BS EN 14350:2020
EN 14350:2020 (E)
8.9 8.10 8.11 9 10 10.1 10.2 10.3 10.4 10.5
Migration of primary aromatic amines (see B.23) ........................................................................... 45 Migration of lead and cadmium from glass (see B.17) .................................................................... 45 Migration of elements from metal (see B.18) ..................................................................................... 46 Consumer packaging ................................................................................................................................... 46 Product information .................................................................................................................................... 46 General ............................................................................................................................................................. 46 Purchase information ................................................................................................................................. 46 Warnings ......................................................................................................................................................... 47 Instructions for use ...................................................................................................................................... 48 Supply chain information for products that contain vulcanised rubber .................................. 49
Annex A (normative) Warnings .............................................................................................................................. 52 Annex B (informative) Rationales ......................................................................................................................... 62 B.1 B.2 B.3 B.4 B.5 B.6 B.7 B.8 B.9
Introduction ................................................................................................................................................... 62 General ............................................................................................................................................................. 62 Preparation of samples for construction and mechanical tests (see 6.1) ................................ 62 Pre-treatment (see 6.3) .............................................................................................................................. 63 Boiling (see 6.4) ............................................................................................................................................ 63 Decoration, inscription and decals (see 7.2) ...................................................................................... 63 Additional requirements for sealing discs (see 7.5) ........................................................................ 63 Volumetric labelling and accuracy requirements (see 7.6.1. and 7.6.2) .................................. 63 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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BS EN 14350:2020
EN 14350:2020 (E)
C.1 C.2 C.3 C.4 C.5 C.6 C.7 C.8
Apparatus ........................................................................................................................................................ 73 Procedure ........................................................................................................................................................ 73 Column .............................................................................................................................................................. 74 Detection .......................................................................................................................................................... 74 Standards ......................................................................................................................................................... 74 Preparation of standard solutions of MBT and antioxidants........................................................ 75 Retention times ............................................................................................................................................. 76 Calculation of MBT and antioxidants ..................................................................................................... 77
Annex D (informative) A-Deviations ..................................................................................................................... 78 Annex E (informative) Good practice for visibility and legibility ............................................................... 79 E.1 E.2 E.3 E.4
General ............................................................................................................................................................. 79 Warnings .......................................................................................................................................................... 79 Font .................................................................................................................................................................... 79 Multi-languages ............................................................................................................................................. 79
Bibliography ................................................................................................................................................................. 80
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BS 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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BS 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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BS 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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