Guidance on information requirements and chemical safety assessment : chapter R.15 : consumer exposure assessment.
Date: 2016-10-28
Institutions: European Chemicals Agency
Subjects: chemical industry, chemical product, consumer protection, dangerous substance, environmental risk prevention, evaluation method, user guide

Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

1 

G U I D A N C E 

Guidance on Information Requirements 
and Chemical Safety Assessment 

Chapter R.15: Consumer exposure 
assessment 

Version 3.0 
July 2016 

 
 
 
 
 
 
 
 
 
 
2  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

LEGAL NOTE 

This  document  aims  to  assist  users  in  complying  with  their  obligations  under  the  REACH 
Regulation.  However,  users  are  reminded  that  the  text  of  the  REACH  Regulation  is  the  only 
authentic  legal  reference  and  that  the  information  in  this  document  does  not  constitute  legal 
advice.  Usage  of  the  information  remains  under  the  sole  responsibility  of  the  user.  The 
European  Chemicals  Agency  does  not  accept  any  liability  with  regard  to  the  use  that  may  be 
made of the information contained in this document. 

Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 

Reference:   
Cat. Number:  
ISBN:  
DOI:   
Publ.date:    
Language:    

ECHA-16-G-07-EN 
ED-01-16-446-EN-N 
978-92-9495-079-6 
10.2823/940476 
July 2016 
EN 

© European Chemicals Agency, 2016 

If you have questions or comments in relation to this document please send them (indicating 
the document reference, issue date, chapter and/or page of the document to which your 
comment refers) using the Guidance feedback form. The feedback form can be accessed via 
the ECHA Guidance website or directly via the following link: 
https://comments.echa.europa.eu/comments_cms/FeedbackGuidance.aspx 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Annankatu 18, Helsinki, Finland 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

3 

Preface 

This document describes the information requirements under the REACH Regulation with 
regard to substance properties, exposure, use and risk management measures, and the 
chemical safety assessment. It is part of a series of guidance documents that are aimed to 
help all stakeholders with their preparation for fulfilling their obligations under the REACH 
Regulation. These documents cover detailed guidance for a range of essential REACH 
processes as well as for some specific scientific and/or technical methods that industry or 
authorities need to make use of under the REACH Regulation. 

The original versions of the guidance documents were drafted and discussed within the REACH 
Implementation Projects (RIPs) led by the European Commission services, involving 
stakeholders from Member States, industry and non-governmental organisations. After 
acceptance by the Member States competent authorities the guidance documents had been 
handed over to ECHA for publication and further maintenance. Any updates of the guidance 
are drafted by ECHA and are then subject to a consultation procedure, involving stakeholders 
from Member States, industry and non-governmental organisations. For details of the 
consultation procedure, please see: 

http://echa.europa.eu/documents/10162/13559/mb_63_2013_consultation_procedure_for_gui 
dance_revision_2_en.pdf 

The guidance documents can be obtained via the website of the European Chemicals Agency 
at: 

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach 

This document relates to the REACH Regulation (EC) No 1907/2006 of the European  
Parliament and of the Council of 18 December 20061. 

1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals 
Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p.1; corrected by OJ L 136, 29.5.2007, p.3). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

Document History 

Version 

Comment 

Version 1 

First edition 

Version 
1.1 

Footnotes added 

Date 

May 2008 

July 2008 

Version 2 

The information on exposure models in Part D of IR&CSA 
was integrated into Chapter 15.4. 

April 2010 

Version 2 

Chapter  R.15.4  on  the  ECETOC  TRA  consumer  tool  for 
exposure  estimation  at  Tier  1  was  subjected  to  a  major 
revision and update, with the inclusion of a new version 
of the ECETOC TRA consumer model. 

April 2010 

Version 2 

The  order  of  chapters  on  i)  the  agreed  standard 
algorithms 
for  calculation  of  consumer  exposure 
(presently R.15.3) and ii) on the ECETOC TRA consumer 
tool  for  exposure  estimation  at  tier  1  (R.15.4)  was 
switched. 

April 2010 

Version 2 

All presentations on higher tiers were moved into  a 
single chapter R.15.6 and an additional Appendix R.15-4 

April 2010 

Version 2 

A  new  chapter  R.15.6  on  risk  characterisation  was 
introduced  and  all  relevant  texts  from  other  parts  were 
moved into it. 

April 2010 

Version 2 

The introduction was updated 

April 2010 

Version 2 

The  chapter  on  RMMs 
(earlier  R.15.3.2.1)  was 
shortened,  moved  to  Chapter  R.15.2.7  and  information 
which duplicated that in R.13 was deleted. 

April 2010 

Version 2 

A  new  Appendix  R.15-1  on  consumer  mixture  and  article 
categories that can be assessed with the ECETOC TRA was 
introduced 

April 2010 

Version 2 

Text on JRC GExFRAME model and EIS-Chemrisks-toolbox 
in Chapter R.15.5.3 and Appendix R.15.3, including  Table 

April 2010 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

5 

Version 

Comment 

Date 

R.15-7, was updated. 

Version 2 

The  default  units  for  the  algorithms  in  R.15.3  were 
updated  to  be  consistent  with  other  guidance  (Chapter 
R.8) and modelling tools. 

April 2010 

Version 2 

Further minor technical and language corrections 

April 2010 

Version 
2.1 

Version 
3.0 

Corrigendum to: 

(i)  replace references to the DSD/DPD by references to 
CLP; 

implement 

(ii) 
nanomaterials arising from RIP-oN3; 

minor 

recommendations 

concerning 

October 
2012 

(iii)  make further minor editorial changes/corrections. 

  The  description  of 

the  workflow  has  been 

July 2016 

streamlined 

  New  specification  of  how to deal   with  infrequent 

uses has been introduced 

  Have removed “migration from article” as a tier 1 

algorithm for dermal exposure 

  Have updated the information on modelling tools 
the 
  Have  harmonized 

text  with  the  updated 

Chapter  R.12  of the IR & CSA Guidance 

  Have integrated relevant parts from Chapter R.17 

(to be obsoleted) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

Notes on the updates 

Most of the changes in the current update provide additional tools and parameters to support 
consumer exposure assessment and exposure scenario building under REACH, or are of an 
explanatory or an editorial nature. 

A registrant having already finalised the consumer exposure estimation based on Chapter R.15 
as published in April 2010 may therefore wish to take the following advice into account: 

  Carefully read the document history to be informed on what has been updated; 
  Check whether the changes in the guidance put into question: 

o 
o 

the scope of the exposure assessment and scenarios already worked out, and 
the outcome of the risk characterisation related to these exposure scenarios. 

If the conclusion of the check is that neither is put into question, it is unlikely that the 
adaptation of the already existing Chemical Safety Report to this guidance update (version 2.1 
to version 3.0) is of high priority. In this respect, it should be highlighted that previous version 
of the Tier I ECETOC TRA consumer tool (version 2, as described in the R15 Guidance, April 
2010) is more conservative than the new ones developed more recently (Version 3.0 and 3.1, 
see Section R.15.4). Therefore an assessment carried out with version 2 of the TRA consumer 
tool without further refinement can still be considered valid. 

This updated guidance (version 3.0) describes how to deal with infrequent uses, in this respect 
existing assessments based on averaging out the event exposure from infrequent events over 
a longer period of time may need revision. 

 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

7 

Convention for citing the REACH regulation 

Where the REACH regulation is cited literally, this is indicated by text in italics between quotes. 

Table of Terms and Abbreviations 

See Chapter R.20 

Pathfinder 

The figure below indicates the location of chapter R.15 within the Guidance Document 
structure. 

No 

Article 14(4) 
criteria? 

Yes 

R15 

Yes 

Risk 
controlled? 

No 

Iteration 

No 

Use advised 
against? 

Yes 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
8  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

Table of Contents 

G U I D A N C E ...................................................................................................... 1 

R.15.  CONSUMER EXPOSURE ASSESSMENT ....................................................... 10 

R.15.1.  INTRODUCTION ........................................................................................... 10 

R.15.1.1.  Aim ........................................................................................................ 10 
R.15.1.2.  Introduction to consumer exposure assessment ........................................... 10 
R.15.1.3.  Workflow for consumer exposure assessment .............................................. 12 

R.15.2.  GENERAL EXPOSURE CONSIDERATIONS RELATED TO CONSUMERS ........ 15 

R.15.2.1.  Routes of exposure ................................................................................... 15 

R.15.2.1.1  Inhalation exposure......................................................................................... 15 
R.15.2.1.2  Dermal exposure ............................................................................................ 15 
R.15.2.1.3  Oral exposure ................................................................................................. 15 
R.15.2.1.4  Other routes of exposure ................................................................................. 16 

R.15.2.2.  Phases of activity, including post-application ............................................... 16 
R.15.2.3.  Frequency of use and duration of exposure .................................................. 17 
R.15.2.4.  Operational conditions and risk management ............................................... 22 
R.15.2.5.  Habits and practices of children.................................................................. 24 
R.15.2.6.  Specific Consumer Exposure Determinants SCEDs ........................................ 25 

R.15.3.  CALCULATION OF EXPOSURE ................................................................ 26 

R.15.3.1.  Inhalation exposure .................................................................................. 28 
R.15.3.2.  Dermal exposure ...................................................................................... 29 

Dermal scenario A: Instant application of a substance contained in a mixture ......................... 29 
Dermal scenario B: a substance migrating from an article .................................................... 32 

R.15.3.3.  Oral Exposure .......................................................................................... 32 

Oral scenario A: exposure of a substance in a product during normal use ............................... 33 
Oral scenario B: exposure of a substance in an article during normal use ............................... 34 

R.15.3.4.  Exposure to non-volatile substances ........................................................... 35 

R.15.4.  THE ECETOC TRA CONSUMER TOOL FOR EXPOSURE ESTIMATION ........... 36 

R.15.4.1.  Consumer Product and Article Categories .................................................... 36 
R.15.4.2.  Input and output parameters ..................................................................... 37 
R.15.4.3.  Default values ......................................................................................... 40 

R.15.5.  ADVANCED REFINEMENTS, HIGHER TIER MODELS AND MEASUREMENTS40 

R.15.5.1.  ConsExpo ....................................................................................................... 41 
R.15.5.2.  Other tools .............................................................................................. 43 

R.15.5.2.1  Substances in articles ...................................................................................... 44 

R.15.5.3.  Overview of the consumer estimation tools .................................................. 44 
R.15.5.4.  Measurements ................................................................................................ 47 

R.15.6.  RISK CHARACTERISATION .................................................................... 48 

REFERENCES ....................................................................................................... 50 

APPENDIX R.15.1 CONSUMER PRODUCT AND ARTICLE CATEGORIES .................. 52 

APPENDIX R.15.2 VALUABLE SOURCES ON EXPOSURE DATA .............................. 57 

Main EU consumer exposure databases ..................................................................... 57 

APPENDIX  R.15.3  COMPUTER  TOOLS  FOR  ESTIMATION  OF  CONSUMER  EXPOSURE 

 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

9 

..................................................................................................................... 62 

APPENDIX  R.15.4  DEVELOPMENT  OF  ECETOC  TRA  CONSUMER  TOOL . AND 

COMPARISON WITH TIER 1 ALGORITHMS 

 ......... 67 

APPENDIX R.15.5 DEMONSTRATION OF CONTROL OF RISKS FOR ARTICLES ...... 70 

APPENDIX  R.15.6  FURTHER  INFORMATION  ON  ASSESSMENT  OF  CHILDREN’S 

EXPOSURE 

 ......... 73 

Table of Tables 

Table R.15- 1: Default scenarios on duration and frequency for consumer exposure assessment . 18 

Table R.15- 2: Explanation of symbols for inhalation exposure ..................................................28 

Table R.15- 3: Explanation of symbols for dermal scenario A ....................................................30 

Table R.15- 4:  Explanation of symbols for oral scenario A .......................................................33 

Table R.15- 5: Vapour pressure bands ...................................................................................38 

Table R.15- 6: Overview of the consumer exposure estimation tools ..........................................45 

Table R.15- 7: Consumer products addressed in the consumer TRA ...........................................52 

Table R.15- 8: Article Categories addressed in the consumer TRA and cross reference to Article 
categories reported in Chapter R.12 ......................................................................................54 

Table R.15- 9: Further information ........................................................................................58 

Table R.15- 10: Differences between Tier I algorithms and ECETOC TRA consumer ......................68 

Table R.15- 11: Explanation of symbols for dermal scenario B ..................................................71 

Table of Figures 

Figure R.15- 1: Workflow for the consumers’ exposure assessment ...........................................14 

 
 
 
 
 
 
 
 
 
 
10  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

R.15.  Consumer exposure assessment 

R.15.1. Introduction 

R.15.1.1. Aim 

This  document  provides  guidance  on  how  to  carry  out  consumer  exposure  assessment  in  the 
context  of  REACH.  REACH  requires,  according  to  Article  14(4),  exposure  assessment  and 
subsequent risk characterisation to be carried out for substances subject to registration, which 
are  manufactured  or  imported  in  quantities  equal  to  or  greater  than  10  tonnes/year,  and  
where the substance fulfils the criteria for any of the hazard classes or categories indicated in 
Article 14(4)2 or is assessed to be a PBT or vPvB. . 

The aim of this guidance chapter is to describe an efficient, step-wise and iterative procedure 
for consumer exposure assessment under REACH, related to substances on their own, in 
mixtures or in articles3. In this guidance, substances on their own or mixtures or articles used 
by consumers are called consumer products. 

This chapter consists of the following sections: 

 

Introduction to consumer exposure assessment (Section R.15.1.2) 

  Workflow for consumer exposure assessment (Section R.15.1.3) 

  General principles related to assessment of  consumer exposure (Section R.15.2) 

  Calculation of consumer exposure at Tier 1 level (Section R.15.3) 

  Tools for supporting exposure scenario building at Tier 1 level (Section R.15.4) 

  Higher tier models and measured data (Section R.15.5), 

  Risk characterisation (Section R.15.6), 

  Overview on information sources and available tools (Section R.15.5 and Appendix 

R.15.2, Appendix R.15.3 and Appendix R.15.4) 

This guidance does not address prevention of accidents for drinking of oxidising, very corrosive 
products or poisonous products. 

R.15.1.2. Introduction to consumer exposure assessment 

The consumer, i.e. a member of the general public who may be of any age, either sex, and in 
any state of health, may be exposed to a substance by using consumer products, or by being 
present when others (e.g. professionals) are using products. A consumer product (substance, 
mixture or article) is a product that can be purchased from retail outlets by members of the 
general public. This includes also chemicals and materials for construction works or car 

2  These are: 

  hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 

1 and 2, 2.15 types A to F 

  hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other 

than narcotic effects, 3.9 and 3.10 

  hazard class 4.1 
  hazard class 5.1 

3 Article 3(3) of REACH provides that “article: means an object which during production is given a special shape, 
surface or design which determines its function to a greater degree than does its chemical composition” 

 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

11 

maintenance sold to both professionals and consumers (do it yourself products). The 
manufacturer/importer (M/I) of substances being part of do-it-yourself products sold at 
retailers should also ascertain that consumer use has been assessed and safe consumer use 
can be assured. 

For consumer exposure assessment under REACH, the addressee of exposure scenarios is the 
formulator of the mixture or the producer of the article sold to the consumers. The means of 
controlling the exposure from consumer products are very limited and cannot normally be 
monitored, or enforced, beyond the point of sale of the products. 

The M/I of substances may initially use a broad or general (conservative) exposure scenario, 
and he may, as a result, be unable to demonstrate control of risk at a generic, conservative 
level. The producer of the mixture or the article may have specific information related to the 
formulation and end use of his product. By making this knowledge available to registrants (e.g. 
in the form of Specific Consumer Exposure Determinants (SCEDs)), downstream user (DU) 
sectors can support registrants in developing more realistic exposure scenarios. Consumers 
may be directly exposed to substances from the products they use, for example solvents in 
adhesives or dyes/finishing chemicals in textiles. Additionally, exposure should be considered 
that does not result from uses by the consumer him/herself but from uses by other actors in 
the public domain, for example: 

  exposure to substances at home after use of decorating or cleaning products by 

professionals; 

  exposure to substances in indoor air (residential air: e.g. household, schools, 

nurseries); 

  exposure to substances in public areas (e.g. swimming pools, recreational areas). 

In REACH guidance, indirect exposure of humans via the environment is defined as the 
exposure of humans via consumption of food, drinking water and inhalation of air which in turn 
are directly influenced by the releases of the substance into the environmental compartments 
air, water and soil. Indirect exposure is not included in consumer exposure assessment in 
REACH. However, it should be reported in the ‘man via the environment’ section in the 
chemical safety report and is further detailed in Chapter R.16 of the IR&CSA Guidance. 

Consumer exposure levels may need to be estimated for long-term (repeated or continuous) 
exposure, and/or for acute/short term exposure (single event, peak exposure), depending on 
the properties of the substance and the nature of the use (see also Section R.15.2.3). 

The way in which consumers are exposed to substances can generally be characterised by: 

 
 

 

the different routes of exposure, separately or in combination; 
the identification of the different phases of activity in handling the consumer product or 
article; 
the duration and frequency of exposure. 

The consumer exposure estimation should normally address the intended uses of the products 
that contain the substances under investigation. However, since consumers may not accurately 
follow instructions for use of products, the exposure estimation should cover the reasonably 
foreseeable uses or use conditions. For example, consumers may over-dose (e.g. by increasing 
the amount of dishwasher detergent in relation to the doses recommended on the product), 
fail to take recommended actions that are designed to minimize the potential for contamination 
(e.g. they may leave containers open after having used the product which can give rise to 
potential inhalation exposure to substances) or use the product for other foreseeable uses 
(e.g. dishwashing product used to wash hands).  Consideration of deliberate abuse is not part 
of the exposure assessment process under REACH. 

If a substance is used in a consumer product type that has different ways of application (e.g. 
brush painting and spray painting) two options exist: 

 
 
 
12  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

  define one contributing scenario covering both types of application: all conditions of use 

are the same and highest exposure estimate is carried forward to risk characterisation. 

  define two contributing scenarios addressing the differences in the conditions of use and 

generate corresponding exposure estimates for both. 

Exposure scenarios can be developed for each use if the operational conditions and risk 
management measures are different between these uses; alternatively, the exposure 
estimation for the two different consumer uses can be used to establish the highest exposure, 
and use this as the worst-case situation to be covered in the exposure scenario. A pre- 
requisite for combining uses is that the recommended operational conditions and RMMs can 
ensure control of risks for all these uses; If the same substance (for a single registration) 
occurs in different consumer products that could reasonably be expected to be used jointly and 
frequently by an average consumer, the risk from aggregated exposure across these products 
should be considered, (see Section R.15.6). 

Certain sub-populations may be exposed differently from others. If, for instance, exposure of 
young children is anticipated, their crawling behaviour and hand to mouth contact may bring 
them into contact with residues of products on the floor. In addition, the children’s small ratio 
of body weight to surface area, compared to that of adults, will have an effect on the exposure 
estimates. Therefore, it has to be ensured that exposure scenarios chosen take into 
consideration exposure routes for the identified relevant consumer sub-populations, and the 
corresponding values for exposure determinants such as body weight and skin surface area 
should then be used in the estimation. Several tools and information sources are available for 
this (see Section R.15.4, Appendix R.15.2 and Appendix R.15.3). 

R.15.1.3. Workflow for consumer exposure assessment 

Chemical safety assessment for consumers usually includes the steps outlined below. Note: 
The first two steps relate to hazard assessment and are not further explained in the current 
guidance. However, they are included in the workflow as the hazard assessment determines 
the scope of the exposure assessment and provides the references for the risk 
characterisation. 

  Collect or generate information on the intrinsic properties of the substance (See Part B and 
Chapters R7a and R.8 of the IR&CSA Guidance) and take into account use patterns and 
routes of exposure. This includes: 

o 

toxicological endpoints (e.g. irritation or corrosion, sensitisation, acute and repeated 
dose systemic toxicity, genetic toxicity, carcinogenicity, reproductive toxicity); 

o  endpoints regarding physicochemical properties (e.g. vapour pressure, water 

solubility). 

