BS PD CEN TR 13387-2004 Child Use and Care Articles-Safety Guidelines

PUBLISHED DOCUMENT PD CEN/TR 13387:2004

Child use and care articles — Safety guidelines

ICS 91.190

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PD CEN/TR 13387:2004

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 29 November 2004

© BSI 29 November 2004

ISBN 0 580 44906 8

National foreword

This Published Document is the official English language version of CEN/TR 13387:2004.

The UK participation in its preparation was entrusted to Technical Committee CW/41, Child use and care articles, which has the responsibility to:

A list of organizations represented on this committee can be obtained on request to its secretary.

Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

— aid enquirers to understand the text;

— present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;

— monitor related international and European developments and promulgate them in the UK.

Summary of pages

This document comprises a front cover, an inside front cover, the CEN/TR title page, pages 2 to 180, an inside back cover and a back cover.

The BSI copyright notice displayed in this document indicates when the document was last issued.

Amendments issued since publication

Amd. No. Date Comments

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TECHNICAL REPORT

RAPPORT TECHNIQUE

TECHNISCHER BERICHT

CEN/TR 13387

September 2004

ICS 97.190 Supersedes CR 13387:1999

English version

Child use and care articles - Safety guidelines

Articles de puériculture - Conseils relatifs à la sécurité Artikel für Säuglinge und Kleinkinder - Sicherheitsleitfaden

This Technical Report was approved by CEN on 23 March 2004. It has been drawn up by the Technical Committee CEN/TC 252.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATIONC OM ITÉ EUR OP ÉEN DE NOR M ALIS AT IONEUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2004 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.

Ref. No. CEN/TR 13387:2004: E

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Contents

page

Foreword..............................................................................................................................................................6 General safety - Contents list ..........................................................................................................................11 1 General safety ......................................................................................................................................12 1.1 Terms/definitions used in the report .................................................................................................12 1.1.1 Terms identical to those given in the definitions in CEN/CENELEC Memorandum no 9.............12 1.1.2 Common terms/definitions .................................................................................................................13 1.2 Built-in safety .......................................................................................................................................13 1.3 Accident data .......................................................................................................................................13 Chemical hazards and risk - Contents list .....................................................................................................14 2 Chemical hazards and risk .................................................................................................................17 2.1 General..................................................................................................................................................17 2.2 Terms related to chemical hazards and risk.....................................................................................18 2.3 Safety philosophy................................................................................................................................19 2.3.1 General..................................................................................................................................................19 2.3.2 General strategy...................................................................................................................................20 2.3.3 Potential hazards of chemical constituents......................................................................................20 2.3.4 Potential characteristics of use..........................................................................................................23 2.3.5 Potential routes of chemical exposure..............................................................................................23 2.3.6 Risk characterisation ..........................................................................................................................27 2.3.7 Risk management ................................................................................................................................27 2.4 Chemical hazard-reducing specifications.........................................................................................28 2.5 Migration of certain elements.............................................................................................................29 2.5.1 Rationale...............................................................................................................................................29 2.5.2 Limits ....................................................................................................................................................29 2.5.3 Requirements .......................................................................................................................................29 2.5.4 Test methodology................................................................................................................................30 2.6 Migration of vinyl chloride monomer.................................................................................................31 2.6.1 Rationale...............................................................................................................................................31 2.6.2 Limits ....................................................................................................................................................31 2.6.3 Requirements .......................................................................................................................................31 2.6.4 Test methodology................................................................................................................................31 2.7 Total content and migration of nickel................................................................................................32 2.7.1 Rationale...............................................................................................................................................32 2.7.2 Limits ....................................................................................................................................................32 2.7.3 Requirements .......................................................................................................................................32 2.7.4 Test methodology................................................................................................................................32 2.8 Total content and migration of plasticisers ......................................................................................33 2.8.1 General..................................................................................................................................................33 2.8.2 Rationale...............................................................................................................................................33 2.8.3 Limits ....................................................................................................................................................33 2.8.4 Requirements .......................................................................................................................................34 2.8.5 Test methodology................................................................................................................................34 2.9 Total content and migration of formaldehyde ..................................................................................38 2.9.1 General..................................................................................................................................................38 2.9.2 Rationale...............................................................................................................................................38 2.9.3 Limits ....................................................................................................................................................38 2.9.4 Requirements .......................................................................................................................................38 2.9.5 Test methodology................................................................................................................................38


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2.10 Total content of flame retardants ......................................................................................................40 2.10.1 General .................................................................................................................................................40 2.10.2 Rationale...............................................................................................................................................40 2.10.3 Limits ....................................................................................................................................................40 2.10.4 Requirements.......................................................................................................................................40 2.10.5 Test methodology................................................................................................................................41 2.11 Migration of N-Nitrosamines and N-Nitrosatable substances ........................................................42 2.11.1 General .................................................................................................................................................42 2.11.2 Rationale...............................................................................................................................................42 2.11.3 Limits ....................................................................................................................................................42 2.11.4 Requirements.......................................................................................................................................42 2.11.5 Test methodology................................................................................................................................42 2.12 Migration of vulcanisation accelerators (and antioxidants) ...........................................................43 2.12.1 General .................................................................................................................................................43 2.12.2 Rationale...............................................................................................................................................43 2.12.3 Limits ....................................................................................................................................................43 2.12.4 Requirements.......................................................................................................................................43 2.12.5 Test methodology................................................................................................................................43 2.13 Total content of volatile compounds.................................................................................................45 2.13.1 Rationale...............................................................................................................................................45 2.13.2 Limits ....................................................................................................................................................45 2.13.3 Requirements.......................................................................................................................................45 2.13.4 Test methodology................................................................................................................................45 2.14 Total content and migration of certain dyes, azo-colourants and disperse dyes ........................46 2.14.1 Rationale...............................................................................................................................................46 2.14.2 Limits ....................................................................................................................................................46 2.14.3 Requirements.......................................................................................................................................48 2.14.4 Test methodology................................................................................................................................48 2.15 Migration of bisphenol A ....................................................................................................................49 2.15.1 General .................................................................................................................................................49 2.15.2 Rationale...............................................................................................................................................49 2.15.3 Limits ....................................................................................................................................................49 2.15.4 Requirements.......................................................................................................................................49 2.15.5 Test methodology................................................................................................................................49 2.16 Total content of organotin compounds ............................................................................................51 2.16.1 General .................................................................................................................................................51 2.16.2 Rationale...............................................................................................................................................51 2.16.3 Limits ....................................................................................................................................................51 2.16.4 Requirements.......................................................................................................................................51 2.16.5 Test methodology................................................................................................................................51 2.17 Total content of pentachlorophenol (PCP) .......................................................................................55 2.17.1 General .................................................................................................................................................55 2.17.2 Rationale...............................................................................................................................................55 2.17.3 Limits ....................................................................................................................................................55 2.17.4 Requirements.......................................................................................................................................55 2.17.5 Test methodology................................................................................................................................55 Mechanical hazards - Contents list ................................................................................................................56 3 Mechanical hazards.............................................................................................................................58 3.1 Terms related to mechanical hazards ...............................................................................................58 3.2 Safety philosophy................................................................................................................................58 3.2.1 Accessibility of mechanical hazards.................................................................................................60 3.2.2 Information...........................................................................................................................................63 3.3 Entrapment hazards ............................................................................................................................64 3.3.1 Introduction..........................................................................................................................................64 3.3.2 Entrapment of head and neck ............................................................................................................64 3.3.3 Entrapment of fingers .........................................................................................................................75 3.3.4 Entrapment of limbs, feet and hands ................................................................................................78 3.4 Hazards from moving parts................................................................................................................79

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3.4.1 Introduction ..........................................................................................................................................79 3.4.2 Hazards with products designed to fold ...........................................................................................79 3.4.3 Hazards from crushing when the product is in use .........................................................................80 3.5 Entanglement hazards ........................................................................................................................81 3.5.1 Introduction ..........................................................................................................................................81 3.5.2 Snagging hazards................................................................................................................................81 3.5.3 Cords, ribbons and parts used as ties ..............................................................................................87 3.6 Choking hazards ..................................................................................................................................89 3.6.1 Introduction ..........................................................................................................................................89 3.6.2 Inhalation of small components.........................................................................................................89 3.6.3 Accessibility of filling materials .........................................................................................................94 3.6.4 Airway obstruction ..............................................................................................................................96 3.7 Suffocation hazards...........................................................................................................................100 3.7.1 Introduction ........................................................................................................................................100 3.7.2 Plastic decals and sheeting..............................................................................................................100 3.7.3 Non air-permeable packaging and wrapping..................................................................................103 3.8 Ingestion hazards ..............................................................................................................................105 3.8.1 Introduction ........................................................................................................................................105 3.8.2 Ingestion of small components........................................................................................................105 3.9 Hazardous edges and projections ...................................................................................................111 3.9.1 Introduction ........................................................................................................................................111 3.9.2 Edges ..................................................................................................................................................111 3.9.3 Rigid protruding parts.......................................................................................................................112 3.9.4 Points and wires ................................................................................................................................113 3.10 Structural integrity.............................................................................................................................114 3.10.1 Introduction ........................................................................................................................................114 3.10.2 Material suitability..............................................................................................................................114 3.10.3 Strength and durability of product...................................................................................................115 3.11 Protective function ............................................................................................................................116 3.11.1 Introduction ........................................................................................................................................116 3.11.2 Barrier function ..................................................................................................................................116 3.11.3 Restraint systems..............................................................................................................................120 3.11.4 Footholds............................................................................................................................................124 Fire and thermal hazards – Contents list .....................................................................................................130 4 Thermal hazards ................................................................................................................................131 4.1 Terms related to thermal hazard ......................................................................................................131 4.2 Safety philosophy..............................................................................................................................131 4.3 Flammability and burning hazards ..................................................................................................132 4.3.1 General................................................................................................................................................132 4.3.2 Rationale.............................................................................................................................................132 4.3.3 Requirements .....................................................................................................................................133 4.3.4 Test equipment ..................................................................................................................................133 4.3.5 Test methodology..............................................................................................................................135 4.4 Hazards from hot and cold surfaces................................................................................................138 4.4.1 Rationale.............................................................................................................................................138 4.4.2 Requirements .....................................................................................................................................138 4.5 Hazards from hot and cold liquids...................................................................................................139 4.5.1 Rationale.............................................................................................................................................139 4.5.2 Requirements .....................................................................................................................................139 4.6 Hazards from contact with flames ...................................................................................................139 4.6.1 Rationale.............................................................................................................................................139 4.6.2 Requirements .....................................................................................................................................139 4.7 Hazards from the melting behaviour of materials ..........................................................................139 4.7.1 Rationale.............................................................................................................................................139 4.7.2 Requirements .....................................................................................................................................139 4.8 Hyperthermia and hypothermia hazards.........................................................................................140 4.8.1 Rationale.............................................................................................................................................140 4.8.2 Requirements .....................................................................................................................................140


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Product information – Contents list .............................................................................................................141 5 Product information ..........................................................................................................................142 5.1 Terms and definitions related to product information ..................................................................142 5.2 Safety philosophy..............................................................................................................................142 5.3 Model requirements to include in standards..................................................................................143 5.3.1 General ...............................................................................................................................................143 5.3.2 Markings.............................................................................................................................................143 5.3.3 Purchase information........................................................................................................................144 5.3.4 Instructions for use ...........................................................................................................................144 5.4 Durability of markings.......................................................................................................................145 5.5 Warning sentences and symbols ....................................................................................................145 5.5.1 General ...............................................................................................................................................145 5.5.2 Examples of non-product-specific (general) warnings .................................................................145 5.5.3 Examples of product-specific warnings .........................................................................................147 5.5.4 Additional sources of information relating to warning sentences...............................................148 5.5.5 Additional sources of information relating to warning symbols..................................................148 5.6 Guidelines for the development of warning sentences and symbols .........................................149 5.6.1 General ...............................................................................................................................................149 5.6.2 Developing warning sentences........................................................................................................149 5.6.3 Developing warning symbols...........................................................................................................150 5.7 Guidelines for the presentation of warning sentences and symbols ..........................................151 5.7.1 General ...............................................................................................................................................151 5.7.2 Presentation of warning sentences.................................................................................................151 5.7.3 Presentation of warning symbols....................................................................................................151 5.7.4 Contrast and paper quality ...............................................................................................................151 Annex A Anthropometric data and abilities of children from birth to 4 years .........................................152 A.1 General ...............................................................................................................................................152 A.2 Terms related to anthropometric data.............................................................................................152 A.3 Recommendations for use of data ..................................................................................................153 A.4 Applications .......................................................................................................................................155 A.5 Tables with body dimensions ..........................................................................................................156 A.6 Tables with force measurements.....................................................................................................167 A.7 Abilities of children ...........................................................................................................................169 A.8 Sources of data..................................................................................................................................170 Annex B Description of risk assessment procedure..................................................................................173 B.1 General ...............................................................................................................................................173 B.2 Qualitative risk analysis....................................................................................................................174 B.2.1 Identification of qualitative characteristics of product use ..........................................................174 B.2.2 Identify possible hazards..................................................................................................................174 B.3 Risk estimation ..................................................................................................................................175 B.4 Risk evaluation ..................................................................................................................................175 B.5 Select safety measures.....................................................................................................................176 Bibliography....................................................................................................................................................177

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Foreword

This document (CEN/TR 13387:2004) has been prepared by Technical Committee CEN/TC 252 “Child use and care articles”, the secretariat of which is held by AFNOR.

This document supersedes CR 13387 :1999

This is a revision of CR 13387 first published in 1999. It is a non-normative CEN publication which provides guidance information on common hazards that should be taken into consideration when developing safety standards for child use and care articles.

These guidelines deal with hazards that are common to child use and care articles. They have been drawn-up by a working group of experts set up by CEN Technical Committee, TC 252 Child use and care articles, with the prime objective of harmonizing the approach to hazard and risk assessment and prevention. The guidelines give recommendations on preventive safety measures to avoid injuries that could be caused by child use and care articles.

The standards being drafted by CEN/TC 252 are for child use and care articles intended for children from birth to 48 months of age who form a very vulnerable group in society. Up to 18 months of age the development of knowledge takes place through the combined use of sensory and motor skills, i.e. children learn to see, hear, taste, smell and feel. Their movements are aimed at achieving familiarity with their environment. As children become older they achieve increased muscular control and balance. Even up to 48 months of age children are unpredictable in their behaviour. Special consideration has to be given to the fact that these children cannot understand how to avoid risks and thus are involuntarily exposed to them.

Child use and care articles constitute a group with large variations between the different products. However many safety hazards associated with this diverse group of products are very similar. These guidelines identify many of these safety hazards and give details that enable similar safety principles to be applied to the drafting of standards across the group of products.

The described measures are based upon safety requirements in existing standards and in standards under development for different groups of articles within the scope of CEN/TC 252.

Where similar safety issues have been applied in standards that have either been developed or are under development by CEN/TC 52 (safety of toys), CEN/TC 136 (safety of playground equipment) and CEN/TC 207 (safety of children’s nursery furniture), these have also been taken into consideration when drafting this document.

The information given in these guidelines reflects the current state of the art. Standards and regulations will continuously be developed. Other sources may also provide useful information for the reader. Some of the test methods offered have yet to be fully validated.


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Introduction

These guidelines present safety specifications and test methodology relating to hazards that are common to child use and care articles. A common approach to product information is also considered.

The general safety philosophy given in section 1 is based on the premise that child use and care articles should be designed to be safe.

Detailed safety information is given in the following sections:

chemical hazards (section 2);

mechanical hazards (section 3);

thermal hazards (section 4);

product information (section 5).

These guidelines contain two annexes and a bibliography:

Annex A contains anthropometric data and details of the abilities of children from birth to 48 months of age;

Annex B describes a risk assessment procedure;

bibliography of reference literature.

How to use these guidelines

The safety specifications and test methods given are intended to give guidance and to lead to consistency when writing safety standards for child use and care articles. In addition, these guidelines can assist those with a general professional interest in child safety.

The safety specifications detailed do not constitute an exhaustive set of specifications that can be directly applied to all child use and care articles. As subsequent sections explain, their applicability to particular products should be decided by experts. When analysing the hazards and risks associated with child use and care articles, the need to balance the reduction of hazards and risk with the capability for manufacture and use of the product should be considered.

There may also be alternative means of achieving similar levels of safety that are not envisaged in these guidelines.

In these guidelines a rationale is given for a particular hazard explaining the potential hazard to the child. Wherever possible, requirements, test equipment and test methods are given which can be used when drafting standards. It should be noted that the terminology in these guidelines is not that required for standards, and that the word shall has to be used in standards, not should as given in these guidelines.

A general safety philosophy is given in section 1 of these guidelines.

Chemical hazards are addressed in section 2. The chemical properties associated with the use of, and availability to, materials for the construction, coating and/or packaging of child use and care articles that may damage a child’s health are considered.

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Mechanical hazards are addressed in section 3. “Mechanical hazard” is a general designation for physical factors which may give rise to injury due to the mechanical properties of products or parts of products.

Thermal hazards are addressed in section 4. “Thermal hazard” is a general designation for the combustible properties of materials and/or their ability to conduct high and low temperatures which may give rise to injuries from burns and scalds.

Product information is addressed in section 5.

Annex A provides tables of anthropometric data and abilities of children from birth to 48 months of age. It presents a compilation of data in current literature. Only sources that explain the method by which the measurements were taken, and of which the sample size was large enough to give reliable results, have been selected.

Annex B describes an outline risk assessment procedure.

The Bibliography contains a list of reference literature and lists the standards that have been considered when drafting these guidelines.

These guidelines do not cover hazards related to acoustics. The sensitivity of children to loud noise is basically unknown. There are scientists who hold the opinion that, since the auditory canal in children is smaller than in adults, there is a difference in amplification which makes children more sensitive to high frequency sounds. Impulse sounds are especially hazardous since permanent damage to hearing may occur after only one exposure to high peak sound levels.

The products on the current work programme of CEN/TC 252 emit little or no noise. However, in the event of a product emitting a potentially hazardous level of noise, requirements to reduce the risk of damage to hearing due to high continuous and/or impulse noise levels given in EN 71-1 may be used. Child use and care articles that are manifestly designed to emit noise should not be capable of harming a child’s hearing. The related restrictions according to the EU-legislation for occupational noise should not be exceeded.

The diagram in Figure 1 may be used as a structure for the understanding and use of these guidelines. The suggested sequence is:

a) Consider the safety philosophy:

read and understand the general safety philosophy given in section 1.

b) Undertake a risk analysis:

conduct a risk analysis following the procedure outlined in Annex B;

for additional guidance refer to ISO/IEC Guide 50;

identify the potential for injury associated with the product e.g. injury statistics and surveillance systems, research studies, recalls, complaint data etc.

c) Establish the ability/age range of the child using the product:

establish an ability/age range for the child who uses the product;

consult the anthropometric data in Annex A;

for additional information consult other sources of data e.g. CHILDATA.


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d) Consult the hazard categories in sections 2 to 4:

consider the chemical hazards identified in section 2 and select any relevant requirements and test methodologies;

consider the mechanical hazards identified in section 3 and select any relevant requirements and test methodologies;

consider the thermal hazards identified in section 4 and select any relevant requirements and test methodologies.

e) Consult the product information in section 5:

determine the wordings for markings, purchase information and instructions for use.

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Figure 1 — Structure for the use of this report


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General safety - Contents list

1.1 Terms/definitions used in the report

1.2 Built-in safety

1.3 Accident data

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1 General safety

Safety is often a balance between being safe from injury and the other demands of a child use and care article, for example, ensuring that the item is fit for purpose as well as meeting consumers’ needs and expectations.

Attention should be paid to:

the child’s stage of development (ability, weight, age, etc.);

the intended or foreseeable use of the product, bearing in mind a child’s unpredictable behaviour. This unpredictable behaviour exposes children to injury in ways that differ from those of adults, making children a particularly vulnerable group in society;

the hazard presented by the product in the environmental circumstances under which the product and the child come into contact with each other.

Where the function of a product or part of a product changes by virtue of its use and is beyond the scope of child use and care articles, appropriate requirements should be applied. For example, toys attached to child use and care articles shall comply with appropriate toy safety requirements.

These recommendations are not exclusive and attention is drawn to the importance of ensuring that all potential hazards relevant to the product are fully addressed e.g. hygiene, the effects of electrical power etc., where other safety standards may apply.

1.1 Terms/definitions used in the report

Terms and definitions specifically related to chemical, mechanical and thermal hazards and also for product information are given in the relevant clauses.

1.1.1 Terms identical to those given in the definitions in CEN/CENELEC Memorandum no 9.

Harm: physical injury and/or damage to health or property.

Hazard: a potential source of harm or a product characteristic which could lead to injury.

Intended use: the use of a product, process or service under conditions or for purposes in accordance with specifications and instructions provided by the supplier (including information for publicity purposes).

Risk: the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm.

Safety: freedom from unacceptable risk of harm. (It should be understood that young children cannot be expected to appreciate risk adequately. Risks generally considered by society as acceptable have to be taken into account when referring to the safety of children).


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1.1.2 Common terms/definitions

Hazard characterisation: the quantitative evaluation of the nature of the adverse health effects following exposure to a risk source(s).

Hazard identification: the identification of a risk source(s) capable of causing adverse effect(s).

Risk analysis: the investigation of available information to identify hazards and to estimate risks.

Risk assessment: the evaluation, including the identification of the related uncertainties, of the likelihood and severity of an adverse effect(s) following exposure under defined means to a risk source(s).

Reasonably: should, where appropriate, take account of the foreseeable use and unpredictable behaviour of children.

1.2 Built-in safety

Standards related to child use and care articles should always be formulated with children and their safety in mind and there is no doubt about their importance in reducing children’s injuries.

Child use and care articles should be designed with the intention of making them safe. Hazards should be eliminated wherever possible. For cases where a hazard cannot be eliminated or sufficiently minimized – by design or safeguards – product related information should be given. However product related information should not be used as an alternative to safe design. ”Built-in” safety, which does not require any further human action, is the most effective means of preventing accidents and injuries associated with products. This is best built-in at the design and manufacturing stages of product development so that no safety device or action is needed when the product is used.

If a safety device is needed, it should wherever possible, be one which works automatically without human intervention. Next in order of effectiveness is a safety device which requires a single action. Least effective is when safety has to be considered in relation to the product each time it is used.

1.3 Accident data

A basis for risk assessment is given in Annex B.

Accident and injury data such as EHLASS “European Home and Leisure Accident Surveillance System” and/or other equivalent information sources should be consulted.

The absence of an accident history cannot be a good reason for an automatic presumption of a low level of risk. Other factors should be taken into account, particularly when the possible severity of injury is high.

Appropriate data may not be available for many reasons, including the absence or ineffectiveness of a data collection system, the time delay in collating and presenting statistics, changes in product design and use conditions etc. For example, historical information related to a product or material used in a hot climate may not apply to its use in colder countries or vice versa.

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Chemical hazards and risk - Contents list

2.1 General

2.2 Terms related to chemical hazards and risk

2.3 Safety philosophy

2.3.1 General

2.3.2 General strategy

2.3.3 Potential hazards of chemical constituents

2.3.4 Potential characteristics of use

2.3.5 Potential routes of chemical exposure

2.3.6 Risk characterisation

2.3.7 Risk management

2.4 Chemical hazard-reducing specifications

2.5 Migration of certain elements

2.5.1 Rationale

2.5.2 Limits

2.5.3 Requirements

2.5.4 Test methodology

2.6 Migration of vinyl chloride monomer (VCM)

2.6.1 Rationale

2.6.2 Limits

2.6.3 Requirements


2.7 Total content and migration of nickel

2.7.1 Rationale

2.7.2 Limits

2.7.3 Requirements


2.8 Total content and migration of plasticisers

2.8.1 General

2.8.2 Rationale

2.8.3 Limits

2.8.4 Requirements



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2.9 Total content and migration of formaldehyde

2.9.1 General

2.9.2 Rationale

2.9.3 Limits

2.9.4 Requirements


2.10 Total content of flame retardants

2.10.1 General

2.10.2 Rationale

2.10.3 Limits

2.10.4 Requirements


2.11 Migration of N-Nitrosamines and N-Nitrosatables substances

2.11.1 General

2.11.2 Rationale

2.11.3 Limits

2.11.4 Requirements


2.12 Migration of vulcanisation accelerators (and antioxidants)

2.12.1 General

2.12.2 Rationale

2.12.3 Limits

2.12.4 Requirements


2.13 Total content of volatile compounds

2.13.1 Rationale

2.13.2 Limits

2.13.3 Requirements


2.14 Total content and migration of certain dyes, azo-colourants and disperse dyes

2.14.1 Rationale

2.14.2 Limits

2.14.3 Requirements


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2.15 Migration of bisphenol A (BPA)

2.15.1 General

2.15.2 Rationale

2.15.3 Limits

2.15.4 Requirements


2.16 Total content of organotin compounds

2.16.1 General

2.16.2 Rationale

2.16.3 Limits

2.16.4 Requirements


2.17 Total content of pentachlorophenol (PCP)

2.17.1 General

2.17.2 Rationale

2.17.3 Limits

2.17.4 Requirements



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2 Chemical hazards and risk

2.1 General

The inherent early vulnerability of young children combined with their different stages of development and learning, exposes them to potential chemical risk from the constantly changing range and variety of child use and care articles to which they have access, either intended or not. This is of considerable importance as chemical hazards and risk represents a more ‘unseen’, usually long-term, danger than mechanical or thermal hazards.

The chemical properties of materials used to manufacture and package child use and care articles, as well as the substances and preparations used in treating and coating these materials, may generate different hazards - hazards resulting from the ingestion, skin contact and inhalation of materials that may have a harmful acute or chronic toxic, carcinogenic or mutagenic and/or allergic and/or corrosive or irritant effect. However, it is important to remember that hazard is only part of the equation and assessment of risk requires the combination of hazard and exposure.

This clause generally only addresses hazard due to the general lack of exposure data available. This remains a critical research need and will form the basis of subsequent revision of these guidelines as relevant data becomes more available.

It is intended that this clause be used in the manner indicated in the safety philosophy (2.3). In this way the nature of the hazard and the risk is identified; the methods indicated in 2.5 to 2.17 may be used to assist derivation of the risk by providing levels of content or migration for specific chemicals. Where risk is considered to exist, an appropriate risk management strategy should be considered. When risk has been eliminated or reduced to the lowest practicable level, the methods indicated in 2.5 to 2.17 may then be considered to ensure acceptable levels are not exceeded. Where a method provided is not considered applicable, or not available at present, a suitable alternative may be considered.

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2.2 Terms related to chemical hazards and risk

A number of different definitions may be found for the following terms, e.g. in ISO/IEC Guide 50 or CEN/CENELEC Memorandum 9, but those used here represent the European Commission’s (EC) independent expert Scientific Committee of Toxicity, Ecotoxicity and the Environment (CSTEE) more detailed guidance on ’standardising’ current variability in (chemical) risk assessment procedures (http://europa.eu.int/comm/food/fs/sc/ ssc/out83_en.pdf).

Risk assessment: the evaluation, including the identification of the related uncertainties, of the likelihood and severity of an adverse effect(s) occurring to people following exposure under defined means to a risk source(s).

Hazard identification: either - the identification of a risk source(s) capable of causing adverse effect(s) to people, together with a qualitative description of the nature of these effect(s):

or - the determination of particular hazards people may be exposed to, including related toxicity data;

or - the determination of substances of concern and the adverse effects they may inherently have on people under certain conditions of exposure, taking into account toxicity data.

Hazard characterisation: either - the quantitative or semi-quantitative evaluation of the nature of the adverse health effects to people following exposure to a risk source(s):

or - the qualitative and, whenever possible, quantitative description of the nature of the hazard (or possible adverse effect[s]) associated with a biological, chemical or physical agent, based on one or more elements, such as mechanisms of action involved, biological extrapolations, dose-response and dose-effect relationships, and their respective related uncertainties.

Exposure assessment: either - the quantitative or semi-quantitative evaluation of the likely exposure of people to a risk source(s) from one or more media:

or - the quantitative and qualitative analysis of the presence of a chemical (including its derivative) which may be present in a given environment and the influence of the possible consequences it may have for a given population of particular concern.

Risk characterisation: either - the quantitative or semi-quantitative estimate, including related uncertainties, of the probability of occurrence and severity of adverse health effect(s) in a given population under defined exposure conditions, based on hazard identification, hazard characterisation and exposure assessment:

or - the integration of evidence, reasoning and conclusions collected in hazard identification, dose-response assessment and exposure assessment and the estimation of the probability, including related uncertainties, of occurrence of an adverse effect if a chemical is administered, taken or absorbed by a particular organism or population;

or - the qualitative and/or quantitative estimation, including related uncertainties, of the severity and probability of occurrence of known and potential adverse effects of a chemical in a given population.

No observable adverse effect level (NOAEL): The highest dose that does not give a biological end-point effect(s).

Tolerable daily intake (TDI)/Acceptable level (in mg/kg of body weight, BW): The maximum permissible amount of a chemical which may find its way into the body, by all routes, and from all sources in the course of an average day during a person’s lifetime.

