Legal Insights On Product Compliance, Safety And Recalls

LegalFeeds©

Rutger Oldenhuis LLM, founder of RecallDesk, regularly writes articles in the field of product compliance, product safety and recalls and is a contributor to a number of media outlets.

The articles and blogs, collectively offered as LegalFeeds©, aim to provide valuable insights and information that can help businesses and consumers alike make informed decisions about product safety and compliance. Whether you’re a manufacturer, retailer, or consumer, the contributions are designed to be informative, engaging, sometimes meant to be funny, and easy to understand.

The articles cover a wide range of topics, from new regulations and standards to industry trends and best practices.

LegalFeeds© is intended for general informational purposes only and should not be considered legal advice. The content may not reflect the most current legal developments, and is not guaranteed to be correct, complete, or up-to-date. No reader should act or refrain from acting on the basis of any information contained in this newsletter without seeking appropriate professional advice based on their situation.

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Fatbikes

By Rutger Oldenhuis LLM – Published in Bike Europe Magazine 3-2024

I’m writing this blog while sitting on a train to Amsterdam. Once I arrive and walk to my destination, I’ll need to watch out for a fairly recent phenomenon: fatbikes. I live in a quiet little village, so I thought it wasn’t that big of a deal. But whenever I come to Amsterdam, I suddenly understand the alarming Dutch news headlines much better. These things can be dangerous! Dozens of them zoom past, often ridden by very young people going at high speeds. It’s no wonder they’ve already caused so many accidents. The issue has caught the attention of politicians as well, and as is often the case, you’re immediately bombarded with half-baked solutions. The most popular ones? A minimum age requirement and mandatory helmets.
But what’s really going on here?

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Fuuuuuut!!!

By Rutger Oldenhuis LLM – Published in Bike Europe Magazine 2-2024

As I wrote in one of my earlier blogs, the upcoming General Product Safety Regulation (GPSR) is food for many more blogs to come. It contains many provisions that go far beyond the current EU General Product Safety Directive (GPSD). In this blog, I would like to draw attention to a new obligation that is introduced in the GPSR: accident reporting. Pursuant to the GPSR, manufacturers must promptly report product-related accidents via the Safety Business Gateway to the competent authorities in the Member State where the accident occurred. The implications of this should not be underestimated. Although reports of accidents may not automatically lead to an obligation to carry out corrective actions (like a recall), receiving multiple reports of accidents involving the same product will obviously trigger authorities to investigate the issue. And if that isn’t all, pursuant to the EU Whistleblower Directive, employees are encouraged to notify the relevant authorities of breaches of EU law, among others in the field of product safety and compliance…

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Helmet hair

Swedish Hövding revolutionized cyclist safety with an innovative airbag system. Claimed to offer up to 8 times better protection than traditional helmets, Hövding sold over 300,000 units over a span of 12 years. The avoidance of “helmet hair” is an important and notable advantage of using an airbag instead of a traditional helmet. No wonder Hövding’s main market is Sweden, where urban cyclists are particularly mindful of their appearance.

However, a shocking turn of events occurred in December 2023…

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Smartphones are the new cigarettes

Interesting news from Recall Land. The safety of Apple’s iPhone 12 has come under scrutiny, as per findings from French regulatory authorities. Their testing revealed that this particular smartphone model did not comply with the legal limits set for radiation emissions. This news is notable not only for the reported safety issue, but perhaps even more so for the safety issues that went unreported. The question is how long smartphone makers and app builders can get away with those safety risks. With the impending EU General Product Safety Regulation (GPSR), smartphone manufacturers and app developers may face a rise in product safety and liability claims. That is, unless they make significant alterations to the design and functionality of their products. Or should they?

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Taking safety seriously

By Rutger Oldenhuis LLM – Published in Bike Europe Magazine 5-2023
In September 2018, a terrible accident took place in the Netherlands. An electric vehicle, called a ‘Stint’, which is a small electric cart primarily used for transporting young children, was hit by a passenger train. These vehicles were commonly used in the Netherlands by childcare centres for transporting groups of children. As a result of the collision, four children lost their lives and two other individuals, a child and the adult driver of the Stint, were seriously injured.

Five years later, the Dutch Public Prosecution Service (OM) is bringing charges against two companies responsible for producing and selling the Stint, along with two company executives, for their involvement in multiple criminal offenses. According to the OM, they wilfully and knowingly put a harmful product on the market. This case serves as a reminder that signing a Declaration of Conformity and using CE marking is much more than just a formality.

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Hoe zit het nou met de wettelijke garantietermijn in Nederland? Mag die korter zijn dan twee jaar?

