Guidance on information requirements and chemical safety assessment

Echa — European Chemicals Agency

Description

Guidance for the implementation of REACHVOL 10Exposure estimation and uncertainty analysis
Chemical industry
Industrial policy
Public health
Target audience: Specialised/Technical

Sujets

• Guide
• Chemical industry
• Public health

Informations

• Publié par: ECHA-EUROPEAN-CHEMICALS-AGENCY
• Nombre de lectures: 114
• Langue: English
• Poids de l'ouvrage: 4 Mo

Extrait

ED-30-08-010-EN-C


Guidance on
information requirements
and chemical safety assessment
Volume 10: Exposure estimation and uncertainty
analysis
Contains Chapters R14, R15, R16, R17, R18 and
R19

May/July 2008



Guidance for the implementation of REACH



Guidance on information
requirements and chemical safety
assessment
Chapter R.14: Occupational Exposure
Estimation

May 2008



Guidance for the implementation of REACH

LEGAL NOTICE

This document contains guidance on REACH explaining the REACH obligations and how
to fulfil them. 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. The European Chemicals Agency does not accept any liability with
regard to the contents of this document.























© European Chemicals Agency, 2008
Reproduction is authorised provided the source is acknowledged.
2 CHAPTER R.14 – OCCUPATIONAL EXPOSURE ESTIMATION
PREFACE

This document describes the information requirements under REACH 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 REACH.

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. These guidance documents can be obtained via the
website of the European Chemicals Agency (http://echa.europa.eu/reach_en.asp). Further guidance
documents will be published on this website when they are finalised or updated.

This document relates to the REACH Regulation (EC) No 1907/2006 of the European Parliament
1and of the Council of 18 December 2006



1 Corrigendum to 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); amended by Council Regulation (EC)
No 1354/2007 of 15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) by reason of the
accession of Bulgaria and Romania (OJ L 304, 22.11.2007, p. 1).
3CHAPTER R.14 – OCCUPATIONAL EXPOSURE ESTIMATION

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 R14 within the Guidance Document.


Information: available – required/needed
Exposure Assessment (EA)Hazard Assessment (HA)
R14
n Y
Dangerous Risk Characterisation (RC)Stop Or PBT?
y n IterationDocument in Risk
CSR controlled?
Communicate
ES via eSDS


4 4CHAPTER R.14 – OCCUPATIONAL EXPOSURE ESTIMATION

CONTENTS
R.14 OCCUPATIONAL EXPOSURE ASSESSMENT ............................................................ 7
R.14.1 Introduction..............................................................................................................................................................7
R.14.2 Types and routes of exposure ..................................................................................................................................7
R.14.3 Determinants of occupational exposure and RMMs................................................................................................9
R.14.4 Exposure estimation with measurements and modelling approaches....................................................................10
R.14.4.1 Introduction.......................................................................................................................................................10
R.14.4.2 Workplace exposure assessment rating criteria ................................................................................................12
R.14.4.3 Core information requirements .........................................................................................................................14
R.14.4.4 Use of measured data ........................................................................................................................................15
R.14.4.5 Selection of measured data ...............................................................................................................................17
R.14.4.6 Use of exposure estimation tools ......................................................................................................................22
R.14.4.7 ECETOC TRA tool...........................................................................................................................................22
R.14.4.8 Easy-to-use workplace control scheme for hazardous substances (EMKG/ BauA-COSHH)..........................37
R.14.5 Higher Tier exposure assessment ................................................................................................46
R.14.5.1 Stoffenmanager exposure model.....................47
R.14.5.2 RISKOFDERM dermal model..........................................................................................................................49
R.14.5.3 Advanced tool ...................................................................................................................................................52
R.14.6 REFERENCES .....................................................................................................................54

TABLES
Table R. 14-1 Workplace exposure assessment rating criteria .................................................................................................13
Table R. 14-2 Availability banding, dustiness and vapour pressure.........................................................................................25
Table R. 14-3 Workplace process categories used in ECETOC TRA......................................................................................26
Table R. 14-4 Process categories and dermal exposure in ECETOC TRA..............................................................................28
Table R. 14-5 Examples of EASE calculations (inhalation) for worker process categories ....................................................30
Table R.14-6 Examples of exposure categories and predicted EASE Dermal Exposures .......................................................32
Table R. 14-7 Modifiers for duration of activity ......................................................................................................................34
Table R. 14-8 Definition of dustiness bands....................................................................................39
Table R. 14-9 Definition of volatility bands.............................................................................................................................40
Table R. 14-10 Scale of use bands/one batch41
Table R. 14-11 Exposure potential bands (EP)*.......................................................................................................................42
Table R. 14-12 Control strategies .............................................................................................................................................42
Table R. 14-13 Predicted exposure ranges................................................................................................................................43
Table R. 14-14 Calculated evaporation times for T = 20°C (gloves) and T = 30°C (skin)......................................................57

5CHAPTER R.14 – OCCUPATIONAL EXPOSURE ESTIMATION

FIGURES
Figure R. 14-1 Relation between process temperature, boiling point and volatility ................................................................40
Figure R. 14-2 Overview of the Easy-to-use scheme as a Tier 1 tool ......................................................................................45

APPENDICES
Appendix R.14-1 Evaporation rate ...........................................................................................................................................56
Appendix R.14-2 Control guidance sheet numbering system and an examp