oSIST prEN 17826:2022
(Main)Child care articles - Chemical hazards - Requirements and test methods
Child care articles - Chemical hazards - Requirements and test methods
This European Standard specifies chemical requirements,test and compliance assessment methods for child care articles within the scope of CEN TC 252.
Excluded from the scope are soothers (EN 1400), soother holders (EN 12586), drinkingequipment, (EN 14350) and cutlery and feeding utensils (EN 14372).
NOTE A non-exhaustive list of standards for child care articles covered by TC 252 is given in Annex A. An up-to-date list can be found on the CEN website:https://standards.cen.eu/dyn/www/f?p=204:105:0
Artikel für Säuglinge und Kleinkinder - Chemische Gefährdungen - Anforderungen und Prüfverfahren
Dieses Dokument legt chemische Anforderungen und Verfahren für Vergleichsprüfungen für Artikel für Säuglinge und Kleinkinder innerhalb des Anwendungsbereichs von CEN/TC 252 fest.
Ausgeschlossen aus dem Anwendungsbereich sind Schnuller (EN 1400), Schnullerhalter (EN 12586), Artikel für flüssige Kindernahrung (EN 14350) und Besteck und Geschirr (EN 14372).
ANMERKUNG Eine nicht erschöpfende Liste von Normen für Artikel für Säuglinge und Kleinkinder, die vom TC 252 behandelt werden, ist in Anhang A angeführt. Eine auf dem letzten Stand befindliche Liste ist auf der CEN Website zu finden: https://standards.cen.eu/dyn/www/f?p=204:105:0.
Articles de puériculture - Risques chimiques - Exigences et méthodes d'essai
Le présent document spécifie les exigences chimiques, ainsi que les méthodes d’essai de référence relatives aux articles de puériculture relevant du domaine d’application du CEN/TC 252.
Sont exclus du domaine d’application les sucettes (EN 1400), les attache-sucettes (EN 12586), les articles pour l’alimentation liquide (EN 14350) et les couverts et la vaisselle (EN 14372).
NOTE L’Annexe A fournit une liste non exhaustive des normes se rapportant aux articles de puériculture couverts par le TC 252. Une liste à jour peut être trouvée sur le site web du CEN : https://standards.cen.eu/dyn/www/f?p=204:105:0
Izdelki za otroke - Kemijske nevarnosti - Zahteve in preskusne metode
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 17826:2022
01-april-2022
Izdelki za otroke - Kemijske nevarnosti - Zahteve in preskusne metode
Child care articles - Chemical hazards - Requirements and test methods
Artikel für Säuglinge und Kleinkinder - Chemische Gefährdungen - Anforderungen und
Prüfverfahren
Ta slovenski standard je istoveten z: prEN 17826
ICS:
97.190 Otroška oprema Equipment for children
oSIST prEN 17826:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 17826:2022
DRAFT
EUROPEAN STANDARD
prEN 17826
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS 97.190
English Version
Child care articles - Chemical hazards - Requirements and
test methods
Artikel für Säuglinge und Kleinkinder - Chemische
Gefährdungen - Anforderungen und Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 252.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17826:2022 E
worldwide for CEN national Members.
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prEN 17826:2022 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 5
4 Requirements . 5
4.1 General chemical requirements . 5
4.2 Compliance assessment for requirements. 6
4.3 Substances on the “Candidate list” . 6
4.4 CMR substances . 7
4.5 Certain elements . 7
4.6 Flame retardants . 8
4.7 Colorants . 8
4.8 Aniline . 10
4.9 Monomers . 10
4.10 Plasticizers . 11
4.11 Sensitizers – Fragrances . 11
4.12 Formaldehyde (other than monomer or preservative) . 14
4.13 Polycyclic Aromatic Hydrocarbons (PAHs) . 14
Annex A (informative) A non-exhaustive list of standards for child care articles covered by
CEN/TC 252 . 16
Annex B (informative) Additional compliance assessment options . 17
B.1 Introduction . 17
B.2 Validation by testing . 17
B.2.1 General . 17
B.2.2 Identify available test reports . 18
B.2.3 Review the test reports . 18
B.2.4 Are the test reports sufficient to confirm compliance? . 18
B.3 Quality Management System (QMS) . 18
B.3.1 General . 18
B.3.2 Valid QMS certification? . 18
B.3.3 Review Chemical Management (CM) process . 18
B.3.4 Review data for validation . 19
B.3.5 Sufficient data for reliability? . 19
Annex ZA (informative) Relationship between this European Standard and the safety
requirements of Directive 2001/95/EC aimed to be covered . 20
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European foreword
This document (prEN 17826:2022) has been prepared by Technical Committee CEN/TC 252 “Child care
articles”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of EU
Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), see informative Annex ZA, which is an integral part
of this document.
