Blog in Bike Europe: Some version of the truth

By Rutger Oldenhuis

“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.

A product is assumed to be safe if it complies with relevant European or national legislation. Next to that, a product is assumed to be safe if it complies with a relevant harmonized standard. According to the European Commission, complying with harmonized standards is the safest way to demonstrate that your products comply with mandatory legal requirements. Producers should take their responsibility and allocate sufficient resources to ensure their products are safe and compliant when placing them on the market. Sometimes that is easier said than done. When I checked my son’s field hockey shoes for their size, I noticed the mandatory shoe labelling was missing. And too often I see products that are missing mandatory CE marking. Some authorities would love to seize those products if they get the chance.

But it takes two to tango. Legislators on their turn should help producers, e.g. by making laws that leave as little room for interpretation as possible. Taking UV protective clothing as an example. In the guidelines of the Personal Protective Equipment Regulation (PPER) the risk of UV protective clothing is classified as Category I, since it is regarded as an “atmospheric condition that is not of an extreme nature”. But the same guidelines literally say that “natural UV-radiation (sunlight) is not an atmospheric condition”, which would mean UV protective clothing should be classified in Category II. Category II products require a far more burdensome conformity assessment than Category I. So which version of the truth is true?

Despite the different conformity assessments, both Category I and II products require CE marking. A small market research revealed not all UV protective clothing (including bicycle clothing) has the required CE marking, which raises the question if all brands are aware of the applicability of the PPER in the first place. This would not be too worrying if only e-labelling was accepted as a means to demonstrate compliance. Labelling changes could be made more easily, e.g. in case of correcting a missing CE marking.

The European Union however is a very slow mover when it concerns e-labelling. One of the arguments that is often heard, is that today still a substantial part of the consumers is digital illiterate. But for the same reasoning: should we then not provide written product information since a substantial part of the population is illiterate? Maybe I’m too simple-minded, but digital illiterates will by definition not buy a product online. They will buy it in a brick and mortar store. It would be fairly easy to offer a printing solution in a shop, either at the checkout or through QR scanners in the shop. Product information would be up-to-date and printing would only be necessary in the local language. If a QR code works for Corona, what’s holding back the European Commission to adopt e-labelling?

“The truth doesn’t have versions”, Diane Keaton replied to Jack Nicholson. Lawyers know better, and a QR code may show different versions of the same truth, depending on the user. One of my favourite albums is “This Is My Truth. Tell Me Yours” by the Manic Street Preachers. And that’s another way of putting it.

Blog in Bike Europe: Lost in Translation

By Rutger Oldenhuis

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.

Necessity of including all languages

I often get the question if all of the official EU languages are necessary for product information, packaging, labelling and manuals. The typical lawyer answer would be: it depends. In general, “the manufacturer, importer and distributor have the obligation to ensure that the product is accompanied by instructions in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. It is for each economic operator which makes available the product in a Member State, to ensure that all the required languages are available”.

For many product categories, specific language requirements may apply for labels, packaging and instructions. Examples are the Machinery and REACH Directives and the Textile Regulation. For high-risk products, the minimum requirement is usually the official language of the EU member state where the products are marketed.

Risks of missed information

Another and – I admit – rather unconventional way of checking which languages are needed: ask yourself whether a ‘Michael Jackson’ or a ‘80 bei Nässe’ situation applies. Would it be important for your customer to understand how to install, use, service or maintain your product? Are there any risks to be considered if they missed any of such information? Als ik nu ineens doorga in het Nederlands, oder auf Deutsch, ou en français, или на по-рядко срещан език като българския? Do you think it may be important for consumers and even professional bicycle mechanics to receive such information in their own language?

In France, they made it pretty easy to answer that question. Based on the French ‘Toubon Law’, “in the designation, offer, presentation, instructions for use, description of the scope and conditions of warranty of a good, product or service, as well as in invoices and receipts, the use of the French language is mandatory.” This is typically interpreted broadly and even includes information on websites as well. Exceptions apply to trademarks and foreign words that are commonly accepted, like ‘t-shirt’ or ‘jeans’.

