Guidance on the preparation of an application for authorisation : January 2021.
Date: 2021-01-30
Institutions: European Chemicals Agency
Subjects: administrative formalities, chemical product, chemicals legislation, information system, user guide

Guidance on Authorisation Applications 

Guidance on the preparation of an 
application for authorisation  

January 2021 

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Guidance on Authorisation Applications 

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. 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 the preparation of an application for authorisation 

Reference: ECHA-20-G-03-EN 
Cat. Number: ED-01-20-507-EN-N 
ISBN: 978-92-9481-673-3 
DOI: 10.2823/352490 
Publ.date:   January 2021 
Language:   EN 

© European Chemicals Agency, 2021 

If you have questions or comments in relation to this document, please send them (quote the 
reference and issue date) using the information request form. The information request form 
can be accessed via the Contact ECHA page at: http://echa.europa.eu/contact 

European Chemicals Agency 

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

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Guidance on Authorisation Applications 

PREFACE 

This document describes the REACH procedure on applications for authorisation. 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 (https://echa.europa.eu/guidance-documents/guidance-
on-reach ). 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 and 
of the Council of 18 December 2006.1 

Version 

Changes 

1.1 

Technical adaptations in response to the conclusions of the General Court’s 
judgments in cases T-837/16 and T-108/17, concerning ‘suitable alternatives 
available’ and the need to prepare substitution plans. It also concerns requests 
by  the  Risk  Assessment  Committee  for  further  information  during  the 
opinion making process. 

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, corrected version in OJ L136, 29.5.2007, p.3). 

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Guidance on Authorisation Applications 

CONTENTS 

GLOSSARY OF TERMS ................................................................................................................ IX 

1.  GENERAL INTRODUCTION AND OVERVIEW OF THE AUTHORISATION 

PROCESS ...................................................................................................................................1 

1.1.  About this guidance ..........................................................................................................1 

1.2.  Structure of the guidance ..................................................................................................1 

1.3.  Who is the guidance for? ..................................................................................................1 

1.4.  Links to other REACH guidance ......................................................................................1 

1.5.  General overview of the authorisation procedure .............................................................2 

1.5.1.  How substances get included in Annex XIV ......................................................3 

1.5.2.  Annex XIV entries ..............................................................................................4 

1.5.3.  Application for an authorisation .........................................................................7 

1.5.4.  What happens after an application for an authorisation has been 

submitted ...........................................................................................................14 

1.5.5.  Factors that are taken into account in granting or refusing an 

authorisation ......................................................................................................16 

1.5.6.  Requirements following granting or refusal of an authorisation ......................19 

1.5.7.  Review of authorisations ...................................................................................20 

1.6.  Summary of important deadlines for applicants and interested third parties in the 

authorisation process .......................................................................................................22 

2.  HOW TO MAKE AN APPLICATION FOR AN AUTHORISATION ...................................24 

2.1. 

Introduction .....................................................................................................................24 

2.1.1.  Main elements of an application for authorisation............................................24 

2.1.2.  Application content ...........................................................................................26 

2.1.2.1.  Adequate control route ......................................................................26 

2.1.2.2.  Socio-economic assessment (SEA) route .........................................27 

2.2.  Compiling an application for an authorisation ................................................................29 

2.2.1.  Substance identity .............................................................................................29 

2.2.2.  Applicants .........................................................................................................30 

2.2.3.  Request for authorisation for specific use(s).....................................................30 

2.2.3.1.  Use(s) covered in an application .......................................................30 

2.2.3.2.  Describing use(s) in the application ..................................................31 

2.2.3.3.  Uses for which authorisation application is not required ..................32 

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2.2.3.4.  Request for authorisation for several uses ........................................32 

2.2.4.  Documentation in support of the application for authorisation ........................32 

2.2.4.1.  Chemical Safety Report ....................................................................33 

2.2.4.2.  Analysis of alternatives .....................................................................34 

2.2.4.3.  Substitution plan ...............................................................................35 

2.2.4.4.  Socio-economic analysis ...................................................................36 

2.2.4.5. 

Justification for not considering certain risks ...................................36 

2.3.  Subsequent Applications .................................................................................................37 

2.4.  Submitting the application for authorisation ...................................................................38 

2.4.1.  Deadlines for submitting applications for authorisation ...................................38 

2.4.2.  How to submit an application ...........................................................................38 

2.4.3.  Fees ...................................................................................................................38 

2.5.  Review reports ................................................................................................................38 

3.  PLANNING FOR SUBSTITUTION: GUIDANCE ON ANALYSIS OF 

ALTERNATIVES ....................................................................................................................40 

3.1. 

Introduction .....................................................................................................................40 

3.2.  What is an alternative? ....................................................................................................41 

3.3.  The focus and scope of the analysis of alternatives ........................................................42 

3.4.  Overview of how an analysis of alternatives is undertaken ............................................44 

3.5.  How to identify possible alternatives ..............................................................................45 

3.5.1.  How to identify the Annex XIV substance functions .......................................45 

3.5.1.1. 

Information on use and function of the Annex XIV substance 
in the CSR .........................................................................................50 

3.5.1.2.  Other sources for information on use and function of the 

Annex XIV substance .......................................................................50 

3.5.2. 

Identifying and gathering information on possible alternatives........................51 

3.5.2.1.  Communication within the supply chain ..........................................51 

3.5.2.2.  Communication outside the supply chain .........................................54 

3.6.  How to determine the technical feasibility of alternatives ..............................................55 

3.6.1.  Technical feasibility criteria..............................................................................55 

3.6.2.  Consideration of process adaptation and changes.............................................57 

3.6.3.  Uncertainties in determining technical feasibility ............................................60 

3.7.  How to compare the risks of the alternative and the Annex XIV substance ..................60 

3.7.1.  General considerations on assessing and comparing the risks ..........................60 

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3.7.2.  Collecting hazard and risk information on alternatives ....................................61 

3.7.3.  Assessing and comparing with the risks of possible alternative 

substances .........................................................................................................64 

3.7.4.  Assessing and comparing with the risks of possible alternative 

technologies ......................................................................................................68 

3.7.4.1.  Comparing with risks of alternative technologies: Human 

Health ................................................................................................70 

3.7.4.2.  Comparing with risks of alternative technologies: 

Environment ......................................................................................71 

3.7.5.  Uncertainties in evaluating risks .......................................................................73 

3.8.  How to determine the economic feasibility of alternatives ............................................73 

3.8.1.  Uncertainties in determining economic feasibility ...........................................77 

3.9.  Research and development that is relevant and appropriate ...........................................77 

3.9.1.  Circumstances that might prompt the inclusion of R&D in the analysis 

of alternatives ....................................................................................................78 

3.9.2.  Documenting R&D in the application ..............................................................80 

3.10.  Concluding on the suitability and availability of alternatives ........................................80 

3.11.  Actions needed to make an alternative suitable and available ........................................83 

3.12.  Considerations for documenting the analysis of alternatives .........................................87 

3.13.  Links to other parts of the application ............................................................................91 

3.13.1.  Substitution plan ...............................................................................................91 

3.13.2.  A socio-economic analysis (SEA) ....................................................................91 

3.14.  Presenting the documentation of the analysis of alternatives to the Agency ..................92 

4.  PLANNING FOR SUBSTITUTION: GUIDANCE ON SUBSTITUTION PLANS ..............93 

4.1. 

Introduction .....................................................................................................................93 

4.2.  Scope and contents of a substitution plan .......................................................................95 

4.3.  Preparing a substitution plan ...........................................................................................95 

4.3.1.  Factors affecting the transfer to the substitute(s) ..............................................95 

4.3.2.  Defining the actions ..........................................................................................96 

4.3.3. 

Identifying and setting progress markers ..........................................................97 

4.3.4.  Defining the timing of the plan .........................................................................97 

4.3.5.  Communication with the supply chain and customers .....................................98 

4.4.  Documenting the plan .....................................................................................................98 

4.4.1.  Presenting the documentation of the substitution plan to the Agency ............100 

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5.  GUIDANCE FOR THIRD PARTIES ON SUBMITTING INFORMATION ON 

ALTERNATIVE SUBSTANCES OR TECHNOLOGIES ....................................................101 

5.1.  Circumstances leading to third party submission of information .................................102 

5.2.  Timing of third party submissions ................................................................................102 

5.3.  Preparation of a third party submission ........................................................................104 

5.4.  Confidentiality ..............................................................................................................107 

REFERENCES ...............................................................................................................................109 

APPENDIX 1. CONSIDERATIONS FOR GROUPING OF SUBSTANCES ..............................112 

APPENDIX 2. APPLICATIONS BY SEVERAL LEGAL ENTITIES .........................................115 

APPENDIX 3. CHECKLIST FOR ANALYSIS OF ALTERNATIVES .......................................118 

APPENDIX 4. CHECKLIST FOR ANNEX XIV SUBSTANCE FUNCTION ............................119 

APPENDIX 5 

BRIEF EXAMPLE OF POSSIBLE METHOD FOR PROFILING 
ENVIRONMENTAL RISK ....................................................................................................121 

APPENDIX 6. CHECKLIST FOR SUBSTITUTION PLAN ........................................................122 

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TABLES 

Table 1.Uses exempted from authorisation ........................................................................................6 

Table 2. Procedure following submission of an application .............................................................14 

Table 3. Information specified in an authorisation ...........................................................................19 

Table 4. Requirements following granting of an authorisation ........................................................20 

Table 5. Summary of key deadlines ..................................................................................................22 

Table 6. Basic information that shall be included in an application for an authorisation .................24 

Table 7. Other information that may be included in an application for an authorisation .................26 

Table 8. Hypothetical examples of summaries of actions needed to address the suitability and 

availability of possible alternatives ....................................................................................85 

FIGURES 

Figure 1. Simplified description of the identification of substances of very high concern and the 

authorisation procedure ........................................................................................................3 

Figure 2. Simplified description for granting of authorisations ..........................................................8 

Figure 3. Granting of authorisations part 1 .........................................................................................9 

Figure 4. Granting of authorisations part 2 .......................................................................................10 

Figure 5. Granting of authorisations part 3 .......................................................................................10 

Figure 6. Timeline for granting of an authorisation. .........................................................................12 

Figure 7. Flow diagram for the assessment of and comparison to risks of alternatives ...................65 

Figure 8. Flow diagram for preparing and implementing a substitution plan ..................................94 

Figure 9. Illustration of timeline for substitution plan ....................................................................100 

EXAMPLES 

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Example 1. Considerations for substance function ...........................................................................48 

Example 2. Illustration of supply chain communication ..................................................................53 

Example 3. Considerations for technical feasibility .........................................................................59 

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ABBREVIATIONS  

BREF   

Best Available Technology Reference Document (guidance under IPPC directive) 

CAS 

CBI 

CMR 

CSA  

CSR 

Chemical Abstracts Service 

Confidential Business Information 

Carcinogenic, Mutagenic or toxic to Reproduction  

Chemical Safety Assessment  

Chemical Safety Report 

DNEL  

Derived No-Effect Level 

DU 

Downstream User 

ECHA  

European Chemicals Agency 

EINECS 

European Inventory of Existing Commercial Chemical Substances 

ELINCS 

European List of Notified Chemical Substances 

ES 

GD 

IPPC 

Exposure Scenario 

Guidance Document under REACH 

Integrated Pollution Prevention and Control (Directive 2008/1/EC) 

IUCLID 

International Uniform Chemical Information Database 

MS 

M/I 

OC 

PBT 

Member State 

Manufacturer/Importer 

Operational Conditions  

Persistent, Bioaccumulative and Toxic 

PNEC   

Predicted No Effect Concentration 

POP 

Persistent Organic Pollutants (Regulation (EC) No 850/2004) 

QSAR  

Quantitative Structure Activity Relationship 

REACH 

Registration, Evaluation, Authorisation and restriction of Chemicals 

R&D 

Research and Development 

RMM   

Risk Management Measure 

SEA 

SDS 

SIEF 

Socio-Economic Analysis 

Safety Data Sheet 

Substance Information Exchange Forum 

SVHC   

Substance of Very High Concern  

Very Persistent and very Bioaccumulative 

Water Framework Directive (Directive 2000/60/EC) 

vPvB 

WFD 

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GLOSSARY OF TERMS 

A glossary of technical terms used within this guidance document is provided below. The European 
Chemicals Agency (ECHA) also has a general glossary of terms relevant to REACH which can be 
found using the following link: REACH Navigator - Glossary 

Adequate control route (for authorisation): An authorisation shall be granted if it is demonstrated 
that  the  risk  to  human  health  or  the  environment  from  the  use  of  the  substance  arising  from  the 
intrinsic properties specified in Annex XIV is adequately controlled in accordance with section 6.4 
of Annex I {Art. 60(2)}, taking into account Article 60(3).  

Agency: The European Chemicals Agency (ECHA) as established by the REACH Regulation. 

Annex XIV:  Annex XIV of REACH lists all substances which are subject  to  authorisation  under 
REACH. The use and placing on the market for a use of substances listed on Annex XIV, either on 
its own, in a mixture or for incorporating into an article, is prohibited from the "sunset" date unless 
an authorisation has been granted for that use or unless an exemption applies. 

Annex XIV substance: The substance listed on Annex XIV that is the subject of the authorisation 
procedure. 

Annex XV: Annex XV of the REACH regulation lays down general principles for preparing Annex 
XV dossiers to propose and justify 

(a) harmonised classification and labelling of CMRs, respiratory sensitisers and other effects 

(b) the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern in 
accordance with Article 59 

(c) restrictions of the manufacture, placing on the market or use of a substance within the Community. 

Proposals for restrictions and identification of substances of very high concern can be prepared by a 
Member  State  or  by  the  Agency  on  a  request  from  the  Commission.  Proposals  for  harmonised 
classification and labelling can be prepared by a Member State. 

Annex XV dossier: A dossier produced in accordance with Annex XV. The dossier consists of two 
parts, the Annex XV report and the Annex XV technical dossier supporting the Annex XV report.  

Applicant: The legal entity or group of legal entities submitting the authorisation application. 

Authorisation: The REACH Regulation sets up a system under which the use of substances with 
properties  of  very  high  concern  and  their  placing  on  the  market  can  be  made  subject  to  an 
authorisation requirement. Such substances are included in Annex XIV of the Regulation, and may 
not be placed on the market or used without an authorisation after the sunset date. This authorisation 
requirement ensures that risks from the use of such substances are either adequately controlled or 
outweighed by socio-economic benefits. An analysis of alternative substances or technologies will 
be a fundamental component of the authorisation process.  

Authorisation application: The documentation submitted to the Agency applying for authorisation 
in order to (continue to) use of substances included in Annex XIV. 

Authorisation review: Authorisations granted will be subject to a review period.  

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Candidate List: The candidate list refers to the list of substances of very high concern (SVHC) from 
which the substances to be included in Annex XIV (list of substances subject to authorisation) are 
selected. The candidate list is established in accordance with Article 59. 

Carcinogenic,  mutagenic  or  toxic  to  reproduction  (CMR):  Substances  meeting  the  criteria  for 
classification as carcinogenic, mutagenic or toxic for reproduction category 1 or 2, in accordance with 
Directive 67/548/EEC, are substances of very high concern2. They may be included in Annex XIV 
and by that made subject  to  authorisation  requirement. CMRs may be non-threshold (i.e. it is  not 
possible to  define a Derived No-Effect  Level  (DNEL)) or threshold (i.e.  it is  possible to  define a 
DNEL) 

Chemical  Safety  Assessment  (CSA):  Chemical  Safety  Assessment  is  the  process  aimed  at 
determining the risk posed by a substance and, as part of the exposure assessment, develop exposure 
scenarios  including  risk  management  measures  to  control  the  risks.  Annex  I  contains  general 
provisions for performing a CSA. The CSA consists of the following steps:  

• Human health hazard assessment 

• Human health hazard assessment of physicochemical properties 

• Environmental hazard assessment 

• PBT and vPvB assessment 

If, as a result of this hazard assessment, the registrant concludes that the substance meets the criteria 
for classification as dangerous according to Directive 67/548/EEC (for substances)3 or has PBT/vPvB 
properties, this triggers further steps in the chemical safety assessment: 

• Exposure assessment  

• Risk characterization.  

Chemical  Safety  Report  (CSR):  The  chemical  safety  report  documents  the  chemical  safety 
assessment for a substance on its own, in a mixture or in an article or a group of substances. 

2   From 1 December 2010, this should read: "Substances meeting the criteria for classification in the hazard classes 
carcinogenicity, gem cell mutagenicity or reproductive toxicity category 1A or 1B in accordance with Annex I to 
Regulation (EC) No 1212/2008". 

3   From 1 December 2010, this should read: "If, as a result of this hazard assessment, the registrant concludes that the 
substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation 
(EC) No 1272/2008: 

(a) 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; 

(b) 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; 

(c) hazard class 4.1; 

(d) hazard class 5.1," 

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In other words the chemical safety report (CSR) is a document, which details the process and the 
results of a chemical safety assessment (CSA). Annex I of the REACH Regulation contains general 
provisions for performing CSAs and preparing CSRs. 

Committee for Risk Assessment (RAC): is an Agency committee that is responsible for preparing 
the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions 
and proposals for classification and labelling under the classification and labelling inventory task and 
any other questions that arise from the operation of the REACH Regulation relating to risks to human 
health or the environment. The RAC consists of at least one but no more than two members from the 
nominees of each Member State appointed by the Management Board for a renewable term of three 
years.  The  Committee  members  may  be  accompanied  by  advisers  on  scientific,  technical  or 
regulatory matters. 

Committee for Socio-economic Analysis (SEAC): is an Agency committee that is responsible for 
preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and 
any  other  questions  that  arise  from  the  operation  of  the  REACH  Regulation  relating  to  the  socio 
economic impact of possible legislative action on substances. The SEAC consists of at least one but 
no more than two members from the nominees of each Member State appointed by the Management 
Board for a renewable term of three year. The Committee members may be accompanied by advisers 
on scientific, technical or regulatory matters. 

Downstream User: Any natural or legal person established within the Community, other than the 
manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course 
of his industrial or professional activities. A distributor or a consumer is not a downstream user. A 
re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user.  

Exposure  scenario:  Set  of  conditions  including  operational  conditions  and  risk  management 
measures that describe how the substance is manufactured or used during its life-cycle and how the 
manufacturer or importer controls, or recommends downstream users to control, exposure of humans 
and  the  environment.  These  exposure  scenarios  may  cover  one  specific  process  or  use  or  several 
processes or uses as appropriate. 

Gross profit of a substance or a product is the difference between the sales revenue and the variable 
and fixed costs of producing the product. Fixed and variable costs (also  known as “cost of goods 
sold”) include e.g. materials and labour. Gross Profit = Revenue − variable costs − fixed costs 

Importer:  Any  natural  or  legal  person  established  within  the  Community  who  is  responsible  for 
import. 

Interested Third Party: Any organisation, individual, authority or company other than the applicant 
or the Agency/Commission with a potential interest in submitting information on alternatives for the 
consideration  of  the  Agency  Committees  in  forming  their  opinions  on  the  application  for 
authorisation. 

Joint application:  An application for authorisation  made  by a number of legal  entities forming a 
group of applicants consisting of manufacturer(s) and/or importer(s) and/or downstream user(s) of 
the Annex XIV substance.  

Latest application date: Annex XIV (list of substances subject to Authorisation) will specify for 
each substance included in that Annex a date or dates, at least 18 months before the sunset date(s), by 
which applications for authorisation must be submitted if the applicant wishes to continue to use the 
substance or place it on the market for certain uses after the sunset date(s) until a decision on the 
application for authorisation is taken. 

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Legal entity: Any natural or legal person established within the Community. 

Manufacturer: Any natural or legal person established within the Community who manufactures a 
substance within the Community 

Operational Conditions (OC): All conditions which have a quantitative impact on exposure, e.g. 
product specifications, duration and frequency of exposure, applied amount of substance per use or 
capacity of surroundings (e.g. room size, receiving environmental compartment)  

Persistent,  Bioaccumulative  and  Toxic  (PBT):  Annex  XIII  of  the  REACH  Regulation  defines 
criteria for the identification of substances that are Persistent, Bio-accumulative and Toxic (PBTs) 
and Annex I lays down general provisions for PBT assessment. PBTs are substances of very high 
concern (SVHC) and may be included in Annex XIV and by that be made subject to authorisation. 

Regulatory procedure: procedure for the adoption of implementing legislation that involves a vote 
by a Committee composed of the representatives of the Member States. The Council and the European 
Parliament  have  a  role  to  play  in  accordance  with  Article  5  of  Council Decision  1999/468/EC  as 
amended by Council Decision 2006/512/EC. Authorisation proposals under REACH will be adopted 
in accordance with this regulatory procedure. 

Regulatory procedure with scrutiny: procedure for the adoption of implementing legislation that 
involves a vote by a Committee composed of the representatives of the Member States and foresees 
a role for the Council and the European Parliament in accordance with Article 5a of Council Decision 
1999/468/EC  as  amended  by  Council  Decision  2006/512/EC.  Decisions  on  the  inclusion  of 
substances in Annex XIV will be taken in accordance with the regulatory procedure with scrutiny. 

Review report: In order to continue placing on the market or using a substance, the holder of the 
authorisation must submit a review report at least 18 months before the expiry date of the time-limited 
review period. 

Risk Management Measures (RMM): Measures in the control strategy for a substance that reduce 
the  emission  and  exposure  to  a  substance,  thereby  reducing  the  risk  to  human  health  or  the 
environment.  

Socio-economic analysis (SEA): The socio-economic analysis (SEA) is a tool to evaluate what costs 
and  benefits  an  action  will  create  for  society  by  comparing  what  will  happen  if  this  action  is 
implemented as compared to the situation where the action is not implemented. Although according 
to Article 62(5) the inclusion of a SEA is optional it should be included as part of an application for 
authorisation whenever the risks to human health or the environment from the use of an Annex XIV 
substance are not adequately controlled. Also when adequate control can be shown, an SEA may be 
produced by the applicant in support to his application. An SEA may also be produced by any third 
party in support to information on alternatives.  

Socio-economic  route  (for  authorisation):  An  authorisation  may  be  granted  if  it  can  be 
demonstrated  that  the  risk  to  human  health  or  the  environment  from  the  use  of  the  substance  is 
outweighed  by  the  socio-economic  benefits  and  if  there  are  no  suitable  alternative  substances  or 
technologies {Art. 60(4)}. 

Substance function: The function of the Annex XIV substance for the use/s being applied for is the 
task or job that the Annex XIV substance is performing. 

Substances of very high concern (SVHC): SVHC in the context of the REACH Regulation are: 

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1. CMRs category 1 or 2 in accordance with Directive 67/548/EEC4. 

2. PBTs and vPvBs meeting the criteria of Annex XIII and 

3.  substances  -  such  as  those  having  endocrine  disrupting  properties  or  those  having  persistent, 
bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which 
do not fulfil the criteria of Annex XIII - for which there is scientific evidence of probable serious 
effects to human health or the environment which give rise to an equivalent level of concern to those 
of  other  substances  listed  in  points  1  and  2  and  which  are  identified  on  a  case-by-case  basis  in 
accordance with the procedure set out in Article 59. 

Substitution plan: Is a commitment to take the actions needed to substitute the Annex XIV substance 
with an alternative substance or technology within a specified timetable. 

Suitable alternative: Includes any alternative to the Annex XIV substance for the use applied for, 
which is safer5 (i.e. entailing a lower risk for human health or the environment) and technically and 
economically feasible in the EU (i.e. not in abstracto or in laboratory conditions or under conditions 
that are of exceptional nature). Furthermore, it must be available from the perspective of production 
capacities  of  alternative  substances,  or  from  the  perspective  of  feasibility  of  the  alternative 
technology, and in light of the legal and factual requirements for putting them into circulation.6 See 
also  the  note  of  the  European  Commission  of  27  May  2020  on  “Suitable  alternative  available  in 
general & Requirement for a substitution plan”7. 

Sunset date: Annex XIV (list of substances subject to Authorisation) will specify for each substance 
included in that Annex the date (called 'the sunset date") from which the placing on the market and 
the use of that substance shall be prohibited. That is unless an exemption applies or an authorisation 
is granted or an authorisation application has been submitted before the latest application date also 
specified in Annex XIV, but the Commission decision on the application for authorisation has not yet 
been taken. 

Supply chain: Is the system of organisations, people, activities, information and resources involved 
in moving a substance from (supplier to customer) i.e. manufacture/importers to downstream users 
and end users. 

Very Persistent and very Bioaccumulative (vPvB): Substances of very high concern, which are 
very persistent (very difficult to break down) and very bio-accumulative in living organisms. Annex 
XIII of the REACH Regulation defines criteria for the identification of vPvBs and Annex I lays down 
general provisions for their assessment; vPvBs may be included in Annex XIV and by that be made 
subject to authorisation.  

4   As from 1 December 2010 this should read: "substances meeting the criteria for classification in the hazard classes 
carcinogenicity, germ cell mutagenicity or reproductive toxicity category 1A or 1B in accordance with Annex I to 
Regulation (EC) No 1272/2008". 

5   REACH recital 73 and paragraph 72 of the General Court’s judgments in case T-837/16. 

6   Article 55 of REACH and paragraphs 72 and 73 of the General Court’s judgments in case T-837/16. 

7  Available at https://echa.europa.eu/documents/10162/13637/ec_note_suitable_alternative_in_general.pdf. 

xiii 

 
 
 
 
 
Guidance on Authorisation Applications 

1. 

GENERAL INTRODUCTION AND OVERVIEW OF THE AUTHORISATION PROCESS  

1.1.  About this guidance 

This  document  provides  technical  guidance  on  how  to  apply  for  an  authorisation  for  the  use  of 
substances included in Annex XIV under 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 (the REACH Regulation). In particular it includes guidance on the mixture 
of an analysis of alternatives, a substitution plan and how interested third parties can contribute to the 
authorisation process. 

1.2. 

Structure of the guidance 

The  introductory  sections  (Chapter  1)  contain  a  general  overview  of  the  authorisation  process, 
including links to other REACH guidance. Chapter 2 provides more detailed guidance how to put 
together  an  application  for  an  authorisation,  and  on  the  specific  information  and  considerations 
needed  for  an  application.  Chapter  3  considers  what  is  needed  when  carrying  out  an  analysis  of 
alternatives; Chapter 4 describes the production of a substitution plan; and Chapter 5 deals with the 
submission of information by third parties.  

1.3.  Who is the guidance for? 

This  guidance  is  primarily  intended  for  use  by  manufacturers,  importers  and  downstream  users 
placing on the market or using a substance included in Annex XIV of REACH (List of substances 
subject  to  authorisation). The guidance is  also  intended  to  be used by third parties  that may have 
information on alternative substances or alternative technologies in relation to a substance included 
in Annex XIV. In general, the user is assumed to have suitable experience for the part of the guidance 
they are using. 

The guidance may also be useful for those within the Member State Competent Authorities and the 
Agency involved in the authorisation process.  

1.4.  Links to other REACH guidance 

This guidance is not intended to be used as stand-alone guidance and takes into account other REACH 
guidance relevant for preparing an authorisation application. The intention of this guidance is not to 
repeat  guidance  that  is  available  elsewhere,  and  the  relevant  sources  of  further  guidance  are 
referenced as appropriate. The most relevant other parts of the REACH guidance are as follows. 

•  Guidance  on  information  requirements  and  chemical  safety  assessment  (CSA).  This 
provides further guidance on carrying out a Chemical Safety Assessment and documenting it 
in  a  Chemical  Safety  Report.  This  guidance  also  includes  advice,  for  instance,  on 
identification/description of uses and on grouping of substances.  

•  Guidance  on  data  sharing.  This  provides  guidance  on  data  sharing  mechanisms  under 

REACH, and includes the communication within SIEF and cost sharing guidance. 

1 

 
 
Guidance on Authorisation Applications 

•  Guidance  for  Downstream  Users.  This  provides  further  guidance  on  the  obligations  of 

downstream users in relation to substances listed in Annex XIV. 

•  Guidance on Socio Economic Analysis – Authorisation. This provides detailed guidance 

for carrying out a socio-economic analysis. 

In addition, separate guidance documents are available for authorities concerning the identification 
of substances of very high concern, priority setting and the inclusion of a substance on Annex XIV,8 
and so these stages of the overall process are not considered in detail in this guidance. However it is 
essential for a potential applicant for an authorisation and other interested third parties to understand 
the process that leads to inclusion of a substance on Annex XIV, as there are a number of formal 
opportunities for commenting and submitting information prior to the substance being included on 
Annex XIV. Early involvement of potential applicants and interested third parties in the process is 
encouraged in order to improve the quality of decision making. Therefore a brief overview of the 
overall authorisation process is given here. The guidance documents on identification of substances 
of very high concern and inclusion of a substance on Annex XIV should be consulted for more details 
on the authorisation procedure concerning inclusion of a substance on Annex XIV. 

1.5.  General overview of the authorisation procedure 

The aim of this Title (VII, authorisation) is to ensure the good functioning of the internal market while 
assuring that the risks from substances of very high concern are properly controlled and that these 
substances are progressively replaced by suitable alternative substances or technologies where these 
are economically and technically viable. To this end all manufacturers, importers and downstream 
users applying for authorisation shall analyse the availability of alternatives and consider their risks, 
and the technical and economic feasibility of substitution {Art. 55}. 

Authorisations apply to substances of very high concern (SVHC) that are included in Annex XIV of 
REACH.  There  is  no  tonnage  limit  for  the  authorisation  requirement.  The  overall  authorisation 
process  involves  several  steps  including  identification  of  substances  of  very  high  concern, 
prioritisation of these substances for inclusion in Annex XIV, the listing of these substances on Annex 
XIV, application for authorisations, granting or refusing of authorisations and reviewing of granted 
authorisations. A simplified description of the overall process is shown in Figure 1. The process up 
to inclusion of the substances on Annex XIV is described in detail in the Guidance on inclusion of 
substances  in  Annex  XIV,  but  some  background  is  included  in  Sections  1.5.1  and  1.5.2  of  this 
guidance. The rest of this guidance relates to the steps following inclusion on Annex XIV.  

8 See https://echa.europa.eu/documents/10162/13640/recom_gen_approach_draft_axiv_entries_2020_en.pdf and 
https://echa.europa.eu/documents/10162/13640/recom_gen_approach_draft_axiv_entries_2020_en.pdf. 

2 

 
 
 
 
 
Guidance on Authorisation Applications 

Figure 1. Simplified description of the identification of substances of very high concern and the 

authorisation procedure 

MS or Agency prepares Annex XV  

SVHC dossier        
 (Art. 59 (2) and 59 (3)) 

 

Candidate list inclusion 
 (Art. 59 (1)) 

 

Prioritisation procedure 
 (Art. 58 (3)) 

 

Annex XIV inclusion     
 (Art. 58 (1)) 

 

Application for authorisation  
(Art. 62) 

 

Authorisation granted/not granted  
(Art. 60) 

 

Review of granted authorisations  
(Art. 61) 

1.5.1.  How substances get included in Annex XIV 

The process is started by a Member State or, on request from the Commission, by the Agency, when 
they produce Annex XV dossiers for identification of substances of very high concern in accordance 
with the procedure laid down in Article 59. Only substances  with the following properties can be 
included in Annex XIV and therefore, be subject to authorisation {Art. 57}. 

a)  Substances  meeting  the  criteria  for  classification  as  carcinogenic  category  1  or  2  in 

accordance with Council Directive 67/548/EEC. 9 

b)  Substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance 

with Council Directive 67/548/EEC. 

9   The  references  to  Directive  67/548/EEC  will  be  replaced  from  1  December  2010  by  references  to  Regulation 

1272/2008 (CLP Regulation). 

3 

 
 
 
 
Guidance on Authorisation Applications 

c)  Substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in 

accordance with Council Directive 67/548/EEC. 

d)  Substances which are persistent, bioaccumulative and toxic in accordance with the criteria 

set out in Annex XIII of the Regulation. 

e)  Substances  which  are  very  persistent  and  very  bioaccumulative  in  accordance  with  the 

criteria set out in Annex XIII of the Regulation. 

f)  Substances - such as those having endocrine disrupting properties or those having persistent, 
bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, 
which do not fulfil the criteria of points (d) or (e) - for which there is scientific evidence of 
probable serious effects to human health or the environment which give rise to an equivalent 
level of concern to those of other substances listed in points (a) to (e) and which are identified 
on a case-by-case basis. 

The  Annex  XV  dossier  should  outline  the  scientific  evidence  for  identifying  the  substance  as  a 
substance of very high concern and candidate for eventual inclusion on Annex XIV. Direction on 
preparing an Annex XV SVHC dossier is included in the Guidance for the preparation of an Annex 
XV dossier on the identification of substances of very high concern. Comments on the Annex XV 
dossier are invited from the Member States, the Agency and interested parties (stakeholders), in the 
latter case via a notice published on the Agency’s website with a deadline set by the Agency {Art. 
59(4)}. These notices include, e.g., information from the Annex XV dossiers on substance identity 
(name, EC and/or CAS numbers), the reason why the substance is believed to meet one or more of 
the criteria set out in Article 57 and the deadline for comments. Guidance on how to submit comments 
is provided in the Guidance on inclusion of substances in Annex XIV. 

Once an agreement has been reached that the substance meets one or more of the intrinsic properties 
outlined  in  Article  57  (see  above),  the  substance  will  be  placed  on  the  candidate  list.  The  main 
implication of placing a substance on the candidate list is that it then becomes eligible for eventual 
inclusion  in  Annex  XIV.  The  Agency,  taking  into  account  the  opinion  of  the  Member  State 
Committee, recommends priority substances to be included on Annex XIV. Priority will normally be 
given to substances with PBT or vPvB properties, or wide dispersive uses, or high volumes {Art. 
58(3)}.The Agency will submit a recommendation for substances to be included in Annex XIV to the 
Commission at least every second year {Art. 58(3)}.  

Before the Agency sends a new recommendation to the Commission, the recommendation is made 
public via the Agency’s  website, and all interested parties are invited to  submit comments  within 
three months of the date of publication. In particular, comments on uses which should be exempted 
from the authorisation requirement are requested. The recommendation may then be updated to take 
account of the comments received {Art. 58(4)}. For consultation purposes, a template for provision 
of comments is made available on the Agency’s website. Guidance on how to submit comments is 
provided  in  the  Guidance  on  inclusion  of  substances  in  Annex  XIV.  The  Commission  takes  the 
decision on the inclusion of substances in Annex XIV in accordance with the Regulatory procedure 
with scrutiny referred to in Article 133(4) {Art. 58(1)}. 

1.5.2.  Annex XIV entries 

The Annex XIV entry for each substance will specify the following {Art. 58(1)}. 

4 

 
 
 
 
Guidance on Authorisation Applications 

•  The identity of the substance as specified in Section 2 of Annex VI; 

• 

the intrinsic property (or properties) of the substance referred to in Article 57 (i.e. properties 
leading to the inclusion in Annex XIV); 

• 

transitional arrangements: 

o 

the date(s) from which placing on the market and use of the substance is prohibited 
unless  an  authorisation  is  granted  (hereafter  referred  to  as  the  sunset  date)  which 
should take into account, where relevant, the production cycle specified for that use; 

o  a date or dates, at least 18 months before the sunset date(s) by which applications for 
authorisation must be received if the applicant wishes to continue to use the substance 
or place it on the market for certain uses after the sunset date(s); these continued uses 
shall  be  allowed  after  the  sunset  date  until  a  decision  on  the  application  for 
authorisation is taken; 

•  review periods for certain uses if appropriate; 

•  uses  or  categories  of  uses  that  are  exempted  from  the  authorisation  process,  if  any,  and 

conditions for such exemptions, if any. 

After the sunset date, substances that are included in Annex XIV cannot be used by a manufacturer, 
importer  or  a  downstream  user,  or  be  placed  on  the  market  by  a  manufacturer,  importer  or  a 
downstream  user  for  a  use  unless  an  authorisation  has  been  granted  for  that  use  (or  where  an 
application for an authorisation has been submitted to the Agency before the deadline specified in 
Annex XIV but no decision has yet been reached) or the use is exempt from authorisation. The process 
for setting sunset dates takes into account, where appropriate, the production cycle specified for the 
use under consideration. Therefore it is important for the potential applicant(s) to be involved at an 
early  stage  in  the  process  and  provide  information  that  is  relevant  for  setting  sunset  dates.  The 
Guidance on inclusion of substances in  Annex XIV should be consulted  for further details  of the 
process for setting sunset dates. 

Certain uses of substances are exempted from the authorisation process. These general exemptions 
are listed in Table 1. In addition, the Annex XIV entry may include substance specific exemptions 
for  uses  or  categories  of  uses,  along  with  any  conditions  that  apply  to  such  exemptions.  Such 
exemptions may be included provided that, on the basis of existing specific Community legislation 
imposing minimum requirements relating to the protection of human health or the environment for 
the use of the substance, the risk is properly controlled {Art. 58(2)}. The Guidance on inclusion of 
substances  in  Annex  XIV  gives  further  examples  of  existing  specific  Community  legislation  that 
could be considered in this respect. The ultimate responsibility for deciding on which uses should be 
exempted lies with the Commission in accordance with the Regulatory procedure with scrutiny. In 
establishing such exemptions, account shall be taken, in particular, of the proportionality of risk to 
human health and the environment related to the nature of the substance, such as where the risk is 
modified by the physical form.  

5 

 
 
 
 
Guidance on Authorisation Applications 

Table 1.Uses exempted from authorisation 

On-site isolated intermediates and transported isolated intermediates {Art. 2(8b)}.  

Use  in  medicinal products  for  human or veterinary  use  within  the scope  of  Regulation  (EC)  No  726/2004,  Directive 
2001/82/EC and Directive 2001/83/EC {Art. 2(5a)}.  

Use in food or feedingstuffs according to Regulation (EC) No 178/2002 including use as a food additive in foodstuffs 
within the scope of Council Directive 89/107/EEC, as a flavouring in foodstuffs within the scope of Council Directive 
88/388/EEC and Commission Decision 1999/217/EC or on foodstuffs drawn up in application of Regulation (EC) No 
2232/96, as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 and in animal nutrition within 
the scope of Council Directive 82/471/EEC {Art. 2(5b)}.  

Use in scientific research and development {Art. 56(3)} (Annex XIV shall specify if the authorisation requirement applies 
to product and process research and development) {Art. 56(3}. 

Use on plant protection products within the scope of Council Directive 91/414/EEC {Art. 56(4a)}. 

Use in biocidal products within the scope of Directive 98/8/EC {Art. 56(4b)}. 

Use as motor fuels covered by Directive 98/70/EC {Art. 56(4c)}. 

Use as fuel in mobile or fixed combustion plants of mineral oil products and use of fuels in closed systems {Art. 56(4d)}. 

Use in cosmetic products within the scope of Council Directive 76/768/EEC (this exemption applies to substances listed 
on Annex XIV on the basis of their hazard to human health only) {Art. 56(5a)}. 

Use in food contact materials within the scope of Regulation (EC) No 1935/2004 (this exemption applies to substances 
listed on Annex XIV on the basis of their hazard to human health only) {Art. 56(5b)}. 

Use  of  substances  when  present  in  mixtures  below  a  concentration  limit  of  0.1%  by  weight.  This  applies  only  to 
substances listed in Annex XIV on the basis of being persistent, bioaccumulative and toxic (PBT) as defined by Art. 
57(d), very persistent and very bioaccumulative (vPvB) as defined by Art. 57(e), or listed in Annex XIV on the basis that 
there is scientific evidence of probable serious effects to human health or the environment which give an equivalent 
level of concern to substances with PBT or vPvB properties, or an equivalent level of concern to substances classified 
as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1 and 2 in accordance with Directive 67/548/EEC, 
as defined by Art. 57(f) {Art. 56(6a)}.  

