SIST-TS CEN/TS 13387-2:2026

SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 13387-2:2024
01-september-2024
Izdelki za otroke - Smernice o splošni varnosti - 2. del: Nevarnosti zaradi kemijskih
lastnosti
Child care articles - General safety guidelines - Part 2: Chemical hazards
Artikel für Säuglinge und Kleinkinder - Sicherheitsleitfaden - Teil 2: Chemische
Gefährdungen
Articles de puériculture - Conseils relatifs à la sécurité - Partie 2 : Dangers chimiques
Ta slovenski standard je istoveten z: FprCEN/TS 13387-2
ICS:
97.190 Otroška oprema Equipment for children
kSIST-TS FprCEN/TS 13387-2:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

kSIST-TS FprCEN/TS 13387-2:2024

kSIST-TS FprCEN/TS 13387-2:2024

FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 13387-2
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
June 2024
ICS 97.190 Will supersede CEN/TR 13387-2:2018
English Version
Child care articles - General safety guidelines - Part 2:
Chemical hazards
Articles de puériculture - Conseils relatifs à la sécurité - Artikel für Säuglinge und Kleinkinder -
Partie 2 : Dangers chimiques Sicherheitsleitfaden - Teil 2: Chemische Gefährdungen

This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 252.
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, Türkiye 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 Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 13387-2:2024 E
worldwide for CEN national Members.

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Contents Page
European foreword . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Regulatory, normative and policy background . 5
4.1 General . 5
4.2 REACH - Short summary . 6
4.2.1 Registration . 6
4.2.2 Authorization . 6
4.2.3 Restrictions . 6
4.2.4 Articles . 7
4.2.5 Recommendations . 7
4.3 Toy Safety Directive and related standards . 7
4.3.1 Short summary of Toy Safety Directive . 7
4.3.2 Toy standards . 9
4.3.3 Recommendations . 10
4.4 CEN Approach on addressing environmental issues in product and service standards . 10
4.4.1 Short summary . 10
4.4.2 Recommendations . 10
5 Basics of Chemical Safety Assessment (CSA) . 10
5.1 General . 10
5.2 Hazard assessment . 11
5.3 Exposure assessment . 13
5.4 Risk characterization . 13
5.5 Example – PAHs. 14
5.6 Example – Migration limit values in Toy Safety Directive . 14
5.7 Recommendations . 15
6 Child care articles specific approaches . 15
6.1 General aspects . 15
6.2 Substances of Very High Concern (SVHC) . 16
6.3 CMR substances . 16
6.4 Certain elements . 16
6.4.1 Regulatory and normative background . 16
6.4.2 Specific child care articles considerations . 17
6.5 Flame retardants . 17
6.5.1 Regulatory and normative background . 17
6.5.2 Specific child care articles considerations . 18
6.6 Colourants . 18
6.6.1 Regulatory and normative background . 18
6.6.2 Specific child care articles considerations . 19
6.7 Primary aromatic amines . 20
6.7.1 Regulatory and normative background . 20
6.7.2 Specific child care articles considerations . 20
6.8 Monomers . 21
6.8.1 Regulatory and normative background . 21
6.8.2 Specific child care articles considerations . 21
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6.9 Solvents (migration) . 21
6.9.1 Regulatory and normative background . 21
6.9.2 Specific child care articles considerations . 22
6.10 Solvents (inhalation) . 22
6.10.1 Regulatory and normative background . 22
6.10.2 Specific child care articles considerations . 23
6.11 Plasticizers . 23
6.11.1 Regulatory and normative background . 23
6.11.2 Specific child care articles considerations . 24
6.12 Sensitizers – Fragrances . 24
6.12.1 Regulatory and normative background . 24
6.12.2 Specific child care articles considerations . 27
6.13 N-Nitrosamines and N-Nitrosatable substances . 27
6.13.1 Regulatory and normative background . 27
6.13.2 Specific child care articles considerations . 27
6.14 Other – Formaldehyde (other than monomer or preservative) . 28
6.14.1 Regulatory and normative background . 28
6.14.2 Specific child care articles considerations . 28
Bibliography . 43

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European foreword
This document (FprCEN/TS 13387-2:2024) 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 Vote on TS.