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1 Scope
This document specifies chemical requirements, test and compliance assessment methods for child care
articles within the scope of CEN TC 252.
Excluded from the scope are soothers (EN 1400), soother holders (EN 12586), drinking equipment,
(EN 14350) and cutlery and feeding utensils (EN 14372).
NOTE A non-exhaustive list of standards for child care articles covered by TC 252 is given in Annex A. An up-
to-date list can be found on the CEN website: https://standards.cen.eu/dyn/www/f?p=204:105:0
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 71-3:2019+A1:2021, Safety of toys - Part 3: Migration of certain elements
EN 71-10:2005, Safety of toys - Part 10: Organic chemical compounds - Sample preparation and extraction
EN 71-11:2005, Safety of toys - Part 11: Organic chemical compounds - Methods of analysis
EN 717-1:2004, Wood-based panels - Determination of formaldehyde release - Part 1: Formaldehyde
emission by the chamber method
EN ISO 14184-1:2011, Textiles - Determination of formaldehyde - Part 1: Free and hydrolysed formaldehyde
(water extraction method) (ISO 14184-1:2011)
EN ISO 14362-1:2017, Textiles - Methods for determination of certain aromatic amines derived from azo
colorants - Part 1: Detection of the use of certain azo colorants accessible with and without extracting the
fibres (ISO 14362-1:2017)
EN ISO 17226-1:2021, Leather - Chemical determination of formaldehyde content - Part 1: Method using
high-performance liquid chromatography (ISO 17226-1:2021)
EN ISO 17234-1:2020, Leather - Chemical tests for the determination of certain azo colourants in dyed
leathers - Part 1: Determination of certain aromatic amines derived from azo colorants (ISO 17234-1:2020)
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3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
article
object which during production is given a special shape, surface or design which determines its function
to a greater degree than does its chemical composition
[SOURCE: REACH, Article 3.3]
3.2
child care article
article used by small children in the scope of CEN TC 252
4 Requirements
4.1 General chemical requirements
This standard supports but does not reduce the responsibility of manufacturers, importers and suppliers
for ensuring that the use of substances not addressed will not endanger the health whilst using child care
articles as intended or in a reasonably foreseeable way.
Parts of the product which shall comply with this standard are defined in the relevant product safety
standards based on their accessibility, function, volume or mass, and reasonable exposure due to sucking,
licking, swallowing, inhalation or prolonged contact with skin.
NOTE 1 ‘Prolonged contact with human skin’ has been defined in REACH in different ways for different
substances. In the REACH restriction on phthalates (2018/2005) it means continuous contact of more than 10 min
duration or intermittent contact over a period of 30 min, per day. In the ECHA Guide relating to the nickel restriction
it means 10 min on three or more occasions within two weeks, or 30 min on one or more occasions within two
weeks. For other substances other definitions may be appropriate.
When these parts of the product are not defined in the relevant product safety standards, the parts of the
products which shall comply shall be defined using the exposure principles described in this standard.
Requirements for substances on the “Candidate list” (4.3) apply to any part of any child care article.
Requirements relating to emissions of volatile organic compounds (solvents (inhalation), fragrances,
release of formaldehyde from resin-bonded wood panels) apply to any part of any child care article
specified in the relevant clause of this standard if exposure cannot be excluded.
NOTE 2 Future editions of this standard may incorporate additional requirements addressing exposure to such
as adults or children other than these using the product.
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4.2 Compliance assessment for requirements
Typically, normative requirements in standards are verified using incorporated or referenced test
methods. However, this approach has its limitations. The application of test methods is expensive and, in
many cases, difficult if not impossible. As an example, generic restrictions of substances classified as CMR
cover potentially hundreds of compounds. It would be extremely difficult to develop, to validate or to
identify appropriate test methods for all of them. But even where such methods are available it may be
more useful and more efficient to assess compliance with the provisions of this standard in a different
way through an evaluation of the technical documentation associated with the product and the
materials/chemicals used for its production.