  Determine the type and the extent of hazards by comparing with classification and labelling 
criteria and by determining derived no-effect levels” (DNELs)4 or derived minimal effect 
levels (DMELs) for all relevant exposure routes; differently from hazard assessment for 
workers, this also includes a DNEL for systemic effects via the oral route. Determine the 
leading hazard for each exposure route.  The conclusions at this step determine i) whether 
a substance should/must not be introduced to consumer uses at all (e.g. CMRs and acutely 

4 A DNEL represents the level of exposure above which humans should not be exposed. DNELs are derived for 
substances based on: Population (workers, consumers and the general population), route (inhalation, dermal and 
ingestion exposure)  and duration (acute and long-term exposure) 

 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

13 

toxic substances) and ii) which hazards are to be addressed in the exposure assessment. 

  Determine the scope of exposure assessment based on the outcome of the hazard 

assessment and the physicochemical properties of the substance: 

o  Determine whether serious local effects on skin and eyes may occur (e.g. due to 
irritation, corrosion or sensitisation) and therefore need to be addressed in the 
exposure assessment. 

o  Determine routes and types of effects for which exposure quantification is required 
(i.e. where a DNEL can be derived based on effects seen in the corresponding 
study(ies). If systemic effects are observed, usually DNELs and corresponding 
exposure estimates for all three routes would be required. 

  Build an exposure control strategy, taking into account that control of consumer exposure 
should largely be based on the design of the product itself (e.g. concentration limits, 
packaging avoiding overdosing; viscosity avoiding splashes). It is assumed that the number 
of consumers following behavioural advice or instructions (including correct use of personal 
protective equipment) is relatively low, and thus these measures are not sufficiently 
effective to control the risks to consumers. Special attention is needed for products where a 
single exposure to eyes and skin may cause serious effects. If the registrant nevertheless 
intends to support such consumer uses in his assessment, he needs to demonstrate that 
there is a negligible likelihood that such effects occur when used by consumers. 

  Build/retrieve contributing scenarios for the product types (mixtures and articles) expected 
to contain the substance. Retrieve realistic information on the conditions of use from use 
maps and exposure assessment inputs (e.g. (SCEDs), see Section R.15.2.6) if available 
from DU sector organisations or single representative customers (i.e. formulators or article 
producers); make use of published exposure studies and surveys on consumer habits and 
practices; ensure that the exposure scenarios sufficiently address local effects such as skin 
sensitisation, corrosion and irritation, if relevant. Consider whether habits and practices of 
adult-consumers may differ from the behaviour of child consumers and define the 
contributing scenarios accordingly. 

  Derive exposure estimates for all contributing scenarios (i.e. product (sub) categories) 

where needed to support the risk characterisation. 

o  Derive exposure estimate for one use event starting with a Tier 1 model, and for 

risk characterisation compare with the DNELs for repeated or continuous exposure 
(long-term DNEL). If the risk characterisation ratio is < 1, the use can be 
considered safe, independently of any considerations on frequency over a year or 
over a day. 
If the risk characterisation is > 1, refine the exposure estimate (either option 
possible) 

o 

  Refine exposure determinants to that given use (e.g. concentration, 

frequency, duration) for instance with the product-use information contained 
within the sector’s SCEDs (if available). With regard to the frequency of use, 
there may be cases where the product is known to be used infrequently only 
and so the assessment may be further refined based on frequency of use 
(see boundaries and additional information in section R15.2.5). 

  Refine the event exposure estimate with higher tier models or measured 

data. If the risk characterisation ratio is < 1, the use can be considered safe. 

  Consider whether risks from combined exposure are to be addressed: 

o  Risks via different routes of exposure are to be taken into account by summing the 

individual risk characterisation ratios under each contributing scenario 

o  Risks resulting from exposure to the substance via simultaneous use of different 
products should, where relevant, also be taken into account through summing of 
risk characterisation ratios across exposure scenarios. For some general advice, 
refer to SectionR.15.6. 

  Conclude whether further refinement of assessment is needed, and finalise the risk 
characterisation. Where DNELs are available the risk characterisation ratio (possibly 

 
 
 
14  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

supported by considerations on uncertainty) is sufficient. Where no DNEL is available 
(qualitative assessment), the registrant is expected to provide an argumentation as to why 
under the conditions described in the exposure scenarios it is unlikely that adverse effects 
occur on use. 

  Document the assessment (including exposure calculations) in the CSR and communicate 

conditions/measures for safe use down the supply chain to the formulators of consumer 
mixtures and the producers of consumer articles. 

The following flowchart (Figure R.15- 1) illustrates the steps described above. 

Figure R.15- 1: Workflow for the consumers’ exposure assessment 

Use maps 

Characterise the substance: 

  Hazards (Classification, 

 

DN(M)Els) 
Substance properties 
driving the exposure 

GUIDANCE R.15 

Determine  scope of exposure assessment: 

  Hazards to be addressed 
 
 

Exposure quantification needed 
Type of risk characterisation 

Build/retrieve contributing scenarios based on: 
  Habits and practices (potentially including 

frequency of use) 
  Other conditions of use 

Iterate the 
assessment 

Estimate the event exposure ; 
potentially consider adjust for shorter 
duration (over a day) and/or 
infrequent use (over a year) 

no 

yes 

Use advised 
against? 

Inform ECHA and 
Downstream users 

no 

yes 

Risk 
controlled? 

CSR and ES via ext-SDS 

Carry out risk characterisation (RC): 
Compare exposure estimate with corresponding DNEL; 
derive risk characterisation ratio 
Potentially adjust for infrequent uses 
For hazards without DNEL: justify that product design 
(and behavioural advice) prevents adverse effects. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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15 

R.15.2.  General 
consumers 

exposure 

considerations 

related 

to 

R.15.2.1. Routes of exposure 

In this chapter, the evaluation of exposure for consumers refers to external exposure. External 
exposure is characterised by the amount of a substance that is inhaled, lands on the skin or is 
ingested. The aim of this evaluation is to generate information that can be compared to DNELs, 
which are also expressed as external exposure values. Consumer exposure estimation will 
need to consider three separate exposure routes: 

inhalation exposure 

 
  dermal exposure 
  oral exposure 

R.15.2.1.1 Inhalation exposure 

Inhalation exposure may occur in the case of substances reaching the breathing zone of 
consumers. This may happen either during the actual use of the consumer product or article 
(e.g. as the result of vaporizing solutions or aerosol-forming mixtures or by use of dusty 
products) or as a result of volatilisation after the product has been used (e.g. evaporation of 
solvents from paints) or due to emissions from articles (by evaporation). Exposure by 
inhalation is expressed as the average concentration of the substance in the inhaled air, and is 
normally presented as an average concentration over a reference period of time, which will 
normally be the duration of exposure resulting from one use event (event exposure). The 
frequency of such use events or the relevance of exposure during short peaks requires more 
particular considerations (see section 15.2.3) 

Inhalation exposure is expressed in terms of external exposure, as a concentration, usually in 
mg/m3. In specific cases, other metrics could also be relevant, for instance number 
concentration and surface area concentration (i.e. n/m3 or cm2/m3) in the case of 
nanomaterials. 

R.15.2.1.2 Dermal exposure 

Dermal exposure is an estimate of the amount of substance contacting the exposed surfaces of 
the skin. It is the sum of the exposure estimates for the various parts of the exposed body 
surface. Dermal exposure can occur from splashes on the skin, from direct hand or body 
contact with the consumer product or article (e.g. jewellery, textiles, straps, belts, shoes), 
from deposition of particles or aerosols from an airborne substance on exposed skin or from 
skin contact with residues of the substance after product use (e.g. residues on clothing after 
laundering or dry cleaning). For heavy use of consumer products, the substances penetrating 
the clothing may represent an important exposure situation. The amount and concentration of 
the substance, the area of skin exposed and the duration and frequency of exposure can 
influence the actual dermal exposure to a substance. Dermal exposure is expressed in terms of 
the amount of substance per unit surface area of the skin exposed (mg/cm2) or as dose 
(mg/kg body weight/day) on skin. Please note: DNELs derived under REACH refer to the 
external dose and should already take into account absorption through the skin. If data on 
absorption are not available, 100% absorption is assumed for DNEL derivation. 

R.15.2.1.3 Oral exposure 

This refers to substances occurring in mixtures that can be ingested resulting in exposure by 
the oral route. Examples are the exposure from residues of finger paints in the hands or 
ingestion of residues from dishwashing products remaining on dishes. Exposure by the oral 
route may also occur as a consequence of migration from articles through sucking, chewing or 

 
 
 
 
 
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licking of toys, children's books, plastic articles or textiles, or by unintentional ingestion of the 
article itself or parts of the article. This is of particular relevance to children due to their hand 
to mouth and/or mouthing behaviour. 

A specific type of oral exposure for children is from the uptake of dust and soil to which release 
of substances from consumer products have absorbed, especially due to release of substances 
from articles e.g. textiles, building materials or computers, TVs. The exposure to products and 
chemicals that are rarely accessible to children should not be considered. 

Migration characteristics of the substance in the matrix, solubility and amounts typically used 
are important determinants to be considered. These parameters, together with concentration 
and contact parameters, are used to quantify the respective exposures. 

Oral exposure is expressed as the amount of substance ingested per kg body weight, and is 
normally presented as an average daily external dose (mg/kg body weight/day). 

R.15.2.1.4 Other routes of exposure 

Besides the three major routes of exposure mentioned previously, in special cases other routes 
of exposure must be considered, e.g. eyes (splashing) or in rare cases, intradermal routes. 
Intradermal exposure occurs when the integrity of the skin is disrupted by the use of consumer 
products (e.g. by earrings, piercings or tattoo inks). In these cases, the exposure is expressed 
as the total amount of the migrating substance and is normally presented as an average daily 
dose. 

R.15.2.2. Phases of activity, including post-application 

Consumer exposure can be characterised by looking at the different phases of activity in which 
the products are actually used. There are up to four phases of activity that are relevant to 
consumer exposure: 

  preparatory activity, which includes tasks like handling and dilution of solid or liquid 

concentrates; 

  application of product by the consumer, including handling of articles during their 

service life; 

  post-use or post-application leading to exposure of the user (e.g. exposure to paints, 

cleaners etc. after use). It is possible that due to chemical reaction the exposure at this 
stage may be to the substance in a different physical state, or that exposure is to a 
different substance, e.g. reaction products of the substance; 
removal/cleaning leading to exposure of the user. This includes activities such as 
emptying and cleaning equipment, stripping coatings, etc. 

 

Each phase of activity may require separate exposure estimation, given that the first phase 
reflects exposure to a concentrate, the second to a diluted solution, the third to a vapour or 
semi-dry residue and the fourth to “waste material” and different individuals may carry out 
each of the activities. If a consumer is exposed to a substance in a particular consumer 
product or article during different phases of activity including post-application phase, the 
contribution of each phase to the exposure may need be taken into account. 

In addition to this, secondary exposure may occur at any stage to people that are not engaged 
in the activities, but happen to be exposed as well (‘bystanders’). In practice however, the 
resulting exposure scenario for the different products should include some or all of these 
phases. The exposure scenario could focus on the phase with the highest risk associated with 
it, provided that the recommended operational conditions or risk management measures are 
also relevant and practicable for the other phases of activity. Additionally, it should be noted 
that very conservative assumptions (e.g. 100% substance release) could cover all the 
application phases (See Section R.15.3: Calculation of exposure). 

 
 
 
 
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R.15.2.3. Frequency of use and duration of exposure 

The large variety of consumer products corresponds to a large variety in the frequency and 
duration of use and exposure. Exposure may occur during use and sometimes it continues 
after use for a certain time. The time, in which external exposure takes place, is defined as 
exposure time or exposure duration5 and can vary from seconds to the whole day. Exposure 
events6 can occur regularly/frequently (e.g. every day) or infrequently/occasionally (only for a 
few times or short periods in a year). Thus, the product-specific time pattern of use and any 
exposure continuing after the end of the use itself need to be considered in the assessment. It 
will mostly be a distribution of consumer behaviour, and for many products the corresponding 
statistical information is not available. 

In general, consumer exposure assessment and risk characterisation should match the 
relevant exposure duration and frequency with the corresponding DNELs. 

The default approach in consumer exposure assessment is to assume that the products 
containing the substance are used on a daily basis over a lifetime, and that control of risk 
should be demonstrated for this use situation (to be described in the exposure scenario). 

The starting point for the assessment is the exposure event that results from one use event. 
All types of effects that have been identified for the substance (usually in studies with 
experimental animals) need to be addressed: 

a)  Effects occurring after a single exposure event: 

o  For acute systemic effects leading to classification and labelling, an acute systemic 
DNEL should be derived. This may in some cases also be relevant for effects not 
automatically leading to classification (such as acute neurotoxicity). For each use, a 
15 min exposure value is to be derived and compared with the acute DNEL for risk 
characterisation (see Guidance R.8). Note: This exposure value should correspond 
to the highest concentration expected during an exposure event. 

o  No threshold may be available for dermal irritation, corrosion or sensitisation. For 

these types of effects, the registrant would need to develop a qualitative 
argumentation to demonstrate under which conditions of use the risk is adequately 
controlled (see Guidance Part E). This may include for example that the 
concentration of an irritant or a corrosive substance in a mixture is below the 
classification limit for the mixture. 

b)  For effects occurring after repeated and/or continuous exposure: 

Usually for these effects, a long-term (chronic) DNEL should be available (unless no 
threshold can be derived). The long-term DNELs cover an exposure level present for 24 
hours every day over a life-time at which no effect is expected. As a conservative 
approach, the risk for a consumer exposure scenario can be characterised by comparing 
the event exposure(s)7 over a day to this DNEL, even if the total exposure duration within 

5 Exposure time/duration is the time scale for the outer exposure, which starts e.g. with a product use and ends when 
the exposure has become negligible. The end of exposure can be determined by consumer activity pattern (e.g. user 
leaves the location of exposure) or by the decrease of the exposure concentration. 

6 Exposure event (according WHO/IPCS glossary of key Exposure Assessment Terminology): “The occurrence of 
continuous contact between an agent and a target.” 

7 The term “event exposure” means the exposure level resulting from one exposure event. If more than one exposure 
event takes place per day, the total exposure in a day is to be determined for comparison with the chronic DNEL. 

 
 
 
 
 
 
 
 
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the day is clearly shorter than 24h and/or exposure does not take place every day (see 
step 1 below). 

It may however be appropriate to adjust the assessment for long-term exposure when i) 
daily exposure time is clearly shorter than 24 hours and/or ii) when the exposure occurs 
only a few times or over a short period per year. For the adjustment (see step 2 to 4), the 
registrant should be able to provide evidence that the use to be assessed indeed leads to 
such exposure pattern, taking into account all routes and sources of exposure. In this 
respect, the sector SCEDs can be helpful as they are targeted to provide additional 
information for refining the default assumptions (i.e. every day use) in specific exposure 
scenarios. Moreover, for some products it may be possible to exclude more frequent use, 
based on the technical purpose of the product. 

Such adjustment of the assessment for long-term exposure may, in particular, be relevant 
for substances or use conditions where the assessment based on the long-term DNEL for 
organ toxicity (systemic toxicity) fails to demonstrate control of risk - even after refinement 
of the event exposure estimates (e.g. modification of input values not related to duration 
and frequency, use of higher tier exposure models or measured exposure data)8. 

The rules and boundaries for adjusting the assessment based on exposure duration and/or 
frequency are explained in the following paragraph. 

In summary, five default scenarios regarding duration and frequency of exposure may be 
applied for consumer exposure assessment. Table R.15-1 provides an overview on these 
scenarios, which are then explained in the steps 1 to 5 below. 

Table R.15- 1: Default scenarios on duration and frequency for consumer exposure assessment 

Scenario 

Frequency 
Duration 

DNEL derivation 
approach 
Risk characterisation 

Remark 

Chronic 

365 d/a, 70 a 
24 h/d 

Derive long-term DNEL 
Compare event exposure to the 
long-term DNEL; 

Conservative starting point (see step 1 
below) 

Chronic 
adjusted  for 
shorter daily 
duration 

365 d/a, 70 a, 
<< 24 h/d 

Adjust long-term DNEL by 
applying modified Haber’s law.; 
For practical reasons: Divide the 
exposure concentration by the 
adjustment factor and compare 
to chronic DNEL. 

The following default adjustment factors 
(rounded) are based on exposure duration 
(calculation see step 3 below) 
 
 
 
 

up to 0.25 h/d => adjustment factor 4.5 
up to 1 h/d => adjustment factor 3 
up to 3 h/d => adjustment factor 2 
up to 8 h/d => adjustment factor 1.5 

Infrequent 

< 15 d/a 
24 h/d 

Derive DNEL for infrequent 
exposure; 
Compare event exposure to 
DNEL for infrequent exposure; 

Alternative starting point: Use the result of 
an appropriate short-term study (e.g. 28 
days) and apply appropriate AFs to derive the 
DNEL for short-term conditions (see step 4 
below). 

8 Note: The recommended workflow in Section R.15.1.3 suggests to first explore the possibilities for refining the event 
exposure estimate before basing the assessment on infrequency and/or short duration. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Scenario 

Frequency 
Duration 

DNEL derivation 
approach 
Risk characterisation 

Remark 

Infrequent 
adjusted  for 
shorter daily 
duration 

< 15 d/a 
<< 24 h/d 

In addition, adjust DNEL for 
infrequent exposure by 
applying modified Haber’s law; 
For practical reasons: Divide the 
exposure concentration by the 
adjustment factor and compare 
to DNEL for infrequent 
exposure; 

The following default adjustment factors 
(rounded) are based on exposure duration 
(calculation see step 3 below) 
 
 
 
 

up to 0.25 h/d => adjustment factor 4.5 
up to 1 h/d => adjustment factor 3 
up to 3 h/d => adjustment factor 2 
up to 8 h/d => adjustment factor 1.5 

assessment 
for acutely 
toxic 
substances 

n.a. 

Derive acute DNEL 
Compare exposure peak with 
acute DNEL (convention: take 
15 min average) 

Complementary assessment 

Approaches to adjustment of the assessment for duration and frequency of exposure 

Several tools used for consumer exposure estimations under REACH foresee the possibility of 
averaging out infrequent exposures over a year (e.g. ConsExpo) or of applying an exposure 
reduction factor of up to 100 to extrapolate from the daily exposure event to an infrequent 
exposure event (ECETOC TRA, version 3.1). It is noted that based on scientific reasoning, this 
practice is strongly discouraged in Chapter R8 of the IR&CSA Guidance9. However, for some 
types of adverse health effects it is valid to assume that the dose needed to trigger this effect 
will decrease with increasing exposure duration and vice versa. In such cases – and in line with 
Guidance R.8, the so-called “modified Haber’s Law” may be applicable (for applicability of 
Haber Law see footnote 10). 

When registrants base the safety assessment for a consumer use on infrequent use or short 
duration of exposure, the following stepwise approach is recommended. In this context, where 
applicable, the relevant procedures described in the IR/CSA Guidance R.8 for deriving a DNEL 
need to be applied. 

Step 1: Compare exposure to the long-term DNEL for daily 24 h exposure 

If the long-term DNEL has been derived in line with the provisions of Chapter R.8, and if this 
comparison already results in a Risk Characterisation Ratio < 1, the risk may be considered 
adequately controlled and no further steps are needed. 

9 “The actual daily dose is independent of the exposure frequency. This means that if for a certain scenario, worker or 
consumer exposure is for instance only for a number of days per year, the exposure value is the actual dose on the 
exposure days, and not the daily dose averaged out (and thus divided!) over the whole year.“ (IR&CSA Guidance, 
Chapter R.8  - Characterisation of dose [concentration]-response for human health, p.8) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Step 2: Determine the relevant use frequency and exposure duration for the product 

Information on exposure duration and frequency of use/exposure can be retrieved from 
published (ideally peer reviewed) surveys on habits and practices, and/or from other 
recognised data sources (e.g. ECHA, RIVM fact sheets, ECETOC, industry peer-review 
initiatives such as HERA, Nordic Council, USEPA etc.) or published literature. Other types of 
information may also be considered. For example, the function of a product may inherently 
determine that it is normally not used in routine daily activity. When available, additional 
supportive information may include aspects such as production volume, market volume, 
purchase frequency, etc. An example on how evidence for the infrequency of use of a 
consumer product can be documented is found at: 
https://www.concawe.eu/uploads/files/sced/Lubricant_liquids_with_base_oils_CONCAWE_SCE 
D_24_1_a_v1-2014-02693-01-E.pdf. 