This document will supersede CEN/TR 13387-2:2018.
The chemical part has been updated compared to the previous edition. Apart from some adaptations
necessary as a result of relevant reference documents which have been adopted or changed after the
publication of the previous edition of the present guidelines some corrections were made. In addition,
the recommendations relating to formaldehyde and preliminary aromatic amines were changed.
The CEN/TS 13387 series comprises the following five parts:
— Safety philosophy and safety assessment (CEN/TS 13387-1);
— Chemical hazards (CEN/TS 13387-2);
— Mechanical hazards (CEN/TS 13387-3);
— Thermal hazards (CEN/TS 13387-4);
— Product information (CEN/TS 13387-5).
CEN/TS 13387-2 is intended to be used in conjunction with CEN/TS 13387-1.
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1 Scope
This document provides guidance information on chemical hazards that are taken into consideration
when developing safety standards for child care articles. In addition, these guidelines can assist those
with a general professional interest in child safety.
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 71-10:2005, Safety of toys — Part 10: Organic chemical compounds — Sample preparation and
extraction
EN 717-3, Wood-based panels — Determination of formaldehyde release — Part 3: Formaldehyde release
by the flask method
EN ISO 14184 (all parts), Textiles — Determination of formaldehyde (ISO 14184, all parts)
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
4 Regulatory, normative and policy background
4.1 General
In Europe child care articles are covered by the Directive on general product safety (GPSD,
Directive 2001/95/EC). This directive contains a general safety requirement and does not address
chemical substances in particular. However, Article 13 of the GPSD provides for the opportunity to adopt
temporary “emergency” measures which may include limit values for chemical substances in consumer
products. Such measures had been adopted for phthalates in toys and child care articles and for
dimethylfumarate (DMF) and both have been later incorporated into REACH. In addition, Member States
can impose actions on products found unsafe.
Restrictions for several specific chemical substances can be found in Annex XVII of the Regulation
concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH,
Regulation (EC) No 1907/2006) “relating to restrictions on the marketing and use of certain dangerous
substances and preparations” as amended.
NOTE If applicable to their type of product or material used, these provisions are expected to be followed by
manufacturers of child care articles.
The Regulation on persistent organic pollutants (POP, Regulation (EC) No 850/2004) restricts
production, placing on the market and use of chemical substances listed in Annex I of the regulation
including constituents of articles. The provisions apply also to child care articles.
Other regulatory provisions relating to chemicals may apply to certain products. For instance, drinking
equipment is subject to the Regulation on materials and articles intended to come into contact with food
(Regulation (EC) No 1935/2004) and plastics components of drinking equipment are regulated by the
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Regulation relating to materials and articles intended to come into contact with foodstuffs. A Directive
covers the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and
soothers (Directive 93/11/EEC). Regulations apply where relevant.
Another example of chemical provisions applicable to child care articles is the Directive on packaging and
packaging waste (94/62/EC) which establishes among others limits for lead, cadmium, mercury and
hexavalent chromium in packaging.
While not directly applicable to child care articles the Directive on the safety of toys (TSD, 2009/48/EC)
is an important reference document addressing a product group with similar exposure characteristics
and providing a high standard of safety in the field of products intended for children. Hence, specific
guidance seems appropriate on how to make use of toys related chemical rules.
It is the intention of the present guidelines to complement existing legal obligations by providing some
practical recommendations keeping in mind legal minimum requirements.
Environmental issues are moving in the spotlight. CEN has adopted a policy: the “CEN Approach on
addressing environmental issues in product and service standards” calls for incorporation of
environmental considerations when product or service standards are elaborated. These aspects are
highly relevant in particular for chemicals as far as child care articles are concerned. Hence, this guide
incorporates also recommendations in this regard.