By Rutger Oldenhuis LLM

Het gebeurt regelmatig: winkels in Nederland die richting consumenten een beroep doen op een garantietermijn van een jaar. Desgevraagd wordt uitgelegd dat Nederland geen wettelijke garantietermijn heeft bepaald, maar die laat afhangen van de eigenschappen van het product. Daarbij wordt dankbaar gebruik gemaakt van informatie verstrekt door diverse overheidsinstanties. Maar klopt die informatie wel? Geldt er in de EU geen minimale wettelijke garantietermijn van twee jaar? RecallDesk heeft dit uitgezocht. De verrassende uitkomst leest u in dit artikel.

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Online platforms become quasi-regulators

By Rutger Oldenhuis LLM – Published in Bike Europe

The rapid growth of e-commerce has transformed the way we shop, allowing us to purchase a wide range of products conveniently from online marketplaces. However, this convenience also brings certain risks, particularly when it comes to product safety. Too often, we see products sold through online platforms that do not comply with relevant EU product legislation. It is not uncommon to find products subject to recalls still being available on online marketplaces. The enforcement of product safety regulations on online marketplaces has traditionally posed challenges for authorities. However, this situation is anticipated to undergo a significant transformation with the implementation of the upcoming EU General Product Safety Regulation (GPSR). An entirely new section has been included with obligations for ‘providers of online platforms’. This seems to be a real game-changer, not only for providers of online platforms but also for companies who sell products through online platforms. Under the GPSR, online platforms will be obligated to implement a comprehensive set of due diligence measures. These measures will ensure that both the platforms themselves and the traders utilising their platforms adhere strictly to relevant laws and regulations when selling products. To get the gist, this blog containts an overview of the upcoming requirements.

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EU product safety law going mental

By Rutger Oldenhuis LLM – Published in Bike Europe

In addition to the far-reaching provisions on recall remedies, the GPSR contains many other provisions that go far beyond the current EU General Product Safety Directive (GPSD), which will be food for many more blogs to come. For example, the GPSR adopts the WHO’s definition of ‘health’, which states: “The World Health Organization defines ‘health’ as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity”. As a result, the concept of ‘product safety’ acquires a more expansive meaning and a new dimension. However, it is not an entirely new phenomenon, which can be demonstrated by the following examples. A Dutch tableware company introduced a new product line called ‘Dutch Glory’, featuring traditional Dutch icons such as pancakes, cheese, clogs, and tulips. The problem was that it also featured an illustration of a smiling Anne Frank. After facing criticism, the company removed the products from the market. Another example is a play clay manufacturer who withdrew a “phallic-shaped toy” from the market in response to parental complaints. Given the GPSR’s extensive interpretation of safety and health, we can anticipate an increase in similar recalls.

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I wonder if ChatGPT would have spotted this

By Rutger Oldenhuis LLM – Published in Bike Europe

I missed my deadline for writing this blog. ChatGPT was overloaded already for days, so I really had to write myself. So, let’s continue where I ended my previous blog.
Being a big fan of my blogs, you know I made a comparison with the car industry, where one hardly ever sees a ‘Stop Ride’ recall, despite the often serious risks. You know that I have made a case for fewer ‘stop using your bicycle immediately’ recalls. You also know that this is not going to happen if we take the (provisional) text of the General Product Safety Regulation (GPSR) literally. In fact, dangerous bicycles and cars, being non-portable, will have to be collected from consumers. The text does not leave any room for proportionality. Was this really intended by the EU Commission? Fortunately, the EU Commission also reads my blogs. And guess what? My assessment of the GPSR turns out to be correct. However, that is only for bicycles, not for cars. Since there is already specific sectoral legislation for cars in place that also handles recalls, the GPSR would not apply to cars. The question is whether that is a correct assessment.

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Article

The New EU Product Safety Law Will Be A Game Changer

By Rutger Oldenhuis LLM – Published in Sporting Goods Intelligence Europe and Eyewear Intelligence

Last December, the text of the long-awaited EU General Product Safety Regulation (GPSR) was finalized, which will replace the outdated EU General Product Safety Directive. The GPSR is expected to come into force by the end of 2024. The ink has yet to dry, but one thing is certain: selling consumer products in the EU will never be the same. In this article I summarize the main highlights of the GPSR.

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Product recalls under the GPSR: beware of the snag!

By Rutger Oldenhuis LLM – Published in Bike Europe

The ink has yet to dry, but the recently approved text of the long-awaited General Product Safety Regulation (GPSR) is set to cause quite a stir. If we follow the text literally, unsafe cars (or any other heavy consumer product) will have to be collected from the end-user.

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Article

The French Triman Logo: To Comply Or Not To Comply?

