Edition #15 - How Product Categorisation Shapes Compliance and Risk

A key step in managing product risks is ensuring your business is correctly identifying which regulations and standards apply to your products. Many compliance failures and costly delays stem from overlooking or misunderstanding these requirements early on.  The first step in determining what is relevant is understanding the general regulatory product categories your product fits into.

Ensuring your business is correctly categorising its products makes it much easier for the relevant legal, safety, and performance requirements to be determined. It also helps in identifying where multiple sets of requirements might apply if your product fits into more than one category. This is an essential part of effective product risk management and ensures your business can plan ahead to meet all necessary obligations.

As products become more complex over time, they tend to enter additional categories. For example, a company might start with a simple mechanical product (machinery or consumer product) and later decide to motorise it (electrical and electronic equipment). They might then add a battery (battery product) and incorporate Bluetooth functionality (communications equipment). You can see how, as the product evolves, it spans more and more regulatory categories. When these additions are overlooked from a compliance perspective, the risk of non-compliance, and associated penalties or safety issues, increases significantly.

For a business to accurately determine where its product fits, it needs to be clear on who the customer is, what the product’s intended use is (and in what environment), and any specific claims made about the product. If you claim a product is, for example, “non-toxic”, “hypoallergenic “, “fire-resistant”, “clinically-proven” or “alleviates pain”, you can inadvertently be categorising your product in a way you haven’t intended. As an example, if you were marketing a walking stick, how you position and communicate that product will influence its category. If you promote it as an aid for a disability or for injury rehabilitation, it becomes a medical device or a therapeutic good. However, if it’s simply marketed as a general walking stick for fitness or leisure, with no therapeutic claims, it would be classified as a consumer product.

Regulatory categories do vary by market or the terminology may be slightly different, but these are some common categories that your products may fit into:

• Animal Feed: Substances or mixtures intended for consumption by animals to provide nutrition, support growth, or maintain health.
• Aviation/Aerospace Products: Aircraft, drones (often separately regulated), and all certified parts and systems used in flight.
• Battery Powered Products: Products containing batteries.
• Biocides: Any chemical substance or microorganism intended to destroy, deter, render harmless, or control harmful organisms by chemical or biological means.
• Chemicals / Hazardous Substances: Any substance or mixture (raw material or final product) with intrinsic hazardous properties (e.g., corrosives, carcinogens, flammables, toxins).
• Child Care Articles: Consumer products designed or intended primarily for children 12 years of age or younger.
• Communications Equipment: Electrical or electronic products that intentionally emit and/or receive radio waves for communication or location purposes (e.g., Wi-Fi routers, Bluetooth devices, mobile phones).
• Construction Products: Products manufactured for incorporation in a permanent way in construction works (e.g., cement, structural steel, insulation materials, plumbing materials).
• Consumer Products: Non-food, non-medicine products intended for use by the general public (e.g., clothing, household goods, DIY tools).
• Cosmetic Products: Substances or preparations intended for contact with external parts of the human body (e.g., skin, hair, nails) for the purpose of cleaning, perfuming, changing appearance, or correcting body odours.
• Electrical and Electronic Equipment: Products that require electric current or electromagnetic fields to operate, including household appliances, IT equipment, and lighting.
• Equipment for Explosive Atmospheres: Equipment and protective systems intended for use in potentially explosive atmospheres, such as environments with flammable gases or dust (commonly referred to as ATEX equipment).
• Fertilising Products: Substances or mixtures intended to supply nutrients to plants or fungi, improve crop yield, or enhance soil properties.
• Food: Substances intended for human consumption, including beverages and chewing gum, but excluding medicinal products.
• Food Contact Materials (FCM): Materials that are intended to come into contact with food (e.g., plastic containers, cutlery, coffee mugs, processing machinery surfaces).
• Gas Appliances: Appliances burning gaseous fuels for purposes such as heating, hot water, cooking, refrigeration, or lighting.
• Lifts: Equipment permanently serving buildings or construction sites, designed to move people or goods between different levels.
• Machinery: Products with parts that move via a drive system other than human or animal power. Typically designed to perform a specific function or task (e.g., industrial machines, agricultural equipment).
• Marine Equipment: Products intended for use on ships, subject to international conventions (e.g., SOLAS) (e.g., life-saving appliances, navigation equipment, fire protection systems).
• Measuring Instruments: Devices intended to determine a quantity, size, or other measurable property, often subject to accuracy requirements (e.g., weighing scales, gas meters).
• Medical Devices or Therapeutic Goods: Products designed to interact with the body for medical or physiological purposes, such as diagnosis, prevention, or managing body functions, but that do not rely mainly on drugs or chemicals to work (e.g., syringes, diagnostic kits, prosthetics).
• Medicinal Product: Substances or combinations of substances intended to treat or prevent disease, or to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action.
• Motor Vehicles and Components: Cars, trucks, motorcycles, trailers, and their essential safety-critical parts (e.g., brakes, lights, emissions systems, safety glass).
• Packaging: Products made of any materials used to contain, protect, handle, deliver, and present goods, from raw materials to processed goods, across the supply chain (e.g., bottles, boxes, pallets).
• Personal Protective Equipment (PPE): Equipment designed to be worn or held by a person to protect against health and safety risks (e.g., helmets, gloves, respirators).
• Pressure Equipment: Vessels, piping, safety accessories, and other components that operate under pressure, typically above 0.5 bar (e.g., boilers, pressure cookers).
• Pyrotechnics: Products designed to produce heat, light, sound, gas, smoke, or a combination of these effects through exothermic chemical reactions (e.g., fireworks, flares).
• Toys: Products designed or intended for use in play by children under 14 years of age.
  

That is in no way an exhaustive list, but you may already notice that your products fit into more than one category.
Another common pitfall, using our walking stick example, is when a product is initially classified as a non-medical device, but later, the marketing team promotes it for use in hospitals or for injury recovery. Even though the product itself hasn’t changed, its intended use and market positioning have, which can introduce significant compliance risks for the business. Ensure that your marketing teams understand that changing users, use environments or making specific claims can have regulatory implications.

The right categorisation ensures that your business can identify the applicable legal, safety, and performance requirements early in the process. Once you are clear on your product categories, you are in a much better place to accurately identify relevant product regulations and standards. Another activity that helps with this is your product risk assessment which we will look at in the next newsletter.