4.2 REACH - Short summary
4.2.1 Registration
All chemical substances manufactured or imported in quantities greater than 1 tonne per year per
manufacturer or importer shall be registered at the European Chemicals Agency (ECHA) unless they are
exempted from the scope of registration. The registration obligations apply to the individual chemical
substances, independently of whether they are on their own, in a mixture or in an article (when the
chemical substance is intended to be released).
4.2.2 Authorization
Chemical substances with properties of very high concern may be subject to authorization before being
allowed to be manufactured or used in the European Union. These are CMRs (carcinogenic, mutagenic
and toxic for reproduction), PBTs/vPvBs (persistent, bio accumulating and toxic/very persistent and
very bio accumulating chemical substances) and chemical substances identified as causing serious and
irreversible effects to humans or the environment equivalent to the effects mentioned above. As a first
step such chemical substances are incorporated in a so-called “candidate list” which is published and
periodically updated by ECHA (twice a year in June and December). The candidate list is also known as
the “SVHC list”. Finally, chemical substances identified as requiring authorization will be taken up in
Annex XIV or REACH. These chemical substances cannot be placed on the market or used for
manufacturing in Europe after a given date, unless an authorization is granted for their specific use, or
the use is exempted from authorization.
For the current list of SVHC please consult the ECHA website.
4.2.3 Restrictions
REACH Annex XVII contained specific restrictions on 61 chemical substances or groups of substances by
the end of 2016 (66 entry numbers, 5 empty entries). These may apply to all uses of the substance or
more specifically to certain product types or exposure scenarios. Some restrictions have particular
relevance to child care and use articles such as the limits on total content for certain phthalate based
plasticizers and total content limits for certain flame retardants in textiles where there is prolonged skin
contact. Some entries, such as the total content restriction for cadmium in certain materials, may apply
to child care and use articles where that material is used to make the finished product.
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4.2.4 Articles
Articles within REACH are defined as an object, which during production is given a special shape, surface
or design which determines its function to a greater degree than its chemical composition (Article 3(3)).
This means that most consumer products including child care articles can be defined as articles. Chemical
substances in articles do not need to be registered under REACH, except chemical substances in articles
that are intentionally released if present in quantities greater than 1 t per manufacturer annually. This
could be for example a product with a perfume scent. Chemical substances that are unintentionally
released during use are not in scope for registration, like plasticizers migrating out of a product over time.
If articles contain chemical substances on the “candidate list” (SVHC list) in a concentration above 0,1 %
(w/w), sufficient information shall be provided (as a minimum the name of the chemical substance) to
the recipient of the article to allow for safe use of the article. For consumers the information about these
chemical substances in the article shall only be given upon request and within 45 days of the request.
(Article 33 of REACH). This requirement is independent of the total tonnage of the chemical substance.
No such requirement exists for other dangerous chemical substances in articles.
If a SVHC substance is present in a concentration above 0,1 % in the article and its import or
manufacturing quantities are above 1 tonne in total per year per company, the ECHA shall be notified of
the presence of the SVHC substance. Such notification requirement does not exist for other dangerous
substances in articles.
Chemical substances integrated in articles are neither subject to registration nor to authorization with
the exception of chemical substances intended to be released. However, SVHC substances used in or for
the manufacturing of articles in Europe may require authorization. Restricted chemical substances
(REACH Annex XVII) cannot be used in articles in the EU, nor can they be present in any article imported
into the EU.
4.2.5 Recommendations
Manufacturers and standardization bodies involved with child care and use articles should be aware of
the developments in REACH and how they apply to the product category. Where the developments are
deemed sufficiently protective of children there is generally no further need to elaborate a current or
future standard unless the development of new scientific knowledge indicates otherwise. Where REACH
covers child care and use articles in a limited way (in particular, imported articles) REACH should not be
considered as a replacement for product specific chemical rules.