Step 3: Adjust for shorter duration of exposure during a day 

An assessor may want to adjust the default assessment from step 1 for a shorter daily 
duration of exposure, if the daily exposure time is significantly shorter than 24 hours (i.e. 8 
h/d or less), and if time extrapolation is considered applicable based on the available 
toxicological information. This can potentially be addressed by time adjustment according to 
the “modified Haber’s Law” as referred to in Chapter R.810. Firstly, an attempt should be made 
to derive a substance specific n-value, if data allow. As a default, the n-value may be set to 3 
according to the AEGL SOP11 to extrapolate from longer duration to shorter durations. 

For example, when using modified Haber’s Law with the default exponent of 3 (i.e. in the form 
of C3 x t = const.) for a case of only 15 min exposure over a day, the chronic DNEL may be 
modified by division by a factor of 4.6 (15 min are shorter than 24 h by a factor of 96, 
therefore the original chronic DNEL may be divided by 96(1/3) or 4.6). Likewise, for 3 h 
exposure, the chronic DNEL may be modified using a factor (divisor) of 8(1/3)  or 2. 

Application of Haber’s Law usually refers to inhalation exposure. 

For practical reasons and to be consistent with the approach for worker exposure assessment, 
the adjustment should be carried out on the exposure side12 (i.e. decreasing exposure 

10 Appendix R.8-8 (pp 102/103), subsection “Modification of the dose descriptor”. If time extrapolation is considered 
valid, then the most appropriate approach is to use modified Haber’s law (Cn x t = k, where ‘C’ is the concentration, 
‘n’ is a regression coefficient, ‘t’ is the exposure time and ‘k’ is a constant). In the absence of suitable data for deriving 
n, a default value of n = 1 for extrapolating from shorter to longer exposure durations and a default value of n = 3 for 
extrapolating from longer to shorter exposure durations should be used as these values lead to the most conservative 
estimates. See also Gaylor (2000), Toxicology 149, 17-19 and Belkebir et al. (2011), Toxicology Letters 204, 148-155. 
The latter highlighted the importance of substance-specific toxicokinetic and toxicodynamic data for the discussion of 
the applicability of Haber´s law in public health risk assessment. The available data may indicate that the modified 
Haber's is only limitedly valid, or should not be applied at all. Indications are when the toxicity of a substance is 
concentration dependent or when the critical toxic endpoint differs over time (e.g. critical effect at high short 
exposures is metabolic acidosis due to overload of blood pH buffer system, whereas the critical effect after low long 
duration exposure within a day is liver damage). If such indications are present, providing insufficient confidence in 
applying the modified Haber's rule, adjustment for shorter durations should not be made. 

11     http://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf 

12 According to Chapter R.8 of the IR&CSA guidance, the modified Haber’s Law is applied to adjust the chronic DNEL to 
a shorter duration of exposure. This would potentially result in various time adjusted long-term DNELs per route, 
depending on product-specific exposure duration. On the other hand Chapter R.8 suggests as default approach to 
include one DNEL per route for long-term exposure, which is also the approach supported by IUCLID. Therefore, the 

 
 
 
 
 
 
 
 
 
 
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21 

concentration by dividing by the adjustment factors instead of increasing the DNEL by 
multiplication). See also step 5 on risk characterisation. 

If - after adjustment according to (modified) Haber’s law - the exposure concentration is found 
to lie below the long-term DNEL, the assessment may stop here with the conclusion that the 
risk is adequately controlled. Otherwise, and if the exposure can be demonstrated to be 
infrequent, proceed to step 4. 

Step 4: Adjust for lower frequency of exposure events over the year 

If exposure to the substance is limited to a few events distributed over the year or limited to a 
period of a few days in a year (infrequent use), this can best be reflected by using a DNEL 
addressing short-term exposure for comparison with the event exposure. The infrequent 
exposure adjustment should usually be limited to cases where not more than 15 days13 of 
exposure occur per year, also taking into account exposure from other uses and sources. 

A DNEL adjusted to infrequent use can be based on the results (e.g., NOAEL) of short-term 
repeated-dose toxicity studies, taking into account the complete toxicological database. By 
default, this DNEL should be derived for 24 h exposure/d. 

The most relevant study for a DNEL adjusted to infrequent exposure14 will usually be the study 
with the shortest exposure duration (greater than the expected exposure) on the most 
relevant route of exposure. In practice, this will often be a subacute study (28 days). In this 
case, the assessment factor of 6 for extrapolation from a subacute study to the long-term 
consumer DNEL can be omitted. If however other studies - e.g. of longer duration or with a 
special focus such as on pre-natal development - have shown relevant effects not covered by 
the subacute study, the study resulting in the lowest DNEL should be selected. 

If the event exposure is found to lie below the DNEL derived in this way (i.e. reflecting 
infrequent exposure), the assessment may stop here with the conclusion that risk is controlled. 
If that conclusion can still not be reached, adjust the exposure to a short duration over a day, 
if appropriate (see step 3). 

Step 5: Risk characterisation 

Depending on the expected exposure pattern, the event exposure is compared to the long- 
term DNEL (see step 1) or to the DNEL for infrequent exposure (see step 4). 

Where adjustments have been made for shorter daily duration, an adjusted exposure value is 
compared to the long-term DNEL (see step 3) or to the DNEL for infrequent exposure (see step 
4). 

adjustment should be made on the exposure side, as the outcome in terms of risk characterisation is the same 
anyway. 

13  The indicative benchmark of 15 days is based on the following considerations: 28 days (duration of a repeated dose 
study) correspond to 4% in the life of an experimental animal (about 2 years). Applying 4% to 70 years (average 
human lifetime), the resulting overall number of exposure days is 1022, which corresponds to 15 days per year. 

14  At the time of writing the current guidance, such a DNEL cannot yet be reported in IUCLID. However, it is foreseen 
to enable such a possibility with the next IUCLID update. 

 
 
 
 
 
 
 
 
 
 
 
 
 
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For acutely toxic substances, also a 15 min inhalation peak exposure value is compared to the 
acute DNEL. 

Step 6: Document the reasons and arguments 

The relevant DNELs should be documented in Chapter 5 of the CSR. Also, when adjusting the 
daily exposure according to (modified) Haber’s law the applicability of time adjustment needs 
to be confirmed (absence of substance characteristics outside the domain, such as a 
concentration driven effect). When substance specific adjustment factors are derived in order 
to deviate from the default exponent used in (modified) Haber’s law, the corresponding study 
data need to be part of the registration dossier and referred to in Chapter 5 of the CSR. 

When adjusting the assessment to infrequent use, the registrant should provide the evidence 
for the infrequency of the use/exposure in the CSR (e.g. based on a survey on habits and 
practices). In addition, the infrequency is to be included as a condition of use into the exposure 
scenario for the CSR (see chapter 9 of the CSR), and communicated (with the extended safety 
data sheet) to the producers of the consumer product, as it may impact on product design or 
product use instructions. 

The risk characterisation for a substance should include consideration on the uncertainties in 
the assessment. Regarding the short exposure duration during a day and/or infrequency of a 
specific use (product), the time pattern of all uses addressed in the CSR is to be reflected. 

R.15.2.4. Operational conditions and risk management 

General information on the use of a substance in consumer products or articles is needed to 
identify the contributing scenarios to be assessed and the relevant exposure pathways. The 
brief general description of consumer uses should follow Chapter R.12 of the IR&CSA 
Guidance. 

Direct exposure from product use will often be the main source of consumer exposure to a 
chemical present in that product. Characterisation of the direct consumer exposure requires 
knowledge of the nature of the products used and of the circumstances of their intended and 
reasonably foreseeable uses. A reasonably foreseeable use is in this respect is e.g. the use of 
dishwashing liquid for handwashing, but not using wall-paint as body paint. 

The conditions of use described in the exposure scenario have to reflect the driving parameters 
of the exposure estimation and its algorithm. Preferably, they should be derived from 
published surveys on consumer habits and practices. Consumer exposure is related to the 
amount of substances in consumer products or articles. Therefore, the amount of the products 
used per event, the quantity of chemical in the product and the frequency and duration of the 
event are essential information needed to estimate consumer exposure. For the assessment, 
conditions of use reflecting the high end of the exposure distribution should be assumed. In 
particular: 

-  The duration of exposure for consumers should either be estimated as 24 hours per day 

as a worst case or by estimating the duration of the specific activities leading to 
exposure (e.g. cleaning of floor or manual dishwashing). For consumer products, and 
especially in indoor situations, the duration of use is not the same as duration of 
exposure (e.g. in the case of painting). In the exposure estimation, it should be taken 
into account that exposure to a substance may also occur after application. 

-  The applied amount of chemical is found by multiplying the handled weight of the 

product with the weight fraction of the substance in the mixture. For using a mixture 
after dilution (e.g. detergent concentrate), the handled weight of the diluted mixture is 
multiplied with the weight fraction in the diluted mixture. The realistic maximum 
amount of chemical in use by consumers varies not only between consumer products 
but also between individuals. For certain types of products it should be assumed that 

 
 
 
 
 
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23 

some consumers use more than the recommended amount, because they expect a 
better product performance. In these cases, individually packed amounts (e.g. tablets 
or separate sachets) will ensure a constant / uniform use amount. 

-  For articles, a possible way to control the risk might be to derive specific concentration 

limits (mg/kg article material) for oral exposure [1] based on the DNEL. By re- 
arranging the Tier 1 equations for oral exposure (see Section R 15.3), it would be 
possible to calculate a content limit for the article, assuming the entire article is 
swallowed, and the substance is completely released (mostly applicable to small articles 
easily swallowed). If such a concentration limit is respected in article production, the 
safe use can be ensured even under the worst case situation. While an exposure 
assessment has to be performed, and the exposure estimate compared with a DNEL to 
demonstrate safe use, this simple method might guide the registrant to set appropriate 
concentration limits in the article in the absence of more specific information from the 
downstream users. 

-  The size of the receiving compartments, normally a room in a flat or a house represents 

one of the most important parameters for the exposure assessment. This descriptor of 
exposure is needed for tier 1 assessments. Also, a standard ventilation rate for rooms 
with closed doors and windows can be considered in the exposure algorithms. 

The exposure routes are related to the type of use and to substance properties. For example, 
inhalation may play a role for volatile substances but also for dust-forming conditions of use or 
conditions promoting mobility of a substance as such, in mixtures or in articles. Substances of 
low volatility can be released by mechanical abrasion (rubbing off), via leaching (e.g. during 
mouthing) or by migration (e.g. due to elevated temperatures or interaction between the 
substance and polymer-matrix) with subsequent release. The Tier 1 calculations for the 
different exposure routes are given in Section R.15.3. 

Effective risk management measures for consumers are usually product-integrated measures. 
For quantitative exposure estimation, only those RMMs which can be controlled by the 
manufacturer of the product should be considered. This means that RMMs may be 
implemented by changing operational conditions or product composition, e.g.: maximum 
concentration used in the product, change of the product form (e.g., pellets or granules 
instead of powder or increasing the viscosity of a product containing a corrosive substance to 
minimise splashes), maximum amount of product used (package size), and type of packaging 
– many dishwasher tablets are now sold encased as gel capsules. 

The use of consumer instructions as RMMs cannot be expected to be highly effective, unless 
consumer behavioural data provide evidence that a sufficient degree of compliance can be 
assumed. The adherence to instructions is fundamentally different for consumers by 
comparison to that in occupational settings where the employer has the duty to ensure good 
operational conditions and use of RMMs. For example, an RMM like “open windows to ensure 
good ventilation” may be a useful advice to consumers but “good ventilation” should not be 
assumed when estimating the exposure. Increasing ventilation rates above default is not 
always a suitable option to iterate an exposure scenario for consumer uses, as adherence to 
the instructions cannot be guaranteed. 

There are limited circumstances for consideration of personal protective equipment (PPE) in 
consumer exposure, because people will not necessarily use PPE even though recommended 
by the manufacturer. Even when PPE is provided with the product (e.g., gloves with a hair 
dye), it cannot be ensured that consumers will use it. The exposure estimation needs to 
consider the reasonable worst-case situation which indicates no use of gloves or other PPE. As 
an element of good practice and personal hygiene, the advice to use household gloves or other 
skin protection should be part of consumer instructions (e.g. for products that are 
irritating/corrosive to the skin, such as strongly acidic, alkaline or oxidising household 
detergents, and caustic oven cleaners). 

 
 
 
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R.15.2.5. Habits and practices of children 

For children’s products and for some consumer products for which the habits and practices of 
children significantly differ from those of adults (e.g. mouthing and crawling behaviour; 
handicrafts in school/kindergarten), the assessor needs to take these habits and practices into 
account and should derive contributing scenarios that are sufficiently protective for both 
children and adults. In addition, the anthropometric parameters (e.g. body weight, inhalation 
rate, body surface) of children and adults differ, which might lead to higher exposures of 
children in comparable exposure situations. This should, for example be taken into account for 
consumer products that are frequently used by children at school (e.g. universal glue) or 
during household activities (e.g. dishwashing products). 

Several children-specific behaviours may influence the exposure to chemicals from consumer 
products, such as: 

•  Hand to mouth behaviour, 
•  Object to mouth behaviour, 
•  Crawling, playing 
• 
•  Sleep (longer duration spent indoors) 

Incidental oral ingestion (swallowing): settled particulate matter and consumer products, 

With respect to the child’s mouthing behaviour, it should be noted that the Committee for Risk 
Assessment (RAC), has discussed mouthing times for children in the context of restriction 
dossiers.  For instance, the opinion on lead and its compounds in articles intended for 
consumer use15  provides information on realistic and reasonable worst case mouthing times 
for the specific articles targeted by the restriction. These data could potentially be used 
as long as the assessment targets the same types of articles as the ones targeted by the 
restriction (see “reference to RAC op.” [2]). In the context of other restriction proposals, 
mouthing times for articles, including toys, containing phthalates have also been discussed ( 
[3] and [4]). 

Furthermore, it should be noted that when looking at a child’s exposure and risk assessment, 
special considerations should be taken with regard to: 

  On a per body weight basis, children typically have higher exposures to environmental 

media than adults. 

  On a body weight basis, toddlers (0.5-4 years) are typically the most exposed age group 

when examining indoor air, outdoor air and soil/dust based upon behaviour and 
physiology. 
Indoor air is an important source of environmental exposure for children. 
Significant inter-individual variability exists in early life stages due to rapid physiological, 
anatomical, and behavioural changes, even within a relatively narrow age group [5]. 

 
 

Therefore, when performing an exposure assessment to a chemical for consumer exposure 
from products within a certain Article Category (AC) or Product Category (PC), the possibility 
of a separate exposure assessment for children should be always considered, unless they are 
clearly not exposed. 

15 Available at: http://echa.europa.eu/documents/10162/f5a59251-8ef0-4f44-bfd4-95bffca7f807 

 
 
 
 
 
 
 
 
 
 
 
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R.15.2.6. Specific Consumer Exposure Determinants SCEDs 

The SCEDs (Specific Consumer Exposure Determinants) provide “information input” into the 
registrant’s consumer exposure assessment. They document the typical conditions of use for a 
substance incorporated into a specific consumer product. This includes information related to 
consumer habits and practices (e.g. quantity of product used, frequency of use, place of use…) 
and information related to product characteristics (e.g. concentration of substance, transfer of 
substance from product to skin surface). 

The SCED format was initially designed to directly feed the information into ECETOC TRA v.3.1 
and Chesar. However it is also possible to use the SCED information in other REACH consumer 
models (such as ConsExpo). 

The SCEDs do not affect the algorithm inherent to the exposure model. 

The SCEDs are developed by downstream sector organisations to transparently document the 
ways in which their products are commonly used by consumers. They are part of the 
information flow up and down the chemicals supply chain under the responsibility of industry, 
as foreseen in REACH. The first SCEDs were made publicly available in 2014, further SCEDs 
followed in 2015. See: 

https://www.concawe.eu/reach/specific-consumer-exposure-determinants-sceds-documents 

https://www.aise.eu/our-activities/product-safety-and-innovation/reach/consumer-safety- 
exposure-assessment.aspx 

Each value within the SCEDs has to be substantiated by reference to suitable information 
sources that are open access and have been published and ideally are peer reviewed (the 
“rationale”)16. Preferably, this will refer to European data sources and/or already be used in 
regulatory processes (within the EU or beyond e.g. EPA, IPCS). 

The SCEDs should lead to exposure scenarios representing conservative conditions of use. 
Where habits and practices significantly vary across European countries/regions, the SCEDs 
should reflect those areas with the highest uses/exposure conditions. It is the responsibility of 
each registrant to check whether the SCED he is using is suitable for his case. 

The Guidance on SCED published by DUCC/Concawe can be downloaded from: 
http://www.ducc.eu/documents/20140424-Guidance%20documents%20on%20SCEDs-Final- 
V1.pdf 

16 Where a value has been copied from the ECETOC TRA defaults and where the original source of information is clearly 
referenced in the TRA documentation a reference to the corresponding ECETOC Technical Report may be sufficient. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
26  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
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R.15.3. Calculation of exposure 

This section summarises the Tier 1 principles and algorithms for consumer exposure 
estimation. The assessor may start the assessment by using tools that implement the Tier 1 
algorithms. Tools for lower tiers of consumer exposure estimation are discussed in Section 
R.15.4  (ECETOC TRA) and Section R.15.5.1 (some ConsExpo sub model), further tools are 
listed in Section R.15.5.2 and Appendix R.15.3. 

As is explained later in this section, the Tier 1 algorithms and the tools require values for the 
calculations of anthropometric data (e.g. surface area of different body parts, body weight, and 
respiration volumes), room volumes and room ventilation etc. The default values used by each 
tool can be found in the tool documentation. Further information on default values for these 
parameters can be found at: 

-  RIVM Fact Sheets (room and anthropometric data, default for Consexpo): 

http://www.rivm.nl/dsresource?objectid=rivmp:266571&type=org&disposition=inline&n 
s_nc=1 

- 

JRC ExpoFacts site (complete collection of EU data, no default proposed): 
http://expofacts.jrc.ec.europa.eu/ 

-  US EPA Exposure factor handbook (containing also default for US): 
http://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252 

The ECHA Biocides Human Exposure expert group (HEAdhoc), has agreed on harmonised 
values to be used for the exposure assessment from Biocidal products as available within 
the Biocides Human Health Exposure Methodology document within Section 2: “Default 
parameters for Exposure Assessment” available on the ECHA website 
(http://echa.europa.eu/about-us/who-we-are/biocidal-products-committee/working- 
groups/human-exposure). These include anthropometric parameters, activity patterns, 
room sizes and ventilations. 

Consumer exposure assessment on the Tier 1 level is rather a decision criterion on a screening 
level than a realistic exposure estimation. In contrast to higher tier assessments, it assumes 
instant and complete release of the substance from the product or from a thin product layer. 
In consequence of this complete release assumption, Tier 1 exposure estimates for the 
application phase also represent the exposure during other phases of activity like the post 
application period. The Tier 1 equations are simple and include few and highly conservative 
parameters which represent worst case situations. Depending on the substance properties and 
the use situation, Tier 1 assessments may already be sufficient to demonstrate safe use. 
Otherwise the assessment needs iteration by modifying the assumed conditions of use and the 
assessment models. In these refined consumer exposure estimations, the use conditions of the 
exposure scenarios are more realistic while the scope of the exposure scenarios is smaller (e.g. 
covers a more specific sub product or article). Moreover, when refinement is needed (and the 
assumption of complete release is no longer valid) phases other than the application of the 
product (e.g. mixing before application, post application) might not be covered anymore by the 
refined assessment. 

