Safety of toys - Part 9: Organic chemical compounds - Requirements

This Part 9 of the !standard" EN 71 for safety of toys specifies requirements for the migration or content of certain hazardous organic chemical compounds from/in certain toys and toy materials (see Table 1) by the following exposure routes:;mouthing;ingestion;skin contact;eye contact;inhalation when used as intended or in a foreseeable way, bearing in mind the normal behaviour of children and the function and design of the toy. This !standard" does not contain requirements for chemical toys, experimental sets or finger-paints, which are addressed by other parts of EN 71. Packaging materials used with toys are not within the scope of the !standard" unless they form part of the toy or have intended play value.

Sicherheit von Spielzeug - Teil 9: Organisch-chemische Verbindungen - Anforderungen

Der vorliegende Teil 9 !der Norm" EN 71 zur Sicherheit von Spielzeug legt Anforderungen an die Migration von bzw. den Gehalt an bestimmten gefährlichen organisch-chemischen Verbindungen aus/in bestimmtem Spielzeug und Spielzeugmaterialien (siehe Tabelle 1) für folgende Expositionswege fest:
   in den Mund nehmen;
   orale Aufnahme;
   Hautkontakt;
   Augenkontakt;
   Inhalation (Einatmung).
Dies gilt für den bestimmungsgemäßen bzw. vorhersehbaren Gebrauch, wobei das übliche kindgemäße Verhalten sowie die Funktion und die Ausführung des Spielzeuges zu berücksichtigen sind.
Diese Norm enthält keine Anforderungen an chemisches Spielzeug, Experimentierkästen oder Fingermal¬farben, die in anderen Teilen von EN 71 behandelt werden.
Die für Spielzeug verwendeten Verpackungsmaterialien fallen nicht in den Anwendungsbereich der Norm, es sei denn, sie bilden einen Teil des Spielzeuges oder verfügen bestimmungsgemäß über einen Spielwert.

Sécurité des jouets - Partie 9: Composés organiques chimiques - Exigences

La présente Partie (9) du document EN 71 relative à la sécurité des jouets spécifie des exigences concernant la migration de certains composés organiques chimiques dangereux provenant des jouets et matériaux-jouets ou la teneur de certains composés organiques chimiques dangereux présents dans ces jouets et matériaux jouets (voir Tableau 1), par les voies d’exposition suivantes.
-   mise en bouche ;
-   ingestion ;
-   contact avec la peau ;
-   contact avec l’œil ;
-   inhalation ;
lors d’une utilisation normale ou prévisible du jouet, en tenant compte du comportement normal des enfants ainsi que de la fonction et de la conception du jouet.
La présente norme ne contient aucune exigence relative aux jouets chimiques, aux coffrets d'expérience ou aux peintures au doigt qui sont traités par d’autres parties de l’EN 71.
Les emballages utilisés avec les jouets n'entrent pas dans le domaine d'application de ce document, sauf s'ils font partie du jouet ou possèdent une valeur ludique.

Varnost igrač - 9.del: Organske kemijske spojine - Zahteve (vključno z dopolnilom A1)

General Information

Status
Published
Publication Date
13-Sep-2007
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
09-Aug-2007
Due Date
14-Oct-2007
Completion Date
14-Sep-2007

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SLOVENSKI STANDARD
SIST EN 71-9:2005+A1:2007
01-oktober-2007

9DUQRVWLJUDþGHO2UJDQVNHNHPLMVNHVSRMLQH=DKWHYH YNOMXþQR]GRSROQLORP

Safety of toys - Part 9: Organic chemical compounds - Requirements

Sicherheit von Spielzeug - Teil 9: Organisch-chemische Verbindungen - Anforderungen

Sécurité des jouets - Partie 9: Composés organiques chimiques - Exigences
Ta slovenski standard je istoveten z: EN 71-9:2005+A1:2007
ICS:
97.200.50 ,JUDþH Toys
SIST EN 71-9:2005+A1:2007 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN 71-9:2005+A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 97.200.50 Supersedes EN 71-9:2005
English Version
Safety of toys - Part 9: Organic chemical compounds -
Requirements

Sécurité des jouets - Partie 9: Composés organiques Sicherheit von Spielzeug - Teil 9: Organisch-chemische

chimiques - Exigences Verbindungen - Anforderungen

This European Standard was approved by CEN on 15 November 2004 and includes Amendment 1 approved by CEN on 26 May 2007.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the

official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-9:2005+A1:2007: E

worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN 71-9:2005+A1:2007 (E)
Contents Page

Foreword..............................................................................................................................................................3

Introduction .........................................................................................................................................................4

1 Scope ......................................................................................................................................................6