Use of substances when present in mixtures below the lowest concentration limits specified in Directive 1999/45/EC or 
in Part 3 of Annex VI to Regulation (EC) No 1272/2008 which results in the classification of the mixture as dangerous. 
This  applies  only  to  substance  listed  in  Annex  XIV  on  the  basis  of  their  classification  as  CMR  category  1  and  2  in 
accordance with Directive 67/548/EEC{Art. 56(6b)}. 

As noted in Section 1.5.1, there are two opportunities for formal comments from interested parties 
prior  to  the  substance  being  included  in  Annex  XIV,  firstly  a  commenting  period  on  the 
non-confidential content of the Annex XV dossier itself {Art. 59(4)} and secondly a commenting 
period  on  the  recommendations  for  inclusion  of  the  substance  in  Annex  XIV  {Art.  58(4)}.  This 
second commenting period in particular, allows comments on uses that have been proposed by the 
Agency for exemption and further uses that should be exempted from the authorisation requirement, 
and information on the production cycle, to be put forward. Guidance on submitting information at 
these points in the process can be found in Guidance on inclusion of substances in Annex XIV. 

If  new  information  becomes  available  to  show  that  the  substance  no  longer  meets  the  criteria  of 
Article 57 then the substance shall be removed from Annex XIV {Art. 58(8)}. In addition, substances 
for which all uses are prohibited, either by the restrictions procedure under Title VIII of the regulation 
or by other Community legislation, shall not be included in Annex XIV or shall be removed from it 
(Art. 58(7)). 

6 

 
 
 
 
 
Guidance on Authorisation Applications 

1.5.3.  Application for an authorisation 

This section outlines the general requirements for an application. More detailed guidance on how to 
put together an application is given in Section 2. A simplified description of the process following 
listing of a substance on Annex XIV is shown in Figure 2. The detailed process is presented in Figure 
3,  

7 

 
 
Guidance on Authorisation Applications 

Figure 4 and Figure 5. Figure 6 outlines the timeline for applications for authorisation. Further details 
of the timetable are included in Table 2. 

Figure 2. Simplified description for granting of authorisations  

Applicant applies for authorisation 

Interested parties: 

information on alternatives  

Figure 3 

 

Agency’s Committees’ draft 
opinions 

Applicant’s comments 

 

Figure 4 

Agency’s Committees’ opinions 

Commission decision 

 

Authorisation granted/not granted 

Figure 5 

8 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on Authorisation Applications 

Figure 3. Granting of authorisations part 1 

9 

 Applicant(Manufacturer, Importer, Downstream user)Application for authorisation of use(s) of substance(s) on Annex XIVShall include: (art. 62. 4)-Substance identity as ref. in section 2 of Annex VI-Identity of applicant-Request for authorisation, specifying the use(s) applied for-Chemical Safety Report (unless already submitted)-Analysis of alternatives (incl. information on R&D, if appropriate)-Substitution plan (where required) -Fee (art 62.7)May include: (art. 62. 5)-Socio-Economic Analysis -Justification for not considering risk AgencyRA C'teeSEA C'teeApplication conform?art. 64. 3yesPrepare opinion(s)Web site-broad info on uses for which application is received-deadline for submission of   info on alternativesart. 64. 2Invite third parties to comment within specified deadlineInterested third partiesRelevant information(e.g. on alternatives and socio-economic impacts)art. 64. 2If necessary ask for additional infoart. 64. 3Bring application in conformity with Art. 62art. 64. 3Acknowledge date of receipt  art. 64. 1Applicantno 
 
 
Guidance on Authorisation Applications 

Figure 4. Granting of authorisations part 2 

10 

 Prepare opinion(s)Further information on alternatives needed (SEA C’tee) art. 64.3Draft opinions-RA Committee: risks to health and environment from use(s) ofthe Annex XIV substance applied for, risks arising frompossible alternatives, and any information from third parties.-SEA Committee: socio-economic factors, and the availability, suitability and technical feasibility of alternativesassociated with the use(s) applied for, and any information from third parties.art. 64.1 and  64. 4AgencyForward draft opinionsnoFurther info on alternativesInterested third partiesFurther info on alternativesPrepare opinion(s)yesApplicantAgencynoyes Wishes to comment?art. 64. 5Comments art. 64. 5Consider comments and revise draft opinionart 64.5Final opinionsart 64.5Indication if he wants to commentAgencyRA C'teeSEA C'teeApplicantyes 
 
 
 
Guidance on Authorisation Applications 

Figure 5. Granting of authorisations part 3 

11 

 Web site:non-confidential partsart 64.6Member StatesCommissionSummaries of the Commission Decisions in the OJart 64.9Decision to grant or deny authorisationDecision in database            art. 64.9ApplicantAgencyFinal opinionsart 64.5Draft authorisation decisionart 64.8Art. 133(3) procedure 
 
 
 
Guidance on Authorisation Applications 

Figure 6. Timeline for granting of an authorisation.  

Applicant 

Interested 
third parties 

Agency and 
Committees 

Commission 

Application with 
fee 

e
n

i
l

d
a
e
d

t
e
S

Information on alternatives 

Submission of 
further 
information if 
required 

Submission of further 
information if requested 

Written notice 
indicating wish 
to comment 

Comments 

h
t
n
o
m
1

12 

U
p

t
o

1
0
m
o
n
t
h
s

2
m
o
n
t
h
s

2
m
o
n
t
h
s

d
a
y
s

1
5

m
o
n
t
h
s

3

Publication of information on 
uses applied for 

Committees may jointly 
require information to bring 
into conformity  

Risk Assessment and SEA 
Committees Draft opinion 

Risk Assessment and SEA 
Committees Final opinions 

Final  opinions 
to Commission 

Commission 
draft decision 

Decision 

Publication in 
OJ 

Database entry 

 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
Guidance on Authorisation Applications 

Applications for authorisations must conform to the requirements of Article 62 of the Regulation. 
These requirements are outlined below. 

The  applications  for  authorisation  are  made  to  the  Agency  {Art.  62(1)}.  Applications  can  be 
submitted by the manufacturer(s), importer(s) and/or downstream user(s) of the substances, and one 
or several  of these {Art. 62(2)} can make an application for authorisation  for the same substance 
covering one or more uses {Art. 62(3)}. The uses applied for can be the applicant’s own use(s) and/or 
uses for which the applicant intends to place the substance on the market. If an actor applies for an 
authorisation for a use(s) of his downstream user(s), he needs to cover all uses in the supply chain 
that are necessary to enable that use(s). For example, if a manufacturer or importer applies for a use 
of his downstream user, but there is a formulator in between him and the DU, his application has also 
to cover the use of the substance in formulation. 

Applications can also be made for a group of substances for one or more uses {Art. 62(3)}. Grouping 
of  substances  can  be  made  on  the  basis  of  similarity  of  physicochemical,  toxicological  and 
ecotoxicological properties, or where these follow a regular pattern as a result of structural similarity 
(Annex XI 1.5). 

Each  application  should  be  accompanied  with  the  fee  required  in  accordance  with  Title  IX  {Art. 
62(7)} and Commission Regulation N° EC 340/2008 on the fees and charges payable to the European 
Chemicals Agency (Annex VI and VII). 

The information that must be included in an application for an authorisation is as follows {Art. 62(4)}:  

(a) the identity of the substance(s), as referred to in Section 2 of Annex VI; 

(b) the name and contact details of the person or persons making the application. 

(c)  a  request  for  authorisation,  specifying  for  which  use(s)  the  authorisation  is  sought  and 
covering the use of the substance in mixtures and/or the incorporation of the substance in 
articles, where this is relevant; 

(d) unless already submitted as part of the registration, a chemical safety report in accordance 
with Annex I covering the risks to human health and/or the environment from the use of the 
substance(s) arising from the intrinsic properties specified in Annex XIV;  

(e)  an analysis of alternatives considering their risks and the technical and economic feasibility 
of  substitution  and  including,  if  appropriate  information  about  any  relevant  research  and 
development activities by the applicant. 

(f)  where  the  analysis  referred  to  in  point  (e)  above  shows  that  suitable  alternatives  are 
available, taking into accounts the elements in Article 60(5), a substitution plan including a 
timetable for proposed actions by the applicant. 

The application may also include {Art. 62(5)}: 

(a) a socio-economic analysis conducted in accordance with Annex XVI; 

(b) a justification for not considering risks to human health and the environment arising either 

from: 

(i)  emissions of a substance from an installation for which a permit was granted in accordance 

with Directive 96/61/EC; or 

13 

 
 
Guidance on Authorisation Applications 

(ii) discharges  of  a  substance  from  a  point  source  governed  by  the  requirement  for  prior 
regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and legislation adopted 
under Article 16 of that Directive. 

Article 60(7) provides that an authorisation shall be granted only if the application has been made in 
conformity with the requirements set out in Article 62. Since the authorisation procedure is legally 
subject to a time frame (provided in Article 64), it is important that the application is in conformity 
with these requirements at the submission stage. 

Where an application for authorisation has already been made, or where an authorisation has already 
been granted for a use of a substance, a subsequent applicant may refer to the appropriate parts of the 
previous application provided that they have permission from the previous applicant. The parts of the 
previous application that can be referred to include the following aspects {Art. 63(1),(2)}: 

•  Chemical Safety Report(s),  

•  analysis of alternatives,  

•  substitution plan, and 

•  socio-economic analysis. 

In  this  case  the  subsequent  applicant  shall  update  the  information  in  the  original  application  as 
necessary  {Art.  63(3)}.  Other  information  needed  for  the  application  shall  be  provided  by  the 
subsequent applicant. In cases where an application for the same substance has already been made, 
the Agency shall treat the applications together provided the deadlines outlined in Section 1.5.4 can 
be met for the first application {Art. 64(7)}. 

The deadline for submission of an application for authorisation will be specified in the Annex XIV 
entry. Manufacturers, importers, or downstream users of a substance that is listed in Annex XIV are 
entitled to submit an application to the Agency after that date, but cannot place the substance on the 
market, or use it themselves, until they have obtained the authorisation. 

1.5.4.  What happens after an application for an authorisation has been submitted 

An  overview  of  the  processes  that  should  be  followed  after  submission  of  an  application  for  an 
authorisation is outlined in Table 2.  

Table 2. Procedure following submission of an application  

Step 

Check appropriate fee paid. 

Acknowledgement  of  date  of  receipt  of  application 
{Art. 64(1)}. 

Broad  (non-confidential)  information  on  uses  for 
which  applications  have  been  received  is  made 
available via the Agency’s web-site, with a deadline 
by  which  information  on  alternative  substances  or 
technologies  may  be  submitted  by  interested  third 
parties. 

Organisation 
responsible 

Agency 

Agency 

Agency 

14 

Timeframe 

Deadline  for information  on  alternative 
substances  or  technologies  will  be set 
by  the  Agency,  within  the  10  month 
window  for  the  Agency’s  Committees 
draft opinions. 

 
 
 
 
 
 
 
Guidance on Authorisation Applications 

Step 

Organisation 
responsible 

Timeframe 

Check  to  ensure  all  information  specified  in  Article 
62 of the Regulation is included in the application. If 
necessary  request  further  information  from  the 
applicant to bring the application into conformity {Art. 
64(3)}. 

Agency’s 
Committees for Risk 
Assessment and 
Socio-economic 
analysis 

Deadline for further information will be 
set by the Agency’s Committees within 
the 10 month window as above.  

If  it  is  considered  necessary,  i)  require  further 
information  from  the  applicant  or  request  further 
information from third parties on possible alternative 
substances  or  technologies  {Art.  64(3)}  and  ii) 
require further information to supplement or refine its 
risk  assessment  {paragraphs  176  and  177  of  the 
judgment of the General Court in Case T-108/17 }. 

Draft  opinions  on  the  application  are  sent  to  the 
applicant {Art. 64(1, 5 and 10)}. 

Agency’s 
Committees for Risk 
Assessment and 
Socio-economic 
analysis 

Agency’s 
Committees for Risk 
Assessment and 
Socio-economic 
analysis 

Deadline for further information will be 
set  by  the  Agency’s  Committee  within 
the 10 month window as above. 

Within ten months of the date of receipt 
of  the  application.  If  the  application  is 
for  a  use  of  a  substance  for  which  an 
authorisation 
been 
granted,  this  will  be  reduced  to  five 
months. 

already 

has 

Written  notice  of  the  intention  to 
comment  shall  be  sent  to  the 
Agency. 

Applicant 

Within one month of receipt of the draft 
opinion.  The  draft  opinion  will  be 
deemed  to  have  been  received  seven 
days after the Agency has sent it. 

If the applicant 
to 
wishes 
on 
comment 
draft 
the 
opinion{Art. 
64(5)}. 

Applicant 

Within two months of receipt of the draft 
opinion 

Comments/argumentation 
from 
applicant.  These  shall  be  sent  in 
writing to the Agency. 

Finalisation  of  opinion  on 
the 
application taking into account the 
written  comments/argumentation 
from applicant. 

Agency’s 
Committees for Risk 
Assessment and 
Socio-economic 
analysis 

The final opinion will be adopted within 
two  months  of  receipt  of  the  written 
comments/argumentation.  The 
final 
the  written 
opinion  along  with 
comments/  argumentation  will  be  sent 
to the Commission, Member States and 
the applicant within a further 15 days. 

Within 15 days of the end of the period 
the  applicant  may 
within  which 
comment, or within 15 days of receipt of 
notice  from  the  applicant  that  they  do 
not intend to comment. 

If  the  applicant  does  not  wish  to  comment  on  the 
draft  opinion,  the  draft  opinion  is  sent  to  the 
Commission, the Member States and the applicant 
{Art. 64(5)}. 

Non-confidential  parts  of  the  opinions  and  any 
associated  documentation  made  publicly  available 
on the website {Art. 64(6)}. 

Agency 

Agency 

Draft authorisation decision {Art. 64(8)}. 

Commission 

Within  three  months  of  receipt  of  the 
opinion from the Agency. 

Final decision granting or refusing authorisation {Art. 
64(8)}. 

Summaries of the Commission decisions, including 
the  authorisation  number  and  the  reason  for  the 
decision,  published  in  the  Official  Journal  of  the 
European Union, and made publicly available in the 
Agency database {Art. 64(9)}. 

Commission in 
accordance with 
comitology 
procedure in Article 
133(3) 

Commission 

15 

 
 
 
 
 
 
Guidance on Authorisation Applications 

Opinions  on  the  applications  will  be  drafted  by  the  Committee  for  Risk  Assessment  and  the 
Committee for Socio-economic analysis as appropriate. The Committees will take into account the 
information submitted in the application, any information submitted by third parties and any other 
relevant information available to the Committees. The draft opinions will be given within ten months 
of the date of receipt of the application and will contain the following elements {Art. 64(4)}. 

Committee for Risk Assessment 

•  An  assessment  of  the  risk  to  human  health  and/or  the  environment  from  the  use(s)  of  the 
substance including the appropriateness and effectiveness of the risk management measures 
as described in the application. 

• 

If relevant, an assessment of the risks arising from possible alternatives. 

Committee for Socio-economic Analysis 

•  An assessment  of  the socio-economic factors  and the availability, suitability and technical 
feasibility  of  alternatives  associated  with  the  use(s)  of  the  substance  as  described  in  the 
application, when the application is made in accordance with Article 62. 

•  Any third party contributions submitted under Article 64 (2). 

Once the draft opinions of the Committees are available there will be an opportunity for the applicant 
to comment on the opinions before the opinions are finalised and sent to the Commission, Member 
States and the applicant. If the draft opinion is to grant an authorisation, the applicant may wish to 
comment  on  the  proposed  conditions,  the  length  of  the  time-limited  review  period  or  monitoring 
arrangements. If the draft opinion is to reject the application, then the applicant will need to look at 
the reasons given for rejecting the application. They will have to consider whether further information 
or argumentation can be provided, to give further support to the application and to argue against the 
reasons given for the rejection. This will need to be clearly focussed on the specific reasons given. 

If  the  applicant  wishes  to  comment  on  the  draft  {Art  64  (5)},  written  notice  of  the  intention  to 
comment shall be sent to the Agency within one month of receipt of the draft opinion. The actual 
comments/argumentation  should  be  sent  to  the  Agency  within  two  months  of  receipt  of  the  draft 
opinion. Within two months of the receipt of the applicant’s comments or 15 days if the applicant 
does not wish to comment, the Committees will adopt their final opinion on the application taking 
into  account  the  written  argumentation  from  the  applicant.  The  opinion  will  be  sent  to  the 
Commission, which will, in accordance with the comitology procedure, decide whether or not to grant 
the authorisation. A summary of the decision will then be published in the Official Journal and made 
publicly available in the Agency database. 

1.5.5.  Factors that are taken into account in granting or refusing an authorisation 

In order to decide whether or not to proceed with an application for an authorisation, it is important 
to understand the factors that will be taken into account in granting an authorisation. This is elaborated 
further later in the guidance (Section 2). The responsibility for granting an authorisation lies with the 
Commission {Art. 60(1)}.  

Authorisations can be granted on two bases. 

16 

 
 
 
 
Guidance on Authorisation Applications 

a.  An authorisation shall be granted if it is demonstrated that the risk to human health or the 
environment from the use of the substance arising from the intrinsic properties specified in 
Annex XIV is adequately controlled in accordance with section 6.4 of Annex I {Art. 60(2)} 
and  taking  into  account  Article  60(3).  In  this  guidance  this  is  referred  to  as  the  adequate 
control route. 

b.  Otherwise,  an authorisation may only  be granted  if it can be demonstrated that the risk to 
human health or the environment from the use of the substance is outweighed by the socio-
economic benefits  and if there  are no suitable alternative substances or technologies {Art. 
60(4)}. In this guidance this is referred to as the SEA route. This is the only possible basis to 
get an authorisation in the following cases. 

o  Where adequate control of the use of a substance according to a) cannot be shown. 

o  For substances included in Annex XIV on the basis of meeting any of the following 
criteria and for which it is not possible to determine a threshold in accordance with 
section 6.4 of Annex 1:  

▪  classification  as  carcinogenic  category  1  or  2  in  accordance  with  Council 

Directive 67/548/EEC10, 

▪  classification  as  mutagenic  category  1  or  2  in  accordance  with  Council 

Directive 67/548/EEC11, 

▪  classification  as  toxic  for  reproduction  category  1  or  2  in  accordance  with 

Council Directive 67/548/EEC12, 

▪  substances identified under Art. 57(f) with the exception of substances having 

PBT or vPvB properties (see below). 

o  For substances included in Annex XIV on the basis of meeting the criteria in Annex 
XIII for persistent, bioaccumulative and toxic (PBT) substances and very persistent 
and very bioaccumulative (vPvB) substances. 

o  For substances included in Annex XIV on the basis of having PBT or vPvB properties 

giving rise to an equivalent level of concern (identified under Art. 57(f)). 

10   From 1 December 2010, it should read:  

-  

substances  meeting  the  criteria  for  classification  in  the  hazard  class  carcinogenicity  category  1A  or  1B  in 
accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008 

11   From 1 December 2010, it should read: 

-  

substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B 
in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/20082 

12   From 1 December 2010, it should read: 

-  

substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, 
adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to 
Regulation (EC) No 1272/2008. 

17 

 
 
 
Guidance on Authorisation Applications 

For substances to be authorised through the adequate control route the Commission’s decision will 
be taken based on the evidence presented in the Chemical Safety Report (CSR), taking into account 
the opinion of the Committee for Risk Assessment. Guidance for this process is available elsewhere 
(Guidance on information requirements and CSA). 

In granting the authorisation and setting any conditions the Commission will take into account all 
discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the 
time of the decision. The Commission shall not consider the risks to human health arising from the 
use of a substance in a medical device regulated by Council Directive 90/385/EEC, Council Directive 
93/42/EEC  or  Directive  98/79/EC  {Art.  60(2)}.For  substances  to  be  authorised  through  the  SEA 
route,  in  cases  where  adequate  control  cannot  be  demonstrated  or  Article  60(3)  applies,  the 
Commission’s  decision  will  take  into  account  the  opinions  of  both  the  Committee  for  Risk 
Assessment and the Committee for Socio-economic Analysis and the following {Art. 60(4a to d)}. 

•  The risk posed by the uses of the substance, including the appropriateness and effectiveness 

of the risk management measures proposed. 

•  The socio-economic benefits arising from the use of the substance, and the socio-economic 
implications of a refusal to authorise the substance as demonstrated by the applicant or other 
interested parties. 

•  The  analysis  of  the  alternatives  submitted  by  the  applicant  under  Article  62  (4e)  or  any 
substitution  plan  submitted  by  the  applicant  under  Article  62  (4f)  and  any  third  party 
contributions submitted under Article 64 (2). 

•  Available information on the risks to human health or the environment from any alternative 

substances or technologies. 

Planning  for  substitution:  One  of  the  fundamental  aims  of  authorisation  is  the  progressive 
replacement of the substances listed in Annex XIV by suitable alternative substances or techniques 
which are economically and technically viable. To this end, the applicant's planned activities with a 
view  to  switching  to  economically  and  technically  feasible  alternatives  is  a  crucial  factor  in  the 
decision to grant an authorisation. The applicant's planning for substitution is mainly reflected in the 
following elements of the application: 

1.  An analysis of alternatives: this is a required element in all applications for authorisation, and 
provides (together with information eventually supplied by third parties) the basis to assess 
whether alternative substances or techniques are available.  

When  assessing  whether  suitable  alternative  substances  or  technologies  are  available,  the 
Commission shall take all relevant aspects into account {Art. 60(5)}, including: 

o  whether the transfer to alternatives would result in reduced overall risks to human 
health and the environment, taking into account the appropriateness and effectiveness 
of risk management measures; 

o 

the technical and economic feasibility of alternatives for the applicant. 

2.  A  substitution  plan:  where  the  analysis  of  alternatives  shows  that  suitable  alternatives  are 
available taking into account the above mentioned elements in Art. 60(5), the applicant must 
submit a substitution plan, including a timetable for proposed actions. 

3.  Where a restriction exists for a use of a substance, an authorisation will not be granted if this 

would result in a relaxation of the existing restriction {Art. 60(6)}. 

18 

 
 
 
 
Guidance on Authorisation Applications 

All authorisations granted will be subject to a time-limited review {Art. 60(8)}. The duration of this 
review period will be determined on a case-by-case basis. The decision over this review period will 
consider all relevant  information, including the elements  listed in  Article 60 (4a to  d) as outlined 
above.  

In particular it is noted that the credibility of the substitution plan and the expected time-frame for 
the replacement of the substance submitted by the applicant, as well as the information on analysis 
of alternatives and information submitted by third parties, may influence the length of the review 
period. In cases where no suitable alternatives have been identified by the applicant, the information 
provided in the analysis of alternatives and the information submitted by third parties under Article 
64(2) will be crucial to determine the length of the review period.  

Specifically, applicants should explain the actions that are required and will be implemented, as well 
as the timelines, to switch to an alternative substance/technology. This will be the case, for instance, 
where there is an alternative available on the market but not yet ready for an immediate substitution 
(i.e. within the "sunset date") by the applicant, or another operator in the same market is already or 
will switch in the near future to alternatives.  

Having  a robust analysis of the alternatives and,  where  applicable, a  credible substitution plan, is 
critical. It should also be considered that third parties (who may provide information under Art. 64(2)) 
or other applicants may have already switched to an alternative and challenge the submission by the 
applicant.  Absence  of  research  and  development  activities  should  lead  to  fixing  shorter  review 
periods.  The  information  that  will  be  specified  in  the  authorisation  when  granted  {Art.  60(9)}  is 
summarised in Table 3. 

Table 3. Information specified in an authorisation 

The natural or legal person(s) to whom the authorisation is granted. 

Information specified 

The identity of the substance(s). 

The use(s) for which the authorisation is granted. 

Any conditions under which the authorisation is granted. 

The time-limited review period. 

Any monitoring arrangements. 

1.5.6.  Requirements following granting or refusal of an authorisation 

Once  the  authorisation  number  has  been  published  in  the  Official  Journal,  the  holder  of  the 
authorisation is required to include without delay the authorisation number on the label before placing 
the substance, or a mixture containing the substance, on the market for the authorised use. The same 
applies to downstream users using an authorisation granted to an actor up his supply chain for that 
use {Art. 65}.  

The  Safety  Data  Sheet  shall  also  be  updated  without  delay  following  granting  (or  refusal)  of  an 
authorisation  {Art.  31(9b)}.  If  a  Safety  Data  Sheet  is  not  required,  the  downstream  users  and/or 
distributors shall otherwise be informed of the details of any authorisation granted or denied {Art. 
32(1b)}. 

19 

 
 
Guidance on Authorisation Applications 

In cases where a downstream user uses the substance on the basis of the authorisation granted to his 
supplier, the downstream user shall notify the Agency within three months of the first supply of the 
substance {Art. 66(1)}. Such notifications will be kept in a register maintained by the Agency that 
will be made available to the Competent Authorities of the Member States on request {Art. 66(2)}. 

The requirements following granting of an authorisation are summarised in Table 4. 

Table 4. Requirements following granting of an authorisation 

Requirement 

Organisation responsible 

Timeframe 

Update the registration to take 
account of the granted authorisation 
{Art. 22(2)}. 

Update the Safety Data Sheet or 
provide downstream users and/or 
distributors with details of the 
authorisation {Art. 31(9b) and Art. 
32(1b)}. 

Holder of authorisation. 

Within the deadline specified in the 
decision. 

Holder of authorisation. 

Without delay following publication of 
the authorisation number in the 
Official Journal. 

Inclusion of authorisation number on 
relevant label for substance and/or 
mixtures containing the substance 
{Art. 65}. 

Holder of authorisation and 
downstream users using the 
substance in accordance with Art. 56 
(2). 

Without delay following publication of 
the authorisation number in the 
Official Journal. 

Notify the use of a substance on the 
basis of an authorisation granted to 
the supplier of the substance {Art. 
66(1)}. 

Maintenance of a register of 
downstream users who have made a 
notification of supply of a substance 
for an Authorised use {Art. 66(2)}. 

Downstream users using the 
substance in accordance with Art. 
56(2). 

Within three months of first supply for 
the Authorised use. 

Agency. 

Continuous. 

In addition to any conditions of use specified in the authorisation, there also is an obligation on the 
holder of the authorisation to ensure that exposure is reduced to as low a level as is technically and 
practically possible {Art. 60(10)}.  

If an authorisation request is refused, the applicant needs to update the registration taking into account 
the decision {Art. 22(2)} within the deadline specified in the decision. Article 22(1) sets out the areas 
of the registration which may need to be updated. 

1.5.7.  Review of authorisations 

As indicated in Section 1.5.5 authorisations granted will be subject to a review period. During the 
review  the  Commission  may  decide  to  amend  or  withdraw  the  authorisation  {Art.  61(3)}  if 
circumstances  have  changed  including  situations  where  suitable  alternatives  have  now  been 
identified. This latter point applies to both routes of authorisation. In order to continue to benefit from 
an authorisation the holder must submit a review report at least 18 months before the expiry of the 

20 

 
 
 
 
 
 
 
Guidance on Authorisation Applications 

time-limited review period. The review report should cover only those parts of the original application 
that have now changed and should contain the following elements {Art. 61(1)}. 

•  Number of current authorisation. 

•  An update of the analysis of alternatives, including information about any relevant research 

and development activities by the applicant, if appropriate. 

•  An update of any substitution plan included in the original application. 

• 

• 

• 

If the update of the analysis of alternatives shows that the requirement to submit a substitution 
plan is applicable, then such a substitution plan, including a timetable for proposed actions by 
the applicant, should be included.  

If the holder cannot demonstrate that the risk is adequately controlled, then an update of the 
SEA included in the original application is required. 

If the holder can now demonstrate that the risk is adequately controlled, then an update of the 
CSR is required. 

•  Updates of any other elements from the original application that have now changed. 

In addition to the review period specified in the authorisation, the authorisation can be reviewed by 
the Commission at any time in light of {Art. 61(2), (4), (5) and (6)} 

•  a change in circumstance of the original authorisation so as to affect the risk to human health 

or the environment, or the socio-economic impact, or 

•  new information on possible substitutes that becomes available, or 

• 

• 

• 

failure to meet an environmental quality standard referred to in the IPPC Directive (Directive 
2008/1/EC), or 

failure  to  meet  the  environmental  objectives  referred  to  in  Article  4(1)  of  the  Water 
Framework Directive (Directive 2000/60/EC) in a river basin relevant to the authorised use, 
or 

if the use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) 
No 850/2004 on Persistent Organic Pollutants (in this situation the Commission will withdraw 
the authorisation for that use). 

In these cases, the Commission will set a reasonable deadline for the holder(s) of the authorisation to 
submit further information necessary for the review.  

In the review, the Commission will, taking into account the principle of proportionality13, decide if 
there  is  a  need  to  amend  the  authorisation  or  withdraw  the  authorisation,  if  under  the  changed 
circumstances  the  original  authorisation  would  not  have  been  granted,  or  if  suitable  alternatives 
become available. If suitable alternatives become available, then the Commission shall require the 
holder  of  the  authorisation  to  present  a  substitution  plan  if  it  was  not  already  done  as  part  of  the 
application or update {Art. 61(3)}. In the case of an authorisation under the SEA route, if suitable 
alternatives become available to the applicant, the Commission will have to withdraw authorisation, 

13   In accordance with the principle of proportionality, as set  out  in Article 5 of the Treaty on European  Union, the 

REACH regulation does not go beyond what is necessary in order to achieve its objectives. 

21 

 
 
 
Guidance on Authorisation Applications 

taking into account the proportionality principle (Article 60(4) makes the granting of an authorisation 
under  the  SEA  route  conditional  upon  the  non-existence  of  suitable  alternatives).  Should  suitable 
alternatives become available in the EU but these are not yet ready for an immediate substitution by 
the applicant or has another operator in the same market switched or will switch in the short future to 
alternatives, the applicants should explain as part of the substitution plan the actions that would be 
required, as well as the time-lines, to switch to an alternative substance/technology.  

In  cases  where  there  is  a  serious  and  immediate  risk  for  human  health  or  the  environment,  the 
Commission may decide to  suspend the authorisation  pending  the review, taking into account  the 
principle of proportionality {Art. 61(3)}. 

At  the  start  of  the  review  process,  the  Agency  will  make  available  via  the  web-site  broad  (non-
confidential) information on uses covered by the application, with a deadline by which information 
on alternative substances or technologies may be submitted by interested third parties {Art. 64(2)}. 

1.6. 

Summary  of  important  deadlines  for  applicants  and  interested  third  parties  in  the 
authorisation process 

The  key  deadlines  for  applicants  and  interested  third  parties  in  the  authorisation  process  are 
summarised in Table 5. The various deadlines in the process for any given substance up to granting 
of the authorisation will be made available via the Agency’s website. 

Table 5. Summary of key deadlines 

Task 

Deadline 

Stakeholders 

Comment  on  Annex  XV  dossier  proposing 
identification of SVHC. 

To be set by the Agency, within 60 
days  of  circulation  of  dossier  to 
Member States. 

(potential) Applicant. 

Interested third parties. 

Comment  on  recommendation  for  inclusion  in 
Annex XIV (Substances subject to authorisation). 

Within three months of the date of 
publication. 

(potential) Applicant. 

Interested third parties. 

Submission of application for an authorisation. 

Submission  of 
information  on  alternative 
substances  or  technologies  and  socio-economic 
impacts. 

Notify Agency of intention to comment on the draft 
opinion  of  the  Agency’s  Committees  for  Risk 
Assessment and Socio-economic analysis. 

Comment  on  draft  opinion  of  the  Agency’s 
Committees  for  Risk  Assessment  and  Socio-
economic analysis. 

Update 
the  Safety  Data  Sheet  or  provide 
downstream  users  and/or  distributors  otherwise 
with details of the authorisation. 

Include  the  authorisation  number  on  relevant 
label for substance and/or mixtures containing the 
substance. 

To  be  set  by 
the  Agency  (a 
minimum of 18 months prior to the 
sunset date). 

Applicant. 

To be set by the Agency. 

Interested third parties. 

Within one month of receipt of the 
draft opinion. 

Applicant. 

Within two months of receipt of the 
draft opinion. 

Applicant. 

Without delay following granting of 
an authorisation. 

Holder of authorisation. 

Without delay following publication 
in the Official Journal. 

 Holder of  authorisation  and 
downstream users using the 
in  accordance 
substance 
with Art. 56(2). 

22 

 
 
 
 
 
Guidance on Authorisation Applications 

Notify the use of a substance on the basis of an 
authorisation granted to a supplier.  

Within three months of first supply.  Downstream users using the 
in  accordance 

substance 
with Art. 56(2). 

It should also be taken into account that the time needed to put together an authorisation application 
could be considerable. The Guidance on inclusion of substances in Annex XIV estimates that around 
12 months may be needed to prepare a new application, but this could be as long as 24 months for 
applicants with less experience of the process. The time needed to prepare a review report is estimated 
at between 6 and 12 months. However, it should be noted that these estimates are made on the basis 
of other procedures under other legislation and need to be revisited when there is practical experience 
from the authorisation procedure. 

23 

 
 
 
Guidance on Authorisation Applications 

2. 

HOW TO MAKE AN APPLICATION FOR AN AUTHORISATION 

2.1. 

Introduction 

Authorisation is required for placing on the market and use(s) of a substance listed in Annex XIV 
after the sunset date. Applications for authorisation can be made by the manufacturer(s), importer(s) 
and/or downstream user(s) of the substance, covering one or more uses and/or one substance or a 
group of substances. In addition applications can be made by separate legal entities or group of legal 
entities. 

This Chapter provides detailed guidance on how to put together an application for an authorisation, 
and on the specific information and considerations needed for the application.  

2.1.1.  Main elements of an application for authorisation 

As described in Section 1.5.3, Article 62(4) and (5) define the content of an application. Tables 6 and 
7 provide a brief description of the content of the application, and also indicate where guidance on 
each item can be found. 

Table 6. Basic information that shall be included in an application for an authorisation 

Identity  of  substance  or 
substances  covered  by  the 
application.  

Information 

Specifying: 

• 

reference to Annex XIV entry 

sufficient 

•  other  information  based  on  Section  2  of 
Annex  VI  of  the  Regulation  which  can  be 
deemed 
to  enable  each 
substance  to  be  identified.  If  it  is  not 
technically possible or if it does not appear 
to  give 
to  be  scientifically 
information on one or more of the items, the 
reasons shall be stated. 

justified 

Guidance that is 
available 

Guidance  on  substance 
identification. 

Guidance on registration. 

Name and contact details of the person or persons making the application. 

Request  for  authorisation(s) 
for specific use(s) 

Specifying, 

• 

• 

the use(s) for which authorisation is sought 

covering the use(s) of the substance(s) on 
its own, in mixtures and/or the incorporation 
of the substance(s) in articles, where this is 
relevant. 

This guidance 

Guidance on information 
requirements and CSA, 
Chapter R.12: Use 
descriptor system 

Chemical  Safety  Report(s) 
(CSR(s)) 

This  is  required  if  it  has  not  already  been 
submitted as part of a registration (although in 
some cases it may be necessary to update the 

Guidance on information 
requirements and CSA. 

24 

 
 
 
 
 
 
 
 
Guidance on Authorisation Applications 

Information 

Guidance that is 
available 

existing CSR(s) so as to provide more detailed 
information). 

The CSR(s) shall cover  all uses applied for. It 
shall cover the risks to human health and/or the 
the 
environment 
substance(s)  arising 
intrinsic 
properties  of  the  substance(s)  specified  in 
Annex XIV of the Regulation.  

the  use(s)  of 

from 

from 

the 

An analysis of the alternatives   The  analysis  of  alternative  substances  and 
techniques shall cover all uses applied for and 
should consider: 

This guidance. 

Substitution plan 

This guidance. 

• 

• 

the risks from the alternatives,  

the  technical  and  economic  feasibility  of 
substitution,  

if  appropriate,  information  on  any  relevant 
research and development activities by the 
applicant. 

Where  the  analysis  of  alternatives  shows  that 
suitable  alternatives  are  available  for  specific 
use(s),  taking  into  account  elements  in  Article 
60(5), 
include  a 
substitution  plan,  including  a  timetable  for 
proposed actions.  

the  applicant  shall  also 

This  may  be  in  particular  the  case  where  a 
suitable alternative is available in general in the 
EU, already developed and possible to be used 
or used by other operators in the EU but not yet 
feasible for the applicant (i.e. within the "sunset 
date").  The  applicant  should  then  explain  the 
actions  that  are  required,  as  well  as  the 
timelines, 
to  an  alternative 
switch 
substance/technology. 

to 

25 

 
 
 
 
 
 
 
 
Guidance on Authorisation Applications 

Table 7. Other information that may be included in an application for an authorisation 

A  socio-economic  analysis 
(SEA). 

justification 

A 
not 
considering the risks to human 
health or environment. 

for 

Information 

Guidance that is available 

This  is  needed  in  cases  where  the  applicant  cannot 
show  adequate  control  of  risks  in  accordance  with 
section  6.4  of  Annex  I  (taking  into  account  article 
60(3)) and the authorisation is applied for on the basis 
that the risk to human health or the environment from 
the use of the substance is outweighed by the socio-
economic  benefits  and 
there  are  no  suitable 
alternatives.  

Guidance on Socio- 
Economic Analysis – 
Authorisation. 

This is applicable to the following situations. 

This guidance. 

•  Emissions of a substance from an installation for 
which  a  permit  has  been  granted  in  accordance 
(Council  Directive 
with 
2008/1/EC). 

IPPC  Directive 

the 

•  Discharges  of  a  substance  from  a  point  source 
governed  by  the  requirement for  prior  regulation 
referred  to  in  Article  11(3)(g)  of  the  Water 
Framework Directive (Directive 2000/60/EC) and 
legislation  adopted  under  Article  16  of  that 
Directive. 

2.1.2.  Application content  

As  stated  in  section  1.5.5,  an  authorisation  can  be  granted  on  the  basis  of  two  different  lines  of 
argumentation, i.e., adequate control or socio-economic reasons. Therefore, this guidance refers to 
two routes: 

• 

• 

the adequate control route {Art. 60(2)}; or 

the socio-economic (SEA) route {Art. 60(4)}. 

2.1.2.1. Adequate control route 

The ‘adequate control route’ applies when it can be demonstrated that the risk to human health or the 
environment from the use of the substance is adequately controlled in accordance with section 6.4 of 
Annex I {Art. 60(2)}.  

If the application is based on the adequate control of risks, it must include: 

•  a CSR (if not already submitted as part of the registration); 

•  an analysis of alternatives; and 

•  a  substitution  plan,  where  the  analysis  of  alternatives  shows  that  suitable  alternatives  are 

available in the EU, taking into account elements in Article 60(5). 

The  basis  for  demonstrating  adequate  control  of  risk  arising  from  the  intrinsic  properties  of  the 
substance specified in Annex XIV is a chemical safety assessment (CSA) which is recorded in a CSR. 
The  Guidance  on  information  requirements  and  CSA  provides  direction  on  carrying  out  the 
assessment.  

26 

 
 
 
 
Guidance on Authorisation Applications 

The evidence whether suitable alternatives are available is presented in an analysis of alternatives. 
The  analysis  must  take  into  account  the  reduction  in  overall  risks  and  technical  and  economic 
feasibility  of  the  alternatives  for  the  applicant.  It  must  be  noted  that  having  a  robust  analysis  of 
alternatives is critical for the application to be considered favourably and that absence of appropriate 
justification as to the existence of alternatives may lead to a negative decision, particularly if third 
parties  under  Article  64(2)}  or  other  applicants  have  submitted  information  on  the  existence  of 
alternative  substances  or  techniques.  In  addition,  the  content  and  robustness  of  the  analysis  of 
alternatives will be a critical element to set the review period. 

Where  suitable  alternatives  are  available,  a  substitution  plan  must  be  included  in  the  application 
outlining the applicant’s commitment to take actions in a specified timetable to replace the Annex 
XIV  substance  with  the  suitable  alternative(s).  Where  suitable  alternatives  are  available  for  the 
applicant, such a substitution plan must also be included together with a justification explaining why 
these alternatives are economically not viable for the applicant.  