Lowest observable (adverse) effect level (LO(A)EL): The lowest observed dose shown to give a biological end-point effect(s).


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2.3.1 General

A new chemicals legislation strategy for registration, evaluation and authorisation of chemicals (REACH) is currently under discussion within Europe. This system will authorise chemical substances of high concern. Such substances will not be permitted for use except for authorised purposes. Whether or how this REACH system will apply to substances and articles is still under debate at the time of publication. It is advised that up-to-date information be sought on REACH as it becomes known.

Existing general European legislation covers both health and environmental effects from chemicals for professional and consumer use, but for the reduction of risks of high concern due to the use of chemicals in certain types of products, the new approach products directives are relevant for ensuring safety. These directives protect people from acute risks from chemicals in products, but the long-term or chronic effects from chemicals are not their main focus. However, child use and care articles do not currently have such a directive.

The Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (currently under revision) covers all packaging placed on the European market and all packaging waste, whether it is used or released at industrial, commercial, office, shop, service, household or any other level, regardless of the material used.

The assessment of health risk from exposure to chemicals is of paramount importance to ensuring children’s safety. When drafting safety standards for child use and care articles it is necessary to consider the possibility of chemical hazards arising from ingestion, skin contact and inhalation of materials used in the construction, coating and/or packaging of these articles. Ingestion is of particular importance as young children frequently mouth anything within reach.

The degree of risk depends on the hazard of the particular chemical constituent, its concentration in the child use and care article, and the extent of exposure (contact with and transfer from the article) to the child. To carry out an assessment of the risk from a toxic substance potentially present in some part of a child use and care article, all the necessary relevant experts should be consulted, for example chemists, toxicologists and socio-economists.

However, risk assessment is intended to be of practical use, and yet there is wide variability in the quality and quantity of data on different risk sources. Until now though, there have been few attempts to systematically co-ordinate such assessments. The International Programme on Chemical Safety (IPCS) has an active programme on harmonisation of approaches to the assessment of health risks. It should help ensure openness, transparency and consistency in the process of hazard identification and evaluation of chemicals, prioritisation of those chemicals, and subsequent adoption of commonly acceptable exposure scenarios and characterisation of the degree of risk. Appropriate risk management strategies should then be considered. The following strategy is based on this recommended approach.

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2.3.2 General strategy

Specification of the problem in an unambiguous and transparent form is essential for an effective risk assessment process. The scientific information necessary for this relates to the:

nature of the hazard (what, why, how, unexpected, scale);

possible adverse effects to health (severity, speed, frequency of effect);

relevant sources of exposure;

age range and development of the child; and

route and nature of exposure.

How these questions are addressed provides the basis of the approach for the risk assessment. Four main stages are generally accepted to be relevant to any assessment:

hazard identification;

hazard characterisation (and prioritisation of chemicals);

exposure assessment; and

risk characterisation.

It is important that there is transparency and consistency in, and therefore between, risk assessment processes. Any assessment should lead to a value judgement being able to be made on the results.

2.3.3 Potential hazards of chemical constituents

It is first necessary to consider what hazardous chemicals might be present in the child use and care article as particular materials give rise to specific hazards.

Table 2.3A illustrates many of the materials that may be used and the main hazardous substances potentially present in each case. It should not be taken as an exhaustive ‘list’ of materials nor of the possible chemical hazards. Readers are also directed to the Ospar list of chemicals for priority action (http://www.ospar.org/documents/02-03/OSPAR03/SR-E/ANNEX12_List%20of%20chemicals%20for%20priority%20action.doc). The possible hazards may be even wider than those indicated in the table, although the chemical risk may not necessarily be significant.


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Table 2.3A — Materials likely to be used and their associated hazards

A=Migration of certain elements. B= Dyestuffs/pigments, C=Flame retardants, D=Plasticisers, E=Formaldehyde, F=Preservatives, G=Allergies, H=Other toxic substances.

Type of Material Type of Hazard

A B C D E F G H

Constructional Bamboo X X X Basketwork X X X Chipboard/plywood X X X X X(j,y) Metals/alloys X X(Ni) Plastics X X X X X X(n,w,y) Rubber X X X X X X(h,s,t) Wood X X X X(j,y) Sheet Fur X X X X X X(m) Leather X X X X(Cr) X(j,y) Paper/board X X X X X(d,j,y) Plastics X X X X X X(n,w,y) Rubber X X X X X X(h,s,t) Textiles X X X X X X X(j,n,p,y) Coatings Enamel X Metal plating X X(Ni) Paint/varnish X X X X Plastics X X X X X Rubber X X X X X X(h,s) Fillings/Paddings Feathers X X X X X(m) Foamed plastics X X X X X Hair X X X Straw X X X Wadding (natural) X X X X X X(p) Wadding (man-made)

X X X X X

Other Bristles X X Cord/string/rope X X X X X X Cork X X X where

Cr- chromium, d- dioxins, h- N-Nitrosamines and N-Nitrosatable substances, j- polychlorophenol, m- fine particles, n- vinyl chloride monomer, Ni- nickel, p- pesticides, s- accelerants/vulcanisation agents, t- volatile compounds, w- bisphenol A, and y- organometallics.

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All such hazards have to be assessed individually to discover the extent of the risk. For each identified chemical, consideration should first be given to relevant toxicological evaluation(s) based on:

information available for supply from related stakeholders (e.g. industry);

literature searching strategy (e.g. published scientific literature in standard toxicological and related texts);

evaluations undertaken for the use of a particular chemical in other consumer product areas (e.g. food contact materials, organic chemical release from toys and cosmetics); and

known accident data, although the absence of accident data does not necessarily indicate the presumption of a low level of risk.

The typical toxicological information to be gathered for a meaningful assessment requires identification of the most significant end-point(s) from the following range of tests:

acute toxicity;

skin and eye irritation;

skin sensitisation;

sub-chronic toxicity;

carcinogenicity;

mutagenicity; and

reproductive toxicity.

For a few chemicals, more detailed examination of aspects of neurotoxicity, immunotoxicity, endocrine toxicity or other special studies may be required. In some cases, knowledge of the mechanism by which the observed toxicity is induced may be required to assess whether the mechanism of action is relevant to people.

The toxicological data should be used to derive a numerical score of toxicological priority as the means of identifying priority chemicals for further assessment. The modified IPS (Informal working group on Priority Setting) ranking scheme, should form the basis of this prioritisation step. It enables combination of toxicological hazard assessment and exposure estimation to determine a human health priority score.

Chemicals should be ranked for mutagenicity, carcinogenicity, reproductive toxicity, skin sensitisation and severe target organ toxicity by the above hazard-ranking procedure. Scores for mutagenicity and reproduction, in particular, may be modified in light of toxicological interpretation of the data.

‘High ranking’ chemicals (based on evidence of effects in animals that may be relevant to humans, or evidence to suggest/clear effects in humans) are already likely to have been prohibited for use in consumer products. It should be noted that chemicals already classified as Category 1 or 2 for carcinogenicity, mutagenicity or toxicity for reproduction under Directive 67/548/EEC are restricted for consumer use. In some cases it is probable that the levels of such chemicals in the products should be kept as low as is practically possible; standards and methods should then be developed at the limit of detection. Where there is insufficient data to evaluate at least the mutagenicity, reproductive toxicity and skin sensitisation end-points, a ‘ranking’ suggesting generation of additional relevant toxicological information should be used. Where there is either no evidence of, or only limited data on, toxic effects in animals or humans and where such data exists, it is either clearly irrelevant or unlikely to occur in humans, a more subjective assessment is required. Consideration should then be made of available usage information, potential exposure routes and amount of migratable chemicals (second tier assessment, see 2.3.5).


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2.3.4 Potential characteristics of use

The qualitative characteristics of the use of the child use and care article should then be identified. Factors that should be considered include the:

intended and foreseen age range and ability of the child;

conditions under which the article is to be used (taking into account the normal behaviour of children, the degree of supervision, the simultaneous use of the article by more than one child and all phases of the life cycle of the article);

environment in which the article is to be used, e.g. indoors taking into account factors such as ventilation;

length of time of exposure to the article; and

likely route(s) of exposure to the article, e.g. ingestion, skin contact or inhalation.

2.3.5 Potential routes of chemical exposure

2.3.5.1 General

There are three major routes by which chemicals can enter the body; ingestion, skin contact and inhalation. Where exposure through more than one route is likely, an additive approach may be used. When data is unavailable for one route of exposure, extrapolation from another route may be possible, although there are inherent uncertainties in such cases.

In addition, there may also be the potential risk of an allergic reaction to natural materials, e.g. fur, feathers, rubber and leather, by children who are particularly disposed to allergies. Furthermore, the presence of mould, if prone to development, may also give rise to allergic reaction.

2.3.5.2 Ingestion

The possible risk of a child ingesting a hazardous substance as a result of mouthing (licking or sucking) an article is the most important of the potential chemical hazards. Ingestion includes both extraction by saliva and the act of swallowing, e.g. paint removed by teeth or extractable chemical constituent from a material, such as plasticiser from polyvinylchloride (PVC).

General guidance in determining daily intake from observed release levels is as follows:

The analytical result obtained for the mass of analyte extracted C (mg) first needs to be converted into a release rate C1, the mass extracted per cm2 of sample per hour of extraction.

×= /hmg/cm2

1 TSCC

where

S is the surface area of the sample in cm2; and

T is the extraction time in hours.

This is then converted into a daily intake, I.

I = C1 x A x M (mg/day)

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where

A is the area of item mouthed by a child in cm2; and

M is the maximum mouthing period in hours/day.

2.3.5.3 Skin contact

A further possible route of exposure is from contact between the child use and care article and a child’s skin. This is usually only a consideration when a child repeatedly touches (part of) an article in use. For example, transfer of a water-soluble chemical, e.g. a dye from a textile such as a bed-sheet. There may be a risk of allergic reaction from skin contact with certain chemical constituents within child use and care articles, e.g. nickel and formaldehyde, although usually direct and prolonged contact is required before the body becomes sensitised.

There may also be the potential transfer, by fingers, of a chemical from a child use and care article to the mouth. However, such problems are usually considered under ingestion where the risk is greater.


The analytical result obtained for the mass of chemical extracted C (mg) first needs to be converted into a release rate C1, the mass extracted per cm2 of sample per hour of extraction.

TSCC×

=1 (mg/cm2/h)

where

S is the surface area of the sample in cm2; and

T is the extraction time in hours.


FMACl ×××= 1 (mg/day)

where

A is the area of skin of the child in cm2 in contact with the material of the child use and care article;

M is the duration in hours/day of skin contact with the material of the child use and care article; and

F is the fraction of chemical absorbed through the skin, e.g. 1 (assumes 100 % absorption) if no data to indicate otherwise.

NOTE it is important that for dermal exposure, these parameters are considered on a case-by-case basis for specific child use and care articles.

2.3.5.4 Inhalation

There is also the potential risk from inhalation of released volatile compounds from child use and care article, e.g. siloxanes from silicone soothers or feeding bottle teats, or formaldehyde from plywood or chipboard. These restrictions should still apply even if the dimensions of the part might mean that the amount of volatile compounds released by the article is minimal.



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The analytical result obtained for the mass of chemical extracted C (mg) first needs to be converted into a release rate C1, the mass extracted per m3 of air per hour of extraction.

TVCC×

=1 (mg/m3/h)

where

V is the volume of air in m3; and

T is the extraction time in hours used in the experiment in hours.


MVRCl ××= 1 (mg/day)

where

M is the maximum exposure period in hours/day; and

VR is the ventilation rate of the child in m3/h.

The following shows accepted ventilation rates used by the US Environment Protection Agency (EPA) in a lead absorption model:

Age (years) Ventilation rate (m3/day) Ventilation rate (m3/h)

0-1 2.0 0.080

1-2 3.0 0.125

2-5 5.0 0.208

5-7 7.0 0.292

NOTE it is suggested that exposure limits should be based on World Health Organisation (WHO) air quality guidelines for those chemicals that have such limits. For others, occupational exposure limits may be available (assume 8 h exposure/day), where an additional safety factor of 10 can be used to reflect the fact that children may be more sensitive than working adults. For some chemicals, TDIs derived from oral exposure may be available. Here assumptions would have to be made as to the extent of absorption from the lungs into the systemic circulation and what proportion of the TDI is to be allocated to child use and care articles. If appropriate data is not available, 100 % absorption should be assumed.

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2.3.5.5 Exposure modelling

Lack of good exposure data is frequently a problem. Where such data is unavailable, ‘best’ or ‘worst case’ exposure estimates may need to be generated; the emphasis is usually on the latter in the first instance with subsequent refinement in the event of any identified concern. Default assumptions should be made about the human body where required. The UK Department of Trade and Industry (DTI) publishes ‘Childata’, which is a useful source of collated information for physical measurements of children. However, there is currently little other validated data available to assist with exposure assessments. Compilation of such data, where it exists, will be included in subsequent revision of this document. In the meantime, common exposure model scenarios and their validation are required to replace the current estimated or measured exposure-related data. Laboratory-based studies may also be used to overcome difficulties associated with the absence of exposure-related data. Literature and information review may be used to establish appropriate exposure parameters and scenarios and to derive relevant criteria for exposure assessment. Existing candidate laboratory studies can then be reviewed or new studies derived and the limit values produced can be used as part of any risk assessment. However, these laboratory-based studies may produce, or be refined to produce, limit values in line with toxicologically acceptable measured or estimated exposure limit values obtained from other sources on a known product. Through validation by collaborative trial, the values obtained from these laboratory-based studies can then be considered against limit values. The CONSumer EXPOsure models application (CONSEXPO 3.0), a computer software modelling tool based on mathematical contact, exposure and uptake models, may be useful in the assessment of human exposure to chemicals from consumer products. It contains the algorithms which are contained in the 1996 EU Technical Guidance Documents in support of the Commission Directive 93/67/EEC - Risk Assessment for new Notified Substances, Commission Regulation 1488/94 - Risk Assessment for Existing Substances and the 1996 EU System for the Evaluation of Substances (EUSES) (EUR 17308 EN).

2.3.5.6 Exposure release levels

The proposed approach of second tier assessment using measured, estimated or predicted intake or exposure has been adapted from the EC Scientific Committee for Food (SCF) strategy based on three exposure classes:

Low level release, corresponding to an intake of <1µg/kg bodyweight (BW)/day:

in such cases, only in vitro mutagenicity data (as the generally accepted critical adverse effect indicator of carcinogenicity) are required. The three accepted tests are the bacterial test for gene mutation, test for clastogenicity and for aneugenicity, and mammalian cell mutation assay (mouse lymphoma assay preferred);

Medium level release, corresponding to an intake of 1-100µg/kgBW/day; and

in such cases, bio-accumulation data (octanol/water partition coefficient), the above three in vitro mutagenicity studies, a 90-day oral study and sensitisation data are required.

High level release, corresponding to an intake of 100-1000µg/kgBW/day:

in such cases, a full data package including absorption, distribution, metabolism and elimination (ADME), reproductive and development studies is required. The need for carcinogenicity data should be considered on a case-by-case basis in light of the results of the mutagenicity studies (genotoxic or non-genotoxic) and the fact that exposure to chemicals in child use and care articles does not constitute life-time exposure.


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2.3.6 Risk characterisation

Risk characterisation presents the comparison of levels of concern with exposure levels.

For risks from most chemicals, a uni-dimensional approach is usually used, based on the assumption that for all effects (other than cancer) there is a threshold level of exposure below which no (observable) adverse effects occur (NOAEL). Data are usually derived by extrapolating from high-dose animal studies to low-dose human exposure, and from small animal groups to the larger diverse human population.

Whilst likely for an individual, biological variability in response to identical exposures within a population makes things more difficult; hence the introduction of uncertainty/safety factors to provide acceptable limits. The tolerable daily intake (TDI) of a chemical is derived by dividing the NOAEL by an appropriate uncertainty factor (usually 100) which represents inter-species and inter-individual differences. Where a NOAEL is unavailable, a lowest observable [adverse] effect level (LO[A]EL) may be used; in such cases a further uncertainty factor (usually 5) may be introduced.

The daily intake is then compared to the TDI for the chemical. The level of chemical released from one particular child use and care article should not exceed some fraction of this TDI. However, child use and care articles are not usually the only possible source of exposure to the chemical. A 10 % contribution to the total fraction from child use and care articles seems reasonable, although there may be justification for a higher value in certain situations.

I (mg/day) < 10 % TDI (mg/kgBW) x W

where

W is the weight of the child in kg.

Quantitative risk assessment by low-dose extrapolation is generally used for non-threshold (e.g. genotoxic) substances, such as N-Nitrosamines, giving an estimate of risk for a particular level of exposure or an estimate of exposure for a pre-defined level of risk. It is necessary to reduce the levels of these chemicals to as low as is reasonably practical.

2.3.7 Risk management

Risk management then weighs the policy alternatives in light of this result and, if required, as a means for selecting and implementing appropriate risk reduction/control options.

The identification of any risks requires safety measures, either to remove the risk completely or, at least, to reduce it to as low a level as is reasonably practical. This may be by limiting access to the chemical hazard(s) by material selection or design, or by limiting or preventing access to the hazard(s) by ‘coating’. This may include, if appropriate, application of the Precautionary Principle. Consensus on this point is usually determined by the state-of-the-art.

However risk assessment results do not account for how individuals and societies value certain adverse consequences, i.e. the public perception of risk. No transparent framework yet exists for allowing risks and benefits to be compared.

Any residual risk that cannot be removed by the above safety measures should be communicated to the user/carer.

Any outcome may need to be amended as new information becomes available or new perceptions developed.

This strategy may give rise to requirements and accompanying test methods, the requirements allowing assessment whether the acceptable level of risk has been reached, rather than prescribing a specific solution.

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2.4 Chemical hazard-reducing specifications

There are available chemicals for which total content or migration limits may be required because of health (toxicological) concerns following identification of toxicological hazard or exposure to low levels of the substances.

The following sub-clauses (2.5 to 2.17) provide general guidance for helping set appropriate limits using the risk assessment approach already identified, for some of the more common chemicals likely to be encountered with child use and care articles. They specifically recommend test methodology (and test equipment) that should be applied to ensure conformance with specified limits:

migration of certain elements (2.5);

migration of vinyl chloride monomer (2.6);

total content and migration of nickel (2.7);

total content and migration of plasticisers (2.8);

total content and migration of formaldehyde (2.9);

total content of flame retardants (2.10);

migration of N-Nitrosamines and N-Nitrosatable substances (2.11);

migration of vulcanisation accelerators (and antioxidants) (2.12);

total content of volatile compounds (2.13);

total content and migration of certain dyes, azo-colourants and disperse dyes (2.14);

migration of bisphenol A (2.15);

total content of organotin compounds (2.16);

total content of pentachlorophenol (2.17).

Additional clauses, e.g. for preservatives, non-ionic surfactants and volatile solvents, are planned for subsequent revision of this document. Standardisers should review current practice in all cases; e.g. work on organic chemical compounds in toys is well underway in CEN/TC 52/WG9 (Safety of toys).


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2.5 Migration of certain elements

2.5.1 Rationale

The rationale for setting limits for the release of certain elements from child use and care articles is that, in general, they are accepted to be cumulative poisons that may pose health risks following relatively low levels of exposure, primarily through the oral route. The aim is therefore to set the strictest limit that can reasonably be achieved and measured, whilst maintaining the desired level of safety.

2.5.2 Limits

For guidance, two sets of standard limits are given below for application to general and specific cases of child use and care articles. These are maximum allowable migration levels; for both environmental and health reasons, the lowest practicable level of incorporation and/or migration should be considered. Articles intended to be mouthed by children should not exceed the specific limits given in Table 2.5A.

Table 2.5A — Specific limits for migration of certain elements

Antimony, Sb 60 mg/kg

Arsenic, As 25 mg/kg

Barium, Ba 250 mg/kg

Cadmium, Cd 50 mg/kg

Chromium, Cr 25 mg/kg

Lead, Pb 90 mg/kg

Mercury, Hg 25 mg/kg

Selenium, Se 500 mg/kg

All other child use and care articles should not exceed the general limits given in Table 2.5B.

Table 2.5B — General limits for migration of certain elements

Antimony, Sb 60 mg/kg

Arsenic, As 25 mg/kg

Barium, Ba 1 000 mg/kg

Cadmium, Cd 75 mg/kg

Chromium, Cr 60 mg/kg

Lead, Pb 90 mg/kg

Mercury, Hg 60 mg/kg

Selenium, Se 500 mg/kg

2.5.3 Requirements

When tested in accordance with the methodology shown in 2.5.4, the migration of certain elements should not exceed the specific or general limits indicated in 2.5.2.

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These guidelines have been based on existing work in the field of toy safety. The test method applicable for the determination of the migration of these elements from child use and care articles is that specified in EN 71-3 Safety of toys - Migration of certain elements. The method has been validated within specified concentration ranges for the individual metals to be determined. Areas of testing (accessibility) are considered in EN 71-1 Safety of toys – Mechanical and physical properties.

For some child use and care articles, there is likely to be an added safety margin built in to the recommended limits when compared to toy safety. EN 71-3 assumes that particles of a toy product (e.g. paint) will become detached and ingested; migration into hydrochloric acid solution (stomach acid simulant) is therefore determined. Whilst some child use and care articles, e.g. babies’ soothers, may be mouthed for relatively long periods, the likelihood of ingestion of detached particles is low. Furthermore, migration of certain elements into artificial saliva simulant has been shown to be generally similar to, or lower than, stomach acid simulant.


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2.6 Migration of vinyl chloride monomer

2.6.1 Rationale

The rationale in setting limits for residual vinyl chloride monomer (VCM) in child use and care articles is that it is listed as a known carcinogen (Fourth Annual Report on Carcinogens, NTP 85-002, 1985). The exposure of most concern is through the oral route. The aim is therefore to set the strictest limit that can reasonably be achieved and measured.

2.6.2 Limits

Child use and care articles should meet the limit for VCM release set for food contact materials of 1 mg/kg.

2.6.3 Requirements

When tested in accordance with the method indicated in 2.6.4, the amount of migrated VCM should not exceed the limit indicated in 2.6.2.


The test method for determining the migration of VCM from child use and care articles is that specified in the official Community method of analysis for Directive 78/142/EEC and its amendments - Materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs.

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2.7 Total content and migration of nickel

2.7.1 Rationale

Nickel is a well-known sensitiser, which may cause serious allergic reactions when in direct and prolonged contact with the skin, e.g. nickel-coated metal clips or metal studs/zippers on clothing or equipment.

The 12th amendment to Directive 76/769/EEC - Restrictions on the marketing and use of certain dangerous substances and preparations, provides restrictions on the use of nickel in jewellery and other items intended to come into direct and prolonged contact with the skin. No definition is given for the interpretation of such contact. However, products intended for very young children should be treated as special cases and prolonged contact should be interpreted as being potentially in contact with the nickel-releasing surface for ≥ 1 h/day for a period of ≥ 4 weeks.

2.7.2 Limits

Nickel should not be used in products intended to or likely to come into direct and prolonged contact with the skin if the rate of nickel release from the part of the product in direct and prolonged contact with the skin is > 0.5 µg/cm2/wk.

Nickel should not be used in products intended to or likely to come into direct and prolonged contact with skin which have a non-nickel coating, unless the coating is sufficient to ensure that the rate of nickel release is not > 0,5 µg/cm2/wk for a period of at least 2 years of normal use of the product.

2.7.3 Requirements

When tested in accordance with the appropriate methodologies shown in 2.7.4, the total content or migration of nickel should not exceed the limits indicated in 2.7.2.


Three test methods and a draft for development have been developed by CEN/TC 283/WG4 - Precious metals, to demonstrate compliance with Directive 76/769/EEC:

EN 1810, Body-piercing post assemblies - Reference test method for the determination of nickel content by flame atomic absorption spectrometry;

EN 1811, Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin;

EN 12472, Method for the simulation of wear and corrosion for the detection of nickel from coated items (followed by EN 1811); and

CR 12471:2002, Screening tests for nickel release from alloys and coatings in items that come into direct and prolonged contact with the skin.


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2.8 Total content and migration of plasticisers

2.8.1 General

Plasticisers are added to polymers to give them specific properties, e.g. flexibility. They are used extensively in PVC, polyvinylidene chloride (PVDC), cellulose-acetate and unsaturated polyesters, etc. Plasticiser levels can be as high as 40 + %. They may also be present in glues and varnishes. They may also be used in lubricants at far lower levels, e.g. 2 %. Exposure to these substances can occur through both the oral and, to a lesser extent, dermal routes.

Guidelines concerning plasticiser migration have traditionally been based on static tests to assess migration from materials and articles in contact with food. However, it is now widely accepted that testing which provides data under more realistic (dynamic) conditions of exposure is more appropriate for assessing indicative plasticiser release from child use and care articles that are intended to be, or which may be, mouthed.

Achieving a predictive laboratory-based (in vitro) method for plasticiser migration has been limited by the lack of validated oral contact time and in vivo migration data as reference points. Adult data, rather than that for children, represents the only practical and ethical means for deriving such data. Since its derivation through child observation and in vivo adult ‘chew and spit’ studies, two methods have been developed and validated, albeit to differing extents. The more validated of the two is currently only applicable to determining one of the potential phthalate plasticisers (di-isononylphthalate) increasingly being found in soft PVC child use and care articles (Dutch Consensus Report, September 1998 and JRC/RIVM EUR 19899 EN, 2001). The other method has wider applicability for all commonly-used phthalate plasticisers as well as other plasticisers (A.O. Earls, I.P. Axford and J.H. Braybrook, J.Chrom.A, 983 (2003) 237-246 and LGC/1999/DTI/002&3, 1999). Hence both are provided in 2.8.5, in addition to a static test, to allow appropriate selection, depending on the likely usage of the article and the plasticiser(s) present.

2.8.2 Rationale

Discussions as to the potential levels of plasticiser migration from certain child use and care articles, have led the CSTEE to review currently available toxicological, migration and exposure data for six phthalate plasticisers (and certain common citrate and adipate plasticisers) and, where possible, set appropriate TDIs.

An additional potential risk is identifiable with highly plasticised PVC articles where pieces of the PVC itself may be ingested. Plasticiser migration from the PVC in the stomach can lead to sharp, rigid PVC that can cause serious injury. Manufacturers should be aware of this potential problem and take precautions to minimise the risk of ingestion of such materials.

2.8.3 Limits

The following guidance in setting total content limits in child use and care articles made from soft PVC is now available. For total plasticiser release from articles intended to be mouthed (e.g. soothers and feeding equipment and utensils), the Commission Decision of 7th December 1999 (1999/815/EC) prohibits the placing on the market toys and childcare articles made of soft PVC containing specified phthalates. This ruling applies only to those articles intended to be placed in the mouth by children under three years of age. The limit is 0,1 % (w/w) in the article of one or more of six specified phthalates: di-butyl phthalate (DBP), di-n-octyl phthalate (DNOP), di-(2-ethylhexyl) phthalate (DEHP), di-isononyl phthalate (DINP), di-iso-decyl phthalate (DIDP), and butylbenzyl phthalate (BBP).

The following general guidance in setting migration limits is currently as follows, but the most up-to-date information should be sought when addressing this issue. For migration release of plasticisers from articles that may be mouthed (e.g. cot rails and upholstery of a highchair or pushchair), the CSTEE (http//europa.eu.int/comm/dg24/health/sc/sct/out19_en.html) recommends the following guideline values for maximum permissible extracted amounts (for a child of 8 kg BW) of 0,8 mg DBP, 3,0 mg DNOP, 0,3 mg DEHP, 1,2 mg DINP, 2,0 mg DIDP, and 1,6 mg BBP per 10 cm2 of article mouthed over a 3 hour time period. These values do not take into consideration the fact that children may be exposed to additional sources of phthalates.

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The CSTEE also recommends that the insufficient toxicological and exposure data for certain citrate and adipate plasticisers (tri-ethylcitrate, tri-butylcitrate, acetyl triethylcitrate and acetyl tributylcitrate, and di-(2-ethylhexyl) adipate) does not make it possible to support their current use as alternatives to phthalates in toys and childcare articles intended to be, or which may be, mouthed. They do however suggest that guidance migration limits could be set, assuming satisfactory data becomes available.

Tri-cresylphosphate and tris-(2-chloroethyl)phosphate are considered under flame retardants (2.10), but are not recommended for use as plasticisers in child use and care articles.

2.8.4 Requirements

When tested in accordance with the appropriate methodologies shown in 2.8.5, the total content or migration of phthalates should not exceed the limits indicated in 2.8.3.

When tested in accordance with the appropriate methodologies shown in 2.8.5, the certain citrate and adipate plasticisers shown in 2.8.3 should not be present.


2.8.5.1 Static test method

A suitable static migration test method is similar to that used for the testing of materials and articles in contact with food. The suggested migration conditions are:

Migration solution: artificial saliva (as BS 6684).

Extraction period: 3 hours.

Sample shape/size: sample prepared with minimum cutting; surface area accurately measured (ignore thickness of sample if > 1 mm).

Sample:liquid ratio: 10 cm2:20 ml.