Jos Speedboat

At home, my brothers and I had our own way of dealing with Michael Jackson’s gibberish. Just for fun, we changed “Just beat it” to “Jos Speedboat” (Jos is a Dutch first name). This was a long time ago and you can image how totally flabbergasted I was when in 2005 a novel written by Dutch author Tommy Wieringa came out, called ‘Joe Speedboat’. What are the odds? A must-read by the way and translated in the official languages of the countries where it was marketed.

Blog in Bike Europe: The French Triman logo: Is the bicycle industry prepared?

By Rutger Oldenhuis

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.

The Triman logo has been mandatory in France since 2015.

Firstly, the list of products that fall under the EPR has been substantially extended. For example, sports equipment, including bicycles, as well as textile clothing, shoes, batteries, and accumulators, are now also included. And since all packaging – including non-recyclable – now also falls under the French EPR scheme, most companies selling in France will be affected by the new legislation.

Secondly, in addition to the Triman logo, so-called ‘Sorting Information’ must be depicted. That means that symbols indicate how consumers should separate the waste from the product and where to dispose of it. If different elements, parts or waste of the product are subject to different disposal procedures, they should be specified element by element.

The requirements of the new French labelling legislation are no sinecure and should not be underestimated. Companies that sell products throughout Europe must adjust their labelling specifically for France. That entails an enormous burden and increase in costs. 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.

Violation of the EU Treaty

But how about the European Union’s Holy Grail: the single market? Doesn’t this new French law create an obstacle to the free movement of goods? Can France impose these additional labelling requirements, just like that? Good questions. It is true that, under certain circumstances, an EU Member State may not simply introduce national legislation if it creates an obstacle to the free movement of goods unless there would be a justification. The key question is therefore whether France has a justification for imposing these draconian labelling requirements. The French legislators think they do, invoking the protection of the environment. The European Commission, on the other hand – spurred on by a large number of business associations – does not, but to date, it has not gone so far as to start infringement proceedings against France.

To comply or not to comply

Although many sources claim the new labelling requirements to be mandatory, the French law actually allows for different labelling than the Triman logo. More importantly, it is likely violating the EU Treaty. That triggers the question for businesses of whether or not to comply with it. Although the French legislator has chosen a relatively mild sanction regime, you can never be sure if your products would ultimately be banned from the market. On the other hand, would France really be confident enough to let it come to legal proceedings now that the labelling requirements are likely to violate the EU Treaty? Tough call! On the bright side, France has made an important exception: wine is excluded from the new labelling requirements. However, I am afraid it will not make the headache any less.

Blog in Bike Europe: E-bike battery fires and what the industry can do about it

By Rutger Oldenhuis

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?

Risk assessment

One of the goals of product design is to minimise the product risks that have been identified with the risk assessment. Complying with a harmonised standard is essential, but only relevant for the risks and risk categories that are covered by that standard. A producer is expected to carry out a risk assessment and check whether the harmonised standard covers all risks of the product.

Safety hierarchy

Once the product risks have been identified, they can be minimised following the Safety Hierarchy principle, which is like a 3-stage rocket. Step 1 is about applying inherently safe design measures (‘safety by design’). Step 2 is about applying safeguarding and complementary protective measures (e.g., a chain guard). Step 3 is about reducing risk through information for use, e.g., a warning on the product and/or in the manual. Typically, all three steps are being used, but with a clear preference and hierarchy. Step 3 is a last resort measure.

Is a warning in a product manual sufficient?

Despite the instructions and warnings for use in product manuals, consumers tend to charge batteries in their bedroom, park their e-bike in the burning sun and continue using their battery after it has dropped or suffered from a crash. Whether that behaviour would lead to an exemption of producer liability is arguable. If warnings are notoriously and continuously ignored, then such careless behaviour becomes foreseeable, and the producer will have to act on that by taking extra precautionary measures.