2 Normative references ............................................................................................................................6

3 Terms and definitions ...........................................................................................................................6

4 Requirements.........................................................................................................................................7

4.1 Limits (see A.4) ......................................................................................................................................7

4.2 Liquids in toys (see A.5) .......................................................................................................................8

4.3 Formaldehyde (see A.6) ........................................................................................................................8

4.4 Methods of analysis (see A.7) ..............................................................................................................8

Annex A (informative) Rationale ....................................................................................................................13

A.1 General..................................................................................................................................................13

A.2 Accessible liquid (see 3.2)..................................................................................................................13

A.3 Polymeric (see 3.6) ..............................................................................................................................13

A.4 Limits (see 4.1).....................................................................................................................................13

A.5 Liquids in toys (see 4.2) ......................................................................................................................14

A.6 Formaldehyde (see 4.3).......................................................................................................................14

A.7 Methods of analysis (see 4.4).............................................................................................................14

A.8 Colourants and primary aromatic amines (see Table 1, Table 2 B and Table 2 C).......................14

A.9 Applicable limit tables (see Table 1)..................................................................................................15

A.10 Limit tables (see Tables 2 A to 2 I).....................................................................................................15

A.11 Toys containing cosmetic components ............................................................................................16

Annex B (informative) Conformity assessment ...........................................................................................17

Annex ZA (informative) Clauses of this European Standard addressing essential requirements or

other provisions of EU Directives......................................................................................................18

Bibliography ......................................................................................................................................................19

Tables of 4.4
Table 1 – Applicable limit tables
Table 2 A – Flame retardants
Table 2 B – Colourants
Table 2 C – Primary aromatic amines
Table 2 D – Monomers (migration)
Table 2 E – Solvents (migration)
Table 2 F – Solvents (inhalation)
Table 2 G a) and b) – Wood preservatives
Table 2 H – Preservatives (other than wood preservatives)
Table 2 I – Plasticisers (migration)
---------------------- Page: 3 ----------------------
EN 71-9:2005+A1:2007 (E)
Foreword

This document (EN 71-9:2005+A1:2007) has been prepared by Technical Committee CEN/TC 52 “Safety of

toys”, the secretariat of which is held by DS.

This document shall be given the status of a national standard, either by publication of an identical text or by

endorsement, at the latest by January 2008 and conflicting national standards shall be withdrawn at the latest

by January 2008.
This document includes Amendment 1 approved by CEN on 2007-05-26.
This document supersedes EN 71-9:2005.

The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ".

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

This standard constitutes part 9 of the European Standard on Safety of Toys.
This part should be read in conjunction with parts 10 and 11.

This !standard" defines contact routes and specifies limits for the migration or content of certain chemical

compounds in toys.
This !standard" contains three annexes:
- Annex A (informative) Rationale
- Annex B (informative) Conformity assessment

- Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other

provisions of EU Directives.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following

countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech

Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and United Kingdom.
---------------------- Page: 4 ----------------------
EN 71-9:2005+A1:2007 (E)
Introduction
The !standard" EN 71 for safety of toys consists of the following parts.
Part 1: Mechanical and physical properties
Part 2: Flammability
Part 3: Migration of certain elements
Part 4: Experimental sets for chemistry and related activities
Part 5: Chemical toys (sets) other than experimental sets
Part 6: Graphical symbols for age warning labelling
Part 7: Finger paints – Requirements and test methods

Part 8: Swings, slides and similar activity toys for indoor and outdoor family domestic use

Part 9: Organic chemical compounds – Requirements
Part 10: Organic chemical compounds – Sample preparation and extraction
Part 11: Organic chemical compounds – Methods of analysis
The !standards" EN 71-9, !EN 71-10" and !EN 71-11" were mandated by the European

Commission (M/229) to address the risks presented by organic compounds in toys by taking into account the

potential exposure and toxicological effects of those substances considered to present the greatest risk to

health.

This !standard" gives requirements for organic compounds in certain toys and toy materials. In drafting

the !standard", CEN/TC 52 considered the risks associated with more than 650 organic compounds. It

was recognized that not all potentially hazardous organic compounds could be addressed. The Commission

further restricted the Mandate to substances classified as dangerous under Council Directive 67/548/EEC.

This !standard", therefore, supports but does not reduce the responsibility of toy manufacturers,

importers and suppliers for ensuring that the use of other substances will not endanger the health whilst

playing with toys as intended or in a reasonably foreseeable way. In addition, there should be no exposure to

children from toys, in amounts which may harm their health, of organic chemical substances which are

classified by other relevant statutes as carcinogenic, mutagenic or toxic for reproduction and for which no

requirements are specified in this !standard".

