Biocides submission manual 3 : active substances. Part A, Initial submissions : version 2.3 (September 2014).
Date: 2015-07-31
Institutions: European Chemicals Agency
Subjects: administrative formalities, chemical element, chemical industry, chemical product, dangerous substance, directive (EU), environmental risk prevention, legislation, regulation (EU), toxic substance, user guide

 Active substances: Initial submissions 

Release date: Sept 2014         1 

MANUAL 

Biocides Submission 
Manual 3 

Active substances 

Part A: Initial submissions 

 
 
 
2 

Biocides Submission Manual 3 – Part A 

Version 2.3  

Version 

Changes 

Version 1.0 

First version 

Version 2.0 

Updated  manual  to  coincide  with  the  release  of  R4BP  3.1.  Main 
changes  include  an  improved  general  layout  and  design,  extra 
summary sheets added and previous summary sheets updated. A 
glossary  section  containing  terms,  definitions  and  identifiers 
applicable to the whole BSM series  can now be found at  the end 
of the manual.  New application types  ‘amendment of  Annex  I  to 
the BPR’ and ‘renewal of AS’ have been introduced (section 3.1) 

Date 

August 2013 

April 2014 

Version 2.1 

Changes  to  Chapter  4  have  been  made  for  AS-ACC  applications 
resulting from amendments to Article 95 of the BPR.  

April 2014 

Version 2.2 

Version 2.3 

Manual updated to reflect the changes in R4BP 3.1.2, namely, the 
removal  of  the  ‘access  level’  selection  in  the  application  wizard 
and relevant screenshots. 

June 2014 

Manual  updated  to  clarify  application  requirements  for  AS-ACC 
applications.  Specifically,  dossier  submission  is  optional  when  a 
letter of access to a complete dossier is available. 

September 2014 

BSM 3 Active substances – Part A: Initial submissions 

Reference:    
ECHA-14-B-03.1-EN 
Catalogue number: ED-02-14-902-EN-N 
978-92-9244-763-2 
ISBN:  
10.2823/53831 
DOI:    

Publ. date: 
Language:    

September 2014
EN 

© European Chemicals Agency, 2014 

Cover page © European Chemicals Agency 

Legal notice: 

Neither the European Chemicals Agency nor any person acting on behalf of the European 
Chemicals Agency is responsible for the use which might be made of the following information. 
A wealth of additional information on the European Chemicals Agency is available on the 
Internet. It can be accessed through the ECHA website (http://echa.europa.eu). 

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 is 
accessible from the Contact ECHA page at: http://echa.europa.eu/contact 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Annankatu 10, Helsinki, Finland 

Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu 

 
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         3 

Table of Contents 

1. Introduction ........................................................................................................... 5 

1.1

 Objective ............................................................................................................................... 5 

1.2

 Icons, abbreviations and terminology ........................................................................................ 6 

1.3

 Manual structure ..................................................................................................................... 7 

1.3.1 Specific application chapters .................................................................................................. 7 

1.3.2 Summarised information for all BSM manuals .......................................................................... 7 

2. General submission information ............................................................................. 7 

2.1

 Application types ..................................................................................................................... 7 

2.2

 Application file types: dossiers and supporting documents ............................................................ 9 

3. Approval (and renewal) of AS and related applications .......................................... 9 

3.1

 Introduction ........................................................................................................................... 9 

3.2

 Approval of active substance .................................................................................................. 10 

3.2.1 What does my application require? ....................................................................................... 10 

3.2.2 Application ‘wizard’ for AS-APP applications ........................................................................... 11 

3.2.3 Pre-submission checklists for AS-APP .................................................................................... 13 

3.3

 Approval of an active substance in additional product types ........................................................ 14 

3.3.1 What does my application require? ....................................................................................... 14 

3.4

 Amendment to the conditions of an approval ............................................................................ 14 

3.4.1 What does my application require? ....................................................................................... 15 

3.5

 Amendment of Annex I to the BPR .......................................................................................... 15 

3.5.1 What does my application require? ....................................................................................... 15 

4. Inclusion in the active substances and suppliers (Article 95) list ......................... 16 

4.1

 Introduction ......................................................................................................................... 16 

4.2

 Submitting an application for AS-ACC ...................................................................................... 16 

4.2.1 What does my application require? ....................................................................................... 16 

4.2.2 Application ‘wizard’ for AS-ACC ............................................................................................ 17 

4.3

 Pre-submission checklists for AS-ACC ...................................................................................... 20 

5. Inquire to share data (for active substance) ........................................................ 21 

5.1

 Introduction ......................................................................................................................... 21 

5.2

 Submitting an inquiry for IN-REA ............................................................................................ 22 

5.2.1 What does my application require? ....................................................................................... 22 

5.2.2 Application ‘wizard’ for IN-REA ............................................................................................. 22 

5.3

 Pre-submission checklist for IN-REA ........................................................................................ 24 

Summary sheet: Application file types ..................................................................... 25 

Summary sheet: Understanding IUCLID datasets ..................................................... 26 

Summary sheet: Creating a dataset and dossier in IUCLID 5.................................... 27 

Summary sheet: How to make a confidentiality claim in IUCLID 5 ........................... 28 

Summary sheet: How to sign-up and login to R4BP 3 ............................................... 29 

Summary sheet: How your application is handled by ECHA ...................................... 30 

Summary sheet: Monitoring the progress of a case .................................................. 31 

 
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Biocides Submission Manual 3 – Part A 

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Glossary of terms and identifiers .............................................................................. 32 

Table of Figures 

Figure 1: Launching the application ‘wizard’ for AS-APP ......................................................... 12 

Figure 2: Launching the application ‘wizard’ for AS-ACC .......................................................... 18 

Figure 3: Selecting a substance in an application ‘wizard’ ....................................................... 19 

Figure 4: Launching the application ‘wizard’ for IN-REA .......................................................... 22 

Figure 5: Selecting a substance in the application ‘wizard’ ...................................................... 23 

List of Tables 

Table 1: Basic application information for applications using the AS-APP ‘wizard’ .................... 8 

Table 2: Basic application information for applications using the respective ‘wizard’ ................ 8 

Table 3: Application requirements for approval of active substance ........................................ 11 

Table 4: Application requirements for AS-ACC ......................................................................... 17 

 
 
 
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         5 

1. Introduction 

1.1

 Objective 

The  purpose  of  this  manual  is  to  provide  guidance  on  how  to  submit  applications  concerning 
active  substances,  through  the  Register  for  Biocidal  Products  (R4BP  3).  The  subsequent 
chapters describe how to submit applications for: 

i) 

Approval of an active substance (AS) and related application types; 

  approval of an AS in an additional product type 
  amendment to the conditions of an approved AS 
  amendment  of  Annex  I  to  the  Biocides  Product  Regulation  (EU)  No  528/20121 

(BPR) 

  renewal of AS  

ii) 

Inclusion in the active substances and suppliers (Article 95) list; 

iii) 

Inquiry to share data (for an AS). 

Certain  application  types  require  the  submission  of  a  dossier  as  part  of  the  application.  This 
dossier should be prepared in IUCLID format (Article 79 of the BPR).  

The  latest  version  of  IUCLID,  version  5,  can  be  downloaded  free  of  charge  from  the 
IUCLID  website  at  the  following  address:  http://iuclid.eu.  For  more  details  about  the 
installation and use of IUCLID 5 go to the website’s Support tab.  

The various chapters in this manual aim to help the applicant identify which IUCLID fields are 
of  prime  importance,  outline  any  supporting  documents  needed  for  the  above  application 
types, as well as describe the application submission process. 

This manual is part of the Biocides Submission Manual (BSM) series and follows on from: 

BSM  1  –  Using  IUCLID  for  biocide  applications,  which  describes  how  to  prepare  a  general 
IUCLID  5  dossier,  giving  you  details  on  the  different  functionalities  in  IUCLID 5,  as  well  as 
explaining the different sections contained within a dossier; and  

BSM  2  –  Using  R4BP  3  for  biocide  applications,  which  describes  how  to  create  a  valid  legal 
entity  in  IUCLID 5,  create  user  accounts  in  R4BP 3  and  gives  a  detailed  description  of  the 
generic steps in an application ‘wizard’2. 

You  can  login  to  R4BP  3  at:  https://r4bp.echa.europa.eu.  If  you  do  not  have  an 
account,  you are advised to consult  the Summary sheet:  How to  sign-up and login to 
R4BP 3 at the end of this manual.   

1   Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  of  22  May  2012 

concerning the making available on the market and use of biocidal products 

2   The application ‘wizard’ will guide you through the various steps of an application form, prompting you 

to include necessary files such as a dossier and supporting documents. 

 
 
 
 
 
                                           
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Biocides Submission Manual 3 – Part A 

Version 2.3  

1.2

 Icons, abbreviations and terminology 

The BSM series uses various icons and manual specific abbreviations throughout each manual. 
The  icons  are  depicted  in  particular  areas  of  the  text  to  highlight  useful  or  important 
information.  

The following icons are used throughout this manual: 

Useful information, guidance, assistance 

Very important note 

The following abbreviations are used throughout this manual: 

Annex I 
Regulation 

Commission  Implementing  Regulation  (EU)  No  88/2014  of  31  January 
2014specifying a procedure for the amendment of Annex I to Regulation (EU) 
No  528/2012  of  the  European  Parliament  and  of  the  Council  concerning  the 
making available on the market and use of biocidal products 

AS 

active substance 

AS-ACC 

AS-APP 

R4BP  3  abbreviation  for  the  inclusion  in  the  active  substance  and  suppliers 
(Article 95) list.  