The applicant must then describe in the substitution plan a list of the actions, including timelines, to 
transfer to an alternative substance or technology as well as any conditions on which a successful 
implementation of the substitution depends This is because the substitution plan includes a list of 
future  actions  which  might  be  subject  to  different  uncertainties.  However,  the  applicant  needs  to 
identify the possible uncertainties and list the actions that will be taken to overcome them.  

It should be kept in mind that the Committee for Risk Assessment may in its opinion disagree with 
the  applicant’s  demonstration  of  adequate  control  which  can  lead  to  a  decision  to  refuse  the 
authorisation. Therefore, the applicant may consider to also include a socio-economic assessment to 
provide evidence to the Committees that the socio-economic benefits outweigh the risks arising from 
the use of the substance {as per Art. 60(4)}. This applies in cases where the analysis of alternatives 
demonstrates that there are no suitable alternatives available because then, the authorisation may still 
be granted on the basis of the SEA consideration. This, however, requires that the application includes 
all necessary information in support of the SEA argumentation.  

Although  not  strictly  required  by  REACH,  a  socio-economic  analysis  can  also  bring  valuable 
information  for  defining  the  length  of  the  review  period  and/or  authorisation  conditions  for 
applications demonstrating adequate control. Guidance for carrying out a socio-economic analysis is 
available (Guidance on Socio- Economic Analysis – Authorisation). 

The applications  may also include a justification for not  considering the  risks to  human health or 
environment for the use(s), as set out in Article 62(5), if applicable. 

2.1.2.2. Socio-economic assessment (SEA) route 

The  ‘SEA  route’  applies  where  it  can  be  demonstrated  that  the  risk  to  human  health  or  the 
environment from the use of the substance is outweighed by the socio-economic benefits and there 
are no suitable alternative substances or techniques {Art. 60(4)}. It applies in circumstances when 
adequate  control  has  not  been  demonstrated  and/or  for  substances  meeting  the  criteria  of  Article 
60(3). The latter include: 

27 

 
 
Guidance on Authorisation Applications 

•  CMR category 1 and 2 substances defined under Article 57 (a), (b) or (c)14, or substances 
listed in Annex XIV as being of equivalent concern defined under article 57 (f), and for which 
it is not possible to determine a threshold; 

•  PBT or vPvB substances meeting the criteria in Annex XIII (article 57 (d) and (e)); 

•  substances which are listed in Annex XIV as being of an equivalent level of concern to PBT 
or vPvB substances defined under article 57 (f). (See section 1.5.5 of this guidance for further 
detail.) 

The application under the SEA route should include: 

•  a CSR; 

•  an analysis of alternatives 

•  a  substitution  plan,  where  the  analysis  of  alternatives  shows  that  suitable  alternatives  are 

available in the EU, and 

•  an SEA. 

Although according to Article 62(5) the inclusion of a SEA is optional in all applications, it should 
be stressed that for applications assessed under the SEA route (that is, for the substances referred to 
in Article 60(3) as well as for substances where adequate control has not been demonstrated) a SEA 
should always be included to provide evidence that the socio-economic benefits outweigh the risks 
arising from the use of the substance {as per Art. 60(4)}. Otherwise the granting of authorisation on 
socio-economic grounds is very unlikely. 

If the application is assessed under the SEA route it should be noted that the authorisation cannot be 
granted when suitable alternatives are available for the applicant. 

The evidence whether suitable alternatives are available is presented in an analysis of alternatives. 
The  analysis  must  take  into  account  the  reduction  in  overall  risks  and  technical  and  economic 
feasibility  of  the  alternatives  for  the  applicant.  It  must  be  noted  that  having  a  robust  analysis  of 
alternatives is critical for the application to be considered favourably and that absence of appropriate 
justification as  to  the  non-existence of  alternatives leads to  a negative decision,  including but  not 
limited to, if third parties under Article 64(2)} or other applicants have submitted information on the 
existence  of  alternative  substances  or  techniques.  In  addition,  the  content  and  robustness  of  the 
analysis of alternatives will be a critical element to set the review period. 

The applicant must explain in the analysis of alternatives why he considers that the identified suitable 
alternatives, which are available in general, are not feasible alternatives for him.  

Where the analysis of alternatives shows that suitable alternatives are available in general, but these 
are  not  (yet)  technically  or  economically  feasible  for  the  applicant,  the  authorisation  can  still  be 

14   Article 57 (a), (b) and (c) will be amended from 1 December 2010, and from that date  this sentence should read: 
"substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or 
reproductive toxicity category 1A or 1B in accordance with Annex I to Regulation (EC) No 1272/2008 defined under 
Article 57 (a), (b) or (c),(…)". 

28 

 
 
 
 
 
Guidance on Authorisation Applications 

granted under Article 60(4), if the socio-economic benefits of the use/s applied for outweigh the risk 
from that use and if the applicant submits a substitution plan in accordance with Article 62(4)(f).  

The substitution plan outlines the applicant’s commitment to take actions in a specified timetable to 
replace the Annex XIV substance with the suitable alternative(s). The applicant must describe in the 
substitution plan a list of the actions, including timelines, to transfer to an alternative substance or 
technique.   

Similar  to  the  adequate  control  route,  the  applications  may  also  include  a  justification  for  not 
considering the risks to human health or the environment for the use(s), as set out in Article 62(5), if 
applicable.  

2.2.  Compiling an application for an authorisation 

The following  sections  go through each section of the application, indicating the information  that 
should be provided. Specific technical guidance on how to compile the application for authorisation 
is contained in user manual(s) available on the Agency’s website.   

Further  guidance  on  specific  aspects  of  the  authorisation  application,  for  example  analysis  of 
alternatives and substitution plans, is given in Chapter 3 and Chapter 4. Appendix 1 provides guidance 
for  substance  grouping  in  the  context  of  authorisation  applications.  Appendix  2  gives  specific 
guidance for groups of applicants wishing to file jointly an application for an authorisation. More 
detailed  guidance  on  carrying  out  a  socio-economic  analysis  is  given  in  the  Guidance  on  Socio- 
Economic Analysis – Authorisation. 

2.2.1.  Substance identity 

Basic information on the identity of the substance is needed for the application for an authorisation. 
The information on substance identity should be based on the Annex XIV entry and on Section 2 of 
Annex VI of REACH.  

Substance identity information should be available as part of the registration dossier for the substance 
or the group of substances considered in the application. In cases where no registration is available 
the information should be collated following the Guidance on substance identification.  

A single application can be made covering several substances that meet the definition of a group of 
substances in section 1.5 of Annex XI of the REACH Regulation. In this case the required information 
on identity will be extracted for each member of the group (see Appendix 1). An argumentation for 
substance  grouping  should  be  included  in  the  application  in  cases  where  the  substances  are  not 
grouped  in  Annex  XIV  but  have  similar  physicochemical,  toxicological  and  ecotoxicological 
properties or where these follow a regular pattern as a result of structural similarity. Appendix 1 gives 
further guidance for substance grouping.  

29 

 
 
 
Guidance on Authorisation Applications 

2.2.2.  Applicants  

Applications for authorisation can be made by the manufacturer(s), importer(s) and/or downstream 
user(s) of the substance(s). In addition applications can be made by either separate legal entities or a 
group of legal entities {Art. 62(2)}.  

Information for each legal or natural person submitting an application should be provided, including: 

•  name, address, telephone number, fax number and email address; 

•  contact person; 

• 

financial and legal identifiers; and 

•  other relevant contact information. 

In this guidance no distinction is made between situations where the applicant is a manufacturer or 
importer and where the applicant is a downstream user, as the main elements that need to be included 
in the application are broadly the same. However, the considerations when deciding whether or not 
to make an application may be different for manufacturers and importers compared to downstream 
users. It is important to note that an authorisation granted to a downstream user also covers the supply 
of  the  substance  to  the  downstream  user  holding  the  authorisation  {Art.  56(1a)}  irrespective  of 
whether  or  not  the  manufacturer(s)  or  importer(s)  have  or  have  not  made  an  application  for  an 
authorisation for that particular use. 

In order to ensure that the process is effective, it is important that, where the potential applicant is not 
(or does not include) a downstream user, he keeps his downstream users of the substance informed 
of  what  will  and  will  not  be  covered  in  the  application.  Similarly,  it  would  be  important  for 
downstream users to provide information on their specific uses back to the applicant. Given the length 
of time it may take to put together an application (see Section 2.4.1) it is important that such dialogue 
starts at an early stage in the process. 

As mentioned earlier, applications can be made by several legal entities. It will be up to each potential 
applicant (whether a manufacturer, importer or downstream user) to decide on a case-by-case basis 
whether he wishes to make an application, either as individual or as part of a group of applicants. 
Appendix  2  discusses  further  the  reasons  and  approach  for  filing  joint  applications  for  an 
authorisation by several legal entities. 

2.2.3.  Request for authorisation for specific use(s) 

2.2.3.1. Use(s) covered in an application 

Each  applicant  can  apply  for  an  authorisation  for  his  own  use(s)  of  the  substance  and/or  uses  for 
which the applicant intends to place the substance on the market. If manufacturers and importers wish 
to prepare applications covering both their own use(s) and any use(s) for which they wish to place 
the  substance  on  the  market,  the  application  would  need  to  cover  the  downstream  uses  of  the 
substance. In this situation, the downstream users themselves would not necessarily need to submit 
an  application  as  long  as  their  uses  were  covered  by  the  application  from  the  manufacturer  or 

30 

 
 
 
 
Guidance on Authorisation Applications 

importer. However, it is important to note that such an application from the manufacturer or importer 
does not preclude the downstream user from making his own application if desired. 

As it is up to each actor to decide, on a case-by case basis, whether or not he wishes to cover his 
downstream users’ use(s) in his authorisation application, it is possible that a potential applicant may 
not wish to apply for an authorisation for a specific use he currently supplies for. Examples (non-
exhaustive) of some of the many possible situations where this could arise include: 

• 

• 

• 

the  applicant  does  not  wish  to  continue  supply  for  economic  reasons  (e.g.  the  costs  of 
preparing an application are high compared to the value of the product), 

the  applicant  cannot  demonstrate  safe  use  and  there  appear  to  be  suitable  alternatives 
available, or 

the applicant cannot demonstrate safe use and the risks to human health or the environment 
from  the  use  of  the  substance  appear  likely  to  outweigh  the  socio-economic  benefit  of 
continued use of the substance. 

In  these  cases  the  downstream  users  of  the  substance  for  the  specific  use  may  wish  to  consider 
developing their own application for their specific use(s). When deciding to do this, they would need 
to consider their own specific case carefully. Non-exhaustive examples of some situations where this 
could arise include: 

• 

the actual use or process used by the downstream user is confidential, 

•  adequate control can be demonstrated at the downstream user site as a result of specific risk 

management measures and operational conditions in place, or 

• 

the downstream user can demonstrate that socio-economic benefits outweigh the risks for the 
specific use employed by him in cases where no suitable alternatives are available for him for 
this specific use.  

In such cases it would be advisable for the downstream user to inform their supplier(s) and, if relevant, 
their  downstream  users  (customers)  of  the  substance  that  they  intend  to  make  an  application  for 
authorisation.  

2.2.3.2. Describing use(s) in the application 

The use or uses should be described in the authorisation application in accordance with user manual(s) 
for  authorisation  applications  made  available  on  the  Agency’s  website.  This  section  should  be 
completed for all applications, irrespective of the basis on which the application is made. This should 
also  cover  any  use(s)  of  the  substance(s)  in  mixtures  and/or  incorporation  of  the  substance  into 
articles, where this is relevant. For applications for a group of substances it is important that the uses 
being applied for are clearly identified for each member of the group. 

It should be remembered that an authorisation is requested for the use(s) described in the exposure 
scenario(s)  and  documented  in  the  CSR  (see  Section  2.2.4.4).  The  key  point  is  therefore  that  the 
description has to relate to the exposure scenario(s) for the use(s) for which authorisation is being 
requested,  as  included  in  the  CSR,  the  analysis  of  alternatives,  and  SEA,  when  available.  The 
development of the description of the use is an iterative process and it should therefore be finalised 
after  the  work  on  the  CSR,  analysis  of  alternatives  and  SEA  has  been  carried  out.  Guidance  on 

31 

 
 
Guidance on Authorisation Applications 

information  requirements  and  CSA  (Chapter  R.12:  Use  descriptor  system)  has  guidance  on 
developing descriptions of uses and this should be consulted, but it may in many cases be necessary 
and useful for the applicants to develop the description further to specify more precisely what use is 
applied for. 

Note that the CSR and in particular the exposure scenario(s) needs to cover all of the relevant life 
cycle steps of the substance associated with the use applied for. For example, if the end use applied 
for is part of a mixture, the step formulating the mixture will need to be included. The service life of 
articles containing the substance may also need to be considered. 

Where the substance forms part of a mixture, the use descriptor system in Guidance on information 
requirements and CSA (Chapter R.12: Use descriptor system) characterises the use of the substance 
by the type of end-use product in which the substance is known to be used. Hence the use of a mixture 
is described in a similar way to the use of a substance. Further information on the specific purpose of 
the substance in the mixture can be added if needed. Where the substance is used in production of 
articles,  the  use  descriptor  system  will  include  the  category  of  article  into  which  the  substance  is 
incorporated (it should be noted that the use of the articles themselves is not subject to authorisation). 

2.2.3.3. Uses for which authorisation application is not required 

The application shall not include the risks to human health arising from the use of a substance in a 
medical device regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC {Art. 62(6)}. 

In addition, Table 1 in section 1.5.2 includes other exempted uses from applications for authorisation. 
Further  to  these  general  exemptions,  the  Annex  XIV  entry  for  each  substance  may  list  substance 
specific  exempted  uses,  or  categories  of  uses,  along  with  any  conditions  that  apply  to  such 
exemptions.  

2.2.3.4. Request for authorisation for several uses 

As mentioned earlier the application can cover several uses. Some of the possible advantages of an 
application considering more than one use are to avoid repetitions and to include a more integrated 
picture of the use of the substance. A main disadvantage is having to produce a complex application 
where there are a high number of uses, or where the application requires both the adequate control 
and SEA routes in order to cover all the uses.  

The applicant should decide on a case-by-case basis if the advantages of combining several uses in 
one application outweigh the drawbacks. Some of the disadvantages of combining several uses in one 
request for authorisation can be addressed through methodical organisation of the application. This 
could  be  achieved  by  either  the  development  of  separate  reports  (i.e.,  the  CSR,  the  analysis  of 
alternatives, the substitution plan, and the SEA, where appropriate) or the development of distinctly 
defined sections in each of these reports. This will facilitate the preparation of the application and its 
processing by the Agency and the Commission. 

2.2.4.  Documentation in support of the application for authorisation 

As  discussed  in  Section  2.1.2,  the  information  contained  in  the  application  may  be  different 
depending  on  the  basis  for  the  argumentation  in  the  application,  i.e.  adequate  control  or  socio-

32 

 
 
 
 
Guidance on Authorisation Applications 

economic benefits. The sections below outline the specific information that will need to be provided 
in support of the application.  

2.2.4.1. Chemical Safety Report 

All  authorisation  applications  need  to  include  a  CSR  or  refer  to  one  submitted  as  a  part  of  a 
registration dossier substances manufactured in quantities of 10 tonnes or more per year per registrant 
must include a CSR as a part of a registration dossier). The CSR(s) should cover the risks to human 
health  and/or  the  environment  (as  appropriate)  from  the  use  or  uses  of  the  substance  applied  for 
arising from the intrinsic properties specified in Annex XIV of the Regulation. 

a) Development and submission 

Where a CSR has been submitted already as part of the registration, and no changes have been made 
for the authorisation application, there is no need to resubmit a copy.  

However,  the  applicants  may  need  to  update  their  original  (registration)  CSR  as  part  of  their 
authorisation application. This may be required for instance where the applicant wishes to provide a 
more precise exposure scenario and/or refine the exposure assessment. It may be advisable to submit 
a revised CSR where the original CSR covers several uses of the substance but the applicant only 
wishes to apply for an authorisation for some of these uses. This may be particularly important where 
some  of  the  uses  not  applied  for  lead  to  high  emissions  that  dominate  the  total  emissions  of  the 
substance. Here, the update to the CSR could consider the effect of the change in the applicant’s use 
pattern on the overall emissions and risk characterisation from the remaining uses. 

If a CSR is not available, then it will be necessary to carry out a Chemical Safety Assessment (CSA), 
record the assessment in a CSR, and submit it as part of the application. In these cases and where a 
CSR  is  updated  for  the  purposes  of  an  application  for  authorisation,  it  only  needs  to  cover  the 
identified uses applied for and can be limited to the risks to human health and/or the environment 
arising  from  the  intrinsic  properties  specified  in  Annex  XIV.  The  hazard  assessment  part  of  the 
applicant’s CSR needs to be based on the Annex XV dossier that led the substance to be included in 
Annex XIV. The remainder of the CSR has to be developed in accordance with Annex I for which 
the  standard  guidance  on  CSA/CSR  can  be  used  (see  Guidance  on  information  requirements  and 
CSA15).  Depending  on  the  substance  properties  this  includes  a  quantitative  or  a  qualitative  risk 
characterisation, in accordance with either Section 6.4 or 6.5 of Annex I and following the general 
CSA guidance.  

The  content  of  the  CSA  varies  depending  on  the  basis  of  the  authorisation  application.  If  an 
authorisation is applied for via the adequate control route, the CSR needs to demonstrate that for the 
uses(s) of the substance(s) concerned, the risks are adequately controlled in accordance with section 
6.4  of  Annex  I.  Therefore,  iteration  of  the  exposure  scenario  or  the  assessment  is  needed  until 
adequate control can be demonstrated. This may include:  

• 

refinement  of  exposure  estimates  to  better  reflect  the  implemented  or  recommended 
conditions of use, e.g. by 

15   The following sections of the Guidance on information requirements and CSA are of particular relevance: Parts A, 
C,  D  and  E  of  the  Concise  Guidance  and  from  the  In-Depth  Guidance  Chapter  R.11.2  on  emission  and  risk 
characterisation for PBT/vPvB substances and Chapters R14 – R18 on exposure estimation. 

33 

 
 
 
Guidance on Authorisation Applications 

o  collecting further information on conditions of use,  

o  use of measured data,  

o  use of better models, or  

•  modification of risk management measures or operational conditions, or  

•  narrowing down the areas of use for which authorisation is applied for.  

If  an  authorisation  is  applied  for  via  the  SEA  route,  possibilities  to  improve  control  of  risks  via 
iteration of the exposure scenario or the assessment need to be considered with a view to demonstrate 
minimisation of emissions and exposures as far as possible, and to show that the likelihood of adverse 
effects  is  reduced.  This  may  include  the  same  actions  as  listed  under  the  adequate  control  route. 
Section A.4.3 of the Guidance on information requirements and CSA outlines further the steps in the 
CSA for the purpose of an authorisation application. 

In cases where a new CSR has been generated for the application, or where an existing CSR has been 
modified, a copy of the new or revised CSR should be appended to the application as an assessment 
report.  

b) CSR for several uses 

In  circumstances  where  one  application  covers  several  uses,  it  is  important  to  clearly  set  out  the 
exposure scenarios for each use. This can be achieved by developing distinctly defined sections for 
each use in the CSR. This will facilitate the preparation of the application and its processing by the 
Agency and the Commission. 

c) CSR for a group of substances 

In the event the application for authorisation is for a group of substances, CSR(s) needs to cover all 
substances  in  the  group  for  which  authorisation  is  sought.  Although  in  principle  it  is  possible  to 
generate one CSR covering the grouped substances and all their uses, this may not be practical in 
case of applications for many substances with many different uses as documentation of all the many 
different combinations (of substances/uses) could result in a poor analysis that lacks transparency and 
consistency. In such situations a CSR for each member of a group may be more appropriate. Appendix 
1 provides additional information for substance grouping.  

2.2.4.2.Analysis of alternatives  

All applications must include an analysis of alternatives. The purpose of this analysis is to determine 
if there are any suitable alternative substances or alternative techniques. There are three main aspects 
that at least should be considered, these are: 

• 

• 

risks from alternatives, 

technical feasibility of substitution, and 

•  economic feasibility of substitution. 

Furthermore, if appropriate, the analysis of alternatives should include information on any relevant 
research  and  development  activities  by  the  applicant.  In  particular,  applicants  should  include 

34 

 
 
 
 
Guidance on Authorisation Applications 

information about research and development that is considered appropriate for the understanding of 
the present or future availability of suitable alternatives to the Annex XIV substance. Future plans for 
research and development may also be documented in the application. This may be appropriate when 
no suitable alternatives have been identified. The information on research and development will be 
taken into consideration in the determination of the review period. In the absence of any relevant 
programme by the applicant intended to allow him to transfer to an alternative, the review period will 
tend to be shorter than in cases where serious actions are taken. In the latter case the review period 
would normally take into consideration the timelines identified by the applicant to accomplish the 
programme.  

It should be noted that in order for an authorisation to be granted under the SEA route, the analysis 
of alternatives must show that there are no suitable alternative substances or techniques (in addition 
to the demonstration that the socio-economic benefits outweigh the risks {Art. 60(4)}).  

In  situations  where  suitable  alternatives  are  available  in  general,  but  these  are  not  technically  or 
economically feasible for the applicant, the authorisation can still be granted under Article 60(4), if 
the  socio-economic  benefits  of  the  use/s  applied  for  outweigh  the  risk  from  that  use  and  if  the 
applicant submits a credible substitution plan in accordance with Article 62(4)(f). 

Detailed guidance on how to carry out an analysis of alternatives is given in Chapter 3. The analysis 
of alternatives should be submitted as part of the application as indicated in the user manual(s) made 
available on the Agency’s website.  

In  circumstances  where  one  application  covers  several  uses,  it  is  important  to  clearly  set  out  the 
alternatives for each use. This can be achieved by developing a separate analysis of alternatives report 
for each use or by developing distinctly defined sections for each use in one report. This will facilitate 
the preparation of the application and its processing by the Agency and the Commission.  

For applications covering a group of substances, it would need to be considered on a case-by-case 
basis whether the analysis of alternatives should cover the group or whether individual reports should 
be generated for each member of the group.  

2.2.4.3. Substitution plan 

The application must include a substitution plan if the analysis of alternatives shows that suitable 
alternatives are available.      

Applicants  should  explain,  as  part  of  the  substitution  plan,  the  actions  and  timelines  required  to 
transfer  to  an  alternative  substance  or  technology.  The  content  of  the  substitution  plan  and  its 
concreteness will depend on several factors. In particular, in situations where it is uncertain when the 
identified suitable alternative will become feasible for the applicant, the applicant needs to describe 
the substitution efforts over the time horizon estimated to be necessary for switching to the alternative 
available in general.16 

The  substitution  plan  should  outline  a  detailed  commitment  by  the  applicant  to  take  actions  in  a 
specified timetable to replace the Annex XIV substance with a suitable alternative. 

16 For more guidance, see page 11 of the Substitution Plan template.  

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Guidance on Authorisation Applications 

Detailed  guidance  on  preparing  a  substitution  plan  is  given  in  Chapter  4  of  this  guidance.  The 
substitution plan should be submitted as part of the  application as indicated in the user manual(s) 
made available on the Agency’s website.  

In  circumstances  where  one  application  covers  several  uses,  it  is  important  to  clearly  set  out  a 
substitution plan for each use. This can be achieved by developing a separate substitution plan for 
each use or by developing distinctly defined sections for each use in one report. This will facilitate 
the preparation of the application and its processing by the Agency and the Commission. 

For applications covering a group of substances, it would need to be considered on a case-by-case 
basis whether the substitution plan should cover the group or whether individual substitution plans 
should be generated for each member of the group.  

2.2.4.4. Socio-economic analysis 

SEA is an approach used to analyse and describe all relevant impacts of granting (or refusing) an 
authorisation. Although not strictly required by the Regulation, an SEA is particularly important in 
circumstances where adequate control of risks cannot be documented (see section 2.1.2.2), and the 
applicant will need to demonstrate that the risk to human health or the environment from the use of 
the substance or substances is outweighed by the socio-economic benefits {Art. 60 (3 and 4)}.  

SEA can also be beneficial in adequate control route applications. For example, applicants can use 
socio-economic  analysis  to  give  the  basis  for  defining  the  length  of  the  review  period  or  any 
conditions in the authorisation decision.  

Annex XVI of REACH outlines the information that may be included in an SEA and more detailed 
guidance for carrying out a socio-economic analysis is given in the Guidance on Socio Economic 
Analysis – Authorisation. The detailed report and supporting information should be submitted as part 
of the application as indicated in the user manual(s) made available on the Agency’s website.  

In  case  one  application  covers  several  uses,  it  is  important  to  clearly  set  out  the  socio-economic 
impacts for each use. This can be achieved by developing a separate SEA report for each use or by 
developing distinctly defined sections for each use in one report. This will facilitate the preparation 
of the application and its processing by the Agency and the Commission. 

Where  a  socio-economic  analysis  is  needed  for  the  application  for  authorisation  for  a  group  of 
substances, it will need to be considered on a case-by-case basis whether a single socio-economic 
analysis covering the whole group, or individual socio-economic analyses for each member of the 
group should be prepared.  

2.2.4.5. Justification for not considering certain risks 

All  applications  may  include  a  justification  for  not  considering  the  risks  to  human  health  or 
environment {Art. 62(5b)}. This applies to uses in installations where emissions of the substances 
are controlled by a permit granted in accordance with the IPPC Directive (European Parliament and 
Council Directive 2008/1/EC) or to point sources governed by the requirements of prior regulation 
referred  to  in  Article  11(3)g  of  the  Water  Framework  Directive  (Directive  2000/60/EC)  and 
legislation adopted under Article 16 of that Directive. 

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Guidance on Authorisation Applications 

For a group of substances it would be possible to develop a justification for not considering certain 
risks provided that all substances in the group are used in installations where emissions of substances 
are controlled by permit in accordance with the IPPC Directive (European Parliament and Council 
Directive 2008/1/EC) or to point sources governed by the requirements of prior regulation referred 
to  in  Article  11(3)g  of  the  Water  Framework  Directive  (Directive  2000/60/EC)  and  legislation 
adopted under Article 16 of that Directive. 

The justification should be submitted as  part of the application as indicated in  the user manual(s) 
made available on the Agency’s website.  

2.3. 

Subsequent Applications 

It is possible for an application for authorisation to refer to previous applications for authorisation for 
the same substance(s) and use(s). Two possible situations exist {Art 63 (1) and (2)}: 

a.  Where an application has been made by other applicants for the same substance(s) and use(s). 

b.  Where an authorisation has been granted for the same substance(s) and use(s).  

In  both  of  these  cases,  a  subsequent  applicant  can  refer  to  the  following  parts  of  the  previous 
application, provided they have permission from the previous applicant or authorisation holder: 

•  Chemical Safety Report(s). 

•  Analysis of alternatives. 

•  Substitution plan. 

•  Socio-economic analysis. 

In  this  case  the  subsequent  applicant  should  update  the  information  in  these  parts  of  the  original 
application as necessary {Art. 63(3)}, and complete the following parts of the application. 

•  General applicant information (see Section 2.2.2). 

•  Substance  identity  (see  Section  2.2.1  –  this  should  relate  to  the  substance  used  by  the 
subsequent  applicant),  including  a  description  for  substance  grouping  (if  applicable  –  see 
Appendix 1) 

•  Request for authorisation for specific uses(s) (see Section 2.2.3 – this can refer to the previous 

applicant’s CSR, SEA or analysis of alternatives and substitution plan as appropriate) 

•  Other information (if appropriate). 

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Guidance on Authorisation Applications 

2.4. 

Submitting the application for authorisation 

2.4.1.  Deadlines for submitting applications for authorisation 

The deadlines for applications for authorisation will be set by the Commission for each substance 
when  it  is  listed  in  Annex  XIV.  Applications  for  authorisation  will  be  made  to  the  Agency  {Art. 
62(1)}.  

The time needed to put together an application for authorisation should not be underestimated. The 
Guidance on inclusion of substances in Annex XIV estimates that around 12 months may be needed 
to prepare a new application, but this may be as long as 24 months for applicants with less experience 
of the process. This should be born in mind when planning an application for authorisation. 

2.4.2.  How to submit an application 

Applications should be submitted to ECHA, via its website, in accordance with user manual(s) on 
how to submit an application made available on the Agency’s website. 

2.4.3.  Fees 

The applicant(s) must pay the required fee in accordance with Title IX {Art. 62(7)} and Commission 
Regulation  N° EC  340/2008 on the  fees and charges payable to the European Chemicals  Agency 
(Annex VI and VII). 

2.5.  Review reports 

Authorisations will be subject to a time-limited review period. The review period will be specified in 
the granted authorisation. In order to continue placing on the market or using a substance, the holder 
of the authorisation must submit a review report at least 18 months before the expiry date of the time-
limited review period. 

The review report should address only the parts of the original application that have now changed but 
should contain the following elements {Art. 61(1)}. 

•  Number of current authorisation. 

•  An update of the analysis of alternatives, including information about any relevant research 

and development activities by the applicant, if appropriate. 

•  An update of any substitution plan included in the original application if appropriate. 

• 

If the update of the analysis of alternatives shows that there is a suitable alternative available, 
then  a  substitution  plan,  including  a  timetable  for  proposed  actions  by  the  applicant,  is 
required. It is noted that under the SEA route, when suitable alternatives become available for 

38 

 
 
 
 
 
 
Guidance on Authorisation Applications 

the applicant, the authorisation must be withdrawn, taking into account the proportionality 
principle. 

If the holder cannot demonstrate that the risk is adequately controlled, then an update of the 
SEA included in the original application is required. 

If the holder can now demonstrate that that the risk is adequately controlled, then an update 
of the CSR is required. 

• 

• 

•  Updates of any other elements from the original application that have now changed. 

Review  report  can  be  created  using  the  Agency  recommended  software  as  indicated  in  the  user 
manual(s)  made  available  on  the  Agency’s  website.  Only  the  parts  that  have  changed  need  to  be 
completed.  Any  more  detailed  reports  and  information  (e.g.  updated  CSRs,  SEAs  etc.)  can  be 
appended to the review report. 

The review report will be assessed through the same process as used for the original authorisation 
request (see Section 1.5.7). 

In addition, an authorisation may be reviewed at any time if circumstances change so that the risks to 
human  health  or  environment  considered  in  the  original  authorisation  are  affected,  or  the  socio-
economic  impact  is  affected.  A  review  can  also  be  triggered  by  new  information  on  possible 
substitutes becoming available. Under these circumstances, the holder of the authorisation will be 
invited by the Commission to submit any information necessary for the review within a deadline set 
by  the  Commission.  The  holder  will  need  to  address  any  specific  aspects  requested  by  the 
Commission, and may also wish to consider the impact of the new information on their CSR and 
SEA.  The  new  information  triggering  the  review  and  information  provided  by  the  holder  will  be 
considered according to the same procedure as for the original request (see Section 1.5.7). 

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Guidance on Authorisation Applications 

3. 

 PLANNING FOR SUBSTITUTION: GUIDANCE ON ANALYSIS OF ALTERNATIVES 

3.1. 

Introduction 

The progressive replacement of SVHCs by suitable alternatives is one of the fundamental aims of 
authorisation  and  is  mainly  translated  into  two  elements  of  an  application  for  authorisation:  the 
analysis of alternatives and the substitution plan. The analysis of alternatives is the first step in the 
process  of  planning  for  substitution,  where  an  assessment  is  made  on  the  availability  of  suitable 
alternative  substances  or  techniques,  their  risks  for  human  health  and  the  environment,  and  their 
economic and technical feasibility for the applicant. The analysis of alternatives may also include 
information about relevant R&D activities by the applicant. While such information is not mandatory, 
it will be a critical factor for fixing the review period, in particular in cases where the analysis of 
alternatives concludes that there are no suitable alternatives. Where the analysis of alternatives leads 
to the conclusion that a suitable alternative is available, the applicant must also provide a substitution 
plan, including a timetable for proposed actions. 

This chapter provides guidance primarily directed to the applicant for authorisation on the analysis 
of alternative substances or alternative technologies to the Annex XIV substance. The chapter sets 
out:  

•  What is an alternative;  

•  What should be the focus and scope of an analysis of alternatives; 

•  How to conduct an analysis to identify and assess possible alternatives; and  

•  How to document the analysis in the application. 

An analysis of alternatives is required in all applications for authorisation according to article 62(4)(e) 
of REACH. Therefore, the applicant for authorisation must document an analysis of alternatives in 
his application. Whilst this guidance focuses on the applicant, who may be a M/I or a DU or indeed 
a group including different legal entities, it is intended to describe a process by which a reasonable 
and logical analysis of alternatives may be approached, conducted and documented. Therefore, it may 
also help third parties to submit well documented information on alternatives17 under the provisions 
in Articles 64(2) and 64(3).  

The guidance is intended to provide considerations for the analysis of alternatives so that users of the 
guidance  may  provide  information  that  documents  their  analysis  in  the  best  possible  light  for 
consideration by the Agency and ultimately by the Commission in the decision whether or not  to 
grant an authorisation.  

This chapter also addresses how, and under what circumstances, the analysis of alternatives links with 
a substitution plan and a socio-economic analysis (SEA). As described in previous sections (1.5.5, 
2.2  and  2.4.4.2)  authorisations  can  be  granted  on  the  basis  of  two  principally  different  lines  of 
argumentation,  i.e.  on  the  basis  of  adequate  control  or  for  socio-economic  reasons,  leading  to 

17   The presentation of an analysis of alternatives by a third party may help to support the case that the alternative is 
suitable and available for the uses set out on the Agency web site. Guidance for third parties is at Chapter 5 of this 
GD. 

40 

 
 
 
 
 
Guidance on Authorisation Applications 

applications assessed via either of two routes, the so called adequate control route or the SEA route. 
The route under which an application is assessed determines  the relevance of SEA. 

Substitution plan: If an application concludes in the analysis of alternatives that a suitable alternative 
is  available,  then  the  applicant  must  prepare  a  substitution  plan  that  sets  out  his  commitment  to 
transfer to that substitute(s), setting out the timing and other considerations for transferral. The detail 
of how to conduct and document a substitution plan is set out in Chapter 4 of this guidance document, 
but the links between the analysis of alternatives and the substitution plan are also highlighted in this 
chapter. It is noted that an authorisation under the SEA route cannot be granted if there are suitable 
alternatives for the applicant. 

Socio-Economic  Analysis  (SEA):  Although  according  to  Article  62(5)  the  inclusion  of  a  SEA is 
optional in all applications, for applications assessed under the SEA route it should be included and 
can also be submitted in the case of applications relying on the adequate control route on a voluntary 
basis.  See  section  1.5.5  for  further  details  on  which  types  of  substances  or  situations  that  are 
applicable  for  the  SEA  route  to  authorisation.  Guidance  for  compiling  an  SEA  in  support  of  an 
authorisation application and submission of an SEA or input to one from a third party as part of the 
authorisation  process  is  set  out  in  a  separate  document  Guidance  on  Socio  Economic  Analysis  – 
Authorisation. Key phases of the analysis of alternatives where links to the SEA are important are 
indicated in this guidance, e.g. in section 3.3 on the scope of the analysis of alternatives, in section 
3.5  on  how  to  identify  possible  alternatives,  and  in  section  3.7  on  comparing  the  risks  of  the 
alternative  with  the  Annex  XIV  substance.  Where  an  SEA  is  developed  an  assessment  of  human 
health and environment impacts will be a necessary part of the SEA. This assessment could be used 
in the analysis of alternatives to assist in the decision regarding comparison of risks for substances 
following the SEA route (see section 3.7.1). 

3.2.  What is an alternative? 

An alternative is a possible replacement for the Annex XIV substance. It should be able to replace 
the function that the Annex XIV substance performs. The alternative could be another substance or 
it  could  be  a  technique  (e.g.  a  process,  procedure,  device,  or  modification  in  end  product)  or  a 
combination of technical and substance alternatives. For example, a technical alternative could be a 
physical means of achieving the same function of the Annex XIV substance or perhaps changes in 
production,  process  or  product  that  removes  the  need  for  the  Annex  XIV  substance  function 
altogether. 

Article  60(5)  provides  that  when  assessing  the  availability  of  suitable  alternative  substances  or 
techniques, all relevant aspects must be taken into account, including:  

a) whether the transfer to the alternative would result in reduced overall risks to human health and 
the environment (as compared to the Annex XIV substance) taking into account risk management 
measures, 

b) the technical and economic feasibility of alternatives for the applicant for replacement of the Annex 
XIV substance.  

The alternative must also be available for the applicant (i.e. can be accessed in sufficient quantity and 
quality) for transferral. As an application may be for a number of uses of the Annex XIV substance, 
it may be that there will be different alternatives that are suitable and available for each different use 
of the Annex XIV substance that has been applied for. 

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Guidance on Authorisation Applications 

According  to  the  criteria  provided  by  the  General  Court,  a  suitable  alternative  can  be  defined  as 
follows: 

•  Risk reduction: the alternative should be safer; 

•  Suitability in the EU: the alternative should:  

-  not  be  an  alternative  suitable  in  abstracto  or  in  laboratory  or  conditions  that  are  of 

exceptional nature;  

-  be technically and economically feasible in the EU; and 

-  be available, from the perspective of production capacities of alternative substances, or of 
feasibility of the alternative technology, and in light of the legal and factual requirements 
for placing them on the market. 

•  Feasibility  for  the  applicant:  the  applicant  should  examine  whether  the  alternatives  - 
identified during the authorisation procedure - are technically and economically feasible for 
him and his downstream users and provide justifications if this is not the case. 

3.3.  The focus and scope of the analysis of alternatives 

The analysis of alternatives may be relatively simple. For example, where an application is being 
compiled for a single use that is being applied for, the applicant may know of one or a few alternatives. 
In this  case, a simple analysis may be able to  fairly rapidly identify their capability to  reduce the 
overall risk and whether they are technically and economically feasible. In addition, some of the work 
might  have  already  been  done  in  relation  to  requirements  of  other  legislation,  e.g.  Directive 
2004/37/EC (‘the carcinogens Directive’) requires employers to consider the substitution of the use 
of a carcinogen or mutagen as the first level of the risk management hierarchy.  

However, the analysis may require a more detailed assessment. For example, the application may 
start from a position in which no alternatives are known, where the function is complex and where 
there are a number of constraints on the function (including, e.g., strict customer requirements for the 
use of specific substances) as well as the supply chain being complex.  

The  focus  of  the  analysis  of  alternatives  is  to  identify  possible  alternatives  to  the  Annex  XIV 
substance and to assess, on the basis of reduction in overall risks, economic and technical feasibility 
of substitution and availability whether they can be used in place of the Annex XIV substance. The 
documentation of that analysis needs to be presented in the application for authorisation and can be 
referred to as the analysis of alternatives report. 

The  applicant’s  analysis  of  alternatives  will  conclude  that  there  is  a  suitable  alternative  available 
when an alternative substance(s) or technology/ies or their combination: 

•  provide an equivalent function to that provided by the substance or makes the substance' use 
redundant (note that a single alternative may not be suitable for all different processes or uses 
for which the original substance was suitable, thus the original substance could be substituted 
by more than one suitable alternative); 

•  will result in reduced overall risks to human health and the environment, taking into account 

appropriateness and effectiveness of risk management measures; 

42 

 
 
 
 
Guidance on Authorisation Applications 

•  are  technically  and  economically  feasible  (for  substitution  in  the  uses  applied  for)  and 

available, for the applicant. 

The  applicant  should  demonstrate  whether  the  above  criteria  are  satisfied  or  not  by  possible 
alternatives. It is in the interest of the applicant to be specific in the assessment of the suitability and 
availability of alternatives and to document the results of the assessment in a transparent way. It is 
also  strongly  recommended  that  the  applicant  demonstrates  that  a  comprehensive  and  adequate 
assessment  of  alternatives  has  been  done.  This  is  because  the  Agency  in  its  opinions  and  the 
Commission in its assessment of whether suitable alternatives are available will take "all relevant 
aspects" into account {Art. 60(5)}, including information submitted by interested third parties.  

