Electronic Cigarette Industry Trade Association

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Summary of British Standards Institute PAS 54115

Summary of British Standards Institute PAS 54115

29, Jul, 2014
PAS providing a guide for the importation and sale of electronic cigarettes and directly related products, with product safety testing methods
 
This summary document is provided to allow industry and other stakeholders, or parties of interest, to have a preview of the sort of provisions ECITA has put forward as the base document for the PAS to the British Standards Institute. We hope that this will enhance the robust public processes which the BSI will be engaging in as the PAS progresses towards publication. The PAS itself will change as the process moves ahead, but this summary is broadly representative of the base document we have submitted to BSI.
 
Please note that this summary only covers the main points from the PAS, and the numbering of this document is not the same as that for the PAS itself. Please also be aware that British Standards documents do not contain legal requirements; the assumption is made that any and all legal requirements will be complied with, as a matter of course, so this PAS – as with all other British Standards – is a ‘best practice’ model. That said, Trading Standards has indicated that they will seek to enforce the PAS recommendations, to ensure a high level of consumer protection.
 
1.    Scope:
 
The purpose of this PAS is to specify guidance for manufacture, importation and sale of electronic cigarettes and directly related products (“Vaping Products”, “VP”), and testing methodologies. It gives guidance on the manufacture and testing of these products.
 
The PAS addresses two audiences: It is applicable to manufacturers and distributors of VP in the UK, and gives guidance on best practice for commercial operations in this sector. The PAS is also intended for laboratories and testing houses engaged in, or planning to be engaged in, the testing of VP, and will define parameters for the test solution, for the test bed atomiser, for the method used to operate VP to gather emission samples, the method and materials for gathering such samples, and an outline for the analysis itself.
 
This PAS is not intended to cover VP which are licensed as medicinal products.
 
2.    Terms, Definitions & Abbreviations:
 
There is an extensive list of terms, definitions and abbreviations included in the PAS. Most of these will be obvious to anyone connected with this sector, but for clarity, the following terms have been defined as follows in the first draft:
 
diluent
 
base liquid used to dilute concentrations of nicotine
 
electronic cigarette (ecig)
 
device which utilises battery power to heat an atomiser to transform eliquid into an aerosol vapour for inhalation
 
excipient
 
base liquid used to create eliquid to which nicotine may or may not be added
 
free eliquid
 
eliquid supplied in packaging separate from hardware
 
hardware
 
devices for use with eliquid but which may be supplied without eliquid
 
pre-filled ecig
 
device for inhalation of eliquid aerosol where battery, atomiser and eliquid cartridge form a composite whole, or where pre-filled replacement cartridges are designed only for use with the original device (commonly referred to as ‘1st generation’ products)
 
refillable ecig
 
device for inhalation of eliquid aerosol which utilises a tank system for holding eliquid, and which tank can be refilled from provided and/or separately purchased eliquid (commonly referred to as ‘2nd and 3rd generation’ products)
 
small vendors
 
small manufacturing business with fewer than 3 employees, producing niche and/or artisanal vaping products for sale to the public and/or to resellers
 
substantial modification
 
changes to products which materially alter the consumer risk profile (CRP)
 
vaping products (VP)
 
term used to describe the wide range of products in the sector as a whole, and which includes both nicotine and non-nicotine containing products
 
(Please note that there are many more terms defined, but the ones not listed here would be relatively obvious to anyone involved in the sector. The same applies to the abbreviations.)
 
Abbreviations
 
TRA   Toxicological Risk Assessment
 
UBR   Unique Batch Reference
 
VP    Vaping Products
 
3   Vaping product safety and quality
 
The PAS recommendations cover:
 
Eliquid manufacturing facilities to ISO 9001, plus food hygiene standards as a minimum
 
