Analytical Data Methodology
Emissions testing on each of your flavours (and sometimes every SKU) is essential for product stewardship and general due diligence. A good lab partner will be able to create a strong methodology that will demonstrate due diligence in the fact, that you understand what’s in your products and that you take consumer safety seriously.
Having a system and benchmarks in place to ensure consistent dosing of nicotine within your products is also essential. There are slight tolerances, but not a great deal. If you use a co-packer to manufacture, make sure you are aware of their systems and have them noted within your own quality management systems to make available when requested.
Ensure you have the methodologies for emissions and nicotine consistency on file as these are an essential aspect for formal notifications as well as good practise. Certain countries specify the methodologies that they require, so it’s important to know the nuances between member states and ensure your product files reflect these differences.
As you would expect, most regulations require you to obtain your testing reports through laboratories that are not affiliated to the tobacco industry or that you have a commercial interest in. If you have conducted your testing internally or through labs that you are invested in then your notifications are likely to be invalid.
Your toxicology studies are made up from your final recipe. Each of your flavour concentrates are made up of chemicals. In some cases hundreds of chemicals in fact. You will need to source all available relevant studies within the key groups of CMR, Cardiopulmonary, Addictiveness, Emissions and Other.
Toxicological Risk Assessment
Your toxicological studies are only part of your obligation. Whilst the studies are required to be submitted with your notification, you are also obliged to ensure your product poses no risk to the consumer. To get any idea of this without clinical trials you should commission a toxicologist to conduct a thorough risk assessment of each product.
Stability testing is not currently a requirement for the EU TPD, but it certainly adds depth to a product stewardship program. Having solid evidence of the life of your product could prove useful in any investigation with an official regulator.
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