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Document Title: Child use and care articles - Soothers for babies and young children - Part 1: General safety requirements and product information
German Designator: DIN EN 1400-1
Date: December 2002
National Foreword Designations:
This standard has been prepared by CEN/TC 252 ‘Child use and care articles’ (Secretariat: France) on the basis of a mandate M/264 given to CEN by the European Commission.
The responsible German body involved in its preparation was the Normenausschuss Gebrauchstauglichkeit und Dienst/eistungen (Usability, Performance and Services Standards Committee), Technical Committee Artikel fUr Sauglinge und Kleinkinder - Essen, Trinken, Saugen und andere Funktionen
Mandate: Prepared Under European Commission Mandate 264
Purchase From DIN: DIN EN 1400 (2013)
View Standard: Documents have been removed from view until resolution of pending litigation. Currently available standards are listed in Table 01.
EN 1400 is a set of 2002 standards covering the general safety requirements for soothers, also known as pacifiers or dummies. EN 1400-1 covers the general safety requirements and product information, EN 1400-2 covers mechanical requirements and test, and EN 1400-3 covers chemical requirements and tests.
The standard covers a variety of important safety aspects of soothers, including the dimension of the shield so that it is not sucked into the baby’s mouth, the presence and size of air holes in the shield so the baby can breath, the ability to grab the ring with one’s fingers in case the soother is stuck in the baby’s mouth, and the fact that the teat of the soother should not have a hole in it or contain any materials such as pellets that could be swallowed in the case of a rupture.
While there were previous standards for soothers in existence, in particular the Austrian standard ONORM S 1558 (1991), EN-1400 is, as the foreword states, the “first time minimum safety requirements and test methods for soothers” have been harmonised across Europe. The foreword goes on to state that “most 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.”
The European soother standard was the result of the pioneering work of Peter W. Röhrig of Austria, the CEO of MAM, a leading manufacturer of these products. As explained by the Austrian Standards institute, Röhrig helped develop the Austrian standard in 1980s, then went on to advocate European standardization and then chaired the CEN TC 252/WG 5 working group that developed EN 1400.
EN 1400 was developed under a very specific Mandate from the European Commission. Mandate 264 was issued December 16, 1997 and required CEN to develop specific standards related to the safety of child-care articles for “very young children who form a vulnerable group in society. Of particular concern with soothers is that the products are “cheap and easy to make and are thus very attractive to manufacturers both within and outside the EU.”
The Mandate relied on a number of studies from the Netherlands, United Kingdom, and the US that specifically identified soothers and other hazards as a threat to public safety. The Mandate specified a number of areas to be covered, including safety information, product hygiene, chemical properties, physical properties, and mechanical properties, criteria that map very closely to the standard that was produced.
Mandate M264 was also used as authorization for revision of the standard for the 2013 release. EN 1400:2013 combines the 3 parts into a unified standard, and includes important improvements to tests, references supply chain information for
the use vulcanised rubber (which may cause protein allergy reactions), and references the EN 71-12 standard for the reduction of nitrosamines.
The topic of soother safety is of grave concern across the globe. In Australia, the topic is covered in AS 2432:1991, “Babies’ dummies,” which forms the basis for the Australian Mandatory Standard and for Consumer Protection Notice No. 4 of 2006. In the US, the standard is published in the Code of Federal Regulations at 16 CFR 1511 , Requirements for Pacifiers. The U.S. Consumer Products Safety Commission has also created a standard Engineering Test Manual and maintains an extensive Guidance Page.
The safety of soothers is not a theoretical issue. The European Commission has a large number of alerts for soothers in the Rapid Alert System for non-food dangerous products (RAPEX), as does the CPSC Recall database. Dozens of sites throughout the world devoted to safe parenting have extensive sections on soother safety issues, evidence of the concern that parents have about this important issue.
Last Updated: May 15, 2014
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