CEN/TR 13387-2:2015

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST-TP CEN/TR 13387:2005
Izdelki za otroke - Smernice o splošni varnosti - 2. del: Kemijske nevarnosti
Child use and care articles - General safety guidelines - Part 2: Chemical hazards
Ta slovenski standard je istoveten z: CEN/TR 13387-2:2015
ICS:
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN/TR 13387-2
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2015
ICS 97.190 Supersedes CEN/TR 13387:2004
English Version
Child use and care articles - General safety guidelines - Part 2:
Chemical hazards
This Technical Report was approved by CEN on 12 January 2015. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 13387-2:2015 E
worldwide for CEN national Members.

Contents Page
European foreword .4
1 Scope .5
2 Regulatory, normative and policy background .5
2.1 General .5
2.2 REACH - Short summary .6
2.2.1 Registration .6
2.2.2 Authorization .6
2.2.3 Restrictions .6
2.2.4 Articles .6
2.2.5 Recommendations .7
2.3 Toy Safety Directive and related standards .7
2.3.1 Short summary of Toy Safety Directive .7
2.3.2 Toy standards .8
2.3.3 Recommendations .9
2.4 CEN Approach on addressing environmental issues in product and service standards .9
2.4.1 Short summary .9
2.4.2 Recommendations .9
3 Basics of Chemical Safety Assessment (CSA) . 10
3.1 General . 10
3.2 Hazard assessment . 10
3.3 Exposure assessment . 12
3.4 Risk characterization . 13
3.5 Example – PAHs. 13
3.6 Example – Migration limit values in Toy Safety Directive . 13
3.7 Recommendations . 14
4 Child use and care articles specific approaches . 15
4.1 General aspects . 15
4.2 Substances of Very High Concern (SVHC) . 15
4.3 CMR substances . 15
4.4 Certain elements . 16
4.4.1 Regulatory and normative background . 16
4.4.2 Specific child use and care articles considerations . 16
4.5 Flame retardants . 16
4.5.1 Regulatory and normative background . 16
4.5.2 Specific child use and care articles considerations . 17
4.6 Colourants . 17
4.6.1 Regulatory and normative background . 17
4.6.2 Specific child use and care articles considerations . 18
4.7 Primary aromatic amines . 18
4.7.1 Regulatory and normative background . 18
4.7.2 Specific child use and care articles considerations . 19
4.8 Monomers . 19
4.8.1 Regulatory and normative background . 19
4.8.2 Specific child use and care articles considerations . 19
4.9 Solvents (migration) . 19
4.9.1 Regulatory and normative background . 19
4.9.2 Specific child use and care articles considerations . 20
4.10 Solvents (inhalation) . 20
4.10.1 Regulatory and normative background . 20
4.10.2 Specific child use and care articles considerations . 21
4.11 Plasticizers . 21
4.11.1 Regulatory and normative background . 21
4.11.2 Specific child use and care articles considerations . 22
4.12 Sensitizers – Fragrances . 22
4.12.1 Regulatory and normative background . 22
4.12.2 Specific child use and care articles considerations . 24
4.13 N-Nitrosamines and N-Nitrosatable substances . 24
4.13.1 Regulatory and normative background . 24
4.13.2 Specific child use and care articles considerations . 25
4.14 Other . 25
4.14.1 Formaldehyde (other than monomer or preservative) . 25
Annex A (informative) Brief description of EU regulatory chemical requirements applicable to

child use and care articles. 26
A.1 Cadmium . 26
A.2 Nickel . 26
A.3 Flame retardants . 26
A.4 Colourants . 26
A.5 Wood preservatives . 27
A.6 Preservatives (other than wood preservatives) . 27
A.7 Plasticizers . 27
A.8 N-Nitrosamines and N-Nitrosatable substances . 27
A.9 Policyclic Aromatic Hydrocarbons (PAHs) . 28
A.10 Persistent Organic Pollutants (POPs) . 28
A.11 Food contact materials . 28
A.12 Packaging . 28
Annex B (informative) Model requirements for use in a standard . 29
B.1 Introduction . 29
B.2 General chemical requirements . 29
B.3 Substances of Very High Concern (SVHC) . 29
B.4 CMR substances . 29
B.5 Certain elements . 29
B.6 Flame retardants . 30
B.7 Colorants . 30
B.8 Primary aromatic amines . 31
B.9 Monomers. 32
B.10 Solvents (migration) . 32
B.11 Solvents (inhalation) . 33
B.12 Plasticizers . 33
B.13 Sensitizers – Fragrances . 33
B.14 N-Nitrosamines and N-Nitrosatable substances . 36
B.15 Formaldehyde (other than monomer or preservative) . 36
Bibliography . 37

European foreword
This document (CEN/TR 13387-2:2015) has been prepared by Technical Committee CEN/TC 252 “Child use
and care articles”, the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TR 13387:2004.
CEN/TR 13387 comprises the following five parts:
— Safety philosophy and safety assessment (CEN/TR 13387-1);
— Chemical hazards (CEN/TR 13387-2);
— Mechanical hazards (CEN/TR 13387-3);
— Thermal hazards (CEN/TR 13387-4);
— Product information (CEN/TR 13387-5).
CEN/TR 13387-2 should be used in conjunction with CEN/TR 13387-1.
The chemical part has been completely rewritten compared to the previous edition.
1 Scope
This Technical Report provides guidance information on chemical hazards that should be taken into
consideration when developing safety standards for child use and care articles. In addition, these guidelines
can assist those with a general professional interest in child safety.
2 Regulatory, normative and policy background
2.1 General
In Europe child use and 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 use and 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. If applicable to their type of product or material used, these provisions are 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 products.
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
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). Applicable regulation will have to be identified 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.
2.2 REACH - Short summary
2.2.1 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).
2.2.2 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.
2.2.3 Restrictions
REACH Annex XVII contained specific restrictions on 64 chemical substances or groups of substances by the
end of 2014. 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 plasticisers 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.
2.2.4 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 use and 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 tonne 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), the supplier has to provide sufficient information (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, EU producers or importers of articles shall notify
the ECHA 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.
2.2.5 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.
2.3 Toy Safety Directive and related standards
2.3.1 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.
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 end of 2014 the substances 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) are listed with a specific limit value of 5 mg/kg (content limit). In addition,
bisphenol A (CAS No 80-05-7) is included with a limit of 0,1 mg/l (migration limit).
According to article 18 manufactures shall, 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 shall furthermore, demonstrate that the toy complies with the requirements set
in Annex II. The assessment shall be kept in the technical documentation.
2.3.2 Toy standards
The following standards dealing with chemical substances in toys relevant for child use and care articles are
currently available:
2.3.2.1 Harmonized standards
— EN 71-3:2013, 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 71-12:2013, 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.
2.3.2.2 Non-harmonized standards
— 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;
— EN 71-11:2005, Safety of toys - Part 11: Organic chemical compounds - Method 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”.
2.3.3 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 use and 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 use and 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.
2.4 CEN Approach on addressing environmental issues in product and service standards
2.4.1 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.
2.4.2 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 use and 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.
3 Basics of Chemical Safety Assessment (CSA)
3.1 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 restrictions for
different types of child use and 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 may 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
have to be minimised 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 use and care articles in particular.
3.2 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.
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.
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.
3.3 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. No definition is given for the
interpretation of such contact. An appropriate time of contact depends on the chemical substance and needs
to be determined on a case-by-case basis.
3.4 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 also needs to consider risks from combined exposures via different routes or via different sources.
This may be the case where the same person is potentially exposed to the same substance via different
routes of entry into the body.
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
...