This means that in practice the applicant may be well advised to consider including in the scope of 
his analysis all possible alternatives, considering both substances and technologies. This applies also 
to cases where the applicant is a M/I and the alternatives may not be products from his own portfolio. 
An incomplete analysis of alternatives by an applicant may lead the Agency to question the accuracy 
of such an analysis and why some possible alternatives have not been assessed if the Agency has 
received  well-documented  information  that  suitable  alternatives  exist.  It  is  also  advisable  for  the 
applicant  to  detail  for  example  relevant  research  and  development  that  he  has  carried  out,  with 
specific  emphasis  as  to  why  a  certain  alternative  substance  or  technology  was  not  technically  or 
economically feasible. 

If the analysis of alternatives demonstrates that there is/are no suitable alternative(s) available for the 
applicant, but that there is/are suitable alternative/s available in general, the applicant should provide 
in the substitution plan information on what would be required to implement these alternatives within 
an estimated timescale (further guidance is given in section 3.10). This information will be key to set 
the review periods. In particular, if no information is provided, the review period would be short, as 
it would be necessary to assess whether there have been any changes.  

The applicant will be a manufacturer/importer (M/I) or downstream user (DU) of the Annex XIV 
substance. Joint applications may also be made (see Chapter 2 on who can make an application).  

The focus and scope of the analysis of alternatives may be influenced by who makes the application 
for authorisation. Box 1 considers the perspective of the M/I and DU in the analysis of alternatives.  

In order for the applicant to best understand what alternatives may be available and what the scope 
of the analysis of alternatives will be, it is recommended that consultation within the supply chain is 
begun  at  an  early  stage.  This  is  so  that  applicants  are  in  the  best  position  to  understand  what 
information is available on use of the Annex XIV substance and on possible alternatives to the Annex 
XIV substance. Consultation within and outside the supply chain is considered in section 3.5.2 and 
issues relating to competition law and confidential business information (CBI) in Box 2. 

Box 1. Perspective of the analysis of alternatives for different actors  

A M/I may find it difficult to have full information on how possible alternatives may fulfil  the  substance’s 
function for downstream uses and he may have to work with DUs to understand this fully if the M/I intends to 
cover downstream uses in his application18.  

18 In such applications, the analysis of alternatives is carried out also from the perspective of the downstream users of the 

substance. 

43 

 
 
 
Guidance on Authorisation Applications 

A DU may wish to make an application because he does not wish to share information on exact use with his 
supplier for reasons of commercial confidentiality. Or he may need to apply because he finds that his use will 
not be supported in an application by his supplier (i.e. the M/I). 

It may of course be an option for M/I and DU  to make a joint application or share information through an 
independent party to ensure that confidential information is not shared within the supply chain. 

Third parties may submit information on alternatives, which will be taken into consideration by the Agency 
and the Commission when assessing whether suitable alternatives exist  

Annex XIV will set a deadline for submitting an authorisation application (see Chapter 2), so the 
amount  of  work  that  can  be  conducted  in  the  analysis  of  alternatives  will  be  limited  by time  and 
resource. In practice, it will make sense to undertake some of the tasks of the analysis of alternatives 
at the same time; as information from one part of the analysis may inform other parts. For example, 
gathering  initial  information  to  ‘screen’ the possible technical  feasibility  of an alternative may be 
combined with screening of alternatives on the basis of risks.  

Where  an  application  is  following  the  SEA  route  the  applicant  may  also  wish  to  consider  the 
information  needs  of the SEA when considering  the analysis of alternatives.  Consideration of the 
information  needs  of  the  SEA  may  prompt  the  applicant  to  collect  information  on  the  possible 
responses of the supply chain to not being able to use the Annex XIV substance, at the same time as 
gathering information on possible alternatives. This is considered in section 3.5. Guidance on Socio 
Economic Analysis – Authorisation is provided in a separate guidance document. 

A  suggested  check-list  for  the  inclusion  of  information  in  the  analysis  of  alternatives  is  given  in 
Appendix 3. Guidance on what to document in the analysis of alternatives and a possible outline for 
the analysis of alternatives report is given in section 3.12. 

3.4.  Overview of how an analysis of alternatives is undertaken 

This guidance chapter sets out how an applicant:  

•  may conduct an analysis of alternatives; and 

•  can document this in the analysis of alternatives report. 

The process involves: 

• 

identifying  possible  alternatives  for  each  use  applied  for  on  the  basis  of  the  functional 
requirements (section 3.5); 

•  assessing the technical feasibility of possible alternatives identified (section 3.6); 

•  assessing  possible  alternatives  for  their  potential  risks  to  the  environment  and  to  human 
health.  For  this  purpose  the  applicant  should  assess  whether  the  alternatives  represent  a 
reduction  in  overall  risk  compared  to  the  Annex  XIV  substance,  taking  into  account  risk 
management measures and operational conditions implemented and recommended (section 
3.7);  

•  assessing the economic feasibility of possible alternatives identified (section 3.8); 

44 

 
 
 
 
 
Guidance on Authorisation Applications 

• 

identifying relevant R&D that is appropriate to the analysis (section 3.9);  

•  assessing the suitability and availability of possible alternatives, on the basis of their technical 
and economic feasibility for the applicant, reduction in risk and accessibility (section 3.10); 
and 

•  determining the actions and timescales that may be required to make suitable alternatives, 
available in general or other identified alternatives, feasible for and available to the applicant, 
taking into account relevant R&D where appropriate (section 3.11). 

Clearly, in order to identify possible alternatives to the Annex XIV substance, the  function of the 
Annex  XIV  substance  needs  to  be  identified  first.  However,  the  further  analysis  of  technical  and 
economic feasibility, the comparative safety of the alternatives and availability need not be addressed 
in  the  order  set  out  in  this  guidance.  The  applicant  should  show  and  document  analysis  of  these 
aspects,  but  the importance of different  aspects  of the analysis will be different  in  each case.  For 
example, it may be clear to the applicant in his analysis of alternatives that all possible technically 
feasible alternatives do not represent a reduction in risk as compared to the Annex XIV substance. In 
this  case  there  would  be  little  merit  in  detailed  analysis  of  the  economic  feasibility  of  these 
alternatives, once it is known that none of them is suitable on the basis of the risks.  

To  properly  assess  possible  alternatives,  consultation  within  and  outside  the  supply  chain  is 
recommended. This is so that the applicants can: 

•  Fully  understand  the  exact  uses  that  are  being  applied  for  and  therefore  understand  the 

function of the Annex XIV substance;  

•  Ensure that they are aware of the technical and economic feasibility of possible alternatives 

for the uses of the Annex XIV substance for which they are applying; 

•  Decide if past, ongoing or planned R&D is relevant and appropriate for the analysis;  

•  Decide if the alternative/s is/are suitable and available in  order to  enable  a transfer to  the 

alternative/s to take place; and 

•  Determine  what  actions  and  timescale  would  be  required  to  make  possible  alternatives 

suitable and available.  

As it is not obligatory to conduct R&D within the analysis of alternatives, this is indicated by a broken 
line in the figure. Applicants may have done or be aware of research and development (R&D) on 
possible  alternatives.  Such  R&D  may  have  highlighted  the  possibilities  and  difficulties  for  using 
particular alternatives. Therefore, it may help in the analysis of alternatives to refer to and explain 
R&D  that  is  relevant  to  showing  how  alternatives  may  or  may  not  be  feasible.  In  addition,  this 
information will be taken into account to fix the review periods. The absence of R&D activities should 
lead to fixing shorter review periods.  

3.5.  How to identify possible alternatives  

3.5.1.  How to identify the Annex XIV substance functions 

The function of the Annex XIV substance for the use/s being applied for is the task or job that the 
Annex XIV substance is performing.  

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Guidance on Authorisation Applications 

The process of identification of alternatives normally begins with the consideration of the function of 
the Annex XIV substance. A detailed and specific knowledge of the exact function that the Annex 
XIV  substance  is  doing  (and  where  and  how,  i.e.  under  what  conditions,  that  function  must  be 
performed) for a particular use, will allow the applicant to look for other ways of performing that 
function. This may be by using another substance or technology or by changing the process or end 
product.  In  the  latter  cases  it  is  possible  that  the  original  function  of  the  substance  may  become 
redundant. 

Knowledge of the precise function of the Annex XIV substance assists in consultation on alternatives 
within  and  outside  the  supply  chain  by  setting  out  the  technical  requirements  that  any  possible 
alternatives must meet. This allows users, suppliers and technologists to assess whether there may be 
possible alternatives and also what actions are needed to make them technically feasible (technical 
feasibility is considered in section 3.6). The users, through co-operation with suppliers, may have 
conducted  possible  research  and  development  on  existing  alternatives,  for  example  trials  of 
alternative substances and technologies, and this may be helpful in identifying and assessing possible 
alternatives (R&D is considered in section 3.9).  

The function of a substance could be related to its physical or chemical properties as well as the form 
it is used in (for example, for a solid this may be as a powder, pellets or granules), the physical state 
may also be dependent upon process conditions. Key questions to be considered for each use when 
determining the functions of a substance can be divided into two main groups: 

1.  Task that the substance performs: This will require an understanding of the exact use of the 
substance including a description and outcome of the process where the use is applied. Key 
questions addressing the task performed by the substance include: 

•  What is the exact use of the Annex XIV substance and what task does it perform? 

This will need to be as specific as possible and the exact function will determine within 
which  limits  possible  alternatives  can  be  identified.  For  example,  a  substance  that 
functions  as  a  solvent  to  degrease  metal  may  be  replaced  by  a  number  of  possible 
substance and technical alternatives. However, if the specific function is to degrease fine-
bore metal tubes to a particular standard of cleanliness, then this will narrow down the 
possible alternatives that can perform this function.  

•  What are the critical properties of the substance for this use? 

The function will depend upon key properties of the Annex XIV substance. For example 
this could be its persistence (e.g. a flame retardant or plasticiser; both of which need to 
have longevity in the final product in order to continue to impart their function for the 
lifetime of the product), or a physical property such as its viscosity or vapour pressure. 
The key properties could be a critical combination of properties that make the function 
possible. 

2.  The conditions under which the substance is used: This will require an understanding of the 
specific process conditions for using the substance and of any conditions or requirements on 
possible end-products resulting from the process. These may impose constraints under which 
the desired function must be performed and thereby influence which alternatives that may be 
used. Key questions addressing the process conditions where the use is applied include: 

•  What  are  the  physical  and  chemical  (process/operational)  conditions  under  which  the 

function must be performed?  

46 

 
 
 
 
Guidance on Authorisation Applications 

Physical conditions will include, for example, temperature and pressure of the process. 
Also there may be considerations of increased or decreased electromagnetic radiation (e.g. 
photosensitivity).  Chemical  conditions  may  include;  the  presence  or  absence  of  other 
chemicals  (introducing  issues  of  chemical  compatibility  such  as  reactivity  and 
flammability),  the  process  pH,  and  the  gaseous  atmosphere  (for  example  increased  or 
decreased  oxygen  partial  pressure  or  other  gases  including  potentially  explosive 
atmospheres), amongst numerous others. 

•  Are there any specific timing conditions for the substance function?  

There may be constraints on the timing for technical delivery of the function  – i.e. the 
function  may  be  delivered  in  a  particular  part  of  a  process  that  is  time-critical  and 
dependent on the properties of the substance; or the function may need to continue for a 
minimum or maximum time period. Note that for some functions the performance cannot 
be judged in the short-term (e.g. coatings and lubricants) because the function is based on 
the longevity of the function and this can only be evaluated over time.  

•  How could the quality of the final product be affected if the substance/process is altered? 

This requires consideration of how the use of an alternative may affect the end products 
in terms of final function. Qualities of the final product may need to be considered over a 
longer  timescale.  For  example,  some  coatings  may  need  to  provide  resistance  to 
weathering over a specific product lifetime. This may also include consideration for the 
final disposal of the product and/or its potential recycling. 

• 

Is the function associated with another process that could be altered so that the use of the 
substance is limited or eliminated? 

For  example  the  Annex  XIV  substance  may  be  used  to  control  emissions  of  another 
substance  or  produce  another  substance.  If  the  need  for  control  is  removed  or  the  end 
product is altered so that the second substance is no longer needed then the Annex XIV 
substance may be more easily substituted or not required at all. 

•  Are  there  features  of  the  end  product  that  determine  the  requirement  for  use  of  the 

substance? 

For example the specific use of the substance may be required because it imparts certain 
characteristics to an  end product  (e.g. due to customer or legal  requirements). Using a 
different end product that performs the same function may enable an alternative to be used 
or may mean the substance is no longer required for the use. 

Appendix 4 presents a check-list for determining the functional requirements for possible alternatives 
(it is not exhaustive) based on functional aspects of the Annex XIV substance. While the check list is 
not mandatory, it gives an indicative list of aspects that should be considered when identifying the 
substance function. 

Example 1 illustrates how substance function might be considered for a particular situation. Available 
information has been used to simulate the possible answers to the questions posed in Appendix 4. 
The functional aspects numbered 1 to 2 in the example and the checklist in Appendix 4 address the 
function of the Annex XIV substance (i.e. the task it performs), aspects 3 to 7 address the process 
conditions for the Annex XIV substance (i.e. what process requirements must be fulfilled, including 
possible legal requirements).  

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Example 1. Considerations for substance function 

Defining substance function is an essential step in understanding the exact use of the Annex XIV substance. 
Clear definition of function and tolerances allow possible alternatives to be assessed on the basis that it may be 
possible to use  them to perform the function of the Annex XIV substance. The example below illustrates a 
possible process for determining substance function for the uses that are to be applied for and how this can be 
documented for presentation in the analysis of alternatives report.  

Substance A is an organic solvent with a strong solvent action, a medium boiling point and high vapour density. 
It  is  used  as  an  industrial  solvent,  primarily  for  vapour  degreasing  and  cleaning  of  metal  parts.  More 
specifically, it is used for the removal of substances such as oils, greases, waxes and buffering compounds, or 
soils. The specific use for this example is: 

Degreasing and cleaning of components that have a complex construction including details that have complex 
construction.  

Components must be free from grease and dirt and dried quickly; corrosion, staining and remaining oil/grease 
deposits are not acceptable. For intricate articles the low surface tension of Substance A allows the cleaning of 
folds, double folds and fine tubes. 

In terms of defining substance function the checklist set out in Appendix 4 is used: 

1 Task performed by Annex XIV substance:  

What is the task that must be performed by the substance? 

The substance is used for degreasing very fine seamless stainless steel tubes (e.g. internal diameter ranging 
from 1 to 5 mm, straight lengths and coils) in particular for use in the aviation industry and for medical devices. 
The function is the rapid removal of grease leaving no residue and no oxidation or staining. See table below for 
further description of applicable criteria. 

2. What critical properties and quality criteria must the substance fulfil? 

Production of clean and dry metallic parts; where the metallic part needs to be dry for the treatment following 
(e.g. coating). The cleaned item must be grease/oil free and free of any staining/oxidation (e.g. from contact 
with water/aqueous solutions.) 

3. Function conditions: 

Task timing and through-put required are indicated in table below. The use of solvent in vapour degreasing 
baths is efficient because solvent is recycled. Primary and secondary cooling coil systems reduce vapour and 
hence solvent loss and use of covers that seal the degreasing bath work chamber from the atmosphere virtually 
eliminate evaporative losses during downtime. 

4. Process and performance constraints 

To produce clean and dry metallic parts, where the metallic part needs to be dry for the following treatment 
(e.g.  coating),  a  solvent  cleaning  should  be  used.  Intricate  parts  and  fine  tubes  limit  access  for  mechanical 
cleaning means.  

5. Is the function associated with another process that could be altered so that the use of the substance is limited 
or eliminated? 

Eliminating any oil or grease on the surface of metal tubing components would negate the need for vapour 
degreasing. However, metal parts would need to be grease/oil/dirt free to the standards required. No staining 
or  oxidation  is  acceptable.  Currently  tubing  production  methods  require  the  use  of  oils  to  ensure  that 
components remain free of oxidation.  

Although aqueous-based cleaning systems are effective in many applications, some aspects of aqueous-based 
cleaning can make it impractical or unusable for certain types of work pieces. Solvent degreasers must be used 
for the removal of oil, flux, grease wax and other stubborn solvent-soluble soils from the metal surface. Intricate 
metal tubes and parts for aerospace and medical instruments are routinely cleaned in vapour degreasers prior 
to assembly, inspection, or further processing. Because no water is used in the process, nearly any part can be 

48 

 
 
 
 
Guidance on Authorisation Applications 

cleaned in a solvent degreaser without concern for quality control issues like the effects of part oxidation, soap 
residue, water stains, and ineffective drying. 

Possible  alternatives  include  other  hydrocarbon  solvents,  aqueous  formulations  and  water  blasting  or  soft 
blasting (shot blasting using a relatively soft medium such as limestone). Continuing improvements in solvent 
recovery technology on hot vapour degreasing baths has reduced the amount of substance A used for hot vapour 
degreasing. These reductions are as a result of better working practices and the use of newer technology. Some 
companies  are  also  attempting  to  find  other  hydrocarbon  solvents  or  water-based  cleaning  agents  as 
alternatives.  

6. What customer requirements affect the use of the substance in this use?  

Customers (including the aerospace industry) require (through operating procedures that must be used) the use 
of solvents for cleaning. Any process change requires customer approval; the time taken and technical and cost 
justification for product change in these sectors are considerable. Quality control inspection criteria demand 
the components be grease/oil stain and oxidation free (non-destructive testing applied). 

7. Are there particular industry sector requirements or legal requirements for technical acceptability that must 
be met and that the function must deliver? 

Medical device and aerospace industries are required to use solvents for cleaning. There may be implications 
for fulfilling legal requirements for product safety in these two product areas such as stringent airworthiness 
and safety requirements (e.g. European Aviation Safety Agency (EASA) Airworthiness Directives)  and the 
Medical Devices Directive (93/42/EEC). These need to be assessed to estimate the minimum time needed for 
changes. 

The  Table  below  provides  an  example  of  how to  summarise  and  document  functional  aspects  and/or 
criteria for determining substance function based on the solvent example in this box: 

Functional 
aspect 

Considerations 

Criterion 

Tolerance 

Testing 

Quality control 

Consequence 

Quality system 
ensures inspection 
according to testing 
schedule that parts 
are grease free. 

Criteria are set out 
in customer specific 
requirements. 

Residual grease could 
cause malfunction of 
instrumentation. 
Therefore, if testing 
reveals residual grease 
parts are rejected and 
cannot be fitted. 

As above 

As above 

None 

Part of non-
destructive 
testing prior to 
use/fitting 

<60% 
humidity 

Part of non-
destructive 
testing prior to 
use/fitting – 
inspection for 
oxidation 

+ 15 seconds 

None 

As above for 
application of 
coatings 

As above for effect on 
application of coatings.  

Grease/oil 
removal 

Necessary degree of 
cleanliness 

Limitation 
of oxidation 

Necessary degree of 
cleanliness 

Requirements from 
further processing (gluing, 
electroplating, painting or 
coating) 

Drying time 

Acceptable or necessary 
duration of the cleaning 
process 

Requirements from 
further processing (gluing, 
electroplating, painting or 
coating 

Quantity of parts to be 
cleaned per hour/per day; 

No oil 
grease 
residue 
staining of 
tubes upon 
heating to 
200oC  

No 
oxidation or 
staining as 
result of 
contact with 
water or 
moisture 

Must be < 1 
minute to 
ensure no 
staining 
prior to 
application 
of other 
coatings  

Task timing 

Quantity of parts to be 
cleaned per hour/per day 

Degreasing 
and drying 
must be 

+ 1 minute 

N/A 

N/A 

Increase in degreasing 
time would 
significantly decrease 
the output of 
components and affect 
the efficiency of the 

49 

 
 
 
 
 
  
 
 
 
Guidance on Authorisation Applications 

Acceptable or necessary 
duration of the cleaning 
process 

completed in 
7 minutes 

process. This affects 
downstream processes 
such as coating of 
tubes. 

3.5.1.1. Information on use and function of the Annex XIV substance in the CSR 

Information on the use of the Annex XIV substance will be documented in the CSR (see Guidance 
on  information  requirements  and  CSA).  This  can  either  be  parts  of  the  CSR  from  substance 
registration or a CSR for authorisation; in the latter case the CSR has only to focus on the properties 
of the substances that have caused it to be listed on Annex XIV {Article 62(4)(d)}. The key part of 
the  CSR  in  this  context  will  be  the  exposure  scenarios  (ES)  for  the  uses  applied  for,  as  the 
authorisation will be possibly granted on the basis of those exposure scenarios. It should be noted 
that use descriptions developed according to guidance for preparing the CSR may not be sufficient 
on their own to describe the use in sufficient detail to determine exact use function19. Some suppliers 
may have used questionnaires to request information from DUs on uses in order to prepare the CSA 
and CSR. These may be a useful source of information on use. 

The applicant will need to elaborate upon the information set out in the CSR based on his knowledge 
of the specific uses being applied for and the function that the substance must perform for each use. 
This  can  be  used  to  determine  the  function  for  each  use  and  will  include  information  on  the 
substance’s physicochemical properties, biological properties and operational conditions as well as 
its functionality.  

3.5.1.2. Other sources for information on use and function of the Annex XIV substance 

Information specifying the exact function of the Annex XIV substance can be found, for example in 
company records (e.g. operating procedures, customer specifications for substance use and product 
specifications)  and  the  wider  literature  (e.g.  industry  technical  literature  describing  specific  uses, 
standard operating procedures and technical research papers). Communication with the supply chain 
can be useful to further define function and use conditions and to ensure that all functions for uses 
applied for in the authorisation have been identified (see chapter 3.5.2.1). It is important to determine 
all the functions of a substance for each use, so that possible alternatives that may deliver or replace 
the equivalent function can be identified. The determination of a specific function and use conditions 
allows clearer communication and consultation within and outside the supply chain as it describes 

19   The Chemical Safety Report (CSR) is a mandatory part of an authorisation application. The CSR must assess the 
exposure scenarios for those uses that are applied for. Authorisations may be granted for uses within the conditions 
specified in such exposure scenarios as amended by the conditions of the authorisation decision if any. The exposure 
scenarios  for  authorisation  applications  therefore  need  to  be  sufficiently  specific  and  precise.  Guidance  for  the 
preparation of the CSR contains advices on the development of the CSR including the specific circumstances for 
authorisation.  

50 

 
 
 
 
 
 
 
 
Guidance on Authorisation Applications 

exactly what is required. Suppliers of alternative substances and alternative technologies can then try 
to match the function performed with possible alternatives. 

3.5.2.  Identifying and gathering information on possible alternatives 

As described above the understanding of the exact tasks the Annex XIV substance performs and the 
conditions  under  which  it  has  to  be  able  to  perform  these  tasks  is  the  starting  point  for  the 
identification of alternative substances or technologies.  

On the basis of the substance function it is useful to identify possible alternatives and at the same 
time gather the information needed to establish their technical and economic feasibility, capability to 
reduce  the  overall  risk  and  availability.  Recommendations  and  considerations  for  identifying 
alternatives and gathering information are given in the sections below. Further guidance on gathering 
information on hazards and risks to health and environment is given in section 3.7. The applicant is 
advised to consider what he will need to consider in his SEA at the stage where he is gathering and 
analysing information for the analysis of alternatives. 

It is advisable to also list possible alternatives which are easily shown not to be suitable. This is to 
document  that  the  applicant  has  considered  the  possible  alternatives  broadly.  However,  the 
information gathering and analysis of such clearly non-suitable alternatives can be kept limited as 
long as it meets its purpose of showing whether they are suitable or not.   

3.5.2.1. Communication within the supply chain 

Consultation with the supply chain with regard to the uses of the Annex XIV substance to be applied 
for will be important at an early stage. This will help to ensure that consideration has been given to 
the exact use of the substance and for supply of information on alternatives that may possibly fulfil 
an equivalent function to the uses applied for. Consultation may also address any necessary changes 
in equipment, the form of the substance and the waste and re-use of the substance (these may also 
have economic consequences). The aim of communication with the supply chain is to identify for 
each use, what the possible alternatives are, and to understand how they perform in relation to the 
required equivalent function. 

Possible sources for the applicant to initially find possible alternatives within the supply chain include 
(the list is not exhaustive): 

•  Applicant's own knowledge (including industry employees/in-house knowledge) 

•  Downstream users 

•  Suppliers 

•  Trade/sector organisations 

Communication with the supply chain will help to: 

51 

 
 
 
 
Guidance on Authorisation Applications 

•  Gain precise knowledge of specific function; 

• 

Identify possible alternatives (substances and technologies); 

•  Provide an understanding of the technical and economic feasibility, safety and availability of 

alternatives; 

• 

• 

Identify information on existing, on-going and planned future research and development on 
alternatives; and 

Identify  possible  responses  of  the  supply  chain  to  not  being  able  to  use  the  Annex  XIV 
substance (for the uses applied for). 

Alternatives can be identified that seem feasible for a particular use; but there may be some factors 
that could make the transfer to such alternatives difficult. For example, a downstream user relying on 
their supplier’s (e.g. M/I) authorisation20 may have the use of a particular substance imposed on them 
through the use of operating procedures that are set out by legislation or their customers (sometimes 
in countries outside the EU) and therefore substitution can only be made with prior consent. In some 
cases this may lead to loss of contract work, which may have economic consequences (economic 
feasibility of alternatives is considered in section 3.8).  

On  the  last  bullet  point  above,  this  information  will  be  useful  to  gather  for  applicants  preparing 
application under the SEA route. Information in the SEA on what downstream users may do if they 
cannot use the Annex XIV substance (i.e. if an authorisation was refused), may be needed to analyse 
if the socio-economic benefits of continued use of the Annex XIV substance (for the uses applied for) 
outweigh the risks to human health and the environment. Gathering this information from the supply 
chain at the same time as information on alternatives will optimize the applicant’s data gathering and 
give a better understanding of what possible alternatives might be used. Guidance on Socio Economic 
Analysis  –  Authorisation  is  set  out  in  a  separate  guidance  document  (this  includes  guidance  on 
developing a consultation plan in Appendix A of the guidance). 

Supply chain communication is an interactive process and can involve all relevant parts of the supply 
chain from downstream users to suppliers, involving the appropriate experts. This is important for 
identifying  possible  alternatives  for  all  uses  applied  for.  Suppliers  may  have  identified  a  possible 
alternative that the downstream users are unaware of and vice versa. Downstream users usually have 
a  clear  understanding  of  the  functions  required  by  a  substance/product/process,  whilst  suppliers, 
manufacturers and importers may have a more informed view on possible alternatives. Contact with 
trade associations could also prove useful in this regard. 

Consultation with the supply chain is an interactive process, so when possible alternatives have been 
identified, the supply chain may have to be consulted further on technical and economic feasibility; 
environmental and human health hazards and risks; as well as availability of alternatives. Guidance 
for Downstream Users sets out guidance on aspects of communication with the supply chain from the 
DU’s point of view. Example 2 illustrates the process of supply chain communication for a substance.  

20   Note that an applicant can be a manufacturer/importer or a downstream user, or a joint application may be made in 

involving a number of legal entities. 

52 

 
 
 
 
 
 
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Example 2. Illustration of supply chain communication  

Substance  B  is  used  as  a  coolant  and  a  lubricant  for  metal-working.  When  coolants/lubricants  containing 
substance  B  are  used,  the  substance  has  potential  emissions  and  risks  for  the  environment.  Workers  are 
potentially exposed to the substance through skin contact or inhalation of dust or mist and there are risks for 
workers through use of the substance.  

The initial view of the supplier (here M/I as applicant) was that it would be difficult to find a suitable substitute. 
The supplier had contacted relevant downstream users in order to gather information to develop the CSR for 
substance  B.  During  this  process  information  on  possible  alternatives  and  process  changes  required  to 
accommodate possible alternatives were gathered.   

As a result of the collected information, the supplier contacted users, to identify possible alternative for the 
substance in the metal working fluid.  

Possible alternatives identified through communication with the supply chain DUs were: 

Possible 
alternative 

Sulphur based oils 

Animal fat oil 

Identified problems 

Possible solutions 

Comments 

Production  of  SO2  during  use  and 
risk  to  workers  also  problem  for 
waste and disposal of substance after 
use  –  environmental  risk  and  cost 
implications. 

Control  of  sulphur  release 
and emission. 

Expensive to fit and require very 
large  investment  in  equipment 
disproportional to benefits 

Problems  with 
temperature – inadequate cooling. 

use 

at 

high 

Addition  of  additives  to 
increase  high  temperature 
resistant properties 

No such additives available  

Vegetable fat oil 

As above 

As above 

As above 

Zinc-based 
compound 

Process 
optimisation 

Increase of environmental risk 

Control of metal in waste – 
emissions treatment. 

Very  difficult  to  remove  metal 
component from waste stream. 

Requires different formulations to be 
used  according  to  the  material  (i.e. 
type  of  metal) 
is  being 
processed. 

that 

Testing required to identify 
possible  reformulation  of 
products in order to reduce 
and eliminate use. 

Requires  drawing  on  R&D  and 
possible 
testing 
technical 
programme.  Business  risks  as 
programme  has  costs  and  may 
not be possible at busy times. 

For  the  options  above  the  details  of  the  relevant  R&D  may  be  appropriate  to  set  out  in  the  analysis  of 
alternatives,  in  particular  where  the  supplier  and  user  identified  that  testing  would  be  required  in  order  to 
understand better if the alternative was a technically and economically feasible option (consideration of R&D 
is in section 3.9). 

This process of collecting information from the supply chain was repeated for each use that is to be applied for 
by the applicant. Information on alternatives can be summarised as in the table above. 

It may also be useful for the applicant to consider the possible barriers to information gathering on 
the  substance  and  possible  alternatives.  For  example,  effective  communication  within  the  supply 
chain may be hindered by aspects of confidential business  information (CBI), which may prevent 
some parts of the supply chain giving full and precise information on specific uses and possibly on 
possible  alternatives.  In  this  case,  the  downstream  user  would  need  to  consider  the  possibility  to 

53 

 
 
 
 
 
Guidance on Authorisation Applications 

supply  that  information  under  a  confidentiality  agreement  with  his  supplier  or  to  make  his  own 
application for the authorisation of that use. Box 2 sets out CBI and competition law in this context. 

Box 2. Competition Law and confidential business information (CBI) 

Competition Law 

EU  Competition  law  is not  intended  to  inhibit  legitimate  activities  of  companies.  Its  objective  is  to  protect 
competition  in  the  market  as  a  means  of  enhancing  consumer  welfare.  Therefore,  agreements  between 
companies or decisions by associations or concerted practices which may affect trade between Member States 
and  which  have  as  their  object  or  effect  the  prevention,  restriction  or  distortion  of  competition  within  the 
common market are prohibited (Article 101 of the Treaty on the Functioning of the European Union). 

The  EU  competition  rules  also  apply  in  the  context  of  REACH-related  activities.  Although  none  of  the 
obligations under REACH require exchanging information or other actions that are in breach of the competition 
rules, when preparing a joint application for an authorisation, applicants need to be aware of the competition 
rules.  While  a  single  exchange  of  information  about  the  use  of  a  substance  will  not  generally  give  rise  to 
antitrust  concerns,  competitors  should  abstain  from  organising  periodic  exchanges  of  information  or  from 
exchanging information on markets, prices, or customers. Also, certain decisions between competitors as to 
whether  an  alternative  is  or  is  not  suitable  could  be  seen  as  unlawful  collusion.  Therefore,  the  use  of  an 
independent third party could be considered by competitors making a joint analysis of alternatives or a joint 
substitution  plan  (particularly  if  they  have  large  market  shares).  Exchanges  of  information  on  uses  and  on 
whether an alternative is suitable between manufacturers/importers and their downstream users will generally 
not give rise to antitrust concerns. 

Further information and considerations can be found in the Guidance on data sharing. 

Confidential business information (CBI) 

Some information or data may be considered by companies to be confidential business information (CBI) that 
they consider important to protect. Whether certain information is CBI, needs to be determined on a case-by-
case basis. CBI issues must not be confused with competition law which refers to situations where the sharing 
of information is likely to lead to distortion of competition (see above). The Guidance on data sharing is also 
considering CBI in detail, including useful options identified to circumvent problems with CBI (e.g. using third 
party experts to assess information which companies do not want to exchange).  

3.5.2.2. Communication outside the supply chain 

For information on possible alternatives, it may be useful to contact other manufacturers, research 
organisations, environmental or  consumer groups, academic institutions, industry experts or other 
third  parties.  This  is  particularly  important  when  a  possible  alternative  is  not  produced  by 
manufacturers/suppliers within the supply chain. 

It will be possible to search within the REACH IT system i.e. IUCLID 5, for substances within the 
same broad category of use, and this may act as a starting point for identifying possible alternative 
substances.  There  may  be  difficulties  associated  with  this  approach,  for  example  where  possible 
alternatives are not part of the applicant’s portfolio of products or where another company holds a 
patent on an alternative technology.  

External sources to be consulted will vary depending on the substance under consideration. It may 
prove useful to consult: 

•  Key suppliers/manufacturer/importers not within the substance supply chain 

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Guidance on Authorisation Applications 

•  Key process/technology developers/producers not within the substance supply chain 

•  Leading academic and research institutions on chemicals and processes 

•  Publicly available tools and databases 

Possible  sources  for  the  applicant  to  initially  find  possible  alternatives  outside  the  supply  chain 
include (the list is not exhaustive): 

•  Academic/trade journals 

•  Trade/labour unions 

•  EU and non-EU programmes on chemical safety 

•  REACH-IT system  

•  Non-confidential  Annex  XV  dossier  information;  comments  from  public  consultation  and 

response to comment 

•  Patents databases  

3.6.  How to determine the technical feasibility of alternatives 

Technical feasibility of an alternative is based on the alternative fulfilling or replacing the function 
of  the  Annex  XIV  substance.  It  is  therefore  closely  linked  to  the  function  that  the  Annex  XIV 
substance performs,  i.e.  the specific task that the Annex XIV substance performs and under what 
conditions the function must be performed as discussed in Section 3.5.1. Therefore, the function of 
the  Annex  XIV  substance  in  the  uses  applied  for  must  be  clearly  defined  before  considering  the 
technical performance and feasibility of the alternative(s).  

In principle, the assessment of technical feasibility may be straight forward as it may be a case of 
selecting an alternative that meets specific functional requirements in order to replace the Annex XIV 
substance. However, the process changes that may be needed in order to accommodate the alternative 
have to be considered in all cases. On the other hand, the determination of technical feasibility may 
require a more detailed analysis and may include research in order to identify whether the alternative 
can perform or replace the function of the Annex XIV substance as well as possible trials to verify 
performance.  

3.6.1.  Technical feasibility criteria 

It  may be possible to develop  technical  feasibility  criteria (i.e. a list  of technical  requirements on 
function  that  must  be  fulfilled  for  an  alternative  to  be  technically  feasible,  see  Box  3).  A  good 
understanding of the substance function is the basis for the development of these criteria. This list of 
criteria  may  include  the  tolerances  of  these  requirements  (i.e.  an  acceptable  range)  and  may  also 
include consideration of the constraints on functionality. For example, for replacing one substance 
with another the criteria may include a criterion on the minimum purity required or minimum physical 
or chemical properties that must be imparted to the end product. For the process changes needed to 
allow the use of an alternative, criteria may include the range of conditions that can be achieved with 

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available technology and evaluation of whether these enable the alternative to be used for the desired 
function. 

Box 3. Technical feasibility criteria and performance analysis  

The development of criteria for evaluating technical feasibility could include a series of steps, as set out below 
(a screen-printing ink cleaner is used as the example*): 

1) Review the functional requirements of the use. For example, for a printing ink cleaner a minimal amount of 
residual ink on the screen after cleaning may be a specified requirement. A performance criterion may be that 
the screen must be cleaned until no visible ink residue remains on the screen surface. 

2)  Identify  relevant  performance  characteristics  that  could  be  qualitatively  or  quantitatively  evaluated.  For 
example these might include the ease of use (e.g. the physical effort required to clean the screens), the time 
required to accomplish the desired function (e.g. cleaning), the effectiveness of the alternative in achieving the 
function,  or  the  effect  of  the  alternative  on  the  quality  of  the  finished  product  (including  aspects  of 
sustainability, e.g. will use of the cleaner reduce the life of the screen). 

3)  Establish  a  performance  scale  for  each  of  the  performance  measures  to  facilitate  evaluation  of  the 
alternative/s.  The  scale  should  consider  both  subjective  and  objective  characteristics.  (For  example,  visual 
inspection could be used to assign a high, medium or low level of cleanliness. A quantitative test, such as light 
transmission through cleaned screens, could be used to quantitatively measure the amount of residual ink left 
on  a  screen  after  cleaning).  Some  objective  characteristics  can  be  evaluated  using  standard  product 
specifications, such as military specifications. 

The technical criteria against which possible alternatives can be appraised for feasibility will depend upon the 
consideration  of  the  function  as  well  as  other  concerns  such  as  customer  requirements.  The  approach  to 
technical feasibility set out here relies upon setting  a basis for technical feasibility that is determined by the 
functioning of the Annex XIV substance (the assumption here is that the Annex XIV substance performs the 
function  adequately,  otherwise  the  applicant  would  not  be  considering  applying  for  continued  use  of  the 
substance). However, this does not disregard the possibility that an alternative may out-perform the original 
substance in terms of technical functionality. 

Evaluation  against  technical  criteria  measures  how  well  an  alternative  performs  to  meet  the  functional 
requirements of the use. Technical performance data can be collected for both current use and the alternative 
processes and used as a basis for an evaluation. The effort required to perform a useful assessment of technical 
feasibility may vary depending on the thoroughness of the study and the specific nature of the process under 
consideration. In the first instance the evaluation would rely on the compiling of performance information from 
literature sources and from consultation rather than the design of an actual operating trial. The focus for the 
user will be on the: 

• 

• 

• 

Design of accurate and reliable performance measures. 

Collection of required data from suppliers. 

Evaluation of relative performance of the alternative. 

* Based on the US EPA document: US Environmental Protection Agency: Cleaner Technologies Substitutes Assessment - 
Office of Pollution Prevention and Toxics Washington, DC 20460 EPA Grant X821-543 

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3.6.2.  Consideration of process adaptation and changes 

The selection of possible alternatives to the Annex XIV substance can be done based on consideration 
of the replacement of substance function with another substance or with a technical  alternative or 
perhaps by eliminating the need for the Annex XIV substance through process change or changing 
the end-product. How to use substance function to identify possible alternatives is considered in the 
previous  section  (section  3.5).  The  determination  of  what  process  adaptations  or  changes  may  be 
needed to replace or remove the need for the Annex XIV substance and whether these are technically 
feasible are considered below.  

The technical feasibility of an alternative will be highly dependent on the possibility of the process 
adaptations and changes that may need to be put in place in order for the alternative to perform the 
desired function. Therefore, the consideration of the questions below for each type of alternative is 
recommended in order to address the technical feasibility of a possible alternative (i.e. substance or, 
technical alternative or process redundancy) 21: 

1.  Is it possible to replace the Annex XIV substance with an alternative substance? 

a.  If yes, what adaptations to the process are needed?  

b.  Are these adaptations technically feasible for the applicant?  

2.  Is it possible to replace the Annex XIV substance with an alternative technology?  

a.  If yes, what adaptations to the process are needed in addition to applying the technology 

for replacing the substance? 

b.  Are these adaptations technically feasible for the applicant? 

3.  Is it possible to make redundant the process or a part of the process in which the Annex XIV 

substance is used? 

a.  If so, what changes are needed?  

b.  Are these changes technically feasible for the applicant? 

Consideration of process conditions influencing the functional requirements have also been given in 
section 3.5.1 The alternative may not need to be used under the same process conditions as the Annex 
XIV substance in order to fulfil the same function. For example, it may be possible that the constraints 
imposed by the use of other chemicals or processes could be adapted or changed to accommodate an 
alternative. However, the constraint may be imposed by the conditions under which the function must 
be performed. 