Temperature: 37 °C.

The migrated phthalate should be extracted into a suitable solvent (e.g. hexane) before quantification. A suitable gas chromatography (GC) method is:

Column: CPSil 5CB, 2 m × 0,222 mm or equivalent.

Carrier gas: nitrogen.

Flow rate: 0,4 ml/min.

Oven temperature 250 °C.

Injector temperature: 270 °C.

Detector: flame ionisation (FID).

Detector temperature: 300 °C.

Split ratio: approx. 1:70.

Internal standards: trimethylhexylphthalate for the determination of DEHP and dibutylphthalate for DINP and DIDP.

A calibration curve for DEHP can be prepared in the usual way using an internal standard. However, since DINP and DIDP are complex isomeric mixtures, quantification is more complicated. The graph may be prepared by plotting the ratio of the sum of the height of the internal standard peaks against concentration. As the isomeric mixtures vary between samples, a new calibration curve should be prepared for each sample.


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2.8.5.2 Total content test method

The method described primarily extracts, identifies and quantifies monomeric phthalates (with wider application to other types of plasticisers) contained in PVC samples. The extraction method uses Soxhlet extraction with diethylether or other suitable solvent. The total solvent extractable plasticiser content is calculated by weight with GC-mass spectroscopy (GC-MS) detection to identify and quantify individual phthalates.

Pre-heat a 150 ml flat-bottomed flask in an oven at (105 ± 5) °C for (30 ± 5) min and allow it to cool in a dessicator prior to accurately weighing. Add approx. 50 ml solvent to the flask. Accurately weigh (2 ± 0,2) g of the article cut into small pieces (<5 mm ∅). Place in a Soxhlet thimble, adding cotton wool to prevent the sample escaping, in a Soxhlet extractor. Connect the flask, extractor and condenser together. Reflux gently on a heating mantle for (360 ± 30) min. After cooling, completely evaporate the solvent and place in an oven for (30 ± 5) min prior to cooling in a dessicator. After (30 ± 5) min, accurately weigh the flask and record the weight. Repeat until the difference between two consecutive weights is ≤ 0,000 5 g.

To the weighed extract, add (50 ± 2) ml of n-hexane or other suitable solvent. Swirl the flask to completely dissolve the plasticiser extract. Decant the solution into a 200 ml volumetric flask. Repeat, adding the rinses to the flask. Make up to the mark. As appropriate, prepare further diluted solutions so that the final concentration in solution is within the linear calibration concentration for phthalate present. Transfer a portion of solvent into a capped vial for GC-MS analysis.

The following GC-MS conditions for phthalate determination have been found to be suitable (see also Table 2.8A):

Model: 5890 GC with a HP5971A MSD with scan range 50 amu to 500 amu.

Column: 30 m, 0.25 mm I.D. & 0.15 µm film thickness, 50 % dimethyl-50 % diphenyl-polysiloxane, e.g. DB-17HT.

Carrier gas: He.

Flow rate: 0.8 ml/min.

Injector temp: 290 °C.

Injection volume: 2 µl.

Injection type: splitless.

Detector: MSD.

Transfer line temp: 280 °C.

MSD mode: electron impact (EI).

Temp. programme: 40 °C for 4 mins, 40 °C to 300 °C @ 10 °C/min, isothermal 4 mins. total run time, 34 mins.

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Table 2.8A — Typical quantitation ions for phthalate plasticisers

Typical quantitation ions for : Tgt ion Q1 Q2 Q3

Di-butylphthalate (DBP) 149 223 278

Butylbenzyl phthalate (BBP) 149 206 238

Di-(2-ethylhexyl)phthalate (DEHP)

149 167 279

Di-n-octyl phthalate (DNOP) 149 279 261

Di-isononyl phthalate (DINP) 149 293 127 167

Di-isodecyl phthalate (DIDP) 149 307 167 141

Compare the obtained GC-MS spectra to known spectra or phthalate ester standards to allow qualitative identification of phthalate ester plasticisers or any other compounds. Plot a calibration graph of the response against known standard concentrations and determine the response of phthalate ester found in the sample.

This method may have to be modified for other branched chain phthalates or other plasticisers.

2.8.5.3 Migration test methods

2.8.5.3.1

A suitable method for determining the release of di-isononylphthalate in saliva simulant from toys (and child use and care articles) using a head-over-heels dynamic agitation device is described in JRC/RIVM EUR 19899 EN, 2001 at www.jrc.cec.eu.int.

In this procedure, the test sample is mechanically treated with a saliva simulant of aqueous salt solution. After 30 mins of dynamic mechanical treatment, the saliva extract is removed for subsequent extraction. The flask and sample are replenished with fresh saliva simulant and subjected to a further mechanical treatment. The pooled saliva simulant extracts are subjected to two successive extractions using cyclohexane in a separation funnel. The amount of DINP in the cyclohexane solution is determined by normal phase high performance liquid chromatography (HPLC) using ultra-violet (UV) detection at 225 nm and validated by GC-MS using a non-polar column. Quantification is achieved using an external standard calibration procedure as well as an internal standard.

The migration levels observed using Dutch PVC reference material containing DINP clearly shows the migration levels for DINP to correlate to the in vivo mean value reported by the human volunteer studies and not the maximum value recommended by the CSTEE as the target value for any methodology. Caution is therefore required when comparing observed migration values with the guidance migration levels recommended by the CSTEE in 7.4.2.

2.8.5.3.2

A suitable method for determining the release of all commonly-used phthalates (including the six CSTEE-specified phthalates) as well as other plasticisers in saliva simulant from (toys and) child use and care articles using a linear horizontal (transverse) shaking water bath is described in A.O. Earls, I.P. Axford and J.H. Braybrook, J.Chrom.A, 983 (2003) 237-246 and LGC/1999/DTI/002&3 (stringent method), 1999 at www.lgc.co.uk.


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In this procedure, the test sample is mechanically treated using a transverse shaking water bath with saliva simulant of aqueous salt solution at elevated temperature (60 °C to 65 ºC) in the presence of 10 stainless steel balls (approx. 12 mm diameter). After 30 mins of dynamic mechanical treatment, the saliva extract is removed for subsequent extraction. The flask and sample are replenished with 50 ml fresh saliva simulant and subjected to a further mechanical treatment. The pooled saliva simulant extracts are subjected to two successive extractions using dichloromethane in a separation funnel. The amount of DINP in the dichloromethane solution is determined by GC-MS using a non-polar column. Quantification is achieved using an external standard calibration procedure as well as an internal standard.

The migration levels observed using LGC PVC reference material containing DINP clearly shows the migration levels for DINP to correlate to the in vivo maximum value reported by the human volunteer studies and recommended by the CSTEE as the target value for any methodology. The migration results may therefore be compared directly with the guidance migration levels recommended by the CSTEE in 7.4.2.

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2.9 Total content and migration of formaldehyde

2.9.1 General

Formaldehyde and its aqueous solution, formalin, may be used in clothing and textile product finishes to give cotton and cotton-containing fabrics ‘easy care’ characteristics, crease resistance and dimensional stability; in urea-, phenol-, acetal- and melamine-formaldehyde resins for the manufacture of plastics, paper and rubber products; and as adhesives in the manufacture of plywood, particle board and other pressed wood products commonly used to manufacture furniture, cabinets, wall panelling and shelves.

Under certain conditions formaldehyde may be released from these items, creating the potential for human exposure either by inhalation, skin contact or ingestion. ‘Off-gassing’ from products into the air is most commonly observed in products such as plywood, particle board and other pressed wood products. It is greatest when the product is new and at higher temperature and humidity, but decreases over time.

2.9.2 Rationale

Formaldehyde is listed in Annex I of Directive 67/548/EEC - Classification, packaging and labelling of dangerous substances, as a Category 3 carcinogen. Such a substance is one that causes concern for people because of possible carcinogenic effects (in this case associated with sites of chronic irritation) observed from animal (in this case inhalation) studies, although the available information is not adequate for making a satisfactory assessment and higher categorisation.

Formaldehyde is also listed as being toxic by inhalation, skin contact and ingestion. It may cause an irritant effect and sensitisation on direct and prolonged skin contact, especially of children, where its concentration is approx. 1 %. If inhaled, emitted formaldehyde may also cause inflammation of the respiratory tract. It is also believed to be one of the most significant allergy-causing agents.

2.9.3 Limits

The maximum content of free and hydrolysable formaldehyde in certain textile and leather products should be 30 mg/kg for textiles for babies, 750 mg/kg for textiles in direct skin contact, and 300 mg/kg for all other products.

For food-contact items, such as bowls and cups, the recommended migration limit for formaldehyde is given in Directive 2002/72/EC - Plastics materials and articles intended to come into contact with foodstuffs, as 15 mg/kg migration liquid (2,5 mg/dm2 sample).

For child use and care articles other than food-contact items, it is recommended that the following migration limits should not be exceeded; 80 mg/kg for wood-based items and 30 mg/kg for articles other than those which are wood-based.

2.9.4 Requirements

When tested in accordance with the appropriate methodologies shown in 2.9.5, the total content or migration of formaldehyde should not exceed the limits indicated in 2.9.3.


For food-contact articles, e.g. feeding bowls and cups, a suitable test method is described in EN ISO 4614:1999, Plastics - Melamine-formaldehyde mouldings - Determination of extractable formaldehyde (ISO 4614:1977), methods 462A and 462B.

Suitable test methods for the determination of formaldehyde release from items that can be cut up, e.g. soothers and textiles, are described in EN ISO 14184-1, Textiles - Determination of formaldehyde – Part 1:


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Free and hydrolysed formaldehyde (water extraction method) and EN ISO 14184-2, Textiles - Determination of formaldehyde – Part 2: Release of formaldehyde (vapour absorption method).

The European Disposables and Non-Wovens Association (EDANA) recommended test methods (ERT) for the determination of free formaldehyde: I, 210.1-99; II, 211.1-99 (under stressed conditions); III, 212.0-96 (determination by HPLC); and IV, 213.0-96 (in processing), are available on http://www.edana.org/story.cfm?section=|edana_nonwovens&story=testmethods.xml.

There are specific requirements for wooden/chipboard items including particle board, plywood and fibre boards. Reference should be made to the following standards, which cover the determination of the content and release of formaldehyde:

EN 717-2, Wood-based panels – Determination of formaldehyde release – Part 2: Formaldehyde release by the gas analysis method;

EN 1084, Plywood: formaldehyde release classes determined by the gas analysis method;

EN 645, Paper and boards intended to come into contact with foodstuffs - Preparation of a cold water extract; and

EN 1541, Paper and board intended to come into contact with foodstuffs – Determination of formaldehyde in an aqueous extract.

NOTE results from gas analysis will not directly correlate with those produced by liquid extraction.

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2.10 Total content of flame retardants

2.10.1 General

The most common flame retardant chemicals are generally brominated and/or phosphorus compounds. The reader is referred to section 4 of these guidelines which provides advice on dealing with thermal hazards. The specific selection of materials that inherently meet this advice offers an alternative to the inclusion of flame retardant chemicals.

2.10.2 Rationale

Some flame retardant chemicals are considered to be unsuitable for use in child use and care articles due to the severity of the toxicological endpoint reported for carcinogenicity, mutagenicity, reproductive toxicity, skin sensitisation or severe organ toxicity and are therefore presumed to offer a human health hazard.

2.10.3 Limits

In considering chemical safety it is advised to avoid the addition of certain flame retardants to specifically reduce flammability. Tri-cresylphosphate and tris-(2-chloroethyl)phosphate have been toxicologically assessed and determined not to be acceptable for use in child use and care articles (CEN/TC52/WG9/TG3 - organic chemical release from toys). Limits of detection are therefore to be applied.

Penta- and octa-bromodiphenyl oxide and short-chain chlorinated paraffins are currently being restricted through Directive 2003/11/EC and Directive 2002/45/EC respectively, and amendment to Directive 76/769/EEC.

Deca-bromodiphenyl oxide and intermediate-chain chlorinated paraffins are currently under review and it is suggested that the most up-to-date information be sought when addressing this issue.

Certain compounds are prohibited in textiles in contact with skin by the EC Directives indicated:

Tris-(2,3-dibromopropyl)phosphate (79/663/EEC);

Tris-(aziridinyl)phosphine oxide (83/264/EEC); and

Polybromobiphenyls (83/264/EEC).

Some brominated flame retardants are to be restricted in electrical and electronic equipment under the Restriction on Hazardous Substances (RoHS) Directive.

2.10.4 Requirements

When tested in accordance with the methodology shown in 2.10.5, the flame retardants in 2.10.3 should not be detected.


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An appropriate screening method is outlined in M.Reiss and R.Eldvik, ‘Identification of brominated flame retardants in polymeric materials by reversed phase liquid chromatography with UV detection’, J. Chrom. A, 827 (1998) 65-71.

In brief, sample solutions in propan-2-ol are analysed using HPLC with the following conditions:

Column: RP-18, 250 mm x 4 mm Hichrom

Mobile phase: 3 % buffered methanol

Column temp: 25 °C

Injection volume: 10 µl

PDA Scan: 190-350 µm

The method has been shown to be suitable for penta- and octa-bromodiphenyl oxide, tetrabromobisphenol A (TBBPA) and its ethers (TBBPA-bis-(2-hydroxyethylether) and TBBPA-bis-allylether), tetrabromophthalic anhydride and 2,4,6-tribromophenol. The penta- and octa-bromodiphenyl oxides do not give good single peak responses but are quantifiable. The suitability of the method for other flame retardants should be demonstrated.

NOTE experience shows that analysis for decabromodiphenyl oxide is likely to require GC-MS-MS. Methodology is under investigation by CEN/TC52/WG9 on organic chemical release from toys.

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2.11 Migration of N-Nitrosamines and N-Nitrosatable substances

2.11.1 General

It has been shown that certain child use and care articles made of elastomer or rubber, i.e. feeding bottle teats and soothers, may release N-Nitrosamines and substances capable of being converted into N-Nitrosamines (N-Nitrosatable substances).

2.11.2 Rationale

The EC SCF has indicated that N-Nitrosamines and N-Nitrosatable substances may endanger human health owing to their genotoxicity. Levels of such genotoxic carinogens are to be reduced to as low a level as practically achievable.

Commission Directive 93/11/EEC regulates the release of N-Nitrosamine and N-Nitrosatable substances from elastomer or rubber teats and soothers.

2.11.3 Limits

The limits shown in Table 2.11A apply:

Table 2.11A — Limits specified through Directive 93/11/EEC

Analyte Limit (mg/kg) Analytical tolerance (mg/kg)

N-Nitrosamines 0,01 0,01

N-Nitrosatable substances 0,1 0,1

2.11.4 Requirements

When tested in accordance with the appropriate methodologies shown in 2.11.5, the migration of N-Nitrosamines and N-Nitrosatable substances should not exceed the limits indicated in 2.11.3.


The analytical methods used to determine the migration of N-Nitrosamines and N-Nitrosatable substances are set out in EN 12868 - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers. Detailed analytical tolerances are shown such that compliance with the requirements of Directive 93/11/EEC can be determined.


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2.12 Migration of vulcanisation accelerators (and antioxidants)

2.12.1 General

Vulcanising agents are utilised in both food-contact and non-food contact applications of rubber child use and care articles, e.g. food-contact rubber seals, feeding bottle teats and soothers, to provide maximum resistance to thermal oxidation and prevent surface cracking caused by atmospheric ozone attack.

2-mercaptobenzothiazole (MBT) was the major vulcanising accelerator in use, but dialkyldithiocarbamate and dialkylthiuram compounds are now being used more widely as alternative vulcanising accelerators. The major route of exposure for these agents is through the oral route, with the dermal route providing an alternative, albeit lesser, contact route.

2.12.2 Rationale

Health concerns have centred on the potential carcinogenicity of compounds structurally similar to 2-mercaptobenzothiazole (MBT), although the SCF have accepted new toxicological studies that do not show a carcinogenic effect (SCF/CS/PM/GEN/M83). Nonetheless levels of MBT incorporation and hence potential migration can be controlled better than was previously the case. The alternative vulcanising accelerators (dialkyldithiocarbamates) are currently less well defined toxicologically.

2.12.3 Limits

The migration of MBT should not exceed 8 mg/kg after a 24 hour extraction period.

The migration of antioxidant 2,6-bis-(1,1-dimethylethyl)-4-methylphenol (BHT) should not exceed 30 µg/100ml or 60 µg/dm2. The migration of antioxidant 2,2-methylene-bis-(6-(1,1-dimethylethyl)-4-methylphenol)) (Antioxidant 2246) should not exceed 15 µg/100ml or 30 µg/dm2.

Acceptable migration levels for the alternative vulcanising accelerators (dialkyldithiocarbamates) have not yet been agreed. Any measured extraction levels should be considered on a case-by-case basis.

2.12.4 Requirements

When tested in accordance with the appropriate methodologies shown in 2.12.5, the migration of vulcanisation accelerators and antioxidants should not exceed the limits indicated in 2.12.3.


2.12.5.1 MBT and antioxidants

A suitable method for determining the migration of certain vulcanising accelerators and antioxidants is provided in EN 1400-3 - Soothers for babies and young children: Safety requirements and test methods.

The method has been shown to be applicable to determining the migration limits for MBT, and the antioxidants BHT and Antioxidant 2246.

2.12.5.2 Dialkyldithiocarbamates

A further method, based on existing literature methods for rubber gloves and foam rubber carpet backing, has been found to be suitable for determining the migration of the alternative vulcanising accelerators shown in 2.12.5.1.

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The principle of the method is the exchange-reaction of the metal-cation in a dithiocarbamate salt complex by a cobalt (II) cation, which results in an increase in stability of the compound. The vulcanising accelerators are removed from the sample, over a defined time period, whilst immersed in an artificial simulant. They are concentrated by solid phase extraction before back extraction of the solid phase with dichloromethane. The dichloromethane extract is treated with cobalt (II) chloride to form the cobalt (II) salt. The solution is re-concentrated and made up in acetonitrile/tetrahydrofuran for HPLC analysis using conditions similar to those specified in EN 1400-3 for the determination of MBT.

This extraction method has shown to be suitable for both zinc diisononyldithiocarbamate and zinc dibenzyldithiocarbamate, but is restricted to one class of dithiocarbamate in the sample because of the potential formation of mixed ligand complexes.


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2.13 Total content of volatile compounds

2.13.1 Rationale

Currently validated methodology for determining individual volatile compounds in child use and care articles, which correlates with ‘real’ exposure scenarios, does not exist. The volatility of these chemicals makes inhalation the major contact route of concern.

EN 1400-3 Child use care articles – Soothers for babies and young children – Part 3: Chemical requirements and tests, specifies allowable total volatile content for silicone rubber teats & soothers.

NOTE Methodology is being investigated under the work of CEN/TC52/WG9 on organic chemical release from toys.

2.13.2 Limits

The total content of volatile compounds from elastomer or rubber teats and soothers should not exceed 0,5 % (m/m).

2.13.3 Requirements

When tested in accordance with the methodology shown in 2.13.4, the content of volatile compounds should not exceed the limit indicated in 2.13.2.


Samples from reusable products should be immersed in boiling water for 10 min without touching the walls of the container.

NOTE 1 This is to remove the surface coating arising from the manufacturing processes and ensure that the materials used are stable in boiling water.

Drain excess water from the sample. Place approximately 10 g of the whole sample into a pre-heated (approx. 1 h) open, shallow container and place the container with the sample in a drying oven at (100 ± 5) °C with fresh air inlet. After 1 h, cool the container with the sample in a dessicator for at least 2 h and weigh (accuracy ± 0,1 mg). Replace the container with the sample in a drying oven at (200 ± 5) °C with fresh air inlet. After 4 h, cool the container with the sample in a desiccator for at least 2 h and re-weigh (accuracy ± 0,1 mg). The content of volatiles is calculated from percentage weight difference.

NOTE It is recommended that the test be carried out at least in duplicate.

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2.14 Total content and migration of certain dyes, azo-colourants and disperse dyes

2.14.1 Rationale

Certain dyes are known to be carcinogenic, mutagenic or toxic to reproduction. Others may be assigned any of the risk phrases R45 (may cause cancer), R46 (may cause heritable genetic damage), R60 (may impair fertility) or R61 (may cause harm to the unborn child) as defined in Directive 67/548/EEC.

The ability to chemically reduce certain azo-colourants, one of the most popular types of organic colorants used by the textile and leather industries, to certain primary aromatic amines is well established. Several of these aromatic amines have been recognised as potential carcinogens for many years and since the 1980s the use of many dyes manufactured from these amines has been withdrawn voluntarily by industry, at least in the western world.

There is also extensive literature on the sensitising potential of disperse dyes. Human patch testing indicates that disperse dyes elicit positive reaction in individuals following exposure through textiles containing these dyes, although the clinical manifestations of the dermatitis are variable.

2.14.2 Limits

The dyes shown in Table 2.14A should not be used.

Table 2.14A — Carcinogenic or mutagenic dyes or dyes toxic to reproduction

C.I. Solvent Yellow 1



C.I. Basic Red 9

C.I. Disperse Blue 1

C.I. Acid Red 26

Additional dyes considered to be carcinogenic or mutagenic dyes or dyes toxic to reproduction by CEN/TC52/WG9/TG3 are shown in Table 2.14B.

Table 2.14B — Additional dyes considered to be carcinogenic or mutagenic dyes or dyes toxic to reproduction

C.I. Basic Violet 1

C.I. Basic Violet 3

C.I. Acid Violet 49

Azo-colourants are restricted by Directive 2002/61/EC and amendment for the 19th time of Directive 76/769/EEC (COM[2000]785). Azodyes which, by reductive cleavage of one or more azo groups, may release one or more of the aromatic amines listed in Table 2.14C in detectable concentrations (i.e. 30 µm/g) in the finished articles or dyed products thereof, should not be used in textile and leather articles which may come into direct and prolonged contact with human skin or oral cavity.


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Table 2.14C — Restricted aromatic amines

Number Aromatic amine CAS No

1 o-toluidine (2-aminotoluene) (95-53-4)

2 o-anisidine (2-methoxyaniline) (90-04-0)

3 4-chloroaniline (106-47-8)

4 6-methoxy-m-toluidine (p-cresidine) (120-71-8)

5 2,4,5-trimethylaniline (137-17-7)

6 4-chloro-o-toluidine (95-69-2)

7 4-methyl-m-phenylenediamine (95-80-7)

8 4-methoxy-m-phenylenediamine (615-05-4)

9 2-naphthylamine (91-59-8)

10 Biphenyl-4-ylamine (4-amino-biphenyl) (xenylamine)

(92-67-1)

11 4,4’-oxydianiline (101-80-4)

12 Benzidine (92-87-5)

13 4,4’-methylenedianiline (4,4’-diaminodiphenylmethane)

(101-77-9)

14 4,4’-methylenedi-o-toluidine (838-88-0)

15 3,3’-dimethylbenzidine (4,4’-bi-o-toluidine)

(119-93-7)

16 4,4’-thiodianiline (139-65-1)

17 3,3’-dichlorobenzidine (3,3’-dichlorobiphenyl-4,4’-ylenediamine)

(91-94-1)

18 3,3’-dimethoxybenzidine (o-dianisidine) (119-90-4)

19 4,4’-methylene-bis-(2-chloroaniline) (2,2’-dichloro-4,4’-methylene-dianiline)

(101-14-4)

20 5-nitro-o-toluidine (99-55-8)

21 4-amino azobenzene (60-09-3)

22 o-aminoazotoluene (4-amino-2’,3-dimethylazobenzene) (4-o-tolylazo-o-toluidine)

(97-56-3)

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Directive 2003/03/EC and adaptation for the 12th time of Directive 76/769/EEC restricts blue colourant Index No. 611-070-00-2 (commonly known as navy blue) for placing on the market or for use for colouring textile and leather articles as a substance or constituent of preparations in concentrations higher than 0,1 % by mass.

The potentially sensitising (disperse) dyes shown in Table 2.14D should only be used if the fastness to (acid and alkaline) perspiration of the dyed yarn or fabric is at least 4.

Table 2.14D — Potentially sensitising dyes





C.I. Disperse Yellow 3

C.I. Disperse Orange 3

C.I. Disperse Orange 37/76

C.I. Disperse Red 1

Due to the migration limits for certain heavy metals, the use of after-chromed dyes is not recommended.

2.14.3 Requirements

The dyes known to be, or proposed as, carcinogenic or mutagenic or toxic to reproduction in 2.14.2 should not be present in textile and leather articles.

When tested in accordance with the appropriate methodologies shown in 2.14.4, the total content and migration of certain azo-colourants and disperse dyes should not exceed the limits indicated in 2.14.2.

Potentially sensitising dyes should not exceed the limits indicated in 2.14.2.


The following methods have been found to be suitable for the determination of aromatic amines arising from the use of certain azo-colourants in leather/textiles:

CEN ISO/TS 17234, Leather – Chemical tests - Determination of certain azo colourants in dyed leathers (ISO/TS 17234:2003).

EN 14362-1, Textiles - Methods for the determination of certain aromatic amines derived from azo colourants – Part 1: Detection of the use of certain azo colourants accessible without extraction.

EN 14362-2, Textiles - Methods for the determination of certain aromatic amines derived from azo colourants – Part 2: Detection of the use of certain azo colourants accessible by extracting the fibres.

NOTE False positives may be possible with respect to the presence of 4-aminoazobenzene and confirmation is recommended.

Test method for determining colour fastness is ISO 105-E04 .


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2.15 Migration of bisphenol A

2.15.1 General

Polycarbonate is one of the most widely used thermoplastic materials with an inherent extreme transparency particularly suitable for a number of child use and care articles, e.g. beverage containers (including feeding bottles and cups) and feeding containers and utensils (including feeding dishes, bowls, and cutlery).

Bisphenol A (BPA) is a key reactant in the production of polycarbonate being ‘chemically bound’ into the polymer. The amount of any free (‘unbound’) BPA, which can migrate into contacting solutions, is therefore expected to be negligible.

2.15.2 Rationale

There is currently strong debate within the scientific community relating to the potential hazard and associated risk effects of BPA in humans.

Information on the toxicokinetics of BPA in humans is not available. In rat oral studies, BPA is absorbed from the gut, readily metabolised and cleared from the body with low potential for distribution, bioaccumulation and transfer to the foetus. Nonetheless, there exists some evidence of enterohepatic circulation and a clear sex difference for the different routes of clearance. There is only poor animal data and limited human information relating to irritation and sensitisation by BPA, but it may be assumed to act as a mild skin irritant/sensitiser. In other animal studies BPA exhibits low acute toxicity and non-significant repeat dose toxicity. Studies do not indicate carcinogenic or reproductive or developmental potential, although adverse effects on fertility are observable at high dose levels.

It is however the observed transient, low level oestrogen mimicking (endocrine disrupting) effect of BPA in specialised short-term exposure laboratory animal tests that is attracting most current attention. However, little is known about the mechanisms through which such agents could cause relevant pathology.

A comprehensive human risk assessment of BPA has been completed under ESR and the EC SCF has reviewed its opinion on BPA. Nonetheless, the most up-to-date information should be sought when addressing this issue.

2.15.3 Limits

EC Directive 2002/72/EC - Materials and articles in contact with food, summarises the European regulations for polymers in contact with food. The EC SCF has established a specific migration limit of 3 mg/kg (or 5 µg/cm2) for BPA in food.

As part of its consideration of the adequacy of the current TDI in light of data relating to low dose effects, the SCF has considered the currently available toxicological data to identify an overall oral NOAEL of 5 mg/kgBW/day (based on recent lowest dose effects of 50 mg/kgBW/day). An uncertainty factor of 500 has been considered appropriate to allow for data uncertainties. This provides the temporary TDI of 0,01 mgBPA/kgBW/day (10 µg/kgBW/day) for food contact plastics that is to be reviewed once significant new data are available.

2.15.4 Requirements

When tested in accordance with the methodology shown in 2.15.5, the level of migration of BPA (converted as appropriate to account for daily intake and body weight) should not exceed the limit indicated in 2.15.3.


BPA is extracted from the test articles into aqueous or fatty food simulants, identified and its level determined by HPLC with fluorescence detection (FLD) for concentrations of BPA below 0,1 µg/ml. Alternative

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methodology, e.g. gas chromatography (GC), has been documented but determination is indirect requiring pre-concentration and derivatisation steps.

Transfer 100 ml of the aqueous or fatty food simulant solution into the article. If this volume is too large for the article, then use a known volume equivalent to 50 % of the capacity of the article. Alternatively, immerse the article in a suitable vessel and add a known volume of simulant solution sufficient to just cover the article. Store under static conditions for 24 h at 40 °C in a drying oven. Repeat the procedure for any other applicable food simulant solution.

For aqueous solutions, following storage in the drying oven, transfer approx. 1 ml of the solution into a vial suitable for HPLC injection.

For fatty food solutions, following storage in the drying oven, weigh (1 ± 0,01) g of the solution into a test tube. Add by volumetric pipette 3,0 ml of n-hexane and mix thoroughly. Then add by volumetric pipette 2,0 ml (1:1) methanol/water and mix for 1 min with a mechanical shaker, vortex. Allow the phases to separate for at least 30 min. Remove, by means of a pipette, approx. 1 ml of the aqueous (lower) layer and transfer the solution into a vial suitable for HPLC injection.

