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Recommendations and guidance on the manufacturing of e-liquids e-cigarettes are now available from the British and French standard agencies. They will inform the European standard being developed by CEN. Once the EU standard is available, the other guides will be withdrawn.
A comparative analysis of the British and French guides, PAS 54115:2015 and XP D90-300-1/2 respectively, can help to shed light on what will be in the EU standard.
In development: The EU E-liquid manufacturing Standard
The following recommendations are common to both the AFNOR and PAS guides:
 these are also TPD requirements
 specifications for the refill mechanism are currently in development
The recommendations presented below are described in the AFNOR, but not the PAS:
In general, the PAS is more focused on the principles of GMP including competent personnel to be in charge of process controls, risk assessments and documentation. It also includes guidance on substantial and minor modifications (with examples) and advice for distributors.
Recommendations exclusive to PAS include:
An accurate nicotine content claim is a recommendation of both guides. However, PAS and the AFNOR take a different view on what the tolerance limit of the nicotine content should be.
AFNOR presents a margin of +/- 5% of label claim for e-liquids whereas the PAS states +/- 10%. Therefore,AFNOR, has tighter limits than PAS.
For e-liquids that have no nicotine, the AFNOR and PAS also do not agree on the tolerance limit:
AFNOR: 0.5 mg/ml PAS: 0.01 % w/v = 0.1 mg/ml
This time the PAS has the tighter limit.
This will be a point of discussion in the development of the EU standard and a tolerance will be agreed. As a point of reference, EU medicines typically have an active ingredient content tolerance of +/- 5%. US medicine regulations differ and active content tolerance is often wider than EU counterparts.
The comparative analysis has highlighted a number of recommendations that are common to both guides. It is likely these will go on to form the EU standard. It is difficult to predict which recommendations exclusive to the PAS or AFNOR will go into the EU version but it is thought AFNOR will be more influential in this regard.
Ahead of the publishing of the official EU manufacturing standard (due Q2 – Q4 2016), we have developed a ‘best guess’ product specification (testing parameters) for e-liquids and devices that we believe will be very close to the official testing criteria. In conjunction with this, please read our post on nicotine concentration limits.