Approval of an active substance, approval in an additional product type,  
amendment to the conditions of approval, amendment of Annex I to the BPR; 
abbreviation used in R4BP 3 

AS-RNL 

Active substance renewal; abbreviation used in R4BP 3 

BP 

BPD 

BPR 

biocidal product 

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 

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 
22  May  2012  concerning  the  making  available  on  the  market  and  use  of 
biocidal products 

BPR fee 
Regulation 

Commission  implementing  Regulation  (EU)  No  564/2013  on  the  fees  and 
charges  payable  to  the  European  Chemicals  Agency  pursuant  to  Regulation 
(EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  concerning 
the making available on the market and use of biocidal products 

BSM 

ECHA 

Biocides Submission Manual 

European Chemicals Agency 

IUCLID 5 

International Uniform Chemical Information Database, version 5 

IN-REA 

Inquiry to share data (for active substance); abbreviation used in R4BP 3  

MSCA 

Member State competent authority 

R4BP 3 

Register for Biocidal Products, version 3 

UUID 

Universally Unique Identifier 

 
 
 
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         7 

1.3

 Manual structure 

1.3.1 Specific application chapters 

This  manual  contains  chapters  on  each  application  type  covered  in  this  manual  (section 1.1), 
e.g.  approval  of  an  AS  (and  related  applications),  inclusion  in  the  active  substance  and 
suppliers (Article 95) list, and inquiry to share data.  

These specific application chapters, generally include: 

  The requirements for each application type, i.e. inclusion of a dossier and/or supporting 

documents,  

 

the key steps in submitting an application through R4BP 3, namely using the application 
‘wizard’, and 

  pre-submission  checklists.  The  checklists  contain  a  series  of  application  specific  tasks 
that  must  be  performed  (or  points  to  be  considered)  when  preparing  your  IUCLID 
datasets  (Substance  and  Mixture/Product)  and  dossier,  and  before  submitting  your 
application. 

1.3.2 Summarised information for all BSM manuals 

At the end of the manual, you will find informative summary sheets, and a glossary containing 
common  terms,  with  their  definitions,  and  the  numeric  identifiers  used  throughout  the  BSM 
series. 

The  summary  sheets  are  intended  to  summarise  key  concepts  from  BSM  1  and  BSM  2,  and 
provide  generic  information  important  to  all  applications  submitted  under  the  BPR.  The 
following areas are covered:  

  Application file types 

  Understanding IUCLID datasets  

  Creating a dataset and dossier in IUCLID 5 

  How to make a confidentiality claim in IUCLID 5 

  How to sign-up and login to R4BP 3 

  How your application is handled in ECHA 

  Monitoring the progress of a case 

2. General submission information 

This chapter introduces some basic information on the application types covered in this manual 
(section 1.1). Detailed information on each application is given in its own specific chapter.  

2.1

 Application types 

Both  tables  below  outline  the  abbreviations  used  for  the  application  types  in  R4BP 3,  who 
should submit an application and whether there is an associated ECHA fee. Table 1 outlines the 
separate  application  types  that  are  submitted  through  the  same  application  ‘wizard’;  the 
‘Approval  of  active  substance’  application  ‘wizard’.  Whereas,  Table  2  outlines  the  other 
application types covered in this manual which use their own application ‘wizard’.  

For more information regarding ECHA fees, please see Annex I and II of the BPR fee 
Regulation. 

 
 
 
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Biocides Submission Manual 3 – Part A 

Version 2.3  

Please note that a subsequent Member State competent authority (MSCA) fee may also apply. 
For more information about MSCA fees, please contact the appropriate MSCA helpdesk. If you 
are  unsure  of  how  to  do  this,  you  may  wish  to  consult  the  ECHA  website  at: 
http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks.   

Table 1: Basic application information for applications using the AS-APP ‘wizard’ 

Application 

Case3 
abbreviation 

Who can submit 

ECHA fee 

Approval of active substance 

AS-APP 

Approval of an active 
substance in an additional 
product type 

Amendment to the 
conditions of an approved 
active substance 

AS-APP 

AS-APP 

Amendment of Annex I       

to the BPR 

AS-APP 

Any person wishing to apply for an 
active substance, in a defined product 
type, to be included in the Union list 
of approved active substances 

Any person wishing to apply for the 
approval of an active substance in an 
additional product type 

Any person wishing to apply for an 
amendment to the conditions of use 
for an approved active substance 

Any person wishing to apply for an 
active substance to be included in 
Annex I to the BPR, or amendment of 
restrictions on that inclusion 

Yes* 

Yes* 

Yes* 

Yes* 

Table 2: Basic application information for applications using the respective ‘wizard’ 

Application 

Case3 
abbreviation 

Who can submit 

ECHA fee 

Active substance renewal 

AS-RNL 

Inclusion in the active 
substances and suppliers 
(Article 95) list 

AS-ACC 

Inquiry to share data (for 
active substance) 

IN-REA 

Any person seeking a renewal of an 
active substance, in a defined product 
type, already included in the Union list 
of approved active substances 

Yes* 

Any person established within the 
Union who manufactures or imports a 
relevant substance, on its own or in 
biocidal products (substance supplier) 
or who manufactures or makes 
available on the market a biocidal 
product consisting of, containing or 
generating that relevant substance 
(product supplier)  

Yes* 

Any person intending to perform tests 
or studies on vertebrates (obligatory) 
or not on vertebrates (optional) for 
the purposes of the BPR 

No 

* 

ECHA shall inform the case owner of the fees payable, to its R4BP 3 message list, and will 
reject the application if the fee is not paid within 30 days of notification. 

3   Once you submit an application, a corresponding case is created in R4BP 3. 

 
 
 
 
                                           
 Active substances: Initial submissions 

Release date: Sept 2014         9 

2.2

 Application file types: dossiers and supporting documents 

Depending  on  the  application  type,  and  the  applicant’s  individual  circumstances,  there  are 
several types of information files that may be required as part of an application. These include:  

  a IUCLID dossier, 

  primary supporting documents, and 

  additional supporting documents (available from the ECHA website). 

A IUCLID dossier may be required as part of your application. It is recommended to use the 
designated IUCLID fields, wherever possible, to store your data.  When a dossier is required it 
should be uploaded in R4BP 3 as prompted by the application ‘wizard’.  

For  a  summarised  guide  on  how  to  prepare  a  general  IUCLID  5  dossier,  please  see 
Summary  sheet:  Creating  a  dataset  and  dossier  in  IUCLID  5  at  the  end  of  this 
manual. 

Supporting documents are often required as part of your application. Depending on the type 
of  application  you  are  submitting,  the  relevant  supporting  documents  may  be  required  either 
attached  in  the  IUCLID  dossier  or  uploaded  directly  using  the  R4BP  3  application  ‘wizard’. 
Specific  instructions  on  where  to  include  relevant  supporting  documents  for  each  application 
type are given in each sub-chapter ‘What does my application require’. 

For  a  summary  of  the  types  of  information  files  that  may  be  required  for  your 
application,  please  refer  to  Summary  Sheet:  Application  file  types  at  the  end  of  this 
manual. 

3. Approval (and renewal) of AS and related applications  

3.1

 Introduction  

The BPR maintains the system established under the Biocidal Products Directive 98/8/EC (now 
repealed)  for  the  approval  of  biocidal  active  substances  (in  a  specific  product  type),  followed 
by the authorisation of biocidal products containing that active substance. 

Any person wishing to apply for the approval of an AS in a specific product type must submit 
an  application  for  approval  of  active  substance,  fulfilling  the  requirements  outlined  in 
Article 6 of the BPR. If the application is successful, the active substance will be approved for 
an initial period not exceeding 10 years. 

If you wish to have an approval of an AS renewed for one or more product types, you need to 
submit  an  application  for  renewal  of  active  substance  550  days  before  the  expiry  date  of 
the approval. For more information concerning the data requirements and submission process, 
please contact the ECHA helpdesk. 

If you wish to apply for the approval of an AS in a different product type to the ones for which 
it is already approved, an application for approval of an active substance in an additional 
product type must be made (section 3.3). 

If an AS has been included in the Union list of approved active substances, certain conditions 
may  have  been  imposed  in  the  approval  decision.  Any  person  wishing  to  amend  those 

 
 
 
 
 
 
10  Biocides Submission Manual 3 – Part A 

Version 2.3  

conditions must make an application to amend the conditions of an approval (section 3.4).  

If  you  wish  to  make  an  amendment  of  Annex  I  to  the  BPR  (i.e.  a  first  inclusion  of  an  active 
substance  or  amendments  of  the  restrictions  on  that  inclusion),  you  will  need  to  make  an 
application  for  annex  I  amendment  (section  3.5),  in  accordance  with  the  Commission 
Implementing Regulation (EU) No 88/20144 (Annex I Regulation).  

3.2

   Approval of active substance 

This sub-chapter outlines the requirements for this application type (i.e. AS-APP, abbreviations 
given in Table 1), and how to submit your application via R4BP 3.  

Following  confirmation that  the  submission  has  passed  the  initial  checks  by  ECHA,  an  invoice 
will be issued, to the case owner’s R4BP 3 message list, with the ECHA fee. Once the ECHA fee 
has been paid, the application is ‘accepted’ by ECHA and forwarded to the relevant evaluating 
MSCA  for  validation  and  evaluation.  Note  that  if  the  ECHA  fee  is  not  paid  within  30  days  of 
notification, the application will be rejected.   