4.3 Toy Safety Directive and related standards
4.3.1 Short summary of Toy Safety Directive
The Toy Safety Directive (TSD) was published in June 2009 (Directive 2009/48/EC). Part III of Annex II
contains the chemical requirements and are summarized below.
Chemical substances that are carcinogenic, mutagenic or toxic to reproduction (CMR) substances of
category 1A, 1B or 2 under the Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC)
No 1272/2008) are only allowed in toys if certain conditions are met:
— If the use and presence of the chemical substance is allowed according to Appendix A of Annex II;
— these chemical substances are inaccessible to children in any form, including inhalation;
— the concentration of the chemical substances does not exceed the concentration limits as set for the
classification of mixtures containing these chemical substances in the CLP regulation.
55 listed allergenic fragrances shall not be used in toys only if the presence is technically unavoidable
under good manufacturing practice and does not exceed 100 ppm. Another 11 allergenic fragrances shall
be declared on a product label if they are present in concentrations above 100 ppm.
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Requirements on migration of 19 elements (aluminium, antimony, arsenic, barium, boron, cadmium,
chromium (III), chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium,
tin, organic tin, and zinc) replacing the previous migration restrictions on 8 elements (antimony, arsenic,
barium, cadmium, chromium, lead, mercury and selenium). The migration limits are set for three
different types of materials:
1) dry, brittle powder-like or pliable toy material,
2) liquid or sticky toy material and
3) scraped-off toy material.
For the elements arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly
toxic, the limits have been set at levels that are half of those considered safe according to the criteria of
the relevant Scientific Committee, in order to ensure that only traces that are compatible with good
manufacturing practice will be present.
Furthermore, N-nitrosamines and N-nitrosatable substances are prohibited for use in toys intended for
use by children under 36 months or in other toys intended to be placed in the mouth. Specific migration
limit values are set.
According to Article 46 the Commission may adopt specific limit values for chemical substances used in
toys intended for use by children under 36 months or in other toys intended to be placed in the mouth,
taking into account food contact material legislation (Regulation (EC) No 1935/2004). These specific
limit values are listed in Appendix C of Annex II. By May 2017 the following substances were included:
— tris (2-chloroethyl) phosphate (TCEP, CAS No 115-96-8), tris-monochloro-propyl phosphate (TCPP,
CAS No 13674-84-5) and tris(1,3-dichloropropyl-2)phosphate (TDCP, CAS No 13674-87-8) with a
specific limit value of 5 mg/kg (content limit);
— bisphenol A (CAS No 80-05-7) with a limit of 0,04 mg/l (migration limit);
— formamide (CAS No 75-12-7) with a limit of 20 μg/m (emission limit) after a maximum of 28 days
from commencement of the emission testing of foam toy materials containing more than 200 mg/kg
(cut-off limit based on content);
— 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI, CAS No 26172-55-4) and 2-methylisothiazolin-
3(2H)-one (MI, CAS No 2682-20-4) in a ratio of 3:1 (CAS No 55965-84-9) as well as its individual
components with limits (content limits) in aqueous toy materials of1 mg/kg (mix), 0,75 mg/kg (CMI)
and 0,25 mg/kg (MI).
— 1,2-Benzisothiazol-3(2H)-one (1,2-benzisothiazolin-3-one, BIT, CAS No 2634-33-5) with a limit in
aqueous toy materials of 5 mg/kg (content limit);
— phenol (CAS 108-95-2) with a limit of 5 mg/l (migration limit) in polymeric materials and a limit of
10 mg/kg (content limit) as a preservative.
NOTE A restriction for aniline is in preparation as well as a reduced limit for bisphenol A.
According to Article 18 manufactures must, before placing a toy on the market, carry out analysis of the
chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy
may present, as well as an assessment of the potential exposure to such hazards. This is also called a
safety assessment. The manufactures must furthermore, demonstrate that the toy complies with the
requirements set in Annex II. The assessment must be kept in the technical documentation.