!Future editions of this standard may address additional organic compounds. Users of this standard are

reminded that compliance with the standard can only provide presumption of conformity with the essential

safety requirements of the Toys Safety Directive in respect of the substances addressed."

This part should be read in conjunction with !EN 71-10", which describes sample preparation and

extraction procedures, and !EN 71-11", which specifies methods of analysis.

At the date of publication, the standard does not specify requirements for chemical compounds which are

prohibited in toys by Council Directive 76/769/EEC of 27 July 1976, as amended, on restrictions on the

marketing and use of certain dangerous substances and preparations.

This !standard" takes into account the opinion of the Toxicology Section of the Scientific Advisory

Committee published in 1992 (EUR 13976) which recommended that certain groups of chemical compounds

used in toys and toy materials need to be given special attention. In drafting this !standard" CEN/TC 52

has considered organic chemicals that can be classified within the following groups:

 Solvents
 Preservatives
 Plasticisers (excluding phthalate plasticisers)
 Flame retardants
 Monomers
 Biocides (wood preservatives)

Phthalate plasticisers were specifically excluded from the scope of mandate M/229.

---------------------- Page: 5 ----------------------
EN 71-9:2005+A1:2007 (E)
 Processing aids
 Colouring agents

During the development of this !standard", CEN/TC 52 has considered the requirements set out in

Council Directive 82/711/EEC as amended and its supporting standards.
---------------------- Page: 6 ----------------------
EN 71-9:2005+A1:2007 (E)
1 Scope

This Part 9 of the !standard" EN 71 for safety of toys specifies requirements for the migration or content

of certain hazardous organic chemical compounds from/in certain toys and toy materials (see Table 1) by the

following exposure routes:
- mouthing
- ingestion
- skin contact
- eye contact
- inhalation

when used as intended or in a foreseeable way, bearing in mind the normal behaviour of children and the

function and design of the toy.

This !standard" does not contain requirements for chemical toys, experimental sets or finger-paints,

which are addressed by other parts of EN 71.

Packaging materials used with toys are not within the scope of the !standard" unless they form part of

the toy or have intended play value.
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

!EN 71-1:2005+A4:2007", Safety of toys - Part 1: Mechanical and physical properties

EN 71-5, Safety of toys – Part 5: Chemical toys (sets) other than experimental sets

!EN 71-10, Safety of toys - Part 10: Organic chemical compounds - Sample preparation and extraction"

!EN 71-11, Safety of toys - Part 11: Organic chemical compounds - Methods of analysis"

EN 645, Paper and board intended to come into contact with foodstuffs – Preparation of a cold water extract

EN 717-3, Wood-based panels – Determination of formaldehyde release – Part 3: Formaldehyde release by

the flask method

EN 1541, Paper and board intended to come into contact with foodstuffs - Determination of formaldehyde in

an aqueous extract

EN ISO 787-9, General methods of test for pigments and extenders – Part 9: Determination of pH value of

aqueous suspension (ISO 787-9:1981)

EN ISO 14184-1, Textiles – Determination of formaldehyde – Part 1: Free and hydrolysed formaldehyde

(water extraction method) (ISO 14184-1:1998)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
---------------------- Page: 7 ----------------------
EN 71-9:2005+A1:2007 (E)
3.1
accessible

contact with the articulated probe when tested in accordance with the ‘accessibility-of-a-part-or-component’

test in !EN 71-1:2005+A4:2007"
3.2 (see A.2)
accessible liquid

liquid in or on a toy or accompanying a toy to which the child is likely to become exposed during normal or

foreseeable use of the toy (e.g. liquid paints, bubble liquids, ink in pens, liquids provided with toys for

squirting)
3.3
mouth-actuated toy

toy which relies on an action of the mouth to operate and which therefore is designed to come into contact

with the mouth during play (e.g. toy whistles, toy imitation novelty teeth). Inflatable toys are not considered

mouth-actuated toys unless they rely on an action of the mouth after inflation
3.4
mouthed
licked, sucked and chewed
3.5
paper

material, marketed as either paper or paperboard, with a maximum mass per unit area of 400 g/m

[!EN 71-1:2005+A4:2007"]
3.6 (see A.3)
polymeric

consisting of plastic, synthetic rubber, natural rubber, silicone polymer but not other natural polymers

3.7
resin-bonded wood

wood-based material, for example, plywood, particle board, chipboard and medium-density fibreboard (MDF)

3.8
textile
woven or knitted fabrics, non-woven fibrous material (e.g. felt)
3.9
toy material
material from which toys and toy components are made
3.10
toy which a child can enter

any toy, having a door, lid or similar device, which encloses a continuous volume greater than 0,03 m and in

which all internal dimensions are 150 mm or more.
4 Requirements
4.1 Limits (see A.4)