In  addition  to  this  sub-chapter,  ECHA  has  provided  guidance  documents  on  its 
website  to  assist  you  in  fulfilling  the  information  requirements  -  Guidance  on 
information requirements. 

3.2.1 What does my application require? 

Table 2 outlines the different types of information files that should be prepared and included in 
an application for approval of an AS. For a description of the different types of information files 
that may be required for an application, please refer to Summary Sheet: Application file types 
at the end of this manual. 

4   Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for 
the  amendment  of  Annex  I  to  Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the 
Council concerning the making available on the market and use of biocidal products.  

 
 
 
 
 
 
 
                                           
 Active substances: Initial submissions 

Release date: Sept 2014         11 

Table 3: Application requirements for approval of active substance  

Application requirements for approval of active substance  

IUCLID dossier 

The application must always contain a IUCLID dossier and must fulfil all of the 
information requirements laid out in Article 6 of the BPR 

Primary supporting 
documents 

i)  A draft risk assessment report5 should always be attached in section 13 

‘Summary and Evaluation’ of the IUCLID dossier 

ii)  Written  confirmation  from  the  proposed  evaluating  MSCA  confirming  their 
agreement to evaluate the application should always be uploaded in step 
3 of the R4BP 3 application ‘wizard’ 

iii)  Whenever  relevant,  attach  in  section  13  ‘Summary  and  Evaluation’  of 

the IUCLID dossier, a: 
letter of access 
- 
‘permission  to  refer’  to  data  granted  by  ECHA  under  Article  63  of  the 
- 
BPR 

Additional supporting 
documents 

The  following  additional  supporting  document  is  always  required  to  be 
uploaded in the R4BP 3 application ‘wizard’: 

i) 

the  supporting  document  approval  of  an  active  substance,  available  from 
the ECHA website 

For  a  summarised  guide  on  how  to  prepare  a  general  IUCLID  5  dossier,  please  see 
Summary sheet: Creating a dataset and dossier in IUCLID at the end of this manual. 

For  detailed  information  on  how  and  what  can  be  claimed  confidential  under 
Article 67(3)  of  the  BPR,  please  consult  BSM  6:  Confidentiality  requests  for  biocide 
applications. Alternatively, consult the Summary sheet: How to make a confidentiality 
claim in IUCLID at the end of this manual. 

3.2.2 Application ‘wizard’ for AS-APP applications 

To launch the correct R4BP 3 application ‘wizard’, click on the ‘NEW APPLICATION’ tab on the 
R4BP  3  taskbar.  Then,  select  ‘AS-APP  -  Approval  of  active  substance’  from  the  list  of 
application types (Figure 1). 

5   The  templates  used  for  the  draft  risk  assessment  report  can  be  found  on  the  supporting  documents 
page of the ECHA website under ‘Template for competent authority report’. The steps to take to attach 
the draft risk assessment report are outlined in BSM 1 - Using IUCLID for biocide applications, chapter 
6.4. 

 
 
 
 
 
 
 
 
 
 
                                           
12  Biocides Submission Manual 3 – Part A 

Version 2.3  

Figure 1: Launching the application ‘wizard’ for AS-APP 

The  R4BP 3  application  ‘wizard’  will  guide  you  through  the  various  steps  of  the  application 
form.  When  navigating  through  the  ‘wizard’,  actions  have  to  be  performed  in  a  particular 
order.  Forward  navigation  occurs  by  clicking  on  the  ‘Next’  button  and  is  disabled  until  the 
mandatory  fields,  marked  with  an  asterisk  ( ),  have  been  filled  in  correctly.  Backward 
navigation  occurs  by  pressing  the  ‘Back’  button  and  allows  you  to  change  previously  saved 
data. You can cancel the submission process at any point by pressing the ‘Cancel’ button. 

The application ‘wizard’ will guide you through the submission steps below. Generic submission 
steps  in  an  R4BP  3  application  ‘wizard’  are  described  in  BSM  2  –  Using  R4BP 3  for  biocide 
applications. 

Step 1.  Set submission details: ‘Case owner6 details’ are automatically filled in as those of 
the logged in user. However, you must select a contact person from  the drop-down 
list  and  the  evaluating  MSCA.  Then,  indicate  to  whom  the  invoice  should  be 
addressed, in the ‘Billing address field’. Note that in all circumstances the invoice will 
be sent to the case owner’s message list in R4BP 3. 

Step 2.  Upload  dossier:  upload  the  final  IUCLID  dossier  (.i5z  format)  with  any  relevant 
supporting  documents  attached  (section  3.2.1).  Click  on  the  ‘+Browse’  button  and 
select the dossier you want to upload. Click on ‘Upload’ and indicate the ‘language’ of 
the dossier using the drop-down lists.  

Step 3.  Upload  supporting  documents:  upload  all  relevant  primary  and/or  additional 
supporting  documents  (section  3.2.1).  Click  on  the  ‘+Browse’  button  and  select  the 
files  you  want  to  upload.  Click  on  ‘Upload’  and  indicate  the  ‘language’  of  the 
supporting documents using the drop-down lists.  

Step 4.  Confirm  application:  carefully  verify  if  the  data  entered  in  the  previous  steps  is 
correct.  If  the  information  entered  is  incorrect,  you  can  update  any  of  the  fields  by 
clicking  the  ‘Back’  button.  When  all  of  the  information  in  the  application  has  been 
verified, confirm the legal declaration and submit your application. 

Step 5. 

Check submission and submission number: After submitting your application, an 
on-screen message will be visible to you and contain a submission number, i.e. the 
unique  number  identifying  this  case  (refer  to  the  glossary  for  more  information  on 

6   Case owner: the legal entity submitting the Article 7 BPR application in R4BP 3. This may be the legal 

entity that is the ‘applicant’ as per Article 7, or a representative of the ‘applicant’. 

 
 
 
 
 
 
 
                                           
 
 Active substances: Initial submissions 

Release date: Sept 2014         13 

numerical identifiers). Check the message instructions to ensure your application will 
be  accepted  for  processing,  for  example,  in  cases  where  a  resubmission  may  be 
required. 

If  you  do  not  receive  this post-submission  message,  your  application has  not  been 
submitted correctly and you will have to start the application process again. 

Step 6.  Monitor  your  case:  as  the  case  owner,  it  is  your  responsibility  to  regularly  check 
your  message  inbox  and  task  items  in  R4BP  3,  to  monitor  the  status  of  your 
submission  and  receive/react  to  requests  from  the  Authorities.  These  may  include 
payment of invoices, or responses to requests for additional information. 

Further information on how your application is processed by  ECHA is summarised in 
Summary sheet: How your application is handled in ECHA at the end of this manual. 

Further  information  on  how  to  track  the  status  of  your  application  in  R4BP 3  is 
summarised in Summary sheet: Monitoring the progress of a case at the end of this 
manual. 

3.2.3 Pre-submission checklists for AS-APP 

This section provides checklists containing a series of tasks that must be performed (or points 
to be considered) when preparing your  IUCLID datasets (Substance and Mixture/Product) and 
dossier,  and  before  submitting  your  application  via the  R4BP  3  application  ‘wizard’.  Note  that 
each pre-submission checklist is application specific. 

For  a  summarised  description  of  IUCLID  datasets,  please  see  Summary  sheet: 
Understanding IUCLID datasets at the end of this manual. 

‘Substance’ dataset checklist: 

  Ensure the dataset template, i.e. ‘view mode’, used to create the main ‘Substance’ dataset is the 

‘BPR Active substance application’. 

  Ensure  the  reference  substance  in  section  2.1  of  the  ‘Substance’  dataset  contains  at  least  one 
identifier (i.e. IUPAC name, EC number, or CAS number) except if your AS is a micro-organism. 
In this case, enter the scientific name of the micro-organism into the ‘IUPAC name’ field. 

  Select one ‘Product type’ in section 7.1 of the ‘Substance’ dataset. If you intend to use the AS in 

additional product types please see section 3.3.  

  Check  that  all  of  the  information  requirements  regarding  the  AS,  according  to  Article  6  of  the 

BPR, are included.  

‘Mixture/Product’ dataset checklist: 

  Ensure the dataset template, i.e. ‘view mode’, used to create the main ‘Mixture/Product’ dataset 

is the ‘BPR Biocidal product authorisation’. 

  Ensure  section  2.3  of  the  ‘Mixture/Product’  dataset  contains  at  least  one  complete  ‘Endpoint 

Study Record’. To complete the endpoint study include a: 

formulation type, and   

o  BP name, 
o 
o  composition  blocks  which  contain  the  function,  concentration  percentage  and  a  link  to 
datasets  for  the  various  components  of  the  representative  BP.  An  AS  (a  ‘Substance’ 
dataset) must be one of the components.  

 
 
 
 
 
 
 
 
14  Biocides Submission Manual 3 – Part A 

Version 2.3  

  Select one ‘Product type’ in section 7.1 of the ‘Mixture/Product’ dataset. If you intend to use the 

AS in additional product types please see section 3.3. 

  Ensure  the  draft  risk  assessment  report  has  been  attached  in  section  13  ‘Summary  and 

evaluation’ of the ‘Mixture/Product’ dataset. 

  Check that all the information requirements regarding the BP, according to Article 6 of the BPR, 

are included.   

  Ensure  you  create  your  dossier  from  the  ‘Mixture/Product’  dataset,  as  outlined  in  BSM  1:  Using 

IUCLID for biocide applications. 