Process change is normally required to accommodate an alternative and technical feasibility should 
not be discounted on the basis that an alternative cannot be simply substituted without any process 
change. For example:  

•  Changing one chlorinated solvent for another with a higher boiling point in vapour degreasing 

baths may mean increased use of energy to produce the necessary vapour.  

21   Considerations on the economic feasibility of replacement of the Annex XIV substances are set out in section 3.8. 

Considerations for the documenting past or future R&D are set out in section 3.9. 

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•  The  design  and  use  of  spraying  nozzles  for  the  use  of  biodegradable  mould  releases;  the 
nozzles  for  the  current  substance  in  use  are  not  effective  with  the  alternative  substance. 
Adaptation of the design of the nozzles allows the alternative to be used. 

• 

In offset printing, certain rubber mixtures for the rollers could not be used, as they tended to 
swell with alternative substance. Using different material for the rollers allowed the use of the 
alternatives. This however required tests to determine the technical feasibility of the new roller 
types (with time implications). 

An alternative substance or technology may also require investment in equipment for it to become 
technically feasible. Therefore, what process changes and investments in equipment and training are 
required should be identified and described. These may include:  

•  Determining what equipment and worker training will be needed for changes in the process 

required in order to accommodate the use of an alternative substance or technique. 

•  Assessing  the  requirements  associated  with  installation  of  equipment  e.g.  space  (housing) 
considerations, health and safety requirements (for installation and operations of equipment) 
and maintenance and repair of equipment.  

•  Calculating the cost of equipment and training requirements22. 

Based on consideration of the constraints, an assessment can be made of whether it is possible for the 
applicant to replace the Annex XIV substance through changes and adaptation to accommodate the 
alternative  or  remove  the  need  for  the  Annex  XIV  substance  function  altogether.  However,  the 
technical  feasibility  of  these  adaptation  or  changes  will  also  be  dependent  on  further  factors. 
Therefore the assessment will also comprise consideration of requirements which may include one 
or more of the following: 

•  Legal requirements: for example relating to product safety. 

•  Customer requirements: for example changes that require customer approval. 

•  Testing or research requirements: for example the process change may need to be tested to 
ensure that it is compatible (this may have fit in alongside normal production processes), or 
research may be needed to analyse the effects of the process change. 

The outcome of the assessment of the technical feasibility of process adaptation or change has to be 
documented  in  the  application.  The  assessment  of  technical  feasibility  of  alternatives  may  clarify 
actions  needed  to  make  an  alternative  technically  feasible  or  reveal  need  for  research  and 
development  to  develop  or ensure the technical  feasibility  of an alternative.  In such case relevant 
action, together with a timetable, and/or R&D should be documented in the application. How to do 
this is set out in further sections of this guidance: 

•  Circumstances  that  might  prompt  the  inclusion  of  R&D  in  the  analysis  of  alternatives  is 

considered in section 3.9.1; and 

•  The listing and documentation of the actions that are needed in order to make an alternative 

suitable and available are set out in section 3.11. 

22   The analysis of economic feasibility is addressed in section 3.8. 

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Example  3  is  intended  to  give  an  illustration  of  the  consideration  of  the  technical  feasibility  of 
alternatives.  

Example 3. Considerations for technical feasibility 

Substance C is used in plating of metals and plastics; it is used to lower the surface tension of metal plating 
solutions  to  prevent  the formation  of mists  containing  potentially  harmful  components  from  the  baths.  The 
substance is used specifically in this application for hard metal and plastic plating and decorative metal plating. 

The importance of the substance for metal plating is that it is stable in ‘hostile’ environments, such as hot metal 
acid, where it can form a foam blanket on the surface of the treatment bath, thereby preventing the release of 
acid mists by acting as a barrier. The substance is considered to be vital to operations of this type ensuring the 
health and safety of workers and reducing the risks of health impacts (including lung cancer and metal exposure 
ulcers) associated with metal plating. Prior to the introduction of the substance, control of metal ion emissions 
was by local extraction – substance C is considered to have made the control of mists more efficient and a 
considerable help to meet Workplace Exposure Limits. 

Suppliers purchase aqueous solutions of the substance C, which they may dilute further and then sell to their 
customers. Typically 10% solutions are used. 

R&D suggests that the substitution of the metal ion with a less hazardous ion of the same metal in some plating 
applications (use 1) would eliminate the need to use any substance for prevention of mist formation. This option 
is not available for use 2 – alternatives for this use are subject to industry research. 

Difficulties with technical feasibility 

Substance alternatives 

There are currently no known alternative chemical mist suppressants to the substance for metal and plastic 
plating. Testing* has shown that substitute mist suppressants, such as substances D and E are not technically 
feasible  because  of  excessive  pitting  of  coatings  and  rapid  breakdown  during  the  process  (electrolysis). 
[*Reference to relevant R&D reports or findings supports this] 

Possible technically feasible alternatives 

Technical alternatives 

A number of options for mechanical mist suppression and improved ventilation have been identified.  

For use 2, the longer time periods of immersion in the electrolyte required to obtain the necessary thickness of 
coating provides the opportunity for greater tank enclosure (compared with use 1 where immersion times are 
measured in minutes rather than hours/days). Whilst causing some interruption to the process of immersing and 
taking out articles, this would eliminate the need for chemical mist suppression to meet occupational exposure 
level when combined with suitably adjusted ventilation extraction (the use of the metal ion is already limited 
in the automotive electric and electronics industries).  

For use 2 applications the use of greater physical tank enclosures presents some operational disadvantages over 
the use of chemical mist suppressants. These include the need to remove and replace the enclosure between 
operations; the advantage of chemical mist suppressants being that they effectively provide a floating chemical 
enclosure through which articles can be raised and lowered. Such disadvantages do not occur with the use of 
improved  ventilation  extraction  alone.  However,  while  these  may  present  operational  disadvantages  over 
chemical  mist  suppressants  there  are  no  technical  disadvantages  from  the  perspective  of  product  quality 
/production standards. 

Process changes making the Annex XIV substance function redundant 

For use 1, the indication from R&D is that the use of the less toxic ion of the metal would eliminate the need 
for substance C (or any other substance for the prevention of mist formation) in this use and would not result 
in any significant technical difficulties and may have a number of technical advantages including: 

• 

production of fewer rejects and freedom from burning  

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• 

• 

• 

• 

better metal distribution and good covering resulting in better corrosion production 

easier draining because of the lower viscosity and lower chemical concentration of metal ion electrolytes 
resulting in less staining of the work. 

uniform coverage without build up on high current density areas  

maintained plating and deposit appearance over a very wide current density range 

3.6.3.  Uncertainties in determining technical feasibility 

It is important to clearly set out what the uncertainties are in the documentation of the analysis of 
alternatives and determine how they may affect the outcome of the assessment of the analysis. Setting 
out the actions required to make an alternative technically feasible for the applicant will therefore be 
a critical part of the analysis. The uncertainties, for example the possible outcome of research, product 
safety23 and technical test-trials will need to be part of the documentation. 

3.7.  How to compare the risks of the alternative and the Annex XIV substance  

3.7.1.  General considerations on assessing and comparing the risks 

The use of a suitable alternative must lead to a reduction in overall risks to  human health and the 
environment compared to the Annex XIV substance. Therefore, in the analysis of alternatives it is 
essential to compare the potential risks of possible alternatives to the Annex XIV substance for the 
uses that are being applied for. This should also include the consideration of the appropriateness and 
effectiveness of risk management measures that control risks. 

Note that for substances included in Annex XIV and following the SEA route to authorisation (based 
on  the  provisions  in  Article  60(4),  see  section  1.5.5.  for  further  details  on  applicability),  an  SEA 
report, which may include an assessment of health and environment impacts made according to the 
Guidance on Socio-Economic Analysis - Authorisation will be available. This assessment could be 
used to support the decision making on whether the possible alternatives will lead to a reduction in 
overall risks or not.  

The  assessment  of  risks  related  to  the  alternatives  has  a  comparative  nature.  It  should  document 
whether or not the transfer to the alternative would result in reduced overall risks to human health 
and  the  environment.  It  is  therefore  important  not  only  to  consider  the  risks  that  resulted  in  the 
requirement for authorisation (based on the substance properties listed in art. 57), but also all other 
possible risks resulting from the Annex XIV substance and the alternative. The aim is to assess the 
effects of the transferral to the alternative in reducing the identified risk of the Annex XIV substance 
while not causing other risks that cannot be controlled. 

For example, in relation to alternative substances, the work involved may include: 

23   Product safety referred to here relates to the possible legal requirements, such as for fire safety as distinct from the 

analysis of safety of chemical within REACH (i.e. in the CSA). 

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•  collecting data on the properties of alternative substances from manufacturers and importers 
or other sources (e.g. registration dossiers on alternatives when these have been registered, or 
from other sources when registration has not yet taken place);  

•  examining the hazard profiles of the alternative substances and comparing them to the hazard 
profile  of  the  Annex  XIV  substance  to  assess  whether  it  is  possible  to  determine  with 
sufficient certainty that the alternative would result in a lower level of risk;  

•  examining the exposure levels of the alternative substance, e.g.,  

o  examining  information  on  emissions  to  the  environment  and/or  environmental 
concentrations of the alternatives and data on current levels of exposure of workers or 
consumers  from  publicly  available  sources  or  impacts  associated  with  alternative 
options; 

o  using exposure modelling 

•  where  necessary,  combining  the  hazard  and  exposure  data  for  alternatives  to  determine 

whether they would result in a lower level of risk 

• 

if appropriate, quantifying and valuing the change in risk following the approach set out for 
the Annex XIV substance. 

The applicant is not required to generate new hazard data or provide a chemical safety assessment for 
each  of  the  alternatives.  Nor  is  it  required  that  the  risks  associated  with  alternative  substances  or 
technologies are assessed in the same detail as the risks associated with the Annex XIV substance. 
The level of effort that needs to be put into this assessment above the documentation of available 
information will be a matter of judgment for the applicant. For example, the comparison of hazard 
profiles  may  indicate  that  the  alternatives  present  a  clearly  lower  level  of  risk.  In  these  cases,  no 
additional  assessment  may  be  necessary.  When  a  comparison  of  hazard  profiles  or  a  lack  of  data 
raises concern, then there may be a need for more detailed assessment of any changes in risk following 
as appropriate the approaches described in the guidance on preparing chemical safety assessment.  

For the purpose of the analysis of alternatives, when the applicant can show that an alternative that 
could be assumed to entail lower risks is not technically or economically feasible for him, it would 
not be necessary to continue with further assessment of the risks of the alternative. However, if the 
applicant considers inclusion of a SEA in his application, it may be useful for the applicant to provide 
information comparing the risks of alternatives to those of his application (even if the alternatives are 
not  feasible for the applicant) to  be used as a basis for the assessment of health and environment 
impacts within his SEA. 

3.7.2.  Collecting hazard and risk information on alternatives 

This section addresses primarily how to collect information on alternatives that are substances, but to 
some extent also provide information relevant for alternative technologies (e.g. see box 4).  

As already mentioned it should be noted that the applicant is not required to generate new hazard data 
or  perform  and  submit  a  chemical  safety  assessment  in  order  to  determine  the  safety  of  possible 
alternatives. However, the applicant should use all information available for him, including public 
information generated by possible registrants of the alternative substances. 

The  guidance  for  preparing  the  CSA  will  be  useful  for  collecting  and  generating  easily  available 
information on hazards and risk and control of risks in order to compare the safety of the alternatives 

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with  the  Annex  XIV  substance.  For  example,  the  applicant  can  use  the  same  basic  information 
strategies in assessing the risks of alternative substances as set out in the Guidance on information 
requirements  and  CSA.  These  approaches  consider  what  the  applicant  might  do  in  cases  where 
information on hazard and exposure of the alternative substance is scarce or are not available, for 
example  because  the  alternative  substance  is  not  registered  under  REACH24.  Where  there  is 
insufficient  information  on  hazards  for  the  purpose  of  concluding  whether  the  overall  risks  are 
reduced by a transfer to an alternative substance, the applicant may for example use methods like 
quantitative structure activity relationships ((Q)SARS) and ‘read-across’ from similar substances.  

The  CSA  guidance  also  includes  detailed  information  on  data  search  strategies  and  databases  for 
collection of available data using publicly available data sources to assist with gathering information 
on possible alternatives. Box 4 gives some further examples of internet based information tools that 
have been developed to assist with comparing safety of alternatives. The examples in Box 4 are only 
examples of the type of information that is freely available and are not recommendations. Note that 
none of the databases is designed specifically for REACH. 

Box  4.  Examples  of  databases  and  tools  to  assist  with  hazard  and  exposure  information  on 
possible alternatives 

There are a number of publicly available databases that have been set up aimed at assisting the substitution of 
dangerous  substances.  Some allow  hazardous properties  of  substances  to  be  searched,  while  others  provide 
examples of how hazardous substances have been substituted (i.e. case studies). Some of these databases are 
listed and commented upon below (these are examples and there are other databases available): 

Examples of alternative comparison tools: 

Tool: P2Oasys Tool to Compare Materials 

Developed by: TURI - Toxics Use Reduction Institute (University of Massachusetts Lowell USA) 

Web reference: http://www.turi.org/ 

Description/comments:  The  aim  of  P2OASys  is  to  allow  companies  to  assess  the  potential  environmental, 
worker,  and  public  health  impacts  of  alternative  technologies  aimed  at  reducing  ‘toxics’  use.  The  tool  is 
supposed  to  assist  companies  in  two  ways:  1)  Examine  the  potential  environmental  and  worker  impacts  of 
‘TUR’ options in a comprehensive manner, examining the total impacts of process changes, rather than simply 
those  of  chemical  changes.  2)  To  compare  TUR  options  with  the  company's  current  process  based  on 
quantitative and qualitative factors. 

Input of data can be quantitative and/or qualitative data on the chemical toxicity, ecological effects, physical 
properties, and changes in work organisation as a result of the proposed option. 

Tool: Column Model 

Developed by: Berufsgenossenschaftliches Institut für Arbeitsschutz - BGIA 

Web reference: http://www.hvbg.de/e/bia/ 

Description/comments: Various types of hazard (health, environmental, fire and explosion, potential emission 
and procedural) are grouped in columns and the attributes of a possible alternative could be compared (with the 

24   Availability of data via REACH-IT will be dependent on whether substances have been registered (above 1 tonne 
per annum). Note that the registration timetable depends on the tonnage band therefore this will determine whether 
and when information is available on possible substance alternatives within the REACH system. It should also be 
noted that the whole registration dossier is not publicly available. 

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Annex  XIV  substance)  within  a  group/column.  This  allows  the  user  to  focus  on  the  hazards  and  exposure 
potential that is most significant for the use of the alternative. 

Because of data uncertainties, data quality and the mix of quantitative, semi-empirical and qualitative data used 
to complete the matrix; a risk index of this type can be subjective. 

Example of hazardous substances database: 

Database: PRIO 

Developed by: KEMI (Swedish Chemicals Agency) 

Web reference: http://www.kemi.se/ 

Description/comments: The aim of PRIO is to facilitate in the assessment of health and environmental risks of 
chemicals so that environmental managers, purchasers and product developers can identify the need for risk 
reduction. To achieve this PRIO provides a guide for decision-making that can be used in setting risk reduction 
priorities. 

The PRIO database is most useful for users identifying the hazardous properties of the substances they use in 
order  to  help  them  in  priority  setting  for  action  on  the  substance,  rather  than  identify  possible  ('safer') 
alternatives to a substance. Listing of alternatives is not currently available, but may be considered in the future. 

Example of substitution experience database: 

Database: CatSub 

Developed by: European Agency of Occupational Safety and Health, Danish Working Environment Authority 
and Danish Environmental Protection Agency 

Web reference: http://www.catsub.dk 

Description/comments: Catsub is a database of examples of the substitution of hazardous substances. The data 
base is populated with some 200 examples which can be viewed. The process of substitution difficulties and 
how these were overcome is provided in the commentary from industry and authorities.  

The database does not provide information ‘look-up’ on hazardous properties of substances or have possible 
alternatives for dangerous substances other than those in the database examples. The examples are in the Danish 
language (apart from eight examples in English). There are plans to develop Catsub into an international tool 
for substitution. 

It should be noted that the information on the comparison on the risks of the Annex XIV substance 
and alternative(s) may be of use in an SEA, if such an analysis is to be performed for the application. 
As  noted  in  sections  3.2  and  3.4.2,  key  information  collected  and  analysed  in  the  analysis  of 
alternatives may be used in the SEA. Conversely, the assessment of health and environment impacts 
that may be carried out as part of the SEA could be used in the analysis of alternatives to support the 
decision making on whether the possible alternatives will lead to a reduction in overall risks or not. 
Box  5  sets  out  the  links  between  the  comparison  of  risks  in  the  analysis  of  alternatives  and  the 
assessment of impacts in the SEA. 

Box 5. Comparison of risks: links to the SEA 

The aim of the SEA as part of an authorisation application is to assess whether the socio-economic benefits of 
the  use  of  the  Annex  XIV  substance  (for  the  uses  applied for) outweigh  the  risks  to  human  health  and  the 
environment  (see  Guidance  on  Socio-Economic  Analysis  -  Authorisation).  To  do  this  two  scenarios  are 
compared: 

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1.  The use of the Annex XIV substance for the uses applied for (this is called the ‘applied-for use’ scenario); 
and 

2.  Not using the Annex XIV substance for the uses applied for (this includes what the response to the ‘non-
use’ (i.e. removal) of the Annex XIV substance would be – this is called the ‘non-use scenario’. 

In order to compare the two scenarios, there is a need to understand what the impacts of the two scenarios are, 
and to assess what the difference is (i.e. the net impact). When assessing the health and environmental impacts, 
a stepwise approach is proposed, whereby the assessment focuses on those impacts that are considered to be 
significant outcomes of the authorisation, with the level of detail and quantification applied determined by the 
extent  to  which  further  information  will  be  needed  in  presenting  a  robust  SEA.  Throughout  the  process, 
judgements will need to be made on what impacts are likely to be significant and how these can best be assessed. 

The basis for the identification and assessment of health and environmental impacts is a proper understanding 
of the changes that granting or not granting an authorisation causes on step 1-3 below: 

1. The use of the Annex XIV substance or the use of any alternative substance or technology. 

2. The resulting emissions and exposures, 

3. The subsequent impacts to health and environment, 

4. If possible, valuation of these changes in impacts can be applied as a last step. 

The stepwise assessment of changes induced needs to be done for the Annex XIV substance as the ‘applied-for 
use’  scenario  and  any  alternative  substance  or  technology  identified  for  under  the  ‘non-use  scenario’. 
Respectively, any other affected process upstream or downstream in relation to the Annex XIV substance or to 
alternative(s) will be analysed.  

The above outline is used as the conceptual framework for identifying, assessing and, if possible, quantifying, 
and ultimately valuating health and environmental impacts in the SEA.  

The analysis of alternatives may have considered replacement or adaptation of the end product that would lead 
to removal of the need for the Annex XIV substance altogether. However, the extent/scope of the analysis of 
alternatives may not have covered the extent of the non-use scenario in the SEA (e.g. use of a non-suitable 
alternative which may be applied in case  the  Annex XIV substance is not granted authorisation). This may 
require the gathering of further information for the impact assessment of the SEA as mentioned in sections 3.3 
and 3.5.2 above.  

3.7.3.  Assessing and comparing with the risks of possible alternative substances  

In principle the assessment of human health and environmental risks for an alternative substance can 
be  conducted  using  the  same  approaches  as  for  the  Annex  XIV  substance  for  which  a  CSR  is 
developed as a part of the application. However, the Guidance on information requirements and CSA 
does  not  consider  the  comparison  of  risks  between  substances  (i.e.  comparing  the  risk  of  the 
alternative with the Annex XIV substance). 

In order to be able to compare the risks arising from the available alternatives one needs to take a 
flexible approach towards the assessment of such alternatives, as well as the Annex XIV substance. 
Ideally  the  assessment  should  address  all  possible  risks  throughout  the  entire  lifecycle  of  the 
substances including all relevant compartments and populations, even those not originally associated 
with  the  identified  risk.  The  reason  for  this  is  that,  while  an  alternative  may  reduce  the  specific 
identified risks of the Annex XIV substance, it may pose other risks at different points in its lifecycle 
or may shift the risks to other compartments/populations when it replaces the substance of concern. 

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In other cases, the use of alternatives may have secondary adverse effects that may not be immediately 
recognisable, for example, an increase in the production of hazardous waste at the end of the lifecycle 
or increased energy consumption.  

It is recommended that the assessment of the risks of possible alternatives is approached in a step-
wise manner, considering whether there is sufficient information on hazard, exposure, risk and risk 
control in order to make an assessment of the risks of the alternative and compare this to the Annex 
XIV substance. Figure 7 illustrates in a general flow diagram how one might address the risks of 
alternatives.  

Figure 7. Flow diagram for the assessment of and comparison to risks of alternatives 

65 

 Possible alternativeIs alternative a substance?Is sufficient information available to describe the risks?Gather available information on hazards, exposures and control of risks (OC and RRM) Describe the risksCompare risksof alternative and Annex XIV substanceDoes use of the alternative lead to reduced overallrisks?Take alternative forwardReject alternativeYYNot possible to compare risksGather available information on risks of technicalalternativesNIs sufficient information available to describe the risks?NYNGather surrogate information on the alternative substance NYSEA information on impactsto support decision (optional)Is sufficient information available to describe the risks?YNNot possible to compare risks 
 
 
 
Guidance on Authorisation Applications 

Note:  Solid  grey  boxes  indicate  where  guidance  on  gathering  hazard  and  exposure  information  and  chemical  safety 
assessment  of  substances  is  set  out  in  Guidance  on  information  requirements  and  CSA  (including  where  surrogate 
information on hazards may be derived such as (Q)SAR and read-across); the dashed box indicates a link to Guidance on 
Socio-Economic Analysis - Authorisation. 

The assessment of alternatives should be based primarily on risk rather than hazard. However, risk-
based replacement of the original substance or process may not always be simple or indeed feasible. 
Therefore, assessing the risks of alternatives substances may be conducted using a tiered approach 
starting from a comparison of the hazardous properties and, if necessary, possibly ending in a full 
assessment of the risks arising from the alternatives.  

A detailed tiered approach is described in Box 6. Each tier increases the level of data required and 
complexity of the assessment. However, the complexity of the assessment is highly dependent on the 
properties  of  the  alternative  substance  or  technology.  For  example,  if  a  clearly  less  hazardous 
substance is available then a comparison of the hazardous properties could be enough, or in the case 
where an alternative technique results in the elimination of emissions of the substance of concern, 
then a description of the resulting emissions could be suitable. Nevertheless, care should be taken to 
assess other possible secondary effects of the alternative, such as possible increases in the production 
of hazardous waste or increased energy consumption. 

Box 6. A tiered approach for assessing the risks of alternative substances 

For alternative substances the tiered approach set out below may be appropriate. Such an approach may include 
the following levels of increasing complexity: 

• 

Tier 1: Comparison of the hazards of the alternative substance to those of the substance of concern.  

Part A: Collection of available hazard information for the alternatives. Where registration dossiers and 
other  REACH-related  information  (Articles  31  and  32)  are  available,  these  may  be  reviewed.  If  such 
sources are not available, other sources should be considered (see section 3.5). Where vital information is 
missing, consideration may be given to generating this, for example, by use of (Q)SARs. Uncertainty on 
the validity of such results should be acknowledged and documented in the analysis. 

Part B: Comparison of the hazard information of alternatives to that of the Annex XIV substance. This 
assessment should be used as a screening process to rank alternatives based on their hazard profile in 
order to help on whether to consider such alternatives as potentially suitable. This comparison should first 
look at those hazard properties of highest concern such as PBT/vPvB, and CMR characteristics. If both 
the Annex XIV substance and the alternative substances have similar properties of concern or when all 
potential  alternatives  have  PBT/vPvB/CMR  properties,  the  applicant  should  take  into  consideration 
information on the potential exposure and any possibilities to better control the exposure25. Furthermore, 
for applications via the SEA route a health and environment impacts assessment may form part of an SEA. 
This assessment can provide further information for the decision on whether the alternative would lead to 
a  reduction  in  overall  risks  or  not.  The  same  principles  apply  when  comparing  less  severe  hazard 
properties. If the alternatives have been registered and have been assessed for risks, PNEC and DNEL 
values for them may be available and these may be compared to those for the Annex XIV substance. Also, 

25   If an alternative substance is already on Annex XIV, it will normally not make sense to transfer to it. If the substance 
is on the candidate list, then a very close consideration on the overall risks should be given before transferring to it. 
If  the  alternative  substance  seems  to  fulfil  article  57  criteria  but  it  is  not  yet  on  the  candidate  list  or  registry  of 
intentions, the applicant should document his reasons for suspecting the substance to be a SVHC and such hazard 
profile could be seen as an argument that the transfer to this substance may not reduce the overall risks. 

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the collection and comparison of information on physico-chemical properties of the alternatives may be 
pursued if it is of particular relevance to the identified risks. 

• 

Tier 2: This would involve the use of information on the alternative substance (properties and hazards) 
within the Chemical Safety Assessment for the Annex XIV substance to perform a quick revised exposure 
assessment and risk characterisation for the alternative for the applications associated with the identified 
risk; there may be three possible situations of increasing complexity: 

1)   If  the  exposure  assessment  for  the  Annex  XIV  substance  shows  that  the  release  estimates  do  not 
depend on the substance properties, then the existing emission estimates for the original substance 
may be used.  

1a)  When the alternative has similar physico-chemical and environmental fate properties to the Annex 
XIV substance, it may be sufficient to use the existing PEC values for the comparison of the PNEC 
or DNEL values of the substance of concern and the alternative; or  

1b)  When the alternative does not  have similar physico-chemical and environmental fate properties to 
the Annex XIV substance, the emission estimates may be used in conjunction with environmental 
fate data on the alternative to calculate its PEC values. These should then be used to revise the risk 
characterisation. 

2)   If the emission estimates in the chemical safety assessment depend on the substance properties, it 
may be possible to estimate whether the alternative would have lower or higher emissions than the 
Annex  XIV  substance  by  simple  consideration  of  the  properties.  However,  it  is  possible  that 
emissions to one compartment may increase while those to another decrease, and it will be difficult 
to make a simple judgement on how this would affect the PECs (for regional concentrations at least). 
In such cases, it may be necessary to estimate the emissions of the alternative substance and then 
carry out similar calculations as those for the substance of concern to generate PEC values. It may 
also be necessary to consider the effect of replacing the substance with the alternative in terms of the 
tonnage  of  the  alternative  that  would  be  required.  For  example,  the  registration  dossier  for  the 
alternative will be based on the current tonnage and uses and is unlikely to consider an increase in 
use or a new use as a result of replacement (see also Appendix 5 on ‘risk profiling’ for environmental 
risks of substance alternatives). 

• 

Tier 3: use of exposure scenarios specific to the alternative substance (rather than those for the Annex 
XIV substance) to perform an assessment of risks for the alternative for the applied for uses across all 
compartments/populations  at  risk.  This  will  effectively  be  similar  to  Tier  2  only  that  the  Exposure 
Scenarios will be specific to the alternative substance for the applications associated with the identified 
risk, if available for example from an annex to the SDS or from a registration dossier for the alternative.  

Note: This approach has been adapted from an approach set out in  Guidance for the preparation of an 
Annex XV dossier for restrictions 

It  may also  be the case that the Annex XIV substance would have to  be  replaced not  by a single 
substance but rather a combination of substances or a complete reformulation of products containing 
the substance or even by alternative substances used within an alternative processes. In such cases, 
the combined effects of such changes may be difficult to assess. Therefore, the analysis may include 
an assessment of the potential effects of each alternative used in isolation and some discussion of the 
envisaged implications of combined effects may be provided. 

For hazard data, the key health and environmental effects of alternatives should be identified where 
this is possible. For alternative substances particular attention should be focussed on carcinogenic, 
mutagenic  or  reproductive  effects  and  PBT  and  vPvB  properties.  These  comparisons  of  similar 
properties  and  effects  between  substances  are  not  necessarily  straightforward  or  simple.  The 
classification  and  labelling  of  possible  alternative  substances  can  be  consulted  in  the  list  of 

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harmonised classifications (Part 3 of Annex VI to Regulation (EC) No 1272/2008 (if available26) and 
the  hazard  statements  applied  to  substances  may  be  useful  in  the  assessment  of  the  comparative 
hazard27. 

The comparison of different hazards and their magnitudes may require value judgments about the 
acceptability  of  different  risks  to  different  endpoints.  For  example,  such  judgements  may  involve 
comparing  different  types  of  health  impacts  (e.g.  liver  toxicity  versus  neurological  effects)  or 
different effects to the environment. Simultaneously ranking health, safety and environmental risk 
may require the applicant to be involved in trade-offs which are not always straightforward. Risks of 
the alternative may also be difficult to compare to those of the Annex XIV substance because they 
may be of a radically different nature. For example, a substance of low toxicity could have an adverse 
effect on the earth’s ozone layer. Alternatives may be more benign with regard to such effects but 
they could be, for instance, flammable, toxic or may pose other hazards to the environment. In these 
cases, the applicant should assess the relative importance, gravity, imminence and implications of the 
different types of risk and decide whether the risks introduced by the alternatives are acceptable and 
why. 

The applicant may also need to consider the wider implications of the risk and impacts in order to 
further  inform  and  support  the  decision  on  whether  the  use  of  the  alternative  would  represent  a 
reduction in risk. This may include addressing risks of various other substances from other processes, 
i.e. upstream or downstream processes related to the manufacture or use of the Annex XIV substance 
and  alternative  substances.  This  may  also  include  external  impacts  or  substances  created 
unintentionally, e.g. emissions from energy generation as well as consumption/production of other 
things such as waste production and water use. 

It may not, however, be necessary to conduct a full comparison of risks on all possible alternatives. 
This  could  be  very  resource  intensive,  especially  if  new  information  needed  to  be  collected  on  a 
number  of  possible  alternatives  in  order  to  compare  risks.  For  alternative  substances  it  may  be 
possible to conduct an initial comparison of risks by focusing on the specific use pattern, tonnage 
used  and  predicted  emissions.  With  key  (but  limited)  information  on  the  physico-chemical,  eco-
toxicological and biodegradation properties, alternatives may be compared in terms of their predicted 
risk. Such a process of so-called risk profiling28 may enable short listing of alternatives that may be 
of lower environmental risk. 

3.7.4.  Assessing and comparing with the risks of possible alternative technologies 

There are difficulties in comparing the risks of a substance and the risks of a technical alternative. 
For example, there may be risks associated with alternative technologies but these may not be of the 
same  nature  that  the  Annex  XIV  substance  risks  present  to  human  health  and  the  environment 

26   The Classification and Labelling Inventory (database) is available at the ECHA website.  

27   For  example,  the  COSHH  Essentials  published  by  the  UK  HSE  provides  a  scheme  by  which  substances  can  be 

grouped by relative hazard on the basis on risk phrases. 

28   An approach developed by the Environment Agency of England and Wales for compiling generic risk assessment 
from  detailed  knowledge  of  likely  release  patterns  and  the  influence  of  key  environmental  properties  of  those 
substances used in a particular industry. A brief description is presented in Appendix 4. 

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However, for it to be suitable, the alternative must represent a reduction in the overall risks to human 
health and the environment as compared to the Annex XIV substance. Therefore, a comparison of 
risks must be conducted and the applicant will need to consider how these different risks might be 
compared in terms of risks to human health and the environment. Note that the introduction of an 
alternative technology to replace the Annex XIV substance may also involve a change in the use of 
other substances in  the relevant  processes. Possible risks of these substances will  also  need to  be 
considered in the assessment following, as far as possible, Guidance on information requirements and 
CSA and section 3.7.3. 

The  comparison  with  technological  alternatives  can  normally  not  be  fully  quantitative  (i.e.  with 
directly comparable numeric values) as the risks will not be expressed in similar terms, but will in 
most cases be qualitative or semi-quantitative. Nevertheless, a clear and transparent description can 
give a good basis for the applicant to conclude whether overall risks are reduced (and for the Agency 
Committee to give its opinion on that). 

Especially in the case where the analysis requires the comparison of the risks of technical or process 
alternatives  with  the  Annex  XIV  substance29  the  applicant  may  also  need  to  consider  the  wider 
implications of the risk and impacts in order to further inform and support the decision on whether 
the  use  of  the  alternative  would  represent  a  reduction  in  risk.  For  alternative  technologies 
consideration  should  for  example  be  given  to  environmental  controls,  working  practices  and 
legislation controlling other risks (e.g., fire and explosion, confined spaces and extreme temperature 
and pressure). Care should be taken to assess other possible secondary effects of the alternative, such 
as possible increases in the production of hazardous waste or increased energy consumption (see also 
Box 7). 

There are systems that have been developed for the qualitative, semi-quantitative and quantitative 
comparison of risks. These range from simple comparisons of hazard information such as the 'column 
model' from Germany's Berufsgenossenschaftliches Institut für Arbeitsschutz – BGIA (see also Box 
4), to more complex systems that consider more far-reaching impacts from the whole life cycle of 
products  such  a  life  cycle  analysis  (LCA)  and  related  methodologies.  With  LCA  methodologies, 
however,  it  may  be  difficult  to  focus  only  on  the  impacts  from  the  alternative  since  the  LCA  is 
concerned with all impacts from the final end product. These methodologies are designed more for 
selection of the sustainable manufacture and use of products than selecting lower risk alternatives for 
hazardous chemicals for particular uses. But the same basic methods and approaches used in LCA to 
describe the effects could be used. 

Some consideration of the possible difficulties in comparing substances risks and risks from technical 
alternatives is given in the example in Box 7. 

Box 7. Comparing risks from substances and technical alternatives 

Cleaning of facades – halogenated solvents vs. high pressurised water 

The cleaning of building facades can use a number of hazardous chemicals. In this example the focus is on the 
use of a chlorinated solvent (that is assumed to be the Annex XIV substance). An alternative cleaning method 
(i.e.  technical  alternative)  for  this  use  is  high  pressure  water  systems.  The  alternative  technique  has  risks 

29   The socio-economic impacts of the possible wider risks of the use of alternatives may be one of the aspects considered 

within an SEA (see Guidance on Socio-Economic Analysis – Authorisation). 

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associated with its use but these are not toxic risks but are due to the physical working environment, waste and 
energy use created by the use of the alternative. The risks of the solvent and the use of high-pressure water are 
summarised below: 

Risks of halogenated solvents:  

 - Exposure of workers with a toxic or carcinogenic substance (risk to workers health) 

 - Contaminated soil (risk to environment) 

 - Dangerous waste (risk to health and environment) 

The identification of risks takes into account risk management measures and operational conditions related to 
the  control  of  exposures.  It  is  of  importance  to  consider  the  actual  effectiveness  of  the  measures.  For  the 
purposes of this example, it is assumed that the effectiveness of risk management measures to control emission 
to  soil  is  limited  due  to  problems  in  putting  them  in  place  as  the  work  moves  from  site  to  site.  Similarly, 
occupational controls are not fully implemented in practise because the use is not in one place and some items 
of personal equipment (e.g. respirator) are found to be physically restrictive for the operator when using the 
substance in particular situations.  

Risks of high pressure water: 

- Accident risk due to high pressure (risk to workers’ health), also for pedestrians (risk to public health) 

- Noise and vibration (risk to workers’ health) 

- Technical Risks: Risk of damages of the façade: mechanical, wetness, oxidation, freezing (technical risk) 

- Waste water (risk to health and environment) 

- Energy consumption (risk to environment) 

As  for  the  substance,  the  risks  are  considered  with  possible  risk  controls  in  place.  As  with  the  use  of  the 
substance, some measures are not fully implemented because of the non-stationary nature of the use scenario. 
When assessing these (non-toxic) risks any obligations under other Community legislation setting requirement 
on the implementation of RMMs and OC has to be taken into account. As above, the actual effectiveness and 
the possibilities to implement these requirements have to be considered. 

3.7.4.1. Comparing with risks of alternative technologies: Human Health 

Physical hazards to human health arising from the use of alternative technologies such as potential 
exposure to extreme temperatures, raised levels of noise and vibration or increased risk of fire and 
explosion are likely to be particularly relevant in the workplace. Comparison of the risks associated 
with use of the Annex XIV substance and those associated with other possible alternatives should 
include these physical risks. However, comparing different types of risks (i.e. toxic with non-toxic) 
is also difficult (see Box 7). 

Although the guidance on the evaluation of human health risks within the Guidance on information 
requirements and CSA is not directly applicable to the consideration of alternative technologies and 
does not address all the different kinds of physical hazards that could be posed by technologies, it 
provides a framework for an assessment that may be applied to the assessment of these risks (i.e. 
comparing hazards with exposure).  

Where hazards have threshold effects; no-effect ‘safe’ levels could be determined. These levels can 
be  compared  to  the  predicted  worker  exposure  level.  The  implementation  of  control  measures  to 
mitigate risk should be included in the assessment.  The safety of an alternative technique may be 

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assessed by comparing residual exposure (i.e. after the implementation of control measures) to effect 
levels. 

Member State Competent Authorities for the protection of worker health will often have information 
available on the assessment and control of non-toxic hazards. It is recommended that such guidance 
is consulted to determine the relevant risks (and control measures) from alternative techniques.  

3.7.4.2. Comparing with risks of alternative technologies: Environment  

The comparison with risks to the environment from alternative technologies replacing the Annex XIV 
substance will probably in many cases primarily address changes in the use of other substances in the 
relevant  processes  caused  by  the  introduction  of  the  alternative  technology.  The  risks  of  these 
substances  will  need  to  be  included  in  the  assessment  and  should  as  far  as  possible  be  assessed 
following the Guidance on information requirements and CSA and section 3.7.3.  

A potential difficulty with comparing environmental risks of alternative technologies to those of the 
Annex XIV substance is that the risk of toxicity and or risk of persistence in the environment may 
need  to  be  compared  with  other  kinds  of  risks.  For  example  such  as  the  risk  presented  by  the 
generation  of  greenhouse  gases  from  increased  use  of  energy  or  risks  by  increased  production  of 
waste etc. However, it should be noted that these risks could also be caused by the release of chemical 
substances and this difficulty is not confined to comparison of substances and technologies.  

Some guidance on determining best available techniques (BAT) has been developed in the framework 
of Integrated Pollution Prevention and Control directive (see Box 8). This offers a methodology to 
allow a comparison of different options in terms of their potential environmental effects considering 
seven broadly defined so called environmental themes. The concept takes into account the likely cost 
and  benefits  of  measures  as  well  as  aiming  to  protect  the  environment  taken  as  a  whole  to  avoid 
creating a new and more serious environmental problem when solving another. 

Box 8. Alternative  techniques  and  comparing  environmental  risks:  ‘cross  media  effects’ 
guidance from IPPC 

Choosing between different options for the control of emissions to the environment has been considered under 
Integrated  Pollution  Prevention  and  Control  (IPPC).  A  Reference  Document  (‘BREF’)  on  Economics  and 
Cross-Media Effects has been developed and published1.  

In  the  BREF  document  the  term  ‘cross-media  effects’  is  used  to  describe  the  environmental  effects  of  the 
options under consideration. Choosing between alternative options might require a choice to be made between 
releasing  different  pollutants  in  the  same  environmental  medium  (e.g.  different  technology  options  might 
release different air pollutants). In other cases, the choice might be between releasing to different media (e.g. 
using water to scrub an air emission thereby producing waste water or filtering a water discharge to produce a 
solid  waste).  The  BREF  also  provides  guidance  on  comparing  the  costs  of  different  abatement  measures 
(including investment costs, operating and maintenance costs, revenues and avoided costs) the possible use of 
this methodology is considered later in section 3.8 on economic feasibility. 