NOTE Samples should be stored refrigerated at + 4 °C in closed containers, free from light.

The quantity of migrated BPA is determined by injecting the test sample solutions into the HPLC and using a derived calibration curve (produced in the usual way) to determine the BPA-content of the test solution, either manually or with data-handling software.

Analytical conditions found to be suitable for determining the level of migrated BPA are:

Either

Column: 250 x 4 mm Nucleosil 100-5-C18.

Column temperature: 25 °C.

Mobile phase: Methanol:water (65:35); isocratic.

Flow: 0,6 ml/min.

Injection volume: 40 µl.

Or

Column: Stainless steel 250 x 4.6 mm packed with C18-coated spherical silicagel, particle size 5 µm (load of 9 % carbon and end-capped) (Hypersil ODS 5 µm).

Mobile phase: Methanol:water (70:30).

Flow: 1,0 ml/min.

Detection:

BPA: fluorescence detector (FLD); excitation wavelength Ex = 275 nm, emission wavelength Em = 313 nm.

Retention time:

BPA; either approximately 10.2 min or 4.5 min respectively.


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2.16 Total content of organotin compounds

2.16.1 General

Organotin compounds are used as fungicides and bacteriocides (disinfectants), and preservatives, in wood, textile, paper and leather. However, their main use (70-90 % of organotins) is as stabilisers for the production of PVC.

2.16.2 Rationale

Tributyltin (TBT) is one of the most toxic anthropogenic chemicals in the marine environment having adverse effects on non-target organisms, e.g. shell deformations in bi-valves and imposex change in dogwhelks, and being bioaccumulative in sediments and to higher trophic levels in the food chain, e.g. fish-eating birds, seals and dolphins. Organostannic (organotin) compounds are restricted for use as anti-fouling and for biocidal purposes by Directive 2002/62/EC and adaptation for the 9th time of Directive 76/769/EEC.

There is growing concern about human health impacts of accumulated organotin residues in blood and tissue resulting from the direct ingestion of contaminated seafood and direct contact with organotin compounds in man-made products, e.g. anti-bacterial shoe insoles and textiles (and through contamination in nappies). The aim is therefore to set the strictest limit that can reasonably be achieved and measured.

2.16.3 Limits

In considering chemical safety it is advised to avoid the addition of organotin compounds. Limits of detection are therefore to be applied.

2.16.4 Requirements

When tested in accordance with the methodology shown in 2.16.5, the total content of organotin compounds should not exceed the limit indicated in 2.16.3.


2.16.5.1 Derivatisation (Capillary GC-MS)

The principle of this EDANA method is sample extraction with a 0,3 M solution of sodium diethyldithiocarbamate in ethanol. After addition of sodium acetate buffer (pH 4,5) to an aliquot of the extract, the organotin species are alkylated with sodium tetraethylborate (20 % in ethanol), extracted, cleaned-up by adsorption chromatography and analysed by GC-atomic emission detection (AED) or GC-MS (EI mode).

NOTE Where present, release tapes and papers, and applicators should be removed from the child use and care article prior to sampling, e.g. baby nappies require the removal of the absorbent core material (cellulose pulp and super-absorbent polymer) - a small amount of residue is usually tolerable.

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The following GC conditions for determination of organotins have been found to be suitable:

GC: GC system with multi-step temperature gradient elution, capability for operating capillary column to 100 kPa inlet pressure, autosampler and data system.

Column: Capillary, 25 m × 0,32 mm, with stationary phase CP-SIL 8CB, OV1 or HP-1, film thickness approx. 0,25 µm.

Carrier gas: He.

Injector: splitless, temperature 300 °C.

Injection vol: 1 µl.

Temp.gradient: 60 °C to 240 °C at 5 °C/min to 290 °C at 10 °C/min.

AED:

Transfer line: 280 °C.

Cavity temp: 280 °C.

Flow rate: Scavenger He at 240 ml/min (measured at the ‘cavity vent’).

Detection: wavelength 270,651 nm or 303,419 nm.

MS: Selected ion monitoring, SIM (quadrupole mass selection detector) for 116Sn, 118Sn and 120Sn.

Transfer line: 290 °C.

Ionising energy: 70 eV.

The chemical identity is confirmed as two conditions are met simultaneously:

The retention times of the chemical in the standards and test samples agree ± 0,05 min or relative retention times agree ± 0,2 %; and

At the correct retention time, the chemical responds by a selective detector, i.e. AED or SIM MS.

As the AED is selective for tin, interference by other components is unlikely. For MS the selected m/e for SIM should not be interfered with significantly by other substances.

The method has been shown to be suitable for identifying and quantifying organotin species of the types RnSnCl(4-n) in absorbent hygiene products and raw materials where R is butyl or octyl and n is 1-3 or 1-2 respectively. The quantification limit is 2 µg/kg.

EDANA hold a list of ‘accredited’ laboratories that are able to perform this test.


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2.16.5.2 ASE/HPLC-ICP-MS

The principle of the method is sample extraction by accelerated solvent extraction (ASE) at elevated temperature and pressure. The sample extract is then diluted in de-ionised water and injected on to a reversed phase HPLC column to separate the organometallic species by retention times. The column outlet is connected to the nebuliser of an ICP-MS to introduce the vapourised sample extract into the plasma in the spray chamber. The resulting positive ions are extracted from the plasma at the interface and ion lenses used to focus the ion beam through the quadrupole mass filter to separate the ions by mass:charge ratio, m/z. Detection of the individual ions of different m/z ratios is achieved by an electron multiplier. Quantitation is achieved by peak area measurement using external calibration with standard solutions. The limit of detection is 50 pg/g (as Sn) for di- and tri-butyltin (DBT and TBT).

The following conditions for ASE extraction of organometallics have been found to be suitable:

Mobile phase: solvent mixture of ammonium acetate/acetic acid/methanol (i.e. approx. 0,5 M ammonium acetate and 1 M acetic acid).

NOTE PTFE liners used in extraction cells and all stainless steel frits replaced by titanium.

Preheat time: 2 min.

Extraction pressure: 2 000 psi.

Heating time: 5 min.

Heating temp: 80 ˚C or 100 ˚C.

Static time: 15 min or 20 min.

Flush: 60 s.

Purge: 100 s.

No. cycles: 1.

The following HPLC and ICP-MS conditions for determination of organometallics have been found to be suitable:

HPLC: HPLC system with vacuum degasser for mobile phase, quaternary pump, autosampler with thermostat, and column compartment. (note: all stainless steel tubing and needle assembly replaced with PEEK).

Stationary phase: C-18 reversed phase (15 cm × 2,1 mm id, 3 µm).

Mobile phase: 65:25:10 (v/v/v) acetonitrile:water:acetic acid with 0,05 % triethylamine.

Internal standard: 0,25 ng/ml Rh.

Flow rate: 0,13 ml/min or 0,2 ml/min.

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ICP-MS: ICP-MS with shield torch and 1.5 mm injector.

Isotopes monitored: 120Sn, 117Sn, 103Rh.

Forward power: 1 250 W to 1 500 W.

Carrier gas flow: 0,5 l/min to 0,9 l/min.

Make-up gas flow: 0,2 l/min to 0,4 l/min.

Optional gas (O2): 5 % (post-nebulisation).

Spray chamber: Quartz, peltier cooled at –5 °C.

Nebuliser: microflow concentric.

Analysis time/sample: approx. 45 min.

The method has been shown to be applicable to the determination of DBT, TBT, diphenyltin (DPhT) and triphenyltin (TPhT) and comparable to derivatisation methodology.


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2.17 Total content of pentachlorophenol (PCP)

2.17.1 General

The broad pesticidal efficiency and low cost make pentachlorophenol (PCP) and its salts (primarily the sodium salt) useful algicides, bacteriocides, fungicides, herbicides, insecticides and molluscicides with a variety of industrial, agricultural and domestic applications. However, in recent years most developed countries have restricted the use of PCP, especially for agricultural and domestic applications. PCP is mainly used as a wood preservative, whose domestic use has been of particular concern because of possible health hazards with its indoor application. Additional exposure to PCP occurs in treated items such as textiles, leather and paper products, and above all, through inhalation of contaminated indoor air making skin contact and inhalation the major exposure routes to be considered.

2.17.2 Rationale

The main toxicological effects of PCP and its salts on man are very similar to those reported in experimental animals. Chloracne, skin rashes, respiratory diseases, neurological changes, headaches, nausea and weakness have been documented. PCP is readily absorbed through intact skin, the respiratory tract and the gut, and distributed in the tissues; bio-accumulation is low. Highest levels are observed in the liver and kidney. Trends in observed biochemical changes suggest effects on liver enzymes, kidney function, immune system suppression and nerve conduction. However, the liver and immune effects may be caused, in whole or in part, by microcontaminants of chlorophenol, namely polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzo-furans (PCDFs) of which H6CDD is the most relevant congener toxicologically.

2.17.3 Limits

In considering chemical safety it is advised to avoid the addition of PCP and its salts. Typical limit of detection of 0.05 mg/kg is therefore to be applied.

2.17.4 Requirements

When tested in accordance with the methodology shown in 2.17.5, the total content of PCP and its salts should not exceed the limit indicated in 2.17.3.


The following method has been found suitable for the determination of pentachlorophenol in pulp, paper and board: EN ISO 15320:2003, Pulp, paper and board – Determination of pentachlorophenol in an aqueous extract (ISO 15320:2003). Although developed for food contact applications, it is applicable to all kinds of pulp, paper and board. This describes a procedure for concentrating the obtained water extract using solid phase extraction on a phenyl cartridge and derivatising (acetylation) the PCP before analysis by GC-ECD or GC-MS.

The following method has been found suitable for the determination of pentachlorophenol in leathers: CEN/TS 14494:2003, Leather – Chemical tests – Determination of the content of pentachlorophenol in leather. This describes a procedure where the leather is steam-distilled and the distillate-containing PCP is liquid-liquid extracted and derivatised (acetylated) in a two-phase reaction before capillary GC-ECD. The method has also been found to be applicable to tri- and tetra-chlorophenol.

There is also a IUC method available from the UK Society of leather technologists and chemists and a UK research association method for leathers (SATRA TM342:1995). There are also other literature methods available for determining PCP in leather, textiles and wood, mainly using Soxhlet extraction or ASE followed by derivatisation and detection by GC-ECD or GC-MS.

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Mechanical hazards - Contents list

3.1 Terms related to mechanical hazards


3.2.1 Accessibility of mechanical hazards

3.2.2 Information

3.3 Entrapment hazards

3.3.1 Introduction

3.3.2 Entrapment of head and neck

3.3.3 Entrapment of fingers

3.3.4 Entrapment of limbs, feet and hands

3.4 Hazards from moving parts

3.4.1 Introduction

3.4.2 Hazards with products designed to fold

3.4.3 Hazards from crushing when the product is in use

3.5 Entanglement hazards

3.5.1 Introduction

3.5.2 Snagging hazards

3.5.3 Cords, ribbons and parts used as ties

3.6 Choking hazards

3.6.1 Introduction

3.6.2 Inhalation of small components

3.6.3 Accessibility of filling materials

3.6.4 Airway obstruction

3.7 Suffocation hazards

3.7.1 Introduction

3.7.2 Plastic decals and sheeting

3.7.3 Non air-permeable packaging and wrapping

3.8 Ingestion hazards

3.8.1 Introduction

3.8.2 Ingestion of small components


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3.9 Hazardous edges and projections

3.9.1 Introduction

3.9.2 Edges

3.9.3 Rigid protruding parts

3.9.4 Points and wires

3.10 Structural integrity

3.10.1 Introduction

3.10.2 Material suitability

3.10.3 Strength and durability of product

3.11 Protective function

3.11.1 Introduction

3.11.2 Barrier function

3.11.3 Restraint systems

3.11.4 Footholds

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3 Mechanical hazards

3.1 Terms related to mechanical hazards

mechanical hazards: physical factors which may give rise to injury due to the mechanical properties of products/product parts

accessible: contact of a part or a component by a child when checked by the accessibility probe, see 3.2.1.3.

reach envelopes: age related physical data on the reach limits of the limbs of children in different postures, see 3.2.1.2.


This section addresses the most widely known mechanical hazards and is intended to provide guidance when drafting standards for child use and care articles.

Anthropometric data and information on the abilities of children related to risks are provided in Annex A. When using these data for setting requirements, adequate safety margins should be considered. These data refer to static anthropometric data and not dynamic anthropometric data. Therefore care should be taken if using these data for anything other than static situations when drafting standards.

When drafting standards, conditions of use should be considered, bearing in mind the behaviour of children. Also to be considered is whether the child will be attended or unattended when using the product and also the child’s access to hazardous features.

For each mechanical hazard a rationale is given, explaining the potential hazard to the child. Requirements, test equipment and test methods are also given. Where appropriate, these can be used when drafting standards.

The mechanical hazards associated with entrapment/entanglement cover more than one clause within this clause. These clauses interact and should be considered together when drafting standards. To assist with this an entrapment/entanglement matrix has been included, Figure 3.2A, which was developed for ISO/IEC Guide 50. The entrapment/entanglement matrix does not impart any hierarchy in the severity of the hazards shown and the specific hazard clause should be referred to.


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Figure 3.2A — Entrapment/entanglement matrix (copied from ISO/IEC Guide 50)

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3.2.1 Accessibility of mechanical hazards

3.2.1.1 General

Within the mechanical section no reference is made to specific areas of access, commonly known as access zones. It would be wrong for this guidance document to specify exact areas of access, as these should be determined in relation to the individual products hazards and risks when drafting the standard. As a general guidance to the types of contact associated with mechanical hazards the following examples are given:

the hazardous part is in reach from the intended position of use in particular by head, mouth, hands or feet. There is high probability for frequent, intensive and/or prolonged contact. Requirements need to address this primary contact;

the hazardous part may be reached by the child or any other child beyond the intended position of use. The product is considered to remain in its intended position(s). Access to hazardous parts is gained by passing, moving around the product or when proceeding to the intended position. The risk of harm deriving from frequent, intensive and/or pro-longed contact may be less probable;

the hazardous part exists, but cannot be reached by a child.

Irrespective of the access category the reasonably foreseeable conditions of use should always be considered when designing children‘s products and/or writing product standards.

3.2.1.2 Accessibility areas

Information for determination of accessibility areas in connection with age group is given in Table 3.2A and Figure 3.2B. These reach envelopes are based on a computer simulation. Therefore the dimensions should be treated with care. If in the future experiments with children are undertaken these figures can be determined more accurately.

Table 3.2A — Reach envelopes for guidance in the specification of accessibility areas in standards - anthropometric data related to Figure 3.2B

Dimension (mm) ›

Overhead

Reach

Overhead

Reach on tiptoes

Span Overhead

Reach

Sitting

Arm

Reach

Buttock-

foot

Lower

Leg

Length

Age group L1 L1' L2 L3 L4 R1 R2

0 to 6 months 760 - 660 550 250 300 150

6 to 12 months 880 960 770 610 290 380 190

12 to 36 months 1 160 1 260 1 020 770 420 550 275

36 to 48 months 1 270 1 370 1 070 810 460 630 315

All dimensions are based on P95 values. L1, L1', L2, L3, L4, have been assessed with the computer program ADAPS (© 79-93 TU-Delft University of Technology, Faculty of Industrial Design Engineering). R1 = buttock - foot length (Annex A, Table 3). R2 = 0,5 x R1.


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79-93 TU-Delft University of Technology Faculty of Industrial Design Engineering

Figure 3.2B — Reach envelopes for determination of accessibility areas

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3.2.1.3 Accessibility of a part or component

An articulated probe is used to determine whether a part or a component of a child use and care article is accessible to the child. The articulated probe is manoeuvred to the part or component being checked and if it makes contact with the part or component it is considered accessible.

The articulated probe, see Figure 3.2C, should be manufactured from a rigid material and have dimensions as shown in Table 3.2B.

Table 3.2B — Dimensions of the accessibility probe

All dimensions are in mm. The tolerance on dimensions ‘a’ to ‘e’ is ± 0,1 mm and on dimensions ‘f’ and ‘g’ is ± 1 mm.

Ra b c d e f g

2,8 5,6 25,9 14,7 44,0 25,4 464,3

Dimensions in millimetres

Key

1 Extension 2 Collar 3 Hemisphere (Ra) 4 Pivot Points

Figure 3.2C — Accessibility Probe


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3.2.2 Information

In order to ensure mechanical safety, the information for the user should include appropriate instructions and warnings. For example, the following features may need to be addressed:

adjustment of harness and need for harness to be used;

opening and closing of movable barriers;

operation of safety locks for foldable parts;

methods of attachment to fixed structures or to other products.

Instructions should also inform the user of the need to inspect the product regularly and also to use only replacement parts that are approved by the manufacturer/supplier.

Product information, section 5 gives detailed advice concerning the presentation of product information.

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3.3 Entrapment hazards

3.3.1 Introduction

To avoid entrapment of head, neck, fingers, feet, and hands, safety distances are recommended in relation to the anthropometric data (Annex A) of the growing child. It is important to take into account the intended age and/or development level of the child. As a priority, those parts of a product which are accessible when a child is using the product as foreseeable, should be considered. It may also be appropriate for gaps and openings beyond these accessible areas to be addressed. Gaps and openings which are inaccessible need not be considered. However, V-shaped openings or V-shaped arrangements of structural members should be avoided.

Important entrapment hazards are:

entrapment of the neck in situations where the child is incapable of raising its body weight to relieve the pressure;

entrapment of fingers, which may cause loss of blood supply to the tips.

If it is possible to position a child use and care article next to other furniture or a wall and create an entrapment hazard between the child use and care article and the other furniture or wall, an instruction should be included to warn carers of this possible entrapment hazard.

When considering entrapment hazards dynamic situations should be considered as well as static hazards. The dynamic situation will increase the force being applied to a trapped torso or finger through the weight, movement or momentum of the child which will increase the risk of injury.

3.3.2 Entrapment of head and neck

3.3.2.1 Rationale

Head and neck hazard occurs when the child is in a position where its body weight is supported by its neck and the child is incapable of lifting its body weight to relieve pressure on its neck. When this occurs it will cause airways to close and restrict the blood flow leading to brain damage.

The risk of head and neck entrapment increases as the child’s mobility and ability increases, enabling the child to access a wider range of hazards and products. The hazard is directly related to the size of the child’s head and torso.

The hazard can be avoided by limiting the size and shape of completely bound, partially bound and ‘V’ shaped openings (see definitions in 3.3.2.3).

3.3.2.2 Requirements

When tested in accordance with 3.3.2.5.1 or 3.3.2.5.2, if completely bound openings allow passage of the small probe(s), the large probe should also pass through the completely bound opening. Completely bound openings that allow the large probe to pass completely through should comply with the requirement for partially bound, V and irregular shaped openings when tested in accordance with 3.3.2.5.3.

Partially bound, V and irregular shaped openings should be constructed so that:

a) portion B of the template does not enter the opening when tested in accordance with 3.3.2.5.3, see Figure 3.3I and 3.3J; or

b) the apex of portion A of the template contacts the base of the opening when tested in accordance with 3.3.2.5.3, see Figure 3.3K.


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3.3.2.3 Definitions

3.3.2.3.1 Completely bound opening

an opening that is edged all around by the material of the product, see Figure 3.3A.

Figure 3.3A — Examples of completely bound openings

3.3.2.3.2 Partially bound opening

an opening that is not completely edged by the material of the product, see Figure 3.3B

Figure 3.3B — Examples of partially bound openings

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3.3.2.3.3 V shaped openings

openings where there is a slot that narrows towards the bottom, see Figure 3.3C.

Figure 3.3C — Examples of V shaped openings

3.3.2.3.4 irregular shaped opening

a bound or partially bound opening that does not have a symmetrical shape which could include hazards, see Figure 3.3D

Figure 3.3D — Example of an irregular shaped opening


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3.3.2.4 Test equipment

3.3.2.4.1 Probe philosophy

To cover all aspects of neck entrapment four types of probes are needed. They are the small torso probe, the small head probe, the large head probe and the template for partially bound and V-shaped openings. The size of individual probes is selected to meet the age range of the children, see the figures for the probes for the various age ranges covered.

The small torso probe, Figure 3.3E, represents the torso of the smallest child likely to encounter the hazard. The probe sizes correspond to the child sizes as follows:

dimension ‘a’ represents the P51) chest depth;

dimension ‘b’ represents P5 thigh clearance;

dimension ‘c’ represents P5 hip breadth.

The dimensions of the small torso probe are based on the anthropometric data in Annex A, but with 0,7(sd) taken off each dimension to give an appropriate size for a child at the 1st percentile2), or minimum size. In reality this means:

‘a’ = chest depth – 0,7 (sd) = chest depth – 6 mm;

‘b’ = thigh clearance – 0,7 (sd) = thigh clearance - 5 mm;

‘c’ = hip breadth – 0,7 (sd) = hip breadth - 10 mm.

Table 3.3A — Torso probe corresponding to smallest child

Age

Months

a

b c

0 to 3 74 28 100

3 to 6 81 38 113

6 to 9 86 40 120

9 to 12 89 42 125

12 to 18 94 48 133

18 to 24 102 49 143

24 to 36 111 51 154

36 to 48 116 55 163

1) For a definition of P5 see Annex A, A.2 Terms related to anthropometric data.

2) For recommendations on this refer to Annex A, A.3 Recommendations for use of data.

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Key

1 Handle

Figure 3.3E — Small torso probe


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The small head probe, Figure 3.3F, represents the head of the smallest child likely to encounter the hazard. The probe sizes correspond to the child sizes as follows:

dimension ‘a’ represents P5 head breadth;

dimension ‘b’ represents P5 head length;

dimension ‘c’ represents P5 head height;

dimension ‘d’ represents P5 neck breadth.

The dimensions of the small head probe are based on the anthropometric data in Annex A, but with 0,7 (sd) taken off each dimension to give an appropriate size of a child at the 1st percentile, or minimum size. In reality this means:

'a’ = head breadth – 0,7 (sd) = head breadth - 4 mm;

‘b’ = head length – 0,7 (sd) = head length - 4 mm;

‘c’ = head height – 0,7 (sd) = head height - 6 mm;

‘d’ = neck breadth – 0,7 (sd) = neck breadth - 4 mm.

Table 3.3B — Head probe corresponding to smallest child

Age

Months

a b c d

0 to 3 96 124 112 42

3 to 6 101 137 119 45

6 to 9 106 145 126 49

9 to 12 111 150 138 52

12 to 18 115 155 144 54

18 to 24 118 158 149 56

24 to 36 120 159 154 57

36 to 48 123 161 156 60


Figure 3.3F — Small head probe

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The large head probe, Figure 3.3G, represents the head of the largest child likely to encounter the hazard. The probe sizes correspond to the child sizes as follows:

dimension ‘a’ represents P95 chin to crown length.

NOTE For a definition of P95 see Annex A, A.2 terms related to anthropometric data.

The dimensions of the large head probe are based on the anthropometric data in Annex A, but with 0,7 (sd) added to each dimension to give an appropriate size of a child at the 95th percentile, or maximum size. In reality this means:

‘a’ = chin to crown length + 0,7 (sd) = P95 chin to crown length + 5 mm.

NOTE For recommendations on this see Annex A, A.3 Recommendations for use of data.

Table 3.3C — Head probe corresponding to largest child

Age months a

0 to 3 175

3 to 6 191

6 to 9 196

9 to12 205

12 to 18 210

18 to 24 215

24 to 36 223

36 to 48 229


Figure 3.3G — Large head probe


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The template for V and irregular shaped openings, Figure 3.3H, is taken from EN 1176-1:1998 and represents head and neck dimensions:


Key

1 B Portion 2 A Portion

Figure 3.3H — V and irregular shaped openings template

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3.3.2.4.2 Selection and use of probes

3.3.2.4.2.1 Probe size

The correct size of probe should be selected from the ranges shown in Figures 3.3A to 3.3C, to suit the age range of the child most at risk when considering the hazard.

By checking the opening with the large head probe, Figure 3.3G, it is possible to ascertain whether the opening is small enough to be a hazard to a child. If the opening is found to be hazardous the opening should be tested to determine if it is large enough for the child to enter either feet first or head first by using one of the appropriate small probes, Figure 3.3E or Figure 3.3F, as indicated below.

3.3.2.4.2.2 Feet first completely bound opening

The small torso probe, Figure 3.3E, should be used to check if the opening is large enough to allow passage of a child’s torso. If it does not pass through the opening the risk of entrapment is reduced.

3.3.2.4.2.3 Head first completely bound opening

The small head probe, Figure 3.3F, should be used to check if the opening is large enough to allow passage of a child’s head. If it does not pass through the opening the risk of entrapment is reduced.

3.3.2.4.2.4 Completely bound openings of irregular shape

When assessing completely bound openings of irregular shape it is necessary to ascertain if the opening is large enough to be a risk. This is done by using the large head probe, Figure 3.3G, as above. Then if the large probe passes through check the irregular opening for neck entrapment using the template for V and irregular shaped openings, Figure 3.3H.

3.3.2.4.2.5 Partially bound openings

For all partially bound openings the template for V and irregular shaped openings, Figure 3.3H, should be used to assess the risk.

3.3.2.5 Test methodology

3.3.2.5.1 Completely bound openings – feet first

Press the small torso probe, Figure 3.3E, with the highest force possible up to 30 N into completely bound openings. If the small torso probe passes completely through the opening, then the large head probe, Figure 3.3G, should pass completely through the completely bound opening with a force of up to 5 N. If completely bound openings contain V or irregular shaped openings, they should be assessed in accordance with 3.3.2.5.3.

3.3.2.5.2 Completely bound openings – head first

Press the small head probe, Figure 3.3F, with the highest force possible up to 30 N into completely bound openings. If the small head probe passes completely through the opening, then the large head probe, Figure 3.3G, should pass completely through the completely bound opening with a force of up to 5 N. If completely bound openings contain V or irregular shaped openings, they should be assessed in accordance with 3.3.2.5.3.


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3.3.2.5.3 Partially bound, V and irregular shaped openings

Position the ‘B’ portion of the test template, Figure 3.3H, between and perpendicular to the boundaries of the opening, as shown in Figure 3.3I or 3.3J as appropriate. If the full thickness of the template cannot be inserted there is no hazard, but if it can there is a hazard, see Figures 3.3I and 3.3J.

If the test template can be inserted to a depth greater than the thickness of the template (45 mm), apply the ‘A’ portion of the test template, so that its centre line is in line with the centre line of the opening. Ensure that the plane of the test template is parallel and applied in line with the opening, as shown in Figure 3.3K. Insert the test template along the centre line of the opening until its motion is arrested by contact with the boundaries of the opening. If the template touches the bottom of the opening there is no hazard, but if the sides of the template touch the side of the opening there is a hazard, see Figure 3.3K.


Key

1 Is not a hazard 2 Is not a hazard 3 Is a hazard 4 Is a hazard

Figure 3.3l — Method of insertion of portion B

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Key

1 Is not a hazard 2 Is a hazard

Figure 3.3J — Method of insertion of portion B

Key

1 Is not a hazard 2 Is a hazard

Figure 3.3K — Method of insertion of portion A


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3.3.3 Entrapment of fingers

3.3.3.1 Rationale

This clause deals with the entrapment of fingers in static openings and gaps. Hazards to fingers associated with moving parts, which result in crushing and shearing are covered in 3.4: Hazards from moving parts.

This hazard occurs when a child’s finger becomes stuck in openings and gaps and the flow of blood to the finger is reduced. Additionally the weight or movement of the child may cause dislocation or displacement of a finger joint.

These hazards increase as the child’s desire to explore its environment increases. Even when a child is mobile, it may not always have the ability to extract its finger or fingers from the hazard.

The hazard can be avoided by limiting the size and depth of openings and gaps.

The hazard associated with fabric and plastic mesh, but not expanded plastic sheet, and holes-in-flexible materials is assessed using a different type of probe to those used for other materials. The probe for mesh and flexible materials has a conical end and a larger diameter, which is more relevant to these materials.

NOTE Examples of flexible materials are textiles, rubbers, silicon and other soft plastics.


There should be no openings between 5 mm and 12 mm unless the depth of penetration is less than 10 mm when tested in accordance with 3.3.3.5.

The finger probe for mesh should not penetrate the mesh to the parallel section of 7 mm diameter when tested in accordance with 3.3.3.5.

The finger probe for mesh should not penetrate holes in flexible materials to the parallel section of 7 mm diameter when tested in accordance with 3.3.3.5.

3.3.3.3 Determination of hazard

The finger entrapment decision-tree, Figure 3.3L, indicates how to determine whether an opening is a hazard that needs to be assessed in accordance with 3.3.3.5. The decision-tree is an aid to determining what and when entrapment hazards should be considered a risk. When using this decision-tree some subjective judgements will have to be made where there is no measurable requirement.

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NOTE Flexible includes materials such as textiles, rubbers, silicon and other soft plastics.