By Rutger Oldenhuis LLM – Published in Sporting Goods Intelligence Europe

In France, a law on product labelling recently entered into force, which is causing quite a stir. The law, which requires companies to use the so called Triman logo and waste sorting pictograms, may have major consequences for companies selling consumer products in France, including sporting goods, apparel and shoes. The requirements of the new French labelling legislation are no sinecure and should not be underestimated. Companies that sell products throughout Europe are expected to adjust their labelling specifically for France. That entails an enormous burden and increase of cost. Large multinationals may – reluctantly – absorb this, but for SMEs, that may not be so easy. Moreover, extra labelling creates more waste, whereas companies – encouraged by the EU Commission – need to reduce their carbon footprint.

Many sources suggest this new law is mandatory, whereas non-compliance would lead to high fines. That is not entirely correct and needs to be nuanced. At the same time, a large number of industry associations (including FESI), supported by the EU Commission, are of the opinion that the French law is violating the EU Treaty. Furthermore, we may expect the EU to come with harmonised labelling in the near future. That leaves companies with a difficult question: should we comply or not? To help companies answering that question, in this article I will explain what the new French labelling requirements essentially are about and will share some insights and practical tips.

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Why a ‘stop using your bicycle immediately’ recall should be rare

By Rutger Oldenhuis – Published in Bike Europe

Wheels that come loose, brakes that don’t work, seatbelts that don’t tighten, and a wrong brake pedal that gets in the way when using the clutch. This is not about bicycle recalls but a selection of recent automotive safety issues that were categorized as ‘serious risk’ and therefore led to a product recall. It doesn’t take much of an imagination to realise what can happen if your car loses a wheel, can’t brake or doesn’t have a properly working seatbelt while driving.

When non-food products pose a serious safety risk and are recalled, market surveillance authorities typically require companies to include in their recall notice the instruction to stop using the product immediately. This is in line with EU recall guidelines.

Car recalls

But when you analyse car recalls, for an industry known for its rigorous quality control processes it is first of all shocking how many serious defects are reported monthly. Along with toys, motor vehicles top the recall rankings. More remarkably, you probably won’t find any mention that car owners should stop using their car immediately. The most common instruction is that car owners make an appointment with their car dealer to have the problem fixed. There are a few known cases where car owners had to park their car outside in a safe place due to the risk of battery fire.

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Article

How Dirty Is Greenwashing?

By Rutger Oldenhuis LLM – Published in Sporting Goods Intelligence Europe

It’s a phenomenon often seen in advertising: exaggeration, also known as “puffery.” Typically, puffing is not regarded as misleading advertising, even though the claims cannot be objectively verified. “We serve the best sandwiches in town!” Everyone will understand that such an advertising claim is completely harmless. For a long time, perhaps something similar could be said about environmental claims used by corporates to market their products or services. Terms like ”green,” ”eco-friendly,” ”conscious” or ”sustainable” are all over the place and almost lost their meaning.

However, in a relatively short period, the tide seems to be turning. NGOs, consumer initiatives, newspapers, activist shareholders, national authorities and the EU Commission are paying more and more attention to companies that use unsubstantiated or vague sustainability claims (also known as ”greenwashing”), with the European Green Deal as an important driver. Not without consequences. And with the recent Shell case, corporates with large carbon footprints may even have more to worry about.

In this article, Rutger Oldenhuis explains the current legal perspective of environmental claims used by corporates to market their products or services, in particular on a business-to-consumer level. What is allowed, and what is not? He will also briefly touch upon the Shell case, which may be the first of alternative legal actions to be expected against climate change. And could greenwashing actually lead to a product recall?

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What we can learn from the disastrous Philips recall

“The health care turmoil in the US is only temporary,” Philips’ CEO said in an interview in 2017. Today, Philips itself seems to be in its worst turmoil ever. The company is recalling millions of medical devices due to the breakdown of foam (PE-PUR) used in the Philips Respironics ventilators and other medical devices, causing serious potential health risks.

And things only seem to get worse – the latest developments are that Philips enlarged the scope of the recall yet again, and their CEO announced he would step down. Typically, we read all of this in the newspapers, but interestingly, the US Food and Drug Administration (FDA) has published observations of their inspections carried out at Philips Respironics Inc., the US-based company that produces the affected medical devices.

Serious observations

The observations provide very detailed insight into the product design and safety processes that FDA claims Philips is not sufficiently in control of. Based on 21 company inspections, they made eight serious observations. Each observation is extensively substantiated with examples.

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E-bike battery fires and what the industry can do about it

By Rutger Oldenhuis – published in Bike Europe

Did you see the horror crash of Formula 1 racer Zhoa at Silverstone this year? He survived, miraculously, due to a mandatory safety measure that was introduced in 2018 by car sports federation FIA: the halo. The halo is a titanium part that is placed over the driver’s cockpit. The design has a strong resemblance with the upper part of a flip-flop – just look at your Havaianas.

