prEN 17647

General principles for manufacturing, filling and holding e-liquids for prefilled containers or products

Applicable to the manufacture, and use in manufacture, of liquids for use in electronic cigarettes and similar vapour producing devices intended for the production of aerosol for consumption by inhalation. Applicable to liquids with or without nicotine content. The standard will specify the minimum safety and quality requirements for the manufacture of such liquids and for their filling and holding when used in the manufacture of prefilled electronic cigarette devices.

Allgemeine Grundsätze für die Herstellung, Abfüllung und Aufbewahrung von E-Liquids für vorgefüllte Behälter oder Produkte

Principes généraux de fabrication, de remplissage et de conservation des e-liquides pour les récipients de recharge ou les cartouches préremplies

Splošna načela izdelave, polnjenja in shranjevanja e-tekočin za napolnjene posode ali izdelke

General Information

• Status: Not Published
• ICS: 65.160 - Tobacco, tobacco products and related equipment
• Technical Committee: CEN/TC 437 - Electronic cigarettes and e-liquids
• Drafting Committee: CEN/TC 437/WG 3 - Requirements and test methods for e-liquids
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 23-Dec-2021
• Completion Date: 23-Dec-2021
• Ref Project: oSIST prEN 17647:2021 - General principles for manufacturing, filling and holding e-liquids for prefilled containers or products

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN 17647:2021
01-marec-2021

Splošna načela izdelave, polnjenja in shranjevanja e-tekočin za napolnjene posode

ali izdelke

General principles for manufacturing, filling and holding e-liquids for prefilled containers

or products

Allgemeine Grundsätze für die Herstellung, Abfüllung und Aufbewahrung von E-Liquids

für vorgefüllte Behälter oder Produkte

Principes généraux de fabrication, de remplissage et de conservation des e-liquides pour

les récipients de recharge ou les cartouches préremplies
Ta slovenski standard je istoveten z: prEN 17647
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
oSIST prEN 17647:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17647:2021
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oSIST prEN 17647:2021
DRAFT
EUROPEAN STANDARD
prEN 17647
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2021
ICS 65.160
English Version
General principles for manufacturing, filling and holding e-
liquids for prefilled containers or products

Principes généraux de fabrication, de remplissage et de Allgemeine Grundsätze für die Herstellung, Abfüllung

conservation des e-liquides pour les récipients de und Aufbewahrung von E-Liquids für vorgefüllte

recharge ou les cartouches préremplies Behälter oder Produkte

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 437.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations

which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC

Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17647:2021 E

worldwide for CEN national Members.
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Contents Page

European foreword ............................................................................................................................................ 3

Introduction .......................................................................................................................................................... 4

1 Scope .......................................................................................................................................................... 5

2 Normative references .......................................................................................................................... 5

3 Terms and definitions ......................................................................................................................... 5

4 E-liquid manufacturing ....................................................................................................................... 7

4.1 Quality system ........................................................................................................................................ 7

4.2 Process ...................................................................................................................................................... 7

4.2.1 Manufacturing facilities ...................................................................................................................... 7

4.2.2 Production equipment ........................................................................................................................ 7

4.2.3 Process control ...................................................................................................................................... 7

4.2.4 Product and production specification ........................................................................................... 9

4.2.5 Batch traceability .................................................................................................................................. 9

4.2.6 Maintenance and sanitation............................................................................................................ 10

4.2.7 Qualification of material and suppliers ...................................................................................... 10

4.2.8 Corrective and preventive actions ................................................................................................ 11

4.2.9 Recalls and withdrawal (serious quality incident management) ..................................... 11

4.2.10 Transportation, storage and distribution .................................................................................. 12

Bibliography ....................................................................................................................................................... 13

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European foreword

This document (prEN 17647:2021) has been prepared by Technical Committee CEN/TC 437 “Electronic

cigarettes and e-liquids”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
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Introduction

E-liquid is a term describing liquid either prefilled in vaping products, or available in other forms so that

consumers can fill the reservoirs or soak the wicking material of vaping products. E-liquids may or may

not contain nicotine. In either case, they generally contain glycerol and/or propylene glycol together with

additional flavouring components. E-liquids are intended to be aerosolised for inhalation by the user.

This document establishes the general principles for manufacturing, filling and holding e-liquids for

prefilled containers or products.