Risk reducing measures

For example, why not sell an e-bike with a sun protective battery bag? Why not have more safety features built in the Battery Management System, like overheating, drop or crash detection, combined with a push message on a mobile app? Most modern mobile phones have a simple strip indicating if there is water damage. Why can’t a battery have a simple crash-sensitive device that indicates if a battery has suffered from external impact? Imagine how that could improve not only the safety of consumers but also reduce the risks for companies using e-bikes for B2B services, like postal, rental and bike-sharing services.

A call on the industry

The increasing number of battery fires are harming the e-bike image. Only safe e-bikes should be allowed on the market. Harmonised safety standards are developed together with industry experts. When developing standards for e-bikes, there is a great opportunity for the industry to raise the bar and improve the safety standard for batteries based on the current state of technical knowledge and possibilities. Take FIA as an example. If flip-flops can do it for Formula 1…

Blog in Bike Europe: What we can learn from the disastrous Philips recall

By Rutger Oldenhuis

“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.

To mention just a few… According to the FDA, there was no documented investigation, risk analysis, or design failure mode effect analysis to support Philips’ rationale for which products were affected by the recall. Philips had not sufficiently demonstrated that other devices, also containing PE-PUR foam, should not be included in the ongoing recalls, as well.

A known problem

Furthermore, already in 2015, Philips was aware and knowledgeable of a preventative maintenance servicing procedure implemented by another Philips entity on affected products, but no further investigation, health hazard evaluation, risk analysis, or design review was performed or documented.

The FDA also claims that the analysis of quality data, such as complaints, was not adequately performed to identify or detect quality problems. No formal Corrective And Preventive Action (CAPA) was initiated or implemented, when appropriate, and no verification of effectiveness was performed. The FDA goes on to say that management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organisation.

Not addressing user needs

Finally, the intended patient population of affected ventilator devices are individuals requiring mechanical ventilation, that potentially lack typical and healthy lung and bodily functions. However, the FDA observed that Philips’ health hazard evaluation documented typical and healthy lung and bodily functions and did not conform to or address the user needs of the intended patient population of these ventilatory medical devices, including patients with a tracheostomy or that lack typical and healthy lung and bodily functions.

So, what can we learn from this?

Companies need to be in control of their product safety and recall processes, before and after market launch. For that purpose, the list of observations could easily be used as a (non-limitative) checklist. For example, ask yourself the following:

Do you have an adequate risk analysis procedure in place?
Do you have a CAPA procedure in place?
Do you have proper design validation procedures in place, considering the intended users and use?
Do you have a proper complaint system in place?
Does the executive management team take ownership of product compliance and safety within your company?
Do you have proper procurement procedures and supplier agreements in place?

I would like to add another observation. Respironics Inc. was acquired by Philips in 2008 for US$5 billon. The affected products were sold from 2009. We can only guess if the product design and safety processes of Respironics were assessed during due diligence. If only Philips could turn back time. However, they must still invent a machine for that…

Blog in Bike Europe: Why a ‘stop using your bicycle immediately’ recall should be rare

By Rutger Oldenhuis

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.

According to an official of the UK’s Driver and Vehicle Standards Agency, “the ‘top level’ of recall is known as a Stop Drive Recall. This is where affected vehicles should not be driven. These are very rare and are akin to aircraft being grounded.”

General rule for other industries

So, while a Stop Drive Recall is ‘very rare’ in the automotive industry, for other non-food products and certainly for bicycles, a ‘stop use immediately’ instruction seems to be the general rule. Remarkably, in the USA, the CPSC recently adopted an internal policy, according to which manufacturers are, by default, requested to consider offering end-users a full refund. Based on my experience, you need robust argumentation to convince the CPSC that other corrective actions are more appropriate.

For end-users and manufacturers, the instruction to immediately stop using a bicycle can be quite onerous. Consumers may need their bicycle to commute, and manufacturers may need time to ensure sufficient replacement parts are in stock and resources available to start a repair programme. Furthermore, a full refund for a bicycle that can be repaired really seems disproportionate and would definitely not meet the sustainability goals of the EU Green Deal.

