Child care articles - Drinking equipment - Safety requirements and test methods

This European Standard specifies safety requirements and test methods relating to the materials, construction, performance, packaging and product information for:
-  Re-usable feeding teats and drinking accessories;
-  Re-usable feeding bottles and drinking cups;
-  Single-use feeding bottles, feeding teats, feeding bags and drinking accessories, which do not contain fluid when purchased.
It does not apply to drinking equipment designed for medical applications or for use under medical supervision.
This document is not applicable to soothers.
Note: Safety requirements and test methods for soothers are specified in EN 1400.

Artikel für Säuglinge und Kleinkinder - Artikel für flüssige Kindernahrung - Sicherheitstechnische Anforderungen und Prüfverfahren

Dieses Dokument legt sicherheitstechnische Anforderungen an die Materialien, Konstruktion, Ausführung, und Verpackung sowie an die Produktinformationen für Artikel für flüssige Kindernahrung fest, die für Kinder im Alter von 0 Monaten bis 48 Monaten (siehe B.2) vorgesehen sind:
-   wiederverwendbare Behälter und wiederverwendbare Trinkhilfen;
-   Behälter für den einmaligen Gebrauch und mit diesen Behältern verkaufte Trinkhilfen;
-   Ernährungssauger für den einmaligen Gebrauch;
-   gebrauchsfertige Ernährungssauger.
Dieses Dokument enthält keine Anforderungen an die Sauberkeit von gebrauchsfertigen Produkten und von Produkten für den einmaligen Gebrauch.
Dieses Dokument gilt nicht für Produkte, die für klinisch medizinische Spezialanwendungen vorgesehen sind, z. B. solche für den Einsatz im Falle einer Lippenkiefergaumenspalte.
Dieses Dokument gilt nicht für Artikel aus Keramik, die für flüssige Kindernahrung vorgesehen sind.
Dieses Dokument gilt nicht für nur zu Aufbewahrungszwecken vorgesehene Beutel.
Dieses Dokument gilt nicht für Artikel für flüssige Kindernahrung, die bereits beim Verkauf Flüssigkeiten oder Flüssignahrung enthalten, und nicht für an ihnen angebrachte Trinkhilfen.
Dieses Dokument gilt nicht für Schnuller. Sicherheitstechnische Anforderungen an Schnuller und entsprechende Prüfverfahren sind in EN 1400 [6] festgelegt.
Dieses Dokument ist nicht auf Besteck und Geschirr anwendbar. Sicherheitstechnische Anforderungen an Besteck und sonstige Ausrüstungsteile zum Füttern sowie entsprechende Prüfverfahren sind in EN 14372 [7] festgelegt.
Für Artikel für flüssige Kindernahrung, die nicht in den Anwendungsbereich fallen, sind nach Möglichkeit die anwendbaren Anforderungen dieses Dokuments zu berücksichtigen.

Articles de puériculture - Articles pour l’alimentation liquide - Exigences en matière de sécurité et méthodes d’essai

Le présent document spécifie les exigences de sécurité relatives aux matériaux constitutifs, à la construction, à la performance, à l’emballage et aux informations relatives au produit des articles destinés aux enfants âgés de 0 à 48 mois (voir B.2) :
-   récipients réutilisables et accessoires pour l’alimentation liquide réutilisables ;
-   récipients à usage unique et accessoires pour l’alimentation liquide vendus avec ;
-   tétines pour l’alimentation liquide à usage unique ;
-   tétines pour l’alimentation liquide prêtes à l’emploi.
Le présent document n’inclut pas les exigences relatives à la propreté des produits prêts à l’emploi et à usage unique.
Le présent document n’est pas applicable aux produits destinés à des applications médicales cliniques spécialisées, tels que ceux destinés aux fentes labiales et palatines.
Le présent document ne s’applique pas aux articles pour l’alimentation liquide fabriqués en céramique.
Le présent document ne s’applique pas aux sachets destinés à la conservation uniquement.
Le présent document ne s’applique pas aux articles pour l’alimentation liquide contenant des liquides ou des denrées alimentaires au moment de l’achat, ni aux accessoires pour l’alimentation liquide qui y sont fixés.
Le présent document ne s’applique pas aux sucettes. Les exigences en matière de sécurité et les méthodes d’essai relatives aux sucettes sont spécifiées dans l’EN 1400 [6].
Le présent document ne s’applique pas aux couverts et à la vaisselle. Les exigences en matière de sécurité et les méthodes d’essai relatives aux couverts et autres articles de vaisselle sont spécifiées dans l’EN 14372 [7].
En ce qui concerne les articles pour l’alimentation liquide exclus du domaine d’application du présent document, tenir compte, dans la mesure du possible, des exigences applicables du présent document.

