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«GUIDANCE Guidance on information requirements and Chemical Safety Assessment Chapter R.16: Environmental exposure assessment Version 3.0 February ...»

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GUIDANCE

Guidance on information requirements and

Chemical Safety Assessment

Chapter R.16: Environmental exposure

assessment

Version 3.0

February 2016

Chapter R.16: Environmental exposure assessment

2 Version 3.0 – February 2016

LEGAL NOTICE

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.16: Environmental exposure assessment Reference: ECHA-16-G-03-EN ISBN: 978-92-9247-775-2 Publ.date: February 2016 Language: 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 using 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 Chapter R.16: Environmental exposure assessment Version 3.0 – February 2016 3

DOCUMENT HISTORY

Version Changes May / July Version 1.0 First edition 2008 May 2010 Redrafting the section about the general workflow of • Version 2.0

exposure estimation:

The workflow for environmental exposure assessment o has been completely redrafted (R.16.1.2). A diagram has been introduced to better illustrate it. First tier assumptions and the iteration/refinement alternatives are also shown. The diagram is consistent with the text and makes clear references to other chapters of the IR-CSA Guidance. Many of the changes in this section and in the whole guidance have been triggered by the need to make the gui

–  –  –

chapters of R.16.5 and R.16.6.

New Appendix 16-4 on detailed regional assessment and • relevant calculations (reorganisation of information originally covered in 16.6.6.8).

New Appendix 16-5 providing more information on • existing models (EUSES and some other tools such as CHARM or the ECPA LET).

New Appendix 16-6 on release estimation from articles.

• Information relevant for the environment previously addressed in Chapter R.17 has been updated and moved to this Appendix.

New Appendix 16-7 on selection and evaluation of • measured data. Information originally covered in Chapter R.16.4 updated and moved to this Appendix.

Substitution of term “wide dispersive” by “widespread” • for better alignment with R.12.

Correction of identified errors in the equations carried • over from the original version of the Guidance.

Update of scientific references and creation of new • unique list at the end of the guidance.

Chapter R.16: Environmental exposure assessment

8 Version 3.0 – February 2016

PREFACE This document describes the information requirements under 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 version 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 State 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 the “Second revision to the Consultation Procedure for

Guidance” at:

http://echa.europa.eu/documents/10162/13608/mb_63_2013_revision_consultation_procedur e_guidance_en.pdf.

The guidance documents can be obtained from the website of the European Chemicals Agency at: http://echa.europa.eu/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 2006 1 and its amendments until 25 September 2015.

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).





Chapter R.16: Environmental exposure assessment

Version 3.0 – February 2016 9

NOTES ON THE UPDATES

The update to version 3.0 of this Guidance consists mainly in a general revision of the structure of the document with the specific aim of presenting in a more readable way the proposed approach for the environmental exposure assessment. The general approach and principles for the environmental exposure assessment remain the same. Most of the changes and additions are meant to improve clarity and consistency and remove redundancies.

The aim of the new structure is to present the main elements and to outline the workflow for a standard assessment in the main body of the guidance. All the technical details and calculations which are embedded in the exposure estimation tools have been moved to new Appendices. Therefore, the information which is not needed for an assessor carrying out his assessment using standard tools (e.g. EUSES), or relevant only when a higher tier assessment is necessary, has been removed from the main body and organised in dedicated appendices.

Particular attention should be given to the modification of elements related to the selection and use of some of the Environmental Release Categories (ERCs) which fall under the scope of the updated of the Guidance R.12 “Use description”.

Registrants having finalised the environmental exposure assessment based on the Guidance R.12 and R.16 as published, respectively, in March 2010 and October 2012 should take into

account the following:

- clarification regarding the applicability domain of ERC7 and ERC9;

- correction of release factor for ERC8C.

If the registrant identifies that his assessment was not valid and if this impacts on the safe use of the chemical he should consider updating it.

Chapter R.16: Environmental exposure assessment

–  –  –

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.16 within the Guidance Document.

–  –  –

Table of contents LEGAL NOTICE

DOCUMENT HISTORY

PREFACE

R.16. ENVIRONMENTAL EXPOSURE ASSESSMENT

R.16.1. Introduction

R.16.1.1. Aim of this guidance

R.16.1.2. Workflow for environmental exposure assessment

R.16.1.3 Scope of the environmental assessment

R.16.1.3.1. Environmental protection targets to be addressed

R.16.1.3.2. Identification of the scope of exposure assessment and type of risk characterisation

R.16.1.4. The environmental exposure assessment approach: main principles................. 25 R.16.1.4.1. Local assessment

R.16.1.4.2 Regional assessment

R.16.2. Release assessment

R.16.2.1. Key elements of a release assessment

R.16.2.2. Conditions of use

R.16.2.2.1 Tonnage information

R.16.2.2.1.1. Estimation of tonnage for uses at industrial sites

R.16.2.2.1.2. Estimation of tonnage for widespread uses

R.16.2.2.1.3. Tonnage for the regional release estimation

R.16.2.2.2 Design of technical process

R.16.2.2.3 Onsite risk management measures

R.16.2.2.4 Biological sewage treatment plant (STP)