R4BP 3 application ‘wizard’ checklist: 

  Ensure  you  have  selected  the  correct  application  type  from  the  list  under  the  ‘NEW 

APPLICATIONS’ tab on the R4BP 3 taskbar; ‘Approval of active substance’. 

  Ensure the case owner is indicated correctly. 

  Ensure  you  have  uploaded  the  correct  dossier  type.  This  must  be  a  ‘BPR  Active  substance 

application’ dossier created through the ‘Mixture/Product’ dataset.  

  Confirm the legal entity UUID included in the dossier header matches exactly the UUID in R4BP 3 

of the case owner.  

  Ensure you have uploaded all the relevant primary and or additional supporting documents. 

3.3

 Approval of an active substance in additional product types 

Following  the  approval  of  an  AS  in  a  specific  product  type,  as  per  Article  9  of  the  BPR,  an 
application  for  the  approval  of  an  AS  in  additional  product  types  can  be  made.  Any  person 
wishing  to  apply  for  the  approval  of  an  AS  in  additional  product  types  must  submit  an 
application via R4BP 3. 

Following  confirmation that  the  submission  has  passed  the  initial  checks  by  ECHA,  an  invoice 
will be issued, to the case owner’s R4BP 3 message list, with the ECHA fee. Once the ECHA fee 
has  been  paid,  the  application  is  ‘accepted’  by  ECHA  and  will  be  forwarded  to  the  relevant 
evaluating MSCA for validation and evaluation. Note that if the ECHA fee is not paid within 30 
days of notification, the application will be rejected. 

3.3.1 What does my application require? 

The  application  must  be  completed  as  outlined  in  section  3.2,  using  the  same  application 
‘wizard’ and fulfilling all  of the same data  requirements.  The  main difference is the  additional 
supporting  document.  The  application  must  always  contain  the  additional  supporting 
document  for  the  approval  of  an  active  substance  in  an  additional  product  type.  For  a 
description  of  the  different  types  of  information  files  that  may  be  required  for  an  application, 
please refer to Summary Sheet: Application file types at the end of this manual. 

3.4

 Amendment to the conditions of an approval 

If  an  AS  is  included  in  the  Union  list  of  approved  active  substances,  certain  conditions  may 
have been imposed in the approval decision. Any person wishing to apply for the  amendment 
to  the  conditions  of  an  approval,  must  submit  an  application  via  the  ‘Approval  of  active 
substance’ application ‘wizard’ in R4BP 3.  

 
 
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         15 

Following  confirmation that  the  submission  has  passed  the  initial  checks  by  ECHA,  an  invoice 
will be issued, to the case owner’s R4BP 3 message list, with the ECHA fee. Once the ECHA fee 
has  been  paid,  the  application  is  ‘accepted’  by  ECHA  and  will  be  forwarded  to  the  relevant 
evaluating MSCA for validation and evaluation. Note that if the ECHA fee is not paid within 30 
days of notification, the application will be rejected. 

3.4.1 What does my application require? 

For  more  information  concerning  the  data  requirements  and  submission  process,  please 
contact the ECHA helpdesk. 

3.5

 Amendment of Annex I to the BPR 

Annex I of the BPR lists active substances with a more favourable environmental, human and 
animal health profile. The application type, amendment of Annex  I to  the BPR, is broken into 
two parts: 

i) 

ii) 

an  application  for  the  first  inclusion  of  an  active  substance  in  Annex  I  to  the  BPR, 
which may be followed by,  
an application for the amendment of the relevant restrictions on that inclusion.  

Any  person  wishing  to  apply  for  an  amendment  of  Annex  I  to  the  BPR  must  submit  an 
application via  the ‘Approval of active  substance’ application ‘wizard’ in R4BP 3 as  outlined in 
section 3.2.2.  

Following  confirmation that  the  submission  has  passed  the  initial  checks  by  ECHA,  an  invoice 
will be issued to the case owner’s R4BP 3 message list, with the ECHA fee. Once the ECHA fee 
has  been  paid,  the  application  is  ‘accepted’  by  ECHA  and  will  be  forwarded  to  the  relevant 
evaluating MSCA for validation and evaluation. Note that if the ECHA fee is not paid within 30 
days of notification, the application will be rejected. 

3.5.1 What does my application require? 

The  data  requirements  for  an  application  for  an  amendment  of  Annex  I  to  the  BPR  are 
dependent  on  the  category  of  Annex  I  to  the  BPR  concerned.  For  details  on  the  full  data 
requirements, please refer to the Annex I Regulation.  

Applicants  seeking  to  include  an  active  substance  in  categories  1,  2,  3,  4  or  5  of  Annex  I 
must specify and provide:  

1.  evidence to demonstrate that the substance complies with the description of the relevant 

category in which they are seeking the inclusion, 

2.  the  identity  of  the  substance  and  the  intended  uses  of  the  products  for  which  an 

authorisation will be sought, 

3.  conclusive evidence to demonstrate that there is a robust consensus of expert opinion that 

the substance does not give rise to concern 

Applicants  seeking  to  include  an  active  substance  in  category  6  of  Annex  I  must  submit  a 
dossier  containing  a  data  package  through  R4BP  3,  equivalent  to  those  submitted  for  active 
substance approvals (see Article 6 of the BPR), allowing a full risk assessment for the intended 
use. 

Applicants seeking to include an active substance in category 7 of Annex I should contact the 
ECHA Helpdesk. 

The  application  must  always  contain  the  additional  supporting  document  for  annex  I 
amendment available on the ECHA website.  

 
  
16  Biocides Submission Manual 3 – Part A 

Version 2.3  

For a description of the different types of information files that may be required for 
an application, please  refer to  Summary Sheet: Application file types  at the  end of 
this manual. 

4. Inclusion 

in 

the  active  substances  and  suppliers7 

(Article 95) list 

4.1

 Introduction  

From  1st  September  2015,  a  BP  cannot  be  made  available  on  the  Union  market  if  it  contains 
active substances (on its own or in biocidal products) supplied by an entity that is not included 
in  the  ‘active  substances  and  suppliers  (Article 95)  list’  (hereinafter  referred  to  as  the  Article 
95 list). Therefore, any person established within the Union who manufacturers or imports an 
AS  (the  ‘substance  supplier’),  must  be  included  in  the  Article  95  list.  In  addition,  any  person 
who  manufacturers  or  makes  available  on  the  EU  market  a  BP  which  consists  of,  contains  or 
generates that active substance (the ‘product supplier’), must also be included in the Article 95 
list if the manufacturer or importer of that active substance is not listed.  

An  application  for  inclusion  in  the  Article  95  list  can  be  made  in  relation  to  existing  active 
substances,  either  approved  or  pending  approval,  or  new  active  substances  that  have  been 
approved.  

4.2

 Submitting an application for AS-ACC 

This sub-chapter outlines the requirements for this application type (i.e. AS-ACC, abbreviations 
given in Table 2), and how to submit your application via R4BP 3.  

Following  confirmation that  the  submission  has  passed  the  initial  checks  by  ECHA,  an  invoice 
will be issued, to the case owner’s R4BP 3 message list, with the ECHA fee. Once the ECHA fee 
has been paid, the application is ‘accepted’ by ECHA and ECHA will perform the validation and 
evaluation. Note that if the ECHA fee is not paid within 30 days of notification, the application 
will be rejected.  

In  addition  to  this  sub-chapter,  ECHA  has  provided  a  guidance  document  on  its 
website to assist you in fulfilling the information requirements  - Guidance on active 
substance suppliers (Currently under revision). 

4.2.1 What does my application require? 

Table 4 outlines the different types of information files that should be prepared and included in 
an  application  for  inclusion in  the  Article  95 list.  For  a  description  of  the  types  of  information 
files  that  may  be  required  for  an  application,  please  refer  to  Summary  Sheet:  Application  file 
types at the end of this manual. 

7    Note  that  Article  95  of  the  BPR  has  been  amended  by  Regulation  (EU)  334/2014  of  the  European 

Parliament and of the Council of 11 March 2014, which entered into force on 25 April 2014.  

 
 
 
 
 
 
 
 
 
 
                                           
 Active substances: Initial submissions 

Release date: Sept 2014         17 

Table 4: Application requirements for AS-ACC 

Application  requirements for AS-ACC  

If your application is based solely on a letter of access to a complete substance 
dossier, a IUCLID dossier is not required. 

IUCLID dossier 

In  all  other  instances  (e.g.  based  on  letters  of  access  together  with 
complimentary information, a mixed-type dossier) a IUCLID dossier is required. 

Whenever relevant, please include: 

i) 

‘permission to refer’ to data granted by ECHA under Article 63 of the BPR, 
attached in Section 13 of your IUCLID dossier 

Primary supporting 
documents 

ii) 

letter  of  access  (containing  information  about  which  product  types  the 
application is for) 

-  When your application is based on a letter of access to a complete 

substance dossier, please upload in the R4BP 3 application ‘wizard’. 

-  When your application is based on a mixed type dossier, please attach 

in section 13 of your IUCLID dossier. 

Additional supporting 
documents 

The  following  additional  supporting  document  is  always  required  to  be 
uploaded in the R4BP 3 application ‘wizard’: 

i)  The  supporting  document  for  the  application  for  the  inclusion  in  Active 
substances and suppliers (Article 95) list available from the ECHA website 

For  a  summarised  guide  on  how  to  prepare  a  general  IUCLID  5  dossier,  please  see 
Summary sheet: Creating a dataset and dossier in IUCLID at the end of this manual. 