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4.3.2 Toy standards
The following standards dealing with chemical substances in toys relevant for child care articles are
currently available:
4.3.2.1 Harmonized standards with references published in the Official Journal:
— EN 71-3:2013+A2:2017 Safety of toys — Part 3: Migration of certain elements:
This standard contains migration limits and test methods for 19 elements (aluminium, antimony,
arsenic, barium, boron, cadmium, chromium (III), chromium (VI), cobalt, copper, lead, manganese,
mercury, nickel, selenium, strontium, tin, organic tin, and zinc).
— EN 71-12:2016, Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances:
This standard contains limits and test methods for N-nitrosamines and N-nitrosatable substances for
toys and parts of toys made from elastomers and intended for use by children under 36 months or
intended to be placed in the mouth and finger paints for children under 36 months.
NOTE At time of publication new versions EN 71-3:2013+A2:2017 and EN 71-12:2016 have been published by
CEN but they are not yet harmonized under TSD.
4.3.2.2 Harmonized standards without references published in the Official Journal:
— EN 71-9:2005+A1:2007, Safety of toys — Part 9: Organic chemical compounds — Requirements;
— 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.
The standards EN 71-9, EN 71-10 and EN 71-11 which do not provide a presumption of conformity to
TSD requirements include limit values and test methods for certain organic chemical compounds such
as:
— flame retardants;
— colorants;
— primary aromatic amines;
— monomers (migration);
— solvents (migration and inhalation);
— wood preservatives;
— preservatives;
— plasticizers (migration).
It should be noted, however, that EN 71-9, EN 71-10 and EN 71-11 cover only a small number of organic
chemical substances. Consequently, the introduction of EN 71-9 includes the following sentence: “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”.
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4.3.3 Recommendations
The applicable requirements in the Directive including generic CMR exclusions and standards dealing
with chemical substances in toys should be considered when establishing requirements for child care
articles. However, the limits should be checked and different values should be considered when e.g. the
exposure and use profile is different compared to toys or if new scientific evidence suggests that the limits
need to be changed.
It is also recommended to carry out an analysis of the chemical hazard that a child use and care article
may present, as well as an assessment of the potential exposure to such a hazard.
Manufacturers and importers of as well as standard setting bodies for child care articles should monitor
the revisions of the limit values given in the Toy Safety Directive and the adoption of specific limits for
toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.
In addition, the developments within CEN/TC 52 should be taken into account. Manufacturers should
consider the latest versions of limit values and test methods in the toys field if referenced in child use and
care standards, as these are normally updated with some delay.
4.4 CEN Approach on addressing environmental issues in product and service
standards
4.4.1 Short summary
The key objective of the “CEN approach on addressing environmental issues in Product and Services
Standards” is to put in place a general framework to systematically address environmental issues in
standardization in order to reduce the environmental impacts of products and services.
The document defines roles and responsibilities for the various parties involved including technical
bodies of CEN, its Strategic Advisory Body on Environment (SABE) including the Environmental Helpdesk
(EHD) and the Team on Environmental Issues in Standardization (ENIS), stakeholders and national
standards bodies.
The framework consists of supporting tools (guidance documents, checklists, trainings, tailored
environmental programmes for technical bodies, etc.) and mandatory elements (review of titles and
scopes of TCs, inclusion of environmental issues in business plans, new work item proposals, formatted
resolutions, agenda item on environmental issues). It is envisaged to provide specific guidance to
TCs/WGs on specific issues including inter alia advice on the coverage of chemicals in product standards.
The functioning of the above is subject to monitoring by the relevant CEN groups and will be periodically
reviewed.
