SIST EN 71-9:2005
(Main)Safety of toys - Part 9: Organic chemical compounds - Requirements
Safety of toys - Part 9: Organic chemical compounds - Requirements
This Part 9 of the document 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 document 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 document unless they form part of the toy or have intended play value.
Sicherheit von Spielzeug - Teil 9: Organisch-chemische Verbindungen - Anforderungen
Sécurité des jouets - Partie 9 : Composés organiques chimiques - Exigences
La présente Partie (9) du document EN 71 relative a 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’oil ;
- 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 possedent une valeur ludique.
Varnost igrač - 9. del: Organske kemijske spojine - Zahteve
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 71-9:2005
01-junij-2005
9DUQRVWLJUDþ GHO 2UJDQVNHNHPLMVNHVSRMLQH=DKWHYH
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
ICS:
97.200.50 ,JUDþH Toys
SIST EN 71-9:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN 71-9
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 97.200.50
English version
Safety of toys - Part 9: Organic chemical compounds -
Requirements
Sécurité des jouets - Partie 9: Composés chimiques Sicherheit von Spielzeug - Teil 9: Organisch-chemische
organiques - Exigences Verbindungen - Anforderungen
This European Standard was approved by CEN on 15 November 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-9:2005: E
worldwide for CEN national Members.
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EN 71-9:2005 (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)
2
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EN 71-9:2005 (E)
Foreword
This document (EN 71-9:2005) has been prepared by Technical Committee CEN/TC 52 “Safety of Toys”, the
secretariat of which is held by DS.
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 European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2005, and conflicting national standards shall be withdrawn at
the latest by August 2005.
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 document defines contact routes and specifies limits for the migration or content of certain chemical
compounds in toys.
This document 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, 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.
3
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EN 71-9:2005 (E)
Introduction
The document 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 documents EN 71-9, prEN 71-10 and prEN 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 document gives requirements for organic compounds in certain toys and toy materials. In drafting the
document, 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 document, 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 document.
Future editions of this document will address additional organic compounds. It might be useful for
manufacturers of toys to consider the risk assessments carried out during the drafting of this document and
published as part of a CEN report which supports the standard. Users of this document 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 prEN 71-10, which describes sample preparation and extraction
procedures, and prEN 71-11, which specifies methods of analysis.
At the date of publication, the standard does not specify requirements for chemical compounds which are
th
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 document 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 document CEN/TC 52 has considered
organic chemicals that can be classified within the following groups:
Solvents
Preservatives
1
Plasticisers (excluding phthalate plasticisers)
Flame retardants
Monomers
1
Phthalate plasticisers were specifically excluded from the scope of mandate M/229.
4
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EN 71-9:2005 (E)
Biocides (wood preservatives)
Processing aids
Colouring agents
During the development of this document, CEN/TC 52 has considered the requirements set out in Council
Directive 82/711/EEC as amended and its supporting standards.
5
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EN 71-9:2005 (E)
1 Scope
This Part 9 of the document 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 document 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 document 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 71-1:1998, Safety of toys - Part 1: Mechanical and physical properties
EN 71-5, Safety of toys – Part 5: Chemical toys (sets) other than experimental sets
prEN 71-10:, Safety of toys – Organic chemical compounds – Sample preparation and extraction
prEN 71-11, Safety of toys – 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.
6
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EN 71-9:2005 (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
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
2
material, marketed as either paper or paperboard, with a maximum mass per unit area of 400 g/m
[EN 71-1:1998]
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
3
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 document 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.
7
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EN 71-9:2005 (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 prEN 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 document 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 prEN 71-10
and prEN 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 prEN 71-10 for a particular toy, toy component and toy material and
compound or group of compounds, compliance with this document 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 document.
8
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EN 71-9:2005 (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
a
1 Toys intended to be mouthed by children under 3 years of age POLYMERIC X X X
a
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
a
7 POLYMERIC X X X
8 Mouthpiece components of mouth-actuated toys WOOD X X X X
9 PAPER X X
2
a
10 Inflatable toys with a surface greater than 0,5 m when fully inflated POLYMERIC X
a
11 POLYMERIC X X
12 Toys worn over the mouth or nose TEXTILE X X X
13 PAPER X X
a
14 POLYMERIC X
Toys which the child can enter
15 TEXTILE X
a
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
a
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 accessible liquids in toys LIQUID X
23 Modelling clay, play clay and similar, except those chemical toys addressed
ALL X X X
by EN 71-5
24 Balloon-making compounds ALL X X X
25 Imitation tattoos with adhesive ALL X X X X
a
26 Imitation jewellery POLYMERIC X X X
a
excluding polymeric coatings with a th
...
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