Figure 3.3L — Decision-tree – finger entrapment


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Probes made from plastics or other hard, smooth material of diameters 5 mm and 12 mm with a full hemispherical end that can be mounted on a force-measuring device, see Figure 3.3M.

Probe for assessing mesh made from plastics or other hard, smooth material as shown in Figure 3.3N.


Key

1 R2,5 or R6 2 Line scribed around circumference showing depth of penetration

3 Ø (5 01,0− ) or Ø (12 1,0

0+ )

Figure 3.3M — 5 and 12 mm probes


Figure 3.3N — Finger probe for mesh

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3.3.3.5 Test Methodology

Check whether the 5 mm probe, Figure 3.3M, with an applied force of up to 30 N, enters 10 mm or more into any accessible opening in any possible orientation. If the 5 mm probe enters 10 mm or more then the 12 mm probe, Figure 3.3M, should also enter 10 mm or more with an applied force of up to 5 N.

Check whether the finger probe for mesh, Figure 3.3N, with an applied force of up to 30 N, penetrates the mesh to the 7 mm diameter.

3.3.4 Entrapment of limbs, feet and hands

3.3.4.1 Rationale

The hazard occurs when limbs, feet and hands become stuck in openings and the child does not have the ability to extract itself. Bruising and swelling may occur which may cause distress, but will not result in permanent damage to the child.

The risk of entrapment of limbs, feet and hands is unlikely to occur with children under 6 months of age. However, the risk will increase as the child’s mobility and development increases.

This hazard is considered to be a low risk and as a result other safety considerations may need to take priority. For example, the spacing of bars to provide a protective function (for example in sides of cots) should be such that a child’s torso cannot slip between them, however this may result in a bar spacing that would trap a child’s limbs, feet or hands.


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3.4 Hazards from moving parts

3.4.1 Introduction

Hazards from moving parts are related to products and parts of products that move in use. The hazard relates to either the whole of the child’s body or parts of the body. A child’s body may be crushed if a product collapses around the child. A child’s fingers may be crushed, cut or even severed if the fingers become trapped between parts of a product that move. Compression points exist if one component can move relative to another part reducing the separation between the components. The risk is most severe if parts of products move under loads such as body weight or component weight.

3.4.2 Hazards with products designed to fold

3.4.2.1 Rationale

Products designed to fold should be designed to avoid crushing, entrapment or suffocation during use due to the product folding. Where products or parts of products are designed to fold, these products should be locked to avoid release through incomplete deployment or by an unintentional action.


Products that fold should have at least two locking or attachment mechanisms which comply with the requirements in 3.4.2.2.1 and 3.4.2.2.2 and should continue to meet these requirements and support the design loads after testing in accordance with 3.4.2.3.

3.4.2.2.1 Incomplete deployment of products

Where a product appears to be ready for use, but the locking mechanisms are not fully engaged (i.e. incomplete deployment), hazardous folding should be prevented. Products could be considered not to be a hazard due to incomplete deployment if the weight of the child using the product acts to prevent folding or detachment or at least one locking mechanism engages automatically when the product is deployed for use.

When tested in accordance with 3.4.2.3 the product should not fold or become detached.

3.4.2.2.2 Unintentional release of locking and attachment mechanisms

Unintentional release of the locking or attachment mechanisms may be considered to be prevented if:

a) the release mechanism is recessed in such a way as to prevent inadvertent activation; or

b) at least one of the locking or attachment mechanism requires the use of a tool (e.g. spanner or screwdriver); or

c) folding or detachment is only possible when two independent locking mechanisms are operated simultaneously; or

d) there are two or more automatically engaging locking mechanisms that cannot be simultaneously released by one unintentional action; or

e) release of the locking or attachment mechanism requires two consecutive actions, the first of which should be maintained while the second is carried out.

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3.4.2.3.1 Endurance test

The locking and/or attachment mechanism should be operated for a set number of cycles. The number of cycles that any one mechanism should be operated should be determined in accordance with the type of product and its likely life cycle.

3.4.2.3.2 Automatic locking mechanisms

With only the automatic locking mechanism(s) engaged or just one automatic locking mechanism engaged, apply a force of 200 N to any part of the product (except the locking release mechanism).

3.4.3 Hazards from crushing when the product is in use

3.4.3.1 Rationale

Products should already have complied with the requirements for finger entrapment, but there should be no crushing or amputation hazards caused by moving parts. These compression points may exist if one component can move relative to another part reducing the separation between the components. This risk is most severe if parts move under loads such as body weight, component weight or the application of powered mechanisms.


When the product is in use there should be no accessible compression points which can close to less than 12 mm, as the result of:

a) the mass or movement of the product; or

b) the movement of body weight by the child using the product; or

c) the application of an external force (either by another child or, unintentionally by the carer, or by a powered mechanism).


Probe made from plastics or other hard, smooth material of diameter 12 mm with a full hemispherical end that can be mounted on a force-measuring device, see Figure 3.4A.


Figure 3.4A — 12 mm probe


Apply a closing force of 200 N to the compression point of any gap. With this force applied check that the 12 mm diameter probe, Figure 3.4A, with an applied force of up to 30 N, penetrates the gap.


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3.5 Entanglement hazards

3.5.1 Introduction

If children become entangled with products there is a risk of strangulation.

To avoid strangulation hazards, protruding parts of products should be of such a shape and size that snagging of children’s clothing is not possible. If cords, ribbons and parts used as ties or leashes are used their length should be controlled so that they cannot encircle a child’s neck.

3.5.2 Snagging hazards

3.5.2.1 Rationale

Accessible protruding parts should be designed to avoid snagging of clothing or cords around or close to the child’s neck. This is particularly important where a child will spend time unattended by the carer (e.g. in a cot).

Holes, gaps and similar openings should be designed to avoid snagging of clothing, buttons, decorations and similar parts around or close to the child’s neck.


When tested in accordance with 3.5.2.4.1, there should be no protruding parts that will retain the ball chain loop and support the spherical mass of the test equipment specified in 3.5.2.3.4.

When tested in accordance with 3.5.2.4.2, there should be no protruding parts that will retain the ball chain or the disc and support the spherical mass of the test equipment specified in 3.5.2.3.5.

When tested in accordance with 3.5.2.4.2, there should be no accessible openings in which the disc can be placed and retained while supporting the spherical mass of the test equipment specified in 3.5.2.3.5.

3.5.2.3 Test Equipment

The test equipment comprises two combinations of the ball chain specified in 3.5.2.3.1, the disc specified in 3.5.2.3.2 and the spherical mass specified in 3.5.2.3.3.

Details of the two pieces of equipment are given in 3.5.2.3.4 and 3.5.2.3.5.

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3.5.2.3.1 Ball chain

The ball chain comprises a maximum of 10 balls per 40 mm when the chain is loaded with a mass of 2,5 kg. The diameter of each ball is (3,2 ± 0,1) mm, see Figure 3.5A.


Figure 3.5A — Ball chain

3.5.2.3.2 Disc

This comprises a round disc of 40 mm diameter with a fixed central bar with a hole at the other end for the 40 mm ring to be attached through, see Figure 3.5B. The ring is free to rotate within the hole in the bar.

Dimensions in millimetres Tolerances ± 0,1 mm

Figure 3.5B — Disc


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3.5.2.3.3 Spherical mass

A smooth spherical mass of (2,5 ± 0,05) kg and 125 mm diameter, see Figure 3.5C.


Figure 3.5C — Mass

3.5.2.3.4 Loop and mass

This comprises a ball chain loop attached to the spherical mass, see Figure 3.5D and 3.5F.

Key

1 Ball chain with peripheral length of (400 ± 5) mm 2 Both ends of the ball chain are fixed within the spherical mass 3 Spherical mass

Figure 3.5D — Loop and mass

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3.5.2.3.5 Disc, chain and mass

This comprises a ball chain with the disc attached at one end and the spherical mass attached at the other, see Figure 3.5E and 3.5F.


Key

1 Disc 2 Ball chain 3 Spherical mass

Figure 3.5E — Disc and mass

Figure 3.5F — Loop & mass and disc & mass

3.5.2.4 Test Methodology

3.5.2.4.1 Loop and mass

Using the loop and mass in Figure 3.5D, hold the spherical mass in one hand allowing the loop to hang freely over the product. Move the spherical mass along/around the product so that the loop is draped or dragged over and across any protruding parts. If the loop is retained by a protruding part lower the spherical mass, see Figure 3.5G.

Repeat the test for a total of 3 times. If during any of the 3 tests, the loop and mass is supported by a protruding part this is considered to be a failure.


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Figure 3.5G — Retention of loop and mass

3.5.2.4.2 Disc and mass

Using the disc and mass in Figure 3.5E, hold the spherical mass in one hand while allowing the ball chain and disc to hang freely over the product. Move the spherical mass along/around the uppermost part of the product so that the ball chain and the disc is in contact with the product. If the ball chain or the disc is retained by the product lower the spherical mass.

Repeat the test at least 3 times. If during any of the 3 tests, the disc and mass is supported by the product it is considered to be a failure.

Place the disc through any accessible gap or opening and lower the spherical mass, see Figure 3.5H.

Repeat the test at least 3 times. If during any of the 3 tests, the disc and mass is supported in an opening this is considered to be a failure.

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Figure 3.5H — Retention of disc and mass


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3.5.3 Cords, ribbons and parts used as ties

3.5.3.1 Rationale

Cords, ribbons and parts used as ties may form an integral part of products, for example for cords, ribbons and parts used as ties on soft articles designed to be attached to other products. Leashes may be used to attach products to the child’s clothing. Strangulation could occur where cords, ribbons and parts used as ties are long enough to wrap around a child’s neck, their length should therefore be controlled. Where cords and ribbons are used for decorative purposes only, their length should be limited to avoid a strangulation hazard.

Where two cords, ribbons or parts used as ties are in close proximity to each other there is the potential for these two cords, ribbons or parts used as ties to form a closed loop. However, to form a loop the two free ends should be tied together and when this is done it is unlikely that the circumference of the loop is more than 360 mm.

Where two cords, ribbons or parts used as ties are in close proximity there is the potential for them to go around the neck in opposite directions and then get twisted to form a loop around the neck. Although this is potentially hazardous it is considered to be a very low risk.

Loops that are large enough to pass over a child’s head could become a strangulation hazard, their circumference should therefore be controlled.

Monofilament threads are made of a single thread of man-made fibre, which are exceptionally strong and cannot be broken during use. If these threads are used in the manufacture of child use and care articles there is the possibility that the thread can become wrapped around any part of the child’s body such as its finger and as the thread will not break there is the possibility that the blood supply will be cut-off. These threads should therefore not be used in child use and care articles.


Cords, ribbons and parts used as ties should have a maximum free length of 220 mm when tested in accordance with 3.5.3.3. The free length is the maximum distance between the fixed and loose end on a single cord or the distance between both loose ends on two cords in close proximity to each other. Cords ribbons or parts used as ties should not have any attachments at their free ends. Cords, ribbons and parts used as ties can be arranged in different formats with one or two cords, ribbons and parts used as ties fixed at the same or similar places, see Figure 3.5I. When two cords, ribbons and parts used as ties are fixed at separate points the distance between these two points, D, should be a maximum of 80 mm.

Loops should have a maximum peripheral dimension of 360 mm when tested in accordance with 3.5.3.3.

Monofilament threads should not be used as cords, ribbons and parts used as ties and loops or as sewing threads.

It should be noted that EN 71 allows cords of over 220 mm in length providing they can separate into lengths no greater than 220 mm when a 25 N force is applied. This approach has not been adopted for child use and care articles. It is considered that the release mechanism could become inoperative when wound around a child’s neck as the force may not be applied to release mechanism.


The length of the cord, ribbon or parts used as ties is measured from the fixing point on the article to the free end of the cord, ribbon or part used as a tie when stretched by a force of 25 N, see Figure 3.5I.

The peripheral dimension of the loop should be measured while a 25 N tensile force is applied.

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Key

1 Child use and care article 2 A cord, ribbon or part used as a tie 3 A cord, ribbon or part used as a tie attached at its mid-point 4 A cord, ribbon or part used as a tie or two cords, ribbons or parts used as ties attached at two separate points L = 220 mm F = 25 N D = 80 mm maximum

Figure 3.5I — Examples of measuring cords, ribbons or parts used as a tie


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3.6 Choking hazards

3.6.1 Introduction

Choking is a serious hazard to young children. If air cannot pass into a child’s lungs irreversible brain damage can occur.

Choking occurs when the child’s internal airways are blocked and its breathing is impeded. If a child swallows small objects they can enter the airways and the trachea. Rounded shapes may present a hazard if because of their shape and size they block the airways at the back of the mouth.

This clause deals with the risk of choking from components that can be removed from a child use and care article. It does not deal with the hazard of unprotected hard foam materials which are used as padding to protect the child from impact injuries against metal components or as protection against thermal hazards. Currently there is no test method to assess this hazard.

3.6.2 Inhalation of small components

3.6.2.1 Rationale

Small objects and accessible components should be of such a size that they do not present a choking hazard by blocking the throat if placed in the child’s mouth.

Children between the age of 0 and 36 months spend time exploring their environment. This exploration includes them twisting and pulling small objects/parts with their fingers, hands or teeth. They may therefore remove components and put them in their mouths. It is important therefore that any components or parts of components are sufficiently large not to cause a choking hazard.

Components should therefore be assessed for their size and shape. The assessment should be made to ensure that components of products that are designed to be removed are sufficiently large not to cause a choking hazard. Components not designed to be removed should be firmly attached to the product. Components should be tested to ensure that they are firmly attached or that if they are not firmly attached do not break into pieces sufficiently small to cause a choking hazard. Components should also be checked to ensure there is no hazard from airway obstruction, see 3.6.4.

The small parts cylinder used for testing is designed to replicate a child’s throat.


When tested in accordance with 3.6.2.4.1, ability to grip, 3.6.2.4.2, torque test and 3.6.2.4.3, tensile test, any component or part of a component that is removed, whether intended to be removed without the use of a tool or not, should not fit entirely within the small parts cylinder Figure 3.6A.

Any component or part of a component that is removed should be assessed in accordance with 3.6.4, Airway obstruction.

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3.6.2.3.1 Small parts cylinder


Figure 3.6A — Small parts cylinder

3.6.2.3.2 Feeler gauge


Figure 3.6B — Feeler gauge

3.6.2.3.3 Clamps

Clamps are required to grip the components being tested in both the torque test, 3.6.2.4.2 (example in Figure 3.6C) and the tension test, 3.6.2.4.3 (examples in 3.6D and 3.6E). However where a clamp is used it should not damage the component being tested. Additionally the clamp shall not affect the result of the test.


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Figure 3.6C — Example of torque test clamp

Figure 3.6D — Examples of tensile test clamps

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Figure 3.6E — Example of a tensile clamp


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3.6.2.4.1 Assessment of child’s ability to grip components

A component is considered to be grippable by a child if it can grip the component between its thumb and forefinger or between its teeth. Where it is difficult to assess whether a child can grip a component, it should be possible to insert the feeler gauge in Figure 3.6B for a least 2 mm using a force of (10 ± 1) N between the component and the underlying layer of the component or the product, for the component to be considered as grippable by the child.

3.6.2.4.2 Torque test

Apply a torque gradually to the component over a period of 5 s in a clockwise direction until either:

a) a rotation of 180° from the original position has been attained; or

b) a torque of 0,34 Nm is reached. (It is recognised that this torque is low and that higher torques may need to be applied.)

The maximum rotation or required torque should be applied for 10 s.

The component should then be allowed to return to a relaxed condition and the procedure repeated in an anticlockwise direction.

Where projections, components or assemblies are rigidly mounted on an accessible rod or shaft designed to rotate together with the projections, components or assemblies, during the test, the rod or shaft should be clamped to prevent rotation.

If a component which is attached by a screw thread that becomes loosened during application of the required torque, the torque should continue to be applied until the required torque is exceeded or the component disassembles or it becomes apparent that the component will not disassemble.

When using clamps and test equipment care should be taken not to damage the attachment mechanism or body of the component.

Check whether any component or part of a component that is removed during the test fits wholly within the small parts cylinder specified in 3.6.2.3.1

3.6.2.4.3 Tensile test

The tensile test should be carried out after the torque test, 3.6.2.4.2, and on the same component as used for the torque test.

Attach a suitable clamp, see 3.6.2.3.3, to the component assessed as being grippable in accordance with 3.6.2.4.1, taking care not to damage the attachment mechanism or body of the component.

Fasten the component in a tensile testing machine and apply a tensile force of up to 90 N to the component to be tested. Apply the force gradually over a period of 5s and maintain for 10 s.

Check whether the component or any part of a component that is removed during the test fits wholly within the small parts cylinder specified in 3.6.2.3.1.

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3.6.3 Accessibility of filling materials

3.6.3.1 Rationale

Where products have internal filling and the external covering to this filling could be reached by a child’s mouth and teeth, it is important that the covering is not punctured to an extent that a child could gain access to the filling.

3.6.3.2 Requirement

No filling should be removed from the product when tested in accordance with 3.6.3.4.


The device, Figure 3.6F, consists of two sets of teeth, see Figure 3.6G, made from H13 high chrome tool steel or equivalent and hardened to 45-50 Rockwell C. There are two teeth at the top and two at the bottom of the device, positioned so that the vertical centre line of one pair of teeth is (1 ± 0,1) mm in front of the centre line of the other set of teeth. In the fully closed position the teeth overlap each other by (1 ± 0,1) mm. The outermost corners of the teeth have a radius of (0,3 ± 0,1) mm.

The teeth are mounted so as to pivot about a point (50 ± 1) mm from the rear most pair of teeth and positioned so that when closed the centre lines of the two pairs of teeth are parallel to each other. The device is equipped with a stop to prevent the distance between the teeth from exceeding 28 mm when fully opened. The closing force of the teeth is set at (50 ± 5) N.

The device is provided with a guide to prevent items entering further into the fully opened jaws by more than 17 mm. The device is equipped with a means whereby a force of (50 ± 5) N can be applied along its centre line in a direction tending to pull the teeth off the sample.


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Key

1 Position of guide 2 Pivot Point

Figure 3.6F — Test device

Figure 3.6G — Test teeth

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The test procedure comprises two stages:

stage 1) pinch the materials between finger and thumb and attach the test device so as to “bite” the smallest amount of materials possible to allow contact with all four teeth and apply a pulling force of 50 N, maintaining it for 10 s, to the device; then

stage 2) open the jaws of the test device as far as possible and push it onto the material as far as the guide, allow the teeth to close on the material and apply a pulling force of 50 N, maintaining it for 10 s, to the device.

This test procedure is applied at two separate points on the product.

If, during the test procedure, the outer material is punctured by the teeth, remove the outer material to expose the layer below or the filling and repeat stages 1 and 2 until the filling cannot be reached or no filling becomes detached. As soon as any filling becomes detached stop the test.

A puncture is defined as occurring when at least one tooth of the bite tester has broken the textile or plastic material to which it is being applied, the tooth passing through the entire thickness of the material. Where the bite tester is applied to materials of a loose weave or open mesh, a puncture is defined as occurring when part of the weave or mesh is broken by at least one of the teeth of the bite tester. Should the teeth of the bite tester pass through materials of a loose weave or open mesh without damaging the material, a puncture has not occurred.

3.6.4 Airway obstruction

3.6.4.1 Rationale

Airway obstruction may be caused by a product or part of a product partially passing through the palatopharyngeal arch into the pharynx. Alternatively airway obstruction may be caused by a product or part of a product twisting in the rear portion of the oral cavity in such a way as to elevate the soft palate, thereby obstructing the flow of air from the nasal passages at the same time as the flow of air is at least partially obstructed within the oral cavity. Hazard level increases if a product or part of a product reaches the posterior portion of the oral cavity. Products or parts of products placed or lodged in the anterior portion of the oral cavity pose less risk because the anterior portion of the oral cavity is larger and is surrounded to the top and sides by rigid structures. The hazard level increases even more if objects pass beyond the palatopharyngeal arch. The most extreme hazard in incidents of airway penetration is that the airway will be completely occluded, therefore preventing the passage of air to the lungs. With some products it may therefore be necessary to restrict the shape and size of components.

Figure 3.6H shows the anatomical position of terms used relating to airway obstruction. This figure has been copied from DTI’s Safety Research report “Safety research into the size and shape of soothers”.

Additionally, products or parts of products which reach the back of a child’s throat may initiate the protective mechanism of the airway, which may cause the child to vomit, a potentially serious situation where the child cannot sit unaided or does not have the ability to remove the object.


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Key

1 Esophagus 2 Spine 3 Oropharynx 4 Soft Palate 5 Nesopharynx 6 Hard Palate 7 Lips 8 Oral Cavity 9 Palatopharyngeal arch 10 Mandible 11 Epiglottis 12 Hypopharynx

Figure 3.6H — Position of anatomical terms used relating to airway obstruction

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3.6.4.2 Protective mechanisms of the airway

The cough reflex and the gag reflex are mechanisms the body has for protecting itself from potential injuries by foreign objects obstructing the airway. Both of these mechanisms are vigorous and dependable in healthy children.

Productive coughs are triggered when foreign objects enter the airway. This reflex is most useful when the objects are small enough to be suspended and contained in the flow of air produced by these coughs and subsequently expelled from the airway.

The gag reflex can be triggered when objects encounter the rear portion of the oral cavity. This reflex protects the pharynx from intrusion by foreign objects. The gag reflex is a spasm of the muscles surrounding the pharynx which will usually propel objects away from the airway. The presence of gagging does not necessarily indicate choking or airway obstruction. Gagging is a defence against these injuries. However, if the muscular spasm of the gag reflex is unsuccessful in expelling the foreign object it may increase the hazard by forcing the highly reactive and flexible tissue at the rear of the oral cavity to grip the foreign object. This clamping action may exert a surprising amount of force and make extraction of the foreign object difficult.


When tested in accordance with 3.6.4.5 the product or any part of a product should not pass through template A and no part of the product should protrude past the base of template A, Figure 3.6I. If the product or part of the product has a nearly spherical, hemispherical or cylindrical end it should not pass through template B and no part of the product should protrude past the base of template B, Figure 3.6I.


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Templates made from plastics or other hard, smooth material with dimensions and either a slot or a hole as shown in Figure 3.6I.


Key

1 Template A 2 Template B

Figure 3.6l — Template A and B


Position and clamp template A or B so that the axis of the slot/hole is substantially vertical and unobstructed at its top and bottom openings.

Orientate the object to be tested in a position which would most likely permit the entry of the object through the slot/hole in the template. Place the object in the slot/hole so that the only force on the object is the force due to its mass.

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3.7 Suffocation hazards

3.7.1 Introduction

Suffocation is a serious hazard to young children. If air cannot pass into a child’s lungs irreversible brain damage can occur.

Suffocation can occur if the child’s external airways, the nose and mouth are blocked simultaneously. The most likely cause of this blocking is if a thin piece of plastic sufficiently large to cover the nose and mouth moulds itself to the child’s face. The more the child breathes the closer the plastic can become attached and air is prevented from getting into the lungs. There is also a risk of suffocation from certain shapes, such as a bowl, half a ball or egg shapes that can be placed over a young child's nose and mouth forming an airtight seal. The available data indicate that children involved in fatalities associated with these shapes are between the ages of 4 and 24 months while “near misses” involve children up to 36 months of age. Specific requirements and test methods are being developed to address this hazard and, depending on their suitablility, will be incorporated within these guidelines in the future.

The risk of suffocation is more likely to occur with thin plastic decals, sheeting and wrapping as thicker ones will not be able to mould themselves to the child’s face. Therefore the thickness of plastic decals, sheeting and wrapping should be controlled.

3.7.2 Plastic decals and sheeting

3.7.2.1 Rationale

Plastic decals is taken to include transfers, plastic labels, adhesive labels etc. Decals should be securely attached to products to prevent a child removing them with its fingers, even after continuous picking at the edges or corners of decals. Decals should also remain securely attached in damp and wet situations. If there is any possibility that the decal would become detached from the product, it should be sufficiently small so that it would not cover both the mouth and nasal airways of a child.

If plastic sheeting is used as an external finish on a product it should be firmly attached to the product and/or of a thickness that would not allow it to mould to a child’s face.


When tested in accordance with 3.7.2.5.2 soaking test, 3.7.2.5.3 adhesion test or 3.6.2.5.3 tension test, plastic decals or plastic sheeting should not be removed or loosened from the product. If plastic decals or plastic sheeting is removed it should have an area greater than 100 mm × 100 mm and an average thickness more than 0,038 mm when tested in accordance with 3.7.2.5.5, plastic sheeting thickness. If the detached plastic decal or plastic sheeting has any dimension less than 100 mm (except thickness) it should not fit wholly within the small parts cylinder Figure 3.7 A in its unfolded condition.


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3.7.2.3 Determination of hazard

The hazard is determined through a sequence of tests that represent a child sucking and picking at a plastic decal or plastic sheeting. The first test is to soak the plastic decal or plastic sheeting to the check that it does not become loosened when wet. This is then followed by the adhesion test, which uses a feeler gauge, Figure 3.7B, to replicate the child picking at the plastic decal or plastic sheeting. Then a tensile force is applied to any part of the plastic decal or plastic sheeting that has lifted away from the product.





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3.7.2.5.1 Test temperature

The following tests should be conducted at a temperature of (20 ± 5) °C.

3.7.2.5.2 Soaking test

Submerge the plastic decal or plastic sheeting to be tested completely in a container of demineralised water at a temperature of (20 ± 5) °C for 4 min. Remove the plastic decal or plastic sheeting from the demineralised water, allowing any excess water to run off. Maintain the plastic decal or plastic sheeting at a temperature of (20 ± 5) °C for 10 min. Then repeat the test a further three times so that the component is submerged a total of four times.

3.7.2.5.3 Adhesion test

Using a force of (25 ± 2) N insert the feeler gauge in Figure 3.7B between the plastic decal or plastic sheeting and the underlying layer or the product at any angle between 0° and 10° from the surface. Repeat this for a further 29 times so that the feeler gauge is pushed between the plastic decal or plastic sheeting and the product for a total of 30 times. The feeler gauge should be pushed between the plastic decal or plastic sheeting and the product at the same position each time.

3.7.2.5.4 Tension test

Attach a suitable clamp to the plastic decal or plastic sheeting taking care not to damage the plastic decal or plastic sheeting. Apply a tensile force of up to 90 N gradually over a period of 5 seconds to the plastic decal or plastic sheeting and maintain for 10 seconds.

3.7.2.5.5 Measuring the thickness

Measure the thickness at 10 equidistant points across the diagonal of any area having dimensions of at least 100 mm × 100 mm.


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3.7.3 Non air-permeable packaging and wrapping

3.7.3.1 Rationale

Enclosures that do not allow air to pass constitute a suffocation hazard. For child use and care articles the main hazard is likely to come from the plastic packaging covering the product. Plastic wrapping and bags should therefore be sufficiently thick so that it will not take the shape of a child’s face and cover its nose and mouth or should be provided with ventilation holes.

Plastic bags should be of such a size that the child cannot put the bag over its face or head.

All materials intended for disposal after delivery to the final destination should be marked with a warning if they may cause, due to their size and material, the risk of interfering with the airways of the child and/or the risk of containing oxygen reduced air.


3.7.3.2.1 Single use packaging

Single use packaging should be marked with the following warning:

PLASTIC BAGS CAN BE DANGEROUS

TO AVOID DANGER OF SUFFOCATION

KEEP THIS BAG AWAY FROM CHILDREN

This requirement does not apply to the following:

shrunk-on film packaging, which is destroyed when the packaging is opened by the user;

bags made of perforated sheets which conform to the requirements in 3.7.3.2.2 a) and b).

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3.7.3.2.2 Repeated use packaging – for example storage bags

Wrapping of flexible plastics used for packaging unless in the form of a bag with an opening perimeter of less than 380 mm, should conform to the following:

a) Wrapping without any backing and of an area greater than 100 mm × 100 mm when tested in accordance with section 3.7.3.4 should have an average thickness of not less than 0,038 mm.

b) Wrapping with an average thickness of less than 0,038 mm and of an area greater than 100 mm × 100 mm should be perforated with 6 mm diameter holes so that a minimum of 1 % of the area has been removed over any area of 30 mm × 30 mm.

c) Bags made of impermeable material with an opening perimeter greater than 380 mm should not have a drawstring or cord as a means of closing.


Measuring device capable of measuring thickness to an accuracy of 1 µm according to ISO 4593.


Prepare the plastic bag by cutting the sides, without stretching, into two single sheets.

Measure the thickness of any sheet at 10 equidistant points across the diagonal of any 100 mm × 100 mm area and average the readings.


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3.8 Ingestion hazards

3.8.1 Introduction

Ingestion is a serious hazard to young children. If small products or components pass into a child’s stomach toxic contamination or internal blockages can occur.

3.8.2 Ingestion of small components

3.8.2.1 Rationale

In order to avoid ingestion of small objects and accessible components, they should be of such a size that they do not pass through the child’s mouth and throat to the stomach.

