CEN/TR 16353:2012

Packaging - Safety guidelines for flexible plastic packaging to minimize the risk of suffocation to children

This European Standard covers the safety of flexible plastics packaging that is likely to be accessible to children in the home and may pose a risk of suffocation.
It includes flexible plastics packaging intended for single or repeated use.

Verpackung - Sicherheitsleitfaden zur Verminderung der Erstickungsgefahr von Kindern durch flexible Kunststoffverpackungen

Dieser Technische Bericht behandelt die Sicherheit von flexiblen Kunststoffverpackungen, die voraussichtlich für Kinder im Haushalt zugänglich sind und eine mögliche Erstickungsgefahr darstellen.
Er gilt für flexible Kunststoffverpackungen für die ein- oder mehrmalige Verwendung.

Emballage - Lignes directrices de sécurité relatives aux emballages en plastique souple pour réduire au minimum le risque de suffocation des enfants

Le présent Rapport technique couvre la sécurité des emballages en plastique souple susceptibles d'être accessibles aux enfants chez eux et d'entraîner un risque de suffocation.
Cela comprend les emballages en plastique souple à usage unique ou réutilisables.

Embalaža - Varnostne smernice za embalažo iz prožne plastike za zmanjšanje tveganja zadušitve pri otrocih

To tehnično poročilo zajema varnostne smernice za embalažo iz prožne plastike, do katere imajo lahko dostop otroci in predstavlja tveganje zadušitve. Vključuje embalažo iz prožne plastike, ki je namenjena enkratni ali večkratni uporabi.

General Information

• Status: Published
• Publication Date: 17-Jul-2012
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: CEN/TC 261 - Packaging
• Drafting Committee: CEN/TC 261/SC 5/WG 26 - Packages made from flexible materials (e.g. flexible plastics, plastic laminates, paper/board laminated, metal foil laminates, textiles)
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Jul-2012
• Due Date: 26-Jul-2012
• Completion Date: 18-Jul-2012
• Ref Project: SIST-TP CEN/TR 16353:2013 - Packaging - Safety guidelines for flexible plastic packaging to minimize the risk of suffocation to children

Overview

CEN/TR 16353:2012 - "Packaging: Safety guidelines for flexible plastic packaging to minimize the risk of suffocation to children" is a CEN technical report that provides practical guidance to reduce suffocation hazards from flexible plastic sheeting and bags that are likely to be accessible to children at home. The report covers both single-use and repeated-use flexible plastic packaging and explains risk assessment, safety strategies (design and labeling), and basic test methodology.

Key Topics and Requirements

• Risk assessment: Evaluate the necessity of flexible plastic packaging, product size, whether the packaging is destroyed at opening (e.g., shrink-wrap), and whether design elements make it attractive to children.
• Thickness threshold: Flexible films larger than 100 mm × 100 mm should have an average thickness of not less than 0.038 mm (typical for PE-LD); stiffness, not just nominal thickness, is the critical parameter.
• Perforation strategy: Films thinner than 0.038 mm and larger than 100 mm × 100 mm should be perforated with 6 mm diameter holes, removing at least 1% of the area over any 30 mm × 30 mm region to allow sufficient airflow.
• Bag opening size: Bags with an opening perimeter less than 380 mm are not generally capable of being placed over most young children's heads and are considered lower risk.
• Closure design: Plastic packaging with an opening perimeter greater than 380 mm should not use drawstrings or cords for closure.
• Warning label: Recommended consumer label text -
  "KEEP THIS PACKAGING AWAY FROM CHILDREN TO AVOID DANGER OF SUFFOCATION" - in the language(s) of sale.
• Test methodology: Measure film thickness on single film samples (if bag, cut into single sheets) at 10 equidistant points across the diagonal of any 100 mm × 100 mm area and average the readings; measuring device accuracy 1 µm.

