector-specific regulations tend to offer a means and a defence to establish a product’s safety from a product liability standpoint.

The costs that can be claimed by the successful party are regulated. While all expert’s costs and court fees can be claimed back, legal costs are subject to specific caps set out under the Belgian Judicial Code and its relevant executing royal decrees. The applicable cap will depend on the total amount of damages awarded to the successful party (or if the claim is rejected, on the total amount claimed by the claimant). 

While third-party funding is not broadly known in Belgium, claimants will usually benefit from legal protection insurance covering their legal costs and benefits associated with legal claims and the enforcement of judgments. 

Consumers may also be entitled to free or partially free legal assistance to file a claim if they meet certain remuneration thresholds (pro-bono lawyers). 

Contingency fees are subject to strict ethical rules for Belgian lawyers and cannot constitute the only source of outcome of an external lawyer handling a litigation case.

Under the Belgian Code of Economic Law, class action proceedings before the courts of Brussels are open to claimants in relation to specific causes of actions, including damage claims based on the Law on liability for defective products. These claims can only be filed by consumer representatives (such as some consumer associations) which fulfil specific criteria set out by the law. The outcome of such proceedings can be the award of damages by the court or a collective settlement between the group of claimants and the defendant. 

More recently, the Collective Redress Directive (EU) 2020/1828 has been transposed in Belgium by the Law of 21 April 2024. This Directive amends and completes these rules on class actions (eg, making a general opt-in regime for claimants, rendering the procedure more efficient and allowing for faster judgments) and should enter into force in the upcoming weeks.

Supreme Court Case of 14 March 2024 (1st Chamber), AR C.23.0100.N

In a case involving damages caused by a cooking appliance, the Supreme Court ruled that the rules applicable to product liability (arising out of an EU directive) and the Belgian rules on tort law can coexist within the same claim but that their causes of action remain different and subject to different conditions. 

For instance, if the substantive base for liability consists in the fact that a defective product has been put into circulation and has caused damage, the producer and the supplier can be held liable and the injured party can seek compensation within the conditions set out under the Law on liability for defective products. However, the mere circumstance of putting a defective product into circulation does not create sufficient legal grounds for a tort claim since the claimant should also demonstrate a breach or negligence from the producer and/or supplier. 

Diesel-Gate – Judgments of the Court of First Instance of Brussels of 18 December 2017 (Admissibility) and 27 July 2023 (Merits)

The Belgian courts ruled in favour of the consumer association Test-Achats in the framework of a class action brought against Volkswagen. Test-Achats had initiated proceedings on behalf of consumers having bought vehicles from Volkswagen equipped with a EA 189 motor and containing a software distorting the results of emissions tests and failing to comply with emission standards.

The court held Volkswagen liable for integrating that manipulated software into the vehicles. Following the judgments, consumers were entitled to compensation up to 5% of the vehicle’s purchase price or 5% of the difference between its purchase price and the resale price. These judgments also apply to vehicles from other brands from the same group (Skoda, Seat, Audi).

There is undoubtedly increased regulatory scrutiny impacting several industries and the life sciences and healthcare industry in particular, with a focus on risk assessment and post-market surveillance. 

Certain provisions of the New Regulation will apply to businesses involved in life sciences and healthcare, reflecting a growing trend. In fact, the provisions concerning the obligations of providers of online marketplaces, the obligations of economic operators in the event of accidents, the right to information and to a remedy for consumers as well as product safety recalls should apply to products covered by EU harmonisation legislation too. 

The renowned (and recently adopted) EU AI Act will impact the healthcare industry as well. Different stakeholders will need to respond to new obligations when utilising technologies dependent on AI or AI-driven digital workflows (eg, telemonitoring tools, digital therapeutics, healthcare robots, patients’ wearables, healthcare providers’ prescription software, medical chatbots and various algorithms used in care centres). 

Interestingly, even regulations seemingly unrelated to the life sciences sector, such as Regulation (EU) 2023/1542 concerning batteries and waste batteries, can have an impact. Manufacturers of battery-powered medical devices and in vitro diagnostic devices (such as pacemakers, electrocardiographs and robotic cameras) may in fact find themselves affected.

Regardless of sectorial impacts, efforts are being made by the European legislator to harmonise product safety standards by adopting rules that apply to both harmonised and non-harmonised products, as exemplified by the New Regulation. The choice to adopt a regulation instead of a directive further underscores the objective of harmonisation. 

It is worth mentioning that the New Regulation and its many associated obligations, particularly for SMEs that may find themselves classified as importers or distributors, can pose significant compliance challenges. The level of compliance required may be particularly burdensome for smaller structures. 

Recognising this risk, the Commission has acknowledged the challenges faced by SMEs and has committed to providing guidelines and advice to support them. Consequently, it is vital for companies to proactively identify compliance and implementation strategies, as the proliferation of legal requirements within the EU will affect all stakeholders.

In Belgium, the response to recent policy developments is still unfolding. The introduction of a new regulatory landscape is relatively recent and it may take time for national legislative production to emerge.

However, it is worth noting that Belgium is already showing signs of aligning with the direction set by the EU. Last November, a bill was introduced that aims to prohibit the marketing of products and services originating from occupied territories and whose production and/or supply result from situations arising from serious violations of international humanitarian law. The objective would be to put in place a restrictive trade measure dictated by reasons of public morality, which goes beyond mere labelling indicating the origin of the products and calls for a ban on the importation of colony products within the EU. This initiative aligns with the objectives of the proposal for a Corporate Sustainability Due Diligence Directive that was just given a final green light by the European Parliament. This Directive would require large companies to prove compliance with environmental and human rights standards within their supply chains. So, although not directly linked to product safety, it highlights how important it has become for companies operating in the EU to closely monitor updates and prepare implementation strategies covering several aspects of their practice.