Children between the age of 0 and 36 months spend time exploring their environment. This exploration includes them twisting and pulling small objects/parts with their fingers, hands or teeth. They may therefore remove components and put them in their mouths. It is important therefore that any components or parts of components are sufficiently large not to pass through the mouth and throat to the stomach where they may become hazardous.

Components should therefore be assessed for their size and shape. This assessment should ensure that products or components are sufficiently large not to cause an ingestion hazard. Components should be tested to ensure that they are firmly attached or that if they are not firmly attached do not break into pieces sufficiently small to cause an ingestion hazard.

The small parts cylinder used for testing is designed to replicate a child’s throat.


When tested in accordance with 3.8.2.4.1, grippability, 3.8.2.4.2, torque test and 3.8.2.4.3, tensile test, any component or part of a component that is removed, whether intended to be removed without the use of a tool or not, should not fit wholly within the small parts cylinder Figure 3.8A.

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3.8.2.3.3 Clamps

Clamps are required to grip the components being tested in both the torque test, 3.8.2.4.2, example at Figure 3.8C, and the tension test, 3.8.2.4.3, examples at 3.8D and 3.8E. However where a clamp is used it should not damage the component being tested. Additionally the clamp should not affect the result of the test.

Figure 3.8C — Example of torque test clamp

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Figure 3.8D — Examples of tensile test clamps


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Figure 3.8E — Example of a tensile clamp

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3.8.2.4.1 Assessment of child’s ability to grip components

A component is considered to be grippable by a child if it can grip the component between its thumb and forefinger or between its teeth. Where it is difficult to assess whether a child can grip a component, it should be possible to insert the feeler gauge in Figure 3.8B for a least 2 mm using a force of (10 ± 1) N between the component and the underlying layer of the component or the product for the component to be considered as grippable by the child.

3.8.2.4.2 Torque test

Apply a torque gradually to the component over a period of 5 s in a clockwise direction until either:

a) a rotation of 180° from the original position has been attained; or

b) a torque of 0,34 Nm is reached. (It is recognised that this torque is low and that other torques are in use.)

The maximum rotation or required torque should be applied for 10 s.

The component should then be allowed to return to a relaxed condition and the procedure repeated in an anticlockwise direction.

Where projections, components or assemblies are rigidly mounted on an accessible rod or shaft designed to rotate together with the projections, components or assemblies, during the test, the rod or shaft should be clamped to prevent rotation.

If a component which is attached by a screw thread that becomes loosened during application of the required torque, the torque should continue to be applied until the required torque is exceeded or the component disassembles or it becomes apparent that the component will not disassemble.

When using clamps and test equipment care shall be taken not to damage the attachment mechanism or body of the component.

Check whether any component or part of a component that is removed during the test fits wholly within the small parts cylinder specified in 3.8.2.3.1

3.8.2.4.3 Tensile test

The tensile test should be carried out after the torque test, 3.8.2.4.2, and on the same component as used for the torque test.

Attach a suitable clamp, see 3.8.2.3.3, to the component assessed as being grippable in accordance with 3.8.2.4.1, taking care not to damage the attachment mechanism or body of the component.

Fasten the component in a tensile testing machine and apply a tensile force of up to 90 N to the component to be tested. Apply the force gradually over a period of 5 s and maintain for 10 s.

Check whether the component or any part of a component that is removed during the test fits wholly within the small parts cylinder specified in 3.8.2.3.1


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3.9 Hazardous edges and projections

3.9.1 Introduction

Sharp edges on products could cause cuts, lacerations and abrasions to a child’s skin. Projecting parts of products could puncture a child’s skin or pierce its eye.

Corners should be considered as sharp edges and projections as they can cause similar injuries. Corners should therefore be protected in a similar way to edges, 3.9.2 or rigid protruding parts, 3.9.3.

3.9.2 Edges

3.9.2.1 Rationale

Sharp edges and corners on products could cause cuts, lacerations and abrasions to a child’s skin.


3.9.2.2.1 Edges on products and components with a thickness greater than 4mm

Edges on components with a thickness greater than 4 mm and an internal angle of less than 120° should have a 2 mm radius or chamfer as examples in Figure 3.9A.


Key

1 Radiused 2 Chamfered

Figure 3.9A — Examples of 2 mm radiused and chamfered edges

3.9.2.2.2 Edges on products and components with a thickness less than 4 mm

Edges on components with a thickness of less than 4 mm should be rounded, folded, rolled or spiralled as examples in Figure 3.9B or have a protective covering as example in Figure 3.9C. Where a component is folded, rolled or spiralled as shown in Figure 3.9B the edge that is folded, rolled or spiralled should have full radius on it to reduce the hazard of sharp edges.

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When tested in accordance with 3.9.2.3 the protective covering should either not be removed or if removed the edge should comply with 3.9.2.2.1 or 3.9.2.2.2.

If after testing in accordance with 3.9.2.3 edges do not conform to the requirements in 3.9.2.2.1 or 3.9.2.2.2 and are considered a hazard they should then be assessed using a method for determining sharp edges. Methods for determining sharp edges have not been included in this report as they have not been validated for child use and care articles.


Figure 3.9B — Examples of folded, rolled and spiralled edges


Figure 3.9C — Example of edge with protective covering


Apply a tensile force of up to 90 N to the protective covering of the product to be tested. Apply the force gradually over a period of 5 s and maintain for 10 s.

3.9.3 Rigid protruding parts

3.9.3.1 Rationale

Tubes, bars, levers or other similar rigid components in the form of projections which constitute a puncture hazard to a child should be protected. The protruding component can possibly injure a falling or crawling child by their make-up, diameter or length. When such components are protected by a covering, it is important that the covering remains firmly in place during the useable life of the product.

Any protruding part should comply with 3.5.2 snagging hazards. The hazard of puncture should therefore be reduced as a child should not be able to fall onto the projection, however there is a risk of the child walking into or contacting an overhead projection.


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Projections should have a minimum cross section of 5 mm or have a protective covering that increases its cross section to more than 5 mm. When tested in accordance with 3.9.3.3 the protective covering should not be removed.


Apply a tensile force of up to 90 N to the protective covering. Apply the force gradually over a period of 5 s and maintain for 10 s.

3.9.4 Points and wires

3.9.4.1 Rationale

Points and wires are a puncture hazard which could present an unreasonable risk. Points and wires should be protected to remove the risk of injury to the child.

The requirement in 3.9.4.2 cannot guarantee the protection of the child’s eyes or the soft tissues of its mouth. The requirement should be supplemented with a subjective assessment to determine if points with a cross section of 5 mm or less are potentially hazardous. Tactile testing can be used for this assessment.

3.9.4.2 Requirement

Points and wires should be provided with a protective covering or rounded, blunted or bent into a ball with a cross section greater than 5 mm. This requirement should apply before and after other tests are conducted on the product.

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3.10 Structural integrity

3.10.1 Introduction

Where inadequate materials are used this could lead to a hazard induced by poor structural integrity so careful choice of materials is necessary.

Where inadequate strength and/or durability could lead to hazardous situations arising from foreseeable use, requirements should be included in standards.

Products should have adequate strength and durability lasting for the overall lifetime of the product.

Internal and external forces, static and dynamic loads and the long term properties of the product should all be considered. Reasonable safety factors and worst case situations should also be taken into account.

In relation to foreseen hazards it may be necessary to test the product for:

deformation under static and/or dynamic loading including impact;

fracture under static and/or dynamic loading including impact;

fatigue failure under cyclic loading;

creep failure under sustained loading;

failure under single excessive loading.

All strength and durability testing should be performed/repeated after subjecting the product to foreseeable conditions that may weaken the product, for example washing, corrosion, extremes of temperature. Static tests should be performed/repeated after cyclic load tests or other endurance tests.

Strength and durability should also be considered for non-rigid fabrics, for example seam strength.

Specific test methods and load factors may be established by reference to existing standards and other appropriate data.

3.10.2 Material suitability

3.10.2.1 Rationale

Material properties can become hazardous during use because of degradation of the material through:

aging from exposure to the sun, UV, saliva or sweat;

decay;

cleaning substances, including shrinkage due to cleaning;

corrosion from exposure to water, air or salts.


The material properties should not be impaired when tested in accordance with 3.10.2.3. These tests should be carried out before the tests in 3.10.3.


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It is the responsibility of the working group drafting a standard to select suitable testing from the plethora that are available in published standards.


The various test methodologies are specified in numerous published standards that can be used in assessing material suitability as explained in the rationale.

3.10.3 Strength and durability of product

3.10.3.1 Rationale

The strength and durability of the product should be sufficient to withstand all foreseen uses of the product. If the product fails through inadequate strength or durability during use the child using the product will be placed in a hazardous situation.


When tested in accordance with 3.10.3.3 there should be no deformation, fracture, fatigue or creep failure to the product or parts of the product. After testing in accordance with 3.10.3 no other hazards should arise, such as Choking Hazards 3.6, Suffocation Hazards 3.7, Ingestion Hazards 3.8 and Hazardous Edges and Projections 3.9.


3.10.3.3.1 Static load test

The product should be loaded with a test mass of at least three times the foreseeable loading. The test mass should be placed in a position similar to that occupied by the child during use. The test mass should remain on the product in a static condition for 24 h.

3.10.3.3.2 Dynamic load test

The product should be loaded with a test mass of at least the foreseeable loading. The test mass should be placed in a position similar to that occupied by the child during use. The product and test mass should undergo dynamic testing that simulates the products use. An example of the dynamic load test is the irregular surface test in EN 1888, Child care articles - Wheeled child conveyances - Safety requirements and test methods.

3.10.3.3.3 Impact test

The product should be impacted with a test mass of at least the foreseen loading (this may have to represent a child on a toy intended to bear the mass of a child, for example a ride on toy). The test mass should strike the product on the points of the product most likely to be impacted during use. Repeated impacts are required similar to those expected during the use of the product.

An example of the impact testing can be found in EN 1930 EN 1930, Child care articles – Safety Barriers – Safety requirements and test methods.

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3.11 Protective function

3.11.1 Introduction

Products that restrict a child’s access to hazards (e.g. safety barrier), products that contain a child within a specific environment (e.g. playpen), products that limit a child’s movement (e.g. safety harness), provide a protective function. Any protective function should be suitable for the age and ability of the child using the product and should not have its function and effectiveness reduced during its use.

3.11.2 Barrier function

3.11.2.1 Rationale

Barriers may be used to either restrict a child’s access to a specific area or to contain a child within a specific area. The barrier should be designed so that a child cannot climb over it, pass under it, pass through it or remove it. Where bars are used to form a barrier they should be spaced sufficiently close together so that a child cannot pass between the bars. However, any spacing should not allow a child’s body to pass between the bars thus giving rise to a potential strangulation hazard, see 3.3.2. Where locking and latching mechanisms are used to keep a barrier in place, these mechanisms should be designed so that a child cannot undo them. Barriers should be designed so that a child cannot displace them.

These barriers will not stop a child from passing their limbs through them, so the distance from the hazard should be considered when drafting a product standard.

The following does not consider the child’s ability to climb and therefore does not consider the child aged over 24 months. It is considered that children aged over 24 months have developed an ability to climb obstacles and research is needed to fully consider this aspect of a child’s development.

The structural integrity of barriers relies on their ability to resist fatigue and impact conditions which could lead to hazardous conditions. Examples of fatigue and impact requirements and tests can be found in EN 716 - Furniture – Children's cots and folding cots for domestic use and EN 1930 – Child care articles - Safety barriers – Safety requirements and test methods.


3.11.2.2.1 Height

When tested in accordance with 3.11.2.4.1 the height should always be equal to or greater than the height specified for the child’s age in Table 3.11A, and its structural integrity should be maintained.

Table 3.11A — Height according to age

Age

Months

Body length (mm) P95

Centre of gravity (% of length)

Centre of gravity calculated from the

ground

Height requirement

for age*

3 to 6 701 58,5 410 450

6 to 9 750 58,5 439 485

9 to 12 794 58,5 464 510

12 to 18 862 58,5 504 555

18 to 24 930 58,5 544 600 * Safety factor of 10 % (rounded up or down) added.


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3.11.2.2.2 Gaps

Gaps between components and between the barrier function and the floor should not allow the small torso probe to pass through or under the barrier, when tested in accordance with 3.11.2.4.2.

3.11.2.2.3 Locking and attachment mechanisms

Where locking and attachment mechanisms are fitted, unintentional release may be considered to be prevented if:

the release mechanism is recessed in such a way as to prevent inadvertent activation; or

at least one of the locking or attachment mechanism requires the use of a tool (e.g. spanner or screwdriver); or

folding or detachment is only possible when two independent locking mechanisms are operated simultaneously; or

there are two or more automatically engaging locking mechanisms that cannot be simultaneously released by one unintentional action; or

release of the locking or attachment mechanism requires two consecutive actions, the first of which must be maintained while the second is carried out.

These requirements should be met after testing in accordance with 3.11.2.4.3.

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3.11.2.3.1 Small torso probe

The small torso probe, Figure 3.11A, represents the torso of the smallest child likely to encounter the hazard. The probe sizes correspond to the child sizes as follows:

dimension ‘a’ represents the P53) chest depth;

dimension ‘b’ represents P5 thigh clearance;

dimension ‘c’ represents P5 hip breadth.

The dimensions of the small torso probe are based on the anthropometric data in Annex A, but with 0,7 (sd) taken off each dimension to give an appropriate size for a child at the 1st percentile4), or minimum size. In reality this means:

‘a’ = chest depth - 0,7 (sd) = chest depth - 6 mm;

‘b’ = thigh clearance - 0,7 (sd) = thigh clearance - 5 mm;

‘c’ = hip breadth - 0,7 (sd) = hip breadth - 10 mm.

3) For definition of P5 see Annex A, A.2 Terms related to anthropometric data.

4) For recommendations on this refer to Annex A, A.3 Recommendations for use of data.


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Table 3.11B — Torso probe corresponding to smallest child

Age

Months

a

b c

0 to 3 74 28 100

3 to 6 81 38 113

6 to 9 86 40 120

9 to 12 89 42 125

12 to 18 94 48 133

18 to 24 102 49 143

24 to 36 111 51 154

36 to 48 116 55 163


Key

1 Handle

Figure 3.11A — Small torso probe

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3.11.2.4.1 Measurement of height

Apply a vertical downward force of 250 N on the centre of the top rail of the barrier. Maintain this force while checking the height of the barrier.

3.11.2.4.2 Gaps

Press the small torso probe, Figure 3.11A, with the highest force possible up to 30 N into the gaps. If the small torso probe penetrates the opening to the base of the “head“ (c), then the gap is considered to be a hazard.

3.11.2.4.3 Endurance test

Open and close the locking and/or attachment mechanism not less than 300 times, or what is appropriate to the product category.

3.11.3 Restraint systems

3.11.3.1 Rationale

Where it may be hazardous for a child to climb out of a product, for example in a pushchair, a restraint system is required to limit the child’s movement. The restraint system should retain the child within the product. For some products it is appropriate to have the restraint system permanently attached to the product and for other products a means of attaching a separate safety harness may be considered to be sufficient, in which case specific anchorage points need be incorporated into the product.

3.11.3.2 Definitions

3.11.3.2.1 Restraint system

system to restrain the child.

3.11.3.2.2 Crotch restraint

device designed to pass between the child’s legs to prevent the child from sliding forward.

3.11.3.2.3 Harness anchorage points

attachment points suitable for the attachment of a child’s safety harness.

3.11.3.2.4 Harness

restraining device comprising a waist belt and straps designed for attachment to harness anchorage points.


3.11.3.3.1 Restraint system

The restraint system should be adjustable.

Any crotch restraint should be capable of being used in combination with other parts of the restraint system.

Straps used for waist and crotch restraint should have a minimum width of 20 mm. Where shoulder straps are included in a restraint system they should be a minimum width of 15 mm.


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When tested in accordance with 3.11.3.5.1, the test dummy, see 3.11.3.4 should not completely fall out of the restraint system. It should be noted that any partial movement of test dummy is not considered a failure.

When tested in accordance with 3.11.3.5.2, the attachment of the restraint system should not break, deform, work loose or become torn/displaced.

When tested in accordance with 3.11.3.5.3 in any orientation, fasteners should not be released or have suffered damage which impairs their operation and function.

When tested in accordance with 3.11.3.5.4 the maximum slippage of adjusters should be 20 mm.

Instructions should be provided for the use of the restraint system.

3.11.3.3.2 Harness anchorage points

When tested in accordance with 3.11.3.5.5 the harness anchorage points should not break, deform, work loose or become torn/displaced.


Test dummy made of a rigid material with a smooth finish and a total mass of (9 ± 0,1) kg, see Figure 3.11B.

Dimensions in millimetres Tolerances: ± 2 mm

Angles ± 2° All corner radii where shown to be 10 ± 1 mm

Figure 3.11B — Test dummy

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3.11.3.5.1 Effectiveness of restraint system

Initially place the test dummy centrally on the seat unit with the 225 mm axis against the back rest and attach the restraint system in accordance with the manufacturers instructions. Fasten any waist restraint around the torso section of the test dummy so that any slackness is removed and the waist restraint is positioned above the leg stumps. If the crotch restraint is adjustable, adjust it so that any slackness is removed. Where shoulder straps are fitted, place a 30 mm cuboid spacer block, made of a hard smooth material, on each shoulder of the test dummy. Adjust each shoulder strap so that any slackness is removed. Remove the spacers.

A means of rotation is used to rotate the product smoothly through 360° at a speed of (4 ± 0,5) RPM in a forward and reverse direction.

Rotate the product through 360° in a forward direction. If necessary reposition the test dummy to its initial position without altering the adjusters on the restraint system. Rotate the product through 360° in the reverse direction. If necessary reposition the test dummy to its initial position without altering the adjusters on the restraint system.

Repeat the forward and reverse rotation cycles for two more sequences, giving a total of 3 forward and 3 reverse rotations. If necessary, after each rotation, reposition the test dummy to its initial position without altering the adjusters on the restraint system.

3.11.3.5.2 Attachment of the restraint system to the product

Gradually apply (150 ± 2) N to each point of attachment of the restraint system in the most onerous direction. Maintain this force for 1 min.

If more than one strap is attached at the same position the (150 ± 2) N should be applied to each strap simultaneously.

3.11.3.5.3 Strength of fastener

A tensile force of 200 N should be gradually applied to the straps either side of the fastener. Maintain this force for 1 min.


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3.11.3.5.4 Effectiveness of the adjustment system

Use approximately 125 mm of the restraint system on either side of the adjustment system.

Fix one end of the test piece into one jaw of a dynamometer and the other end into another jaw. The distance between the jaws should be 200 mm.

Draw a line across the width of the test piece flush with each jaw.

Set the jaw movement speed to (500 ± 10) mm/min. Reduce the distance between the jaws to 150 mm. Subject the test piece to a tensile strain until the latter reaches (100 ± 10) N. When this strain has been reached, return the distance between the jaws to 150 mm.

Conduct the test for a total of 10 times.

Measure the distance between the lines drawn flush with the jaws. The difference between this dimension and original dimension of 200 mm is the amount of slippage.

3.11.3.5.5 Strength of harness anchorage points

Gradually apply (150 ± 2) N to the harness anchorage point in the most onerous direction. Maintain this force for 1 min.

If more than one harness anchorage point is attached at the same position, the (150 ± 2) N should be applied to each harness anchorage point simultaneously.

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3.11.4 Footholds

3.11.4.1 Rationale

Footholds on rigid structures which provide barrier protection (see 3.11.2) should be avoided as the presence of footholds could enable a child to climb the barrier. A child will find it very difficult to gain a foothold on a flexible component which does not also have a rigid structure associated with it.

It should be noted that this rationale and all the following text is hypothetical. None of it has been fully validated or verified by research on children’s climbing ability. If this type of research is carried out it may change the rationale behind assessing the hazards of footholds.


There should be no footholds on rigid components when tested in accordance with 3.11.4.5.

Where there is a rigid structure obscured by a flexible material there should be no footholds when tested in accordance with 3.11.4.5.


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3.11.4.3 Test equipment (Templates)

A strip of 10 mm thick transparent material cut to the shape as shown in Figure 3.11C, marked on one face with the pattern as shown.

The sides of the template should be square to the faces. All edges and corners should be left as machined without any radius.


Key

1 Triangular cells plotted on a 5 x 5 grid

Figure 3.11C — Template for the foothold test (example of left hand template)

Two templates are required to provide a left and right hand template. The marking shown in the Figure 3.11C are on the bottom face of each template to avoid parallax errors.

3.11.4.4 Determination of a foothold

3.11.4.4.1 Continuous structure

A foothold exists on a continuous structure if four triangles marked on the template are completely obscured by the structure being checked. These four triangles must have at least one side in common with another of the triangles, see Figure 3.11D below.

Key

This shaded area denotes one triangle, four shaded areas denotes four obscured triangles

Figure 3.11D — Examples of obscured triangles indicating a foothold on a continuous structure

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3.11.4.4.2 Non-continuous structure

A foothold exists on a non-continuous structure if two or more triangles marked on the template are completely obscured on the outside of the bold lines of the template by the structure being checked. The two or more triangles on either side of the template must have at least one side in common with each other, see Figure 3.11E below.

Key

This shaded area denotes one triangle

Figure 3.11E — Examples of obscured triangles indicating a foothold

3.11.4.4.3 Wire, thin structures or similar parts

A foothold exists on a wire, thin structure or similar part if it projects across the bold lines on the template, see Figure 3.11F below. Any wire, thin structure or similar part with a minimum width of 5 mm should be checked in accordance with 3.11.4.5.3.

Key

This denotes a wire, thin structure or similar structure

Figure 3.11F — Examples of a foothold on a wire, thin structure and similar parts


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3.11.4.5.1 Footholds on a continuous support at an angle less than 55°

Using either the left or right hand template place the template with its marked face on any continuous structure inclined at less than 55° to the horizontal. Orientate either template, Figure 3.11C, to check whether any four triangles are obscured indicating a foothold, see Figure 3.11G for examples.

3.11.4.5.2 Footholds on a non-continuous support at an angle less than 55°

Using either the left or right hand template place the template with its marked face on any non-continuous structure inclined at less than 55° to the horizontal. Orientate either template, Figure 3.11C, to check whether any triangles are obscured either side of the bold lines on the template indicating a foothold, see Figure 3.11H for examples.

3.11.4.5.3 Wire, thin structures or similar parts at an angle less than 55°

Using either the left or right hand template place the template with its marked face on any wire, thin structure or similar parts at an angle less than 55° to the horizontal. Check whether the wire, thin structure or similar part has a line of contact extending between the two bold lines marked along the template, Figure 3.11C, see Figure 3.11I for examples.

3.11.4.5.4 Intersecting or adjacent structures where the second structure prevents slipping

Using either the left or right hand template place the template with its marked face on any structure, thin structure or similar parts between 55° and 80° to the horizontal where there is also a supporting structure. Orientate either template, Figure 3.11C, to check whether any four triangles are obscured indicating a foothold, see Figure 3.11J for examples.

3.11.4.5.5 Flexible materials

Where flexible materials or fabrics are covering rigid components the template is pushed against the flexible material or fabric with a horizontal force of up to 30 N acting along the longitudinal axis of the template. Orientate either template, Figure 3.11C, to check whether any four triangles are obscured by the rigid components indicating a foothold.

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Figure 3.11G — Examples of footholds on a continuous support at an angle less than 55°

Figure 3.11H — Examples of footholds on a non-continuous support at an angle less than 55°


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Figure 3.11l — Examples of footholds on wire, thin structures or similar parts at an angle less than 55°

Figure 3.11J — Examples of footholds on intersecting or adjacent structures where the second structure prevents slipping

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Fire and thermal hazards – Contents list

4.1 Terms related to thermal hazards


4.3 Flammability and burning hazards

4.3.1 General

4.3.2 Rationale

4.3.3 Requirements

4.3.4 Test equipment


4.4 Hazards from hot and cold surfaces

4.4.1 Rationale

4.4.2 Requirements

4.5 Hazards from hot and cold liquids

4.5.1 Rationale

4.5.2 Requirements

4.6 Hazards from contact with flames

4.6.1 Rationale

4.6.2 Requirements

4.7 Hazards from the melting behaviour of materials

4.7.1 Rationale

4.7.2 Requirements

4.8 Hyperthermia and hypothermia hazards

4.8.1 Rationale

4.8.2 Requirements


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4 Thermal hazards

4.1 Terms related to thermal hazard

flammability: ability of material to burn with a flame under specified test conditions.

flaming: undergoing combustion in the gaseous phase with the emission of light.

ignitability: ability to obtain sustained combustion under specified test conditions when a material is exposed to an ignition source.

flash effect: rapid spread of flame over the surface of a material, without combustion of the basic structure at that time as specified in EN 1103.

thermal hazard: hazard caused by high or low temperatures.


This section addresses thermal hazards and is intended to provide guidance for the reduction of these hazards when drafting standards for child use and care articles.

Thermal hazards include hazards associated with flammability and the burning characteristics of materials, contact with hot and cold surfaces and liquids, contact with flames, contact with products that melt on heating and overheating or exposure of a child to very low temperatures.

Chemical products such as flame retardants which might confer chemical hazards should be avoided in child care articles. It is recommended that flammability requirements are not so onerous that only products treated with these flame retardants could meet the requirements. Where possible materials should be used which will comply with the requirements without the use of flame retardants.

The following materials should not be used in the manufacture of child care and use articles:

celluloid (cellulose nitrate) and materials with similar behaviour except when used in varnish or paint;

materials with a pile surface which produces surface flash on contact with a flame.

In addition child care and use articles should not contain flammable gases, extremely flammable liquids, highly flammable liquids, flammable liquids and flammable solids. For EU countries the categories are defined in articles 2.2.(c) and 2.2.(d) in Directive 79/831/EEC amending Directive 67/548/EEC "Classification, packaging and labelling of dangerous substances."

It should be noted that different legal requirements may exist in some countries.

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4.3 Flammability and burning hazards

4.3.1 General

Some child and use and care articles, for example a soother, do not need flammability requirements, other products may need testing for flash effect, flammability or for both of these.

Standards for child use and care articles, when specifying requirements, currently refer to EN 71 Safety of toys – Part 2 Flammability. The requirements establish limits for the propagation of the flame if a textile material is ignited. Additionally EN 71 –2 states that there should be no flash effect when textiles are tested in accordance with EN 1103, Textiles and textile products - Burning behaviour- Fabrics for apparel - Detailed procedure to determine the burning behaviour of fabrics for apparel.

The significant characteristics of a material’s reaction to fire which should be considered are:

ignitability;

flame propagation;

rate of heat release;

rate of smoke;

toxic flue gases;

rate of evolution of gas;

flaming debris.

Their relative importance depends on the product and the way the product is constructed and used.

It should be taken into consideration that the combustion of some materials might produce toxic fumes which is the most common reason for deaths in relation to fires.

4.3.2 Rationale

For the majority of child use and care articles, the probability that they will come close to or be in contact with a source of ignition is low. However, if the child use and care article should come close to, or be in contact with an ignition source, the carer shall be able to remove the child before injury occurs. If there is the possibility that the product will come in contact with a source of ignition, any rate of spread of flame should be extremely slow.


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4.3.3 Requirements

Child use and care articles for which flammability requirements are appropriate should, depending on the characteristics of the material and the type of child use and care article in question, comply with one of the two following requirements:

No flash effect when tested in accordance with EN 1103;

No flash effect when tested in accordance with EN 1103 and a maximum rate of spread of flame of 30 mm/s when tested in accordance with 4.3.4.

4.3.4 Test equipment

4.3.4.1 General

The test equipment and test method for determination of the rate of spread of flame is given in EN 71-2 and is summarized below.

4.3.4.2 Test chamber

To ensure the safety of test personnel and good test practice, tests should be carried out in a test chamber in which the movement of air is less than 0,2 m/s at the start of the test and is not affected by operation of mechanical apparatus during the test. It is essential that the volume of air in the test chamber is not affected by reduction in the level of oxygen concentration. When an open fronted chamber is used for testing, it should be possible to position the test sample at least 300 mm from the walls of the chamber. The temperature of the chamber should be maintained in the range 10 °C to 30 °C with a relative humidity of 15 % to 80 %.

4.3.4.3 Ignition source

The test flame should be obtained from a burner as described in EN ISO 6941 Textile fabrics – Burning behaviour – Measurement of flame spread properties of vertically oriented specimens Annex A and should be operated with butane or propane gas as appropriate. The burner should have a flame of (40 ± 2) mm measured from the end of the burner tube to the top of the flame with the burner in the vertical position. The burner should be pre-heated for 2 min prior to the test in 4.3.5.3.

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4.3.4.4 Sample holder

The sample holder intended to secure the specimen during the test should be made of material resistant to gas corrosion and consists of two U-shaped metal plates with internal dimensions of 600 mm × 80 mm. There are four attachment points on the upper plate, two 50 mm from the open end and two 550 mm from the open end of the frame (see Figure 4.3A).

Key

1 Top 2 Bottom 3 Attachment points with 100 % white mercerised cotton marker threads 4 Sample

Figure 4.3A — Sample holder


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4.3.5.1 Preparation of the sample

Each test should be carried out on a sample from a new product.