Exposure quantification may be relevant for three routes: 

Inhalation: A substance may be released into a room as a gas, vapour or airborne particulate 
(e.g. a carrier/solvent in a cosmetic formulation, a powder detergent, dust), or by evaporation 
from liquid or solid matrices, like articles (e.g. wooden wall panels, PVC flooring). Tier 1 
algorithms assume that all the substance is released at once into a standard room 
(instantaneous release) with immediate mixing, and no removal takes place due to ventilation. 
The main input parameter to be determined by the assessor is the amount of substance 
available for release in the standard room and the number of use events per unit of time. The 

 
 
 
 
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27 

amount results from the product/article amount per use event and the concentration of the 
substance in it. Some lower tier tools enable release modification based on vapour pressure of 
the substance. The estimated exposure is expressed in mg/m3, averaged over the exposure 
event or over the day (24 h). Note: In order to support the assessment of outdoor uses some 
lower tier tools define a “virtual standard room” to generate an exposure concentration based 
on instantaneous release. 

Dermal A: The substance is contained in a mixture. This option is applicable when, for 
example, hands are dipped into a solution containing the substance under evaluation, or 
splashes occur (painting). Tier 1 assessment assumes that all the substance contained in a 
contact layer of 0.01 cm thickness will be available to form the dermal load on the skin 
surface. Note that this Tier 1 assumption may not be valid for continuous immersion of body 
parts 

The main input parameters to be determined by the assessor are the fraction of the substance 
in the mixture, the exposed skin contact area and the number of use events per unit of time. 

The estimated exposure is expressed as dermal load per use event, calculated as the amount 
of substance per unit surface area of skin or as an external dose in mg/kg of bodyweight (per 
use event or per 24 h) 

Dermal B: The substance is contained in an article matrix and migrates to the skin surface. 
This option is for example applicable when residual dyes in clothing or additives in plastic 
articles are in contact with skin. For covering this route of exposure, ECETOC has extrapolated 
the rationale from the liquids (see “Dermal A” above) assuming that all the substance 
contained in a contact layer of 0.001-0.01 cm thickness (depending on the article) will be 
available to form the dermal load on the skin surface17. 

The main input parameters to be determined by the assessor are the fraction of the substance 
in the article, the exposed skin contact area and the number of use events per unit time. 

The estimated exposure is expressed as dermal load per use event, calculated as the amount 
of substance per unit surface area of skin or as an external dose in mg/kg of bodyweight (per 
use event or per 24 h). 

Oral A: The substance is contained in a mixture or in an article and a part of the product/ 
article is unintentionally swallowed during normal use. This option is for example applicable for 
the use of finger paints or for residues from dishwashing on the dishes. The main input 
parameters to be determined by the assessor are concentration of the substance in product 
when swallowed, the amount ingested per event and the number of use events per unit time. 
Oral exposure is expressed as external dose (mg/kg bw) (per use event or per 24 h). 

Oral B: The substance is contained in an article and migrates to the surface. Licking and 
sucking (e.g. by children) may promote leaching of the substance from the article matrix. This 
option, directly derived from the scenario “Dermal B above” is applicable for example when a 
substance migrates from a pen, cutlery or textiles. The main input parameters to be 
determined by the assessor are the fraction of the substance in the article, the area subject to 

17 Several studies focusing on dermal exposure (also to articles) are currently under developing phase (like DRESS – 
DeRmal Exposure aSsessment Strategies, study founded by CEFIC - LRI). When final results become available, they 
might constitute a basis to refine concepts and calculations for estimating dermal exposure, including Tier I equations. 

 
 
 
 
 
 
 
 
 
 
28  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
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sucking or licking and the number of use events per unit time. Oral exposure is expressed as 
external dose (mg/kg bw) (per use event or per 24 h). 

R.15.3.1. Inhalation exposure 

The Equation R.15- 1 represents a worst-case situation by assuming that the substance is 
directly available as a gas or vapour. The equation applies to both volatile substances and 
airborne particulates. For inhalation exposure, the concentration of the substance in the room 
air (e.g. mg/m³) must be estimated; the inhalatory dose (mg/kg body weight/day) can then 
also be estimated. The event duration is assumed to be 24 hours in the worst case. For a Tier 1 
evaluation, it is assumed that 100% of the substance in the consumer product or article will be 
released at once into the room and there is no ventilation. There should be a clear description in 
the CSR of the uncertainties associated with the estimated values and the consequences for the 
risk characterisation. The two essential parameters used that the assessor should know are: 

  Amount of product used or article weight 

  Fraction of substance in the product or in the article (concentration) 

The concentration in air after using an amount Qprod  of the product becomes: 

𝑸����  ∙ 𝑭����� 

����  = 

� 

���� 

∙ ���� 

Equation R.15- 1 

When the inhalable and/or respirable fraction is known, it should be taken into account. If the 
product contains releasable nanomaterials then the assumption should be made that it is 
entirely within the respirable fraction if not otherwise known. The non-respirable fraction can 
be swallowed and oral exposure may also need to be considered (see Equation R.15- 8 and 
Equation R.15- 9). For the purpose of calculating overall systemic exposure via different 
exposure pathways, see Section R.15.6. 

The air concentration Cinh results in an inhalatory dose Dinh  of: 

� 

��� 

= 

 𝑭 ����∙� ����� 𝒂��𝑻 ����𝒂��  ∙ � 

�� 

Equation R.15- 2 

Table R.15- 2: Explanation of symbols for inhalation exposure 

Input 
parameter 

Description 

Unit 

Qprod 

Amount of product/article used 

Fcprod 

Weight fraction of substance in product/article 

Vroom 

Room size (default 20 m3) 

[g] 

[g.gprod 

-1] 

[m3] 

Fresp 

Respirable fraction of inhaled substance (default 1) 

[-] 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
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Input 
parameter 

Description 

Unit 

IHair 

Ventilation rate of person 

Tcontact 

Duration of contact per event (default 1 day) 

BW 

Body weight 

N 

Mean number of events per day 

[m3.d-1] 

[d] 

[kg] 

[d-1] 

Output 
parameter 

Cinh 

Dinh 

Description 

Unit 

Concentration of substance in air of room 

[mg.m-3] 

Inhalatory dose (intake) of substance per day and body weight 

[mg.kgbw

-1.d-1] 

It should be noted that for Tier 1 assessment for short-term local exposure, the value for Vroom 
could be reduced (e.g. to 2 m3) to represent the volume of air immediately surrounding the 
user (‘breathing zone’). If this is not sufficient, higher tier models may be more appropriate. 
Inhalation exposure can occur to a substance that is released relatively slowly from a solid or 
liquid matrix (e.g. solvent in paint, plasticizer or monomer in a polymer, fragrance in furniture 
polish). In these cases, a simple Tier 1 screening model will usually overestimate exposure. 
Improved estimation models are further described in Section R.15.5. 

R.15.3.2. Dermal exposure 

Dermal scenario A: Instant application of a substance contained in a mixture 

The model is used as a first Tier worst case approach or if details on how the skin is exposed 
to the compound are not known. If more precise information is available, the amount of 
product can be changed to reflect the actual use. The exposure expressed as dermal load Lder is 
calculated as the amount of product per unit surface area of skin or as external dose in mg/kg 
of bodyweight. The essential parameters used for this model are: 

  Weight fraction compound: the fraction of the compound in the total product 
  Amount of product: the amount of total product applied to the skin 
  The surface area of the exposed skin 

The dermal load is calculated as: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
30  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
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𝑸����  ∙ 𝑭����� 

𝑳���  = 

� 

�𝒌�� 

∙ ���� 

Equation R.15- 3 

and the external dose Dder as: 

� 

��� 

= 

𝑸 ����∙𝑭�����∙� 
�� 

∙ ���� 

Equation R.15- 4 

In cases where the substance is contained in a liquid into which certain parts of the body are 
dipped, the equation is not based on the mass of the substance applied to a certain area of 
skin, but rather on the concentration of the substance in the mixture that is in contact with the 
skin. First, the concentration Cder of a substance in contact with skin is calculated. Depending 
on how the parameters are provided, three analogous calculations are used: 

Cder = 

 

C 

1000  RHOprod   Fc 

1000  Q 

prod 

D 

 

prod 

D 

prod 

 



Fcprod   1000 

Vprod    D 

Equation R.15- 5 

The total dermal load Lder is then calculated using: 

𝑳��� = ���� ∙ 𝑻���� 

Equation R.15- 6 

The dermal dose is then derived as: 

� 
��� 

= 𝑳���∙��𝒌��∙� 
�� 

Equation R.15- 7 

Table R.15- 3: Explanation of symbols for dermal scenario A 

Input 
parameter 

Cprod 

D 

Description 

Unit 

Concentration of substance in product before dilution 

[g.cm-3] 

Dilution factor (If not diluted, D =1) 

[-] 

RHOprod 

Density of product before dilution 

Amount of product used 

Qprod 

Fcprod 

Weight fraction of substance in product before dilution 

[-] 

[g.cm-3]] 

[g] 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
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31 

Input 
parameter 

Description 

Unit 

Vprod 

Vappl 

THder 

Askin 

BW 

N 

Volume of product used before dilution 

[cm3] 

Volume of diluted product actually contacting the skin 

[cm3] 

Thickness of product layer on skin (default 0.01 cm) 

[cm] 

Surface area of the exposed skin 

Body weight 

Mean number of events per day 

[cm2] 

[kg] 

[d-1] 

Output 

Description 

Unit 

Cder 

Lder 

Dder 

Dermal concentration of substance on skin 

[mg.cm-3] 

Amount of substance on skin area per event 

[mg.cm-2] 

Amount  of  substance  (external  dose)  that  can  potentially 
be  taken  up  (account  later  for  actual  dermal  absorption) 
per body weight 

[mg.kgbw

-1.d-1] 

Further 
applications 

Description (see  the text below) 

V*

appl 

Fcder 

Volume of diluted product actually remaining on the skin 

[cm3] 

Fraction of the applied product remaining on the skin 

[-] 

The above dermal equations also apply to: 

  a non-volatile substance in a medium used without further dilution. In this case the 

dilution factor (D) is set to 1; 

  a non-volatile substance contained in an undiluted medium removed from the skin by, 

for example, wiping or rinsing and drying (e.g., liquid soap). Recalculate the V*
volume of application based on  volume of application (Vappl) as V*  
a 
Fcder is the fraction of the product remaining on the skin; 

ppl=Vappl.Fcder; where 

appl “real” 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
32  Guidance on Information Requirements and Chemical Safety Assessment 
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Example R.15- 1: Calculating dermal exposure to a substance in a solution 

The identified use is a waterborne “Washing and cleaning products” 

In  this  example,  the  undiluted  cleaning  product  is  a  surfactant-water  mixture,  where  the 
weight fraction of the surfactant (Fcprod in Equation R.15- 5) is 0.1 (=10%). It is assumed that 
the  density  of  the  product  can  be  set  to  1  (RHO  =  1  in  Equation  R.15-5)  and  thus  the 
concentration of the substance in the undiluted product is 0.1 g/cm3 or 100 g/L (Cprod = 0.1  
in Equation R.15- 5). 

Exposure  is  calculated  for  a  situation in  which  the  hands  are  dipped  into  the  diluted  product. 
The concentration of the substance after dilution (dilution factor D = 40) is 0.0025 g/cm3. The 
dermal concentration of substance on skin (Cder) is 2.5 mg/cm3. 

Lder = Cder THder 
with the thickness of layer (THder). The thickness of the layer in direct exchange with the skin  
is assumed to be 0.01 cm by default). 

is applied to derive the dermal  load to  skin (Lder) by  multiplication of  Cder 

Lder = Cder THder =  2,5 mg/cm3  * 0.01 cm = 0.025  mg/cm2. 

In  a  Tier  1  scenario,  default  parameters  leading  to  worst-case  assessment  are  applied. 
Accordingly,  the  body  surface  area  of  males  is  assumed,  but  the  body  weight  of  women  (60 
kg) is applied. The surface area of the exposed skin(Askin) for hands (fronts and backs) for males 
is 840 cm². 

Using  the  Dder  =   der 

L 

 A 

skin 

BW 

 n 

, the external dermal dose (in mg per kg body    weight can be 

calculated. 
L 

Dder  =   der 

 A 

skin 

BW 

 n 

= 0.025 mg/cm2 *840 cm²* 1/60 kg = 0.35 mg/kg bw 

RMMs  are  not  considered  in  the  quantitative  exposure  estimation  because  consumer 
compliance  to  the  advice  ‘wear  gloves  while  cleaning’  cannot  be  ascertained.  However,  it  is 
considered  a  good  practice  to  add  this  as  a  labelling  instruction  for  consumer  use.  In  Tier  1 
assessments, exposure times are not taken into account. 

Dermal scenario B: a substance migrating from an article 

The  Tier  I  algorithm  to  calculate  dermal  exposure  (e.g.  dermal  dose)  to  substance  migrating 
from  an  article  is  similar  to  the  equation  presented  in  the  previous  paragraph  for  mixtures  
(e.g. ) where: 

  Cder, Askin, n is referred to the article (i.e. concentration C of the substance in the article, 

skin surface A in contact with the article) 

  TH (Thickness of product layer on skin) is generally set to 0.001 for    article (instead of 

0.01 for mixtures) 

This algorithm is used in ECETOC TRA consumer tool (see section R.15.4) 

R.15.3.3. Oral Exposure 

Oral exposure is expressed as external dose (mg/kg bw). The parameters used are: 

Weight fraction compound: the fraction of the compound in the product 
Amount ingested: the total amount of product swallowed 

 
 
 
 
 
 
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Oral scenario A: exposure of a substance in a product during normal use 

The concentration in the product as swallowed is calculated from: 

Coral = 

C 

1000  RHOprod   Fc 

1000  Q 

 

prod 

D 

 

prod 

D 

prod 

 



Fcprod   1000 

Vprod    D 

Equation R.15- 8 

and the oral dose is then given by: 

D  = 

oral 

ForalVappl Coral n 1000 
BW 

 

Qprod  Fcprod  n 1000 
BW 

If an undiluted product is swallowed, D = 1. 

Table R.15- 4:  Explanation of symbols for oral scenario A 

Equation R.15- 9 

Input 
parameter 

Description 

Unit 

Cprod 

Concentration of substance in product before dilution 

D 

Dilution factor 

RHOprod 

Density of product before dilution 

[g.cm-3] 

[-] 

[g.cm-3] 

Qprod 

Amount of product before dilution 

[g] 

Fcprod 

Weight fraction of substance in product before dilution 

[g.gprod

-1] 

Vprod 

Volume of product before dilution 

Vappl 

Foral 

BW 

N 

Volume of diluted product per event in contact with 
mouth 

Fraction of Vappl that is ingested (default = 1) 

[-] 

Body weight 

Mean number of events per day 

[kg] 

[d-1] 

[cm3] 

[cm3] 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
34  Guidance on Information Requirements and Chemical Safety Assessment 
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Output 

Description 

Coral 

Concentration in ingested product 

Doral 

Intake per day and body weight 

Unit 

[mg.m-3] 

[mg.kg   -1.d-
1] 

bw 

These  equations  may  also  be  used  to  estimate  exposures  arising  from  ingestion  of  the  non- 
respirable fraction of inhaled airborne particulates. 

For some products, exposure due to hand mouth contact can be calculated (e.g. finger paints). 
The  volume  of  product  swallowed  is  related  to  the  oral  contact  area  Askin  and  the  thickness  of 
product  layer  TH  on  that  part  of  the  hand  (default  0.01  cm).  It  is  assumed  that  100%  of 
substance present on the hand is transferred and available for ingestion. 

Oral scenario B: exposure of a substance in an article during normal use 

The  Tier  I algorithm for oral exposure to substance in an article is similar to those presented 
for  a  product.  The  only  difference  is  how  the  amount  (or  volume)  of  product  migrating  from 
article and being ingested (Qprod or Vprod in the previous algorithms) is  calculated. 

The  volume  of  product  swallowed  is  calculated  based  on  the  article  area  in  contact  with  the 
mouth  Askin  (default  10  cm2)  and  the  thickness  of  article  layer  TH  assumed  to  be  in  contact 
during mouthing (default 0.01 or 0.001 cm). It is assumed that 100% of substance present in 
the contact layer is transferred and available for ingestion. 

Vprod (volume product swallowed) = Askin x  TH 

Equation R.15- 10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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R.15.3.4. Exposure to non-volatile substances 

Non-volatile substances (i.e. substances having low vapour pressure) can be released from 
products via migration (e.g. softeners) or by mechanical abrasion (e.g. pesticides, flame 
retardants), or by heating (e.g. soldering and welding, articles used at elevated temperature 
like candlewick or cake pan). 

Because some of these substances can be found in house dust, house dust may present an 
important path for exposure to non-volatiles. In small children, exposure via house dust can 
account for about 50% of the total exposure [6]. Therefore, exposure via house dust may need 
to be considered when preparing a chemical safety assessment for REACH. 

It is anticipated that non-volatiles occurring in any products used in private households may 
contribute to accumulation in house dust. For example, the substance in articles may become 
available for inhalation due to rubbing or while handling or working with the article (e.g. 
building materials, hobby materials etc.). The resulting dust can be inhaled. Therefore, use 
specific exposure via house dust is difficult to predict. Contact with house dust itself may lead 
to dermal exposure and, in small children, to oral exposure due to mouthing behaviour. A 
conservative estimate of 100 mg/day has been proposed for house dust intake for children [7]. 

In standard lower tier assessments using TRA consumer model with default values provided by 
the tool, ECETOC assumes that exposure to non-volatile substances via house dust is covered 
by the model exposure estimate (see discussion in Section R.15.4.2.). For higher tiers, the 
concentration of the substance of concern can be evaluated or measured in house dust and 
multiplied by the estimated intake value mentioned above. For example, if the concentration of 
a substance in house dust is 1 μg/g, then the intake of the substance would be 0.1 μg/day. 

 
 
 
 
 
 
 
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R.15.4. The  ECETOC  TRA  consumer  tool  for  exposure 
estimation 

ECETOC has released different versions of the TRA Consumer tool during recent years to better 
capture exposure refinement options, while maintaining algorithms for exposure estimation, 
which are largely based on Tier 1 algorithms documented in Section R.15.3 . Three recent 
versions of TRA are briefly described and compared with each other and to Tier 1 algorithms in 
Appendix R.15.4 

References to be consulted for better comprehension of the TRA consumer tool are: 

 

 

 

“Addendum to ECETOC Targeted Risk Assessment Report No. 93 - Technical Report No. 
107” - [8]; 
“ECETOC TRA version 3: Background and Rationale for the Improvements - Technical 
Report No. 114” – [9] 
“Addendum to TR114: Technical Basis for the TRA v3.1 - Technical Report No. 124” 
[10] 

The above mentioned documentation is freely available at http://www.ecetoc.org/tra. The 
description in the following paragraphs always refers to the latest version of TRA tool at the 
time of writing, ECETOC TRA Consumer v.3.1. 

ECETOC TRA is the main consumer tool that allows batch processing of exposure calculations 
and risk characterisations for many product and article categories. The ECETOC TRA consumer 
tool v 3.1 is integrated in the CHEmical Safety Assessment and Reporting tool (CHESAR) 
developed by ECHA. Therefore, main features of the tool are presented in this guidance. 
However, the assessor will have to decide whether the assumptions that are integrated into 
the tool are suitable for the consumer uses and risks that he has to assess. 

R.15.4.1.  Consumer Product and Article Categories 

The core concept of the TRA tool is to provide a setting of defaults for 46 specific product and 
article types relevant for consumer use. The product and article types driving the exposure 
estimate in the TRA are referenced to the broader product and article categories in the use 
descriptor system as presented in Chapter R.12 of the IR&CSA guidance. 

In the initial assessment the TRA enables derivation of worst case exposure estimates for 
broad product categories (so called sentinels) which contain more specific product 
subcategories. If it turns out that adequate control of risk cannot be demonstrated on this 
basis, an assessment of the more specific product type can be launched. More than one 
sentinel product/article and/or product subcategory can be evaluated simultaneously, but the 
tool will not aggregate the exposure estimates. The product/article categories and 
subcategories for which a TRA exposure estimate can be derived are listed in Appendix R.15.1. 