The  BREF  is  focused  comparing  alternative  options  for  determining  what  represents  the  best  available 
technology  (BAT)  for  controlling  emissions  from  industrial  processes  in  order  to  achieve  a  high  level  of 
protection for the environment as a whole. It is not specifically intended to allow a comparison between the 
specific use of a substance and a possible alternative. The BREF does however offer a methodology to allow a 
comparison of different options in terms of their potential environmental impact, taking into account different 
environmental media, different environmental impacts and the costs of each option. 

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The cross-media methodology consists of four steps. However, the first two steps (called ‘guidelines’ in the 
BREF) describe the process for identification of abatement technology and compiling an inventory of emissions 
for each option. Whilst this is not so relevant for identification of alternatives under the REACH authorisation 
process, it presents a framework for the selection of techniques that may be helpful. Steps (guidelines) 3 and 4 
in  which  the possible  effects and risks  from  different  techniques  are  compared  and  interpreted  are of  more 
direct use. The BREF also describes how the economic viability of different options can be evaluated.  

Where  the  BREF  may  be  helpful  is  where  it  considers  effects  other  than  toxic  effects  on  humans  and  the 
environment (such as ozone depletion, climate change, eutrophication and acidification etc.). The BREF does 
set out assessing toxic effects, but the methodology is based on toxicity factors that have been derived from a 
number of air pollutants for human health and the derivation of PNECs (based on the TGD for new and existing 
substances). For assessing the risks of the Annex XIV substance and alternative substances the guidance within 
REACH, i.e. Guidance on information requirements and CSA should be used where relevant.  

The BREF guidelines are summarised below: 

Guideline 1 -  Scope and identify the alternative options: the initial step in the process is to scope and identify 
the alternative options that are available and that could be implemented. The boundaries of the 
assessment need to be set at this stage, with the normal expectation being that the assessment 
will be restricted to the boundary of the IPPC process. 

If at this stage there is sufficient justification to come to a conclusion, the user should stop and 
set out the justification for the decision. 

Guideline 2 -  Inventory of emissions: this step requires the user to establish an inventory of emissions for each 

of the alternative options under consideration.  

If at this stage there is sufficient justification to come to a conclusion, the user should stop and 
set out the justification for the decision. 

Guideline 3 -  Calculate the cross-media effects: this step allows the user to express the potential environmental 
effects anticipated from each of the pollutants within seven environmental themes (e.g. human 
toxicity, global warming, aquatic toxicity, etc.). This is so that a wide range of pollutants can 
either be compared directly or aggregated and expressed as a total effect. 

Two approaches are described which allow the mass emissions of an individual pollutant to be 
expressed  as  an  equivalent  effect  (e.g.  the  Global  Warming  Potential  of  a  wide  range  of 
greenhouse gases can be expressed as kg of CO2 equivalents). These allow individual pollutants 
to be summed and expressed as a total potential effect within each of the seven environmental 
themes2. The user may then be able to compare the alternatives to estimate which option has the 
lowest potential effect in each theme. 

If at this stage there is sufficient justification to come to a conclusion, the user should stop and 
set out the justification for the decision. 

Guideline 4 -  Interpret the cross-media effects: this final step in the cross-media guidelines discusses how the 
user can interpret which of the alternative options offers the highest level of protection for the 
environment. Different approaches for comparing the result of  the cross-media assessment are 
discussed. 

The degree of uncertainty in the basic data collected for Guidelines 1 and 2 is relatively low compared to the 
uncertainty after subsequent manipulation when guidelines 3 and 4 are applied. 

1 European Commission (July 2006) Integrated Pollution Prevention and Control Reference Document on Economics and Cross-Media 
Effects 
2 Environmental themes/cross media effects are: human toxicity, global warming, aquatic toxicity, acidification, eutrophication, ozone 
depletion and photochemical ozone creation. 

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3.7.5.  Uncertainties in evaluating risks 

The  uncertainties  in  determining  chemical  safety  are  set  out  in  the  Guidance  on  information 
requirements and CSA. However, that guidance does not consider the uncertainties associated with 
determining  risks  that  are  wider  than  toxicity  or  physico/chemical  effects  when  considering 
substances and in particular technical alternatives. 

The quality of the data that is used to assess the risks of alternatives is important. This is because a 
decision on the relative risks of the alternative (i.e. as compared to the Annex XIV substance) may 
be based on these data. The applicant may need to evaluate the quality of the data available and to 
compare data from different sources where necessary. There may be quantitative measures available 
regarding the uncertainty that can be attributed to data. For example, reported output of emissions 
may be measured or estimated based on a range (e.g. ± 5 %). Using such data it may be possible to 
consider the upper and lower ranges to allow a sensitivity analysis. 

It may also be possible to give a qualitative indication of the data reliability using a rating score. This 
may help to give a guide to the confidence the applicant has in the data and may help to indicate the 
depth of a sensitivity analysis. See the Guidance on information requirements and CSA for further 
guidance on evaluating data quality and reliability.  

It is important that data of ‘inferior’ quality are not suppressed nor excluded from the assessment by 
considering only data of highest quality. Otherwise, if less reliable data are excluded, then applying 
the methodology might become a barrier to considering alternatives. New and innovative alternative 
techniques  will  often  not  have  as  much  data  available  as  established  techniques.  If  only  data  of 
inferior quality are available, then conclusions should be drawn cautiously. However, conclusions 
can still be drawn and can form the basis for further discussion or to identify where more reliable data 
needs to be obtained. 

Uncertainties will apply to the risk assessments for the Annex XIV substance and to the alternatives, 
but may not apply equally. This needs to be considered in drawing the conclusions. 

3.8.  How to determine the economic feasibility of alternatives 

The economic feasibility of an alternative is to be addressed within the analysis of alternatives and is 
focused on the economic viability of the use of the alternative in the uses applied for. It focuses on 
the changes in applicant's costs and revenues including possible pass-through of cost to customers if 
he was to transfer to an alternative substance or technique. The assessment will not regard the wider 
impact on society or the wider economy.  

The assessment may consider the economic impacts of the transferral to an alternative and the use of 
an alternative within the supply chain. The assessment may include: 

•  The investment and recurrent costs of the alternative substance or technology including how 

they may change over time. 

•  Other  costs  of  transferral  to  the  alternative  –  including  equipment,  training,  energy  use, 
regulatory costs, potential down-time and handling to the extent these are not covered under 
recurrent costs. 

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•  The cost of R&D – including trials30. 

•  The time spent and other costs by downstream users in re-specifying alternative products. 

•  Potential  market  distortions:  For  example  if  an  alternative  is  produced  by  only  a  single 
company  (monopoly)  or  a  very  limited  number  of  companies  (oligopoly).  However,  one 
should note that if a producer of an alternative  would abuse its dominant  market  position, 
competition authorities of Member States should be notified. 

One criterion for an alternative to be economically feasible is whether the net present value of the 
revenues minus costs is positive. In other words, the issue is that using the alternative should result 
in generating gross profit. 

Box 9. Economic feasibility: links to socio-economic analysis 

While the assessment of economic feasibility focuses on the economic viability of the possible alternative for 
the applicant; SEA addresses the wider social and economic benefits of the continued use of the Annex XIV 
substance  (granted  authorisation)  and  compares  this  to  possible  the  social  and  economic  impacts  of  the 
withdrawal of the Annex XIV substance from the market (refused authorisation).  

Applications  for  authorisation  for  Annex  XIV  substances  that  cannot  be  adequately  controlled  can  only  be 
granted if it is shown that the socio-economic benefits outweigh the risks to human health and the environment 
and  there  are  no  suitable  alternatives  to  the  Annex  XIV  substance.  The  way  to  assess  the  socio-economic 
benefits is by conducting a socio-economic analysis (SEA) and guidance on how to conduct and document an 
SEA  supporting  an  authorisation  application  is  in  a  separate  Guidance  on  Socio-Economic  Analysis  – 
Authorisation. The entry point to the SEA is that the analysis of alternatives has concluded that there are no 
suitable alternatives. (SEA may also be used to support authorisation application for Annex XIV substances 
which can be adequately controlled.) 

Some of the same techniques that are used and explained in the guidance for SEA may be used in the assessment 
of economic feasibility and where relevant reference is made to the separate  Guidance on Socio-Economic 
Analysis – Authorisation, including: 

 - Consistency in cost analysis; 

 - Discounting;  

 - Relevant product/substance life-times 

These techniques are set out and explained in the technical guidance for SEA because that guidance includes 
the consideration of economic methodologies and is a good reference if the applicant chooses to use and apply 
such techniques to his assessment of economic feasibility. Since applications under the SEA route will have to 
include documentation of an SEA, the applicant will need to refer to that guidance in this case anyway.  

The basis of determining the economic feasibility of alternatives can be called a cost analysis. This 
identifies  the  costs  associated  with  the  Annex  XIV  substance  and  compares  this  to  possible 
alternatives,  calculating  the  comparative  costs  between  them.  The  analysis  should  also  include 
possible changes in revenues due to substitution. Such revenues would be deducted from the costs.  

30   This should be documented along other aspects of R&D, see section 3.9 on research and development. 

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The  costs  and  revenues  identified  should  reflect  only  the  uses  applied  for  and  take  account  of 
economic consequences of any related changes in the production volume. It is recommended that, as 
a minimum, the cost analysis identifies and compares the direct and indirect costs and revenues of 
the use of the Annex XIV substance and the use of alternative(s). Data may also be collected on future 
liability costs31 and indirect benefits32 that occur due to the transferral to an alternative. 

Appendix  I  of  the  Guidance  on  Socio-Economic  Analysis  –  Authorisation  provides  practical 
information  and  further  guidance  on  how  to  estimate  economic  feasibility  in  the  analysis  of 
alternatives. The appendix builds on this section as well as Chapters 3.4 (Economic impacts), to some 
extent 3.5 (Social impacts) and Appendices B, C, D, E and F of the Guidance on Socio-Economic 
Analysis - Authorisation. 

The process can be summarised as: 

•  Categorise and determine the costs and revenues that are incurred by producing or using the 

Annex XIV substance and the alternative(s). 

• 

Identify possible liability issues and less-tangible benefits that can result from the transferral 
to the alternative. 

•  Perform a comparative cost analysis of current use of the Annex XIV substance versus the 

alternative/s. 

A stepwise process for considerations in determining economic feasibility is set out below33: 

1)  Determine the data requirements for the cost analysis, including data showing if the revenues 
of the applicant would be affected as a result of producing or using the alternative substance 
or technology.  It is advisable that these data are collected  at  the same time as data on the 
technical feasibility of alternatives (see section 3.5.2). Data should be collected on a "per unit 
production basis", or some other basis that allows a comparative evaluation of the trade-off 
issues (for example human health and environmental risks and energy use). Obtain these data 
and  additional  relevant  cost-related  data  for  example  on  energy  use,  risk  management 
measures,  regulatory  status,  process  safety  and  market  information.  Determine  whether 
resource consumption rates, waste generation rates, and worker activities data for the Annex 
XIV  substance  and  alternatives  are  consistent.  If  the  data  are  not  consistent,  it  may  be 
necessary to have knowledgeable industry personnel review and resolve any inconsistencies34. 

31   It can be difficult to quantify costs that are incurred as a consequence of uncertain future liability for clean-up of 
hazardous substance releases or for liabilities from personal injury claims stemming from environmental releases or 
product use. 

32   These are benefits that may occur but cannot be readily quantified (e.g. reduced health maintenance costs because of 

a safer work environment, or increased product sales as a result of better product performance). 

33   Based on US Environmental Protection Agency: Cleaner Technologies Substitutes Assessment - Office of Pollution 

Prevention and Toxics Washington, DC 20460 EPA Grant X821-543 

34   To ensure that the cost analyses for alternatives are comparable, these data should be used in actual cost calculations 
only if the data are available for all of the alternatives being evaluated. There may not be sufficient data contain on 
new or novel alternatives that are not widely used. 

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2)  Estimate the direct costs associated with the operation of the Annex XIV substance and the 
alternatives  using  the  data  gathered  in  and  checked  in  Step  1.  Direct  costs  include  capital 
expenditure,  operating  costs,  and  maintenance  costs.  Waste  management  costs  are  also 
examples of direct costs (but many businesses allocate these costs to overhead). The costs 
relating  to  the  application  procedure  (fees,  personal  costs  for  drafting  and  updating 
authorization dossier) should also be included. Estimate the revenues from the sales of the 
Annex XIV substance (or the product  using the substance) as well as the revenues for the 
alternative. 

3)  Estimate possible indirect costs, indirect benefits and possible liability issues for the Annex 

XIV substance and alternatives:  

a.  If there is a reasonable indication of possible liability in connection with the use of the 
Annex XIV substance or the alternatives, this should be considered. In most instances, 
the  estimation  of  future  liability  cost  is  subject  to  a  high  degree  of  uncertainty. 
Therefore, the need to quantify the future liability may be less important than assessing 
how likely it is that the risk of liability could materialise in future. 

b.  If possible, identify any less-tangible benefits that could result from the transferral to 
an  alternative.  The  benefits  of  a  cleaner  product,  process,  or  technology  can  be 
substantial and should not be overlooked when performing a cost analysis. 

4)  Perform cost analysis of the Annex XIV substance and alternative(s) using the data on costs 
and revenues collected in Step 1 and possibly in Step 3. (Further guidance on how to ensure 
the consistency of the cost analysis can be found in Appendix I and Chapter 3 of the Guidance 
on  Socio-Economic  Analysis  –  Authorisation.  This  provides  guidance  on  dealing  with; 
exchange rates, inflation, double counting and discounting. These are crucial aspects to any 
robust cost analysis.)  

The above points present a generic approach for considerations to assess the economic feasibility 
of alternatives. In addition, it may be possible to support the cost analysis using financial ratios 
that may be available as these are the figures that are routinely reported for financial performance 
of companies (such as for reporting to shareholders or for internal financial reporting). However, 
in many cases these financial ratios are company wide figures rather than product specific, and 
furthermore,  such  figures  are  not  available  for  the  future.  Therefore  their  use  is  likely  to  be 
limited. (Possible financial ratios which can be used for assessing economic feasibility are set out 
in chapter 3 of the Guidance on Socio-Economic Analysis – Authorisation.) 

Apart from analysing if the net present value of the revenues minus costs is positive applicants 
may use other methods to document whether an alternative is economically feasible for them, but 
it is recommended that any such explanation is sufficiently detailed, particularly if the applicant 
concludes that the alternative is not economically feasible for them. A simple conclusion that the 
alternative  is  not  economically  feasible  for  the  applicant  that  is  not  supported  by  sufficient 
justification could be considered insufficient by the Agency, particularly if other applicants have 
identified that alternative as being suitable for them. 

The example presented in Box 10 illustrates simple supporting arguments for non-feasibility of 
an alternative on an economic basis (based on the example above). Note that these are descriptive 
examples and use in  an application would have to  be supported by evidence (i.e. data) and/or 
references. 

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Box 10. Simple example of supporting information  

If the alternative had a negative NPV it could be argued that the alternative was not economically feasible. This 
may be based on the assumption that the price of the product is unchanged. A qualitative assessment of the 
market  provides  some  supporting  evidence  for  this  assumption  that  the  price  will  not  increase  (although 
references and data where possible should be used for an actual authorisation application).  

Current market synopsis of the applicant’s product: 

• 

• 

The market for the product produced with the use of Annex XIV substance is price driven by a highly 
competitive  international  market  (i.e.  the  use  can  take  place  either  within  or  outside  EU  where  no 
authorisation  is  needed).  There  are  approximately  60  producing  companies,  with  no  single  producer 
having a dominant share of the market. Any increase in the price of the product will mean a substantial 
loss  in  demand  for  the  applicant’s  product.  This  is  because  the  costs  of  transporting  rival  imported 
products accounts for only a very small fraction of the product price. The threat of imports and competition 
from rival products ensures the applicant product price does not increase (in order to some on pass on 
some of the capital costs required to use the alternative) with the overall price remaining sufficiently low 
to make competing products less attractive than the applicant’s product.  

Due  to  low  product  prices  combined  with  low  entry  costs  for  new  entrants  to  the  market,  current 
profitability is kept low by market forces. If sufficient profits were made in the industry then new entrants 
would have the incentive to enter the market (i.e. enter the market with a lower price to gain market share 
at the cost of a small reduction in profitability). Therefore if it is not possible to pass on some of the capital 
costs of the alternative, it is not economically feasible to invest and raise the capital required to use the 
alternative, even though there will be some savings in operating costs.  

The qualitative analysis above only considers the implications of using the alternative to the applicant. Impacts 
such as unemployment and health benefits are not included because they are not part of the economic feasibility 
analysis. Guidance on Socio-Economic Analysis – Authorisation is provided in separate document and chapter 
3 of that guidance provides further details on how to analyse the market for a substance. 

3.8.1.  Uncertainties in determining economic feasibility 

The evaluation of economic feasibility may be based on the average cost of a substitute at a "typical" 
or "model" facility. Neither the cost analysis nor the assessment of technical performance are intended 
to give absolute cost or performance information, but they may result in comparative information on 
the relative cost or performance of the Annex XIV substance and alternatives. This analysis together 
with  the information  on  the impact  of the substitution costs on the operating margin and on their 
possible  pass  over  of  the  costs,  would  give  the  basis  upon  which  the  applicant  can  demonstrate 
whether an alternative is economically feasible for him. However, the uncertainties in the assessment 
of economic feasibility should be clearly stated in the documentation of the analysis of alternatives. 
Chapter 4 of the Guidance on Socio-Economic Analysis – Authorisation can be used for guidance on 
how  to  carry  out  uncertainty  analysis  and  Appendix  F  of  the  SEA  guidance  contains  several 
uncertainty techniques which may be relevant  when determining  if an alternative is  economically 
feasible.  

3.9.  Research and development that is relevant and appropriate 

Article 62(4)(e) states that the application shall include: an analysis of the alternatives considering 
their risks and the technical and economic feasibility of substitution and including, if appropriate, 
information about any relevant research and development activities by the applicant; 

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This means that the applicant should document in the analysis of alternatives of his application any 
relevant  information  on  research  and  development  that  is  considered  appropriate  for  the 
understanding  of the  Agency  and the Commission of the present  or future availability of suitable 
alternatives  to  the  Annex  XIV  substance.  Although  not  mandatory,  it  is  noted  that  it  is  strongly 
advisable to provide this information if available, in order to strengthen his analysis of alternatives, 
particularly when it is concluded that there are no suitable alternatives available. Also, the applicant 
may plan to initiate new R&D and may decide to document this in the application. These plans will 
play a critical role in fixing the review period. This may be appropriate when no suitable alternatives 
have been identified. The Commission, when deciding on the duration of the time-limited review, 
would take this information into account. 

In case the applicant concludes that suitable alternatives are available in general, but the substitution 
by the applicant depends on the results of ongoing research, development or testing, the commitment 
to  undertake  the  necessary  actions  in  terms  of  R&D  activities  and  the  related  timeline  should  be 
described in  the substitution plan, alongside the uncertainties associated to it and the contingency 
measures to address them. 

This  section  addresses  the  consideration  of  R&D  in  the  analysis  of  alternatives,  it  includes 
consideration of: 

•  Under  what  circumstances  it  would  be  appropriate  to  report  (document)  R&D  that  the 

applicant considers to be relevant to the analysis of alternatives; 

o  Examples of relevant types of R&D and what they may involve;  

o  The costs of R&D; and 

•  Documenting R&D in the application (see also section 3.12). 

3.9.1.  Circumstances that might prompt the inclusion of R&D in the analysis of alternatives 

The  applicant  should  consider  that  past,  current  (on-going)  or  planned  research  and  development 
activities are appropriate for inclusion in the analysis of alternatives for example in the following 
situations:  

•  The results of past or current R&D activities can be used to support the documentation that 
sufficient  analysis  of  identified  possible  alternatives  has  been  made.  This  is  particularly 
relevant  when suitable alternatives have not been identified or have been identified on the 
market but are not available for the applicant for an immediate substitution.  

•  R&D  related  to  generating  information  on  risks,  economic  or  technical  feasibility  of  the 
identified  possible  alternatives,  in  order  to  support  the  arguments  made  in  the  analysis  of 
alternatives. 

•  When R&D is needed because transferring to the alternative would require major changes in 
the production processes or in the supply chain; or because the transfer include fulfilling legal 
product safety or other requirements that may take many years. This may include test trials 
by the applicant, his suppliers or downstream users, that are necessary to ensure functioning 
and acceptability of the alternative. 

•  The lack of any possible alternatives may prompt the initiation of R&D on novel substances 
and/or techniques. Although there is no obligation for the applicant to initiate such research 

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and development, it may be very valuable to show such research has, is being, or is planned 
to be conducted to support the analysis of alternatives.  

In summary, as mentioned above, information from any relevant research and development activities 
by the applicant should be considered appropriate to include in the analysis of alternatives or in the 
substitution plan, whenever this information can be used to increase the understanding of the Agency 
and the Commission regarding the reasons for present alternatives being non-suitable and prospects 
for future availability of suitable alternatives in the uses applied for. The information on research and 
development will also be taken into account by the Commission when deciding on the duration of the 
time limited review period. 

Below some examples are given showing different reasons for presenting R&D on the basis of past, 
current and future activities: 

•  Past R&D may be demonstrating why a certain alternative is not technically feasible, or that 
processes are unable to be adapted to accommodate an alternative. This R&D may take the 
form  of test  trails  for example. Test  trials  may also  be  related to  the manufacturing of the 
alternative.  For  example,  where  the  R&D  has  focused  on  the  possibility  to  achieve  the 
required purity of an alternative substance. Test trials with end products may have focused on 
the  quality  of  the  end  product  manufactured  using  the  alternative.  (For  example,  in  the 
production of paper, by investigating the possibility of coating drying cylinders without using 
the Annex XIV substance or with  an  alternative  and testing  the quality  of paper produced 
against  customer  quality  requirements.)  Past  R&D  may  also  demonstrate  that  possible 
alternatives are not technically feasible on the basis that they have not been demonstrated to 
meet legal standards for product safety. 

•  Ongoing R&D may be able to show that there are efforts being made to search for alternatives, 
or  that  currently  technically  unfeasible  or  unavailable  alternatives  are  being  subject  to 
research on what would be required to make them feasible. For example, what needs to be 
done  to  make  an  alternative  available  and/or  feasible?  This  may  relate  to  sourcing  or 
production of the alternative or industry and legal requirements that must be satisfied before 
products can be accepted. This R&D may have addressed what testing must be done and what 
criteria need to be satisfied before an alternative can be used for a particular function. It should 
also clearly set out the timing for such product testing and research. In some industry sectors 
the timing for such product safety development and testing can take many years. 

•  Future (planned) R&D will have a similar role to ongoing R&D and may be able to show a 
planned commitment to continued investigation of alternatives that have been shown to be 
currently not technically feasible and investigating what will be needed to make them suitable. 
R&D could also focus on the continued search for replacements for the Annex XIV substance 
such as molecular or product design. It may address known, possible or anticipated changes 
in  product  design  and  consumer  need.  For  example,  there  could  be  indications  of  further 
technological changes that reduce the need for the Annex XIV substance or will make use of 
the substance redundancy due to trends in industry design or new technology in the longer 
term. 

The  applicant  may  also  identify  research  and  development  undertaken  by  suppliers,  industry, 
regulators,  universities,  research  institutes  and  others  by  using  in-house  information,  publicly 
available information and/or by communicating within and outside the supply chain.  

The costs of R&D can be considerable and vary widely from sector to sector. Expenditure on R&D 
may  also  be  the  subject  of  commercial  confidentiality.  However,  the  cost  of  R&D  should  be 

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considered and may help to show, in cases where there are no suitable and available alternatives, a 
commitment to replace the Annex XIV substance when that becomes a possibility. The cost of further 
R&D  needed  should  also  be  considered  within  the  assessment  of  the  economic  feasibility  of  an 
alternative.  

3.9.2.  Documenting R&D in the application  

The applicant may wish to consider supporting an application by including details of: 

•  Results of past relevant research and development activities; 

•  The current status of relevant research and development activities regarding alternative(s) for 

the applicant and for other users; 

•  Planned future relevant research and development for identification of possible alternatives 

to the Annex XIV substance.  

Further recommendations  on what  to consider in documenting  relevant  research and development 
activities is given in section 3.12. 

3.10.  Concluding on the suitability and availability of alternatives 

The  analysis  of  alternatives  is  the  process  of  determining  the  suitability  of  the  alternative  and 
consideration  of  its  availability.  There  are  three  main  aspects  that  the  applicant  should  assess  in 
relation to the suitability of the alternative for each use applied for: 

• 

• 

reduction of overall risks to the environment and to human health (taking into account the 
appropriateness and effectiveness of risk management measures); 

technical feasibility for the applicant (based on the alternative fulfilling the specific function); 
and 

•  economic feasibility for the applicant (based on the assessment of the economic consequences 

of transferral to the alternative). 

The guidance here is intended to show how the applicant can draw together his analysis and conclude 
on the suitability and the availability of alternatives. This process focuses on the three main aspects 
mentioned above. However, it should be borne in mind that according to Article 60(5) not only these 
but  all  relevant  aspects  shall  be  taken  into  account  by  the  Commission  in  assessing  whether  an 
alternative is suitable and available. Consequently, the applicant should include any other relevant 
aspects  in  his  assessment  and,  in  particular,  an  assessment  of  whether  suitable  alternative/s  is/are 
available in the EU.   

The  process  for  the  analysis  of  alternatives  that  may  be  considered  to  be  step-wise,  considering 
different aspects of an alternative’s feasibility, risks and availability separately and bringing these 
together in a final decision. However, in reality although this may be possible, it is more likely that 
all these aspects will be considered simultaneously. Further to this, consultation within and outside 
the  supply  chain  on  alternatives  will  not  be  a  single  process  in  advance  of  selecting  possible 
alternatives for further investigation; but rather it will be iterative, with continued consultation and 
information gathering at each stage of the process. 

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The  alternative  must  represent  a  reduction  in  risk  compared  to  the  Annex  XIV  substance.  The 
alternative  must  also  be  technically  and  economically  feasible.  For  risk,  the  evaluation  is  one  of 
comparing  the  alternative  with  the  Annex  XIV  substance.  In  terms  of  technical  and  economic 
feasibility, the evaluations are whether the alternative is viable for the applicant, including if relevant 
his  downstream  users  in  the  uses  applied  for.  The  applicant  can  refer  to  any  of  these  aspects  or 
combination thereof when demonstrating that an alternative is not suitable. 

The applicant should show and document  analysis of these aspects, but the extent of the different 
parts  of  the  justifications  that  should  be  provided  by  the  applicant  will  depend  on  the  specific 
circumstances of the case. If the applicant concludes that there are no suitable alternatives, then the 
analysis  of  alternatives  should  clearly  document  the  reason  why  no  such  alternatives  exist.  For 
example,  the  applicant  should  document  in  as  much  detail  as  possible  why  identified  alternatives 
resulting  in  an  overall  reduction  of  risks  were  not  technically  or  economically  viable  for  him.  In 
addition, in this case the applicant is encouraged to provide information on planned or ongoing R&D 
activities concerning potential alternative substances or technologies or to describe the commitment 
to undertake the necessary R&D activities towards substitution. 

In these cases it is not necessary to explain in full length the examination of the risks of such potential 
alternatives. 

The level of detail will of course depend on the relative importance of each aspect in determining the 
alternative as not suitable. For example, it may be clear to the applicant that all technically feasible 
alternatives do not represent a reduction in risk as compared to the Annex XIV substance. In this case 
there  would  of  course  be  little  merit  in  detailed  analysis  of  the  economic  feasibility  of  those 
alternatives that are not suitable on the basis of the risks. 

The  focus  of  the  analysis  will  be  the  compilation  of  the  information  from  the  assessments  of  the 
various aspects of the alternatives and weighing them together and considering any possible trade-
offs between them in order to draw a conclusion on the suitability and availability: 

•  Compilation of the results of the assessments of technical feasibility, economic feasibility and 

risk; comparing the Annex XIV substance and the alternatives; 

•  Compilation of information on the uncertainties in the data that should be considered in the 

decision-making process;  

• 

Identification of the possible ‘trade-offs’ between technical feasibility, economic feasibility 
and  risk;  comparing  the  original  substance  and  possible  alternatives.  For  example,  some 
reduction  in  end  product  performance  resulting  from  the  use  of  an  alternative  could  be 
acceptable (subject to, for example, product safety approval) on the basis of the reduction in 
risk and the decreased costs in exposure control; and  

•  Consideration of the availability of suitable alternatives: e.g. whether there is enough of the 

alternative available at a certain point in time and if it is accessible to the applicant. 

Alternative  techniques  can  be  regarded  as  available  when  they  are  developed  enough  to  allow 
implementation  in  the relevant  industrial  sector and they are reasonably  accessible without undue 
delay to the operator. Alternative substances can be regarded as available when they are reasonably 
accessible without undue delay to  the operator in  the required quantity  (i.e. the global production 
capacity should not be severely constrained due to the new demand). To be considered available, both 
techniques and substances have to fulfil the relevant legal requirements (e.g. a substance may need 
to be registered in accordance with REACH before it can be manufactured, imported, placed on the 
market or used; or the change of the substance used in production may require approval under other 

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legislation; a major change to the production facility may require a permit in accordance with the 
IPPC-directive.)  

An important issue in identifying the availability of alternatives is also timing: alternative substances 
may not be available immediately or they may not be available in the required tonnages but could 
become available in the market at some point in the future. To assess this, knowledge of the quantities, 
relevant  markets  and the current  trends  and research within  them would be useful. On alternative 
techniques the same basic consideration applies: is the necessary equipment or technology already 
available in the market in sufficient quantities? The time needed to invest, install and make alternative 
techniques  operational  should  be  considered.  This  applies  also  to  alternative  substances  that  need 
changes in processes or equipment. In both cases fulfilling the legal requirements may require time.  

When assessing the time constrains the applicant will have to consider the sunset date, i.e. the date 
from  which  the  placing  on  the  market  and  the  use  of  the  substance  is  prohibited  unless  an 
authorisation is granted. The sunset date will take into account, where appropriate, the production 
cycle specified for that use (Article 58.1(c)(i)) and will be at least 18 months after the deadline for 
receiving  the  authorisation  applications  (Article  58.1(c)(ii)).  Should  the  substitution  be  possible 
before the sunset date, the alternative will be considered available from this perspective. 

For the reviews of authorisations the holder of an authorisation will have to submit an update of the 
analysis of alternatives taking into account any new possible substitutes. He should verify the grounds 
for concluding on availability (or non-availability) of suitable alternatives referring also to the list of 
recommended  actions  to  make  possible  alternatives  suitable  and  available  (see  section  3.11), 
contained in his original application. It should be noted that under the SEA route authorisations will 
have to be withdrawn when suitable alternatives exist for the holder of the authorisation, having due 
regard to the proportionality principle.  

Box 11 sets out some considerations on suitability and availability of alternatives for different types 
of applicants and for a third party. 

Box 11. Availability of suitable alternatives for different actors 

The consideration of whether an alternative is available will depend upon the perspective of different actors in 
the authorisation process. For example:  

Manufacturer/importer (M/I) as the applicant: The M/I should not  a priori take the view that any alternative 
that is not or cannot be part of his product portfolio is not an alternative that is available to him. He will need 
to consider what alternatives may be suitable on the basis of technical and economic feasibility, considering 
possible alternatives from outside of his portfolio and even from outside of his sector (for example, possible 
alternatives  for  one  or  more  uses  that  he  may  be  applying  for  may  be  a  change  in  process  or  a  technical 
alternative rather than a substance). He may also wish to consider the suitability of the alternative for other 
parts of the supply chain. 

Downstream user (DU) as applicant or contributor to an application: The DU, who is in perhaps the best position 
to understand his use most fully, may not be familiar with the supplier’s portfolio, and be only aware of what 
alternative(s) is(are) technically and economically feasible for his use(s).  

Third party, contributing information on alternatives: The third party may have less resource for investing in 
research to understand all the possible alternatives but may have experience of what may be suitable or available 
for broad uses. Note, however, that third parties could be suppliers of alternatives. In this case they may have 
the full technical knowledge of the alternative. However, they have to submit information on alternatives on 
the  basis  of  ‘broad  information  on  uses’  on  the  Annex  XIV  substance  published  on  the  Agency's  website. 

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Therefore,  the  information  may  not  be  able  to  be  tailored  to  the  specific  uses  that  are  the  subject  of  the 
application. 

If the analysis of alternatives concludes that suitable alternatives are available to the applicant, an 
authorisation cannot be granted in accordance with Article 60(4) (‘socio-economic route’). 

3.11.  Actions needed to make an alternative suitable and available 

If the analysis of alternatives demonstrates that the possible alternatives are currently not available or 
not suitable to the applicant, the applicant should provide the following additional information as part 
of the substitution plan, when the requirement to submit a substitution plan is applicable: 

• 

research and development activities needed, e.g.: 

o  What research and development activities are needed and/or planned to  develop an 
alternative  substance(s)  or  technology(ies),  or  develop  equipment  or  processes 
enabling the use of alternative(s); and 

o  What testing must be done and what criteria need to be satisfied before an alternative 
can be used for a particular function – including clearly setting out the timing for such 
product testing and research. 

The applicant is however expected to include this information in the analysis of alternatives, when 
the substitution plan requirement is not applicable. 

The inclusion of the additional information listed above would support the applicant’s assessment 
that the alternatives are not available for the applied-for uses within the given timetable. It will also 
be  taken  into  account  when  fixing  the  review  period  of  the  authorisation.  The  actions  needed  for 
making a non-suitable and/or non-available alternative into a substitute will most likely have been 
considered  by  the  applicant  in  determining  the  various  parts  of  the  analysis  of  alternatives.  For 
example,  in  the  consideration  of  technical  feasibility  the  applicant  will  have  determined  why  the 
possible alternative is not technically feasible and on what basis. It may be that the alternative is not 
technically feasible because it has not yet satisfied the legal safety or performance criteria that are 
required for the end product. Here the list of actions would include what needs to be done for the 
alternative to be allowed to be used and the timetable necessary for these actions. Furthermore, the 
possible  costs  of  such  actions  may  well  have  been  considered  in  the  assessment  of  the  economic 
feasibility of the alternative, or may be available in an SEA.  

In  the  list  below  some  examples  are  given  of  situations  where  the  applicant  should  include 
information  on  actions  needed  to  make  the  alternative  suitable  and  available  (this  list  is  not 
exhaustive): 

•  The transfer to the alternative requires investments that take considerable time (time needed 
to plan the necessary changes, to purchase the equipment needed, to build any constructions, 
to install, to train the personnel, etc.); 

•  The  transfer  to  an  alternative  substance  requires  regulatory  approval  (e.g.  production  of 
aircraft or medical equipment), or change to an alternative technique requires a review of a 
permit (e.g. under the IPPC Directive); 

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•  The transfer to an alternative requires customer approval (e.g. for use in products that must 
be  tested  for  technical  performance  over  long  time  periods,  or  where  the  transfer  to  an 
alternative up in the supply chain may affect the quality of the end products and testing by 
several downstream user levels is required );  

•  An alternative substance is currently not produced in sufficient quantity; and 

•  Costs  related  to  investment  in  new  equipment/techniques  may  depend  on  other  planned 

investments, age of the current equipment, etc. 

Example  4  illustrates,  for  a  hypothetical  substance  and  situation,  how  the  applicant  identified  the 
actions that may be needed to make a possible alternative suitable and available.  

Example 4. Actions needed to make a possible alternative suitable and available 

Scenario description 

Substance  H  (a  vPvB  substance)  is  an  active  ingredient  in  coatings  that  are  used  to  prevent  corrosion  in 
commercial/industrial  machinery.  The  coatings  are  used  in  production  of  the  machinery  and  also  for 
professional  maintenance  and  repair  of  machines.  Substance  H  is  only  used  professionally  by  trained 
technicians and exposure of workers and the environment to substance H is well controlled both during machine 
manufacture  and  repair  and  maintenance.  The  CSR  details  the  operational  conditions  and  risk  reduction 
measures in place. The applicant is the downstream user of the substance. 

There are very prescriptive legal safety requirements that mean that any change in manufacture, maintenance 
or repair of the machines is subject to considerable safety criteria and legal requirements. Addressing the safety 
criteria and legal requirements takes a minimum of five years.  

The machines have a long service life (30+ years, if well maintained). The continued use of the Annex XIV 
substance  is  required  to  maintain  and  repair  machines  during  their  service  life.  As  there  is  no  available 
alternative that is technically feasible, a refused application would mean that machines would be manufactured 
outside the EU and existing machines could not be repaired and maintained and therefore would not be available 
for use. 

Alternative that is not technically feasible for the applicant 

There is a possible substance alternative that may be used to replace the function of the Annex XIV substance. 
However this alternative has  not been subject to any safety testing, so it is not yet  shown to be  technically 
feasible or available for the applicant (or anyone) to use for the desired function.  

The identification of actions needed to transfer from the Annex XIV substance to the possible substance 
alternative 

This includes what testing has currently been done on product safety and what further work is required for it to 
satisfy product safety legislation (noting that the alternative may fail to fulfil the product safety requirements). 
It also includes a description of the time required for product safety testing. To document this, the applicant 
sets out (in the analysis of alternatives report in the application): 

- The safety requirements that must be met; 

- What product safety testing has been done and what the results were for the possible alternative; 

- What further testing needs to be completed for the legal requirements to be met; and 

- The time-line for the completion of the testing programme for the possible alternative.  

The task here is bringing together all the aspects of the alternative that lead to it being concluded as 
not suitable and not available and assessing what would have to be done to make it a suitable and 

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available substitute. The applicant will have concluded that these actions are not currently possible 
for him, otherwise he would not have concluded that there are no suitable and available alternatives. 
Therefore, for each aspect of the evaluation of alternatives (i.e. technical and economic feasibility, 
reduction  in  risk  and  availability  of  the  alternatives)  the  applicant  can  consider  the  actions  and 
timescale  required  to  make  the  alternative  suitable  and  available.  Table  8  illustrates  hypothetical 
examples of how the information may be summarised. 

Table 8. Hypothetical examples of summaries of actions needed to address the suitability and 
availability of possible alternatives  

Aspect of 
analysis 

Outcome of analysis of 
alternatives 

Technical 
feasibility 

Not  feasible  on  the  basis  that 
the 
the 
required  purity  of 
substance cannot be achieved 
(see:  ref  to  reported  R&D  and 
assessment 
technical 
feasibility). 

of 

Economic 
feasibility 

feasible 

Not 
because 
introduction  of  the  technical 
alternative would mean that no 
currently used equipment could 
be  used  (i.e.  this  would  mean 
that  the  current  assets  would 
be  zero  as  sale  value  of 
equipment  would  be  very 
limited). 
replacement 
would  mean  re-housing  and 
relocation  of  all  users.  The 
investment 
in  capital  and 
operational costs are too large 
to be borne by any users. This 
prevents the possibility of costs 

The 

Action to address suitability/availability 

R&D is addressing the possible methods that may be able to provide 
the required purity (99.9%) at the volumes needed. These include: 

• 

• 

• 

‘Method 1’ 

‘Method 2’ 

‘Method 3’ 

The method that indicates that the required purity can be achieved will 
be subject to R&D to investigate the possibility to scale the production 
to  deliver  the  required  volume.  Actions  required  with  indicative 
timescales are: 

•  Completion of lab scale R&D to determine which method can 

be used to deliver the required purity: x to y months.  

•  Confirmation of lab scale results on purity: x to y months.  

•  Planning of pilot plant for initial production: x to y months. 

•  Pilot scale production on-line and conformation of purity: x to 

y months. 

•  Product testing and customer approval: x to y months. 

•  Commercial  scale  production  initiation  to  x%  of  required 

tonnage: x to y months. 

•  Scale up to full commercial production: x to y months.  

Total timescale required x to y months/years.  

Details of the proposed R&D programme are at (ref).  

The capital and operational costs could only be overcome by very large 
financial investment in the industry, which is currently not possible (as 
essentially this would mean firms changing the business they are in). 
This would require considerable financial assistance for phase out of 
the Annex XIV substance and phase in of the alternative over at least 
an x year period.  