Izdelki za otroke - Pripomočki za pitje - Varnostne zahteve in preskusne metode

General Information

Status
Published
Public Enquiry End Date
04-Dec-2018
Publication Date
18-Jun-2020
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
22-May-2020
Due Date
27-Jul-2020
Completion Date
19-Jun-2020

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SLOVENSKI STANDARD
SIST EN 14350:2020
01-september-2020
Nadomešča:
SIST EN 14350-1:2005
SIST EN 14350-2:2005
Izdelki za otroke - Pripomočki za pitje - Varnostne zahteve in preskusne metode
Child care articles - Drinking equipment - Safety requirements and test methods
Artikel für Säuglinge und Kleinkinder - Artikel für flüssige Kindernahrung -
Sicherheitstechnische Anforderungen und Prüfverfahren

Articles de puériculture - Articles pour l’alimentation liquide - Exigences en matière de

sécurité et méthodes d’essai
Ta slovenski standard je istoveten z: EN 14350:2020
ICS:
97.190 Otroška oprema Equipment for children
SIST EN 14350:2020 en,fr,de

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

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SIST EN 14350:2020
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SIST EN 14350:2020
EN 14350
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2020
EUROPÄISCHE NORM
ICS 97.190 Supersedes EN 14350-1:2004, EN 14350-2:2004
English Version
Child care articles - Drinking equipment - Safety
requirements and test methods

Articles de puériculture - Articles pour l'alimentation Artikel für Säuglinge und Kleinkinder - Artikel für

liquide - Exigences en matière de sécurité et méthodes flüssige Kindernahrung - Sicherheitstechnische

d'essai Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 14 March 2020.

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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14350:2020 E

worldwide for CEN national Members.
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SIST EN 14350:2020
EN 14350:2020 (E)
Contents Page

European foreword ...................................................................................................................................................... 5

Introduction .................................................................................................................................................................... 7

1 Scope .................................................................................................................................................................... 8

2 Normative references .................................................................................................................................... 8

3 Terms and definitions ................................................................................................................................... 9

4 Description ...................................................................................................................................................... 11

5 Test equipment and tolerances ............................................................................................................... 19

5.1 Small parts cylinder ..................................................................................................................................... 19

5.2 Indentor............................................................................................................................................................ 20

5.3 Fixture for security/retention test ......................................................................................................... 21

5.4 Probes for holes (finger traps) test ........................................................................................................ 21

5.5 Templates A and B ........................................................................................................................................ 22

5.6 Tolerances ....................................................................................................................................................... 22

6 Construction and mechanical properties – General and sample preparation ....................... 23

6.1 Sample preparation for construction and mechanical properties ............................................. 23

6.2 General.............................................................................................................................................................. 23

6.3 Pre-treatment (see B.4) .............................................................................................................................. 23

6.4 Boiling (see B.5) ............................................................................................................................................ 23

6.5 Conditioning ................................................................................................................................................... 23

7 Construction and mechanical requirements and tests ................................................................... 23

7.1 Order of testing for construction and mechanical properties ...................................................... 23

7.2 Decoration, inscription and decals (see B.6) ...................................................................................... 25

7.3 Visual and tactile examination ................................................................................................................. 25

7.4 Small parts ....................................................................................................................................................... 25

7.5 Additional requirements for sealing discs (see B.7) ........................................................................ 25

7.6 Requirements and tests for containers ................................................................................................ 25

7.7 Requirements and tests for drinking accessories............................................................................. 28

7.8 Protective covers (see B.11) ..................................................................................................................... 31

7.9 Handles and clips (see B.13) ..................................................................................................................... 32

7.10 Finger traps ..................................................................................................................................................... 33

7.11 Protruding parts............................................................................................................................................ 33

7.12 Cords or loops ................................................................................................................................................ 35

8 Chemical requirements and test methods ........................................................................................... 36

8.1 General.............................................................................................................................................................. 36

