EN 17647:2022
(Main)General principles for manufacturing, filling and holding e-liquids for prefilled containers or products
General principles for manufacturing, filling and holding e-liquids for prefilled containers or products
This document establishes the general principles for manufacturing, filling and holding e-liquids for prefilled containers or products.
FprCEN/TS 17633 and FprEN 17648 are intended to be used in conjunction with this document.
Allgemeine Grundsätze für die Herstellung, Abfüllung und Aufbewahrung von E-Liquids für vorgefüllte Behälter oder Produkte
Dieses Dokument legt die allgemeinen Grundsätze für die Herstellung, Abfüllung und Aufbewahrung von E Liquids für vorgefüllte Behälter oder Produkte fest.
FprCEN/TS 17633 und FprEN 17648 sind dafür vorgesehen, in Verbindung mit diesem Dokument angewendet zu werden.
Principes généraux de fabrication, de remplissage et de conservation des e-liquides pour les récipients de recharge ou les cartouches préremplies
Le présent document établit les principes généraux de fabrication, de remplissage et de conservation des e-liquides pour les récipients de recharge ou les produits préremplis.
Les FprCEN/TS 17633 et FprEN 17648 sont destinés à être utilisés conjointement avec le présent document.
Splošna načela izdelave, polnjenja in shranjevanja e-tekočin za predhodno napolnjene posode ali izdelke
Uporablja se za izdelavo ter uporabo pri izdelavi tekočin, namenjenih za elektronske cigarete in podobne naprave, ki proizvajajo paro in se uporabljajo za proizvodnjo aerosola za vdihavanje. Uporablja se za tekočine z nikotinom ali brez. Ta standard določa minimalne varnostne in kakovostne zahteve za izdelavo takih tekočin ter za njihovo polnjenje in shranjevanje, kadar se uporabljajo pri izdelavi predhodno napolnjenih elektronskih cigaret.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Splošna načela izdelave, polnjenja in shranjevanja e-tekočin za predhodno
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: EN 17647:2022
ICS:
65.160 Tobak, tobačni izdelki in Tobacco, tobacco products
oprema and related equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17647
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
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 European Standard was approved by CEN on 13 June 2022.
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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17647:2022 E
worldwide for CEN national Members.
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
European foreword
This document (EN 17647:2022) has been prepared by Technical Committee CEN/TC 437 “Electronic
cigarettes and e-liquids”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2023, and conflicting national standards shall
be withdrawn at the latest by January 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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 the United
Kingdom.
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 might or
might 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 manufacturers 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.
1 Scope
This document establishes the general principles for manufacturing, filling and holding e-liquids for
prefilled containers or products.
1 2
FprCEN/TS 17633 and FprEN 17648 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 https://www.electropedia.org/
— ISO Online browsing platform: available at https://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
contamination
presence of an unwanted and unintended substance or material
3.4
e-liquid
base liquid, which might or might not contain nicotine and/or other ingredients, intended for
transformation into an aerosol by a vaping product
3.5
e-liquid cartridge
e-liquid container that can be loaded directly into a vaping product, which can be disposable
3.6
e-liquid homogeneity
variation of property values of the e-liquid, either between separate containers of e-liquid, or to
variations within each container
Under preparation. Stage at the time of publication: FprCEN/TS 17633:2022.
Under preparation. Stage at the time of publication: FprEN 17648:2022.
3.7
ingredient
any compound or mixture of compounds intentionally included in an e-liquid
EXAMPLES Vegetable glycerol, Propylene glycol, nicotine, flavourings.
3.8
manufacturer
any entity which manufactures a product or has a product designed or manufactured, and/or markets
that product under their name or trademark
3.9
nicotine
(S)-3-(1-methyl-2-pyrrolidinyl) pyridine, conforming to the Chemical Abstracts Service nomenclature
under n° CAS: 54-11-5
3.10
prefilled container
receptacle containing an e-liquid, which can be used to refill an open system vaping product
Note 1 to entry: Also called refill bottle.
3.11
product batch
product manufactured in a defined production schedule and specified volume from identified
components/base ingredients according to the batch specification
3.12
reservoir
component for holding e-liquid to supply to the atomizer
Note 1 to entry: E-liquid reservoir also refers to tank.
3.13
vaping product
product, that vaporizes e-liquid to generate an inhalable aerosol carried by air drawn through the device
by the user
Note 1 to entry: Vaping product also referred to as electronic cigarette, vapour product, personal vaporizer or
ENDS/ENNDS.
Note 2 to entry: Vaping product differs from tobacco product in that they do not contain tobacco.
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.
A quality system is 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, processing product, and the various manufacturing operations.
The quality system shall cover the process as described in 4.2.
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 can 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 to all manufacturing facilities regardless of their
locations.
4.2.2 Production equipment
Production equipment that can impact the quality of the ingredients or final product shall be specified,
documented and calibrated if required. Production equipment shall 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 specified.
— Quality control with specified 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 specified 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
determine conformity of finished goods with requirements/specifications prior to release or
distribution.
— Shelf life: There shall be a clear shelf life established for the product, with supporting
documentation to demonstrate how this was established.
— E-liquid homogeneity: The homogeneity of the e-liquid product between mixing and bottling
shall be tested, if required, during
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