The content is applicable to producers and distributors in Europe and forms a guide for regulators,

enforcement authorities and commercial operators in the area. It is also applicable to consultancies,

laboratories and testing houses engaged in or advising on, the manufacturing of e-liquids and e-liquid

components.

This document can provide state of the art guidance; however, in cases where national regulations

currently exist, said regulations take precedence over this document.
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1 Scope

This document establishes the general principles for manufacturing, filling and holding e-liquids for

prefilled containers or products.

prEN 17633:2021 and prEN 17648:2021 are intended to be used in conjunction with this document.

2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
batch number
unique number which identifies a specific product batch
3.2
batch specification

document itemizing the inputs and processes for manufacturing a specific product batch that can be used

for batch traceability purposes
3.3
vaping products

product, that vapourises e-liquid to generate an inhalable aerosol carried by air drawn through the device

by the user

Note 1 to entry: Vaping products also referred to as electronic cigarette, vapour product, personal vapouriser or

ENDS/ENNDS.

Note 2 to entry: Vaping products differs from tobacco products in that they do not contain tobacco.

3.4
e-liquid

base liquid, which may or may not contain nicotine and/or other ingredients, intended for transformation

into an aerosol by an electronic cigarette
3.5
importer

owner of, or a person having the right of disposal over, products that have been brought into the territory

of the European Union
3.6
manufacturer

any entity which manufactures a product or has a product designed or manufactured, and/or markets

that product under their name or trademark
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3.7
product batch

products manufactured in a defined production schedule and specified volume from identified

components/base ingredients according to the batch specification
3.8
vaping
action of generating an aerosol with an airflow from an electronic cigarette
3.9
e-liquid cartridge

e-liquid container that can be loaded directly into an e-cigarette, which can be disposable

3.10
refill container

receptacle containing an e-liquid, which can be used to refill an open system electronic cigarette

Note 1 to entry: Also called refill bottle.
3.11
e-liquid reservoir
component for holding e-liquid to supply to the atomizer
Note 1 to entry: E‐liquid reservoir also refers to tank.
3.12
contaminant
unwanted and unintended substance or material
3.13
contamination
presence of a contaminant
3.14
ingredient
any compound or mixture of compounds intentionally included in an e-liquid
EXAMPLE Vegetable glycerol, Propylene glycol, nicotine, flavourings.
3.15
nicotine

(S)‐3‐(1‐methyl‐2‐pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature

under n° CAS: 54‐11‐5
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4 E-liquid manufacturing
4.1 Quality system

A quality system is required in order to ensure that the products consistently meet applicable

requirements and specifications.
Quality system required:

• to establish, implement and apply an effective and documented quality assurance system;

• to establish and maintain an effective quality control system;

• to establish and maintain appropriate records, either in paper or electronic form, on specifications,

formula and processing product, and the various manufacturing operations.
The quality system shall cover process as follows.
4.2 Process
4.2.1 Manufacturing facilities

Facilities manufacturing and handling e-liquids shall establish and implement a hazard analysis and risk-

based preventive control. The hazard analysis shall consider biological, chemical, and physical hazards

which may be present in the product because they occur naturally, are unintentionally introduced, or are

intentionally introduced.

Facilities shall also monitor their controls, conduct verification activities to ensure the controls are

effective, take appropriate corrective actions, and maintain records documenting these activities.

The requirements for e-liquids shall be applicable for domestic and foreign facilities.

4.2.2 Production equipment

Production equipment that can impact the quality of the ingredients or final product shall be defined,

documented and calibrated if required. Production equipment may not lead to contamination. Heavy

metals, micro-biological contaminations and polymers (e.g. PTFE) should be considered.

4.2.3 Process control

The following controls shall be in place to produce predictable consistent vaping products:

• Process description: A full process description shall be available, where all process steps are included

and defined
• Quality control with defined sampling plan and quality parameters for:

• Incoming material inspection: The manufacturer shall perform a minimum of one test on each

batch of material to verify its identity. In the absence of additional manufacturer testing,

confirmation shall be provided that each material batch meets requirements/specification (e.g.

material batch testing supporting documentation from suppliers). The manufacturer shall have

a documented process for evaluation of material suppliers

• Process control: Process control procedures and methods that can impact the quality of the

ingredients or final product shall be defined and documented

• Finished goods inspection: Written procedures shall be established and followed for the

inspection, review and approval of finished goods, including packaging and labelling, to

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