‘Serious risk’

We can assume that ‘serious risk’, by definition, has a similar meaning for a car, a bicycle, or any other product. According to the EU risk assessment methodology, if we take the highest severity injury level (level 4), there is a ‘serious risk’ if the probability of damage during the foreseeable lifetime of a product is more than 1/10,000. A car recall may easily involve hundreds of thousands, if not millions, of cars. A quick math tells us that in the event of a serious risk, between the announcement of the car recall and the repair, many (new) incidents could have already occurred. Yet car owners are not instructed to stop driving their cars. To put things into perspective, not many bicycle or component recalls will affect more than 10,000 products. However, manufacturers still need to tell their end-users to stop using their bicycles immediately.

Why the difference?

We may wonder why market surveillance authorities treat similar situations differently. Of course, we understand the practical implications of not being able to drive a car anymore. Still, as mentioned before, the same goes for bicycles and other vehicles that are used daily for commuting. And when do you ever see a car manufacturer offering end-users a full refund?

We can only guess why cars are compared to aircraft when it comes to recalls. Perhaps it’s their notoriously strong lobbying forces? Of course, serious safety risks call for quick and proper corrective action, but what car recalls tell us is that a Stop Drive Recall in the bicycle industry often seems disproportionate and excessive and should therefore be the exception rather than the rule. Perhaps it is time for the bicycle industry to compare itself more to the car industry. Aircraft will be the next step.

Dit blog is geschreven door Rutger Oldenhuis LLM, oprichter van RecallDesk en specialist in product veiligheid en product recalls. Het blog is eerder gepubliceerd in Bike Europe Magazine. U kunt de blogpost ook online lezen op Bike Europe (lidmaatschap is soms vereist).

Interview met oprichter RecallDesk in SGI Europe

Op 13 mei 2021 heeft SGI Europe een interview gepubliceerd met Rutger Oldenhuis, de oprichter van RecallDesk:

New RecallDesk eases burden of product recalls in Europe

The expensive product recall at Peloton Interactive, which is expected to lead to extraordinary charges of $125 million for this fast-growing American home fitness equipment company, is sending out a strong signal that the sporting goods industry must be bet- ter prepared to face similar issues, partly because the technology behind the products is becoming more and more sophisticated.

RecallDesk, a new company based in the Netherlands, claims to be the first specialized service provider in Europe that can help suppliers and importers in the broader consumer goods sector to prevent or minimize similar losses through its legal, risk management or operational support.

According to the OECD, which has its own recall portal, the sporting goods industry, including the now booming bike segment, is the fifth-largest issuer of product recalls issues on a list led by the toy and automotive industries.

Rutger Oldenhuis, the 46-year-old lawyer who is running the new company, has gathered a lot of experience in this area as the head of Shimano Europe’s legal department for more than 16 years. He has also been a vice chairman of the legal committee of the World Federation of the Sporting Goods Industry (WFSGI).“Recalls always happen when it’s least expected,” says Oldenhuis, recommending prevention as the best possible methodology to avoid serious consequences. Besides taking product compliance seriously, he proposes that any consumer goods company should prepare in advance a “recall plan” that would include a detailed recall procedure in case it is required, with a checklist and a communication template, pointing out that even national importers must adhere to certain safety standards.

“A well-conducted recall may not harm your brand, but instead even increase your customers’ trust,” he adds. A recent survey conducted by the European Commission shows that 54.4 percent of consumers have raised their level of confidence in a brand or a retailer after learning about a product recall. In addition, 63.5 percent of them have started paying more attention to product recalls after such an experience.

Typically, a generalist law office takes care of product recalls, but its intervention may not have the best possible effects because of limited expertise in the area. As the Peloton case shows, a recall may hit a company’s P&L badly and yet not many companies seem to be aware of the possibilities to recover substantial recall costs. For example, in certain Euro- pean countries such as Germany and the Netherlands, they may be subject to recovery based on statutory insurance law. RecallDesk can advise on recovering recall costs and conduct an audit of a company to optimize its liability insurance. RecallDesk is building up a pan-European network of experts in this area.