8.2 Preparation of samples for chemical tests .......................................................................................... 36

8.3 Requirements by component and material ......................................................................................... 36

8.4 Volatile compounds content of silicone components intended to be put in the mouth

or in contact with food (see B.14) ........................................................................................................... 40

8.5 N-nitrosamines and N-nitrosatable substances release ................................................................. 41

8.6 Migration of certain elements (see B.16 and B.21) .......................................................................... 41

8.7 2-mercaptobenzothiazole (MBT), antioxidant and formaldehyde release (see B.19,

B.20, B.24)........................................................................................................................................................ 43

8.8 Colour fastness (see B.15) ......................................................................................................................... 44

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SIST EN 14350:2020
EN 14350:2020 (E)

8.9 Migration of primary aromatic amines (see B.23) ........................................................................... 45

8.10 Migration of lead and cadmium from glass (see B.17) .................................................................... 45

8.11 Migration of elements from metal (see B.18) ..................................................................................... 46

9 Consumer packaging ................................................................................................................................... 46

10 Product information .................................................................................................................................... 46

10.1 General ............................................................................................................................................................. 46

10.2 Purchase information ................................................................................................................................. 46

10.3 Warnings .......................................................................................................................................................... 47

10.4 Instructions for use ...................................................................................................................................... 48

10.5 Supply chain information for products that contain vulcanised rubber .................................. 49

Annex A (normative) Warnings .............................................................................................................................. 52

Annex B (informative) Rationales ......................................................................................................................... 62

B.1 Introduction ................................................................................................................................................... 62

B.2 General ............................................................................................................................................................. 62

B.3 Preparation of samples for construction and mechanical tests (see 6.1) ................................ 62

B.4 Pre-treatment (see 6.3) .............................................................................................................................. 63

B.5 Boiling (see 6.4) ............................................................................................................................................ 63

B.6 Decoration, inscription and decals (see 7.2) ...................................................................................... 63

B.7 Additional requirements for sealing discs (see 7.5) ........................................................................ 63

B.8 Volumetric labelling and accuracy requirements (see 7.6.1. and 7.6.2) .................................. 63

B.9 Tear resistance test (see 7.7.1) ................................................................................................................ 64

B.10 Print adhesion of markings and decorations (see 7.6.3) ............................................................... 64

B.11 Protective covers (see 7.8) ........................................................................................................................ 64

B.12 Push-pull valves (see 7.7.2) ...................................................................................................................... 65

B.13 Handles and clips (see 7.9)........................................................................................................................ 65

B.14 Volatile compounds content (see 8.4) ................................................................................................... 65

B.15 Colourants (see 8.8) ..................................................................................................................................... 66

B.16 Migration of certain elements (see 8.6) ............................................................................................... 66

B.17 Migration of lead and cadmium from glass (see 8.10) .................................................................... 68

B.18 Migration of elements from metal (see 8.11) ..................................................................................... 68

B.19 Antioxidant release (see 8.7) ................................................................................................................... 69

B.20 Formaldehyde release (see 8.7) .............................................................................................................. 71

B.21 Cr VI limit (see 8.6) ...................................................................................................................................... 71

B.22 Mercaptobenzothiazole (MBT) release (see 8.7) .............................................................................. 71

B.23 Migration of primary aromatic amines (see 8.9) .............................................................................. 71

B.24 Migration conditions for elastomeric materials ............................................................................... 72

Annex C (informative) Method for the determination of 2-mercaptobenzothiazole (MBT)

and antioxidants specified in Table 7 ................................................................................................... 73

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SIST EN 14350:2020
EN 14350:2020 (E)

C.1 Apparatus ........................................................................................................................................................ 73

C.2 Procedure ........................................................................................................................................................ 73

C.3 Column .............................................................................................................................................................. 74

C.4 Detection .......................................................................................................................................................... 74

C.5 Standards ......................................................................................................................................................... 74

C.6 Preparation of standard solutions of MBT and antioxidants ........................................................ 75

C.7 Retention times ............................................................................................................................................. 76

C.8 Calculation of MBT and antioxidants ..................................................................................................... 77

Annex D (informative) A-Deviations ..................................................................................................................... 78

Annex E (informative) Good practice for visibility and legibility ............................................................... 79

E.1 General.............................................................................................................................................................. 79

E.2 Warnings .......................................................................................................................................................... 79

E.3 Font .................................................................................................................................................................... 79

E.4 Multi-languages ............................................................................................................................................. 79

Bibliography ................................................................................................................................................................. 80

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SIST EN 14350:2020
EN 14350:2020 (E)
European foreword

This document (EN 14350:2020) has been prepared by Technical Committee CEN/TC 252 “Child care

articles”, 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 December 2020, and conflicting national standards

shall be withdrawn at the latest by June 2021.