Actions required (with indicative timescales) to overcome the financial 
barriers to substitution for each of estimated 200 users are: 

• 

Identify  possibilities  for  re-housing/relocation  possibilities 
required to house and operate new equipment (approx. cost 
to  each  user  firm  depending  on  location  €  x  to  y):  Possible 
timescale: x to y months. 

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is 

onto 

barrier 

passed 

because 

the 
being 
the 
customer, 
the 
economic 
investment 
to 
accommodate  the  alternative. 
Phase  out/phase 
is  not 
possible as the systems are so 
different 
economic 
(see 
feasibility analysis - ref)  

costs 

in 

to 

Risks 
human 
health 
the 
environment 

and 

and 

health 

for  which 

The  alternative  has  not  been 
demonstrated  to  represent  an 
overall  reduction  in  the  risk  to 
human 
the 
environment  as  compared  to 
the Annex XIV substance. This 
is  because  the  alternative  is  a 
nanoparticle 
the 
possible risks to human health 
and  the  environment  have  not 
yet  been 
fully  understood. 
There  is  evidence  to  suggest 
that release to the environment 
and exposure to workers could 
the 
cause 
control of risks is still uncertain 
since  the  hazards  are  not  well 
understood and the operational 
conditions  and  risk  reduction 
yet 
are 
measures 
developed  (see  consideration 
of risks of the alternative - ref) 

risks.  However, 

not 

• 

Investment  in  new  equipment  required  to  accommodate 
alternative (approx. cost to each user firm € x) – action to find 
funds or investor: Possible timescale: x to y months. 

•  Set  up  and  testing  of  equipment  and  facility  (including, 
relocation,  recruitment, 
training/retraining,  detailing  and 
documentation  of  new  operating  procedures,  health  and 
safety  and  other  legal  requirements).  Approx.  cost  to  each 
user firm  depending on location € x to y). Timescale: x to y 
months. 

•  Customer  approval  for  use  of  alternative,  including  product 
testing. Approx. cost to each user firm € x. Timescale: x to y 
months. 

Estimated cost per user facility ranges from € x to y M per user firm 
(total estimated cost (i.e. for 200 firms) ranges from € x to y billion).  

Estimated timescale ranges from x to y years for each user. 

(Details  of  the  financial  analysis  are  presented  in  the  analysis  of 
alternatives under the assessment of economic feasibility) 

Understanding  of  the  hazards  and  exposure  presented  by  the 
alternative  is  required  before  appropriate  control  measures  can  be 
developed  to  ensure  that  the  possible  risks  from  the  alternative  are 
adequately  controlled.  This  is  possible  but  is  dependent  on  further 
research  and  development  of  appropriate  tests  to  determine  the 
hazards of  such materials and development of appropriate exposure 
control measures. 

Actions  required  to  determine  the  human  health  and  environmental 
safety of the alternative are: 

•  Completing  of  documentation  of  the  test  methodologies  for 
determining the environmental hazard of nanoparticles. This 
is being completed by an international initiative. Timescale for 
completion of ring-test for aquatic toxicity testing: x year/s.  

•  Publishing of test guidelines that can be used by industry: x 

years.  

•  Development  of 

test  programme 

to  determine 

the 

environmental (aquatic toxicity) hazard – x year/s. 

•  Completion  of  test  programme  for  human  health  hazard:  x 

year/s*. 

•  Development  of  risk  reduction  measures  for  the  effective 

control of emissions to the environment: x years 

•  Development of occupational control measures for workplace 

exposure: x year/s*. 

 (*Human health testing programme and development of controls could 
be  planned  and  conducted  at  the  same  time  as  the  environmental 
testing.) 

Total time required to be able to assess the risks and develop effective 
control measures – x years. 

Note: Entries in the table are summaries for different hypothetical alternatives and situations. Each aspect is considered individually. 
However, the total actions and time required to make a possible alternative suitable and available should include consideration of all the 
aspects that have been identified leading to the conclusion that the alternative is not suitable or available. Some actions may be 
conducted at the same time. 

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3.12.  Considerations for documenting the analysis of alternatives 

REACH  does  not  specifically  describe  the  minimum  documentation  required  for  the  analysis  of 
alternatives. However, Article 62(4)(e) sets out the information on alternatives that shall be part of 
the analysis. This includes consideration of the risks of alternatives and the technical and economic 
feasibility of substitution and, if appropriate, information on any relevant research and development 
activities by the applicant. Furthermore, the applicant should note that according to Article 60(5) the 
Agency's opinions and the Commission’s assessment of the application with regard to the suitability 
and availability of alternatives is not limited to reduction in overall risks or technical and economic 
feasibility of the alternative, but will take all relevant aspects into account. This could for example 
include information on alternatives from interested third parties. Therefore, in order to demonstrate 
that adequate steps have been taken to identify possible alternatives or to demonstrate whether or not 
possible alternatives are suitable and available the applicant would be well advised to document a 
comprehensive analysis of all possible alternatives and take all relevant aspects into account. 

It is important that the documentation is clear and transparent. This means that for each part of the 
analysis the applicant should try to present the information in a logical way that describes how they 
came to their conclusion on each aspect of the analysis. It should present the information used to 
come  to  decisions,  including  data/information  gaps  and  assumptions  made,  as  well  as  provide 
explanations and justifications for the conclusion made addressing the uncertainties, and reference 
the  material  that  has  been  used.  In  this  way  the  Agency  can  see  what  is  being  presented,  what 
assumptions have been made, what conclusions are drawn and how those conclusions were drawn. 

Information  on appropriate research and development  activities could  be included under the most 
relevant heading for each separate case. For example it could be addressed under section 2 on the 
analysis  of  substance  function  or  under  section  4.1  on  the  assessment  of  technical  feasibility  of 
alternatives.  The  applicant  may  also  consider  adding  a  separate  heading  for  research  and 
development, e.g. under section 4 on the assessment of suitability and availability. 

The guidance below is intended to be an indication of what could be documented for each aspect of 
the analysis of alternatives following the structure of the analysis of alternatives format published on 
the Agency’s website. Under these headings the applicant should document the results of his analysis 
for each use applied for (noting that he may indicate which data he regards as confidential).  

Summary of the analysis of alternatives 

This section could present a summary of the findings and conclusions of the analysis regarding the 
identification of possible alternatives and the suitability and availability of alternatives for each use 
applied for. Furthermore, any findings on actions needed to make possible alternatives suitable and 
available and the timescales for these actions should also be included. 

Introduction 

The applicant could use this introduction to describe any appropriate background information for the 
analysis of alternatives. 

Analysis of substance function 

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Detailed information should be presented on the precise functions or tasks performed by the Annex 
XIV substance for each of the uses applied for. This should also include a description and outcome 
of  the  process  where  the  use  is  applied  and  under  what  process  conditions  the  function  must  be 
performed.  Examples  of  functional  requirements  to  take  into  consideration  may  include:  critical 
substance  properties  related  to  the  desired  equivalent  function,  quality  criteria,  process  and 
performance constraints, customer requirements or legal requirements for technical acceptability.  

For all functions the applicant may wish to report any obstacles or difficulties identified or expected 
in relation to finding possible alternatives and their consideration as substitutes.  

Identification of possible alternatives 

The possible alternatives identified for each use should be presented and described in detail in this 
section. For substance alternatives this would include the identity and a summary table of relevant 
properties. For technical alternatives a description should be given of the technology to be introduced 
in order to achieve the same function as the Annex XIV substance, or to possibly remove the need 
for the Annex XIV substance function altogether by other changes to the process. 

A  description  of  the  data  searches  and  consultations  that  have  been  made  should  be  included.  In 
particular in cases where no possible alternatives have been identified this documentation needs to 
be  detailed  and  thorough.  In  such  cases  also  including  information  on  research  and  development 
activities supporting the lack of possible alternatives would be appropriate. 

Data searches 

The extent and results of searches for data and information on possible alternatives should be detailed 
and in particular how these were incorporated into the analysis of alternatives. 

Consultation 

The  applicant  may  wish  to  document  consultation  undertaken  during  the  analysis.  Such 
documentation  should  be  transparent  and  auditable.  When  documenting  the  communication  to 
support an application the applicant may wish to include: 

•  Details on which parts of the supply chain have been consulted; 

•  Details on other organisations that have been contacted; 

•  Details on the possible alternatives that have been identified through this process and evidence 

of (non)availability of (suitable) alternatives.  

Technical feasibility 

Technical feasibility is a key aspect for determining the suitability of alternatives. Here the applicant 
needs to present a transparent analysis of technical feasibility of alternatives in terms of the possible 
provision of equivalent function. There may be a number of alternatives for different uses, therefore 
the applicant must clearly document the consideration of the technical feasibility for each use that is 
being applied for and consider each alternative for that use in turn. 

If an approach developing technical feasibility criteria has been taken (see Box 3 section 3.6), the 
applicant should clearly document how the criteria for equivalent function were applied to possible 
alternatives to determine technical feasibility. For example, which data were used (citing the sources) 

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and how they were used including any assumptions made, i.e. what was the process by which criteria 
were developed and applied.  

The  applicant  should  also  document  the  process  changes  required  for  possible  transfer  to  the 
alternative as well as the requirements for equipment, risk management measures, energy, personnel 
changes  and  training  needs  (amongst  others)  and  how  these  affect  the  technical  feasibility  of  the 
alternatives. 

The analysis will be different depending on who the applicant is. For example, the technical feasibility 
of an alternative may depend upon process changes, use of equipment or risk reduction measures that 
are available to the manufacturer but not to downstream users for technical or economic reasons. An 
important consideration will be the uncertainties in data evaluation and how these have been dealt 
with.  The  applicant  should  clearly  indicate  the  effect  that  these  uncertainties  may  have  on  the 
assessment of technical feasibility. 

Reduction in overall risks to human health and the environment 

An important consideration for documenting the assessment of the reduction of overall risks to human 
health  and  the  environment  by  use  of  possible  alternatives  will  be  what  data  have  been  used  to 
compare  the  risks  of  the  Annex  XIV  substance  and  the  alternative.  For  example  as  mentioned  in 
section 3.7, there is likely to be less information available on alternatives than there is for the Annex 
XIV substance (but noting that if the alternative has been registered and a CSR has been carried out, 
there may actually be a similar amount of information on the risks as for the Annex XIV substance). 
Therefore, the documentation will need to set out how the assessments have been conducted, what 
data were used and what assumptions have been made (for example the use of assessment factors for 
hazard data and conservative emissions for exposure scenarios).  

Further to this, how any comparison between risks of different types has been dealt with will need to 
be  described  and  clearly  documented.  For  example  how  have  different  health  effects  or  different 
environmental effects been compared and weighed against each other? For alternative technologies, 
where the risks may be physical such as temperature or vibration, how have these risks been compared 
to toxic risks of the Annex XIV substance? The conclusions drawn on the possible reduction in risk 
to human health and the environment will need to be supported by the data used; highlighting the 
uncertainties within those data and how they have been addressed.  

Economic feasibility 

As with technical feasibility the evaluation of economic feasibility is from the applicant’s perspective. 
It will be important, for each use, to set out how the analysis has been conducted detailing the data 
and  the  methodology  used  for  analysis.  It  will  also  be  important  to  set  out  the  perspective  of  the 
analysis,  as  the  economic  feasibility  of  an  alternative  may  be  different  for  a  downstream  user 
compared to a supplier. For example, a downstream user may be able to easily consider the economic 
feasibility  of  an  alternative  (provided  it  is  technically  feasible  and  reasonably  accessible)  by 
assessment of the direct cost of possible transfer. However, for a supplier this could mean having to 
implement  changes  in  production process  and the loss of customers for the product  related to  the 
Annex XIV substance that cannot switch to the alternative and, as such, the analysis would be more 
complex. The analysis will therefore be different depending on who the applicant is. As such, the 
documentation of the assessment of economic feasibility will need to clearly set out the boundaries 
of the assessment and show the reasoning for the setting of these boundaries. 

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The documentation of the assessment of economic feasibility will need to set out the sources of data 
and importantly the uncertainties in the data sources used and how these have been dealt with (i.e. 
what the assumptions are). 

Research and development activities 

When  documenting  any  relevant  research  and  development  activities,  for  example  the  following 
issues should be considered: 

•  What is the purpose of documenting the R&D?  

o  Demonstrating that a possible alternative is not technically feasible for an applied use. 

o  Demonstrating that the alternative does not satisfy product safety legislation or rules. 

o  Demonstrating research  and development  on novel  substances  and/or techniques to 
show that such research has, is being, or is planned to be conducted to support the 
analysis of alternatives. 

•  Who did/does/will do the R&D, who was/is/will be participating/consulted (e.g., in house, 

trade organisation, commissioned or from literature only)? 

•  What was/is/will be done? 

•  What were the results/findings? 

•  What were the changes implemented and other follow-up actions taken? 

The applicant should note that he may indicate parts of the application that are confidential {Art. 118 
and  119}.  This  may  be  of  importance  with  regard  to  research  and  development  on  possible 
alternatives, but also other confidential information that he considers would have a detrimental effect 
on his business, if they were to be made public (see Box 2). 

Conclusions on suitability and availability of alternatives 

The documentation of the steps taken to identify whether alternatives are suitable and available will 
need  to  set  out  that  a  sufficient  analysis  of  alternatives  has  been  conducted.  Clear  reasoning  and 
transparent documentation will be essential to demonstrate that a proper consideration has been made 
of the technical and economic feasibility, reduction in overall risks and availability of alternatives.  

This  is  especially  important  in  cases  where  the  conclusion  is  that  no  suitable  alternatives  are 
identified. In these cases the applicant should also provide information in the  substitution plan on 
what actions and time scales are needed to make the alternative a suitable replacement for the Annex 
XIV substance in the uses applied for. 

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3.13.  Links to other parts of the application 

3.13.1. Substitution plan 

If an application concludes in the analysis of alternatives that a suitable alternative(s) is available, 
then the applicant must prepare a substitution plan that sets out his commitment to transfer to that 
substitute(s), setting out the timing and other considerations for transferral.  

This section should include a presentation of a list of actions that would be needed in order to make 
the  alternative(s)  technically  and/or  economically  feasible,  and  available  in  the  uses  applied  for, 
including the time frame required for these actions to be implemented as well as potential obstacles 
(see section 3.11 and Table 9). This should apply in particular in cases where the conclusion is that 
no suitable alternative is available for the applicant but there is a suitable alternative available in the 
EU  although  not  yet  ready  for  an  immediate  substitution  (i.e.  within  the  "sunset  date",).  This 
information will be considered for determining the review period of the authorisation decision. 

Guidance for how to produce a substitution plan is set out in Chapter 4 of this guidance. 

3.13.2. A socio-economic analysis (SEA)  

An SEA is required for applications under the SEA route and can also be submitted in the case of 
applications under the adequate control route on a voluntary basis. Guidance for compiling an SEA 
in support of an authorisation application and submission of an SEA or input to one from a third party 
as  part  of  the  authorisation  process  is  set  out  in  the  Guidance  on  Socio-Economic  Analysis  – 
Authorisation. 

A key link between the analysis of alternatives and the SEA will be communication with the supply 
chain on the possible response to an authorisation not being granted. For example, this may lead to 
the use of alternatives that were found to be unsuitable. The SEA may have to consider the socio-
economic impact of such a scenario. Another key area is the comparison of the safety of alternatives 
with the Annex XIV substance (see section 3.7, Box 5). While the analysis of alternatives is focused 
on the Annex XIV substance function and whether this can be replaced or made redundant; the SEA 
may  need  to  consider  a  wider  boundary.  This  may  be  considering  the  consequences  of  use  of  an 
unsuitable alternative or the wider consequences of removal of function in end-products. This would 
usually be beyond the scope of the analysis of alternatives. However, the SEA assessment of health 
and  environmental  impacts  could  be  used  in  the  analysis  of  alternatives  to  assist  in  the  decision 
regarding comparison of risks for substances following the SEA route. 

The applicant is advised to consider what he will need to consider in his SEA at the stage where he 
is gathering and analysing information for the analysis of alternatives. This will help to optimise data 
gathering and help the applicant to have a wider consideration of possible alternatives to the Annex 
XIV substance, especially where there are possibilities to make redundant the use of the substance by 
changes  in  end-product.  Key  phases  of  the  analysis  of  alternatives  where  links  to  the  SEA  are 
particularly important are indicated in the guidance, especially in:  

•  section 3.3 on the focus and scope of the analysis of alternatives;  

•  section 3.5 on how to identify possible alternatives; and  

•  section 3.7 on comparing the risks of the alternative with the Annex XIV substance. 

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3.14.  Presenting the documentation of the analysis of alternatives to the Agency 

Applications should be made via the Agency’s website. Applications can be prepared as indicated in 
the  user  manual(s)  made  available  on  the  ECHA’s  website.  Supporting  documents  such  as  the 
analysis of alternatives and an SEA should be appended to the application. 

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4. 

PLANNING FOR SUBSTITUTION: GUIDANCE ON SUBSTITUTION PLANS 

4.1. 

Introduction 

If the applicant has found a suitable alternative to the Annex XIV substance for use(s),) for which he 
is  applying  for  an  authorisation,  and  which  is  available,  he  must  provide  a  substitution  plan.  A 
substitution plan is a commitment to take the actions needed to substitute the Annex XIV substance 
with a suitable alternative substance or technology within a specified timetable.  

The information contained within a substitution plan will be used by the Agency Committees when 
forming their opinion and by the Commission when considering granting an authorisation and it will 
be  taken  into  account  when  determining  the  duration  of  the  time-limited  review  period  of  an 
authorisation decision35.  

This section of the guidance addresses the preparation of a substitution plan in accordance with {Art. 
62(4)(f)}. It encompasses guidance on the following elements: 

•  Scope and contents of a substitution plan  

•  How to prepare and document a substitution plan:  

o  Identifying the actions required for substitution. 

o  Defining a timetable for those actions. 

o  Documenting the plan for submission with the application. 

Figure  8  illustrates  the  overall  proposed  process  of  developing  a  substitution  plan;  including 
consulting with downstream users/the supply chain, where relevant, to get necessary information and 
to ensure that it is workable; documenting the plan; and submitting it with the application. The figure 
also includes later stages (i.e. post granting of an authorisation) relating to initiating the introduction 
of the substitute and updating the plan as a result of authorisation conditions and for the authorisation 
review process. However, the guidance set out here focuses on the preparation and documentation of 
the substitution plan that is presented as part of the application. 

35   Various other factors are taken into account in determining the duration, as set out in Article 60(8), see Section 1.5.5. 
Note that the holder of an authorisation has to comply with any conditions of the authorisation. This may require him 
to  take  different  actions  than  he  had  presented  in  his  substitution  plan  included  in  the  authorisation  application. 
However, once an authorisation is granted there is no obligation to re-submit an up-date of the substitution plan, until 
the authorisation is due for review. 

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Figure 8. Flow diagram for preparing and implementing a substitution plan 

94 

 Analysis of alternatives (Chapter 3)Suitable alternatives available for each useUse 1Use 2...etc.Substitute for use 1Substitute for use 2Substitute for use 3Customer/supply chain consultationDescription of ActionsDefinethe actions that are required to implement transferral Identification of TimingAssess the timings for each of the actions and the sequence in which they will be addressedAssessing and monitoring the transferralIncluding implementation of any condition in the  Commission decision on the authorisationDocument changes(internally in preparation for authorisation review)Document changes as part of authorisation review processConsider factors affecting transfer (extracted from the Analysis of Alternatives)Factorscouldforexamplebe related to:Availability;Timing considerations of supply;Price and market;Process changes:Training, equipment;Standards and regulations on productsafetySubstitution plan for applicationSocio-Economic Analysis(optional) 
 
 
 
 
Guidance on Authorisation Applications 

4.2. 

Scope and contents of a substitution plan 

A substitution plan can only be developed for those uses for which a suitable alternative is available. 

It should be noted that different alternatives may be suitable for different uses applied for, so a number 
of substitution plans may need to be developed and included in the authorisation application. The 
overall  process  of  preparing  and  submitting  a  substitution  plan  is  expected  to  be  similar  amongst 
different types of applicants (e.g. M/I or DU).  

The key elements of the substitution plan are the list of actions required for transferral to the substitute 
and the timing for those actions. The substitution plan therefore needs to include: 

•  A description of proposed actions and justifications why those actions are required; 

•  Who will conduct the proposed actions; 

•  A timetable for proposed actions that will lead to transferral to the substitute and justification 

why the actions require the time allocated; and   

•  What the uncertainties are in  achieving the actions within the timescale and what possible 

mitigation is to be considered. 

4.3. 

Preparing a substitution plan 

The preparation of the substitution plan involves a number of activities summarised in the bullet list 
given below. It should be noted that the order of the bullets do not imply that they should be carried 
out following that sequence. Especially supply chain consultation will have been an important part 
already  in  the  analysis  of  alternatives  and  will  be  crucial  also  in  detailing  the  actions  for  the 
substitution plan.  

• 

Identifying the factors affecting the transfer to the substitute(s); 

•  Determining the actions required for transferring to the substitute;  

•  Determining what time is needed for each of those actions; 

•  Consultation with the supply chain on actions and timings;  

•  Planning  the  management  of  the  actions  including  consideration  of  uncertainties  and 

mitigation; and  

• 

Identifying how to follow up the progress of the plan.  

Each of these aspects is considered in the sub-sections below. In Appendix 6 a possible check-list for 
a substitution plan is presented. This list is intended to assist the applicant in planning how to develop 
a substitution plan and identifying the essential issues to be considered. 

4.3.1.  Factors affecting the transfer to the substitute(s) 

The main factors that affect the suitability and availability of the alternative will have been addressed 
in the analysis of alternatives. Therefore, the substitution plan should be based on the considerations 
of these factors for the alternative and especially on how these different factors may influence the 
actions needed and the timing for the transfer to the substitute. Some examples are given below: 

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•  Availability (considered in the assessment of availability in the analysis of alternatives): How 
soon can the substitution be made based on current markets? The substitution plan will need 
to take account of the ability of the market to supply the substitute and within which timetable. 
The transferral will be dependent on continuing supply of the substitute. The possibility of the 
substitute being phased in could also be taken into consideration. 

•  Price and the market (considered in the assessment of economic feasibility in the analysis of 
alternatives):  For  example  how  potential  changes  in  the  market  for  the  alternatives  may 
change the availability of the substitute (perhaps not considered in the analysis of alternatives 
in the wider context of the supply chain). This may also have links to a supporting SEA that 
considered  the  wider  impacts  of  transferral  in  terms  of  socio-economic  impact  and  may 
consider more complex analysis of a justification for the timing of transferral. 

•  Process  change  (considered  in  the  assessment  of  technical  feasibility  in  the  analysis  of 
alternatives): Changes in equipment and production processes (including training and health 
and safety considerations) may be required to accommodate the use of the alternative. In some 
cases this may take considerable time and resource. 

•  Process  change  (considered  in  the  assessment  of  technical  feasibility  in  the  analysis  of 
alternatives):  Regulations,  standards  and  customer  requirements  may  require  testing  and 
changing  of  operating  procedures  as  well  as  product  safety  requirements.  These  factors 
require actions that have a considerable influence on the timing of the plan (for example legal 
product safety requirements can often take substantial time to complete). 

The appraisal of these factors will enable actions to be defined on how these factors can be addressed 
so  that  the  substitute  can  be  transferred  to,  in  a  way  that  is  achievable  and  manageable  for  the 
applicant.  This  appraisal  can  then  be  used  for  the  derivation  of  the  justification  required  for  each 
action and/or the time needed for the action in the documentation of the substitution plan.  

4.3.2.  Defining the actions  

The  actions  are  defined  as  individual  tasks  or  sets  of  tasks  that  address  distinct  aspects  of  the 
transferral process. It is recommended that the list of actions should contain the following elements: 

•  A series of actions proposed by the applicant (though not necessarily always for the applicant 

to undertake) to carry out the substitution. 

•  A proposed timescale/date for the completion of each action (see section 4.3.4 below). 

•  A justification statement to present the rationale behind each action/timescale proposed by 

the applicant. 

•  Detail  of  uncertainties  associated  with  actions  and  possible  problems  that  may  affect  the 
actions or the timing of actions. This should include consideration of measures that can be put 
in place to mitigate any problems that may arise.  

•  A process for reviewing progress against the proposed timetable for the actions. This assists 
with  investigating  reasons  for  lack  of  progress  and  with  planning  and  initiating  corrective 
actions when the plan is in progress. 

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4.3.3.  Identifying and setting progress markers 

In case the analysis of alternatives has identified a suitable alternative which is available in general 
but not yet technically and/or economically feasible for the applicant, or an alternative feasible for 
the applicant but not available to him, this section should include a list of actions that would be needed 
in order to make the alternative(s) technically and/or economically feasible in the use(s) applied for 
and/or  available  to  the  applicant,  including  the  time  frame  required  for  these  actions  to  be 
implemented as well as potential obstacles. 

The identification of critical actions or groups of actions that must be completed in order to ensure 
that the substitution can be carried out in practice will facilitate the development of the substitution 
plan and later support its implementation. Progress markers (‘milestones’) essentially represent the 
completion of key stages (e.g. groups of actions) in the plan and allow progress to be measured and 
assessed against the timetable of the substitution plan. It is useful to document these milestones in the 
substitution plan as this will help the Committees in assessing the effectiveness and practicality of 
the substitution plan.  

It is important to bear in mind when setting milestones that, whatever milestones are chosen, they 
must be relevant to the analysis conducted earlier in the development of the substitution plan (i.e. to 
those elements to which the most significant uncertainty or highest level of risk are attached or on 
which the success of the overall substitution plan depends). 

The next stage is determining what review criteria will be used. This can be as simple as assessing 
whether or not  a milestone target  has  been  achieved in  line with  the proposed timetable.  In more 
complex substitutions, a broader set of review criteria may be warranted such as: 

• 

Is the project on target with the proposed timetable?  

•  Are all outstanding actions from the last review complete?  

•  Have all high risks (to the substitution plan) been mitigated? If not how many remain? 

•  Are all interdependencies currently being managed? 

Such criteria as given above are illustrative only and should be set in discussion with supply chain 
stakeholders in the substitution plan. Documenting in the substitution plan how the applicant plans to 
follow up and document the progress against the plan increases the credibility of the plan and will 
facilitate in the update of the plan for the review of the application (if and when appropriate).  

4.3.4.  Defining the timing of the plan 

The timetable for actions can be drafted using a number of methods. At its simplest it could be a short 
list of key actions and associated timescales.  

The key element of the substitution plan timetable is the start and end dates for the identified actions. 
Both are critical and must be made with full and appropriate consideration of the factors affecting the 
transfer to the substitutes and the uncertainties that should be identified in the preparatory work to 
produce the substitution plan. The setting of an end date (i.e. the date at  which completion of the 
substitution plan is made) should be guided by the development of the list or series of actions and 
individual dates for completion of each of these actions. 

For each action that has been identified, it is required that the substitution plan contains a justification 
made by the applicant as to why such an action is required and a justification for the time allowed for 

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it  to  be  implemented.  In  many  cases  this  may  be  obvious  (for  instance,  the  supply  of  sufficient 
quantities of the alternative(s) may take a certain amount of time).  In other cases, the justification 
may be more complex and draw upon information from a wide range of sources. 

When setting the timetable it may be important to consider issues such as (list is not exhaustive): 

•  Periods of stakeholder consultation and/or information dissemination; 

•  Potential  delays  from  other  parties,  particularly  where  information  is  being  supplied  by 

another company or person outside of direct programme/project control; 

•  Customer approval timescales (for example industry standards); and 

•  Other legislation (e.g. that affects the final product). 

4.3.5.  Communication with the supply chain and customers 

In developing a substitution plan, good communication with key stakeholders in the supply chain is 
in many cases important to ensure that the plan will be practical and implementable. Supply chain 
communication will also be important for gathering information to identify the actions needed for 
substitution and timings for those actions and to understand the conditions necessary for these actions 
to succeed.  

It will be important for all relevant parts of the supply chain to be aware of the need to replace the 
substance and input to the development of the plan. An applicant that is a manufacturer of the Annex 
XIV substance may, for example, benefit by taking into account his customers’ or suppliers’ needs 
in developing the substitution plan. 

The  presentation  of  information  on  communication  could  be  used  in  the  justifications  for  actions 
needed, where appropriate, to demonstrate that the substitution plan, and especially the timetable, has 
a practical basis and takes into account implications for the supply chain and end users. It can also be 
used to show how the applicant and downstream users intends to carry out the substitution in the uses 
applied for in accordance with the timetable set out. 

4.4.  Documenting the plan 

The format of the substitution plan is not set out in the REACH Regulation. Due to the nature of the 
substitution  plan  the  structure  must  be  flexible  to  meet  the  requirements  of  the  application.  As 
illustrated in a format published on the Agency’s website, the applicant is prompted by questions to 
set out the detail of each aspect of the plan, so that a full documentation of the plan may be presented 
to  the  Agency/Commission  in  the  authorisation  application36.It  may  be  helpful  to  document  a 
summary of the justification for actions to be taken and the actions themselves in the plan. In many 
cases, a simple table of issues referenced to justification statements may be sufficient to demonstrate 

36  All 

the  elements 

in 
https://echa.europa.eu/documents/10162/13637/sub_plan_template_en.pdf/bbc85402-4610-4102-af74-
4c5b8637ec3f 

the  Substitution  Plan  are 

that  should  be  described 

indicated 

in 

the 

format 

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a  considered  approach  with  suitable  transparency.  In  others,  a  more  complex  approach  may  be 
required. An example is provided in Box 12.  

Box 12. Summarising actions of the substitution plan and their justifications  

Table A. Example of an action list summary table 

Ref. 

Factor affecting 
transferral 

Keep this brief and 
if necessary, refer 
back to other 
documents or parts 
of the substitution 
plan 

A1.1  Sufficient supply 

of alternative 
substance 

A1.2 

A1.3 

Proposed Action 

Resource 

Review 

Timescale 

When proposing actions, focus on 
succinct statements including the 
following: 

Indication of any uncertainty/how 
this will be managed. 

Links to any proposed mitigation 
measures. 

Agree contracts in principle with 
supplier to allow sufficient 
quantities to be developed. Monitor 
progress through regular meetings. 

Who is 
responsible for 
completing the 
action. 

Availability of 
staff resources  

Who is 
responsible for 
reviewing the 
action 

This may be 
a date or a 
timeframe 
(e.g. within 
6 months) 

Suppliers in 
place and staff 
availability for 
undertaking 
work confirmed 

Manager/skilled 
person in place 
to review 
decisions 

12 months 

Table B. Example of an action list justification statement summary table 

Ref. 

Rationale/Justification 

When writing the justification try to consider the following elements: 

Why the action is required? 

What additional information supports the action? 

Are there any constraints relating to the action (e.g. resources). 

The rationale behind setting any dates for completion? 

Additional Reference 

It is important that links 
supporting 
to 
information  be  made, 
for  example  arguments 
made  within  the  socio-
analysis 
economic 
be 
report 
referenced. 

should 

Estimation/quantification of the level of risk associated with completing the action. 

Whether the action is on the critical path. 

A 1.1  Substance  Y  (the  replacement  for  substance  X)  has only  recently  become  available 
commercially. Current production is only 25% of that needed for full replacement of 
substance X in this use. 

for 
Contact 
supplier of substance Y. 

details 

Detailed discussions have been undertaken with the supplier of substance Y and 12 
months  is  considered  the  most  realistic  estimate  of  the  time  required  to  reach  the 
desired level of supply. 

This is critical to achieving full substitution. If there is not full replacement of X with 
Y, it will no longer be possible to produce the required number of medical devices, 
etc. 

A 1.2 

A1.3 

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Summarising  the  actions  against  timescales  and  their  justifications  are  intended  as  a  presentation  of 
considerations of the applicant based on a wide range of factors. Some of which are likely to be presented in 
further detail in other documents, such as the analysis of alternatives and the socio-economic analysis.  

The actions should be set out against a timeline for achieving these actions with progress markers 
and key stages indicated. This can be described simply against a timescale and illustrated in a table 
or using a timeline illustration or project management graphic tool such as a Gantt chart. How this is 
done is dependent upon the complexity of the plan. A possible illustration is set out below. 

Figure 9. Illustration of timeline for substitution plan 

In order to demonstrate transparency within the substitution plan, the sources of information used by 
the applicant should be clearly referenced. The most appropriate method of this may be inclusion of 
an  appendix  or  a  referencing  system  to  other  documents  submitted  as  part  of  the  authorisation 
application (or available elsewhere). 

4.4.1.  Presenting the documentation of the substitution plan to the Agency 

The substitution plan should be submitted as part of the application for authorisation as indicated in 
the user manual(s) made available on the Agency’s website. 

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5. 

GUIDANCE  FOR  THIRD  PARTIES  ON  SUBMITTING  INFORMATION  ON  ALTERNATIVE 
SUBSTANCES OR TECHNOLOGIES  

The guidance in this chapter has been drafted to assist third parties in their submission of information 
about alternative substances and technologies to the substance for which authorisation is sought or 
reviewed. The aim is to assist third parties in making effective submissions to the Agency. Further 
detailed guidance on how to perform an analysis of alternatives primarily directed to the applicant 
for authorisation is given in chapter 3. Interested third parties may find the guidance in that chapter 
useful in order to submit a well-documented information on alternatives.  

It should be noted that interested parties also have an opportunity to contribute further evidence to 
support  the  decision  making  process  on  the  Annex  XIV  substance  on  the  basis  of  its  technical 
performance, on economic grounds or its environmental/human health impacts through contribution 
to the SEA process (guidance on this process is given in Guidance on Socio-Economic Analysis – 
Authorisation). 

This chapter describes the overall context within which third parties may wish to provide information 
and  the  interactions  between  the  applicant,  downstream  users,  the  Agency  and  third  parties.  The 
guidance  chapter  is  intended  to  assist  all  third  parties:  any  organisation,  individual,  authority  or 
company other than the applicant or the Agency/Commission with a potential interest in submitting 
information on alternatives including: 

•  The suppliers of alternative substances or technologies; 

•  Academics/innovators who have developed or have knowledge of an alternative substance or 

technology; 

•  NGOs and Trade Unions; 

•  Governmental and intergovernmental agencies; and 

•  Downstream users. 

Submissions  from  third  parties  may  be  extremely  important  to  the  Agency’s  Committees’ 
considerations  on  authorisation  applications.  The  applicant  may  not  be  aware  of  the  alternative 
substance or technology proposed by the third party and the Agency may only become aware of the 
existence  of  alternatives  through  the  submissions  made  by  third  parties.  In  addition,  technical, 
economic and safety information provided by third parties on alternative substances or processes may 
influence the Committees’ assessment of suitability.  

The extent to which information submitted by third parties can influence the decision process  will 
depend on the quality and clarity of information submitted and the extent to which third parties are 
able to help to demonstrate the technical and economic feasibility of using an alternative substance 
or technology as well as assessment of its capability to reduce the overall risk. In accordance with 
Article 64(3) any information submitted by third parties will be taken into account by the Agency 
when preparing an opinion. In this regard, it should be noted that, in deciding whether an alternative 
is suitable for the applicant, the Agency will have to consider the economic and technical feasibility 
for the applicant. 

Third parties do not have access to the detailed information within the application for authorisation 
and must base their submissions on the information provided by the Agency on its website about the 
broad use of a substance for which authorisation is sought or being reviewed. Third parties should 
pay special attention on when describing what function the alternative fulfils, for which uses their 

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alternative is  suitable and under which  conditions is  can be used. For example, a lubricant  that is 
specially  designed  for  extreme  temperatures  and/or  use  with  specific  material;  should  not  be 
described simply as a lubricant without any accompanying information about the conditions of use.  

Information must be submitted within a specified time period (see below), if it is to be considered by 
the  Agency.  It  may  be  appropriate  to  submit  information  even  before  technical  feasibility  for  a 
specific use has been fully established. For instance, a convincing case may be presented that the 
innovation is sufficiently promising to warrant further research, further research is planned and the 
innovation  would  be  likely  to  have  a  major  benefit  for  human  health  or  the  environment.  This 
information may inform the specification of a review period for the authorisation by the Agency. 

The Agency is not required to respond to submissions made by third parties but may choose to request 
further information.  

5.1.  Circumstances leading to third party submission of information 

Third  parties  may  wish  to  submit  information  about  potentially  suitable  alternatives  that  are 
technically feasible and safer for human health and/or the environment. They may have a particular 
interest in indicating how the use of a chemical could be entirely avoided by use of an alternative 
technology or by optimizing the process such that the chemical is no longer required or very much 
less is used. 

5.2.  Timing of third party submissions 

Third parties are specifically invited to submit information on alternatives when the Agency publishes 
information on its website about uses for which applications have been received or when the Agency 
indicates  on  its  website  that  an  authorisation  is  subject  to  review  (Art.  64(2)).  The  Agency  will 
indicate a deadline for the submission of information which will be within the 10-month period that 
the Agency’s Committees for Risk Assessment and Socio Economic Analysis have to prepare a draft 
opinion. Article 64(3) indicates that third parties may also be invited by the Committee for Socio-
economic  Analysis  to  provide  additional  information  on  possible  alternative  technologies  and 
substances.  

The  sunset  dates37  given  in  the  Annex  XIV  list  provide  an  indication  of  the  likely  timing  of 
applications  for  authorisation.  Applications  for  authorisation  should  be  made  before  the  deadline 
specified in the Annex XIV entry, which will be at least 18 months before the sunset date, in order 
that use of the substance shall be allowed after the sunset date if a decision has not been taken by that 
time. Once an application is submitted, the Agency’s Committees for Risk Assessment and Socio 
Economic Analysis must issue a draft opinion within a 10-month period. 

Submissions  on  proposed  alternatives  are  likely  to  be  most  effective  in  influencing  the  decision 
process if submitted during the consultation period defined under Article 64(2) that is specifically 
tailored for the consideration of alternatives. There are however two earlier periods of consultation 
during which interested parties may wish to comment: 

37   Date from which the placing the market and use of the substance shall be prohibited unless an authorisation is granted 

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•  Following  the  preparation  of  an  Annex  XV  dossier38  by  the  Agency/Member  State,  the 
Agency is required by Article 59(4) to place a notice on its website inviting comment from 
interested parties. Details of this process are provided in the Guidance for the preparation of 
an Annex XV dossier on the identification of substances of very high concern and Guidance 
on inclusion of substances in Annex XIV. 

•  Once the Agency has considered the Annex XV dossier, Article 58(4) requires the Agency to 
publish its recommendations on priority substances and uses to be included on Annex XIV on 
its website and to invite comments, in particular on uses which should be exempted from the 
authorisation requirement, from ‘all interested parties’. 

These  earlier  phases  of  the  procedure  provide  an  early  indication  of  substances  that  may  become 
subject to authorisation. In addition, these phases provide information about why substances have 
been placed on Annex XIV. This may assist third parties in the preparation of a submission that can 
demonstrate a suitable alternative when a certain  use(s) is  applied for.  It  should be noted that the 
inclusion in the candidate list does not set any presumption when the substance would be subject to 
authorisation.  

As well as the formal opportunities for input of information and commenting, some third parties (for 
example users of a substance for which an application for authorisation is being made) may wish to 
maintain a two-way dialogue with the applicant for the authorisation to ensure that information on 
the actual uses, and what is and is not being covered by the application is clear to both parties, and 
the best available information is used to generate the application. Communication within the supply 
chain is addressed in more detail in Chapter 3.  

Following the granting of an authorisation, third parties may still submit relevant information to the 
Agency. All authorisations will include a time limited review period and the holders of authorisations 
are required to submit a review report at least 18 months before the expiry of this period. In addition, 
Article  61  (2)  indicates  that  the  Agency  may  review  authorisations  at  any  time  if  circumstances 
change so as to affect the risk to human health or the environment or the socio-economic impact, or 
if new information  on possible substitutes becomes available. The  review process  will include an 
invitation for third parties to submit further information within a specified time period following the 
publication of broad information on uses on the Agency’s website.  