The advice to the consumer e.g. on a care label or on its packaging should be followed:

if the advice indicates that the product is not intended to be washed, the sample should not be washed or soaked before testing;

if the advice recommends a method of washing or cleaning, the sample should be treated in accordance with these recommendations.

Where no recommendations are given relating to washing or cleaning, the sample should be treated, before testing, in accordance with the following instructions:

Immerse the sample in tap water (approximately 20 °C) at a ratio of at least 1,20 mass of the sample to volume of water, and allow it to stand for 10 minutes. Drain and repeat twice. Rinse by immersing the sample in demineralized water for 2 min. Drain and dry by a method appropriate to the sample and, where appropriate, restore the pile as near as possible to its original condition.

Cut test samples of at least 610 mm × 100 mm dimensions from each material available on the product. Each test sample should be made of one material. Where possible the sample should not include seamed edges or edges decorated with lace trimmings. As seams modify the rate of spread of flame, they should, if present, be placed in the upper part of the sample holder.

If there is insufficient material to make a full sample piece as described above, two equal pieces of the same material with dimensions of 310 mm × 100 mm may be used so that when they overlap, a full sample of at least 610 mm × 100 mm is achieved. In order to ensure that there is no gap at the overlap, staples may be used to secure the joint.

Before testing, the sample should be conditioned for at least 7 h in a temperature of (20 ± 5) °C and at a relative humidity of (65 ± 5) %. The samples should be tested within 5 min of removal from the conditioning atmosphere.

4.3.5.2 Holding the sample

Place the sample on the sample holder slightly tensioned to avoid creases, waving or curling and clamp the sample holder together. Attach the marker threads at the attachment points across the sample at no more than 2 mm from the surface of the sample, with a device to indicate when the thread is severed.

Position the sample holder at (45 ± 1)° to the horizontal.

4.3.5.3 Ignition source

Position the burner in a vertical position so that the distance between the edge and the top of the burner is (30 ± 2) mm (see Figure 4.3B). Maintain the burner with the flame for (10 ± 1) s.

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Key

1 Sample 2 Attachment points for 100 % mercerised white cotton marker threads 3 Sample holder, inclined 45° to the horizontal 4 Flame (40 ± 3) mm 5 Burner

Figure 4.3B — Burner


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4.3.5.4 Flaming

If flaming occurs, the timing device is started when the first thread is severed by the flame and stopped when the second thread is severed.

4.3.5.5 Results

After applying the ignition source, if the sample fails to ignite and if the first thread has not been severed, the sample is considered to have met the requirements.

If flaming occurs and the first marker thread is severed and the flame extinguishes before severing the second thread, the material tested is considered to be self-extinguishing and is considered to have met the requirements.

If the second marker thread is severed, the time is recorded and the rate of spread of flame is calculated in mm/s to the nearest mm/s.

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4.4 Hazards from hot and cold surfaces

4.4.1 Rationale

Contact of parts of the child care article with the skin or the mouth of the child is very common. If these surfaces are too hot or cold burns can occur.

As children have limited ability to react to contact with hot and cold surfaces, they require protection. Children do not touch in the same way as adults. Up to 24 months of age children do not have reflexes that are quick enough to enable them to remove their hands from what is burning them. They shall not have the ability to get away from hot surfaces. It is estimated that the contact period before a child’s reflexes respond can be up to 15 s. (Extract from EN 563:1994 "Safety of machinery – Temperature of touchable surfaces – Ergonomics data to establish temperature limit values for hot surfaces.").

It is unlikely that child use and care articles would be designed to generate heat in use and that any change in temperature of the article would be a result of exposure to the sun or cold temperatures.

Should a child use and care article be designed to generate heat, EN 563 recommends the following maximum temperatures:

Metal Glass Plastics Wood

47 °C 52 °C 54 °C 56 °C

The temperature values given above are in degrees Celsius (°C). They are the temperatures of the article.

4.4.2 Requirements

Where a part of a child use and care article is likely to be exposed to extremes of temperature and the child will have access to these parts, the standard should require that these parts have a covering so that the child cannot gain access to them.


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4.5 Hazards from hot and cold liquids

4.5.1 Rationale

Hot liquids can result in scalds. Children are at risk if they can get access to hot liquids while using a child care and use article for example being able to reach a cup of hot liquid when the child is in a table mounted chair. Another potentially dangerous situation is where liquid is too hot in a feeding bottle. The risk from cold liquids is less likely to occur with child use and care articles.

4.5.2 Requirements

Where the use of a child use and care article could result in a child having access to hot liquids, warnings should be given in the product information warning carers to the dangers associated with hot liquids. Attention should be drawn to risks associated with feeding bottle heaters and heating of feeding bottles in microwave ovens, where uneven temperatures may occur.

4.6 Hazards from contact with flames

4.6.1 Rationale

Flames are an obvious hazard to adults but to children they may be an attraction. Where a child use and care article is designed to protect a child against access to flames, for example a fireguard, it is important that its protective function is adequate.

4.6.2 Requirements

Any protective barrier should prevent a child reaching the open flames.

4.7 Hazards from the melting behaviour of materials

4.7.1 Rationale

Some solid products such as some plastics soften or liquefy when heated. Any skin contact is likely to result in serious injury.

4.7.2 Requirements

Where possible materials that can melt or soften should not be used. If alternatives cannot be found these materials, if likely to become heated, should be contained so that the child cannot gain access to them.

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4.8 Hyperthermia and hypothermia hazards

4.8.1 Rationale

Overheating, hyperthermia, a rise in the child’s core temperature, can occur if the child is in a hot environment for example in a room or in a car. This is a factor that has been associated with sudden infant death syndrome. Combinations of room temperature and products that cause heat build-up constitute a hazard.

A lowering of body temperature, hypothermia results in a lowering of the child’s core temperature. This hazard is mainly associated with children becoming shut in cold stores or caught outdoors in adverse weather conditions. It is unlikely that hypothermia will need to be considered in relation to child use and care articles.

4.8.2 Requirements

A warning concerning the dangers of overheating should be provided where appropriate.


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Product information – Contents list

5.1 Terms and definitions related to product information


5.3 Model requirements to include in standards

5.3.1 General

5.3.2 Markings

5.3.3 Purchase information

5.3.4 Instructions for use

5.4 Durability of markings

5.5 Warning sentences and symbols

5.5.1 General

5.5.2 Examples of non-product-specific (general) warnings

5.5.3 Examples of product-specific warnings

5.5.4 Additional sources of information relating to warning sentences

5.5.5 Additional sources of information relating to warning symbols

5.6 Guidelines for the development of warning sentences and symbols

5.6.1 General

5.6.2 Developing warning sentences

5.6.3 Developing warning symbols

5.7 Guidelines for the presentation of warning sentences and symbols

5.7.1 General

5.7.2 Presentation of warning sentences

5.7.3 Presentation of warning symbols

5.7.4 Contrast and paper quality

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5 Product information

5.1 Terms and definitions related to product information

product information: texts and images that may accompany or be associated with a specific child use and care article. This includes labels, certification marks, markings, leaflets, manuals and brochures.

marking: product information permanently attached to the child use and care article or, where the packaging creates the risk, to its packaging.

purchase information: product information provided at the point of sale prior to the purchase decision. This includes mail order catalogues, tele-sales, internet etc.

instructions for use: product information provided during the use phase. This includes information for assembly, installation, operation, storage, maintenance, repair and disposal.


Safety related product information should only be provided in relation to known hazards of the child use and care article under consideration. Over-labelling can obscure important safety information. A risk analysis (see Annex B) should be applied to identify those hazards for which safety-related product information is required and also to identify the information that should be marked on the child use and care article.

It is recommended to specify signal words, warning sentences and symbols in standards. Standardised sentences and symbols (see 5.5) can be incorporated into the standard, dependent on the product and the hazard under consideration. In the case of more severe hazards, a signal word, preferably WARNING!, should be added. Hazards and consequences should be specified if not obvious. Sentences and symbols should not be prescribed in standards, unless they have been developed in accordance with the guidelines given in 5.6.

It is recommended to specify requirements on the presentation of sentences and symbols (see 5.3 for model requirements). The requirements needed depend on the type of information.

Markings are recommended in the case of safety information that requires extra attention where for example the hazards involved are severe, or because the hazard occurs every time the product is used or because unsafe behaviour is likely to occur. Markings on the product are also recommended for identification purposes.

Purchase information informs the potential buyer about the safety-related characteristics of the child use and care article that the buyer needs to know in order to be able to decide whether the product meets the foreseeable conditions of use.

Instructions for use inform the user of the child use and care article concerning the things the user needs to know in order to be able to experience the necessary level of safety during the lifetime of the product. The instructions for use should include all purchase information and all markings.

The reader should note that a guidance document in the field of safety of consumers and children under mandate M/292 is currently being drafted.


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5.3 Model requirements to include in standards

5.3.1 General

Information should be given to avoid the possible consequences of product-related hazards which cannot be eliminated by design, or sufficiently controlled by safeguarding or shielding. The information given should relate to the type or model of the child use and care article with which it is provided. Other safety information should not be given, unless relevant. Information should be understandable (see the guidelines given in 5.6). Other information should not be presented in such a way that it interferes with the effectiveness of the safety information prescribed below.

The information should be legible (see the guidelines given in 5.7), and should be presented at least in the official language(s) of the country of sale. In the case of different languages, these should be easy to distinguish, e.g. by separate presentation. All product information should still be legible and understandable after repeated consultation of the information carriers.

It is recommended to include sections 5.3.2, 5.3.3 and 5.3.4 into the clause in the standard on product information. Parts irrelevant to the product should be omitted.

5.3.2 Markings

5.3.2.1 General

Markings should be permanently attached to the product.

Where packaging could create a risk, markings should be permanently attached to the packaging.

Markings should not hinder product use nor create new risk.

Markings should not become detached and should be legible and understandable after performing the durability test given in 5.4.

If marking the product with the following information would not be possible (e.g. the product, or parts of the product are too small) the information may be presented in an alternative way. However, additional efforts should be made to draw the user’s attention to the information. The creation of new risks (e.g. choking or suffocation) should be prevented.

5.3.2.2 Visible markings

Markings should be visible during the time or occasion when the corresponding hazard can occur.

The following information should be marked on the product:

Specific warning sentences and symbols which are selected as the basis of the safety philosophy described in 5.2;

If the packaging creates a risk of suffocation, it should be visibly marked with the following warning sentence, “WARNING!: Keep this (plastic) cover away from your child to avoid suffocation”.

5.3.2.3 Additional markings

The product should also be marked with the following information which need not always be visible:

Identification of the product.

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The identification is adequate if products with different use characteristics can be distinguished by the user of the product. The supplier should decide whether separate parts of the product, or different product batches are given a separate identification:

Identification of the responsible supplier.

The identification is adequate if one of the following descriptions is given:

name and full postal address of the supplier in the country of sale;

name and place of settlement of the supplier in the country of sale, in such a way that the address and/or telephone number can easily be traced, e.g. with the help of a telephone directory;

name of the brand or supplier of the product if the brand name or the supplier is well-known and there are several easily recognisable points of sale in the country of sale.

5.3.3 Purchase information

The following information should be visible at the point of sale prior to the purchase decision:

specific warning sentences and symbols which are selected on the basis of the safety philosophy described in 5.2;

if the purchase information is easily removable or provided separate from the product, precautions should be taken to ensure permanent availability of this information during the purchase phase, e.g. by providing additional facilities such as a display or instructions for retailers.

5.3.4 Instructions for use

Where instructions are provided separate from the product, or designed to be kept separate from the product, it should be easy to store, include all safety-related information and be visibly marked: “Read these instructions carefully before use, and keep them for future reference. Your child may be hurt if you do not follow the instructions”.

The instructions for use should contain the following information:

assembly, installation, operation, storage, maintenance, repair and disposal;

specific warning sentences and symbols which are selected on the basis of the safety philosophy described in 5.2;

all markings and all purchase information should be repeated;

symbols marked on the product or the packaging should be repeated together with the corresponding warning sentence.


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5.4 Durability of markings

Suitable requirements and a test method for testing the resistance of markings against cleaning should be given in the standard.

5.5 Warning sentences and symbols

5.5.1 General

This section gives an overview of warning sentences and symbols for inclusion in the safety standards for child use and care articles and other children’s products. The sentences have been selected from various standards and draft standards for children’s products. They have been revised to comply with the guidelines given in 5.6. The sentences are divided in two parts, a basic set of warnings for the hazards that apply to many children’s products and a set of examples of product-specific warnings.

Warning sentences and symbols relevant to the product under consideration should be incorporated into the product information requirements of standards for child use and care articles. A product or product feature should be filled in between parentheses in “this (.…)”, see 5.5.2.

Translated sentences should be checked to ensure that they still comply with the guidelines given in 5.6.

In the case of severe hazards, a signal word, preferably WARNING! should be added at the beginning of a warning sentence or at the top of a list of warnings. Hazards and consequences should be specified if not obvious.

5.5.2 Examples of non-product-specific (general) warnings

WARNING! Keep this (plastic) cover away from your child to avoid suffocation.

WARNING! Do not use this (....) once:

your child can sit up unaided;

your child is taller than x cm;

your child weighs more than x kg;

the (.…) may collapse/fall over. Your child may be hurt.

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WARNING! Never leave your child unattended in/with this (....) Your child may be hurt. (specify hazards and consequences if possible)

The following symbol can be used in addition to the safety sentence (at least for a transitional period of time until acceptable comprehension is achieved). Negating stroke in red.

Figure 5.5A — Example of warning symbol

WARNING! Do not use this (....) if any part is broken, torn or missing. Your child may be hurt. (specify hazards and consequences if possible).

WARNING! Before each use check the fittings and tighten if necessary. Your child may be hurt. (specify hazards and consequences if possible).

WARNING! Read these instructions carefully before use and keep them for future reference. Your child may be hurt if you do not follow the instructions. (specify hazards and consequences if possible).

WARNING! Keep this (…) away from children under 3 years old. Your child may choke on small parts.

A symbol is available, see EN 71-6 "Safety of toys - Graphical symbol for age warning labelling." It should be noted however, that small parts are not permitted in most child use and care articles.


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5.5.3 Examples of product-specific warnings

WARNING! Never attach ribbons or cords to a soother. Your child may be strangled.

WARNING! If this table mounted chair slips your child may be hurt. Do not use on the following:

a table top less than x mm thick;

an unfixed/loose table top;

a table leaf;

a single pedestal table;

a glass table;

a card table or other lightweight table.

WARNING! Always use this carrycot, with or without a stand, on a firm and level surface. The carrycot might tip over with the child inside it. Your child may be hurt.

WARNING! Never use this pushchair for more than x child(ren). The pushchair may collapse. Your child may be hurt.

WARNING! Do not use replacement parts or accessories other than those approved by the manufacturer or distributor. (specify hazards) Your child may ... (specify consequences)

WARNING! Guard all dangers (like stairs, fire places, hot surfaces, etc.). Your child can move fast in this baby walking frame and may be hurt.

WARNING! Do not place this playpen near open fires and hot surfaces. Your child may burn itself.

WARNING! Do not use this baby carrier as a car seat. Your child may ........ (specify consequences)

WARNING! Always use a safety harness on your child. Adjust it correctly to fit your child. Your child may .......... (specify consequences)

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5.5.4 Additional sources of information relating to warning sentences

ISO/IEC Guide 37:1995, Instructions for Use of Products of Consumer Interest.

Instructions for Consumer Products-Guidelines for Better Instructions & Safety Information for Consumer Products, Consumer Safety Unit, Department of Trade and Industry, HMSO Books, London, England, 1988.

ANSI Guide for Developing User Product Information. ANSI, New York, USA.

Trommelen, M. Products for children: Standardisation of warnings, Amsterdam, The Netherlands, Consumer Safety Institute, 1994.

5.5.5 Additional sources of information relating to warning symbols

ISO TR 7239: Development and principles for application of public information symbols.

ANSI Z535.3, Criteria for Safety Symbols.

ANSI Z535.4, Product Safety Signs and Labels.

ISO 3864-1, Graphic symbols - Safety colours and safety signs – Part 1: Design principles for safety signs in workplaces and public areas.

ISO 9186, Graphical symbols – Test methods for judged comprehensibility and comprehension.

ENV 1178-1, Furniture – Children's high chairs for domestic use - Part 1: Safety requirements (ISO 9221-1, modified).

Akerboom, S.P. et al. Products for children: Development and evaluation of symbols for warnings, The Netherlands, Consumer Safety Institute, 1995.

Trommelen, M. Products for children: Testing of warning symbols in Europe. Amsterdam, The Netherlands, Consumer Safety Institute, 1997.


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5.6 Guidelines for the development of warning sentences and symbols

5.6.1 General

A new warning sentence or symbol should only be prescribed by a standard when it has been drafted according to the applicable guidelines given 5.6.2 and when its effectiveness has been tested.

Even if these guidelines are taken into account, the understanding of the safety-related information should be checked in realistic purchase and use conditions and within the target population.

It is recommended to inform the secretariat of CEN/TC 252 about any new sentence or symbol introduced with a product or a standard. The secretariat can also be approached for advice about the product information section of draft standards.

5.6.2 Developing warning sentences

Warning sentences should describe the nature and the consequences of the hazard(s), give guidance on what to do and what to avoid. They should comply with the following warning grammar:

Instruction part / Hazard part / Consequence part.

Or, in more detail (specific for the English language):

(Adverb of frequency) + Verb (predicate sentence) + Product (-features) + Conditions / Hazard(s) / Consequence(s).

In the case of severe hazards, a signal word, preferably WARNING! should be added at the beginning of a warning sentence or at the top of a list of warnings. Hazards and consequences should be specified if not obvious.

Warning sentences should be understandable. The following guidelines, established from scientific monitoring of human eye movements, should be observed:

the average number of words per sentence varies between 15 and 25, with a maximum of 30 words; the average number of syllables per word is less than 1,5 (although for some European languages this criterion might be too strict);

the words used are simple, frequent and familiar, concrete rather than abstract, specific rather than general, and used consistently throughout the text;

the style makes use of action verbs (e.g. use instead of utilisation), personal and possessive pronouns (e.g. your child instead of the child);

the style makes use of action verbs (e.g. use instead of utilisation), personal and possessive pronouns (e.g. your child instead of the child), and the imperative mood (e.g. avoid instead of you should avoid);

ambiguous words, double negatives, abbreviations, acronyms, technical terms and jargon should be avoided;

sentences are affirmative rather than negative; negative sentences can be used to prevent undesirable actions (e.g. never leave your child unattended);

each sentence contains only one command, main idea or new piece of information;

operating procedures are explained by illustrations and diagrams;

illustrations, tables and symbols are placed below or next to the text which refers to them;

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if pieces of safety related information are included in a larger text, e.g. a manual, this text begins with a conspicuous summary of all essential safety-related information.

5.6.3 Developing warning symbols

It is recommended to restrict the use of safety-related symbols to a concise set of symbols concerning main hazards that apply to a range of child use and care articles and other children’s products.

Every effort should be made to ensure that a symbol does not already exist.

Symbols should be developed according to recognised standards. They should be fully developed and tested across consumers from all social, economic and cultural groups throughout Europe.

Newly developed symbols should be adopted in a recognised catalogue of symbols and consumer education should be considered.

Even if these guidelines are taken into account, the understanding of the safety-related information should be checked in realistic purchase and use conditions and within the target population.


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5.7 Guidelines for the presentation of warning sentences and symbols

5.7.1 General

This section gives an overview of criteria and guidelines for a legible presentation of warning sentences and symbols. Even if these guidelines are taken into account, the legibility of the resulting product information should be tested in realistic purchase and use conditions and with the target population. Criteria and guidelines for a legible presentation of warning sentences and symbols have been established by scientific monitoring of human eye movements.

5.7.2 Presentation of warning sentences

the x-height of letters in continuous text in manuals etc. should be at least 1,5 mm (between 9 and 12 points letter size);

the x-height of letters in on-product text should be at least 3 mm when anticipating optimum reading conditions, e.g. viewing distance 0,5 m and good lighting, or 8 mm when anticipating difficult reading conditions, e.g. viewing distance 2 m and poor lighting;

upper case, italics, bold print or underlining should be avoided for long strings (more than one line);

the typeface sans-serif is recommended; it has clear, open faces; it is solid rather than delicate looking; it has an x-height that is large in proportion to the whole character; it does not have any idiosyncratic features (examples of good typefaces are Gill Sans, Universe and Helvetica);

the variety of typefaces and sizes should be limited;

the space between lines should equal the space between words, and should not exceed 25 % of the letter size;

the lay-out should be consistent throughout the text, the text should be left justified, and the paragraphs separated by white lines.

5.7.3 Presentation of warning symbols

the size of significant details in symbols should be at least 1 mm (or more when viewing distances of more than 1 m are expected);

warning symbols should have a height of at least 12 mm (or more when viewing distances of more than 1 m are expected and when the symbol is placed on large surfaces);

safety symbols should be presented in such a way that the proportion of elements and the colours are such as prescribed.

5.7.4 Contrast and paper quality

text and illustrations should be in dark ink on light paper without underlying patterns;

colour combinations red-green and blue-yellow should not be used;

the opacity of paper should be at least 2,0;

the use of paper with a glossy finish should be avoided.

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Annex A

Anthropometric data and abilities of children from birth to 4 years

A.1 General

This annex provides tables of anthropometric data and abilities of children from birth to 4 years related to risks. It presents a compilation of data encountered in current literature. Only sources that explain the method by which the measurements were taken, and of which the sample size was large enough to give reliable results have been selected.

Because the difference between European populations is relatively small for children up to 4 years, only one source for each measurement has been used.

NOTE The European population are fairly homogenous (Eveleth and Tanner 1990). At 1 year the maximum difference in mean of length of boys is 3 cm. At 4 years this is about 3,5 cm. The maximum difference in mean of weight is 0,8 kg at year, and 1,6 kg at 4 years. These differences are small compared to the within one age group.

If possible the mean value, standard deviation, the 5th and the 95th percentile are mentioned.

When these data are used in safety requirements a safety margin should be included. This safety margin depends of the required safety level.

The data given in the tables are taken from different publications listed in A 8.

Additional data can be obtained from the report: CHILDATA, the handbook of Child Measurements and Capabilities (Consumer Safety Unit, Department of Trade and Industry, UK). This document gives an overview of the most important data sources for child safety.

A.2 Terms related to anthropometric data

standard deviation (sd): this is a parameter of the normal distribution used to indicate the amount of variance in an attribute. Approximately 68 % of a population will lie within the mean ± 1 × sd.

5th percentile (P5): the value of a normal distributed variable which covers the smallest 5 % of the population. Exactly 5 % of a population is smaller than the P5-value.

95th percentile (P95): the value of a normal distributed variable which covers 95 % of the population. Exactly 5 % of a population is bigger than the P95-value.


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A.3 Recommendations for use of data

As a principle the most onerous situations should be taken into account. Maximum data for the biggest child in the age group and minimum data for the smallest child should be used depending on which one gives the most onerous situation. Some examples are given in A.4 and Figure A4.A shows the difference between the P5/P95 values.

Most anthropometric data is provided at the P5 and P95 values and not the minimum and maximum values, for example P1 and P99. To derive the minimum or maximum value from the P5 and P95 data you need to calculate a value of the Standard deviation (sd) that is subtracted from or added to the P5 or P95 values. To do this use sd scores or z scores, which are given in Table A.3A To obtain the sd figure determine the difference between z values, that is subtract the z value for P5 or P95 from the z value for P1 or P99. This difference between the z values is then used to determine the P1 and P99 values by multiplying the sd by this value and then subtracting or adding this figure to the P5 or P95 values. The following examples show the calculations:

P1 z value = -2,33 P99 z value = 2,33

P5 z value = -1,64 P95 value = 1,64

∴ -2,33-(-1,64) = -0,69 ∴ 2,33-1,64 = 0,69

It is recommended that 0,7 rather than 0,69 is used in the following formula to determine the minimum and maximum vales to be used. Therefore 0,7×sd is subtracted from P5 and 0,7×sd added to P95 to obtain the minimum and maximum values.

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Table A.3A — Standard deviation scores - p and z values of the normal distribution

p z p z p z p z

1 -2,33 26 -0,64 51 0,03 76 0,71

2 -2,05 27 -0,61 52 0,05 77 0,74

3 -1,88 28 -0,58 53 0,08 78 0,77

4 -1,75 29 -0,55 54 0,10 79 0,81

5 -1,64 30 -0,52 55 0,013 80 0,84

6 -1,55 31 -0,50 56 0,15 81 0,88

7 -1,48 32 -0,47 57 0,18 82 0,92

8 -1,41 33 -0,44 58 0,20 83 0,95

9 -1,34 34 -0,41 59 0,23 84 0,99

10 -1,28 35 -0,39 60 0,25 85 1,04

11 -1,23 36 -0,36 61 0,28 86 1,08

12 -1,18 37 -0,33 62 0,31 87 1,13

13 -1,13 38 -0,31 63 0,33 88 1,18

14 -1,08 39 -0,28 64 0,36 89 1,23

15 -1,04 40 -0,25 65 0,39 90 1,28

16 -0,99 41 -0,23 66 0,41 91 1,34

17 -0,95 42 -0,20 67 0,44 92 1,41

18 -0,92 43 -0,18 68 0,47 93 1,48

19 -0,88 44 -0,15 69 0,50 94 1,55

20 -0,84 45 -0,13 70 0,52 95 1,64

21 -0,81 46 -0,10 71 0,55 96 1,75

22 -0,77 47 -0,08 72 0,58 97 1,88

23 -0,74 48 -0,05 73 0,61 98 2,05

24 -0,71 49 -0,03 74 0,64 99 2,33

25 -0,67 50 0 75 0,67

p z p z

2,5 -1,96 97,5 1,96

0,5 -2,58 99,5 2,58

0,1 -3,09 99,9 3,09

0,01 -3,72 99,99 3,72

0,001 -4,26 99,999 4,26 z = standard deviation or z score

p = percentile

This is copied from CHILDATA, ADULTDATA and OLDER ADULTDATA as published by the DTI.


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A.4 Applications

Accessibility

To calculate the accessibility area of a child in different situations the size of the tallest child in the age group should be taken into account. The accessibility area is dependent on the position of the child. It can be lying, sitting or standing. Besides the margin mentioned in A.3, a margin should be added to cover the dynamic reach of children. Most measurements are taken in a static position of the subject.

Openings

A trapping hazard is present when an opening is large enough to be entered by a child, and too small to get out again. In practice these openings will be tested by means of test probes. Anthropometric data are necessary to determine the size and shape of these probes.

To determine if a body part can enter an opening, a probe, which represents the smallest child, is needed. To determine if a body part can get out, a probe representing the largest child is needed.

Structural integrity

When using force exertion data it should be noted that the standard deviation of these measurements is very high, which means that the differences between children are relatively large. The data given in A.6 are all static force exertions. For estimation of dynamic forces a dynamic force factor should be added.

Figure A.4A — Scatter diagram and P5/P95 of the stature (source Steen-bekkers 1989). The marked area shows which part of the population is covered by the P5-P95 36 to 48 months

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A.5 Tables with body dimensions

Table A.5A — Weight, length and centre of gravity of the body

dimension Age group (months)

01 0-3 3-6 6-9 9-12 12-18 18-24 24-36 36-48

1 weight (kg) mean

sd

P5

P95

3,5

-

2,8

4,3

5,3

1,0

3,7

6,5

6,7

1,0

5,2

8,2

8,4

1,0

6,5

10,0

9,2

1,1

7,5

10,9

10,9

1,2

8,8

12,7

12,2

1,2

10,5

14,5

14,3

1,8

11,8

17,5

16,5

2,0

13,8

20,1

2 body length or statue (mm)

mean

sd

P5

P95

500

20

465

535

588

35

520

631

639

36

584

701

705

30

647

750

744

32

687

794

796

40

740

862

850

40

799

930

933

46

865

1016

1013

45

946

1098

3 a centre of gravity (% of length)

mean

sd

P5

P95

58,5

1,9

55,3

61,5

3 b centre of gravity, seated (% of sitting height

mean

sd

P5

P95

49,0

4

42,4

55,6

47,5

3

42,6

52,5

45,5

3

40,6

50,5

44,0

3

39,1

49,0

42,5

3

37,6

47,5

41,0

3

36,1

46,0

39,0

2

35,7

42,3

38,0

2

34,7

41,3

NOTE Weight data for newborn children. Hayes 1983. Length data: Pheasan 1988. It should be noted that length measurement of newborn children may not be accurate.

NOTE The centre of gravity is expressed as a percentage of the straight body length measured from the reference plane. Is approximately the same for all ages.


