How to spot hidden or emerging issues for your products: top 3 takeaways

Identifying and resolving unexpected challenges of products evolving into additional regulatory areas.

The first in our new Product Compliance Corner series, the How to spot hidden or emerging issues for your products webinar detailed how to identify and predict upcoming challenges for products which cross sectors, therefore having to comply with multiple regulatory requirements.  

Our expert speakers Stacey Bowers, Global Product Compliance Manager; Nidia Calvo, Americas Managing Analyst; and Nhat Nguyen, Chief Analyst – discussed how to navigate regulations for ‘Frankenstein’ products, shared tips and advice on product stewardship, and outlined approaches to avoid blind spots in compliance.  

Read on for our top takeaways.

Know your product

Though it may sound obvious, the first step to identifying hidden issues for product compliance is for manufacturers to really know “the full extent of [their] product”, Nidia Calvo begins. Manufacturers need to outline the scope of their product, detailing all its functions to dictate which sector(s) it falls into. Knowing the individual chemicals and components involved in its design, and “how the trends” will impact its position on the market. 

Stacey Bowers recalls that there are considerations for standards on inclusivity, depending on the intended user of the product. For example, ISO standards for products intended for people with disabilities or the elderly address ergonomic factors, so “all abilities and ages can use the product in a safe and effective way.” With an “ageing population living longer than previous generations… it changes the potential parameters for the product use, [including] how long we expect it to be used, and by whom,” Stacey says.  

Regulatory authorities help businesses understand if their product is aimed at a specific target audience, like children. In the US, the CPSC defines a children’s product as “a consumer product designed or intended primarily for children 12 years of age or younger.” The CPSC considers the following, which businesses can also employ to help categorize their product: 

  • The labeling which details its intended use 
  • Whether the packaging, display, promotion, or advertising of the product represents it as for children 
  • Whether the product is commonly recognized as being for children. 

There are additional safety factors to consider, Stacey continues: “will they play with it, smash it on the ground, stick it in their mouth? Does it break into little shards? Is their lead or cadmium in the paint?” 

For all products, but particularly those targeting certain age groups, manufacturers need to scrutinize the materials present. To avoid the risk of non-compliance further down the lifecycle, businesses should consider if the materials are permitted in all countries they hope to go to market in, if they will be banned in the future (such as the emerging restrictions on PFAS), and if they need to be prematurely removed from the manufacturing processes. Creating futureproof products avoids recalls and revenue loss.  

To ultimately dictate how a product is regulated, government regulatory authorities would ask the following: 

  • What are the product’s features or functionality? 
  • Does it contain chemical substances, and are they to be released during the product’s use? 
  • Has it been treated with biocides or pesticides for cleaning? 
  • How is it powered: by a battery or charger? 
  • Does it use Wi-Fi or Bluetooth? 
  • Are there lasers inside? 
  • Is it powered by an app? 
  • Is there a display panel? 
  • Does it come with accessories, like cases and earbuds? 

Know what you’re manufacturing, from the materials in its composition to its functions and intended use, and businesses will avoid the risk of compliance gaps and blind spots when pushing their product to market in various countries.

Anticipate the impact of Frankenstein products

Frankenstein products, as described by our Enhesa Product Intelligence experts, is “the idea of products that have added new and emerging technologies or functionality” which covers more than one sector. “The more features or functions you add to a product, the more complex the regulatory requirements may become,” Stacey warns.   

Stacey gives refrigerators as an example of a potential Frankenstein product. They’ve “been made the same way for the last 100 years, but [some] now have the addition of a camera inside to show you whether you’re out of milk.” Where the fridge itself must meet standard regulations for kitchen appliances and electronic safety, the extra feature also means manufacturers must meet compliance standards for cyber security and data protection. Regulatory authorities will question whether the appliance can be hacked from a phone app, for instance, opening up possibilities of data insecurity, where hackers can learn about the user and their finances. “As technology gets more sophisticated… it opens up new complexities to the way products are regulated,” Stacey says.  

Other Frankenstein products could include: 

  • Medical cots for ambulances these have to meet regulations for mattresses and bedframes, as well as Wi-Fi and Bluetooth to send patient health data, which additionally springboards into cyber security and data protection requirements 
  • Smartwatches – if these are marketed as counting steps, monitoring heart rates, and reporting on sleep, not only do they have to meet standard requirements for jewelry and heavy metals, but also medical regulations  
  • Tractors and machinery – with the addition of cameras, Wi-Fi and Bluetooth, machinery has to pass electrical safety regulations, radio and telecommunications, cyber security, data protection, and WEEE 
  • Manual versus powered toothbrushes – a manual toothbrush will follow standard safety rules, but a powered toothbrush will also be subject to charging radiofrequency requirements, battery regulations, mercury restrictions and EPR, restrictions on lead and phthalates, and also possibly CPSC requirements for sharp points and small parts and Reese’s Law for button safety for toothbrushes marketed towards children

Survey the geographical landscape

Lastly, our experts remind listeners that the geographical landscape will have a decisive impact on the product’s ability to go to market. 

Firstly, manufacturers should identify where the product will be imported, distributed, marketed, and sold. Some of the most onerous, “meaning having significant regulations or standards”, countries include Europe (particularly France), China, South Korea, and many US states, including California, Maine, Minnesota, and New York. Manufacturers may find that while they comply with EU regulations on their products, specific nuances in France could trip them up, Nidia notes. In countries without a generic structured framework, our experts recommend having a chemical framework which follows US TSCA or REACH to cover the foundation for other countries.  

Further, our expert Stacey warns of potential conflicts in jurisdictions that “will have a significant impact, or desire, on your ability to market,” such as political uproar in two countries. Some countries may refuse to do business with each other, and this is something manufacturers must be aware of before distributing their product. 

Our experts have observed industry professionals undertaking some different approaches to manage the potential conflicts of operating in multiple jurisdictions, including: 

  • Taking the most conservative approach globally 
  • Taking a regional approach (Americas, EMEA, APAC) 
  • Take a country-specific approach

Managing the complexity of product compliance

In summary, our experts shared their compliance checklist for manufacturers to consider when pushing products to market: 

  1. Know your product 
  2. Survey the geographical landscape 
  3. Consider applicable policy areas 
  4. Anticipate the impact of ‘Frankenstein’ products 
  5. Share your knowledge 
  6. Consult trusted external resources 

To uncover where to find the required information for compliance, businesses need to know “the main things to look after and focus on,” Nidia says. It “all goes back to your product definitions and what your product is,” Nhat Nguyen concludes.

Maintain product compliance

Watch the full webcast recording for access to this insightful conversation between our experts.

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