EN 1400:2013+A1:2014/FprA2
(Amendment)Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
Child use and care articles - Soothers for babies and young children - Safety requirements and test methods
This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers. This European Standard is applicable to products that resemble or function as a soother. Some soothers may be marketed with other functions. This standard is applicable to these products (some examples are given in Annex C). This European Standard does not apply to products designed for specialist clinical medical applications, e.g. those relating to Pierre-Robin Syndrome or premature babies (see Annex C). The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts of EN 14350 [2], [3].
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Sicherheitstechnische Anforderungen und Prüfverfahren
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de sécurité et méthodes d'essai
Izdelki za otroke - Dude za dojenčke in mlajše otroke - Varnostne zahteve in preskusne metode - Dopolnilo A2
General Information
- Status
- Not Published
- Technical Committee
- CEN/TC 252 - Child use and care articles
- Drafting Committee
- CEN/TC 252/WG 5 - Feeding, drinking, sucking and similar functions
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 22-Mar-2018
- Due Date
- 06-Nov-2018
- Completion Date
- 22-Mar-2018
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 08-Jul-2015
Overview
EN 1400:2013+A1:2014/FprA2 is a European Standard developed by the European Committee for Standardization (CEN) that specifies safety requirements and test methods for soothers (pacifiers) intended for babies and young children. This standard ensures that soothers meet strict criteria related to materials, construction, performance, packaging, and product information, aiming to minimize risks associated with their use. It applies to products that resemble or function as a soother, including some multifunctional items, but excludes specialist medical devices and feeding teats, which are covered under EN 14350.
Key Topics
Materials and Construction: Rigorous safety requirements target the composition of materials, including vulcanised rubber, silicone rubber, thermoplastics, and various decorative components. The standard enforces limits on migration of harmful elements and compounds from these materials into the child's mouth.
Migration Limits of Harmful Elements: EN 1400 outlines maximum allowed migration levels for toxic elements such as arsenic, barium, nickel, chromium VI, organic tin, and others. These limits reflect the latest toxicological data, ensuring protective thresholds based on tolerable daily intake (TDI) values.
Bisphenol A (BPA) Restrictions: Special provisions govern the release of BPA, a chemical of concern in plastics manufacturing. The standard mandates a maximum migration level of 0.01 mg/l for BPA in polycarbonate or polysulphone soothers. Additional national deviations, such as France’s complete ban on BPA in soothers, are incorporated.
Testing Procedures: The standard includes detailed test methods to evaluate migration of elements, release of substances like antioxidants and formaldehyde, color fastness, and volatile compound content. These tests simulate real-use conditions to confirm safety.
Packaging and Product Information: EN 1400 requires clear labeling and instructions to inform consumers about the safe use, maintenance, and disposal of soothers.
Applications
This standard is essential for manufacturers, importers, and retailers of soothers and related child care products. Compliance with EN 1400 benefits:
Product Safety Assurance: Helps ensure the safety of babies and young children by minimizing exposure to toxic substances and physical hazards associated with pacifier use.
Regulatory Compliance: Supports manufacturers in meeting European safety legislation and facilitates market access across CEN member countries.
Quality Control: Provides standardized testing procedures for consistent quality assurance during production.
Consumer Confidence: Clear labeling and adherence to safety requirements build trust among parents and caregivers choosing appropriate soothers for their children.
Product Development: Technical committees and product designers can refer to this standard to innovate safer, compliant soothers incorporating multifunctional features without compromising safety.
Related Standards
EN 14350 (Parts 1 & 2): Specifies safety requirements and test methods for feeding bottles and teats, which complement EN 1400 for child feeding and soothing products.
EN 71 Series: Offers test methods for migration of elements and compounds used to simulate mouthing conditions, referenced in EN 1400 for migration testing.
Chemical Safety Regulations: EN 1400 aligns with European chemical safety directives and risk assessments, including guidance from agencies such as EFSA (European Food Safety Authority).
National Deviations and Amendments: Some countries may apply specific modifications (e.g., France’s ban on BPA in soothers), emphasizing the need for compliance with both EN 1400 and local regulations.
By conforming to EN 1400:2013+A1:2014/FprA2, stakeholders in the child care sector ensure that soothers meet the highest safety standards, protecting infants and young children from potential chemical and mechanical hazards while facilitating market confidence and regulatory compliance across Europe.
Frequently Asked Questions
EN 1400:2013+A1:2014/FprA2 is a draft published by the European Committee for Standardization (CEN). Its full title is "Child use and care articles - Soothers for babies and young children - Safety requirements and test methods". This standard covers: This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers. This European Standard is applicable to products that resemble or function as a soother. Some soothers may be marketed with other functions. This standard is applicable to these products (some examples are given in Annex C). This European Standard does not apply to products designed for specialist clinical medical applications, e.g. those relating to Pierre-Robin Syndrome or premature babies (see Annex C). The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts of EN 14350 [2], [3].