For  detailed  information  on  how  and  what  can  be  claimed  confidential  under 
Article 67(3)  of  the  BPR,  please  consult  BSM  6:  Confidentiality  requests  for  biocide 
applications. Alternatively, consult the Summary sheet: How to make a confidentiality 
claim in IUCLID at the end of this manual. 

4.2.2 Application ‘wizard’ for AS-ACC 

To launch the correct R4BP 3 application ‘wizard’, click on the ‘NEW APPLICATION’ tab on the 
R4BP 3 taskbar. Then, select ‘AS-ACC - Inclusion in the Article 95 (active substance suppliers) 
list’ from the list of application types (Figure 2).  

 
 
 
 
 
 
 
 
 
 
18  Biocides Submission Manual 3 – Part A 

Version 2.3  

Figure 2: Launching the application ‘wizard’ for AS-ACC 

The  R4BP  3  application  ‘wizard’  will  guide  you  through  the  various  steps  of  the  application 
form.  When  navigating  through  the  ‘wizard’,  actions  have  to  be  performed  in  a  particular 
order.  Forward  navigation  occurs  by  clicking  on  the  ‘Next’  button  and  is  disabled  until  the 
mandatory  fields,  marked  with  an  asterisk  ( ),  have  been  filled  in  correctly.  Backward 
navigation  occurs  by  pressing  the  ‘Back’  button  and  allows  you  to  change  previously  saved 
data. You can cancel the submission process at any point by pressing the ‘Cancel’ button. 

The application ‘wizard’ will guide you through the submission steps below. Generic submission 
steps  in  an  R4BP  3  application  ‘wizard’  are  described  in  BSM  2  –  Using  R4BP 3  for  biocide 
applications. 

Step 1.  Set submission details: ‘Case  owner8 details’ are automatically filled in as those 
of  the  logged  in  user.  However,  you  must  select  a  contact  person  from  the  drop-
down  list.  In  the  ‘Details  of  relevant  person9’,  enter  the  asset  owner’s10  ‘Company 
UUID’ or select ‘Same as case owner’.  

Then, pick the AS for which you are applying to be included in the Article 95 list for, 
by clicking on the pointer (
) in the ‘Active substance’ field (Figure 3). Clicking on 
the AS will automatically fill in the other fields, i.e. the common name, EC number 
and CAS number, if available in the database. 

8   Case  owner:  the  entity  submitting  the  Article  95  BPR  application.  It  may  be  a  representative  of  the 

entity supporting the AS approval (asset owner). 

9   The ‘relevant person’ will be the entity included in the Article 95 list.  

10  Asset  owner:  the  entity  to  be  included  in  the  Article  95  list.  It  may  be  the  same  as  the  case  owner 

where no representative is appointed. 

 
 
  
 
 
                                           
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         19 

Figure 3: Selecting a substance in an application ‘wizard’ 

If you cannot find the relevant AS in the drop-down list, please contact the ECHA 
Helpdesk via the webform. 

Step 2.  Upload dossier: when relevant, upload the final IUCLID dossier (.i5z format) with 
any relevant supporting documents attached (section 4.2.1). Click on the ‘+Browse’ 
button and select the dossier you want to upload. Click on ‘Upload’ and indicate the 
‘language’ of the dossier using the drop-down lists.  

Step 3.  Upload letter of access: when relevant, upload the letter of access, by clicking on 
the  ‘+Browse’  button  and  selecting  the  file  you  want  to  upload.  Click  on  ‘Upload’ 
and indicate the ‘language’ of the letter of access using the drop-down lists.  

Step 4.  Upload supporting documents: upload the additional supporting document, and 
any  other  relevant  supporting  documents  for  your  application  (section 4.2.1),  by 
clicking on the ‘+Browse’ button and selecting the files you want to upload. Click on 
‘Upload’  and  indicate  the  ‘language’  of  the  supporting  document  using  the  drop-
down lists.  

Step 5.  Confirm  application:  carefully  verify  if  the  data  entered  in  the  previous  steps  is 
correct. If the information entered is incorrect, you can update any of the fields by 
clicking  the  ‘Back’  button.  When  all  of  the  information  in  the  application  has  been 
verified, confirm the legal declaration and submit your application. 

Step 6.  Check submission and submission number:  After submitting your application, 
an on-screen message will be visible to you and contain a submission number, i.e. 
the unique number identifying this case (refer to the glossary for more information 
on numerical identifiers). Check the message instructions to ensure your application 
will be accepted for processing, for example, in cases where a resubmission may be 
required. 

If you do not receive this post-submission message, your application has not been 
submitted correctly and you will have to start the application process again. 

Step 7.  Monitor your case: as the case owner, it is your responsibility to regularly check 
your  message  inbox  and  task  items  in  R4BP  3,  to  monitor  the  status  of  your 
submission  and  receive/react  to  requests  from  the  Authorities.  These  may  include 
payment of invoices, or responses to requests for additional information. 

 
 
 
 
 
 
 
 
 
 
 
20  Biocides Submission Manual 3 – Part A 

Version 2.3  

Further information on how your application is processed by ECHA is summarised in 
Summary sheet: How your application is handled in ECHA at the end of this manual. 

Further  information  on  how  to  track  the  status  of  your  application  in  R4BP 3  is 
summarised in Summary sheet: Monitoring the progress of a case at the end of this 
manual. 

4.3

 Pre-submission checklists for AS-ACC 

The section provides checklists containing a series of tasks that must be performed (or points 
to  be  considered)  when  preparing  your  IUCLID  datasets  (Substance  and  Mixture/Product), 
dossier  and  before  submitting  your  application  via  the  R4BP  3  application  ‘wizard’.  Note  that 
each pre-submission checklist is application specific. 

If you are uploading a IUCLID dossier, to ensure ECHA can process your application 
correctly  you  need  to  submit  a  valid  dossier.  This  can  only  be  done  by  creating  a 
‘Mixture/Product’  dataset.  This  dataset  need  only  contain  one  section  (IUCLID 
section 2.3), and must be used to create the dossier. 

For  a  summarised  description  of  IUCLID  datasets,  please  see  Summary  sheet: 
Understanding IUCLID datasets at the end of this manual. 

‘Substance’ dataset checklist: 

  Ensure  the  dataset  template,  i.e.  ‘view  mode’,  used  to  create  the  main  ‘Substance’  dataset  is 

‘BPR Active substance application’. 

  Ensure the substance in section 2.1 of the ‘Substance’ dataset contains at least one identifier (i.e. 
IUPAC name, EC number, or CAS number).  The molecular and structural formulae must also be 
included. 

  Ensure section 2.8 of the ‘Substance’ dataset includes the method of manufacturing. This can be 

included in the free text field provided, or as an attachment in this section. 

  Ensure  all  the  primary  and  additional  supporting  documents  that  are  relevant  (e.g.  letter  of 

access, see section 4.2.1) have been attached in section 13 of the IUCLID dossier. 

‘Mixture/Product’ dataset checklist: 

  Ensure the dataset template, i.e. ‘view mode’, used to create the main ‘Mixture/Product’ dataset 

is the ‘BPR Biocidal product authorisation’. 

  Ensure section 2.3 of the ‘Mixture/Product’ dataset contains a complete ‘Endpoint Study Record’. 

To complete the endpoint study, include a composition block containing: 

the function: ‘Active substance’, 

o 
o  concentration percentage, 
o 

the name of the AS and a link to the main ‘Substance’ dataset containing information on 
the AS. 

  Select at least one ‘Product type’ in section 7.1 of the ‘Mixture/Product’ dataset. 

  Ensure  you  create  your  dossier  from  the  ‘Mixture/Product’  dataset,  as  outlined  in  BSM  1:  Using 

IUCLID for biocide applications. 

 
 
 
 
 
 
 
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         21 

R4BP 3 application ‘wizard’ checklist: 

  Ensure  you  have  selected  the  correct  application  type  from  the  list  under  the  ‘NEW 
APPLICATIONS’  tab  on  the  R4BP  3  taskbar;  ‘AS-ACC  -  Inclusion  in  the  Article  95  (active 
substance suppliers) list’. 

  Ensure that the case owner and relevant person are indicated correctly. 

  When relevant, ensure you have uploaded the correct dossier type. This must be a  ‘BPR Active 

substance application’ dossier created through the ‘Mixture/Product’ dataset.  

  Confirm the legal entity UUID included in the dossier header matches exactly, either the UUID in 

R4BP 3 of the case owner or the relevant person.  

  When relevant, ensure you have uploaded any letters of access. 

  Ensure  you  have  uploaded  the  supporting  document  for  the  application  for  the  inclusion  in  the 

active substance and suppliers (Article 95) list. 

5. Inquire to share data (for active substance) 

5.1

 Introduction  

The  purpose  of  an  inquiry  to  share  data  is  to  avoid  unnecessary  or  repeated  studies,  in 
particular  tests  on  vertebrate  animals  (Article  62  of  the  BPR).  According  to  Article  62  of  the 
BPR, any person intending to perform tests or studies shall, in the case of data involving tests 
on  vertebrates;  and  may,  in  the  case  of  data  not  involving  tests  on  vertebrates,  submit  a 
written  request  to  ECHA  to  determine  whether  such  tests  or  studies  have  already  been 
submitted. 