This list does not include all types of consumer products. A registrant under REACH cannot rely 
on this list as giving the complete overview on which consumer uses of the substance he 
potentially has to assess. If a category of interest is not addressed by the TRA, then the 
registrant could check whether his products and use conditions can be approximated by some 
TRA categories, and if so make use of the TRA with appropriate justification of any deviations 
and adaptations. The registrant could also consider assessing the exposure by Tier 1 algorithm 
calculations (Section R.15.3) or by other tools like ConsExpo. 

Moreover, ECETOC TRA enables the user to define a new (sub)product or article type, e.g. one 

 
 
 
 
 
 
 
 
 
 
 
 
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not covered by the list in Appendix R.15.1 or being a specific product for which habits and 
practices and related input parameters are defined at the sector organisation level (so called 
SCED, see Chapter R.15.4.5). Single registrants are advised to select this functionality only 
when they use the products type and related input parameters as contained in the SCED 
proposed by sector organisations. 

The user of the ECETOC TRA tool is advised to always check: 

 
 

If the use he wants to cover fits the (sub)category of product or article chosen 
If the scenario (e.g. target population covered, input parameters) described by the selected 
(sub) product or article category fits the use he wants to cover. 

R.15.4.2.  Input and output parameters 

One algorithm per exposure route (dermal, oral, inhalation) is used to calculate the exposure 
for all consumer product and article categories. For the sentinel product/article, the exposure 
estimates for each route corresponds to the highest exposure estimate of the individual 
product/article subcategories within the sentinel. The algorithms for each exposure route are 
fully described in ECETOC Technical Reports TR 114 and TR 124. In the following text only 
input and output parameters are described. 

Inhalation route 

Output parameters 

The ECETOC TRA calculates the inhalation exposure as 
 

concentration in room air (mg/m3), resulting from one or more events of product/article 
application on the day of exposure; 

Or  as 
  dose (amount per kg bodyweight) inhaled over the duration of the event (depending on the 

product category 20 min to 8h). 

Input  parameters – Lower tier standard calculation 

  Product ingredient (g/g): ECETOC TRA provides a default for each product or article 

type; this can normally be overwritten by the user; 

  Amount of product used per application (g/event): ECETOC TRA provides a default for 

each product or article type; this can be overwritten by the user, who has to support his 
choice with proper justification; 

  Spray application: ECETOC TRA provides a default for each product type (whether the 
product is intended to be sprayed or not); for some “not spray” products, the default 
setting can be modified by the user (from “not spray” to “spray”); 

  Frequency of use (events/day): the default value is assigned for each product type 

(normally 1 event/day) and is not modifiable by the user; 

  Exposure time (hr): the default value is assigned for each product type and is not 

modifiable, unless a new (sub)product category is defined by the user; 

The chemical physical parameters needed to run the exposure assessment are reported below: 

  Molecular weight (g/mol), which enables the calculation of the saturated vapour 

concentration 

  Vapour pressure (Pa), which enables the calculation of the saturated vapour 

concentration and fraction released to air (see table below). 

 
 
 
 
 
 
 
 
 
 
 
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For substances with a vapour pressure < 10 Pa in non-spray application, only a fraction of the 
substance in the products or article is assumed to be transferred to air (vapour pressure bands 
A to D, see Table R.15- 5). 

Table R.15- 5: Vapour pressure bands 

Vapour pressure of compound of 
interest 

Released % of the amount 
available for instantaneous release 

Band 

≥ 10 Pa 

all compound 

between 1 and 10 Pa 

10 % of the compound 

between 0.1 and 1 Pa 

1 % of the compound 

< 0.1 Pa 

0.1 % of the compound 

A 

B 

C 

D 

Any substance with a vapour pressure higher than 10 Pa is assumed to be completely released 
into air instantly. For a substance with low volatility only a fraction of it is assumed to be 
released into the air. However, for all spray products it is assumed that substances are 
released fully and instantly into the air. 

Note: for activities taking place at a temperature different from ambient temperature (e.g. 
dishwashing products), the vapour pressure of the substance should be adapted to the process 
temperature; in such a case, the operating temperature should be reported in the exposure 
scenario as well. 

ECETOC assumes that the TRA tool covers also the exposure of non volatile compounds, such 
as flame retardants and plasticizers in house dust. This is because the tool assumes that 0.1 % 
of the non-volatile compound evaporates immediately and is inhaled in the standard room with 
standard ventilation. Therefore, ECETOC assumes also that this exposure covers not only the 
inhalation exposure, but also the dermal and oral exposure to this substance via house dust. 
Note that when inhalation exposure is refined by higher tier options in the ECETOC TRA tool, 
the resulting exposure levels may no longer cover exposure via the house-dust route. 

Note: the tool does not cover exposure arising from dusty materials or from dust-generating 
consumers’ activities, since releases from a product are driven by the substance’s vapour 
pressure. 

Dermal route – Lower tier standard calculation 

Output parameter 

External dermal dose (expressed in mg/kg bw / day) over the day of exposure, resulting from 
one or more events of product/article application. 

Input parameter 

  Product ingredient (g/g): ECETOC TRA provides a default for each product and article 

type; this can be normally overwritten by the user 

  Skin contact areas: ECETOC TRA provides a default for each product and article type 

according to one of eight categories (see below); each one is characterized by a default 
surface area for adults and children. This can be overwritten by the user, who has to 
support his choice with proper justification; if the selected target group is children, then 
the dose is adjusted to the child body weight. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  Frequency of use (events/days): the default value is assigned for each product type 

(normally 1 event/day) and is not modifiable by the user 

  Thickness layer (cm): represents the thickness of the layer in contact with the skin and 
it is set to 0,01 for mixtures and 0,001 for articles; it is not modifiable by the user 

Note: the dermal model only covers direct contact with the product or article, which in most 
cases can be considered the predominant route for dermal exposure; indirect dermal contact 
(e.g. via vapours or spray clouds) is not covered by the tool. The skin contact areas linked to 
product/article subcategories can be expressed in one of ten categories each characterized by 
a default surface area for adults and children: 
1  – fingertips 
2  – two fingerprints 
3 – palm of one hand 
4 - inside (palms) of both hands / one hand 
5 - hands 
6  - hands and forearms 
7  - upper part of the body 
8 - lower part of the body 
9 - whole body except feet, hands and head 
10 - whole body 

Oral route – Lower tier standard calculation 

Output parameter 

External oral dose (expressed in mg/kg bw /day) over the day of exposure, resulting from one 
or more events of product/article application 

Input parameter 

  Product ingredient (g/g): ECETOC TRA a provides default for each product type; this 

can be normally overwritten by the user 

  Volume of product swallowed: ECETOC TRA provides a default for each product or 

article type. The volume for some product or article categories depend on the contact 
surface area and thickness of the layer (see discussion in Section R.15.3– Oral route – 
Scenario B). In such cases, the user can overwrite default surface area, providing 
proper justification. 

  Frequency of use (events/days): the default value is assigned for each product type 

(normally 1 event/day) and is not modifiable by the user 

REACH does not deal with accidents or assessment of consumer exposure to food, food-related 
or pharmaceutical products. This limits the relevance of consumer oral exposure to situations 
where: i) substances as such or in mixtures are unintentionally swallowed (e.g. ingestion 
through hand-mouth contact) or ii) where articles are mouthed by small children. 

Higher tier option in ECETOC tool 

ECETOC TRA offers the option to perform additional refinement calculations which are beyond 
the first tier approach. Therefore, they need careful considerations by the assessor, including 
the issues discussed under 15.2.5 and 15.3. These refinement calculations are based on the 
following additional input parameters: 

  Transfer factor (Inhalation, Dermal, Oral). For the inhalation route this factor may 
be used to reduce the amount of substance (as such or in a mixture) to the amount 
actually available for instant release. For example, during tank filling with 70 l of 
gasoline, not all these 70 l are available to be released into air. The inhalation transfer 
factor (amount of the substance actually available for release into the air) should not be 
confused with the fraction releases to air (driven by vapour pressure). For the dermal 

 
 
 
 
 
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route the factor may be used if there is evidence that the dermal load on skin in the 
dermal contact area is smaller than the load resulting from instantaneous release of all 
substance present in 0.01 cm (respectively 0.001 cm) contact layer. If the transfer 
factors are set to a value different from default (100%), a scientifically sound and 
robust argumentation should be provided by the registrant to justify the proposed 
value. If he cannot rely on peer-reviewed scientific exposure studies, it is highly 
unlikely that the necessary knowledge to justify transfer factors would be available at 
the level of a single registrant; therefore the advice is to use the transfer factors only in 
the context of SCEDs developed at the sector organization level (e.g. consumer product 
formulators or article producers or importers, see Section R.15.2.6). 

Frequency over the year. Only when a new (sub)product category is defined, can the 
user choose to set the frequency band (frequent, occasional, infrequent, very 
infrequent) over the year. Compared to the frequent (daily) exposure, the exposure 
would be reduced by up to a factor of 100 by this procedure. However, following the 
considerations in Section R.15.2.3 of this guidance, it cannot be advised to use this 
function as it is. 

  Outdoor/Indoor use. Only when a new (sub)product category is defined, can the user 

select an outdoor instead of an indoor use in order to refine the calculation for the 
inhalation route. The registrant should consider that due to the many influences on 
outdoor air dispersion in a housing environment, the assumption of equal distribution of 
the substance in outdoor air may not be valid. Especially for spray products, a peak 
exposure in a smaller space has to be assumed and this function should not be used. 

R.15.4.3.  Default values 

Default values associated with subcategories, such as amount of product used per application 
and exposure time (for the inhalation route), were obtained from the RIVM (The National 
Institute for Public Health and the Environment, Netherlands) fact sheets for specific products, 
in order to build consistency with ConsExpo. When product-specific fact sheets were 
unavailable, values were derived using expert judgment. The supporting reference for the 
default values used to calculate exposure can be viewed for each subcategory in the ‘defaults’ 
table. Only potentially significant exposure routes are ‘flagged’ for exposure assessment. A 
qualitative justification of why a particular route is not relevant for a particular product is 
provided in the documentation of the tool. 

In some cases one route is more dominant than others. Then only the most dominant route is 
described, for instance dermal exposure for grease pastes (PC24), inhalation exposure for 
spray application of aircare products (PC3) and dermal exposure for fertilizers (PC12). This is 
important to realize, especially for situations where the most dominant route can be excluded, 
e.g. due to product characteristics. Exposure for the other route(s) should then still be 
considered. This means that it needs to be checked whether the contribution of the second 
route becomes significant if exposure for the primary route is reduced to a large extent. 

Use scenarios have been defined for all product and article subcategories according to the 
potential exposure of consumers to these (sub)categories. The defaults used are presented in 
the “defaults” table of the tool. The references for the defaults (RIVM reports, conservative 
expert estimates) are specified in Appendix E of the ECETOC Technical report 107 (ECETOC 
2009). Default values such as body weight, surface area, room volume and ventilation rate 
were obtained from the RIVM general fact sheet [11]. 

R.15.5. Advanced  refinements,  higher  tier  models  and 
measurements 

More advanced refinement of exposure calculation and higher tier models may include, for 

 
 
 
 
 
 
 
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example, the consideration of time-dependent processes of migration and release of the 
substance from a matrix, the deposition (adsorption) to other matrices (e.g. dust) and its 
release (desorption) as well as the disappearance from the medium (e.g. by decrease of room 
air concentrations due to ventilation or degradation). Expert assessors should normally 
conduct these assessments. 

Higher tier consumer exposure estimation uses more sophisticated and detailed and more 
realistic parameters than Tier 1 tools. Therefore, a detailed description of the scenario and 
reference to the models used for calculations, including all assumptions and results should be 
reported in the CSR. 

R.15.5.1. ConsExpo 

The ConsExpo (version 4.1) computer tool (downloadable from www.consexpo.nl) is a well- 
known higher Tier tool for expert consumer exposure assessment. All the equations used are 
published in the ConsExpo manual [12]. An evaluation of the higher tier models showed that 
ConsExpo has a reasonable coverage of many other available higher tier models [13]. If 
parameters are specified as distributions, ConsExpo can perform a distributed (Monte Carlo) 
calculation. The program will draw a set of random numbers from the specified distributions 
(uniform, normal, lognormal, triangular) for distributed parameters and calculate the endpoint 
of choice with this set. For the non-distributed parameters the specified point value is taken. 
Exposure and dose distributions reflect stochastic parameters and these distributions can be 
depicted and percentiles can be quantified. The program can provide sensitivity analyses for 
each stochastic parameter, where mean exposures or doses as a function of the value of a 
selected stochastic parameter are depicted and analysed. The ConsExpo model contains an 
associated database reflecting the RIVM factsheets, which contains default parameters for a 
large number of consumer products and scenarios (higher tier, see www.consexpo.nl). 

Inhalation exposure 

The concentration of a chemical in room air will depend on the amount of chemical present in 
the room, the room size, ventilation of the room, vapour pressure of the compound and the 
rate at which the compound is released into the air. A refined estimation should consider time. 
Modelling exposure therefore requires data that describe the duration of use and the duration 
of primary and secondary exposure. For instance, 1 kg of paint may be used over a period of 2 
hours, followed by secondary exposure of 10 hours, which must be considered by the model 
chosen for estimating this exposure. As a further additional variable, room ventilation has to 
be taken into account for inhalation exposure. Depending on the information available on 
physicochemical properties of the compound and the use of the product, different models are 
available in ConsExpo. 

The instantaneous release model. The model assumes that all compound is released from the 
product at once into the room. When the ventilation rate is set at 0, this will result in the Tier 1 
algorithms as described in Section R.15.3. The model is comparable to the ECETOC TRA 
inhalation model when the ventilation rate is set to 0.6 exchange per hour and the volume of 
the room is set to 20 m3. 

The constant rate model describes the release of a compound with a constant rate of release 
over a certain period of time. During this time, the compound is simultaneously removed from 
the air by ventilation of the room. In addition to the parameters used in the Tier 1 inhalation 
model, the constant rate model also uses the emission duration, i.e. the time during which the 
compound is released. 

The evaporation model describes the release of the compound from the surface of the product 
by evaporation, and can be used if information on the application duration, the release area 
and the release rate of the compound from the product is available. The release rate is 
estimated from the temperature, the molecular weight, vapour pressure, and the mass 
transfer rate (the coefficient, which describes the transport conditions from the boundary layer 

 
 
 
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immediately above the liquid surface). The tool is suitable to estimate releases from mixtures 
but not from articles; for the latter, a more targeted model (Section R.15.5.2.1) has been 
developed by RIVM. 

The spray model describes the indoor inhalation exposure to slowly evaporating or non-volatile 
compounds in droplets that are released from a spray can. For volatile substances released 
from a spray can, the evaporation model should be used to calculate exposure to the volatiles. 
Inhalation is influenced by many factors such as the size of the droplets, the breathing pattern 
and human physiology. 

General exposure parameters needed for this model are spray duration, exposure duration, 
room volume, room height, ventilation rate and spray direction. The specific spray parameters 
are the mass generation rate, the airborne fraction, the weight fraction of non-volatiles, the 
mass density of the total of non-volatile compounds, the weight fraction of the substance in 
the mixture, and the initial particle distribution. 

Dermal exposure 

For higher tier assessments, extractability of substances from articles e.g. textiles should be 
considered. For migrating substances, only the part of the total amount available to/in contact 
with the skin is able to penetrate the skin. The models estimating dermal exposure in 
ConsExpo are described here below: 

The instant application model describes a low tier estimate. The model does not include the 
product layer thickness that is included in Tier I algorithms in Section R.15.3 and ECETOC TRA. 

Constant Rate model. Similarly to the Tier 1 ‘dermal scenario A’ model, the constant rate 
model assumes that any compound in the product is directly applied to the skin. The model 
calculates the amount of product per unit surface area of skin or per kg of body weight over a 
period of time. Therefore, if a good estimate can be made of the time during which the 
compound is applied, this model can be used instead of the instant application model. Two 
additional parameters are required for this model: the release duration and the rate at which 
the product is applied to the skin. 

Rubbing Off model. This describes a secondary exposure situation in which a surface (e.g. 
table top, floor) is treated with a product and dermal exposure arises from contact with the 
treated surface. The additional parameters used in this model are the transfer coefficient 
(treated surface area in contact with skin/ time), the dislodgeable amount, the contact time 
and the rubbed surface. 

Diffusion model. This describes the diffusion of substance into skin due to direct application of 
a product to the skin. After application, the compound diffuses through the product to the skin. 
The diffusion model can be used if the diffusion coefficient of the compound in the product is 
known or can be estimated. The model requires the following additional parameters: the 
diffusion coefficient, the layer thickness of the applied product and the exposure time. 

Migration model. This describes the migration of a compound from a material to the skin when 
dermal contact with the material occurs. The migration is specified as a 'leachable fraction': 
the amount of substance that migrates to the skin per unit amount of product. Typically, this 
fraction has to be determined in extraction experiments with sweat simulant. This model can 
be used, for instance, to estimate exposure to dyes leaching from clothing to the skin. 

Oral exposure 

The models estimating oral exposure in ConsExpo are described here below: 

The direct intake model describes a low tier estimate, and is comparable to the algorithm 
described in Section R.15.3 and in Section R.15.4 (ECETOC TRA tool). 

Constant Rate model. This describes a scenario in which the compound is taken in over a 
certain period of time, e.g. to estimate (secondary) exposure originating from dermal exposure 
on the hands and subsequent hand-mouth contact. The additional parameters used in this 

 
 
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model are ingestion rate and exposure time. 

Oral Migration from Packaging Material. This secondary exposure model calculates the 
exposure to compounds from packaging material via food18. The migration of the compound 
into the food is calculated from the concentration of the compound in the packaging material, 
the contact area of the packaging and the food and the initial migration rate. The oral 
exposure resulting from food consumption is subsequently calculated by assuming that the 
migrated compound is homogeneously distributed over the food and that the intake of the 
compound is therefore proportional to the fraction of packaged food consumed. 

R.15.5.2. Other tools 

There are sector specific tools, largely based on Tier I algorithms, where habits and practices 
from sector organizations are specified and used as input parameters. Two models need to be 
mentioned: 

  AISE (International Association for Soaps, Detergents and Maintenance Products) has 
developed a model, REACT Consumer Tool, which allows quantitative estimation of 
exposure to substances that are present in products (washing and cleaning - PC 35, air 
freshener – PC3 and polishes and wax – PC31) used by consumers. The tool calculates 
exposure via inhalation, dermal, and oral routes separately and also provides a 
summation of all the relevant exposure routes. The model uses as input parameter 
habits and practices coming from the HERA Project (see Appendix R.15.2). It should be 
noted that the tool does not cover the evaporation of volatile substances from the 
product, since it considers the inhalation route relevant for spray applications only. The 
tool is freely available on the AISE website (www.aise.eu). 

  ESIG (European Solvent Industry Group) has developed the EGRET consumer tool 

(2010). The tool takes the default assumptions and algorithms (equations) described in 
the ECETOC TRA, but it introduces refined default values for those product categories 
relevant to solvents. Since the tool addresses all Product Categories (PC) potentially 
applicable to solvents, additional PCs (not assessed by ECETOC TRA) are covered by the 
ESIG tool (e.g. anti-freezing and de-icing products – PC4, different fuel products – 
PC13, functional fluids – PC17). Relevant characteristics of the tool are presented 
hereafter. First, the tool suggest refined default values for product subcategories which 
are not agreed among stakeholders (as is the case for the ECETOC TRA tool). Second, 
the model introduces automatic refinement if the event exposure exceed the long term 
DNEL. Some of these refinements consist in additional measures on the part of the 
consumer and may not be easy to communicate or implement (e.g. “open windows”); 
or linear averaging of the event exposure over the day and over the year, which might 
be in contradiction with provisions reported in Section R.15.2.3. The tool is freely 
available at ESIG website (www.esig.org)19. 

Several previous route-specific models and general consumer exposure models are now 

18 ConsExpo model covers consumer exposure situations beyond the scope of REACH. Please note that. Exposure from 
food or food-related products is outside the scope of REACH. 

19 Following feedback from users and stakeholders, notably discussions at ENES and experiences arising from the (mis) 
application of EGRET in some 2010 chemical safety assessments, ESIG initiated a revision of EGRET in 2014. The most 
recent version of EGRET (v.2) now accommodates improved functionalities to address this feedback and in particular 
to minimize potential misuse of the model in the future. The updated tool was officially released in December 2015 and 
is now available for downloading at the ESIG website. 