This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers. This European Standard is applicable to products that resemble or function as a soother. Some soothers may be marketed with other functions. This standard is applicable to these products (some examples are given in Annex C). This European Standard does not apply to products designed for specialist clinical medical applications, e.g. those relating to Pierre-Robin Syndrome or premature babies (see Annex C). The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are included in all parts of EN 14350 [2], [3].
EN 1400:2013+A1:2014/FprA2 is classified under the following ICS (International Classification for Standards) categories: 97.190 - Equipment for children. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1400:2013+A1:2014/FprA2 has the following relationships with other standards: It is inter standard links to EN 1400:2013+A2:2018, EN 1400:2013+A1:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1400:2013+A1:2014/FprA2 is associated with the following European legislation: EU Directives/Regulations: 2001/95/EC; Standardization Mandates: M/264. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1400:2013+A1:2014/FprA2 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 1400:2013+A1:2014/oprA2:2017
01-februar-2017
,]GHONL]DRWURNH'XGH]DGRMHQþNHLQPODMãHRWURNH9DUQRVWQH]DKWHYHLQ
SUHVNXVQHPHWRGH'RSROQLOR$
Child use and care articles - Soothers for babies and young children - Safety
requirements and test methods
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder -
Sicherheitstechnische Anforderungen und Prüfverfahren
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Exigences de
sécurité et méthodes d'essai
Ta slovenski standard je istoveten z: EN 1400:2013+A1:2014/prA2:2016
ICS:
97.190 Otroška oprema Equipment for children
SIST EN 1400:2013+A1:2014/oprA2:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN 1400:2013+A1:2014/oprA2:2017
SIST EN 1400:2013+A1:2014/oprA2:2017
DRAFT
EUROPEAN STANDARD
EN 1400:2013+A1:2014
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
December 2016
ICS 97.190
English Version
Child use and care articles - Soothers for babies and young
children - Safety requirements and test methods
Articles de puériculture - Sucettes pour nourrissons et Artikel für Säuglinge und Kleinkinder - Schnuller für
jeunes enfants - Exigences de sécurité et méthodes Säuglinge und Kleinkinder - Sicherheitstechnische
d'essai Anforderungen und Prüfverfahren
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 252.
This draft amendment A2, if approved, will modify the European Standard EN 1400:2013+A1:2014. If this draft becomes an
amendment, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration.
This draft amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN
worldwide for CEN national Members. 1400:2013+A1:2014/prA2:2016:2016 E
SIST EN 1400:2013+A1:2014/oprA2:2017
EN 1400:2013+A1:2014/prA2:2016 (E)
Contents Page
European foreword .3
1 Modification to the Introduction .4
2 Modification to 10.2 Materials .4
3 Modification to 10.3 Migration of certain elements (see B.21) .5
4 Modification to 10.6 Bisphenol A release (see B.20.5, B.26 and Annex H) .5
5 Modification to Annex B .6
6 Modification to Annex H .8
SIST EN 1400:2013+A1:2014/oprA2:2017
EN 1400:2013+A1:2014/prA2:2016 (E)
European foreword
This document (EN 1400:2013+A1:2014/prA2:2016) has been prepared by Technical Committee
CEN/TC 252 “Child use and care articles”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
SIST EN 1400:2013+A1:2014/oprA2:2017
EN 1400:2013+A1:2014/prA2:2016 (E)
1 Modification to the Introduction
Add the following text
"Since the publication of EN 1400:2013+A1:2014 it has come to the attention of the Technical
Committee that some of the TDI's used to calculate the limits of a certain number of element migration
from soothers are out of date. During the drafting of this amendment the Technical committee reviewed
all the previous sources of TDI's to ascertain the current state of knowledge.
The migration limits for Arsenic, Barium, and Nickel have been changed to reflect the latest information.
In addition migration limits for Chromium VI and Organic Tin have been added.
The Technical Committee has also included a requirement for Bisphenol A (BPA) in soothers based on
the most recent TDI from the 2015 EFSA Opinion and an A-Deviation from France."
2 Modification to 10.2 Materials
Replace Table 4 by the following:
Table 4 — Requirements and Tests on materials
Requirement 10.3.1 10.4.1 10.5.1 10.5.1 10.5.1 10.6. 1 10.7.1 10.8.1
a
Clause
Test Clause 10.3.2 10.4.2 10.5.2 10.5.2 10.5.2 10.6.2 10.7.2 10.8.2
Vulcanised x x x x x x
...
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