The time line below summarises the opportunities available to third parties to comment on Annex 
XIV substances. The guidance in this chapter relates to the specifically to the stages after placement 
of a substance on Annex XIV including the granting of authorisation and the subsequent review of 
authorisations.  

38   Annex XV dossier proposing the identification of substances of high concern. For further information see Guidance 

on inclusion of substances in Annex XIV). 

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A time line illustrating the opportunities for third parties contribution is shown below: 

Agency actions 

Third party actions 

Notice that Annex XV dossier has been prepared placed 
on Agency website (Article 59(4)) 

Substance placed on candidate list, recommendations for 
priority substances published on Agency’s website (Article 
59(10)) 

Substance  placed  on  Annex  XIV,  applicant  applies  for 
authorisation,  Agency  publishes  information  on  broad 
uses on website (Article 64(2)) 

Agency may request further information from third parties 
(Article 64(3)) 

Granting of authorisation (Article 60) 

Review of authorisation (Article 61) 

Comments invited from interested parties within specified 
time period (Article 59(4)) 

Comments invited from interested parties, in particular on 
uses that should be exempted within 3 month time period 
(Article 58(4)) 

Information on alternatives invited from third parties within 
a specified time period (Article 64(2)) 

Interested  parties  may  still  provide 
alternatives to the Agency (Article 61(2)) 

information  on 

Comments invited from interested parties  

(Article 61, 64(2)) 

5.3. 

Preparation of a third party submission 

All information submitted by third parties must be taken into account by the Agency, but submissions 
are most likely to be effective if information is presented in an organised logical fashion that will 
enable the Agency to take proper account of the arguments and information presented. Third parties 
may wish to state their interests in respect to the outcome of the authorisation process. 

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Third party submissions should be based on the information provided by the Agency on use and, if 
possible,  include  sufficient  technical  detail  to  enable  the  Agency  to  assess  the  availability  and 
suitability of the proposed alternative. If possible, the extent to which the alternative can deliver an 
equivalent function to that provided by the substance in relation to the use(s) specified by the Agency 
should be clearly described. 

A  single  alternative  may  not  be  suitable  for  all  different  processes  or  uses  for  which  the  original 
substance was suitable, thus the original substances could be substituted by more than one suitable 
alternative. Third parties may submit information relevant to a limited number of uses or describing 
several alternatives for different uses. Third parties may submit information about alternatives that 
are still under development, where technical feasibility and reduced risks to human health and/or the 
environment  have  still  to  be  fully  established.  Although  it  would  not  be  possible  to  immediately 
introduce the alternative, the Agency will take such information into account when setting of a review 
period for the authorisation. 

Third  parties  may  wish  to  take  account  of  the  information  requirements  placed  on  the  applicant 
(Chapter 2), in setting out their submissions. The guidance provided for applicants on the analysis of 
alternatives may be of particular relevance (Chapter 3). Ideally, submissions would include a good 
description  of  the  proposed  alternative  and  indicate  its  relevance  within  the  context  of  the 
authorisation process. A suggested format for third party submissions is provided on the Agency’s 
website.  

In making an assessment of the suitability and availability of proposed alternatives, third parties may 
wish to take account of the information provided by Agency on the inclusion of the substance on 
Annex XIV that led to the application for authorisation and on the uses for which authorisation is 
sought.  

To the extent that it is possible (which is likely to be limited by the information available about use), 
third parties should provide any information that is relevant to the application and seek to demonstrate 
that the proposed alternative(s): 

•  Meet(s) technical performance specifications relevant to the uses described by the Agency; 

•  Are/is safer for human health and/or the environment, and/or 

•  Are/is economically feasible including reasonably accessible in sufficient quantities to meet 

the probable annual volume required for the use of interest. 

An alternative should have adequate technical performance that is fit for purpose. Third parties may 
wish to consult with the supply chain in order to inform their submission. Although it is unlikely to 
be possible to fully demonstrate technical and economic feasibility for the applicant, combined with 
reduced risks for health/environment, third parties should include any information that is relevant to 
the assessment of suitability. A statement that alternative X can be used should be supported by data 
and  information  demonstrating  for  which  use(s)  and  under  which  use  conditions  it  is  a  plausible 
substitute.  

When providing information on an alternative substance, third parties may wish to consider what data 
are available that can be used to demonstrate lowered risks and to provide a description of these data 
in their submission. For substances already registered under REACH, information may be available 
from within REACH IT to demonstrate lowered risks to human health or the environment. When 
providing information on alternative technologies third parties would ideally seek to demonstrate that 
their use would lead to a reduction in human or environmental risks. Where alternative substances or 
technologies  are  readily  available,  it  would  be  helpful  to  describe  the  predicted  costs,  if  known, 

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associated  with  using  an  alternative  in  relation  to  those  associated  with  the  substance  subject  to 
authorisation.  Where  alternatives  are  not  currently  readily  available,  the  costs  of  making  them 
available and predicted costs of use would be useful. 

In as far as it is possible, third parties should describe as clearly as possible the extent to which an 
alternative is better or worse than the subject of the authorisation application for each of the three 
criteria: technical and economic feasibility and reduction of overall risks. When assessing whether 
suitable  alternatives  are  available  the  Agency  is  required  to  take  into  account  all  relevant  aspects 
concerning the alternative(s), as stated in Article 60 (5) including whether: 

• 

the  transfer  to  alternatives  would  result  in  reduced  overall  risks  to  human  health  and  the 
environment, taking into account the appropriateness and effectiveness of risk management 
measures; and 

•  be technically and economically feasible for the applicant. 

In considering risks to human health and the environment, a life cycle analysis approach may be taken 
for the specified use of the substance. Some examples of hypothetical situations are given in Box 13.  

Box 13. Examples of third party consideration of alternative substances 

Substance: carcinogenic organic solvent 

Specified use: solvent used for extraction during laboratory analysis 

Proposed alternative: organic solvent with similar chemical and physical properties but not known to be carcinogenic, 
mutagenic  or  toxic  to  reproduction; similar potential to  persist in  the  environment  or  bioaccummulate  as  the  original 
solvent.  

Functionality: Alternative solvent is  unlikely to provide same range of functionality as current solvent, but for many 
analytical protocols, the performance of the alternative is adequate. 

Technical feasibility: suitably as a laboratory solvent demonstrated for 4 widely used analytical protocols. Although 
alternative  solvent  is  more  flammable  than  the  original  solvent  and  therefore  may  not  be  suitable  for  larger  scale 
applications; suitability of alternative solvent not demonstrated for all potential uses and its suitability would need to be 
validated for each analytical protocol. 

Economic  feasibility:  alternative  solvent  is  more  expensive,  but  as  only  small  quantities  are  used,  the  calculated 
overall cost to laboratories of substitution is extremely small in comparison to the overall costs of maintaining laboratory 
facilities. 

Risk reduction: levels of human exposure similar for both solvents, but alternative not associated with cancer risk; 
environmental risks similar for both solvents 

Substance: carcinogenic organic solvent 

Specified use: solvent used for cleaning of reaction vessels used in polymer production 

Proposed alternative: treatment with water heated to 90oC followed by treatment with an alternative organic solvent 
with similar intrinsic properties, including environmental hazards, but no proven potential to cause cancer  

Functionality: the hot water was not capable of removing congealed fragments of part formed polymer from the reaction 
vessel, but the two stage process was demonstrably effective and resulting in a lower use of the alternative solvent than 
would have been required if the hot water step had been omitted. The water requires treatment before discharge to the 
environment and the use of hot water presents safety issues. 

Technical  feasibility:  Alternative process  was  adequate  for  the  intended  purpose  but  introduced  a  requirement  for 
facilities for wastewater treatment that had not previously existed. 

Economic  feasibility:  An  analysis  of  the  cost  of  heating  and  subsequently  treating  the  water  indicated  that  these 
represent substantial additional  process  costs.  The alternative  solvent is  currently more expensive  than  the  original 
solvent but this is likely to change as the demand for alternative solvents increases. 

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Risk reduction: levels of human exposure lower for alternative solvent which is not associated with cancer risk, giving 
rise  to  an  overall  reduction  in  health  risks;  reduced  quantities  of  solvent  use  associated  with  small  reduction  in 
environmental risks; introduction of new hazard in form of hot water 

Substance: carcinogenic organic solvent 

Specified use: solvent used for cleaning of nozzles used in polymer extrusion 

Proposed alternative: organic solvent with similar chemical and physical properties, poses similar risks to environment 
but not known to be carcinogenic 

Functionality: Solvent was demonstrated to be effective in use provided a longer washing time was allowed. 

Technical feasibility: Although the alternative solvent provided an equivalent function, the longer washing time had an 
adverse impact on the overall production schedule. 

Economic feasibility: The cost of the alternative solvent is similar to that of the original solvent. The longer washing 
time means that operators may need to have an increased number of spare nozzles available as the longer turnaround 
time means than individual nozzles are used less frequently. Over a ten year period, the calculated additional costs 
were small in relation to total operational costs. 

Risk reduction: levels of human exposure similar for both solvents, but alternative not associated with cancer risk; 
environmental risks similar for both solvents 

Substance: carcinogenic metal 

Specified use: used with other metals in high strength alloy 

Proposed alternative: reformulated alloy excluding metal carcinogens 

Functionality: reformulated alloy is more brittle than original alloy and not suitable for all applications 

Technical feasibility: The reformulated alloy can be produced using existing production facilities 

Economic  feasibility: Market  demand  for  reformulated  alloy  is  likely  to  be  smaller  than  for  the  original  formulation 
because of its lower technical performance. It is estimated that future demand will fall to 50% of current levels. 

Risk reduction: Reduction in human exposure to the metal carcinogen 

Substance: carcinogenic solvent  

Specified use: dry degreasing of surfaces such as plate glass 

Proposed alternative: specialist textile which eliminates need for solvent use 

Functionality:  the  textile  is  highly  effective  in  removing  grease  from  smooth  surfaces,  but  less  effective  on  rough 
surfaces; textile becomes progressively less effective as it becomes saturated with grease but can be regenerated by 
treatment with an environmentally friendly detergent 

Technical  feasibility:  The  textile  can  provide  a  similar  quality  of  cleansing  for  smooth  surfaces  as  the  solvent  but 
requires manual cleaning to be undertaken whereas the solvent can be used within automated process 

Economic feasibility: For small scale processes employing manual cleaning, there is a small long term saving in cost 
through discontinuation of use of the solvent, although initial investment in the textile is required. For processes that are 
currently automated, the transition to manual cleaning is likely to greatly increase labour costs and process time and 
the  replacement  of  a  solvent  based  process  by  a  manual  process  employing  the  textile  is  likely  to  give  rise  to 
unacceptably high additional costs. 

Risk reduction: Use of the textile eliminates the need for human exposure to the carcinogenic solvent 

5.4.  Confidentiality 

Third parties wishing to submit information on alternatives should take account of the right of access 
to documents of the Community institutions. Under Art. 2(1) of Regulation 1049/2001, any citizen 
of the Union, and any natural or legal person residing or having its registered office in a Member 
State, has a right of access to documents of the Community institutions, except for a defined number 
of reasons including where disclosure would undermine the protection of: 

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(a) the public interest as regards: 

— public security, 

— defence and military matters, 

— international relations, 

— the financial, monetary or economic policy of the Community or a Member State; 

(b) privacy and the integrity of the individual, in particular in accordance with Community legislation 
regarding the protection of personal data. 

or where disclosure would undermine the protection of: 

— commercial interests of a natural or legal person, including intellectual property, 

— court proceedings and legal advice, and 

— the purpose of inspections, investigations and audits, unless there is an overriding public 
interest in disclosure.  

Similarly, the institutions may grant access to documents to any natural or legal person not residing 
or not having its registered office in a Member State (Art. 2(2)).  

In case of a request for a third party document, according to Article 4(4) of Regulation 1049/2001, 
“[the  Agency]  shall  consult  [the  provider  of  the  comments]  with  a  view  to  assessing  whether  an 
exception in paragraph 1 or 2 is applicable, unless it is clear that the document shall or shall not be 
disclosed.”  

Under Article 118 of REACH disclosure of information on the full composition of a mixture; on the 
precise use, function or application of a substance or mixture; on the precise tonnage as well as on 
links between a manufacturer or importer and his distributor or downstream user normally will be 
deemed to undermine the protection of the commercial interests of the concerned person. Thus, an 
exception  according  to  Article  4(2)  in  the  right  of  access  of  Regulation  1049/2001  will  normally 
apply. 

Third parties should clearly indicate within their submissions the information that they wish to remain 
confidential and the reasons for not disclosing submitted information. The Agency may grant access 
to documents, unless any of the above reasons applies. Therefore, if clear reasons for not disclosing 
information are not provided, the Agency reserves its right to decide that access can be given to your 
comments. 

Third  parties  who  have  requested  that  information  remains  confidential  may  still  decide  to  make 
available: 

•  certain parts of the document to anyone requesting access to it or  

•  certain parts or all of the document to a restricted number of actors requesting access to it. 

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References 

1999/217/EC:  Commission  Decision  of  23  February  1999  adopting  a  register  of  flavouring 
substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of 
the European Parliament and of the Council of 28 October 1996 (notified under number C(1999) 
399). Official Journal L 084, 27.03.1999, p1-137. 

Berufsgenossenschaftliches Institut für Arbeitsschutz – BGIA (2006): The column model: An Aid to 

substitute assessment.  

Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of  laws,  regulations  and 
administrative provisions relating to the classification, packaging and labelling of dangerous 
substances. Official Journal P 196, 16.08.1967, p1-98. 

Council  Directive  76/768/EEC  of  27  July  1976  on  the  approximation  of  the  laws  of  the  Member 

States relating to cosmetic products. Official Journal L 262, 27.09.1976, p169-200.  

Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition. 

Official Journal L 213, 21.07.1982, p8-14. 

Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws  of the Member 
States relating to flavourings for use in foodstuffs and to source materials for their production. 
Official Journal L 184, 15.07.1988, p61-66. 

Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member 
States  concerning  food  additives  authorized  for  use  in  foodstuffs  intended  for  human 
consumption. Official Journal L 040, 11.02.1989, p27-33. 

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member 
States relating to active implantable medical devices. Official Journal L 189, 20.7.1990, p17-
36. 

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products 

on the market. Official Journal L 230, 19.08.1991, p1-32. 

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal L 169, 

12.7.1993, p1-43. 

Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and 

control. Official Journal L 257, 10.10.96, p26-40. 

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning 
the placing of biocidal products on the market. Official Journal L 123, 24.04.1998, p1-63. 

Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the 
quality of petrol and diesel fuels and amending Council Directive 93/12/EEC. Official Journal 
L 350, 28.12.1998, p58-68. 

Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro 

diagnostic medical devices. Official Journal L 331, 7.12.1998, p 1-37.  

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the 
approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member  States 

109 

 
 
 
Guidance on Authorisation Applications 

relating to the classification, packaging and labelling of dangerous mixtures. Official Journal L 
200, 30.07.1999, p1-68. 

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 200 establishing 
a  framework  for  Community  action  in  the  field  of  water  policy.  Official  Journal  L  327, 
22.12.2000, p1-73.  

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to veterinary medicinal products. Official Journal L 311, 28.11.2001, 
p1-66. 

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community  code  relating  to  medicinal  products  for  human  use.  Official  Journal  L  311, 
28.11.2001, p67-128. 

European Commission (July 2006) Integrated Pollution Prevention and Control Reference Document 

on Economics and Cross-Media Effects 

European  Commission  (2020)  the  “Suitable  alternative  available  in  general  &  Requirement  for  a 
substitution 
at 
https://echa.europa.eu/documents/10162/13637/ec_note_suitable_alternative_in_general.pdf/5
d0f551b-92b5-3157-8fdf-f2507cf071c1  

available 

plan”. 

2020, 

dated 

Note 

May 

27 

Federal Ministry of Labour and Social Affairs (BMAS) Germany. Technical Rules for Hazardous 
Substances; Substitution -a general framework for the integrated assessment of the feasibility 
of substitution. TRGS 600, (2007).  

Judgment of the General Court (2009a) Judgment of the in case T-837/16, Kingdom of Sweden v. 
at 

European  Commission, 
http://curia.europa.eu/juris/document/document.jsf?text=&docid=211428&pageIndex=0&doc
lang=en&mode=lst&dir=&occ=first&part=1&cid=14256428  

2019,  ECLI:EU:T:2019:144.  Available 

7  March 

Judgment of the General Court (2019b) in case T-108/17, ClientEarth v. European Commission, 4 
at 

April 
ECLI:EU:T:2019:215. 
http://curia.europa.eu/juris/document/document.jsf?text=&docid=212665&pageIndex=0&doc
lang=en&mode=lst&dir=&occ=first&part=1&cid=14256547 

Available 

2019, 

Okopol/Kooperationsstelle (2003) Substitution of hazardous chemicals  in products  and processes: 
Report compiled for the Directorate General Environment, Nuclear Safety and Civil Protection 
of the Commission of the European Communities Contract No B3-4305/2000/293861/MAR/E1 

Regulation  (EC)  No  2232/96  of  the  European  Parliament  and  of  the  Council  of  28  October  1996 
laying down a Community procedure for flavouring substances used or intended for use in or 
on foodstuffs. Official Journal L 299, 23.11.1996, p1-4 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 
laying down the general principles  and requirements  of food law, establishing the European 
Food Safety Authority and laying down procedures in matters of food safety. Official Journal 
L 031, 01.02.2002, p1-24. 

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 

on additives for use in animal nutrition. Official Journal L 268, 18.10.2003, p29-43. 

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Guidance on Authorisation Applications 

Regulation  (EC)  No 726/2004  of  the  European  Parliament  and  of  the  Council  of  31 March  2004 
laying down Community procedures for the authorisation and supervision of medicinal products 
for human and veterinary use and establishing a European Medicines Agency. Official Journal 
L 136, 30.4.2004, p1-33. 

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on 
persistent  organic  pollutants  and  amending  Directive  79/117/EEC.  Official  Journal  L  158, 
30.04.2004, p7-49. 

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 
on  materials  and  articles  intended  to  come  into  contact  with  food  and  repealing  Directives 
80/590/EEC and 89/109/EEC. Official Journal L 338, 13.11.2004, p4-14. 

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. Official Journal L 396, 30.12.2006, p1-849. 

Directive 2008/1/EC of the European Parliament and of the Council of 15 January 2008 concerning 

integrated pollution prevention and control. Official Journal L 24, 29.1.2008, p8-29. 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 
on classification, labelling and packaging of substances and mixtures, amending and repealing 
Directives  67/548/EEC  and  1999/45/EC,  and  amending  Regulation  (EC)  No  1907/2006. 
Official Journal L 353, 31.12.2008, p. 1–1355. 

TemaNord 97 Nordic Council of Ministers, The use of decision-aid methods in the assessment of risk 

reduction measures in the control of chemicals, TemaNord 1997:622 

The Danish Ecological Council, “Hazardous Chemicals Can Be Substituted”; February 2006. 

The Massachusetts Toxics Use Reduction Institute (2005). Alternatives Assessment for Toxics Use 

Reduction: A Survey of Methods and Tools. Methods and Policy Report No. 23 

US  Environmental  Protection  Agency:  Cleaner  Technologies  Substitutes  Assessment  -  Office  of 

Pollution Prevention and Toxics Washington, DC 20460 EPA Grant X821-543 

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Appendix 1. Considerations for grouping of substances 

An application for a group of substances is only possible if it is for a group in accordance with Article 
62 (3). A description of the reasons for considering the substances as a group is required. It should 
be submitted as part of the application, in accordance with specific instructions in user manual(s) 
made available on the Agency’s website. It should outline the argumentation for the grouping, based 
for example on similarity of physicochemical, toxicological and ecotoxicological properties, or where 
these follow a regular pattern as a result of structural similarity.  

The group or category is most likely to have already been created as part of the registration process 
or for the Annex XV dossier which lead to inclusion on Annex XIV. In such cases, the argumentation 
for considering the substances as a group will already have been prepared, and the  benefits  of an 
application for a group should be relatively easy to determine. The majority of the guidance in this 
section relates to the situation where the applicant wishes to form a new group for the application. 
However,  some  of  these  considerations  may  be  useful  in  deciding  whether  to  apply  for  an 
authorisation for all members of an existing group. 

The definition of a group of substances is given in Section 1.5 of Annex XI of the Regulation, and 
according to this definition, grouping of substances can be made only on the basis of similarity of 
physicochemical,  toxicological  and  ecotoxicological  properties,  or  where  these  follow  a  regular 
pattern as a result of structural similarity. Similarities may be based on: 

•  a common functional group; 

• 

the common precursors and/or the likelihood of common breakdown products via physical 
and biological processes, which result in structurally similar chemicals; or 

•  a constant pattern in the changing potency of the properties across the category. 

It is important to note that this definition precludes grouping of substances based on similarity of use 
alone.  Further  guidance  on  grouping  of  substances  is  given  in  the  Guidance  on  information 
requirements and CSA. 

A1.1  Reasons for grouping substances 

The main reason for grouping of substances for an application for authorisation is that savings in time 
and effort can be made in some situations, particularly where common information can be used for 
the application. Possible situations that are envisaged with a group of substances are outlined below. 
For each situation, although there is nothing to stop an applicant from submitting a single application 
covering the group of substances, there may be some cases where the complexity of the situation will 
outweigh any benefit from reduction of information and effort needed. Therefore, it is advisable that 
the applicant assesses the benefits from grouping on a case-by-case basis. 

a)  All members of the group have the same uses, and the application for authorisation is made 
for all of the uses of the group. Here, as the same uses are considered for all substances, the 
information  needed for the application for all substances may be similar, or could  involve 
consultation  with  the same users or industry sectors, and so could  then be collected at  the 
same time. 

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b)  All members of the group have the same uses, but the application for authorisation is made 
for only some specific uses of each substance within the group. Similar to above, if the specific 
uses  considered  are  common  to  more  than  one  of  the  substances  in  the  group,  then  the 
necessary information could be collected at the same time. If, on the other hand, the specific 
uses are all different for each substance in the group, there would appear to be little advantage 
in treating the substances as a group, as the information for each substance would probably 
need  to  be  collected  separately,  and  the  application  would  be  complex  and  may  lack 
transparency and clarity. 

c)  Members of the group have different uses, and the application for authorisation is made for 
different uses for each substance. Here there would appear to be little advantage in grouping 
the substances. 

Another consideration when grouping substances is the basis that will be used for the application, 
i.e.,  whether  the  “adequate  control  route”  or  the  “socio-economic  analysis  route”  can  be  used. 
Different  documentation  may  be  needed  for  applications  by  these  two  routes  and  so  there  would 
appear to be little advantage in grouping substances where different routes will be used for individual 
substances.   

When deciding whether or not to submit an application for a group of substances, a key consideration 
is maintaining clarity in the applications. In complex cases, it may be preferable to submit separate 
applications for each member of the group. In this case it may still be possible to use some of the 
same supporting information for each application if this information was collected for the group as a 
whole.  

A1.2  Argumentation for grouping substances for authorisation 

Several possibilities could be envisaged as a basis for describing the arguments for the grouping of 
substances. Examples are given below.  

a)  The substances were treated as members of a group or category in the context of registration 
(i.e.  for  the  purpose  of  the  CSR  or  use  of  read-across  for  the  purpose  of  preparing  the 
registration  dossier).  In  this  case  an  argumentation  for  considering  the  substances  as  a 
group/category would already exist in the registration dossier and the same reasons could be 
used  as  a  basis  for  considering  the  substances  as  a  group/category  for  authorisation,  if 
compliant with Section 1.5 of Annex XI. 

b)  The  Annex  XV  dossier(s)  for  inclusion  of  the  substance  in  the  Candidate  List  treated  the 
substances as a group or category or used a read-across approach for the substances. Here, 
reference to the Annex XV dossier in the application for authorisations would be sufficient 
for considering the substances as a group/category for authorisation.  

c)  Grouping  based  on  a  common  impurity  or  degradation  product,  or  constituent  of  multi-
constituent substance, if the impurity/degradation product/constituent is the reason why the 
substances were listed on Annex XIV. Again the Annex XV dossier for the substances should 
provide  the  necessary  background  for  considering  the  substances  as  a  group/category  for 
authorisation. 

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d)  The  substances  are  considered  as  a  group  or  category  based  on  structural  similarity.  The 
arguments  that  could  be  used  here  could  be  structured  around  common  structural  features 
and/or functional groups or a constant and predictable pattern in the properties of relevance 
across the category. The properties of relevance here would be the properties outlined in the 
Annex  XV  dossier  that  lead  to  the  substance  being  identified  as  a  substance  of  very  high 
concern, and so subsequently listed in Annex XIV. In this case the Guidance on information 
requirements  and  CSA  (Chapter  R6.2)  should  be  used  to  develop  the  argumentation.  If 
necessary,  it  is  possible  to  draw  on  substances  not  listed  in  Annex  XIV  to  strengthen  the 
argumentation, although such substances themselves cannot be the subject of the application 
for authorisation. 

For a review report, the argumentation for the grouping should be reconsidered in light of any new 
data that has become available. 

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Appendix 2. Applications by several legal entities 

A2.1  Reasons for joint applications  

Possible advantages for joint applications: 

•  Sharing of costs needed to put together the necessary documentation required. 

•  Broader range of experience and expertise. 

•  Ensuring the specific conditions of use of downstream users are covered. 

Possible disadvantages for joint applications: 

•  Commercial and confidentiality issues relating to the use(s) of the substance. 

•  Not all uses of the substance may be relevant to each legal entity. 

•  Disagreements over the information. 

Applicants  who  want  to  submit  a  joint  application  should  refrain  from  exchanging  commercial 
sensitive  information  prohibited  under  the  competition  rules  (e.g.  information  about  prices  or 
customers). Exchanging information about substance identity or substance properties is permissible 
under the competition rules. However, exchanging detailed information about alternatives could give 
raise to concerns, particularly if there is a concerted action as to whether, when, and how companies 
switch to an alternative. Therefore, when preparing the analysis of alternatives, parties may consider 
the use of an independent third party. 

A2.2  Approach for joint applications by groups of applicants 

The  basic  approach  for  an  application  by  a  group  of  applicants39  would  be  to  firstly  identify  the 
manufacturer(s),  importers  and  downstream  users  that  are  involved  in  the  supply  chain  for  the 
substance.  

If a SIEF has been created for the substance, the interested members of the SIEF could form a useful 
basis  for  the  formation  of  group  for  the  application.  SIEFs  have  no  legal  status  in  relation  to 
applications for authorisations, but they may be a useful platform in cases where the substance has 
been (pre-)registered by more than one company. However an application for an authorisation from 
a group of applicants need not be limited to the group of, or a subgroup of, the members of a SIEF 
(e.g. manufacturers and importers of substances that have been identified as suitable for read-across).  

39   The REACH Regulation does not specify what form of co-operation should be used for applications from more than 
one applicant. This could include formal consortia or other forms of cooperation. The term group of applicants is 
used here to cover all forms of possible cooperation between manufacturer(s); importer(s) and/or downstream user(s) 
acting as applicants for authorisation. 

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It may also be beneficial to include downstream users in the group of applicants if they are not already 
members of the SIEF. Such downstream users could be identified, for example, based on the known 
customers of the members of the SIEF etc., or through relevant trade associations etc.  

The Guidance on data sharing gives detailed guidance on how to put together SIEFs and other forms 
of collaboration, and how to deal with issues in relation to Confidential Business Information (CBI) 
and competition laws. This guidance could also be useful in the case of applications for authorisations 
by a group of applicants, however, it will be up to the applicants themselves to decide how they share 
information and prepare the joint application. 

Possible situations that could be envisaged when considering an application for authorisation from a 
group of applicants are outlined below.  

•  The  potential  group  of  applicants  consists  of  actors  in  one  supply  chain  (manufacturer  or 
importer  and  downstream  user(s)).  The  different  actors  will  have  knowledge  on  different 
aspects required for the application and can effectively contribute to a joint application. For 
example, a downstream user has detailed knowledge on actual conditions under which he uses 
the substance contributing to an accurate exposure scenario while the manufacture or importer 
may have better knowledge on how to perform an exposure assessment and develop the CSR 
on the basis of that exposure scenario. The downstream users have good understanding on the 
requirements for an suitable alternative, knowledge of all actors is relevant for a SEA, etc.  

•  The potential group of applicants consists of manufacturer(s) and/or importer(s), all supply 
the substance for the same uses, and the application is for all uses of the substance. In this 
case there would appear to be an advantage in developing a group for the application as the 
information needed for the application would be common to all members of the group. 

•  The  potential  group  of  applicants  consists  of  manufacturer(s)  and/or  importer(s)  and/or 
downstream user(s), and the application is for only some of the uses. Here the advantages of 
developing a group for the application would need to be considered on a case-by-case basis 
as not all information that will be needed for the application may be relevant to all members 
of the group. 

•  The  potential  group  of  applicants  consists  of  manufacturer(s)  and/or  importer(s)  and/or 
downstream user(s) that each supply the substance for different uses, and the application is 
for all uses of the substance. Here it could be questioned whether there is any benefit derived 
in developing a group for the application. 

The  same  situations  could  also  arise  where  the  application  is  for  a  group/category  of  substances. 
However here,  as discussed at  length in  the  Guidance on information requirements and CSA, the 
formation  of  a  group/category  may  also  be  dependent  on  which  chemicals  are  of  interest  to  the 
companies sponsoring the category.  

Subsequent applications {Art. 63}, whereby a second legal entity wishes to make an application for 
authorisation when an application has already been submitted by another applicant or an authorisation 
has already been granted to another legal entity, are discussed in Section 2.2.5 of this guidance. 

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A2.3  Completing the application 

For  groups  of  applicants  the  following  points  should  be  taken  into  account  when  completing  the 
application. 

•  The application should identify the members of the group of applicants  and also  the main 

contact point. 

•  The application must have CSR(s) covering all the uses applied for by the group of applicants. 
In some cases it may be possible to use the existing CSRs of the group members (if available) 
but it is also possible that a single, consolidated CSR covering the uses for which authorisation 
is applied for, may need to be generated. The Guidance on information requirements and CSA 
should be followed in this case. 

•  An analysis of alternatives and where included in the application, an SEA and/or a substitution 

plan have to cover all uses applied for and can be submitted jointly.  

•  There may be issues in relation to Confidential Business Information (CBI) and competition 
laws in  relation  to  an application for a group of applicants.  The Guidance on data sharing 
gives more detailed guidance on these aspects but, if in doubt, legal advice should be sought. 

How a single application from multiple applicants will be created in practice will be elaborated in a 
separate user manual.  

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Appendix 3. Checklist for analysis of alternatives 

Analysis of Alternatives Checklist 

The following checklist can be used by the applicant for cross-referencing the key components of an 
analysis of alternatives against their own preparatory work. 

Yes 

No 

✓ 

 

The analysis of alternatives includes the following information: 

1. 

Identification of Annex XIV substance function for the uses applied for 

2. 

Identification of possible alternatives(s) – substances and/or technologies for the uses applied for 

3.  The assessment of risks to human health and the environment of the alternatives and whether the 

transfer to alternatives would result in reduced overall risks; 

4.  The assessment of the technical feasibility of the alternative(s) for substitution;  

5.  The assessment of the economic feasibility of the alternative(s) for substitution;  

6.  The assessment of availability of the alternative(s).  

7.  Cases  where  there  is  a  suitable  alternative  available  on  the  market  but  not  yet  ready  for  an 
immediate  substitution  (i.e.  within  the  "sunset  date")  or  another  operator  in  the  same  market  is 
already or will switch in the short future to alternatives. 

8.  A  justification  for  the  conclusion  of  the  analysis  of  alternatives  if  it  concludes  that  there  are  no 

suitable alternatives available.  

a.  Reference to an SEA (if the application is for an Annex XIV substance which cannot be 

adequately controlled; i.e. for an application under the socio-economic route) 

9.  A justification for selection of the alternative 

a.  Reference to a substitution plan  

10.  Relevant R&D is documented and explained where appropriate 

11.  References to all information sources cited 

12.  Confidential data is clearly indicated as such. 

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Appendix 4. Checklist for Annex XIV Substance Function  

The following checklist can be used to assist in determining the functional requirements of possible 
alternatives based on functional aspects of the Annex XIV substance (it is not exhaustive). 

Functional aspect1 

Explanation 

1. Task performed by Annex XIV substance 

What is the task that must be performed by the substance? 

Consider in detail what is required of the specific task that must be 
performed by the Annex XIV substance and why and how this must 
be performed.  

Sources of information: 

Exposure  scenarios  in  CSA/R  –  this  will  detail  the  operational 
conditions (Guidance on information requirements and CSA). 

Supply chain: More specific information detailing exact use, quality 
criteria and specific product requirements will need to be gathered 
from  downstream  users  (if  they  are  not  the  applicant)  –  (see 
Guidance on information requirements and CSA).  

Note: the exact description of the function may be considered to be 
confidential information by the user – i.e. they may not wish to impart 
details of the exact process for manufacture. In that case the DU can 
information  under  a  confidentiality 
consider  providing 
agreement. Alternatively he can consider making his own application 
for that use.   

the 

This should include the tolerance range for acceptability, i.e. what is 
the acceptable range for performance (for example maximum drying 
time for a solvent or coating, or temperature tolerance). 

This  will  give  an  indication  of  the  amount  of  substance  that  is 
required for the function and the speed and duration of the task. 

For  example these could  be physical and chemical  constraints  as 
well as temporal and quality constraints. 

Consider  the  circumstances  under  which  the  task  must  be 
performed. How do these conditions determine the qualities of the 
Annex XIV substance i.e. what are the constraints? These could for 
example  be  physical  (e.g.  extreme  pressure  or  temperature,  or 
confined  space),  chemical  (e.g.  possible  reaction  with  other 
chemicals in the process or pH), or biological (stability for biological 
systems  e.g.  microorganisms  involved  in  the  process  e.g.  a 
bioreactor) that may dictate how the task is performed. 

For  example  the  Annex  XIV  substance  may  be  used  to  control 
emissions  of  another  substance  or  produce  another  substance.  If 
the need for control is removed or the end product is altered so that 
the  second  substance  is  no  longer  needed  then  the  Annex  XIV 
substance may be more easily substituted or not required at all. 

For example, customers may have particular operating procedures 
that  must  be  followed  and  contractual  arrangements  that  demand 
use for a certain length of time. 

For example some substances are long lifetime products that must 
be tested for technical performance and acceptability for use over a 

119 

2. What critical properties and quality criteria must 
the substance fulfil? 

3. Function conditions 

What  is  the  frequency  of  performing  the  task 
(continuous or batch process)? 

How much of the substance is used/consumed in 
the process. 

4. Process and performance constraints 

What  are  the  process  constraints  of  the  task? 
Does  the  task  have  to  be  performed  under 
particular conditions?  

5. Is the function associated with another process 
that  could  be  altered  so  that  the  use  of  the 
substance is limited or eliminated? 

6. What customer requirements affect the use of 
the substance in this use?  

7.  Are 
sector 
requirements or legal requirements2 for technical 

there  particular 

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acceptability  that  must  be  met  and  that  the 
function must deliver? 

long  period.  Also  the  function  may  need  to  deliver  a  function  that 
meets  particular  standards  (such  as  fire  safety  requirements, 
product safety or component worthiness). 

Notes: 

1.   Functional aspects suggested are not an exhaustive list, but an indication of the main considerations that may assist 

the applicant in determining function. 

2.   This is considered further in section 3.6 on technical feasibility. 

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Appendix 5  Brief example of possible method for profiling environmental risk  

‘Risk profiling’ may be used for comparing environmental risks of different substances used within 
the same specific industry sectors (using emission scenario information) and a similar technique may 
be adapted for human health. An outline of the technique is set out in Box A. The technique may be 
helpful for assessing the comparative risk of alternative substances and for indicating the potential 
risk of the alterative if used in the same use pattern (i.e. assuming the same emission scenarios). 

Box A. Risk profiling for environmental risks 

Risk  profiling1  is  a  technique  developed  to  allow  the  generic  assessment  of  the  environmental  risks  of 
substances that have similar function. It uses the same principles used in the risk assessment of chemicals for 
assessing the need to limit risks based on comparison of exposure with effects, but instead of focusing on a 
single substance, a range of possible substances used within a use pattern can be considered and the physical 
and chemical characteristics that lead to risks can be evaluated. 

The  prediction  of  emissions  from  the  life  cycle  phases  of  substances  can  be  determined  based  on  the 
combination of the type of industry in which the substance is manufactured and uses to which the substance is 
put. These combinations determine the predicted emissions to environmental compartments based on the so-
called A and B tables in the Guidance on information requirements and CSA and within the European Union 
System for the Evaluation of Substances (EUSES). Furthermore, more specific emissions from some industrial 
sectors have been documented in emission scenario documents. The emissions can be used to derive predicted 
environmental concentrations (PEC) for environmental compartments. However, certain key physico-chemical 
properties (biodegradability, octanol-water partition, and vapour pressure and water solubility) have the most 
influence on the environmental fate of a substance released into the environment. Therefore for substances with 
the same use pattern (i.e. releases to the environment) for the same tonnage use, risks will be determined by 
exposure  (determined  by  key  properties)  and  the  toxicity  of  the  substance  (i.e.  the  predicted  no-effect 
concentration - PNEC).  

By using the calculations for determining the environmental fate of substances based on key properties and 
basic information on the aquatic toxicity of the substances, the combinations of these features and the tonnage 
used  of  substances  that give rise  risks  can  be  investigated.  Therefore  for  particular  use patterns  that  define 
releases to the environment a theoretical ‘profile’ of the key physico-chemical properties, toxicity and tonnage 
use can be investigated. Combinations that lead to risks can be avoided and those that do not can be investigated 
further. 

The utility for the analysis of alternatives is that for use patterns with known emission characteristics and for 
particular tonnage uses, the combinations of physico-chemical and toxicological characteristics substances that 
give rise to a risk can be compared to and between possible alternatives. This can be based on a small amount 
of  information  on  the  alternative  substances  (e.g.  readily  biodegradable,  octanol-water  partition  and  acute 
aquatic toxicity). The alternatives that indicate a potential risk can be avoided and those that do not can be 
selected for further investigation. 

1. Environment Agency (2004) R&D Report: “Development and Assessment of Risk Profiles for Substances: 
Application to Specific Industry Sectors – Plastics Additives and Lubricant Additives 

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Appendix 6. Checklist for substitution plan  

Substitution Plan Checklist 

The following checklist can be used by the applicant for cross-referencing the key components of a 
substitution plan against their own preparatory work. 

Element 

Yes 

No 

✓ 

 

1. The substitution plan includes the following information 

•  A list of actions detailing (as a minimum) the information presented in 2 (e-h).  

•  A timetable for implementation of actions 

• 

The method used to communicate information to stakeholders and the supply chain 

•  References to supporting information or reports (e.g. SEA)  

2. The list of actions includes: 

•  A series of actions proposed by the applicant (though not always for the applicant to undertake) 
to facilitate or carry out the substitution or to switch to an alternative available in general, but 
not yet technically and/or economically feasible for the applicant. 

•  A proposed timetable with a deadline for the completion of each action. 

•  A justification to present the rationale behind each action/timetable proposed by the applicant. 

•  A reviewing progress against proposed actions/timetable. (This may take the form of a progress 

chart so that progress can be tracked against the planned action (for example a Gantt chart). 

3. A substitution timetable should be presented within the plan that: 

•  Contains a start-date for implementation of the substitution plan 

•  Contains an end-date by which substitution is anticipated to be complete 

•  Contains a timetable with a deadline for each action 

• 

Is realistic given the limitations identified in the substitution plan 

•  Contains references to suitable justifications for proposed dates  

•  Highlights the milestones set within the action plan 

•  Highlights the internal progress review and internal progress reporting (i.e. by the applicant)  

4.  Internal  review  of  overall  substitution  position  for  the  purpose  of  the  review  report,  where 
relevant: 

•  Are there any new/emerging alternatives that were not present before? 

• 

Is the substitution still the best available option? 

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