 
 
 
 
 
 
 
 
 
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integrated into the US EPA E-Fast model (US EPA, 2015) (see Computer tools for estimation of 
consumer exposure, Appendix R.15.3). 

Other potentially relevant tools are described in Appendix R.15.3. 

R.15.5.2.1 Substances in articles 

Regarding the exposure to substance in articles, RIVM has developed (2010) the Emission 
Model to specifically estimate the inhalation exposure after release of chemicals from solid 
materials [14]. The model takes into account the diffusion of a substance in a material, the 
mass transfer from material into air and removal of the substance from residential air by 
ventilation. The tool simulates time profiles of the air concentration and mean air 
concentrations arising from emission. The model is based on well-established modelling of 
emissions from building materials, and is designed for specific shapes (e.g. slab like articles 
like panels, flooring, etc.); extrapolation to other shapes may introduce an unknown degree of 
uncertainty. The model, its underlying assumptions and an overview of available input data 
and methods to estimate key input parameters are described in [14]. The program is freely 
available for download from www.consexpo.com. 

R.15.5.3. Overview of the consumer estimation tools 

Table  R.15-  6  below  shows  an  overview  of  the  modelling  tools  mentioned  in  Sections  R.15.4 
and  R.15.5.  It  includes  a  brief  description  of  the  tools,  the  main  characteristics  and  the  tool 
boundaries. 

 
 
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Table R.15- 6: Overview of the consumer exposure estimation tools 

Model 

Summary 

Main characteristics 

Boundaries 

ECETOC TRA 
v.3.1 

Partially 
(inhalation/dermal/oral) 

based  Tier  1 

algorithms 

Allows  batch  processing  of  exposure 
calculations a for many PCs/ACs 

Default values provided for all PCs/ACs 
covered by the tool 

Possible to define a new product/article 
subcategory 

It is integrated in Chesar 

Consexpo 

Higher  tier  model  which  contains  4  sub 
models for inhalation, 5 for dermal and 3 
for oral exposure 

Possible 
distribution (uncertainty analysis) 

perform 

to 

Montecarlo 

an 

associated 

database 
Contains 
reflecting  the  RIVM  factsheets,  which 
contains  default  parameters  for  a  large 
number  of  consumer  products  and 
scenarios 

It allows lower tier assessment as well as 
higher  tier  assessment  when  transfer 
factors, 
and 
outdoor/indoor use are set by the user 

frequency 

bands 

Consexpo contains mainly higher tier sub 
models,  for  which  a  relevant  number  of 
is  needed.  If  the 
input  parameters 
is  not  supported  by  RIVM 
scenario 
factsheet, 
to 
estimate  those  parameter’s  values  by 
himself 

registrant  needs 

the 

The  tool  does  not  cover  exposure 
arising from dusty materials or from 
dust-generating activities 

Indirect  dermal  contact  (e.g.  via 
vapours  or  spray  clouds)  is  not 
covered by the tool 

Evaporation model (inhalation) is not 
suitable  to  estimate  exposure  from 
solid material 

Spray  model 
estimate  exposure 
substances in the sprayed product 

is  not  suitable  to 
from  volatile 

 
 
 
 
 
 
 
 
 
 
 
 
 
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Model 

Summary 

Main characteristics 

Boundaries 

EGRET 

Based on the same principle of TRA v.3.1 
(inhalation/dermal/oral). 

New products are added and default 
provided to cover solvent sector. 

New refined default are proposed for all 
the PCs covered by the tool 

REACT 

Based 
(inhalation/dermal/oral). 

largely  on  Tier  1algorithms 

It contains several sub products within 
PC3, PC31, PC35. 

For  all  sub  products  default  values 
coming from HERA project are given 

refined 

It  allows  lower  tier  assessment  (as  for 
TRA)  as  well  as  higher  tier  assessment 
when 
are 
proposed,  transfer  factors  introduced, 
frequency  over  the  day/year  assumed 
(linear  averaging),  outdoor  activities  or 
extra ventilation assumed. 

default 

values 

Same as TRA v. 3.1 

Can  be  considered  as  Tier  1  tool  with 
refined  sub  product  categorisation  (PC3, 
PC31,  PC35)  and  refined  default  values 
assigned to them 

The 
the 
tool  does  not  cover 
evaporation  of  volatile  substances 
from  the  product.  It  covers  the 
inhalation  route  in  case  of  spray 
products only 

RIVM 
emission 
model 

from 

It  estimates 
  solid  
releases 
materials  to  indoor  air  and  subsequent 
inhalation  exposure  concentration  in  a 
room.  It  is  based  on  Tier  2  algorithms 
which  take  diffusion  and  mass  transfer 
mechanism from solid material to indoor 
air 
are 
represented  by  profile  concentration  in 
indoor air for the selected time 

Exposure 

account. 

into 

it 

tool, 

such 

requires 
as 

input 
As  Tier  2 
diffusion,  
parameters 
partitioning coefficient and mass transfer 
coefficients. Values and equation on how 
to  derive  them  are  reported  for  a  
number of materials and substance types 
in the guidance supporting the tool 

The  tools  does  not  cover  releases 
from  liquid  mixture.  It  does  cover 
slab 
(e.g.  panels, 
flooring) only 

like  articles 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version 3.0 - July 2016 

47 

R.15.5.4. Measurements 

In general measured data are preferred over modelled data, provided that they are reliable 
and representative for the situation that needs to be assessed. For most consumer exposure 
scenarios, measurements of the actual exposure of consumers will not be available. However, 
it may be possible that for one or more of the parameters used in the estimations 
measurements are available and can be used to override the default values (see Appendix 
R.15.4 for room volumes, air exchange rates, migration rates, ad- and desorption as well as 
absorption rates). If needed, reasonable worst-case assumptions can be replaced by 
considering measured parameter values and their variability. 

Exposure data, including releases from articles and room concentrations, might be generated 
within other legislative frameworks, such as the product safety legislation. The latter could be 
very interesting for an assessor under REACH since they may be already available for a 
representative range of conservative scenarios. For example, the Construction Products 
Regulation (CPR) might be a source of information to support the assessment under REACH of 
some mixtures or articles used as building materials. Under this framework, some Member 
States (Belgium, France, Germany) require the testing of some construction products (e.g. 
floorings, adhesives) to measure the emissions to indoor air of some substances and the 
testing simulates the indoor concentration arising from such releases. This testing is done in a 
standardised default “chamber test” (relative humidity 50% and temperature 23 C) according 
to the project European Standard prEN 16516. 

There may be measurements of external exposure (i.e. concentrations in the environment in 
which the contact takes place) as well as measurements of internal exposure (e.g. in blood or 
tissues) available. Non-volatile substances may accumulate in house dust. For such 
substances, release from consumer articles e.g. furniture, textiles, and building material may 
be monitored by measurements performed in house dust. The uptake is then calculated by 
multiplying the concentrations with dust uptake defaults. Measurements of concentrations in 
house dust yield 'aggregate' values, including possibly the contribution of environmental 
sources or products not regulated under REACH, such as cosmetics. Such measurements are 
then to be regarded as upper limits of exposure. Monitoring data may be available e.g. on 
substances with a (potential) PBT or vPvB profile. Measured data have to be representative of 
the Exposure Scenario to be assessed, i.e. they reflect the conditions of use set in the ES. 

Data from biomonitoring or occupational exposure programmes may be valuable for consumer 
exposure estimations, although their number, representativeness and quality will often vary 
widely. Measured data from surrogate substances or analogues and surrogate scenarios (e.g. 
chamber measurements) may also be useful when estimating exposure levels. 

Several sources of measured data are reported in Appendix R.15.2. 

 
 
 
 
 
 
 
48  Guidance on Information Requirements and Chemical Safety Assessment 
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Version 3.0 - July 2016 

R.15.6. Risk Characterisation 

Risk characterisation is expected to address both qualitative assessment (for hazards with no 
DNELs available) and quantitative assessment (hazards where DNELs are available) for each 
use and its contributing scenario. 

  Qualitative risk characterisation: Provide the arguments that the conditions of use as 

described in the exposure scenario will make it unlikely that adverse effects occur. Most 
often this refers to hazards like irritation, corrosion and sensitisation. For the inhalation 
route exposure estimates may be helpful to demonstrate that the exposure concentration is 
indeed limited to the minimum or absent. Where CMR substances with no threshold are to 
be assessed for consumer uses (potentially relevant for substances in articles), the risk 
characterisation can additionally be referred to a Derived Minimum Effect Level (DMEL). If 
the estimated exposure is lower than the DMEL, the measures described to prevent 
exposure can be considered appropriate. 

  Quantitative risk characterisation: Compare the estimated exposure via the relevant 
routes with the DNELs and derive risk characterisation ratios (RCR). The Tier 1 exposure 
estimation and/or information from higher tier tools/models and/or measured data (if 
deemed necessary) can be used in the quantitative risk characterisation (see Part E of the 
IR&CSA guidance). If the exposure is below the DNEL, the risk is considered controlled 
(RCR < 1). For consumers normally the risk is to be characterised against DNELs for long- 
term systemic hazards. Depending on the duration and frequency of the event and the 
substance properties (toxicity and half-life in body) a particular risk characterisation for 
acute or short term single (infrequent) exposure events may be appropriate. This may 
be based short-term DNELs or on long-term DNELs (using adjustment factors) 

A risk characterisation is required for all uses and their contributing scenarios, differentiated 
according to routes of exposure. Risks from combined exposure across the three routes is 
to be characterised by building the sum of RCRs per contributing scenario. 

For products designed for use by children or for consumer products for which the habits and 
practices of children significantly differ from those of adults (e.g. mouthing and crawling 
behaviour) particular risk characterisation for children should be provided. The assessment 
should be based on the specific body parameters of children. 

According to REACH Annex I, the registrant should consider risks from 
combined/(aggregated)20 exposure across different uses (products) relevant for his 

20 Please note, that the REACH terminology is not fully aligned with the one used at OECD and WHO level with regard 
to the use “combined exposure or risk”. Under REACH this always refers to one substance and not to combination of 
different substances. 

The WHO/IPCS Framework on Combined Exposure defines the terms aggregated and cumulative exposure as: 

Aggregate exposure: The demographic, spatial and temporal characteristics of exposure to a single chemical 
through all relevant pathways (e.g. food, water, residential uses, occupational) and routes (e.g. oral, dermal, 
inhalation). Aggregate risk is the risk associated with multiple pathways/routes of exposure to a single chemical. 

Cumulative exposure: Defines the aggregate exposure (see above) to multiple chemicals. Cumulative risk is the 
combined risk from aggregate exposure to multiple chemicals (and may be restricted to chemicals that have a 
common mechanism of toxicity). 

 
 
 
 
 
 
 
 
 
 
 
 
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49 

substance. He is, however, not obliged to carry out a risk characterisation related to uses of 
the substance not covered in his own registration." 

In the context of this guidance, the addition of routes will be referred to as “combination” while 
the addition of sources will be referred to as “aggregation”. 

Risks resulting from exposure to the substance via simultaneous use of different products may 
be taken into account (where relevant) through summing up of risk characterisation ratios for 
systemic effects across exposure scenarios. This could be relevant for instance when products 
are used routinely together (e.g. cleaning products) and the risk characterisation for the single 
product use is close to 1. However please note that simply summing up the RCRs resulting 
from Tier 1 tool estimates leads to a rather conservative outcome. In most cases more 
sophisticated (e.g. probabilistic) methods and corresponding datasets will be needed, in order 
to properly reflect the co-use pattern of products across consumers. Such methods are under 
development for certain product groups (see also [15] and [16]). Exposure to the substance 
via different products may also be relevant when adjusting assessments for short duration 
over the day, or when characterising the risk related to infrequent exposure. 

In addition to direct exposure resulting from the use of products, the general population may 
be exposure to the substance via the environment (ambient air, drinking water and food). In 
the environmental assessment these routes are considered by default and the resulting risk 
characterisation for long-term systemic effects may need to be taken into account when 
assessing the overall exposure to a substance (see Chapter R.16 of the IR&CSA Guidance 
which explains the assessment of exposure of man via the environment). 

The outcome of the risk characterisation is used to decide whether safe use can be 
demonstrated or if further iterations are needed. Once the final iteration has shown sufficient 
control of risks for consumers the assessment can be finalised. This is the case if i) the 
exposure estimates are below the DNEL and ii) the likelihood of effects due to irritation, 
corrosion and sensitisation or other non-threshold effects is negligible. 

The RMMs and operational conditions ensuring control of risk for consumers (i.e. mainly the 
characteristics of a safe consumer product and the underlying assumption on habits and 
practices) should be documented in final exposure scenarios. 

If certain consumer uses are not supported or are advised against due to health risks, this 
should be recorded in the CSR and communicated via the extended Safety Data Sheet 
(extended SDS). 

In order to produce a meaningful risk characterisation it is important for the assessor to 
understand and take into account the uncertainties associated with the information/data that is 
provided (related to both hazard assessment and exposure assessment). The registrant is 
expected to include a reflection on the most significant uncertainties in his assessment into 
section 9.0 of the CSR. Chapter R.19 of the Guidance on IR&CSA contains more information on 
using uncertainty analysis. 

 
 
 
 
 
 
 
 
 
 
50  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

REFERENCES 

[1] 

J. Van Engelen, M. Park, P. Janssen, A. Oomen, E. Brandon, K. Bouma, A. Sips and M. 
Van Raaij, “Chemicals in Toys. A general methodology for assessment of chemical safety 
of toys with a focus on elements. RIVM report 320003001/2008,” 2008. [Online]. 
Available: 
http://www.rivm.nl/dsresource?objectid=rivmp:272028&type=org&disposition=inline. 

[2]  RAC, “RAC Opinion on an Annex XV dossier proposing restrictions on lead and lead 

compounds in jewellery. ECHA/RAC/ RES-O-0000001304-85-03/F. Chemicals concerned: 
Lead and its compounds,” 2011. [Online]. Available: 
http://echa.europa.eu/documents/10162/aa4af911-5dae-4cf2-a337-6bdf81ee7536. 

[3]  ECHA, “Evaluation of new scientific evidence concerning DINP and DIDP in relation to 

entry 52 of Annex XVII to REACH Regulation (EC) No 1907/2006,” 2013. [Online]. 
Available: http://echa.europa.eu/documents/10162/31b4067e-de40-4044-93e8- 
9c9ff1960715. 

[4]  RAC, “Opinion on the ECHA’s draft review report on “Evaluation of new scientific 

evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to Regulation 
(EC) No 1907/2006 (REACH)”,” 2013. [Online]. Available: 
http://echa.europa.eu/documents/10162/13579/rac_opinion_dinp_didp_en.pdf. 

[5]  E. Cohen Hubal, J. Moya and S. Selevan, “A lifestage approach to assessing children’s 

exposure,” Birth Defects Research (Part B), vol. 83, no. 6, p. 522–529, 2008. 

[6]  M. Wormuth, M. Scheringer, M. Vollenweider and K. Hungerbühler, “What are the 

sources of exposure to eight frequently used phthalic acid esters in Europeans?,” Risk 
Analysis, vol. 26, p. 803 – 823, 2006. 

[7]  A. Oomen, P. Janssen, A. Dusseldorp and C. Noorlander, “Exposure to chemicals via 

house dust, RIVM rapport 609021064,” 2008. 

[8]  ECETOC, “Addendum to ECETOC Targeted Risk Assessment Report No. 93 - Technical 

Report No. 107,” December 2009. [Online]. Available: http://www.ecetoc.org/technical- 
reports. 

[9]  ECETOC, “ECETOC TRA version 3: Background and Rationale for the Improvements. 

Technical Report No. 114,” July 2012. [Online]. Available: http://www.ecetoc.org/tra. 

[10]  ECETOC, “Addendum to TR114: Technical Basis for the TRA v3.1 - Technical Report No. 

124,” 2015 June 2014. [Online]. Available: http://www.ecetoc.org/technical-reports. 

[11]  J. te Biesebeek, M. Nijkamp, B. Bokkers and S. Wijnhoven, “General Fact Sheet. General 
default parameters for estimating consumer exposure - Updated version 2014. RIVM 
report 090013003/2014,” 2014. [Online]. Available: 
http://rivm.nl/Documenten_en_publicaties/Wetenschappelijk/Rapporten/2014/december  
/General_Fact_Sheet_General_default_parameters_for_estimating_consumer_exposure_ 
Updated_version_2014. 

 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

51 

[12]  J. Delmaar, M. P. Park, and J. van Engelen, “ConsExpo 4.0. Consumer Exposure and 

Uptake Models; Program Manual. RIVM report 320104004/2005.,” 2005. [Online]. 
Available: 
http://rivm.openrepository.com/rivm/bitstream/10029/7307/1/320104004.pdf. 

[13]  D. J. E. J. Park MVDZ, “Comparison of consumer exposure modelling tools. Inventory of 

possible improvements of ConsExpo. RIVM report 320104006,” 2006. [Online]. 
Available: 
https://rivm.openrepository.com/rivm/bitstream/10029/13405/1/320104006.pdf. 

[14]  J. Delmaar, “Emission of chemical substances from solid matrices. A method for 

consumer exposure assessment. Report 320104011/2010,” 2010. [Online]. Available: 
http://www.rivm.nl/dsresource?objectid=rivmp:24644&type=org&disposition=inline&ns_ 
nc=1. 

[15]  A. Karabelas, “ Realistic estimation of exposure to substances from multiple sources 

(TAGS). B5-CERTH,” [Online]. Available: http://cefic-lri.org/projects/b5-certh-realistic- 
estimation-of-exposure-to-substances-from-multiple-sources-tags/. 

[16]  N. von Goetz, “Estimation of realistic consumer exposure to substances from multiple 

sources and approaches to validation of exposure models. B7-ETHZ,” [Online]. Available: 
http://cefic-lri.org/projects/b7-ethz-estimation-of-realistic-consumer-exposure-to- 
substances-from-multiple-sources-and-approaches-to-validation-of-exposure-models/. 

[17]  ECETOC, “Technical report no. 93. Targeted Risk Assessment,” 2004. [Online]. Available: 

http://www.ecetoc.org/tra. 

[18]  R. Krätke and T. Platzek, “Migrationsverfahren und Modelle zur Abschätzung einer 

möglichen Exposition mit Textilhilfsmitteln und -farbmitteln aus Bekleidungstextilien 
unter Anwendungs-bedingungen,” Bundesgesundheitsblatt - Gesundheitsforschung - 
Gesundheitsschutz, vol. 47, p. 810–813, 2004. 

[19]  ETAD, “ Final Report on Extractability of Dyestuffs from Textiles. Ecological and 

Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD), Project A 
4007.,” 1983. 

[20]  OECD, “Report on OECD workshop on children's exposure to chemicals. Series on Testing 

and Assessment No. 209. ENV/JM/MONO(2014)29.,” 2014. [Online]. Available: 
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2 
014)29&doclanguage=en. 

[21]  OECD, “Assessing the risk of chemicals to children’s health: an OECD-wide survey. Series 

on Testing & Assessment No. 192. ENV/JM/MONO(2013)20.,” 2013. [Online]. Available: 
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2 
013)20&doclanguage=en. 

 
 
 
 
 
 
52  Guidance on Information Requirements and Chemical Safety Assessment 
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Version 3.0 - July 2016 

Appendix R.15.1 Consumer product and article categories 

Chapter R.12 (on Use description) of the Guidance on IR&CSA provides lists of the Product 
Categories (PCs) and Article Categories (ACs). Table R.15- 7 and Table R.15- 8 list PCs and 
ACs which describe uses regulated by REACH and which are generally considered to potentially 
result in significant exposures of consumers. These PCs and ACs with specific subcategories 
can be assessed by using the ECETOC TRA consumer tool. The tables were agreed upon as a 
non- exhaustive list of relevant consumer product and article categories by the ECHA 
consumer expert group comprised of representatives of ECHA, ECETOC, RIVM, BfR, INERIS 
and the Danish EPA during 2008-2009. Table R.15- 8 also provides cross references between 
ACs as provided in Chapter R.12 and a list of AC subcategories proposed by ECETOC for the 
assessment. Please note that this list does not cover all the relevant consumer uses (see 
Section R.15.4.1). 