4.4.2 Recommendations
If specific guidance on addressing chemical substances in product standards is made available by CEN’s
advisory bodies on environmental issues it should be taken into consideration. Environmental concerns
should be taken on board in the development of standards for child care articles, i.e. also environmental
effects of chemical substances should be addressed. This means to not only consider human health but
also environmental impacts, e.g. to eliminate PBTs or vPvB substances.
5 Basics of Chemical Safety Assessment (CSA)
5.1 General
The scope and limit of chemical substance restrictions in regulations and standards are most often based
on a chemical safety assessment (CSA). This assessment determines the scope relevancy of the restriction
(e.g. type of material, accessibility, etc.) and provides recommended safe limit value based on the
exposure profile and use of a product or product group. To be able to adopt and adapt chemical substance
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restrictions for different types of child care articles it is important to understand the key aspects of a
chemical safety assessment.
CSA is the process that identifies and describes the conditions under which the use and/or presence of a
chemical substance could be considered safe. There are three major steps in the CSA process. These are:
— Hazard assessment;
— Exposure assessment;
— Risk characterization.
The hazard assessment requires the collection and evaluation of all available and relevant information
on the intrinsic properties of the chemical substance. The objective of the hazard assessment is to identify
the hazards of the substance, assess their potential effects on human health and the environment, and
determine, where possible, the threshold levels for exposure considered as safe (the so called no-effect
levels).
The exposure assessment is the process of measuring or estimating the dose or concentration of the
chemical substance to which humans and the environment are or can be exposed, depending on the use
of the chemical substance and the use of products in which it is present.
Within the exposure assessment, the definition of the conditions under which the chemical substance is
used and present, as well as how a product or product group containing the chemical substance is used
is critical in order to determine the potential level of exposure. The information on the conditions under
which a chemical substance and the product or product group containing the chemical substance is used
is called the exposure scenario. For each exposure scenario, the potential exposure levels of humans
and if relevant the environment need to be determined.
The third step in the CSA process is the risk characterization. For the risk characterization, the levels of
exposure are compared with the threshold levels for each relevant effect.
Risks are regarded as controlled when the potential exposure levels to the chemical substance are below
the threshold levels which are considered as safe. For effects with no threshold levels, emissions and
exposures shall be minimized or avoided for risks to be considered to be controlled.
In the following parts the main steps of a CSA are briefly explained and complemented by specific
considerations for chemicals used in child care articles in particular.
5.2 Hazard assessment
The hazard assessment normally comprises the following steps:
1) Hazard Identification:
Hazard identification is the determination of what hazards are associated with the chemical
substance. The information on the types of hazard can come from the classification and labelling of
the chemical substance or other available relevant toxicological and ecotoxicological information.
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
(CLP Regulation) provides criteria to classify substances and preparations as dangerous (e.g. very
toxic, toxic, harmful) based on their intrinsic properties. The classification of a substance as
dangerous is a critical input for the hazard identification.
ECHA has published a database which contains classification and labelling information on notified
and registered substances received from manufacturers and importers. It also includes the list of
harmonized EU classifications.
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Other relevant and available toxicological and ecotoxicological information on the intrinsic
properties of a chemical substance not covered by the classification and labelling information can be
found, for instance, in the publically available REACH registration dossiers as published on the ECHA
website.
For example the toxicological properties of the chemical substance when exposed via dermal (skin)
contact, oral contact or inhalation and the effect of the chemical substance if the exposure is short-
term (acute) or long term (chronic) can be found in these dossiers.
2) Derivation of threshold levels:
The derivation of threshold levels is the determination of the relationship between the hazard and
the dose (exposure amount). In principle for almost every hazard there is a minimum dose under
which no effect is expected anymore, a threshold level.
Several thresholds are available to be used in a chemical safety assessment.