RecallDesk can also jump in to advise a company on how to mitigate the effect of a product recall when it becomes inevitable or when it is hit by a consumer complaint on a safety issue, taking eventually the lead in managing the recall. In most instances, Oldenhuis says, a voluntary recall is better than a mandatory recall ordered by national consumer safety protection authorities, where the European Commission subsequently takes action on a wider scale. In Europe, voluntary recalls are generally done in nine out of ten cases, but they are not as widely publicized as in the U.S., where the Consumer Safety Protection Commission (CSPC) has a louder voice.

More information is available on www.recalldesk.com.

Successen bij claims recallschade

De afgelopen 1,5 jaar heeft RecallDesk met succes meer dan €300,000 recall schade geclaimed voor zijn klanten. Veel bedrijven die met een terugroepactie worden geconfronteerd, weten niet dat ze hier recht op hebben. Laat staan hoe ze er aanspraak op kunnen maken. Het zal u verbazen welke schade en kosten kunnen worden gevorderd. Neem contact op met RecallDesk als u meer wilt weten over de mogelijkheden, ook als u (recent) een recall hebt uitgevoerd.

Contact: info@recalldesk.com

Liability in case of e-bike battery fire – Eurobike 2022 Presentatie

Rutger Oldenhuis, oprichter van RecallDesk, zal tijdens Eurobike 2022 /Eurobike Academy een presentatie geven over “Liability in case of e-bike battery fire”.

Battery fires are an increasing concern in the bicycle industry. Product safety and liability are closely linked. This lecture will give insight on questions like ‘who within the supply chain is liable for a battery fire’, ‘can liability be excluded’, ‘what if a consumer did not follow the user instructions’, ‘what if the battery was refurbished’, ‘what if the cause of the battery fire could not be determined’, ‘how do insurance companies look at the risk of batteries’, and more.

Rutger Oldenhuis is an experienced and seasoned lawyer, holding a master degree in both civil and tax law. He has been Head of Legal of Shimano Europe for almost 17 years. In April 2021 Rutger became an independent legal consultant and founded RecallDesk, which is specialized in product safety and recalls.

Categories	Workshops & Presentations , EUROBIKE ACADEMY
Date	July 13, 2022, 3 p.m. – 3:45 p.m.
Location	Portalhaus: Room, Transparenz 1
Speaker	Rutger Oldenhuis

More Information

Presentatie: Do you Recall? RecallDesk in samenwerking met ProductIP

Op 17 mei 2022 geeft RecallDesk een presentatie met als titel “Do you Recall?” in het kader van ProductIP‘s Compliance Tuesday.

Een product recall kan grote impact hebben op uw onderneming. We gaan het hebben over best practices op het gebied van product recalls, waarbij o.a. de volgende onderwerpen aan de orde zullen komen:

– Wat kunt u doen om een recall te voorkomen?
– Hoe kunt u zich op een recall voorbereiden?
– Tips voor het managen van recalls?
– En als het u toch overkomt, wat kunt u doen om de impact te beperken?

About ProductIP’s Compliance Tuesday

For any serious company involved in manufacturing, retail and trade of non-food consumer goods, product compliance has become an integral part of their operation. To support you with this substantial challenge ProductIP organizes since 2012 Compliance Tuesday sessions where experts offer you insight in regulatory changes, a potential impact on your business, and how to deal with those.

Visitors to Compliance Tuesday confirmed that it brought them knowledge and a valuable extension of their professional network. Access to Compliance Tuesday is free, reservation is required. Compliance Tuesday sessions are also open for non-ProductIP-users.

Deelname

17 mei 2022 || English – Zoom | 11:00 – 12:00 || NL – Live | NL 13:45 – 15:30

Presentatoren: Rutger Oldenhuis || RecallDesk & Caspar ter Horst || ProductIP

Deelnemen