The starting point for a compliance assessment is the gathering of information on the materials and
chemicals used in the manufacture of the child care article. A comprehensive information in the form of
a bill of materials (BOM), a bill of substances (BOS) and in support of these, safety data sheets (SDS),
regulatory declarations by materials manufacturers, certificates, test reports, where applicable, shall be
compiled. A description of the use/location of the material shall be given in a way that makes it possible
to assess whether the provisions of the standard are fulfilled, e.g. to determine whether a part can
reasonably be expected to lead to an exposure due to sucking, licking, swallowing, inhalation or
prolonged contact with skin.
The harmonized hazard classification of substances present in the final product shall be determined e.g.
by using the relevant databases operated by ECHA.
NOTE 1 Harmonized hazard classifications of substances are included in Part 3 of Annex VI of the Regulation on
classification, labelling and packaging of substances and mixtures (Regulation EC/1272/2008, “CLP-Regulation”).
Finally, it shall be determined whether substances restricted in this standard are present in parts
specified in the relevant clauses in amounts exceeding the relevant thresholds where it is indicated that
compliance assessment may be used instead of testing.
Unless explicitly stated in this standard testing is not required, however, additional (supporting) testing
may be useful for managing compliance. The implementation of a Quality Management System (QMS)
with appropriate considerations for managing chemicals and chemical risks throughout the value chain
may also assist in compliance assessment. These additional compliance assessment options are described
in Annex B (informative).
NOTE 2 The above procedure was inspired by the “Guidance document on the application of Directive
2009/48/EC on the Safety of toys: Technical documentation, specifically Part IV Chemical Requirements.
4.3 Substances on the “Candidate list”
Substances included in the Candidate list (including substances in Annex XIV) of REACH shall not exceed
0,1 % in components of child care articles 18 months after publication on the Candidate list.
Components which are not accessible without using tools are not covered by the requirement.
Where more specific limits for substances on the Candidate list are stipulated in this standard such limits
prevail over the generic ones.
Evaluation of this clause shall be done in accordance with 4.2.
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4.4 CMR substances
Substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A,
1B or 2 under Regulation (EC) No 1272/2008 shall not be present in any part which, due to their
accessibility, function, volume or mass, can reasonably lead to an exposure due to sucking, licking,
swallowing, inhalation or prolonged contact with skin if exceeding the following limits:
— for carcinogenic and mutagenic substances 0,1 %, 0,1 % and 1 % (for cat. 1A, 1B and 2);
— for substances toxic to reproduction 0,3 %, 0,3 % and 3 % (for cat. 1A, 1B and 2);
— in accordance with the specific limits included in Annex VI, Table 3.1 of Part 3 of Regulation (EC) No
1272/2008.
This requirement does not apply to nickel in child care articles and child care article components made
of stainless steel.
NOTE It is envisaged to incorporate future exemptions included in Appendix A of the TSD in amendments to
this standard.
Where more specific limits for CMR substances are stipulated in this standard such limits prevail over
the generic ones.
Evaluation of this clause shall be done in accordance with Clause 4.2.
4.5 Certain elements
The migration of elements from any parts which, due to their accessibility, function, volume or mass, can
reasonably lead to an exposure due to sucking, licking, swallowing, or prolonged contact with skin shall
not exceed any of the limits given in Table 1.
The method described in EN 71-3:2019+A1:2021 shall be used.
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Table 1 — Migration limits of certain elements
Element mg/kg
Aluminium 28 130
Antimony 560
Arsenic 47
Barium 18 750
Boron 15 000
Cadmium 17
Chromium (III) 460
Chromium (VI) 0,053
Cobalt 130
Copper 7 700
Lead 23
Manganese 15 000
Mercury 94
Nickel 930
Selenium 460
Strontium 56 000
Tin 180 000
Organic tin 12
Zinc 46 000
4.6 Flame retardants
Materials made of plastics, foams, textiles and wood shall not contain any substances typically used as
flame-retardants (but may be used for other purposes) exceeding the limits given in Table 2.
For the listed flame retardants with a limit value, methods shall be used with a suitable limit of
quantitation (LOQ) allowing to verify the indicated limits.
Table 2 — Flame retardant limits
Compound CAS Number Limit
Tri-o-cresyl phosphate (TOCP) 78–30–8 see clause plasticizer
Tris(2-chloroethyl) phosphate (TCEP) 115–96–8 5 mg/kg
Tris(1,3-dichloropropyl-2) phosphate (TDCPP) 13674–87–8 5 mg/kg
Tris-monochloro-propyl phosphate (TCPP)
...
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