  • Personal Protective Equipment
  • Traceability of all ingredients throughout the supply chain
  • Proper batch control, to reduce the negative impact of product recall procedures, should these become necessary
  • EP/USP grade diluents (PG/VG) and nicotine, with supporting documentation including Certificate(s) of Analysis and Certificate(s) of Conformity
  • Base liquid nicotine concentration verification before manufacturing finished eliquids, by titration, isotope dilution analysis, or other suitable method
  • Food grade for flavourings, whether natural or artificial, except naturally-extracted tobacco flavourings (including Tobacco Absolute). (NB: Excipients used for these products should be of EP/USP grade, with supporting documentation including Certificate(s) of Analysis and Certificate(s) of Conformity)
  • Natural extracts should be additionally subject to a TRA (see below), and removed from the manufacturing process if a problem is identified by the TRA. (Problem substances identified in this way may be added to the list of substances which should not be present in eliquid. See Figure 1 below.)
  • Product recall procedures to ensure that resellers all the way through the supply chain are informed immediately if a product recall is instigated
  • Lists the documentation manufacturers should have for each product (including hardware as separate from eliquids), such as information on ingredients, test reports, TRAs, etc., and outlines the requirements for Technical Dossiers (for each product)
  • Recommends a Toxicological Risk Assessment (TRA) for each chemical component of the ingredients and emissions (including from atomising hardware). (NB: It is not necessary to repeat TRAs for the same flavouring compound or other ingredient, so TRAs can be reused across a wide range of eliquid products which all use the same ingredients and/or flavouring compounds.)
  • Includes an exemption from emission testing for small mod-makers who make non-atomising hardware (i.e. mods that hold batteries)
  • Includes recommendations for substantial modifications to products (eliquids and/or hardware), to trigger a new Technical Dossier if the Consumer Risk Profile (CRP) is altered by the modification (unless for exempted mods)
  • Hardware manufacturing recommendations to ensure traceability for all components used in the manufacturing process, thus considerably reducing the negative impact of product recalls should these become necessary; also recommendations for cleaning of hardware prior to shipping/packaging to ensure that microbial contamination is minimised. (Exclusively hardware manufacturing facilities do not need to be to the same high standard as those for manufacturing eliquids.)
  • A TRA is required for each chemical component of the ingredients and emissions (including from atomising hardware)
  • Recommendations for testing frequency, dependent upon the type of product. These are designed to minimise the regulatory burden while ensuring a high level of consumer protection
 
4     Vaping product labelling, packaging and instructions
 
  • Draws attention to CLP requirements for concentrations over 2.5%
  • Advises the following for lower concentrations:
 
CAUTION:
 
Store locked up and out of the reach of children and pets
 
Only for use in electronic cigarettes*
 
Seek medical advice if you feel unwell
 
* Refer to device manufacturer for refilling instructions
 
  • Child-resistant and tamper-evident packaging
  • Marking/statement that sale is for over 18s only
  • Allergy warnings for nuts and PG (where appropriate)
  • Requires that device operating instructions including safety information for charging, safe storage and handling, and instructions on proper operation to facilitate effective use
  • Shelf-life should be indicated, and the product should remain within specification throughout the stated shelf-life
  • Bottles should be fitted with a delivery spout capable of accurately delivering refill liquid into the appropriate part of the atomising device without spillage
  • Recommendations about giving healthcare advice and/or warnings to consumers. If manufacturers wish to include these, this should be simply stated as: “If you have any concerns about your health when using this product, please consult your doctor or other healthcare professional.”
 
5       Vaping product claims
 
  • Provides guidance on not making medicinal or unprovable claims, and states that marketing must not be targeted at children or non-smokers
  • Provides guidelines on not making unsupported – and/or unsupportable – equivalence (to cigarette) claims
  • Provides guidance on hardware performance claims, to avoid confusion and disappointment for the consumer
 
