E-cigarette Manufacturing: The EU Standard

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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  Once the EU standard is available, the other guides will be withdrawn.

 

Comparative analysis of PAS 54115:2015 and  XP D90-300-1/2

 

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.

 

e-liquid-e-cigarette-manufacturing

In development: The EU E-liquid manufacturing Standard

Recommendations common to both Standards

 

The following recommendations are common to both the AFNOR and PAS guides:

 

  • Refilling tanks should occur without spillage [1,2]
  • Packaging should comply with BS EN 8317 [1]
  • CLP Regulation 1272/2008 identification of ingredient [1]
  • High purity of ingredients [1]
  • Control of CMRs [1] and respiratory sensitizers, diacetyl and ethylene glycol
  • Consideration for allergens
  • Consideration for microbial contamination
  • Test for nicotine content and delivery per puff/dose [1]
  • Product marketing should be free from health and medicinal claims.
  • Batteries comply with BS EN 62133

Notes:
[1] these are also TPD requirements
[2] specifications for the refill mechanism are currently in development

 

Recommendations unique to AFNOR XP D90-300-1/2

 

The recommendations presented below are described in the AFNOR, but not the PAS:

  • Test methods are provided such as:
    • Leakage – to demonstrate the e-cigarette will not leak when filled with e-liquid
    • Drop Test – to show e-cigarette can withstand impact from a fall
  • Size of the opening to the refillable tank is specified.
  • Ingredients not to be used in e-liquid include: Oil, fat, mineral derivatives or certain sugars.
  • Maximum concentrations are provided for chemical and metal contaminants of particular interest.
  • Control of antimony and arsenic.
  • Example test methods to measure nicotine concentration and contaminants are provided.
  • The use of certain plastics in the composition of refill bottle or cartridge is prohibited.
  • E-liquid delivery spout should not flow faster than a specified number of drops per minute.

 

Recommendations exclusive to the PAS 54115:2015

 

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:

  • Control of diethylene glycol and acetylpropionyl
  • Toxicological risk assessment
  • Tamper evident packaging

 

Difference in tolerance limit of nicotine content between the Standards

 

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.

 

Why is the difference significant?

 

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.

 

Conclusion

 

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.

 

UPDATE 15/02/16

 

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.

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