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Table A.5B — Standing/lying dimensions

Dimension (mm) Age group (months)

0-3 3-6 6-9 9-12 12-18 18-24 24-36 36-48

4 inside leg length mean 189 223 247 271 293 330 362 413

sd

P5

P95

18

162

218

17

198

248

17

219

271

17

242

307

17

266

325

21

295

359

21

326

3950

27

371

454

5 chest depth mean

sd

P5

P95

95

8

80

106

106

8

87

115

108

9

92

118

111

9

95

126

117

9

100

129

122

8

108

137

129

8

117

143

134

9

122

153

6 chest breadth mean 122 138 147 151 158 163 158 164

sd 13 8 11 12 11 12 12 11

P5 100 122 125 132 138 144 136 143

P95 147 151 162 170 175 185 174 182

7 shoulder breadth mean 176 200 203 212 225 232 241 253

sd 13 15 16 14 13 13 14 12

P5 146 171 175 185 198 210 219 237

P95 194 217 228 230 244 255 263 276

8 hip breadth mean

sd

P5

P95

128

15

110

147

140

14

123

160

150

15

130

170

155

14

135

175

161

12

143

182

170

12

153

190

181

11

164

199

189

10

173

205

9 hip depth mean

sd

P5

P95

77

12

57

98

89

11

72

108

93

11

77

113

96

11

78

115

98

10

82

116

99

10

84

117

-

-

-

-

-

-

-

-

10 chest circumference mean 377 434 457 471 491 507 512 535

sd 36 24 24 17 22 23 25 29

P5 318 391 420 441 453 469 471 490

P95 433 471 495 501 524 541 553 582

11 thigh circumference mean 199 252 266 271 282 291 297 320

sd 28 26 26 21 20 25 25 29

P5 156 211 232 240 247 253 260 274

P95 245 293 302 308 315 331 339 367

NOTE Measurements are taken in lying position for children up to 18 months.

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Table A.5C — Sitting dimensions

Dimensions (mm) Age group (months)

0-3 3-6 6-9 9-12 12-18 18-24 24-36 36-48

12 sitting height Mean

sd

P5

P95

391

28

347

430

423

24

375

458

457

23

423

500

476

22

433

507

494

21

456

527

515

24

469

549

549

25

513

589

574

24

536

619

13 shoulder height sitting

Mean

sd

P5

P95

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

302

20

273

334

314

16

282

340

334

21

303

371

352

19

321

383

14 shoulder-elbow length

Mean

sd

P5

P95

109

9

93

124

123

10

107

138

131

12

108

147

145

10

123

156

157

9

134

164

162

10

142

174

179

14

159

198

193

12

174

215

15 hip breadth sitting Mean

sd

P5

P95

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

174

12

157

193

184

12

163

206

191

14

170

216

200

13

179

220

16 popliteal height Mean

sd

P5

P95

112

12

87

123

122

11

107

140

134

12

111

155

145

10

128

163

184

16

160

200

202

12

182

220

224

16

199

252

253

18

223

281

17 buttock-popliteal length

Mean

sd

P5

P95

121

19

97

155

136

16

113

164

151

16

124

175

168

18

140

190

199

19

160

219

219

16

190

240

244

17

214

271

266

17

238

294

18 buttock-foot length

Mean

sd

P5

P95

231

19

197

260

268

24

234

303

299

23

257

335

338

25

285

375

365

25

319

405

415

34

361

465

508

32

460

552

567

35

513

632

19 thigh clearance Mean

sd

P5

P95

52

7

39

62

59

9

43

70

62

9

45

75

69

9

47

82

70

10

53

85

72

10

54

90

80

9

56

96

82

10

60

99

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Table A.5D — Hand and foot dimensions

Dimensions (mm) Age group (months)

0-3 3-6 6-9 9-12 12-18 18-24 24-36 36-48

20 hand length Mean

sd

P5

P95

68

6

54

76

74

6

61

83

80

5

70

86

89

6

76

97

93

6

80

100

95

6

86

105

102

7

92

114

109

7

98

121

21 hand diameter Mean

sd

P5

P95

36

3

32

42

38

3

35

42

40

3

35

45

41

3

38

45

44

3

38

48

46

3

42

52

46

3

42

52

47

3

42

52

22 hand thickness Mean

sd

P5

P95

13

3

10

17

13

2

10

17

14

3

10

19

14

3

10

19

15

3

11

19

16

3

11

19

16

2

13

19

16

2

13

20

23 fist breadth Mean

sd

P5

P95

42

4

34

48

46

5

37

53

49

4

42

54

51

5

43

58

54

6

45

61

55

5

46

61

57

5

49

65

59

6

50

67

24 thumb breadth Mean

sd

P5

P95

9

1

7

10

9

1

7

10

10

1

9

11

11

1

10

12

11

1

10

12

11

1

10

13

13

1

11

14

13

1

11

15

25 little finger breadth

Mean

sd

P5

P95

7

1

6

8

7

1

6

8

8

1

6

9

8

1

6

9

8

1

6

9

8

1

7

10

9

1

8

10

9

1

8

11

26 foot length Mean

sd

P5

P95

86

5

76

92

90

8

78

102

99

7

90

115

106

7

96

117

124

9

111

144

131

8

118

144

146

9

133

159

158

9

145

176

27 foot breadth Mean

sd

P5

P95

37

4

32

43

39

4

34

47

42

4

36

50

45

4

39

53

52

4

45

59

56

5

48

64

59

5

52

67

63

5

55

70

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Table A.5E — Head dimensions

dimensions (kg or mm) Age group (months)

0-3 3-6 6-9 9-12 12-18 18-24 24-36 36-48

28 estimated head weight (kg)

Mean

P5

P95

1,2

1,0

1,5

1,7

1,3

2,0

1,8

1,5

2,2

2,0

1,6

2,4

2,2

1,8

2,6

2,3

1,9

2,8

2,5

2,1

3,0

2,7

2,2

3,2

29 head length Mean

sd

P5

P95

139

6

128

146

154

6

141

163

158

6

149

170

163

6

154

174

168

6

159

176

172

6

162

182

174

7

163

184

178

7

165

189

30 head breadth Mean

sd

P5

P95

106

5

100

115

117

5

105

125

123

5

110

129

125

6

115

134

128

4

119

136

130

5

122

139

133

5

124

141

135

5

127

143

31 head height Mean

sd

P5

P95

136

10

118

148

145

8

125

157

151

9

132

163

158

9

144

172

163

8

150

175

168

8

155

180

174

9

160

187

180

9

162

195

32 chin to crown length

Mean

sd

P5

P95

161

6

148

170

177

7

162

186

180

7

170

191

189

7

177

200

193

7

182

205

198

7

186

210

205

7

195

218

211

7

199

224

33 head circumference

Mean

sd

P5

P95

395

14

370

420

435

16

403

457

448

13

428

466

461

14

440

485

478

15

454

503

485

15

460

510

500

16

474

524

510

15

484

535

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0-3 3-6 6-9 9-12 12-18 18-24 24-36 36-48

34 neck breadth Mean

sd

P5

P95

57

5

46

63

61

6

49

69

63

5

53

70

65

5

56

73

67

6

58

75

69

5

60

77

70

6

61

80

73

5

64

82

35 neck circumference

Mean

sd

P5

P95

214

21

182

247

214

11

192

234

218

19

187

247

219

13

186

239

219

12

186

235

223

12

205

240

237

12

213

253

241

14

217

260

36 mouth breadth Mean

sd

P5

P95

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

32

4

26

37

34

4

28

39


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Table A.5F — Functional measurements

dimension (mm) Age group (months)

12-18 18-24 24-36 36-48

37 grip reach forward mean

sd

P5

P95

-

-

-

-

-

-

-

-

378

31

340

446

411

36

371

476

38 grip reach (stretched) mean

sd

P5

P95

497

65

416

570

546

55

450

647

677

61

574

770

751

49

667

836

39 reaching height standing

mean

sd

P5

P95

869

57

774

962

945

39

888

1014

1059

63

955

1161

1170

64

1075

1271

40 reaching height sitting mean

sd

P5

P95

579

36

525

633

621

28

574

633

683

43

618

750

740

44

667

819

41 step height mean

sd

P5

P95

245

41

180

325

266

44

208

351

340

55

258

426

392

65

293

487

42 grip circumference mean

sd

P5

P95

60

8

50

74

62

8

50

70

68

6

59

78

75

7

63

86

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A.6 Tables with force measurements

Table A.6A — Pulling with full hand (Brown 1973, n=100)

age pull force (N)

(months) mean P5 P95

24-36 97 48 169

36-48 122 67 184

Table A.6B — Pushing with full hand (Brown 1973, n=100)

age push force (N)

(months) mean P5 P95

24-36 56 30 97

36-48 78 33 128

Table A.6C — Grip strength (Owings 1977, n=40)

a age grip strength (N)

(mm) (months) mean P5 P95

20 30-42 42-54

31 41

14 23

46 63

30 30-42 42-54

50 67

28 43

78 96

40 30-42 42-54

49 67

24 38

83 96

50 30-42 42-54

43 60

- 28

- 88

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Table A.6D — Three-point pinch strength (Owings 1977, n=40)

a age pinch strength (N)

(mm) (months) mean Sd

20 30 to 42 42 to 54

21 26

4 5

50 30 to 42 42 to 54

24 29

6 7

Table A.6E — Five-point pinch strength (Owings 1977, n=40)

a age pinch strength (N)

(mm) (months) mean sd

20 30 to 42 42 to 54

25 29

7 5

50 30 to 42 42 to 54

28 32

8 9

Table A.6F — Summary of bite strength data found in literature (Wu Y 1978)

age maximum bite

(months) strength (N)

0 to 18 111

18 to 36 222

> 36 445

P1=mean-2,33•sd; P5=mean-1,65•sd; P95=mean+1,65•sd; P99=mean+2,33•


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A.7 Abilities of children

Table A.7A — Overview of the development of children from birth to 4 years

Age months Ability that may occur Development linked to risks

0 to 3 Birth reflexes, startle, palmar grasp, rooting, crawling reflex

Strong need for sucking, can hold head up for only a few seconds , risk of suffocation

3 to 6 Can turn over from back to stomach, actively gripping objects

Risk of crushing and squeezing

6 to 9 Voluntary crawling and creeping, sitting without support

Can both crawl away and grip things, increased risk for choking on foreign objects and poisoning

9 to 12 Supported walking, can arise from a back-lying position

Can pull down hot pans and heavy objects

12 to 15 Walking without support, can use spoon, can build a tower of 2 blocks

15 to 18 Can walk backwards, can walk up the stairs, can take clothes off

Can climb on small chair and fall off, likes to put fingers in small holes, risk for electric shock, burns and scalds from hot liquids

18 to 24 Climbs on furniture to look out of windows, can build tower of 8 blocks

24 to 36 Can run well, rides on tricycle, turn door handles, can put on a piece of clothing

Trains body by fast movements, likes to walk stairs, the child’s abilities are often over-estimated by the adults, uses tools like chair to reach window

36 to 48 Can hop, can recognize colours, can dress without supervision

Knows how to reach things that are stored in e.g. high cupboard, risk for poisoning, cutting and burning

Table A.7B — Ability to climb fences (Nixon 1979)

Age group % of children able to climb fence height (mm)

(months) 600 900 1 200 1 400

24 to 36 21 0 0 0

36 to 48 88 53 20 0

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A.8 Sources of data

Table A.8A Publications used as source of data for Tables A.5A to A.5F

Pheasant S.A. Bodyspace: Anthropometric ergonomics & design. Taylor and Francis, London 1986.

Hayes A., L. Dayly, N.G. O’Brien, D. MacDonald. Anthropometric Standards for Irish Newborn. Irish Medical Journal, 76(2) February, 60-70, 1983.

Steenbekkers L.P.A. Ergonomische gegevens voor kinderveiligheid (Ergonomic data for child safety). School of Industrial Design Engineering, Delft University of Technology, 1989.

Steenbekkers L.P.A. Child development, design implications and accident prevention. Delft University Press, 1993

Snyder R.G., M.L. Spencer, C.L. Owings, L.W. Schneider. Physical characteristics of children as related to death and injury for consumer product design and use. Report no UM-HSRI-B1-75-5. CPSC, Washington DC, USA, 1975.

Snyder R.G., L.W. Schneider, C.L. Owings, H.M. Reynolds, D.H. Golomb, M.A. Schork. Anthropometry of infants, children and youth to the age 18 for product safety design.Report no UM-HSRI-77-17. CPSC, Washington DC, USA, 1977.

Schneider L.W., R.J. Lehman, M.A. Pflug, C.L. Owings. Size and shape of the head and neck from birth to four years. University of Michigan, Transportation Research Institute, 2901 Baxter Rd., Ann Arbor, Michigan, 1986

British Standard: Body measurements of boys and girls from birth up to 16.9 years. BSI 7231: Part 1 : 1990


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Table A8.B Publications used as source of data for Tables A.6A to A.6F and A.7A to A.7B

Brown W.C. and Buchanan C.J. 1973. A study of the strength capabilities of children ages two through six.

Owings C.L., Norcutt R.H., Snyder R.G., Golomb D.H. and Lloyd K.Y. 1977. Gripping strength measurements of children for product safety design.

Krogman W.M. 1971. The manual and oral strength of American white and negro children, ages 3-6 years. Closure Committee of Glass Manufacturers Institute.

Wu Y C, 1978. An evaluation of children’s biting strength for toy safety.

Nixon, J,W., J.H. Pearm and G.M. Petrie, 1979. Childproof Safety Barriers. An ergonomic study to reduce child trauma due to environmental hazards. Australian Peadiatric Journal, Vol 15, p 260-262.

dimension 0 to 24 months 24 to 48 months source N Source n

1 Weight

Birth weight

Steenbekkers 1989

Hayes 1983

30

8050

Steenbekkers 1993

-

80

2 Stature Steenbekkers 1989 30 Steenbekkers 1993 80

3 Centre of gravity Snyder 1975 100 Snyder 1975

4 Inside leg length BSI 7231 80 BSI 7231 140

5 Chest depth Schneider e.a. 1986 30 Steenbekkers 1993 80

6 Chest breadth Snyder e.a. 1977 30 Snyder e.a. 1975 65

7 Shoulder breadth Schneider e.a. 1986 30 Steenbekkers 1993 80

8 Hip breadth Steenbekkers 1989 30 Steenbekkers 1993 80

9 Hip depth Snyder 1975 100/20 -

10 Chest circumference BSI 7231 80 BSI 7231 140

11 Thigh circumference BSI 7231 80 BSI 7231 140

12 Sitting height Snyder e.a. 1977 30 Steenbekkers 1993 80

13 Shoulder height sitting Steenbekkers 1989 50 Steenbekkers 1993 80

14 Shoulder-elbow length Snyder e.a. 1977 30 Snyder e.a. 1975 65

15 Hip breadth sitting Steenbekkers 1989 50 Steenbekkers 1993 80

16 Popliteal height Steenbekkers 1989 30 Steenbekkers 1993 80

17 Buttock-popliteal length Steenbekkers 1989 30 Steenbekkers 1993 80

18 Buttock-foot length Snyder e.a. 1977 30 Steenbekkers 1993 80

19 Thigh clearance Snyder e.a. 1977 30 Snyder e.a. 1975 65

20 Hand length Snyder e.a. 1977 30 Snyder e.a. 1975 65

21 Hand diameters Steenbekkers 1989 30 Steenbekkers 1993 80

22 Hand thickness Steenbekkers 1989 30 Steenbekkers 1993 80

23 Fist breadth Snyder e.a. 1977 30 Snyder e.a. 1975 80

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24 Thumb breadth Snyder e.a. 1977 30 Steenbekkers 1993 80

25 Little finger breadth Steenbekkers 1989 30 Steenbekkers 1993 80

26 Foot length Steenbekkers 1989 30 Steenbekkers 1993 80

27 Foot breadth Steenbekkers 1989 30 Steenbekkers 1993 80

28 Head length Schneider e.a. 1986 30 Steenbekkers 1993 80

29 Head breadth Schneider e.a. 1986 30 Steenbekkers 1993 80

30 Head height Schneider e.a. 1986 30 Steenbekkers 1993 80

31 Chin to crown length Schneider e.a. 1986 30 Steenbekkers 1993 80

32 Head circumference Schneider e.a. 1986 30 Steenbekkers 1993 80

33 Neck breadth Schneider e.a. 1986 30 Snyder e.a. 1975 65

34 Neck circumference Schneider e.a. 1986 30 Snyder e.a. 1975 65

35 Mouth breadth Snyder e.a. 1977 65

36 Grip reach forward Snyder e.a. 1977 65

37 Grip reach forward (stretched) Steenbekkers 1989 50 Steenbekkers 1993 80

38 Reaching height standing Steenbekkers 1989 50 Steenbekkers 1993 80

39 Reaching height sitting Steenbekkers 1989 50 Steenbekkers 1993 80

40 Step height Steenbekkers 1989 50 Steenbekkers 1993 80

41 Grip circumference Steenbekkers 1989 50 Steenbekkers 1993 80


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Annex B

Description of risk assessment procedure

B.1 General

Figure B.1 — Risk assessment procedure

This annex specifies a procedure to investigate, using available information, the safety of child use and care articles by identifying hazards and estimating risks associated with the article. It is of particular assistance in areas where appropriate standards are not available.

The annex does not stipulate levels of acceptability, which, because they are determined by a multiple of factors, cannot by their nature be set down in this annex. It is not intended to give detailed guidance on risk management.

The risk analysis procedure illustrated in Figure B.1 can be used as a help to analyse hazards which are features of the product, and identifies possibilities to reduce the risks connected with those hazards.

In accordance with CEN/CENELEC Memorandum no 9, the following definitions are used:

harm: physical injury and/or damage to health or property;

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hazard: a potential source of harm or a product characteristic which could lead to injury;

risk: the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm.

B.2 Qualitative risk analysis

B.2.1 Identification of qualitative characteristics of product use

The following questions can serve as a useful guide when identifying characteristics which could affect safety.

What is the intended use?

Factors that should be considered include who uses the product and under which conditions it is to be used. Also to be taken into consideration is the normal behaviour of small children and all possible phases of product life. Special attention shall be given to the child’s development and ability at the age for which the product is intended.

What is the foreseeable use?

Using the product in a way other than intended, in particular handling by (older or younger) children.

Mistaking the product for something other than it is intended for.

The simultaneous use of the product by two or more children.

In which environment will it be used?

Whether the product is used indoors in room environment or outdoors where rain and temperature have to be taken into consideration. Also, the likely interaction with other products has to be considered.

Will the product be used with the child attended or unattended?

For what period of time will the child is exposed to the hazard?

B.2.2 Identify possible hazards

Using the hazards covered by this report as an aide-memoire, all potential hazards associated to the product should be identified.

Consideration should be given to known accident data. The absence of an accident history should not be taken as an automatic presumption of a low level of risk. Consideration should be given to all characteristics identified in B.1.1. The outcome should be a list of possible accident scenarios.


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B.3 Risk estimation

Risk is a combination of several factors to be evaluated. The greatest emphasis on safety provision should be where the potential consequences could include death, permanent disability or scarring, or where minor injuries occur very frequently.

a) Evaluate the severity of a possible injury or damage to the health. The most severe injury or damage to the health that is likely to occur from each identified hazard should be taken into account even if the probability of the event is not high. In general, severity may be classified in a number of categories, e.g.:

minor and reversible;

serious and reversible, or minor and irreversible;

serious and irreversible;

death.

b) Evaluate the probability of an injury caused by the identified hazard, taking into consideration, frequency of use, if the child is unattended, and the accessibility to the hazard at the age and ability of the child.

The probability can also be classified, for example as likely, possible, unlikely and virtually impossible. However, if feasible, the probability should be quantified in a more meaningful way, such as the expected number of injuries per year and per n exposed persons. Convenient figures are usually found when n is taken as 106 or 108. Agreement can then be reached on the probability that is acceptable for each severity class.

When estimating the probability, factors that should be taken into consideration are:

accident numbers, if available for the specific scenario;

numbers of people (adults and children separately where applicable) that could be exposed;

likelihood of the specific scenario occurring at a single exposure;

likelihood of persons recognizing the hazard and avoiding the injury.

B.4 Risk evaluation

The aim of risk evaluation is to compare the estimated level of risk with the level that is acceptable. As indicated at the beginning of this annex, it is outside the scope of the annex to stipulate levels of acceptable risk. Consensus on this point should be reached in each committee that formulates product standards. Generally, however, accident scenarios associated with high risk (severity, probability or both) should be addressed by setting stringent requirements.

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B.5 Select safety measures

Safety measures are a combination of the measures incorporated at the design stage and those measures required to be implemented by the user/carer. Four approaches should be considered:

remove the identified hazard as much as possible;

limit the access to the hazards by design;

limit or prevent the access to the hazards by barriers, harnesses etc.;

inform the user/carer about residual risk which cannot be removed by design of safeguarding techniques.

These four approaches should be considered in the order given here. Each approach may give rise to requirements and accompanying test methods. The requirements should allow assessment as to whether the acceptable risk level has been reached, rather than prescribing a specific design solution.


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Bibliography

[1] Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

[2] Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations.

[3] Directive 94/27/EEC of 30 June 1994 amending for the 12th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations.

[4] Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.

[5] Directive 78/142/EEC of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs.

[6] Directive 79/831/EEC of 18 September 1979 amending Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances.

[7] Directive 90/128/EEC of 23 February 1990 relating to plastics materials and articles intended to come into contact with foodstuffs.

[8] Directive 93/11/EEC of 15 March 1993 concerning the release of the N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers.

[9] Mandate to CEN/CENELEC in the field of consumer safety related to the safety of child-care Articles M264.

[10] Mandate to CEN/CENELEC in the field of safety of consumers and children, Product information M292.

[11] Instructions for consumer products. Guidelines for better instructions and safety information for consumer products. Department of Trade and Industry, HMSO Books, London, England, 1988 ISBN: 0115146504.

[12] Childata, the handbook of child measurements and capabilities, Department of Trade and Industry, London, UK 2002 URN 02/799.

[13] Safety research into the shape and size of soothers, Department of Trade and Industry, London, UK 1998 URN98/876.

[14] Akerboom, S.P. et al. Products for children: Development and evaluation of symbols for warnings, The Netherlands, Consumer Safety Institute, 1995.

[15] Trommelen, M. Products for children: Standardisation of warnings. Amsterdam, The Netherlands, Consumer Safety Institute, 1994.

[16] Trommelen, M. Products for children: Testing of warning symbols in Europe. Amsterdam, The Netherlands, Consumer Safety Institute, 1997.

[17] Wogalter, S.M. et al Warnings and risk communication, Taylor & Francis. London, 1999.

[18] CEN/CENELEC Memorandum No 9 Guidelines for the inclusion of safety aspects in standards.

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[19] ANSI Guide for Developing User Product Information. ANSI, New York, USA, 1990.

[20] ANSI Z 535.3, Criteria for Safety Symbols.

[21] ANSI Z 535.4, Product Safety Signs and Labels.

Standards which have been considered when drafting this report

[22] EN 71-1, Safety of toys – Part 1: Mechanical and physical properties.

[23] EN 71-2, Safety of toys – Part 2: Flammability.

[24] EN 71-3, Safety of toys – Part 3: Migration of certain elements.

[25] EN 71-6, Safety of toys – Part 6 Graphical symbol for age warning labelling.

[26] EN 120, Wood based panels – Determination of formaldehyde content - Extraction method called the perforator method.

[27] EN 563, Safety of machinery – Temperature of touchable surfaces – Ergonomics data to establish temperature limit values for hot surfaces.

[28] EN 645, Paper and boards intended to come into contact with foodstuffs - Preparation of a cold water extract

[29] EN 716-1, Furniture – Children's cots and folding cots for domestic use – Part 1: Safety requirements.

[30] EN 716-2, Furniture – Children's cots and folding cots for domestic use – Part 2: Test methods.

[31] EN 717-2, Wood-based panels – Determination of formaldehyde release – Part 2: Formaldehyde release by the gas analysis method.

[32] EN 1084, Plywood – Formaldehyde release classes determined by the gas analysis method.

[33] EN 1103, Textiles - Burning behaviour- Fabrics for apparel - Detailed procedure to determine the burning behaviour of fabrics for apparel.

[34] EN 1176-1, Playground equipment – Part 1: General safety requirements and test methods.

[35] EN 1176-2, Playground equipment – Part 2: Additional specific safety requirements and test methods for swings.

[36] EN 1176-3, Playground equipment – Part 3: Additional specific safety requirements and test methods for slides.

[37] EN 1176-4, Playground equipment – Part 4: Additional specific safety requirements and test methods for runways.

[38] EN 1176-5, Playground equipment – Part 5: Additional specific safety requirements and test methods for carousels.

[39] EN 1176-6, Playground equipment – Part 6: Additional specific safety requirements and test methods for rocking equipment.

[40] ENV 1178-1, Furniture – Children's high chairs for domestic use - Part 1: Safety requirements (ISO 9221-1, modified).


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[41] ENV 1178-2, Furniture – Children's high chairs for domestic use - Part 2: Test methods (ISO 9221-2, modified).

[42] EN 1272, Child care articles – Table mounted chairs - Safety requirements and test methods.

[43] EN 1273, Child care articles – Baby walking frames - Safety requirements and test methods.

[44] EN 1400-1, Child use and care articles – Soothers for babies and young children – Part 1: General safety requirements and product information.

[45] EN 1400-2, Child use and care articles – Soothers for babies and young children – Part 2: Mechanical requirements and tests

[46] EN 1400-3, Child use and care articles – Soothers for babies and young children – Part 3: Chemical requirements and tests

[47] EN 14362-1, Textiles – Methods for the determination of certain aromatic amines derived from azo colorants – Part 1: Detection of the use of certain azo colorants accessible without extraction

[48] EN 14362-2, Textiles – Methods for the determination of certain aromatic amines derived from azo colorants – Part 2: Detection of the use of certain azo colorants accessible by extracting the fibers

[49] EN 1466, Child care articles – Carry cots and stands - Safety requirements and test methods.

[50] EN 1541, Paper and board intended to come into contact with foodstuffs – Determination of formaldehyde in an aqueous extract.

[51] EN 1810, Body-piercing post assemblies - Reference test method for the determination of nickel content by flame atomic absorption spectrometry.

[52] EN 1811, Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin.

[53] EN 1888, Child care articles – Wheeled child conveyances – Safety requirements and test methods.

[54] EN 1930, Child care articles – Safety Barriers – Safety requirements and test methods.

[55] EN 12221-1, Changing units for domestic use – Part 1: Safety requirements.

[56] EN 12221-2, Changing units for domestic use – Part 2: Test methods.

[57] EN 12227-1, Playpens for domestic use – Part 1: Safety requirements.

[58] EN 12227-2, Playpens for domestic use – Part 2: Test methods.

[59] CR 12471,Screening tests for nickel release from alloys and coatings in items that come into direct and prolonged contact with the skin

[60] EN 12472, Method for the simulation of wear and corrosion for the detection of nickel from coated items.

[61] EN 12868, Child use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers

[62] EN ISO 15320, Pulp, paper and board – Determination of pentachlorophenol in an aqueous extract (ISO 15320).

[63] EN 45002,General criteria for the assessment of testing laboratories.

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[64] EN 50088, Safety of electric toys.

[65] CEN ISO/TS 17234, Leather – Chemical tests – Determination of certain azo colourants in dyed leathers (ISO/TS 17234:2003).

[66] EN ISO 4614, Plastics - Melamine-formaldehyde mouldings - Determination of extractable formaldehyde (ISO 4614:1977).

[67] EN ISO 6941, Textile fabrics – Burning behaviour – Measurement of flame spread properties of vertically oriented specimens (ISO 6941:2003).

[68] EN ISO 14184-1, Textiles - Determination of formaldehyde - Part 1: Free and hydrolysed formaldehyde (water extraction method) (ISO 14184-1:1998)

[69] EN ISO 14184-2, Textiles - Determination of formaldehyde - Part 2: Released formaldehyde (vapour absorption method) (ISO 14184-2:1998)

[70] CEN/TS 14494, Leather – Chemical tests – Determination of the content of pentachlorophenol in leather.

[71] ISO 3864-1, Graphic symbols - Safety colours and safety signs – Part 1: Design principles for safety signs in workplaces and public areas.

[72] ISO 4593, Plastics - Film and sheeting – Determination of thickness by mechanical scanning.

[73] ISO 8124-1, Safety of toys – Part 1: Safety aspects related to mechanical and physical properties.

[74] ISO 9186, Graphical symbols – Test methods for judged comprehensibility and comprehension.

[75] ISO/IEC Guide 37, Instructions for use of products of consumer interest.

[76] ISO/IEC Guide 50, Safety aspects -- Guidelines for child safety.

[77] ISO/IEC Guide 51, Safety aspects - Guidelines for their inclusion in standards.

[78] ISO TR 7239, Development and principles for application of public information symbols.

[79] ISO E105-E04 Textiles - tests for colour fastness – Part E04: Colour fastness to perspiration.

[80] BS 4569, Method of test for ignitability (surface flash) on pile fabrics and assemblies having pile on the surface.

[81] BS 6684, Specification for safety harnesses (including detachable walking reins) for restraining children when in perambulators (baby carriages), pushchairs and high chairs and when walking.

[82] ASTM F963, Standard Consumer Safety Specification on Toy safety.


PD CEN/TR 13387:2004

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BS PD CEN TR 13387-2004 Child Use and Care Articles-Safety Guidelines

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