6     Testing methodologies
 
  • Provides information on what should be tested for with quantification (exact measurement of levels present): nicotine, formaldehyde, acetaldehyde and acrolein, as well as diacetyl (and related ketones) and 2,3 pentanedione. Other constituents may be measured from peak area (considered to be semi-quantitative)
  • Levels of tin, silver, lead, mercury, cadmium, nickel and chromium should also be measured, as should silicon, as a proxy for the amount of wick particles. (If silicon levels are high, a more rigorous investigation of wick structure and durability should be carried out)
  • In order to avoid the problems of automatically activating the wide range of manual batteries, the output under load of a battery/atomiser combination should be measured, and this voltage replicated using a bench power supply. This may then be automated easily. (A suggested method for this is also provided)
  • For atomising hardware supplied without liquid, a test solution of 78% PG, 18% VG, 2% water, and 2% nicotine is suggested
  • Atomising devices should be tested at a range of power outputs
  • A solvent trap is suggested for collecting the emitted vapour
  • The use of control measurements is required to minimise environmental effects on measurements
  • A test bed atomiser is described in detail, for testing liquids supplied separate from atomising hardware (See CAD annexed hereafter)
  • It is recommended that pre-filled devices be tested as composite units for the emissions testing of the eliquid and hardware
A ‘blacklist’ of eliquid components is suggested:
 
 
  • Where atomising hardware is supplied without a battery, it is suggested that it is tested at a range of power levels to determine a safe operating range
  • Batteries and chargers should be tested in combination to ensure that appropriate charge voltage/current is applied, and that charging stops when the battery is fully charged
 
 
Annex 1 – Computer Animated Design for Test Bed Atomiser
 
 Please note: We are in the process of having a prototype test bed atomiser built, and it is likely that some of the measurements will change. As soon as we are able to update this CAD (should this be necessary), we shall publish the updated version.
 
 
 
 
 
 
 
 
 
Annex 2 – Method for Coiling the Wick for the Test Bed Atomizer
 
Equipment
 
1.5mm diameter silica wicking material
 
0.2mm diameter 80/20 nichrome wire
 
1.2mm diameter stainless steel (316) coiling rod, at least 50mm in length, preferably 100mm
 
Test Bed Atomizer
 
A cross-headed screwdriver, to fit a pan head M1.6 screw
 
Care should be taken not to introduce contamination to the wick and/or coil during construction. Care should be taken not to pull the silica wicking material when situated in the coil, as this can cause damage to the wick.
 
Method
 
1. Cut silica wicking material to 100mm length.
 
2. Cut a 150mm length of nichrome wire.
 
3. Fold the silica wicking material in half and hold in line with the coiling rod.
 
4. With both the coiling rod and silica held firmly between thumb and index finger, place wire across the coiling rod and silica at a 90° angle, in the middle of the doubled up lengths of silica, leaving a minimum of 30mm over hanging. Slide the wire under thumb and hold firmly.
 
5. With an even tension, tightly wind the wire around both the coiling rod and silica to form a 4 turn coil. Making sure the ‘tails’ of the wire finish on the same side. (Make sure that the coil turns are evenly spaced and are not touching each other.)
 
6. Slide the coiling rod out from inside of the coil, leaving the silica wicking material inside the coil.
 
7. Unscrew the positive pin (center) a few turns and wrap one of the coil ‘tails’ tightly between the underneath of the screw head and the top of the positive pin, one full turn clockwise. Make sure that the coil is close to the pins. The centre coil turns around the wick should not be touching the pins.
 
8. Repeat step 7, using the loose ‘tail’ and one of the negative pins. (Make sure that the coil keeps its shape and that the coil on situated to the side of the 2 pins).
 
9. Gently tighten both screws so that the coil is secure. (Be careful not to over-tighten the screws, causing the coil to become misshaped).
 
10. Cut excess wire off the tails, so they do not protrude from the pin.
 
11. Check the resistance of the coil, using an appropriate multi-meter. The range should be 2.0Ω ±0.1. (If the resistance falls outside of this range, you will need to discard the wick and coil and start from step 1.)
 
12. Place the test bed atomizer on the stand. Gently cut the loop on the silica wicking material, creating two equal ends. Ensure all of the wicking material is inside the base well and is touching the base.
 
13. Using a 1 ml liquid sample, fully saturate the silica wicking material and then place the remainder of the sample into the well in the test bed atomizer.
 
14. Visually inspect the coil when heated during a 2 second activation, to ensure no sections of the coil glow orange/red. If this occurs a new wick and coil should be constructed.
 
15. Replace top cap, ensuring no wick is caught in the threads.
 
Begin test.
 
 
 
We trust that as many industry colleagues as possible will want to engage in this process, as well as any other affected stakeholders, including test houses. Do please contact us if you have any comments or suggestions relating to this standard.