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.

This document supersedes EN 14350-1:2004 and EN 14350-2:2004.
The main changes compared to the previous edition are listed below:

— The standard has been completely renewed and a new structure was given. The former two parts

were joined together into one standard. A whole series of new aspects had to be considered,

following changes in the market and the regulatory background.

— Introduction: Completely reworded and references to European regulations were renewed.

— Clause 3: Completely restructured and partly described in more detail. Definitions for completely

new parts were added.
— Clause 4: Several completely new parts were added.
— Clause 5: This clause is completely new.
— Clause 6: This clause is completely new.

— Clause 7: The whole clause has been divided into several sub-paragraphs for individual

components of drinking equipment and the associated tests to improve the clarity of the sequence.

Several paragraphs for new items and their tests were added.

— Clause 8: This clause was completely restructured and subdivided. The requirements and test

conditions have been set with the consideration of the likely chemical exposure: food contact,

mouthing or ingestion. Chemical requirements and test methods were set for materials (like

rubber, silicon, TPE, metal, glass) and exposures (mouthing and swallowing) which are recently not

covered by harmonised legislations. Requirements for substances (e.g. Phthalates and BPA)

covered by harmonised regulation (like REACH, (EU) 10/2011 or its amendments) have not been

included.
— Clause 10: Revised and partly reworded.
— Clause 11: This clause on Test report is completely new.

— Annex A: This normative annex with translations of warnings into 24 languages is completely new.

— Annex B: This informative annex with rationales is completely new.
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SIST EN 14350:2020
EN 14350:2020 (E)

— Annex C: This informative annex on Method for the determination of 2-mercaptobenzothiazole

(MBT) and antioxidants specified in Table 7 was revised and enlarged.

— Annex E: This informative annex on good practice for visibility and legibility is completely new.

This document has been prepared under a mandate M/264 given to CEN by the European Commission

and the European Free Trade Association. The standard is developed in support of the EU

Directive 2001/95/EC (GPSD).

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.
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SIST EN 14350:2020
EN 14350:2020 (E)
Introduction

This document harmonises minimum safety requirements and test methods for children’s drinking

equipment. Some of the provisions have been taken from other existing national and European

Standards and for these provisions the Technical Committee has relied on previous validation.

A significant choking hazard can arise if the component parts of drinking equipment become separated

during use. This hazard is addressed in this document by the inclusion of a security test. However, as

the fixing of such products to the container is user-dependent, the risk of an accident cannot be

completely eliminated. This document sets out labelling requirements stating that parents or carers

should not leave children unattended whilst being fed with a product containing a feeding teat or using

a container made of glass and that children should not be allowed to use feeding teats as a soother.

The Technical Committee considered the possibility of standardizing both sizes of feeding teats and

ranges of flow rates. However, it was decided that the many combinations of container systems

precluded being standardized. It is recommended that all container and drinking accessory

combinations are matched components. Providing meaningful flow rate information is difficult because

of several factors including hole diameter, teat thickness, hole shape/type of feed, and also how

individual infants suck the teat. Accordingly, it was decided not to include a test for flow rate but to

recommend that manufacturers provide information on flow rate and hole size that is appropriate to

their particular product.

This document sets chemical requirements and test methods for materials (like rubber, silicon, TPE etc)

and exposures (mouthing and swallowing) not covered by harmonised legislations. Where this

document sets migration limits for substances also covered by legislation, the requirements of this

document with stated test conditions must be regarded as additional.

Materials and chemical risks included in the standard (Table 3) do not present a definitive list but the

considered opinion of the Technical Committee based on current knowledge of likely risks.

All food contact materials and articles are regulated by Regulation (EC) No 1935/2004 [1], Regulation

(EC) No 2023/2006 [39] and relevant implementation measures, at European or national level.

All plastics components of drinking equipment intended to come into contact with food are specifically

regulated by the Regulation (EU) 10/2011 [2] on plastic materials and articles intended to come into

contact with food and its amendments.

