Long Fill Aroma
Testing long fill products meet General Product Safety Regulations (GPSR) 2005 and other unique regulatory compliance, which sets them apart from short fills
Long fill aroma products are nicotine free flavoured e-liquids and are also known as long fills or aromas. The flavoured e-liquids are designed to be vaped in e-cigarettes and are sold in smaller 10ml, 20ml, 30ml and 60ml bottles.
In Europe, long fills are becoming increasingly popular because consumers can change the flavour of the product by adjusting the ratio of propylene glycol (PG) to vegetable glycol (VG) in the base liquid to suit their own personal tastes.
Long fills are not directly covered by the Tobacco Products Directive (TPD) in most countries, except for Austria, Netherlands and Greece. Their safety is covered by the General Product Safety Regulations (GPSR) 2005, which also covers zero nicotine short fill products.
As there are high levels of flavour concentrate in long fill aroma products, Safety Data Sheets (SDS) are required – they must comply with the new REACH regulation EC NO 1907/2006 Annex II of 2019. Also, from December 2020, long fill e-liquids need to be notified on the European Chemicals Agency (ECHA) Poisons Centres register.
The General Product Safety Regulations (GPSR) 2005 governs the safety of short fill or zero nicotine products. Regulation 5 states, ‘No producer shall place a product on the market unless the product is a safe product.’ (Supply and possession is also covered in this.) A safe product is defined in regulation 2 as, ‘…does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons…in particular….the effect of the product on other products..’
‘Reasonable consumer expectations concerning safety,’ in regulation 6 indicates that the standards for e-cigarette liquids should be applied to short fills. Additionally, where a product is not directly regulated under its own regulations, they should be assessed to the nearest harmonised standard – which in this case is the Tobacco Products Directive (TPD) legislation.
Failure to ensure short fills or zero nicotine e-liquids comply with GPSR 2005 could result in a £20,000 fine or imprisonment for up to three months. The only defence is to be able to show all reasonable steps were taken and due diligence was exercised.
Trading Standards and the MHRA agree that short fills or zero nicotine products need to be reviewed in accordance with TPD, and undergo a full technical assessment. Some companies offer a risk-based approach to short fill testing. A thorough detailed analysis of products is required in order to sell products safely and legally. Note: If we have tested your long fill product under TPD (providing there is no formulation change) we can list it as a zero nicotine product at a reduced administrative charge.
We undertake your emissions testing in-house from our own laboratory to current standards. Our recently upgraded laboratory has the potential to cover the most rigorous requirements of the FDA and PMTA requirements in the United States, giving us the full capability of emissions testing to all global requirements. In preparation for future global standards, we have recently invested into updating our laboratory as we move from High-Performance Liquid Chromatography (HPLC) to Gas Chromatography Mass Spectrometry (GCMS).
Making science simple: So, what’s the difference between HPLC and GCMS? In brief, GCMS provides more robust methodologies. To compare, in a non-science world it’s the difference between having an Android phone or an Apple phone. Hope that helps! Our tests analyse emissions for aldehydes, volatile organic compounds (VOCs) and other stipulated derigants. We profile over 750 chemical components!
Due to the high levels of flavour concentrates that involve unique labelling requirements, long fill aroma products require Safety Data Sheet (SDS). Working to the very latest standards, our fully trained and qualified staff will provide you with new approved Safety Data Sheets (SDS). They are available in all languages of the EU and others from around the world. Our SDS comply with REACH regulation (EC) No 1907/1148 Annex II, 2019.
We have developed a risk-based approach to toxicology assessments where compounds are assessed at each stage to ensure we can be confident in their safe use. If there are red flags on a basic toxicology assessment, we are then able to undertake a detailed exposure related toxicology assessment that allows us to put our support behind products that might otherwise appear to be borderline.
In our formulation review, we access data from all of the major flavour houses and review your formulations for safety and efficacy, as above. Please note that if a constituent is banned under TPD , it is not allowed for zero nicotine short fill either. We will also check your packaging for compliance with Classification, Labelling and Packaging (CLP) in the same way.
We conduct a full TPD grade emissions test, which we benchmark against our known history of samples to ensure that no products likely to degrade are being generated at high levels. At a later date, if you decide to update and notify your product as a nicotine containing product, we are able to upload the information quickly and easily as the in-depth work has been completed.
Our testing comes with complete assurance with our highly regarded compliance pack and certification. This allows our clients to demonstrate to wholesalers and distributors that they have undertaken rigorous testing to ensure their products are of an excellent standard.
We list our clients products on our own zero nicotine directory – zero.expert. This is used by Trading Standards and the MHRA to check which products are compliant.
Please note starting in December 2020, long fill e-liquids will need to be notified on the European Chemicals Agency (ECHA) Poisons Centres register.
Companies around the world have trusted ADACT with their regulatory compliance.
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