Table R.15- 7: Consumer products addressed in the consumer TRA 

Descriptor 

Product Subcategory 

Glues, hobby use 

PC1:Adhesives, sealants 

Glues DIY-use (carpet glue, tile glue, wood parquet 
glue) 

PC3: Air care product 

Glue from spray 

Sealants 

Air care, instant action (aerosol sprays) 

Air care, continuous action (solid & liquid) 

Waterborne latex wall paint 

PC9a:Coatings, paints , 
thinners, removers 

Solvent rich, high solid, water borne paint 

Aerosol spray can 

Removers  (paint-,  glue-,  wall  paper-,  sealant- 
remover) 

PC9b:Fillers,  putties,  plasters, 

Fillers and putty 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Descriptor 

Product Subcategory 

modelling clay 

Plasters and floor equalizers 

Modelling clay 

PC9c: Finger paints 

Finger paints 

PC12: Fertilizers 

Lawn and garden preparations 

PC13: Fuels 

PC24: 
release products 

Lubricants, 

greases, 

Liquids 

Liquids 

Pastes 

Sprays 

PC31: Polishes and wax blends 

Polishes, wax / cream (floor, furniture, shoes) 

Polishes, spray (furniture, shoes) 

Laundry and dish washing products 

PC35:  Washing  and  cleaning 
products 
solvent 
(including 
based products) 

Cleaners, 
products, 
cleaners, metal cleaners ) 

liquids 
sanitary 
floor  cleaners,  glass  cleaners,  carpet 

(all-purpose 

cleaners, 

Cleaners, trigger sprays (all-purpose cleaners, sanitary 
products,  glass cleaners) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
54  Guidance on Information Requirements and Chemical Safety Assessment 
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Table R.15- 8: Article Categories addressed in the consumer TRA and cross reference to Article 
categories reported in Chapter R.12 

Descriptor 

Article subcategory (ECETOC) 

Article category (Chapter R.12) 

Clothing (all kind of materials), towel 

Bedding, mattress 

AC5:Fabrics, 
textiles 
apparel 

and 

Toys (cuddly toy) 

AC5f: 

textiles  and  apparel 

Fabrics, 
:  
articles  with  intense  direct  dermal 
contact during normal use 

AC5g:  Fabrics,  textiles  and  apparel  : 
articles  with  intense  direct  dermal 
contact  during  normal  use:  bedding 
and mattresses 

AC5b:  Fabrics,  textiles  and  apparel  : 
toys  intended  for  children’s  use  (and 
child dedicated articles) 

AC5e:  Fabrics,  textiles  and  apparel  : 
furniture  & 
including 
furniture coverings 

furnishing, 

Car seat, chair, flooring 

Or 

AC5a:  Fabrics,  textiles  and  apparel  : 
large surface area articles 

Purse, wallet, covering steering wheel 
(car) 

AC6g: other leather articles 

AC6: 
articles 

Leather 

Footwear (shoes, boots) 

Furniture (sofa) 

AC8:Paper 
articles 

Diapers 

Sanitary towels 

AC6f:  Leather  articles  :  article  with 
intense  direct  dermal  contact  during 
normal use 

AC6e:  Leather  articles  :  furniture  & 
furnishing, 
furniture 
including 
coverings 

AC8f1:  Paper  articles:  articles  with 
intense  direct  dermal  contact  during 
normal use: personal hygiene articles 

AC8f1:  Paper  articles:  articles  with 
intense  direct  dermal  contact  during 
normal use: personal hygiene articles 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Descriptor 

Article subcategory (ECETOC) 

Article category (Chapter R.12) 

Tissues, paper towels, wet tissues, toilet 
paper 

AC8f1:  Paper  articles:  articles  with 
intense  direct  dermal  contact  during 
normal use: personal hygiene articles 

Printed  paper 
books) 

(papers,  magazines, 

Rubber handles, tyres 

AC10:Rubber 
articles 

Flooring 

Footwear (shoes, boots) 

Rubber toys 

Furniture (chair) 

AC8f2:  Paper  articles:  articles  with 
intense  direct  dermal  contact  during 
normal  use:  printed  articles  with 
dermal  contact  in  normal  conditions  
of use 

AC10e:  Rubber  articles:  furniture  & 
furnishing, 
furniture 
including 
coverings 

Or 

AC10g: other rubber articles 

AC10a: Rubber articles: large surface 
area articles 

AC10f:  Rubber  articles:  article  with 
intense  direct  dermal  contact  during 
normal use 

Rubber 

AC10b: 
toys  
intended  for  children’s  use  (and  child 
dedicated articles) 

articles: 

AC11e: Wood articles: furniture & 
furnishings 

Walls and flooring (also applicable to 
non-wood materials) 

AC11a: Wood articles: large surface 
area articles 

AC11:Wood 
articles 

Small toys (car, train) 

Toys, outdoor equipment 

AC11b:  Wood  articles:  toys  intended 
for children’s use (and child dedicated 
articles) 

AC11f:  Wood  articles:  articles  with 
intense  direct  dermal  contact  during 
normal use 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
56  Guidance on Information Requirements and Chemical Safety Assessment 
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Descriptor 

Article subcategory (ECETOC) 

Article category (Chapter R.12) 

Plastic, larger articles (plastic chair, 
PVC-flooring, lawn mower, PC) 

AC13:Plastic 
articles 

Toys (doll, car, animals, teething rings) 

AC13a:  Plastic  articles:  large  surface 
area articles 

Or 

AC13e:  Plastic  articles:  furniture  & 
furnishing, 
furniture 
coverings 

including 

Or 

AC13g: Other plastic articles 

AC13b: Plastic articles: toys intended 
for children’s use (and child dedicated 
articles) 

Plastic, small articles (ball pen, mobile 
phone) 

AC13f:  Plastic  articles:  articles  with 
intense  direct  dermal  contact  during 
normal use 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix R.15.2  Valuable sources on exposure data 

Main EU consumer exposure databases 

BUMAC Database 

The BUMAC database is a well-designed consumer product emission database created within 
the framework of the EPHECT Project. The EPHECT Project focuses its efforts on European use 
and use patterns of relevant consumer products and contributes to a better understanding of 
multiple exposures to air pollutants emitted by typical household products. The specific 
objective of the BUMAC database is the creation of a database on the state-of-the-art of 
emissions and health end points from consumer products. The primary purposes of the 
database development were to: a) Create an overview of the available consumer products 
emission data; b) Create an overview of the existing data gaps. 

The BUMAC database is set-up as a compilation of data on the current state-of-the-art on 
consumer product compositions and emissions, on test chamber experimental results, 
exposures, risks and health end points. Qualitative data were assured by using only data 
outcomes from procedures derived from standardized emission test protocols. The key indoor 
air pollutants and emerging pollutants studied comprise: (1) compounds prioritized by relevant 
international concerted actions or international organizations, such as INDEX, BUMA and WHO 
and (2) compounds reported in open literature as (potentially) hazardous and occurring in this 
type of consumer product. They include gaseous and particulate matter emissions, secondary 
reactions and degradations of coated surfaces. The database allows a clear view on current 
research gaps. 

The database is accessible via the webpage of EPHECT Project: 
https://esites.vito.be/sites/ephect/Pages/home.aspx 

IPCheM Database 

IPCheM - the Information Platform for Chemical Monitoring - is a single access point for 
locating and retrieving chemical monitoring data collections managed and available to the 
European Commission, European Agencies, Member States, international and national 
organisations and researchers. The Platform aims to support a more coordinated approach to 
collecting, storing and accessing monitoring data on chemicals and chemical mixtures, in 
humans and in the environment. IPCheM is a de-centralised system, providing remote access 
to existing information systems and data providers. The database contains also a “Product and 
indoor air module” associated to exposure inside the buildings. Indoor and outdoor sources of 
air pollution include chemical emissions from construction and consumer products. The Joint 
Research Centre Institute for Health and Consumer Protection is responsible for this module. 

The database is accessible via the link: https://ipchem.jrc.ec.europa.eu/ and it will soon be 
available to the general public. 

 
 
 
 
 
 
58  Guidance on Information Requirements and Chemical Safety Assessment 
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Table R.15- 9: Further information 

Acrony 
m 

AIHC 

BVL 

CEPA 

Full name 

Country 

Remarks 

Contact 

US 

DE 

US 

American 
industrial health 
council (1994). 
Exposure factors 
handbook 

Federal office for 
Consumer 
Protection and 
Food  Safety 
Food monitoring, 
focus to Germany 

Air toxic Hot 
Spots Program 
Risk Assessment 
Guidelines 
Californian 
Environmental 
Protection 
Agency. 

Update coordinator, Suite 
760, 2001 Pennsylvania 
Ave. NW, Washington DC 
20006-1807 

mailto:poststelle@bvl.bund. 
de 

https://www.bvl.bund.de 

www.oehha.ca.gov/air/hot_ 
spots/finalStoc.html 

Anthropometric 
data on adults 
and children, 
behaviour data, 
given as 
distributions 

German 
monitoring data 
on undesired 
substances in 
foodstuffs, 
cosmetics and 
consumer 
articles. 

Part IV Technical 
Support for 
Exposure 
Assessment and 
Stochastic 
Analysis 

CH-PR 

Swiss product 
register 

CH 

Product 
information, 
given on request 

Contact: Dr P. Bormann, 
Swiss Federal Health Office, 
Bern, Switzerland 

ECETOC 

CEPE 

EU 

EU 

Exposure Factors 
Sourcebook for 
European 
Populations (with 
focus on UK data) 

European Council 
of producers and 
importers of 
paints, printing 
inks and artists' 
colours 

Probability 
analysis 
Anthropometrics 
Time activity 
patterns 

European 
industrial 
association, 
focus on paints, 
printing inks and 
artists’ colours 

www.ecetoc.org 

http://www.cepe.org/efede 
/public.htmh 

 
 
 
 
 
 
 
 
 
 
 
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Acrony 
m 

AISE 

Full name 

Country 

Remarks 

Contact 

International 
Association for 
Soaps, 
Detergents and 
Maintenance 
Products 

International 
Association, 
focus on 
household 
cleaning and 
maintenance 
products 

https://www.aise.eu/h 

JRC-IHCP  European 

Exposure Factors 
(ExpoFacts) 
Sourcebook 
(based on CEFIC- 
LRI project) 

30 European 
countries: 
EU member 
states in 
addition to 
Iceland, 
Norway and 
Switzerland 

Database of 
statistics and 
reference factors 
affecting 
exposure to 
environmental 
contaminants 

http://expofacts.jrc.ec.euro 
pa.eu 

The Danish EPA 

DK 

ChEmiTec 
s 

Project finansed 
by the Swedish 
EPA 

SE 

Kemikaliei 
nspektion 
en 

Swedish 
Chemicals Agency 

SE 

http://www.mst.dk/English 
/ 

http://www.chemitecs.se/ 

http://www.kemi.se 

Study reports on 
chemicals in 
consumer 
products and 
articles 

Research and 
studies on 
emission of 
organic 
chemicals from 
articles 

Webpage on 
mass flow 
analysis of 
substances, 
statistics on use 
of chemicals in 
Sweden 

PR-FIN 
(KETU) 

Finnish product 
register 

FIN 

Product 
information 

www.valvira.fi 

Climate and 
Pollution Agency 

NO 

http://www.klif.no 

Webpage on 
various 
substances found 
in articles 

 
 
 
 
 
 
 
 
 
 
 
 
 
60  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

Acrony 
m 

Full name 

Country 

Remarks 

Contact 

Finland’s 
environmental 
administration 

FIN 

DTU 

Food. National 
food institute 

DK 

http://www.ymparisto.fi/ 

http://www.food.dtu.dk 

Information of 
substances in 
textiles can be 
found here 

Information on 
migration from 
food packet 
materials. 

OECD 

OECD Task Force 
exposure 
assessment 

Work on 
consumer 
exposure 
ongoing 

http://www.oecd.org/chemi 
calsafety/assessmentofche 
micals/oecdactivitiesonexpo 
sureassessment.htm 

EPHECT 

VITO 

BE 

RIVM 

Emission tool 
report 

NL 

EU Project on 
consumer 
products to be 
potential sources 
of hazardous air 
pollutants in 
dwellings. 

Information on 
emissions from 
articles related to 
consumer 
exposures 

PR-S 

PR-D 

SPIN 

RefXP 

Swedish product 
register 

SE 

Danish product 
register 

DK 

Product 
information 

Product 
information 

Nordic SPIN 
database 

NO, SE, DK, 
FI, IS 

DE 

Exposure Factors 
Database 
Umweltbundesam 
t 

Product 
information from 
the Nordic 
product registers 

Update of AUH 
data with 
probabilistic 
focus 

https://esites.vito.be/sites/ 
ephect/Pages/home.aspx 

http://www.rivm.nl/dsresou 
rce?objectid=rivmp:24644& 
type=org&disposition=inlin 
e 

www.kemi.se 

http://www.at.dk/ 

www.spin2000.net 

http://www.umweltbundesa 
mt.de/service-e/uba- 
datenbanken-e/index.htm 

 
 
 
 
 
 
 
 
 
 
 
Guidance on Information Requirements and Chemical Safety Assessment 
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Version 3.0 - July 2016 

61 

Full name 

Country 

Remarks 

Contact 

Acrony 
m 

RIVM 

NL 

te Biesebeek et 
al., ConsExpo 
General Fact 
Sheet 

RIVM- 
paint 

NL 

Bremmer HJ, Van 
Engelen, JGM 
(2007) Factsheet 
paint 

NL 

US 

EU 

RIVM-DIY  Ter Burg W. et al. 
(2007) Factsheet 
Do It Yourself 
products 

US EPA 

HERA 

Environmental 
Protection Agency 
(1997). Exposure 
Factors 
Handbook. 

Human and 
Environmental 
Risk Assessments 
on ingredients of 
household 
cleaning products 

CEFIC 

European 
Chemical 
Industry Council 

EU 

www.rivm.nl 

www.rivm.nl 

General 
information, 
room volumes, 
room ventilation 
data 

Use data on 
paints, paint 
classification, 
characterisation 
of paint use, 
focus on NL 

Use data on do it 
yourself 
products. 

www.rivm.nl 

Substantial 
compilation of 
exposure factors 

www.epa.gov 

www.heraproject.com 

http://www.cefic.org/ 

Data on 
household 
cleaning 
products, 
collected by 
A.I.S.E and 
CEFIC 

European 
industrial 
association (all 
chemical 
industries) 

 
 
 
 
 
 
 
 
 
 
62  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

Appendix R.15.3 Computer 
consumer exposure 

tools 

for  estimation  of 

INTRODUCTORY REMARKS 

All the computer tools mentioned in this section can be helpful in performing exposure 
assessments. It has to be kept in mind while using them that they are designed to address 
different scenarios (e.g. routes, products or articles types) and thus reflect different scientific 
approaches. First of all, the assessor must be aware that the scenarios governing the model 
characterisation are different. For instance, the ConsExpo inhalation exposure scenarios (see 
Section R.15.5.1) are based on a one room lay-out, while the CEM program (US-EPA) 
considers exposure in a whole house with different rooms and differentiated scheme of times 
staying in the rooms throughout a day of users and non-users. It is clear that these differences 
in the scenario must lead to different results and the assessor has to document the reasons for 
favouring a specific model. 

Note: This section does not discuss the models presented elsewhere in the guidance text, 
namely ECETOC TRA (Section R.15.4), ConsExpo (Section R.15.5.1) and other tools such as 
RIVM Emission tool (Section R.15.5.2). 

US EPA Wall Paint Exposure Assessment Model (WPEM) 

The Wall Paints Exposure Assessment Model (WPEM) estimates the potential exposure of 
consumers and workers to the chemicals emitted from wall paint which is applied using a roller 
or a brush. WPEM is a user-friendly, flexible software product that uses mathematical models 
developed from small chamber data to estimate the emissions of chemicals from oil-based 
(alkyd) and latex wall paint. This is then combined with detailed use, workload and occupancy 
data (e.g., amount of time spent in the painted room, etc.) to estimate exposure. The output 
of WPEM was evaluated in a home used by EPA for testing purposes and, in general, the 
results were within a factor of 2. The WPEM provides exposure estimates such as lifetime and 
average daily doses, lifetime and average daily concentrations, and peak concentrations. 

Specific input parameters include: the type of paint (latex or alkyd) being assessed, density of 
the paint (default values available), and the chemical weight fraction, molecular weight, and 
vapour pressure. Occupancy and exposure data are provided by the model as default values 
but the model is designed to be flexible and the user may select other values for these inputs: 
activity patterns on weekdays/weekends for workers or occupants, and during the painting 
event; number of exposure events and years in lifetime; room size (volume); building type 
(e.g., office, single family home); number of rooms being painted; air exchange rates; etc. For 
those chemicals for which the mathematical emissions model does not apply, emissions data 
can be entered manually. 

Status and availability 

WPEM Version 3.2, a Windows-based tool is available. The model has been peer reviewed by 
experts outside the EPA. This model was developed under contract for the EPA's Office of 
Pollution Prevention and Toxics, Economics, Exposure, and Technology Division, Exposure 
Assessment Branch. WPEM was developed under the Design for the Environment Program, 
Designing Wall Paints for the Indoor Environment. This project was accomplished in 
coordination and cooperation with the National Paint and Coatings Association (NPCA), in 
addition to paint manufacturers and chemical suppliers. 

The model, user's guide and background document is available as a pdf file via 

 
 
 
 
 
 
 
 
 
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Version 3.0 - July 2016 

63 

http://www.epa.gov/oppt/exposure/. 

Consumer Exposure Model (CEM) 

The Economics, Exposure and Technology Division (EETD) of the Office of Pollution Prevention 
and Toxics (OPPT) of the EPA is responsible for conducting specific activities in support of the 
Agency's risk assessment process. One of these responsibilities is to assess new and existing 
chemical substances under the Toxic Substances Control Act (TSCA). CEM, developed by 
Drewes and Peck (1999) is designed to provide EETD's Exposure Assessment Branch and 
Chemical Engineering Branch with an easy way to perform consumer inhalation and dermal 
exposure assessments for OPPT's new and existing chemical programs. The methods used to 
perform these assessments often involve generic screening-level techniques to allow 
exposures to be estimated rapidly. CEM has been programmed in C++/Windows and is 
designed to be run on a personal computer. 

CEM is an interactive model which calculates conservative estimates of potential inhalation 
exposure and potential for absorption through dermal exposure to consumer products. 
Consumer inhalation exposures modelled in CEM use the same approach and calculations as 
the Multi-Chamber Concentration and Exposure Model (MCCEM), as well as scenarios depicted 
in the Screening -Level Consumer Inhalation Exposure Software (SCIES). Dermal exposures 
are modelled using the same approach and equations as the DERMAL Exposure Model. CEM 
allows for screening-level estimates of acute potential dose rates, and estimation of average 
and lifetime average daily dose rates. Because the model incorporates upper percentile and 
mean input values for various exposure factors in the calculation of potential exposures / 
doses, the exposure / dose estimates are considered “high end” to “bounding” estimates. 

The dermal portion of CEM uses a film-thickness approach which assumes that exposure 
occurs from a thin layer of the consumer product on a defined skin surface area to determine 
potential exposure. Few data exist on the actual thickness of films of various products on 
human skin. Therefore, due to the uncertainty associated with the amount of product forming 
a film on the skin the dermal exposure estimates are considered less certain than those 
calculated in the inhalation portion of CEM. Absorbed dermal dose rates can be calculated 
using a permeability coefficient or a log octanol/water partition coefficient, but these values 
and their use in calculating exposure also involves uncertainty. Absorbed exposure can only be 
calculated for the User-Defined Scenario in CEM. 

The consumer exposure scenarios were selected for inclusion in the model by EETD because 
they are products or processes for which exposure assessments are most frequently performed 
during the new chemical review process. In addition to these scenarios, users are able to 
create their own scenario. CEM is user friendly and provides on-line help to assist the user in 
optimizing model use. 

The CEM programme covers most of the scenarios needed for consumer exposure modelling. It 
should be noted that input data are needed for 50th and 95th  percentiles. 