Therefore, for example the Bisphenol A - requirement has not been included in this document. [40]

Phthalates in childcare articles are restricted by Annex XVII of the REACH Regulation [3] and have not

been included in this document.

Latex protein allergy risk has not been included in this document. There is no published information

that sensitization is caused by feeding teats and there is an extremely low incidence of latex protein

allergy among young children and babies. Nevertheless, provision for packaging information for feeding

teats made from natural rubber latex has been included in this document.

It is recommended that manufacturers and suppliers operate to EN ISO 9001 standard for quality

management systems [4]. It is also recommended that laboratories operate to EN ISO/IEC 17025,

General requirements for the competence of testing and calibration laboratories [5].

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SIST EN 14350:2020
EN 14350:2020 (E)
1 Scope

This document specifies safety requirements relating to the materials, construction, performance,

packaging and product information for drinking equipment intended for children of 0 to 48 months (see

B.2) of age:
— Re-usable containers and re-usable drinking accessories;
— Single-use containers and drinking accessories sold with these containers;
— Single-use feeding teats;
— Ready to use feeding teats.

This document does not include requirements for the cleanliness of ready to use and single use

products.

This document does not apply to products designed for specialist clinical medical applications, e.g.

those relating to cleft lip palates.
This document does not apply to drinking equipment made from ceramics.
This document does not apply to bags intended for storage only.

This document does not apply to drinking equipment which is supplied with fluids or food when

purchased and to feeding accessories fixed to it.

This document is not applicable to soothers. Safety requirements and test methods for soothers are

specified in EN 1400 [6].

This document is not applicable for cutlery and other feeding utensils. Safety requirements and test

methods for Cutlery and other feeding equipment are specified in EN 14372 [7].

For drinking equipment excluded from the scope, consider the applicable requirements of this

document whenever possible.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN 71-3, Safety of toys - Part 3: Migration of certain elements

EN 12868, Child use and care articles - Method for determining the release of N-nitrosamines and N-

nitrosatable substances from elastomer or rubber teats and soothers

EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696)

IEC 60454-2, Pressure-sensitive adhesive tapes for electrical purposes, Part 2: Methods of test

ISO 188:2011, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests

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SIST EN 14350:2020
EN 14350:2020 (E)
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 https://www.iso.org/obp/ui
3.1
matched components
components which are intended to be used together whilst feeding a child

Note 1 to entry: Their dimensions are matched to fit together and fulfil the relevant safety requirements.

Note 2 to entry: See definitions 3.2 to 3.9.
3.2
drinking accessory
device fitted to a container which permits a child to obtain fluid from it
3.2.1
feeding teat
elastic drinking accessory other than a straw

Note 1 to entry: there is no accepted scientific definition for the word “elastic”. The Technical Committee intended

to describe by "elastic"products made of silicone rubber, latex rubber, etc.
3.2.2
drinking spout
non-elastic drinking accessory other than a straw
3.2.3
push-pull valve

drinking accessory equipped with a valve designed to be manually operated by a push-pull, twist or

similar action
Note 1 to entry: A push-pull valve is also known as a “sports cup spout”.
3.2.4
straw

drinking accessory consisting of a cylindrical hollow tube which is in contact with the mouth and

through which fluid is sucked
3.2.5
protruding part
drinking accessory when assembled for its intended use on a container
3.3
container
feeding bottle, drinking cup or feeding bag
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SIST EN 14350:2020
EN 14350:2020 (E)
3.3.1
feeding bottle

container which is capable of holding fluid incorporating a graduated scale suitable for visual

measurement and is intended for feeding a child through a suitable drinking accessory

3.3.2
drinking cup

container other than a feeding bottle or feeding bag capable of holding a fluid intended for feeding a

child

Note 1 to entry: Drinking cups are also known as “beakers” in the English language

3.3.3
feeding bag
bag capable of holding fluid and designed to be used with drinking accessories
Note 1 to entry: Feeding bags are also known as feeding liners.
3.3.4
feeding bag holder
support for a feeding bag
Note 1 to entry: see Figure 4 No 8.
3.4
locking ring
component used to secure a drinking accessory to a container
3.5
sealing disc
component used to create a seal between the container and the locking ring
3.6
protective cover
component to cover a drinking accessory
3.6.1
detach
...

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