Testing  on  vertebrates  for  the  purposes  of  the  BPR  must  only  be  undertaken  as  a  last  resort 
and must not be repeated if already performed and submitted to ECHA, or an MSCA, under the 
BPD or the BPR. An inquiry to share data is also necessary for data sharing dispute procedures, 
in accordance with Article 63 of the BPR.   

It  is  possible  to  submit  a  request  to  share  data  for  either  an  AS  or  a  BP.  This  manual  only 
covers AS applications, for  more information on how to submit an inquiry to share data  for a 
BP, please consult BSM 4a: Biocidal products - Initial submissions. 

An inquiry to share data is obligatory before performing any tests or studies 
involving vertebrates. 

An  inquiry  to  share  data  under  Article  62  of  the  BPR  is  a  pre-condition  to 
starting a data sharing dispute procedure under Article 63 of the BPR. 

After submitting your inquiry, ECHA will determine whether such tests or studies have already 
been  submitted  under  the  BPD  or  the  BPR.  If  ECHA  determines  such  tests  or  studies  have 
already been submitted, ECHA will provide the name and contact details of the data submitter 
to  the  prospective  applicant.  If  the  data  submitter  and  data  owner  are  not  the  same  person, 
the obligation is on the data submitter to ‘facilitate contact’ between the prospective applicant 
and the data owner (Article 62(2) of the BPR). 

 
 
 
 
 
 
 
22  Biocides Submission Manual 3 – Part A 

Version 2.3  

5.2

 Submitting an inquiry for IN-REA 

This  sub-chapter  outlines  the  requirements  for  this  inquiry  application  (i.e.  IN-REA, 
abbreviation  given  in  Table  2),  and  how  to  submit  your  inquiry  via  R4BP 3.  Following 
confirmation  that  the  submission  has  passed  the  initial  checks  by  ECHA,  the  application  is 
accepted and ECHA will assess the inquiry. 

5.2.1 What does my application require? 

When submitting an inquiry to share data, the applicant need only indicate the name of the AS 
they are interested in. 

When  submitting  an  inquiry  to  share  data  for  an  AS,  please  keep  in  mind  that  you  can  only 
inquire about tests or studies that have been submitted under the BPD or the BPR.  

Only  one  AS  is  permissible  per  application.  If  you  wish  to  inquire  about  more 
than one AS, please submit separate applications for each one. 

5.2.2 Application ‘wizard’ for IN-REA 

To launch the correct R4BP 3 application ‘wizard’, click on the ‘NEW APPLICATION’ tab on the 
R4BP 3 taskbar. Then, select ‘IN–REA - Inquire to share data (for active substance)’ from the 
list of application types (Figure 4). 

Figure 4: Launching the application ‘wizard’ for IN-REA 

The  R4BP 3  application  ‘wizard’  will  guide  you  through  the  various  steps  of  the  application 
form.  When  navigating  through  the  ‘wizard’,  actions  have  to  be  performed  in  a  particular 
order.  Forward  navigation  occurs  by  clicking  on  the  ‘Next’  button  and  is  disabled  until  the 
mandatory  fields,  marked  with  an  asterisk  ( ),  have  been  filled  in  correctly.  Backward 
navigation  occurs  by  pressing  the  ‘Back’  button  and  allows  you  to  change  previously  saved 
data. You can cancel the submission process at any point by pressing the ‘Cancel’ button. 

The application ‘wizard’ will guide you through the submission steps below. Generic submission 
steps  in  the  R4BP  3  application  ‘wizard’  are  described  in  BSM  2  –  Using  R4BP  3  for  biocide 
applications. 

 
 
 
 
 
 
 
 
 Active substances: Initial submissions 

Release date: Sept 2014         23 

Step 1. 

Set submission details: ‘Case owner11 details’ are automatically filled in as those 
of  the  logged  in  user.  However,  you  must  select  a  contact  person  from  the  drop-
down list. In the ‘Asset owner12 details’, enter the proposed asset owner ‘Company 
UUID’ or select ‘Same as case owner’.  

Then, pick the AS for which you are inquiring about, by clicking on the pointer (
) 
in the ‘Active substance’ field (Figure 5). Clicking on the AS will automatically fill in 
the other fields, i.e. the common name, EC number and CAS number, if available in 
the database. 

Figure 5: Selecting a substance in the application ‘wizard’ 

If you cannot find the relevant AS in the drop-down list, please contact the ECHA 
Helpdesk via the webform. 

Step 2.  Upload supporting documents: since all the information needed to process your 
application  is  collected  in  the  first  step  of  this  application  ‘wizard’,  please  refrain 
from  attaching  any  supporting  documents  in  Step  2.  Click  the  ‘Next’  button  to 
progress to the final step of the application ‘wizard’. 

Step 3.  Confirm  application:  carefully  verify  if  the  data  entered  in  the  previous  steps  is 
correct. If the information entered is incorrect, you can update any of the fields by 
clicking  the  ‘Back’  button.  When  all  of  the  information  in  the  application  has  been 
verified, confirm the legal declaration and submit your inquiry. 

Step 4.  Check  submission  and  submission  number:  After  submitting  your  application, 
an on-screen message will be visible to you and contain a submission number, i.e. 
the unique number identifying this case (refer to the glossary for more information 
on numerical identifiers). Check the message instructions to ensure your application 
will be accepted for processing, for example, in cases where a resubmission may be 
required. 

If you do not receive this post-submission message, your application has not been 
submitted correctly and you will have to start the application process again. 

11  Case owner: the legal entity submitting the Article 62 BPR written request. It may be a representative 

of the prospective applicant (asset owner). 

12  Asset  owner:  the  legal  entity  that  is  the  prospective  applicant  under  Article  62  BPR.  It  may  be  the 

same as the case owner where no representative is appointed. 

 
 
 
 
 
 
 
 
                                           
 
 
24  Biocides Submission Manual 3 – Part A 

Version 2.3  

Step 5.  Monitor your case: as the case owner, it is your responsibility to regularly check 
your  message  inbox  and  task  items  in  R4BP  3,  to  monitor  the  status  of  your 
submission  and  receive/react  to  requests  from  the  Authorities.  These  may  include 
payment of invoices, or responses to requests for additional information. 

Further information on how your application is processed by ECHA is summarised in 
Summary sheet: How your application is handled in ECHA at the end of this manual. 

Further  information  on  how  to  track  the  status  of  your  application  in  R4BP 3  is 
summarised in Summary sheet: Monitoring the progress of a case at the end of this 
manual. 

5.3

 Pre-submission checklist for IN-REA 

The  section  provides  a  checklist  containing  points  to  be  considered  before  submitting  your 
inquiry. Note that each pre-submission checklist is application specific. 

R4BP 3 application ‘wizard’ checklist: 

  Ensure  you  have  selected  the  correct  application  type  from  the  list  under  the  ‘NEW 

APPLICATIONS’ tab on the R4BP 3 taskbar; ‘Inquire to share data (for active substance)’. 

  Ensure that the case owner and proposed asset owner are indicated correctly. 

  Ensure that you have selected the correct active substance. 

  Ensure there are no supporting documents uploaded. 

 
 
 
 
 
 
  25 

Summary sheet: Application file types 

To compile a complete application, several types of information files may be required as part of 
the  application.  The  different  types  of  information  files  include  IUCLID  dossiers,  primary 
supporting  documents  and  additional  supporting  documents.  The  required  file  types  are 
dependent  on the application being submitted. Please  refer to the specific application chapter 
to  see  the  file  types  required  for  your  application.  Below  is  a  summary  of  the  different  file 
types, and how these documents should be included. 

IUCLID dossier 

Most  application  types  require  the  submission  of  a  dossier,  which  must  be  in  IUCLID  format 
(Art.  79  of  the  BPR),  as  part  of  an  application.  For  more  information  on  how  to  prepare  a 
general IUCLID dossier, please consult BSM 1: Using IUCLID for biocide applications. 

Primary supporting documents 

Depending  on  the  application  type,  primary  supporting  documents  commonly  required  may 
include, but are not limited to, a draft risk assessment report, a draft summary of the product 
characteristics 13 (SPC), and written confirmation from a proposed evaluating MSCA confirming 
their agreement to evaluate the application. Other primary supporting documents that may be 
required  include,  but  are  not  limited  to,  a  letter  of  access,  a  ‘permission  to  refer’  to  data 
granted by ECHA under Article 63 of the BPR, and a decision on technical equivalence. 

In some instances, the primary supporting document will be issued to you by Authorities e.g. a 
decision  on  technical  equivalence,  or  a  ‘permission  to  refer’  to  data;  or  from  industry  actors 
e.g.  a  letter  of  access.  In  other  instances,  you  will  need  to  prepare  the  primary  supporting 
document yourself e.g. a draft risk assessment report14 or a draft SPC. In this instance, there 
are  IT  tools  to  assist  you  available  on  the  ECHA  website.  Where  possible,  the  primary 
supporting documents should be included in Section 13 of the IUCLID dataset using the attach 
function  (
).  Alternatively,  when  no  IUCLID  dossier  is  required,  the  primary  supporting 
documents  can  be  uploaded  in  the  R4BP  3  application  ‘wizard’  using  the  ‘+  Browse’  and 
‘Upload’  buttons.  Check  section  5.2  of  BSM  2:  Using  R4BP  3  for  biocide  submissions  for  full 
instructions. 