CEM is now integrated in the E-Fast program, available via 
http://www.epa.gov/oppt/exposure/pubs/efastdl.htm 

 
 
 
 
 
 
 
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Version 3.0 - July 2016 

US EPA Multi-Chamber Concentration and Exposure Model (MCCEM) 

Features 

The Multi-Chamber Concentration and Exposure Model (MCCEM) Version 1.2 (GEOMET, 1995) 
was developed for the US EPA Office of Pollution Prevention and Toxics to estimate indoor 
concentrations for chemicals released in residences). The features of MCCEM include: 

  MCCEM needs time-varying emission rates for a chemical in each zone of the residence 
and outdoor concentrations. The emission rates of pollutants can be entered into the 
model either as numbers or as formulas; 
inhalation exposure levels are calculated from the estimated concentration if the user 
specifies the zone where an individual is located in a spreadsheet environment; 
  MCCEM has data sets containing infiltration and inter-zonal airflow rates for different 

 

types of residences in various geographic areas. The user can select from the data sets, 
or can input zone descriptions, volumes and airflow rates; 
concentrations can be modelled in as many as four zones (chambers) of a residence; 
the programme is capable of performing Monte Carlo simulation on several input 
parameters (i.e., infiltration rate, emission rate, decay rate, and outdoor concentration) 
for developing a range of estimates for zone-specific concentrations or inhalation 
exposures; 
the programme has an option to conduct sensitivity analyses of the model results to a 
change in one or more of the input parameters; 
the percentage of cases for which modelled contaminant concentrations are at or above 
a user-specified level of possible concern or interest is determined. 

 
 

 

 

Theoretical 

This multi-chamber mass-balance model has been developed by using air infiltration rates and 
corresponding inter-zonal air flows for a user-selected residence or a user-defined residence. 
This model provides a spreadsheet to the user for entering time-service data for emission rates 
in one or more zones, the zone of exposure, and concentration values of the contaminant 
outdoors. 

Information assembled by Brookhaven National Laboratory concerning measured infiltration or 
exfiltration airflow, inter-zonal airflow, and the volume and description of each zone for 
different types of structures in various geographic areas has been incorporated in the software 
for access by users. Two generic houses represent average volume (408 m3) and flow 
information in summer or fall/spring that has been compiled from a large number of 
residences. One generic house has a bedroom as the first zone and the remainder of the house 
as the second zone. The other, with the same total volume as the first, has a kitchen as the 
first zone and the remainder of the house as the second zone. The features of the generic 
houses are noted in the Exposure Factors Handbook (US EPA, 1997). 

Remarks 

The user's guideline listing good examples enable risk assessors to conduct the exposure 
assessment quite easily within MCCEM. In addition, MCCEM contains a database of various 
default house data that are needed to complete each calculation such as air-exchange rates, 
geographically based inter-room air flows, and house/room volumes. However, the so many 
data parameters might cause a confusion to risk assessors who aim to evaluate exposure for a 
typical population at the first Tier approach. 

The MCCEM model is available via http://www.epa.gov/oppt/exposure/pubs/mccem.htm 

 
 
 
 
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65 

INTERA – Cefic LRI Program 

The INTERA computational platform is a web-based computer program that was developed in 
the framework of the CEFIC Long-range Research Initiative (LRI) funded INTERA project. It 
was developed to enable the exposure assessment of compounds in indoor settings over the 
“full-chain”. The program offers a number of exposure models and a database containing 
several types of data. The data includes human physiological parameters, emission data from 
consumer products and from indoor concentration levels, and building characteristics. An 
exposure assessment in INTERA is a step-by-step process, starting with the basic information 
on chemical, products and the exposed population. Subsequently, suitable models are selected 
per exposure route, according to the product usage scenario. 

All models for oral, dermal and inhalation route can be considered as higher tier models where 
for example release rates from products or sources is a requested input in the models. 
Moreover, most of the equations have been set in such way that they describe the internal 
exposure all as a function of time. 

The model needs information on the substance of interest, the exposed subjects and 
residential settings and on the specific scenario. A scenario does not necessarily involve a 
consumer product or article and therefore the information requested is dependent on the 
scenario, following a step-wise approach. The inputs requested and not included in the 
database are substance-material specific release factors, such as the migration/release rates 
from products (oral and dermal), emission rates (inhalation), and concentrations in matrices 
(dermal and oral), this means that no default values are available for these parameters. The 
fraction absorbed from ingested quantities may also be requested from the user. Data included 
in the databases are human physiological data, residential settings and certain scenario 
parameters such as exposure durations, frequencies of use and skin areas contacted. For a 
number of substances, exposure information, e.g. indoor air concentrations of volatile 
substances are included in the database. 

The output is given in amount of chemical taken up by the body as a function of time (µg/h or 
in mg/kg bw /d). Input and output can be presented as distributions. The user has the option 
to generate graphical representations of the exposure. 

The driving factors for exposure are the concentrations in the matrices, the migration from the 
matrices and the duration of contact. If the internal exposure is calculated using a fraction, 
e.g.  in case of ingestion where not all substance ingested will be taken up, then the fraction is 
also considered a driving factor for exposure. One of the basic assumptions is that the release 
from the matrices is constant over time, once contacted. In other words, the release of a 
substance is considered independent of its concentration in the matrix and no depletion of 
substance takes place (oral and dermal exposure). Diffusion processes in materials are not 
taken into account. Regarding the air concentration, it is assumed that equilibrium will be 
reached immediately. 

Uncertainty analyses are possible, via the use of distributions and the Monte-Carlo Markov 
chain technique. 

The INTERA computational platform is currently online at: http://www.intera.cperi.certh.gr/ 
The platform contains a user guide from which information can be obtained about the platform 
itself and the data and models that are included. 

 
 
 
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BAMA/FEA Indoor Air model 

The BAMA Indoor Air Model is a simple but powerful tool, developed by British Aerosol 
Manufactures Association (BAMA) and European Aerosol Federation (FEA) that can be used to 
predict the concentration of aerosol components within a room after a suitable time interval 
after spraying. The Model can be used to rapidly generate predicted air concentrations for a 
wide range of use conditions for spray products. The model is particularly useful for generating 
time weighted values for estimating longer term exposure, for example longer than 90 
minutes. Validation work shows that by that time, the volatile ingredients and aerodynamically 
stable particle (less than 10 m) are well mixed in modelled volume (i.e. room) and larger 
particles have dropped out. Therefore, the model can be used to generate reliable estimates 
for exposure lasting more than 2 hours. 

On the other hand, the tool has an important limitation when applied to the assessment of 
short term exposure, for example during the application of the spray product, since the model 
assumes an immediate and perfect mixing within the modelled room volume; in particular, for 
products sprayed away from the body or on horizontal surfaces, the BAMA model is likely to 
over-predict short term exposure because the breathing zone will be outside the spray clouds. 
On the contrary, for products sprayed at the body or on vertical surfaces, the breathing zone 
will be in the spray cloud and the model will lead to an underestimation of the short term 
exposure. 

Key parameters to run the model are: room volume, ventilation rate, ingredient fraction, 
discharge rate of the spray, duration of spraying. 

The output parameters are different averaged air concentrations: 15 minutes, 4, 8, 16 and 24 
hours averaged air concentrations in the room. Also exposure profile of the air concentration is 
given by the tool; it is also possible to model multiple spray events during one day. 

The model is freely available at: http://www.bama.co.uk 

 
 
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67 

Appendix R.15.4 Development of ECETOC TRA Consumer 
tool and comparison with Tier 1 Algorithms 

ECETOC TRA Consumer tool version 2 (ECETOC, 2009) was the result of a substantial revision 
of the previous version TR 93 [17]. TRA version 2 combined the conservatism of first Tier 
assessment tools with the expert knowledge documented in the RIVM fact sheets (see RIVM, 
http://www.rivm.nl/en/healthanddisease/productsafety/ConsExpo.jsp#Fact_sheets  and 
Section R.15.4.3). It used default values taken from the RIVM fact sheets (except for the cases 
when no such value is available); main differences between ECETOC TRA consumer version 2 
and the Tier 1 algorithms documented in Section R.15.3 can be summarised as follow: 

  For the inhalation route the ECETOC algorithm includes a parameter for modifying the 
fraction of substance released to air for substances with a vapour pressure < 10 Pa in 
non-spray applications. 

  For exposure from articles via the dermal route, the assumed thickness of layer in 

contact with skin is reduced from 0.01 cm (widely accepted default for mixtures and 
used already in EU existing chemicals risk assessment procedures) to 0.001 cm in order 
to take account of the reduced mobility of substances in an article matrix. The figure 
0.001 cm was chosen based on expert judgement, as no scientific data was available. 

The ECETOC TRA Consumer tool version 2 aimed to balance the Tier 1 assumptions and the 
generic applicability to a wide range of product categories in order to deliver reasonably 
plausible outcomes. For each product use category a rationale is available that justifies the 
basis of the default values and assumptions. 

In 2012 ECETOC released the TRA Consumer version 3.0 where some refinement of the 
exposure have been made possible, while keeping the same structure (based on product or 
article category and subcategories) and algorithm of the version 2; these refinements are 
summarised here below: 

  The calculation of saturated vapour concentration as the upper bound value of 

concentration of substance in air of the room is applied to all of the inhalation scenarios 
for non-spray products. 
Inhalation exposure estimates account for basic ventilation (default value of 0.6 air 
exchange per hour) in the standard room (20 m3). 

 

  Dermal and oral transfer factors have been introduced to potentially reduce dermal and 
oral exposure. By default both transfer factors are set to 1, assuming 100% of the 
substance is available for oral and dermal exposure; users with relevant, specific 
information or knowledge on the pattern of transfer of a substance from a product or 
article matrix to skin or mouth might reduce oral or dermal exposure by means of 
transfer factors. 

In 2014 ECETOC released the TRA Consumer version 3.1, which incorporates all the changes 
mentioned above, with the possibility (already present in version 3.0, but now revised) for the 
user to create a new (sub)product or article category, setting all input parameters. This option 
has been introduced to support the creation of SCED (Specific Consumer Exposure 
Determinants) which are described in detail in Section R.15.2.6. The user, only while creating 
a new (sub)category, can also set the following new input parameters having an impact on the 
calculation of consumer exposure: 

  The inhalation transfer factor (by default set to 1) in order to reduce the amount 

released to air during the use of the product or article; the user is advised to deviate 
from the default only when specific information supporting the choice is available. 

  Select the outdoor scenario for consumer exposure; if selected, the “room” volume 

(100 m3) and ventilation (2.5 air exchanges per hour) are increased compared to the 

 
 
 
 
68  Guidance on Information Requirements and Chemical Safety Assessment 
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Version 3.0 - July 2016 

indoor scenario, reducing the estimated air concentration. 

  For short term and infrequent uses, is now possible to introduce a frequency over the 
year less than once per day, reducing the exposure estimation according to a factor 
depending on bands set by ECETOC. These bands are defined as follows: frequent uses 
(at least once a week, no reduction of exposure), occasional uses (between once a 
week and once a month), infrequent uses (between once a month and once every six 
month) and very infrequent uses (no more than once every six month). 

The differences between generic Tier1 algorithms (Section R.15.3) and ECETOC TRA Consumer 
tool (v.2, v.3.0 and v.3.1) are summarised in the table below. 

Table R.15- 10: Differences between Tier I algorithms and ECETOC TRA consumer 

Route of 
exposure 

Inhalation 

ECETOC TRA v. 2 

ECETOC TRA v. 3.0 

ECETOC TRA v. 3.1 

Modifying  factor  for 
inhalation according 
to VP bands for VP 
<10 Pa 

Modifying factor for 
inhalation according to 
VP bands for VP <10 Pa 

Modifying factor for 
inhalation according to VP 
bands for VP <10 Pa 

Basic ventilation rate 
taken into account to 
reduce air concentration 
in standard room 

Basic ventilation rate taken 
into account to reduce air 
concentration in standard 
room 

Upper bound for air 
concentration based on 
saturated Vapour 
concentration 

Upper bound for air 
concentration based on 
saturated Vapour 
concentration 

Inhalation transfer factor 
introduced. Unless default is 
used (=1), this reduces air 
concentration* 

Possible to select that use 
takes place outdoor, which 
reduces air concentration 
compared to indoor uses* 

 
 
 
 
 
 
 
 
 
 
 
 
 
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69 

Route of 
exposure 

ECETOC TRA v. 2 

ECETOC TRA v. 3.0 

ECETOC TRA v. 3.1 

Reduction of the exposure 
by frequency over the year 
according to frequency 
bands (occasional, 
infrequent, very 
infrequent)* 

For exposure to article, the 
thickness of layer is set to 
0.001 instead to 0.01 

Dermal 

For exposure to 
article, the thickness 
of layer is set to 
0.001 instead to 
0.01 

For exposure to article, 
the thickness of layer is 
set to 0.001 instead to 
0.01 

Dermal transfer factor 
introduced. Unless 
default is used (=1), this 
reduces dermal dose 

Dermal transfer factor 
introduced. Unless default is 
used (=1), this reduces 
dermal dose 

Reduction of the dose by 
frequency over the year 
according to frequency 
bands (occasional, 
infrequent, very 
infrequent)* 

Oral 

Oral transfer factor 
introduced. Unless 
default is used (=1), this 
reduces oral dose 

Oral transfer factor 
introduced. Unless default is 
used (=1), this reduces 
dermal dose 

Reduction of the dose by 
frequency over the year 
according to frequency 
bands (occasional, 
infrequent, very 
infrequent)* 

* Only possible when creating new (sub)product or article category 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
70  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

Appendix R.15.5 Demonstration of control of risks for 
articles 

Tier 1 algorithms to calculate exposure to substances in articles via all routes are 
reported and analysed in Section R.15.3, while more refined exposure estimation models 
are reported in Section 15.5. The aim of this appendix is to complete the information on 
exposure estimation already provided in the main text. 

Dermal exposure to a substance migrating from an article 

The exposure calculation will involve estimating the amount of substance which will 
migrate from the area of the article in contact with skin during the time of contact (for a 
screening assumption, consider 24 hrs). The essential parameters used for this model 
are: 

Weight fraction compound: the fraction of the compound in the total product 

Amount of product: the total amount of product applied to the skin 

The surface area of the exposed skin 

The migration rate of the substance 

The contact time of the substance 

Skin contact factor (set at 1 for default), a factor that can be used to account for the fact 
that the product is only partially in contact with the skin. 

Examples of such potential exposure situations are skin contact with substances in 
textiles see [18] for details or printing ink from a newspaper or magazine. For migrating 
substances, only a fraction of the total amount of substance on the skin is able to reach 
the skin. It should be noted that it should be checked whether the estimated daily 
uptake exceeds the theoretical maximum. This maximum can be derived from the 
amount of product used (g), the concentration of the substance (g.g-1) in the product, 
and the use frequency (d-1). Extractability in simulated body fluids for several classes of 
dyestuffs and different fabric types has been evaluated by [19]). 

The dermal load is calculated as: 

Lder = 

Qprod  Fcprod  Fcmigr   Fcontact   Tcontact  1000 
Askin 

In case a surface density Sdprod for an article is available (in mass per unit area), the 
equation reverts to: 

 
 
 
 
 
 
 
 
 
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71 

Lder = SDprod  Fcprod  Fcmigr  Fcontact Tcontact 

Equation R.15- 11 

The external dermal dose in mg per kg of bodyweight is then calculated as: 

 Lder  Askin  n 

Dder = 

BW

Equation R.15- 7 

Table R.15- 11: Explanation of symbols for dermal scenario B 

Input parameter 

Description 

Unit 

Qprod 

Fcprod 

Fcmigr 

Fcontact 

Tcontact 

SDprod 

Askin 

Cder 

BW 

Amount of product used 

[g] 

Weight fraction of substance in product 

[g.gprod

-1] 

Rate (fraction) of substance migrating to skin 
per unit time 

[g.g-1.t-1] 

Fraction of contact area for skin, to account for 
the  fact  that  the  product  is  only  partially  in 
contact with the skin (default = 1) 

[cm2.cm-2] 

Contact duration between article and skin 

[d] 

Surface density (mass per unit area) 

[mg.cm-2] 

Area of contact between product and skin 

[cm2] 

Dermal concentration of substance on skin 

[mg.cm-3] 

Body weight 

[kg] 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
72  Guidance on Information Requirements and Chemical Safety Assessment 
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Input parameter 

Description 

Unit 

n 

Mean number of events per day 

Output 

Description 

[d-1] 

Unit 

Lder 

Dder 

Dermal load on the skin that is expected due to 
migration 

[mg.cm-2] 

Dermal dose per day and body weight 

[mg.kgbw 
- 

1.d-1] 

Other sources of information 

For  some  classes  of  articles,  release  from  articles  during  their  service  life  is  given  in 
relevant  OECD  emission  scenario  documents  (e.g.,  on  plastic  additives;  OECD  2004). 
Although developed to estimate release rates to the environment, they can also serve as 
source  of  information  to  estimate  consumer  exposure  (e.g.  to  estimate  releases  to  
indoor air). 

ECHA  has  recently  published  an  illustrative  example  on  consumer  exposure  to  
substances  in  article21.  While  the  example  focuses  on  a  specific  semi  volatile  substance  
in  building  material,  a  general  framework  guiding  the  assessor  to  build  exposure  
scenario and performing consumer exposure estimation for substances in articles is also 
provided. 

21   http://echa.europa.eu/documents/10162/13632/csr_sia_exposure_examples_en.pdf 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix R.15.6 Further information on assessment of 
children’s exposure 

A decision tree on when to assess children’s exposure was presented at an OECD 
workshop in 2013 in the Netherlands [20]. This preliminary decision tree followed an 
information request within the OECD-Task Force on exposure assessment with respect to 
children’s exposure assessment (see survey with regard to children’s exposure 
assessment [21]). The workshop on children’s exposure to chemicals focused on 1) 
when children specific exposure assessment should be performed and what kind of 
products should be focused on, and 2) how to make progress on identified possible 
projects, which led to the development of the decision tree. 

Work is ongoing to refine the decision tree, and to include case studies to be able to test 
and further improve the decision tree. This project within the OECD-TFEA continues in 
2015-2016, and will be published thereafter. 

This children’s exposure decision tree might help in deciding if children’s exposure should 
be addressed separately or not in a risk assessment. It could be considered that for 
certain product/product categories or certain substances the exposure and risk 
assessment for adults covers the risk to children as well. Currently, there is no 
structured approach for children’s exposure assessment within risk assessment. Based 
on their behaviour and body characteristics, the exposure of children may be different 
from that of adults. The decision tree aims  to guide this, by providing a checklist. 
Questions to be asked are: 
 
 

Is the product/article (category) intended for use by consumers? 
Is the product specifically meant for children -> if yes, include a separate exposure 
assessment for children. 

  Could consumers come into contact with the product? Directly or indirectly? If yes, 

please check if it would be relevant to children’s exposure. 

Checklist for relevance of (in)direct exposure to children (different from adults): 

• 

inhalation: 

o  Vapour pressure 
o  Duration 
o  Frequency 
o  Emission from product/article 

•  oral 

o  Duration 
o  Frequency 
o  Leaching 
o  Oral exploration/mouthing 
o  Dust 

•  dermal 

o  Duration 
o  Frequency 
o  Leaching 
o  Crawling 
o  Surface area 

  When relevant -> include an exposure assessment for children and adult users. 

The challenges for children specific exposure assessment are: 

1)  when and how to assess the use of similar consumer products as adults (e.g. 

cosmetic products, textiles, adhesives, etcetera), in children and/or adolescents, 

 
 
 
 
 
 
74  Guidance on Information Requirements and Chemical Safety Assessment 
Chapter R.15: Consumer exposure assessment 
Version 3.0 - July 2016 

2)  consumer product surveys are predominantly focused on adults, which do not 

necessarily reflect children’s behaviour, 

3)  reasonable foreseeable use or not, e.g. mouthing of objects not meant for 

mouthing. 

 
 
EUROPEAN CHEMICALS AGENCY 
ANNANKATU 18, P.O. BOX 400, 
FI-00121 HELSINKI, FINLAND 
ECHA.EUROPA.EU