Derived-No-Effect Level (DNEL)
The Derived No-Effect Level or DNEL is the level of exposure to the substance above which humans
should not be exposed. The DNEL is typically based on the NOAEL (No-Observed-Adverse-Effect-
Level) of a chemical substance, The NOAEL is the greatest concentration or amount of a substance,
found by observation or experiment, which causes no statistically significant detectable adverse
effect in the exposed population. The NOAEL is scaled by a safety factor, conventionally but not
always of 100, to account for the differences between test animals and humans (factor of 10) and
possible differences in sensitivity between humans (another factor of 10).
The lowest value available (for the most sensitive end point) is used for risk characterization.
However, in some cases (e.g. for mutagenic carcinogens) no safe threshold level can be obtained. In
such cases, a semiquantitative value, known as the DMEL or Derived Minimal Effect level may be
developed. DMELs can be used later on in the risk characterization process in the same way as DNELs.
DNELs and DMELs can be found in publically available REACH dossiers or can be calculated based on
available toxicological information.
Predicted-No-Effect Concentration (PNEC)
The environmental counterpart of the DNEL is the Predicted No Effect Concentration or PNEC – it is
the concentration of a substance in any environment below which adverse effects will most likely not
occur during long term or short-term exposure. The PNEC needs to be determined for each
environmental sphere (aquatic, terrestrial, atmospheric, sewage treatment, food chain).
PNECs can be found in publically available REACH dossiers or can be calculated based on available
ecotoxicological information.
Tolerable Daily Intake (TDI)
In the field of consumer products limits are often based on TDI (Tolerable Daily Intake) values which
indicate the amount of a substance that can be taken in daily over a lifetime without appreciable
health risk. They are a special form of a DNEL.
Important is that before a TDI is used in the risk assessment, the underlying data are checked to
determine if it up-to-date and relevant for the type of exposure.
kSIST-TS FprCEN/TS 13387-2:2024
FprCEN/TS 13387-2:2024 (E)
No threshold chemical substances
Chemical substances, especially when carcinogenic, mutagenic or toxic for the reproduction, without
a threshold value, should be eliminated as far as possible, i.e. banned using a low level of detection
unless any exposure can be excluded.
5.3 Exposure assessment
An exposure assessment entails the following two steps:
1) Development of exposure scenarios:
Exposure scenarios provide a quantitative estimate of an exposure associated with the use of a
chemical substance or a product containing the substance. The qualitative characteristics of the use
of the child use and care article should be identified and used to determine the relevant exposure.
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 expected exposure to the article; and
— likely route(s) of exposure to the article, e.g. ingestion, skin contact or inhalation.
2) Exposure estimation:
When estimating exposure, there are three major routes by which chemicals can enter the body: oral
(ingestion and licking/sucking), dermal (skin) and inhalation.
For child care articles the oral contact route (biting off particles, mouthing, licking and sucking) and
dermal contact are the most relevant. Depending on the properties of certain chemical substances
inhalation could also be a factor.
3) Prolonged contact with the skin:
Sometimes limits are established for “prolonged” contact with the skin. An appropriate time of
contact depends on the chemical substance and needs to be determined on a case-by-case basis.
5.4 Risk characterization
A quantitative risk characterization is carried out by comparing the estimated exposure level for a given
exposure pattern with the lowest threshold value, i.e. the critical DNEL/DMEL, for that exposure pattern.
The comparison needs to be done for each exposure pattern resulting from a given exposure scenario.
The risk characterization also needs to consider risks from combined exposures via different routes or
via different sources. This can be the case where the same person is potentially exposed to the same
substance via different routes of entry into the body.
kSIST-TS FprCEN/TS 13387-2:2024
FprCEN/TS 13387-2:2024 (E)
The risk will be considered to be adequately controlled if the estimated exposure levels do not exceed the
appropriate threshold levels. If there is no threshold it is therefore recommended to reduce the levels of
the substances as far as technically feasible using a precautionary approach.
Child care articles are usually not the only potential source of exposure to a chemical substance. When
assessing the safe use of a chemical substance in a child use and care article, exposure should contribute
only to a fraction of the TDI. In the field of toys normally a 10 % allocation is made. However,
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