Additional supporting documents 

Additional supporting documents are used to assist ECHA with the processing of an application 
made  under  the  BPR.  Standard  templates  for  additional  supporting  documents  can  be 
downloaded  from  the  ECHA  website.  Upon  completion,  they  are  to  be  included  in  your 
application.  Please  refer  to  the  specific  application  chapter  to  see  how  these  additional 
supporting documents should be included in your application. 

13  A  IUCLID  5  Report  Generator  plug-in  is  available  to  assist  you  in  preparing  a  draft  SPC  by 

automatically extracting all the relevant information available from the BP dossier. 

14  The draft risk assessment report should be used similarly to that under the BPD. Details on the format 
to  be  used  can  be  found  in  the  ‘Technical  Notes  for  Guidance  on  Dossier  Preparation  including 
preparation  and  evaluation  of  study  summaries  under  Directive  98/8/EC  Concerning  the  Placing  of 
Biocidal Products on the Market’ in appendices 5.1 to 5.3. 

  
 
 
 
 
 
 
                                           
26 

Summary sheet: Understanding IUCLID datasets 

A  ‘dataset’  is  an  editable  repository  of  technical  and  scientific  data  related  to  an  active 
substance, all components of a biocidal product and the biocidal product15 itself, and is used to 
create a non-editable ‘dossier’. IUCLID provides two different dataset types, one for substance 

data  and  the  other  for  mixture/product  data:  i)  ‘Substance’  dataset  (
‘Mixture/Product’16 dataset (

). 

)  and  ii) 

One IUCLID dataset should be created for each component of the biocidal product, along with 
one for the biocidal product16 itself. All these individual datasets are then linked to each other 
in order to create a valid dossier. To assist you with data entry, you can customise the sections 
in  a  dataset  via  the  ‘view  mode’  (i.e.  dataset  template)  selector.  By  default,  the  dataset 
template  is  set  to  ‘Complete’.  However,  you  should  change  this  by  using  the  black  arrow  to 
open a drop-down list. Note that this list contains numerous dataset templates accommodating 
various chemical regulations e.g. BPR, REACH, CLP etc.  

To create a valid biocide dossier, at least two ‘main’ dataset templates must be completed: 

i) 

ii) 

a ‘BPR Active substance application’ template - for information concerning an active 
substance17, and 
a  ‘BPR  Biocidal  product  authorisation’  template  -  for  information  concerning  the 
biocidal product, biocidal product family, or representative biocidal product.  

Note that all dossiers must contain at least the two ‘main’ datasets. Even in 
cases  where  there  is  no  relevant  biocidal  product,  e.g.  in  the  case  of  technical 
equivalence  assessment  and  Article  95  dossiers.  Please  consult  the  relevant 
Biocide Submission Manuals for more information. 

Supplementary  dataset  templates,  e.g.  ‘BPR  Basic  information’,  should  be  used  to  include 
information  concerning  other  components  of  the  biocidal  product,  e.g.  solvents,  emulsifiers, 
attractants, etc. 

All  datasets  (main  and supplementary)  must  be  linked  to  the  main  ‘Mixture/Product’  dataset, 
i.e.  ‘BPR  Biocidal  product  authorisation’.  This  is  done  in  IUCLID  section  2.3  ‘Biocidal  product 
composition’ of the main biocidal product dataset.   

BPR Basic 
information 
(substance) 

BPR Basic 
information 
(mixture) 

BPR 
Substance 
of concern 

Main 
'Substance' 
dataset 

Main 
'Product' 
dataset 

Dossier (.i5z file) 

15   A biocidal product may refer to a single product, a product family or a representative biocidal product in the case of 

an application for approval of active substance. 

16   In IUCLID terminology, a ‘Mixture/Product’ dataset refers to a biocidal product dataset. 

17   An active substance may be a substance or a micro-organism 

 
  
 
 
 
 
 
 
                                           
  27 

Summary sheet: Creating a dataset and dossier in IUCLID 5 

A  ‘dataset’  is  a  repository  of  data  related  to  an  active  substance18,  all  components  of  a 
biocidal product and the biocidal product19 itself. A ‘dossier20’ is a non-editable snapshot file of 
the information entered into the datasets. IUCLID provides two different dataset types, one for 
substance  data  and  the  other  for  mixture/product  data.  Both  dataset  types  contain  specific 
‘view modes’ that work as a template, enabling appropriate data entry. Below is a summary of 
the steps to follow when preparing a dossier in IUCLID: 

Step 1: Install and open IUCLID. The latest version of IUCLID, version 5, can be downloaded 
free of charge from the IUCLID website: http://iuclid.eu. 

Step 2: Create a new ‘Substance’ dataset by clicking ‘New’ next to the Substance (
) icon on 
the IUCLID 5 homepage. Alternatively, you can ‘Update’ an existing dataset. Create a dataset 
for each substance component of the biocidal product. 

Step 3: Enter active substance information into the ‘Substance’ dataset. Start by choosing the 
correct dataset template using the ‘view mode’ selector. Click the ‘edit’ button (
) and input 
specific data complying with relevant information requirements.  

To  create  a  valid  dossier,  a  ‘Mixture/Product’  dataset  must  always  be  created  and 
used  to  create  your  dossier.  The  ‘Mixture/Product’  dataset  should  be  linked  to  the 
‘Substance’ dataset containing information on the active substance.  

Step 4: Create a new ‘Mixture/Product’ dataset by clicking ‘New’ next to the ‘Mixture/Product’  
(
)  icon  on  the  IUCLID  5  homepage.  Alternatively,  you  can  ‘Update’  an  existing  dataset. 
Create a dataset for each mixture/product component of the biocidal product. 

Step  5:  Enter  biocidal  product  information  into  the  ‘Mixture/Product’  dataset.  Start  by 
choosing  the  correct  dataset  template  using  the  ‘view  mode’  selector.  Click  the  ‘edit’  button     
(
)  and  input  specific  data  complying  with  relevant  information  requirements.  Ensure  that  a 
link  to  the  ‘Substance’  datasets  and  any  additional  ‘Mixture/Product’  datasets  has  been  made 
in section 2.3 of the main ‘Mixture/Product’ dataset. 

Step  6:  Create  a  dossier  by  right-clicking  on  the  relevant  ‘Mixture/Product’  dataset  and 
selecting  ‘Create  dossier’  from  the  menu.  Select  the  correct  dossier  type,  i.e.  ‘BPR  Active 
substance approval’ or ‘BPR Biocidal product authorisation’.  

  Verify your dossier, and if you find any mistakes, you will need to update the section in 

the corresponding dataset and create a new dossier. 

Step  7  Export  your  dossier  from  IUCLID  5,  save  it  on  your  local  IT  environment  in  the 
appropriate .i5z format, and submit it as part of an application via R4BP 3. 

  For  more  detailed  instructions,  please  consult  BSM  1:  Using  IUCLID  for  biocide 

applications. 

18  An active substance may be a substance or a micro-organism 

19  A biocidal product may refer to a single product, a product family or a representative biocidal product 

in the case of an application for approval of active substance. 

20  In accordance with Article 79 of the BPR, create the dossier using the IUCLID software program. 

  
 
 
 
 
                                           
28 

Summary sheet: How to make a confidentiality claim in IUCLID 5 

In accordance with Article 67 of the BPR, ECHA is required to make publicly available and free 
of  charge  certain  information  it  holds  on  active  substances  and  biocidal  products.  However, 
certain  information  can  be  claimed  confidential  according  to  Article  66(4)  of  the  BPR,  if  the 
person  submitting  the  information  also  submits  a  justification  as  to  why  publishing  the 
information  could  be  harmful  for  their  commercial  interests  or  those  of  any  other  party 
concerned.  This  page  summarises  how  to  make  a  confidentiality  claim  in  IUCLID  5.  For  more 
detailed instructions, please consult BSM 6: Confidentiality requests for biocide applications. 

‘Flag’ a IUCLID 5 field as confidential: 

Step 1: Click the confidentiality claim flag (

) to open the ‘Set flags’ window.  

Step 2: Select the type of confidential claim from the pick list: ‘CBI’, ‘IP’, or ‘no PA’. 

Step 3: Include an appropriate justification (

) in the justification text box for every 

confidentiality claim flagged. It is strongly recommended that the template provided 
should be completed (edited as appropriate), for each confidentiality claim.  

Step 4: Select the relevant regulatory programmes from the list provided. If you select 

‘other:’ from the list then you must input the relevant regulatory programme in the 
adjacent free text field. 

Step 5: Click on ‘OK’ to complete. 

A  yellow  flag  (
confidential. 

)  indicates  that  the  field  has  been  ‘flagged’  as 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
Summary sheet: How to sign-up and login to R4BP 3 

To  login  to  R4BP  3  you  must  first  sign-up  as  a  ‘company’  in  REACH-IT.  To  initiate  account 
creation, select ‘Sign up as a Company’ on the REACH-IT sign-up page, as no other account 
type  is  valid  in  R4BP 3.  Below  is  a  summary  of  how  to  create  an  account  and  then  login  to 
R4BP  3.  For  more  detailed  instructions,  please  consult  BSM  2  –  Using  R4BP  3  for  biocide 
applications. 

  29 

A  ‘Terms  and  conditions’  page  is  displayed  and  you  are  encouraged  to  read  the  terms  and 
conditions  of  REACH-IT  use.  If  you  ‘Accept’  the  terms  and  conditions,  you  will  be  guided 
through the steps in the registration process, with the aid of a registration ‘wizard’: 

Step 1: Enter user details. Ensure you record the ‘User ID’ specified in this step as it cannot be 
changed and will be used every time you login to R4BP 3 or, for account management, 
in REACH-IT. 