Applications and Users

This technical report is intended for:

• Packaging designers and manufacturers creating flexible plastic packaging for consumer goods.
• Product safety engineers and compliance teams assessing suffocation risk and implementing mitigations.
• Retailers and brand owners specifying packaging safety requirements for supply chains.
• Regulators and standards bodies, and child-safety advocates seeking alignment with European guidance. Practical implementations include adding ventilation holes, specifying minimum film stiffness/thickness, removing hazardous closures, and including clear suffocation warnings on disposable packaging.

Related Standards

• EN 71-1: Safety of toys - mechanical and physical properties
• EN 1930: Child care articles - safety barriers - requirements and test methods

CEN/TR 16353:2012 complements these standards by focusing specifically on suffocation risks from flexible plastic packaging and practical mitigation measures. Keywords: CEN/TR 16353:2012, flexible plastic packaging, suffocation risk, children safety, packaging safety guidelines, ventilation holes, 0.038 mm.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2013
Embalaža - Varnostne smernice za embalažo iz prožne plastike za zmanjšanje
tveganja zadušitve pri otrocih
Packaging - Safety guidelines for flexible plastic packaging to minimize the risk of
suffocation to children
Verpackung - Sicherheitsleitfaden für flexible Kunststoffverpackungen zur Reduzierung
des Risikos der Erstickung von Kindern
Emballage - Lignes directrices de sécurité relatives aux emballages en plastique souple
pour réduire au minimum le risque d'étouffement des enfants
Ta slovenski standard je istoveten z: CEN/TR 16353:2012
ICS:
55.040 0DWHULDOLLQSULSRPRþNL]D Packaging materials and
SDNLUDQMH accessories
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN/TR 16353
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2012
ICS 55.040
English Version
Packaging - Safety guidelines for flexible plastic packaging to
minimize the risk of suffocation to children
Emballage - Lignes directrices de sécurité relatives aux Verpackung - Sicherheitsleitfaden zur Verminderung der
emballages en plastique souple pour réduire au minimum Erstickungsgefahr von Kindern durch flexible
le risque d'étouffement des enfants Kunststoffverpackungen

This Technical Report was approved by CEN on 25 March 2012. It has been drawn up by the Technical Committee CEN/TC 261.

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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16353:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Terms and definitions .5
3 Risk assessment .5
4 Safety strategies .5
4.1 General .5
4.2 Single use packaging .6
4.3 Repeated use packaging .6
5 Test equipment .7
6 Test methodology .7
Bibliography .8

Foreword
This document (CEN/TR 16353:2012) has been prepared by Technical Committee CEN/TC 261 “Packaging”,
the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
Introduction
This document presents guidance to minimize the risk of suffocation of children from flexible plastic
packaging.
Babies and young children play with anything to which they have easy access. Their lack of understanding of
hazards is such that they will use materials in ways for which they were not intended. Death or serious brain
injury can occur to young children as a result of suffocation when their nose and mouth become covered or all
the oxygen in the enclosure in which their heads are trapped is used up.
Parents and carers have a major role to play in reducing the risk of suffocation through supervision of children
and careful storage or disposal of packaging materials but it is not a reliable or complete solution. If the
packaging of products can be made safer without loss of functions, appropriate measures should be carefully
considered and implemented.
1)
This document recognises that flexible plastic packaging is necessary to protect products , for example by:
 allowing the consumer to carry the product easily;
 preventing moisture contaminating the product;
 protecting the product from physical damage;
 ensuring that multiple units of a product remain together for transit, for example on a pallet.
Not all of these types of packaging are readily accessible to consumers.
Manufacturers should have regard for the safety aspects of any flexible plastic packaging that they use as well
as for environmental reasons.
NOTE Specific requirements for packaging materials are included in standards, including EN 71-1[1] and EN 1930
[2]. The guidance contained in this Technical Report does not replace that contained in specific standards.

)
The term “product” used for convenience throughout this document is intended to include anything
...