SIST-TP CEN/TR 13387-2:2018
(Main)Child use and care articles - General safety guidelines - Part 2: Chemical hazards
Child use and care articles - General safety guidelines - Part 2: Chemical hazards
This document provides guidance information on chemical hazards that should be 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.
Artikel für Säuglinge und Kleinkinder - Allgemeine Sicherheitsrichtlinien - Teil 2: Chemische Gefahren
Dieses Dokument stellt anleitende Informationen zu chemischen Gefährdungen bereit, die bei der Erarbeitung von Sicherheitsnormen für Artikel für Säuglinge und Kleinkinder berücksichtigt werden sollten. Außerdem können diese Leitlinien für Personen mit allgemeinem beruflichem Interesse an der Sicherheit von Säuglingen und Kleinkindern nützlich sein.
Articles de puériculture - Conseils relatifs à la sécurité - Partie 2 : Dangers chimiques
Le présent Rapport technique fournit des informations de recommandation concernant les dangers chimiques qu’il convient de prendre en considération lors de l’élaboration de normes de sécurité relatives aux articles de puériculture. De plus, le présent guide peut faciliter la tâche des personnes portant un intérêt professionnel général à la sécurité des enfants.
Izdelki za otroke - Smernice o splošni varnosti - 2. del: Nevarnosti zaradi kemijskih lastnosti
Ta dokument podaja smernice o kemičnih nevarnostih, ki bi jih bilo treba upoštevati pri razvoju varnostnih standardov za uporabo izdelkov za otroke. Poleg tega lahko te smernice pomagajo ljudem s splošnim strokovnim interesom za varnost otrok.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2018
1DGRPHãþD
SIST-TP CEN/TR 13387-2:2015
Izdelki za otroke - Smernice o splošni varnosti - 2. del: Nevarnosti zaradi kemijskih
lastnosti
Child use and care articles - General safety guidelines - Part 2: Chemical hazards
Artikel für Säuglinge und Kleinkinder - Allgemeine Sicherheitsrichtlinien - Teil 2:
Chemische Gefahren
Articles de puériculture - Conseils relatifs à la sécurité - Partie 2 : Dangers chimiques
Ta slovenski standard je istoveten z: CEN/TR 13387-2:2018
ICS:
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TR 13387-2
TECHNICAL REPORT
RAPPORT TECHNIQUE
July 2018
TECHNISCHER BERICHT
ICS 97.190 Supersedes CEN/TR 13387-2:2015
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 Technical Report was approved by CEN on 16 March 2018. 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 13387-2:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Regulatory, normative and policy background . 6
4.1 General . 6
4.2 REACH - Short summary . 7
4.2.1 Registration . 7
4.2.2 Authorization . 7
4.2.3 Restrictions . 7
4.2.4 Articles . 7
4.2.5 Recommendations . 8
4.3 Toy Safety Directive and related standards . 8
4.3.1 Short summary of Toy Safety Directive . 8
4.3.2 Toy standards . 9
4.3.3 Recommendations . 10
4.4 CEN Approach on addressing environmental issues in product and service standards . 11
4.4.1 Short summary . 11
4.4.2 Recommendations . 11
5 Basics of Chemical Safety Assessment (CSA) . 11
5.1 General . 11
5.2 Hazard assessment . 12
5.3 Exposure assessment . 14
5.4 Risk characterization . 14
5.5 Example – PAHs. 15
5.6 Example – Migration limit values in Toy Safety Directive . 15
5.7 Recommendations . 16
6 Child care articles specific approaches . 16
6.1 General aspects . 16
6.2 Substances of Very High Concern (SVHC) . 17
6.3 CMR substances . 17
6.4 Certain elements . 17
6.4.1 Regulatory and normative background . 17
6.4.2 Specific child care articles considerations . 18
6.5 Flame retardants . 18
6.5.1 Regulatory and normative background . 18
6.5.2 Specific child care articles considerations . 19
6.6 Colourants . 19
6.6.1 Regulatory and normative background . 19
6.6.2 Specific child care articles considerations . 20
6.7 Primary aromatic amines . 21
6.7.1 Regulatory and normative background . 21
6.7.2 Specific child care articles considerations . 21
6.8 Monomers . 22
6.8.1 Regulatory and normative background . 22
6.8.2 Specific child care articles considerations . 22
6.9 Solvents (migration) . 22
6.9.1 Regulatory and normative background . 22
6.9.2 Specific child care articles considerations . 23
6.10 Solvents (inhalation) . 23
6.10.1 Regulatory and normative background . 23
6.10.2 Specific child care articles considerations . 24
6.11 Plasticizers . 24
6.11.1 Regulatory and normative background . 24
6.11.2 Specific child care articles considerations . 25
6.12 Sensitizers – Fragrances . 25
6.12.1 Regulatory and normative background . 25
6.12.2 Specific child care articles considerations . 28
6.13 N-Nitrosamines and N-Nitrosatable substances . 28
6.13.1 Regulatory and normative background . 28
6.13.2 Specific child care articles considerations . 28
6.14 Other – Formaldehyde (other than monomer or preservative) . 29
6.14.1 Regulatory and normative background . 29
6.14.2 Specific child care articles considerations . 29
A.1 Organostannic compounds . 30
A.2 Cadmium . 30
A.3 Nickel. 30
A.4 Chromium VI. 30
A.5 Lead . 31
A.6 Flame retardants . 31
A.7 Colourants . 31
A.8 Wood preservatives . 31
A.9 Preservatives (other than wood preservatives) . 32
A.10 Plasticizers . 32
A.11 N-Nitrosamines and N-Nitrosatable substances . 32
A.12 Policyclic Aromatic Hydrocarbons (PAHs) . 32
A.13 Alkylphenolethoxylates (APEOs) . 33
A.14 Perfluorinated Compounds . 33
A.15 Persistent Organic Pollutants (POPs) . 33
A.16 Food contact materials . 34
A.17 Packaging . 34
B.1 Introduction. 35
B.2 General chemical requirements . 35
B.3 Substances of Very High Concern (SVHC) . 35
B.4 CMR substances . 35
B.5 Certain elements . 35
B.6 Flame retardants . 36
B.7 Colorants . 37
B.8 Aniline . 38
B.9 Monomers . 38
B.10 Solvents (migration) . 38
B.11 Solvents (inhalation) . 39
B.12 Plasticizers . 40
B.13 Sensitizers – Fragrances . 40
B.14 N-Nitrosamines and N-Nitrosatable substances . 43
B.15 Formaldehyde (other than monomer or preservative) . 43
Bibliography . 44
European foreword
This document (CEN/TR 13387-2:2018) has been prepared by Technical Committee CEN/TC 252 “Child
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 shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TR 13387-2:2015.
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/TR 13387 series 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 is intended to be used in conjunction with CEN/TR 13387-1.
1 Scope
This document provides guidance information on chemical hazards that should be 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
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://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. If applicable to their type of product or material used, these
provisions shall 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 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.
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.
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), the supplier shall 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.
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.
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 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.
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+A1:2014, 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 harmonised 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”.
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 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 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 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.
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-
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