An alternative to the TPD?

Will ECITAs Publically Available Standard (PAS) be suitable?

Most people will be reading about pre-implementation of the TPD in Sweden and Denmark over the past week or so among the vaping community social media. It can clearly be seen that Sweden have taken their interpretation to the most negative end with 100% medical route for e-cigs. As vapers or vendors and even manufacturers, we must consider what alternatives there will be, IF ANY.

For the time being, all vapers, vendors and manufacturers are looking toward Totally Wicked Ltd and their battle against the TPD at European Court level which is based on how legally flawed the process of creating Article 20 and attaching it to the TPD without correct legal consideration etc. I would expect that all readers have already supported Totally Wicked Ltd in their battle but just in case you have not yet, please pledge support at http://article20legalchallenge.com/ . While the legal battle is looking strong to make the EU Commission and Parliament completely rethink regulation of e-cigs and e-liquid. So, if the TPD is thrown out, what have we got?

Essentially we will have the same standards for e-liquid bottles and label requirements for hazard warnings etc. which are the minimum standards expected for all chemical product within the EU and the world. Is this amount of regulation enough? Can we suggest that having an e-liquid made in a kitchen or garage and bottled in a compliant bottle is what we are happy with? Most certainly would most definitely disagree. We must then consider what further sensible regulations could be put in place to ensure good quality and above all else, safe(r) e-liquid.

One route is the Publically Available Standard (PAS) 54115 which is being put together by ECITA. This has been in the making for some time and had a public consultation which ended in November 2014 and is due for estimate release in May 2015. The PAS is compiled by the industry in conjunction with the British Standard Institute (BSI), which is a world renowned body for industry and product standards. You may know BSI from certain industries or products by the “kitemark” which is an internationally renowned symbol of quality. The PAS is a set of standards for, on the whole, manufacturing of e-liquids. So what would this mean for the vaper, the vendor and the manufacturer? In one single word, QUALITY. It must be stressed that the PAS is industry wide applicable, if they want to work to it but it will not be enforced by BSI as in other industries.

As the product used by the vaper and sold by the vendor is made mostly manufacturers that we may never see. The vaper puts trust in the manufacturer to make a fantastic tasting product of a high quality. So what does the PAS mean for the manufacturer? Some say that it’s just Article 20 in another form, so lets break it down.

1 – Labelling & Packaging – The current state of affairs with labelling but changes to CLP requirements for nicotine concentrations below 2.5% which is in line with the reclassification of nicotine toxitity. 3 suggested “safety phrases” for all lower concentrations. There will also be familiar sights which vendors and vapers will know such as batch identification and information of shelf-life (e.g. an expiry date) and the current “OVER 18s ONLY” or similar phrase/symbol. Some vapers will have noticed that some e-liquids taste really good and have the CLP requirement but have no other information which can be used in a situation of complaint etc.

2 – Product Claims – Here we have what can be called “common sense” to avoid any claims worded in such a way that can infer that the e-liquid/hardware is medicinal in nature e.g. a smoking cessation product and avoid any working that suggests the e-liquid/hardware is aimed at children or non-smokers. This is where the current advertising standards, in the UK for example, as given by the CAP and BCAP in November 2014. There will also be guidelines on the dreaded “equivalence to cigarettes” or “puff equivalence” idea for e-liquid and 1st gen devices. If this claim is made, you must back it up. Claims about hardware performance will also be provided with guidance in order not to confuse nor disappoint end users. That’s you by the way!

Before we move on, it must be highlight that PAS 54115 may look suspect or uncanny to the TPD in what follows to some readers. Let’s have some more perspective, PAS 54115 regarding the physical manufacturing of e-liquid must be carried out to Food Hygiene Standards as a minimum. This means keeping any work area clean, tidy and keep cross-contamination to the least possible level, NONE! As you all know, there is nothing worse than having your candyfloss juice have an undertone of roast beef. The PAS also, at time of writing, does not indicate the requirement for pharmaceutical style environmental control, such as GMP or ISO classes for “clean rooms”. If the manufacturer believes that this route is for them then go ahead. For example, Digbys Juices work in an ISO Class 6 Clean Room environment. So what else is given as guidance on the e-liquid manufacturing?

3 – The Paper trail – ECITA suggests that manufacturer should work to aspects of ISO 9001. This is an internationally recognised Quality Management System. In other words, lots and lots of paperwork to back up everything you claim and produce. The aspects of ISO 9001 include:

• Traceability – making sure you can follow the path of a single ingredient through from supplier to customer.
• Batch Control – a batch code system in order to aid traceability and reduce the need for product recalls.
• Product Recall Procedures – if anything does go wrong with an ingredient etc there are instructions on what to do through the entire supply chain to resellers.

We’ll have documents which prove the raw material/ingredient quality. These are known as Certificates of Analysis/Conformity. This is to ensure that EP/USP grade PG,VG and Nicotine are used and can be proven to be as such.

4 – Other documents, Risk Assessment & Testing Methods – This is where the TPD may be seen by some of you. Keeping it as brief as possible, the PAS gives:

• Toxicological Risk Assessments – deciding how deadly an e-liquid ingredient is according to the chemicals it has in it and will also include emissions from a PAS designated “test atomiser”
• Technical Dossier – sounds daunting? It’s a collection of all documents about a single product e.g. Strawberry 1.2% (12mg/ml) 50PG/50VG 10ml will have test reports, supplier information, Risk Assessments all filed and stored together relating to that one product.
• Base Nicotine Testing – to be done before any manufacturing takes place. This is to ensure that your nicotine is of the % concentration which it says on the container when supplied or diluted in-house.
• Quantification of Black-listed Chemicals – EXACT measurements to be provided for all known “nastiness” like diacetyl and acetyl propionyl. This is highly likely to be done via Gas Chromatography-Mass Spectroscopy or other suitable methods( if you are an analytical chemist)

It must not be forgotten that ECITA, for its member companies, also provides advice on hardware but at this moment in time, ECITA only can only advise on plugs and batteries. The PAS, ensures that manufacturers of hardware ensure meet the aspects of ISO 9001 as mentioned previously and also suggests hardware should be cleaned before shipping and other suggestions. Further standards for hardware etc. will be suggested to IEEE by Richard Pruen, which will not be discussed here.

Now that you know what has been suggested by ECITA, which is now being finalised with approval of BSI and the feedback of a working group, do you think it is an appropriate set of rules for regulating of e-liquid manufacturing and selling? No opinion will be given from the writer of this piece but others have already given theirs during the consultation such as Clive Bates .

Information contained in this piece about PAS 54115 was taken from an ECITA Blog in July 2014 and is a draft version. Details are subject to alteration by the time of release of PAS 54115, however, we all hope that whatever it contains is sensible and reachable for all companies who want to be involved.