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
- Directive
- Harmonized Standard2001/95/EC - General product safety
Relations
- Effective Date
- 19-Jan-2023
- Referred By
EN ISO 16089:2025 - Machine tools - Safety - Stationary grinding machines (ISO 16089:2025) - Effective Date
- 28-Jan-2026
- Effective Date
- 08-Jul-2015
Overview
EN 1400:2013+A1:2014/FprA2 is a European Standard developed by CEN that specifies the safety requirements and test methods for soothers designed for babies and young children. This standard ensures that soothers, commonly known as pacifiers, meet strict safety criteria regarding their materials, construction, performance, packaging, and product information. The standard applies to all products that look or function as a soother, including some with additional features, but excludes specialist medical devices and feeding teats.
Key Topics
Material Safety and Composition
The standard outlines requirements for the types of materials that can be used in soothers, focusing on minimizing harmful chemical migration. Specific migration limits for a wide range of elements, including arsenic, barium, nickel, chromium VI, organic tin, and Bisphenol A (BPA), are set to protect children’s health.Construction and Performance
EN 1400 defines how soothers should be constructed to avoid hazards like choking, ingestion of small parts, and sharp edges. Mechanical strength and durability are tested to ensure long-term safe use.Chemical and Toxicological Testing
The standard specifies test methods for detecting hazardous substances, such as nitrosamines, nitrosatables, formaldehyde, and color fastness. It includes test protocols to measure the release and migration of specific chemicals to ensure exposure stays well under established safety limits.Product Information and Labeling
Packaging and information requirements ensure caregivers receive clear, unambiguous instructions for safe use, cleaning, and maintenance of soothers. Proper labeling significantly reduces misuse risks.Exclusions
Products intended for specialist medical use or for premature babies and conditions like Pierre-Robin Syndrome are excluded from this standard. Feeding teats are covered under EN 14350.
Applications
Manufacturers of Soothers
EN 1400 guarantees that products are safe before reaching the market. Manufacturers must conduct specified tests for chemical migration, physical durability, and provide compliant labeling to achieve CE marking and legal market access across Europe.Importers and Distributors
Compliance with EN 1400 is essential for importing or distributing soothers in the European Union and EFTA member states. Adhering to this standard helps prevent recalls, legal issues, and reputational damage.Testing Laboratories
Laboratories conduct the prescribed safety and migration tests according to EN 1400 to certify soother products, providing independent assurance of product safety.Regulatory Authorities and Market Surveillance
Enforcement agencies use EN 1400 as a benchmark for checking soother safety and monitoring compliance, ensuring hazardous products are swiftly removed from the EU/EEA markets.
Related Standards
- EN 14350 - Safety requirements and test methods for feeding teats and drinking equipment, covering products not included under EN 1400.
- EN 71-10 / EN 71-11 - Methods for sampling and chemical analysis in toys, referenced for simulating chemical migration.
- National and EU Legislation
Individual countries, such as France, may impose additional restrictions (e.g., stricter regulations on Bisphenol A).
Practical Value
Choosing soother products compliant with EN 1400 ensures maximum child safety, reduces the risk of hazardous exposures, and aligns with legal requirements in European markets. Manufacturers, importers, and retailers demonstrate their commitment to child health and safety by adhering to this recognized European Standard. Additionally, compliance supports market credibility, parent confidence, and a higher standard of consumer protection across the childcare industry.
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 ISO 16089:2025, 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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...