4.1.1 Table 1 specifies toys, toy components and toy materials for which this !standard" contains

requirements. An “X” is indicated in columns 2A – 2I when requirements are given in the limit Tables 2 A – 2 I

for certain groups of organic chemicals. The toys and accessible toy components specified in Table 1 shall

not contain or release the organic compounds in the relevant limit tables in amounts which exceed the limits

specified.
---------------------- Page: 8 ----------------------
EN 71-9:2005+A1:2007 (E)

4.1.2 If a limit specified in a limit table is expressed as “Action limit”, the relevant limit shall be the limit of the

applicable method as specified in !EN 71-11".
NOTE See also 4.4 relating to methods of analysis.

4.1.3 If a particular toy or toy component fits more than one of the descriptions given in Table 1, then the

limit tables indicated for each of the descriptions shall apply to that toy or accessible toy component.

4.2 Liquids in toys (see A.5)

4.2.1 Toys shall not contain accessible liquids classified in accordance with Directive 1999/45/EC as very

toxic, toxic, harmful, corrosive, irritant or sensitising; and the accessible liquids shall not contain substances

that are classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2. However, as a

derogation, liquids present as ink supplied in writing instruments may be classified ‘R36 Irritating to eyes’.

4.2.2 Accessible liquids in toys shall not have a pH of less than 3,0 or greater than 10,0 when tested in

accordance with EN ISO 787-9. This requirement does not apply to ink supplied in writing instruments.

4.2.3 Toys shall not contain liquids classified in accordance with Directive 1999/45/EC as R65 ‘Harmful:

may cause lung damage if swallowed’.
4.3 Formaldehyde (see A.6)

4.3.1 Accessible textile components of toys intended for children under 3 years of age shall not contain free

and hydrolyzed formaldehyde in excess of 30 mg/kg when tested in accordance with EN ISO 14184-1.

4.3.2 Accessible paper components of toys intended for children under 3 years of age shall not contain

formaldehyde in excess of 30 mg/kg when tested in accordance with EN 645 and EN 1541.

4.3.3 Accessible resin-bonded wood components of toys intended for children under 3 years of age shall

not release formaldehyde in excess of 80 mg/kg when tested in accordance with EN 717-3.

NOTE This !standard" also contains requirements for formaldehyde as a monomer (see Table 2 D) and as a

preservative (see Table 2 H).
4.4 Methods of analysis (see A.7)

The analysis of toys and toy materials for chemical compounds for which limits are given in Tables 2 A to 2 I

shall be performed in accordance with the sampling procedures and test methods described

in !EN 71-10" and !EN 71-11". Alternative methods are acceptable only if they are capable of

achieving at least the accuracy, precision and sensitivity of the standard methods and have been validated to

show that the results are equivalent to those of the standard methods.

If a first-action method is given in !EN 71-10" for a particular toy, toy component and toy material and

compound or group of compounds, compliance with this !standard" may be shown by using that method

alone. A first-action method shall not be used to show non-compliance with the requirements of this

!standard".
---------------------- Page: 9 ----------------------
EN 71-9:2005+A1:2007 (E)
Table 1 – Applicable limit Tables (4.1) (see A.8 and A.9)
Limit table
2 A 2 B 2 C 2 D 2 E 2 F 2 G(a) 2 G(b) 2 H 2 I
SPECIFIC TOY/TOY COMPONENT Toy material

1 Toys intended to be mouthed by children under 3 years of age POLYMERIC X X X

2 POLYMERIC X X X
Toys, or accessible toy components, with a mass of 150 g or less intended to
3 WOOD X X X X
be played with in the hands by children under 3 years of age
4 PAPER X X

5 Toys and accessible components of toys intended for children under 3 years TEXTILE X X X

6 of age LEATHER X X X
7 POLYMERIC X X X
8 Mouthpiece components of mouth-actuated toys WOOD X X X X
9 PAPER X X
!deleted
10 POLYMERIC
Inflatable toys with a surface greater than 0,5 m when fully inflated X
text"
11 POLYMERIC X X
Toys worn over the mouth or nose
12 TEXTILE X X X
13 PAPER X X
14 POLYMERIC X
Toys which the child can enter
15 TEXTILE X

16 Components of graphic instruments sold as toys or used in toys POLYMERIC X X X

17 Toys and accessible components of toys for indoor use WOOD X X
18 Toys and accessible components of toys for outdoor use WOOD X
19 Toys and components of toys which mimic food POLYMERIC X X X
20 Solid toy materials intended to leave a trace ALL X X
21 Coloured accessible liquids in toys LIQUID X X X
22 Non-coloured ac
...

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