R.16.2.2.5 Waste treatment operations

R.16.2.2.6 Frequency of release

R.16.2.2.7 Environmental conditions impacting on exposure

R.16.2.3. Release estimation methods

R.16.2.3.1 Environmental Release Categories (ERCs)

R.16.2.3.2 Specific Environmental Release Categories (SPERCs)

R.16.2.3.3 Other published sources

R.16.2.3.4 Site-specific information

R.16.2.4. Specific considerations for article service life

R.16.3. Biological sewage treatment plant

Chapter R.16: Environmental exposure assessment 12 Version 3.0 – February 2016 R.16.3.1. Introduction

R.16.3.2. Biological STP model

R16.3.2.1 Default fate in a biological STP

R.16.3.2.2 Refinement of behaviour in biological STP based on further substance properties

R.16.4 Exposure estimation

R.16.4.1 Introduction

R.16.4.1.1 Principles

R.16.4.1.2. Existing tools for exposure estimation

R.16.4.1.3. Use of environmental measured data

R.16.4.1.4 Decision on the environmental concentrations used for exposure estimation. 55 R.16.4.2. Distribution and fate of the released substance in the environment.................. 56 R 16.4.2.1 Principle

R.16.4.2.2 Partitioning in the environment – specific cases

R.16.4.2.3 Degradation in the environment

R.16.4.3. Exposure estimation

R.16.4.3.1. STP concentration for evaluation of inhibition to microorganisms............... 60 R.16.4.3.2. Concentration in freshwater

R.16.4.3.3. Concentration in sediment compartment

R.16.4.3.4. Concentration in marine aquatic compartment

R.16.4.3.5. Concentration in soil

R.16.4.3.6. Concentration in groundwater

R.16.4.3.7. Concentration in atmosphere

R.16.4.3.8. Predators (secondary poisoning)

R.16.4.3.9. Humans exposed indirectly via the environment

R.16.5 Risk characterisation

R.16.6. Summary of the assessment

APPENDIX A.16-1: ENVIRONMENTAL RELEASE CATEGORIES

APPENDIX A.16-2. FATE OF CHEMICALS IN A WASTEWATER TREATMENT PLANT

BASED ON THE SIMPLETREAT MODEL

APPENDIX A.16-3 MODEL CALCULATIONS

A.16-3.1 Characterisation of environmental compartments

A.16-3.2 Fate and distribution in the environment

A.16-3.2.1 Partition coefficients

A.16-3.2.2 Degradation rates in the environment

Chapter R.16: Environmental exposure assessment

Version 3.0 – February 2016 13

A.16-3.3. Exposure and intake estimation

A.16-3.3.1 Wastewater treatment – estimation of effluent concentrations and PECstp..... 103 A.16-3.3.1.1 Refinement based on further substance properties

A.16-3.3.2 Calculation of PEClocal for the atmosphere

A.16-3.3.3 Calculation of PEClocal for the aquatic compartment (freshwater)................. 114 A.16-3.3.4 Calculation of PEClocal for the sediment compartment (freshwater and marine water)

A.16-3.3.5 Calculation of PEClocal for the marine aquatic compartment

A.16-3.3.6 Calculation of PEClocal for the soil compartment

A.16-3.3.7 Calculation of concentration in groundwater

A.16-3.3.8 Predators (secondary poisoning)

A.16-3.3.9 Humans exposed indirectly via the environment

APPENDIX A.16-4 MODEL FOR REGIONAL ASSESSMENT

A.16-4.1 Releases at regional level

A.16-4.2.Continental release estimation

A.16-4.3 Calculation of PECregional

APPENDIX A.16-5. MODELS FOR ENVIRONMENTAL ASSESSMENT

A.16-5.1 EUSES

A.16-5.2 TGD excel sheet

A.16-5.3 Other exposure estimation tools

APPENDIX A.16-6. RELEASE FROM ARTICLES

A.16-6.1 General work flow

A.16-6.2 Emission and exposure pathways

A.16-6.3 Release and exposure estimation for the environment

A.16-6.3.1 General considerations

A.16-6.3.2 Detailed release estimation for service life

A.16-6.4 Refined exposure estimation

A.16-6.4.1 Release rates of substances from articles

APPENDIX A.16-7. SELECTION OF MEASURED DATA

A.16-7.1 Quality of the sampling and analytical techniques

A.16-7.2 Selection of representative data for the environmental compartment of concern

Chapter R.16: Environmental exposure assessment

–  –  –

A.16-7.3 Outliers

A.16-7.4 Treatment of measurements below the limit of quantification................. 173 A.16-7.5 Data comparability

Table of tables Table R.16-1 Environmental protection targets

Table R.16-2: Default estimation of tonnage for site for different life-cycle stages............. 39 Table R.16-3: Situations in which the assessment based on a specific ERC would also cover an assessment based on another ERC

Table R.16-4: Derivation of PEC-values in EUSES

Table R.16-5: Summary of the protection targets and relevant considerations on risk characterisations

Table R.16-6: Overview on determinants for the default and refined exposure assessment. 71 Table R.16-7: Default parameters to derive the environmental release rate

Table R.16-8: Characterisation of environmental compartments



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