Developing a new consumer product? Maybe you’ve come up with the hottest new gadget or e-liquid flavour and are eager to get the product out to market as soon as possible…

Prior to mass production, a safety evaluation is key. A preliminary screening assessment of the component ingredients during early development could save you a lot of time and money further down the line.

The general safety assessment process

Manufacturers invest considerable hard work, time and resources in innovating and developing new consumer products. Bringing these products to market is an equally demanding task. Take Electronic Nicotine Delivery Systems (ENDS) and e-liquids for example. Whether you are planning on selling your brand new and exciting e-liquid in the UK, EU or USA, some form of safety assessment is essential. In the initial phases of the safety assessment process, a crucial step is the human health hazard review. These reviews examine each component ingredient of the e-liquid formulation. Following this, testing may be conducted on the e-liquid itself (e.g., to detect impurities and monitor stability) as well as the emissions that are formed in the aerosol, and a health risk assessment would be undertaken. As you might expect, these processes are time-consuming and expensive.

A spanner in the works

Let’s imagine that your new product looks really promising and you are ready to begin the process of bringing it to market. In assessing its safety, perhaps somewhat hastily, you commission a series of expensive analytical tests to chemically characterize the product. Additionally, you hire toxicologists to evaluate the results and conduct health risk assessments. You may have even gone ahead and designed the packaging, planned the marketing, and the sales team have potential buyers eager to purchase. Discovering that the product is unsafe during this process, due to a problematic component ingredient, would be devastating. Having to go back to the drawing board at this stage is clearly a real set-back, especially as the costly testing that has already been conducted may no longer be fit-for-purpose.

Avoid costly mistakes

The good news is that this costly scenario can easily be avoided by performing a screening assessment of the component ingredients during the product development phase. This simple but effective process is a cost-effective means to give your product the best chance of passing the safety assessment and reaching the market.

Which ingredients could case problems?

Some chemicals may possess undesirable toxicological properties (i.e., hazards) that could pose a health risk to consumers. Certain hazardous chemicals are therefore not permitted in consumer products. For example, consumable products like e-liquids should not contain any chemicals with Carcinogenic, Mutagenic or Reprotoxic (CMR) properties. Other ingredients are outright banned; for example, diacetyl (which imparts a buttery flavour) is banned for use in ENDS products as inhalation of this carbonyl compound has been known to cause lung damage. This also highlights another important consideration – the intended route of exposure. Ingredients like diacetyl and acetaldehyde may be Generally Recognised As Safe (GRAS) as food additives in the USA, but the intake of these respiratory toxicants in inhalation products might pose a health risk to consumers.

Bibra's screening process

To identify such substances of concern, our team of toxicologists routinely conduct hazard screening assessments of ingredients by identifying human health classifications, consulting the key toxicity data and, where needed, performing (Quantitative) Structure-Activity Relationship ((Q)SAR) analysis to predict certain hazards (e.g., sensitisers). This exercise will alert you to substances of concern.

Therefore, conducting a screening assessment early in the product development stage holds immense value for manufacturers. If safety concerns have been identified, reformulation would be relatively straightforward and inexpensive. Or, if no chemical ingredients are flagged as a concern, then companies can have more confidence in advancing their products further towards market.

In summary, incorporating a early screening assessment of component ingredients is not just a step, but a strategic move in product development. This approach not only mitigates the risk of late-stage setbacks but also helps ensure the safety and viability of your product, ultimately safeguarding your investment, reputation, and consumer trust. By getting toxicologists involved from the outset, manufacturers can navigate the complex landscape of product safety with greater confidence and efficiency. Remember, in the dynamic world of consumer products, the early identification of potential hazards is not just about compliance – it's about commitment to excellence and consumer well-being. Get the toxicologist involved early on! To learn more about our screening process, contact us today.

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