Perhaps that was the reason why nobody in car racing really liked the introduction of the halo until they saw it actually serve a purpose. Since its introduction, several drivers owe their lives to the halo, including Zhoa. It’s a great example of ‘safety by design’ and the FIA can take pride that they have pushed through with this innovation, despite all the opposition. And from flip flops, it’s only a small jump to e-bike battery safety.

Thermal runaway

Battery fires, mainly caused by so-called thermal runaway events, are an increasing concern in the bicycle industry. In e-bike paradise, the Netherlands, there are 6-8 battery fires reported every week, but the real number is probably even higher. Thermal runaway events can have many different causes and the risks can be serious. Some batteries are ticking time bombs and should not be on the market in the first place. So, what can the industry do to minimise the risks?

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The French Triman logo: Is the bicycle industry prepared?

By Rutger Oldenhuis – published in Bike Europe

In France, a law on product labelling recently entered into force, which is causing quite a stir. The law may have major consequences for companies selling consumer products in France, including bicycles. An informal ‘round the table’ with various sources suggests, however, that this new French law is not known yet to everyone in the bicycle industry. So, what is it about?

Triman logo + Sorting Information

As of 1 January 2022, a law has entered into force in France that requires companies to place the so-called Triman logo on products or packaging that are subject to ‘Extended Producer Responsibility’ (EPR). The Triman logo has been mandatory in France since 2015, but the number of products involved was limited and the logo was also allowed to ‘only’ be placed on the website. However, the new law goes a lot further.

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How M&M’s can make cycling safer

By Rutger Oldenhuis – published in Bike Europe

In the music world, a contract for live concerts typically has an appendix, also known as a ‘rider’, that includes all kinds of very detailed technical and practical rules and demands of a band. Some bands are known for adding insane or absurd requests to a rider – rock band Van Halen was one of them. Their wish list included “M&M’s (WARNING: ABSOLUTELY NO BROWN ONES!)”. Their contract further stipulated the following: “There will be no brown M&M’s in the backstage area, upon pain of forfeiture of the show, with full compensation”.

For a long time, this Van Halen clause was misunderstood for being yet another crazy demand from a bunch of spoiled rockers. But nothing could be further from the truth and businesses and their lawyers could really learn from it.

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That’s a Bingo!

By Rutger Oldenhuis – published in Bike Europe

For most companies, a product recall is like fantasy – it happens to others, not them. Some companies may ignore a suspected recall, hoping it continues to be a fantasy. But that fantasy can become your worst nightmare. If there are signals within your company indicating a possible product safety issue, you better take the appropriate action. I am not sure if media outside the Netherlands paid any attention to the Philips recall lately, but their stock market value at some point dropped 50% because Philips allegedly ignored product complaints from the market involving a medical device since 2015.

Another example is last year’s Peloton treadmill recall. Publicly arguing with the CPSC (Consumer Product Safety Commission) in the USA and denying a potential safety issue while reports of adults, children and pets being pulled under the rear of the treadmill have been received is definitely not the way a suspected recall should be handled.

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Lost in translation

by Rutger Oldenhuis – published in Bike Europe

Michael Jackson is famous for many things, not least because of his misheard lyrics. Even native speakers have trouble understanding what he is actually singing and his version of “Come on!” is just inimitable: “Shamone!”. When I drove back from the Eurobike show early September, I noticed the sign I always see when driving across Germany: ‘80 bei Nässe’ (80 when raining). Only this time I wondered: what if foreigners don’t understand what that means? What if they just continue pushing their car to its limit when it starts raining?

As weird as the combination of these examples may seem, what they have in common is ‘language’. In Michael Jackson’s case, you can just continue listening, even if you don’t have a clue what he is singing. You may even not listen to him at all if you don’t like his music. But if you continue driving 200 km/h on a road that gets wet, you put yourself and your fellow drivers at risk.

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Some version of the truth

by Rutger Oldenhuis – published in Bike Europe

“I have always told you some version of the truth”, Jack Nicholson said to Diane Keaton in one of my favourite comedies “Something’s gotta give”. But it could very well have been a lawyer who said it. Indeed, attorneys-at-law are trained to defend your version of the truth, being supported by laws that often leave room for various interpretations.

It’s no surprise that even judges often argue about the legal truth. During my career as inhouse lawyer, one of my main tasks was to give as little work to attorneys-at-law and judges as possible. Mitigating legal risks (compliance) was key. Anti-trust, privacy, data protection, intellectual property, transfer pricing, ESG, anti-bribery and corruption. And last but not least: product safety and product compliance.

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