Step 2: Enter  company  information.  There  are  two  ways  to  achieve  this,  by  importing  an 
existing  LEO21  or  by  manually  inputting  the  data  into  the  designated  fields  of  the 
‘wizard’, and thus creating a LEO. 

Ensure you create one LEO per legal entity, and use the same LEO both in REACH-IT 
sign-up and IUCLID 5 installation. 

Step 3: Enter  billing  information.  Invoices  will  be  created  based  on  the  information  specified 

here. 

Step 4: Enter contact person information. This is a mandatory step for R4BP 3 users.  

Step 5: Carefully  verify  the  data  entered  into  the  previous  steps.  Update  any  incorrect  data 

and then click ‘Next’ to create the account. 

Step 6: A conclusion page will appear. From this page you can go to the REACH-IT homepage, 
for  account  management,  and,  if  appropriate,  export  your  legal  entity’s  LEO  to  your 
local IT environment. 

You can then login to R4BP 3 at: https://r4bp.echa.europa.eu/r4bp-web-industry/  

To  login  to  R4BP  3,  enter  your  ‘User  ID’  and  password  stipulated  during  account  creation  in 
REACH-IT, enter the security CAPTCHA characters, and click ‘Login’. 

When you login to R4BP 3 for the first time a ‘Terms of Service of R4BP 3’ page is displayed 
and you are encouraged to read the terms of service of R4BP 3 use. If you ‘Accept’ the terms 
of service, you will be directed to the R4BP 3 homepage.

21  A Legal Entity Object (LEO) is used to unequivocally identify a legal entity in the IT systems (REACH-
IT, R4BP 3 and IUCLID). A LEO can be created and then exported to your local  IT environment from 
either the IUCLID website or REACH-IT. 

  
 
 
 
 
                                           
 
30 

Summary sheet: How your application is handled by ECHA 

Once an application is submitted via R4BP 3, it is subsequently processed in a series of steps. 
It is the case owner’s responsibility to regularly check the ‘Message list’ in R4BP 3, to monitor 
the status of the application (messages are sent after each processing step) and receive/react 
to  requests  from  the  Authorities.  Below  is  a  summary  of  the  steps  that  the  application  goes 
through,  carried  out  by  ECHA.  For  more  detailed  information,  please  consult  BSM  2:  Using 
R4BP 3 for biocides. 

It  is  not  possible  to  receive  regular  e-mail  notifications  when  new  R4BP  3  internal 
messages arrive, so regular checking of the ‘Message list’ in R4BP 3 is advised. 

Application processing steps carried out in ECHA 

Virus scan and file format validation: In general, all applications undergo a virus scan and 
file  format  validation  after  submission.  These  checks  verify  that  the  application  and  any 
attached  files  are  in  the  correct  format.  If  a  virus  is  identified  or  an  incorrect  file  format  is 
used,  the  submission  will  be  deemed  unsuccessful  and  the  case  owner  will  have  to  resubmit 
the application in the correct file format. 

Business  Rules  Confirmation:  If  the  virus  scan  and  format  check  passes,  the  ‘business 
rules22’ check is carried out.  Only submitted applications meeting all of the business rules will 
be allowed to proceed to the next processing step. If a business rule is not met, the application 
will not be allowed to progress to ‘acceptance’, and a message or task item will be sent to the 
applicant informing them how to proceed. 

Acceptance  task  and  invoicing:  Depending  on  the  type  of  application  submitted,  an  ECHA 
submission  fee  may  be  calculated,  an  invoice  generated  and  sent  to  the  case  owner’s 23 
‘Message list’ in R4BP 3. All invoices must be paid within the given deadline for an application 
to  be  ‘accepted’  by  ECHA.  If  an  invoice  is  not  paid  by  the  given  deadline  the  application  is 
rejected at this stage. For more information concerning invoices, please see BSM 5 – invoicing 
in R4BP 3.  

Confidentiality  claim  screening:  ECHA  screens  all  biocide  dossiers  for  confidentiality 
requests according to Article 67(3) and 67(4) of the BPR. The MSCA will however, perform the 
confidentiality assessment.   

Accepted applications will be forwarded to the appropriate evaluating authority - in most cases 
this  will  be  the  MSCA  nominated  by  the  applicant  during  the  submission  process,  but  it  may 
also be ECHA, e.g. for an assessment of technical equivalence. Once forwarded, the application 
will  be  validated  and  then  evaluated.  The  outcome  of  each  stage  will  be  relayed  to  the 
applicant  within  the  appropriate  time  period  and,  where  relevant,  published  on  the  ECHA 
website accordingly e.g. legal entities included in the Article 95 list. 

22  A  set  of  pre-requisites  that  must  be  fulfilled  before  ECHA  can  establish  that  the  application  can  be 

handled properly and that the required regulatory processes can be carried out.   

23  The  legal  entity  that  submitted  the  application  via  R4BP  3.  This  may  be  the  same  as  the  ‘applicant’ 

(asset owner) in the BPR, if no representative is appointed. 

 
  
 
 
 
 
 
 
                                           
         31 

Summary sheet: Monitoring the progress of a case 

What is a case? Once an application has been submitted via R4BP 3, it becomes a ‘case’ and 
is  visible  in  the  ‘My  cases  list’  located  in  the  ‘CASES’  tab  of  the  R4BP 3  taskbar.  Every  case 
goes  through  several  processing  steps  in  ECHA,  before  it  is  forwarded  to  the  relevant 
Authority.  Through  the  case  details  you  can  manage  and  view  the  progress  of  the  submitted 
application. The following is a guide aimed to assist with the task of monitoring the progress of 
a case. 

Receiving  messages:  The  outcome  of  each  processing  step  is  relayed  as  a  message  to  the 
case owner24 via the R4BP 3 message list, accessed through the ‘MESSAGES’ tab in the R4BP 3 
taskbar.  During  the  processing,  authority  users  will  send  messages  to  the  case  owner, 
providing information concerning the status of the case or requesting additional information. 

History  of  events:  For  a  description  of  what  processing  steps  the  case  has  gone  through, 
click  on  the  case  number  hyperlink  to  open  the  ‘Case  details’  page.  Then  click  the  ‘Events 
history’ sub-tab, which contains a subject column that will provide you with an up-to-date list 
of  all the  steps  that  the  case  has  gone  through  (e.g.  submission,  format  check,  invoice  sent, 
resubmission requested, etc.).   

Detailed information on how to monitor your case can be found in BSM 2: Using 
R4BP 3 for biocides. 

24  The  legal  entity  that  submitted  the  application  via  R4BP  3.  This  may  be  the  same  as  the  ‘applicant’ 

(asset owner) in the BPR if no representative is appointed. 

  
 
 
 
 
 
 
 
 
                                           
32 

For the purposes of the Biocides Submission Manual (BSM) series, the definitions in Article 3 of 
the  Biocidal  Product  Regulation  (EU)  No  528/2012  (BPR)  apply.  The  most  relevant  definitions 
are reproduced below, together with other defined terms that are used in the BSM series. 

Glossary of terms and identifiers 

Terms and definitions 

Active 
substance 

A  substance  or  a  micro-organism  that  has  an  action  on  or  against  harmful 
organisms (Article 3(1)(c) of the BPR). 

New active 
substance 

A  substance  which  was  not  on  the  market  on  14  May  2000,  as  an  active 
substance  of  a  biocidal  product  for  purposes  other  than  scientific  or  product 
and process-orientated research and development (Article 3(1)(e) of the BPR). 

Existing active 
substance 

A substance which was on the market on 14 May 2000 as an active substance 
of a biocidal product for purposes other than scientific or product and process-
orientated research and development (Article 3(1)(d) of the BPR). 

Asset 

In the R4BP 3 context, an asset is a regulatory decision on an application (with 
a unique asset number) related to  either an active substance (e.g.  a  decision 
on  technical  equivalence  or  approval  of  an  active  substance)  or  a  biocidal 
product (e.g. a national authorisation or a Union authorisation). 

Asset owner 

The  legal  entity  that is  the  ‘applicant’  under  the  BPR.  It  may  be  the  same  as 
the case owner where no representative is appointed. 

Authorities 

Meaning the European Chemicals Agency, Member State competent authorities 
and the Commission. 

Authority 
users 

The authority users are comprised of the European Chemicals Agency, Member 
State competent authorities and the Commission. 

Biocidal 
product 

Any  substance  or  mixture,  in  the  form  in  which  it  is  supplied  to  the  user, 
consisting of, containing or generating one or more active substances, with the 
intention  of  destroying,  deterring,  rendering  harmless,  preventing  the  action 
of, or otherwise exerting a controlling effect on, any harmful organism by any 
means other than mere physical or mechanical action. 

Any  substance  or  mixture,  generated  from  substances  or  mixtures  which  do 
not  themselves  fall  under  the  first  indent,  to  be  used  with  the  intention  of 
destroying,  deterring,  rendering  harmless,  preventing  the  action  of,  or 
otherwise exerting a controlling effect on, any harmful organism by any means 
other than mere physical or mechanical action. 

A  treated  article  that  has  a  primary  biocidal  function  shall  be  considered  a 
biocidal product (Article 3(1)(a) of the BPR). 

Relates to an application and is created after the submission of an application 
in  R4BP  3,  by  a  case  owner.  It  includes  all  of  the  steps  in  the  application 
process, which leads to the creation, or the update, of an asset (the regulatory 
decision).  Through  a  case,  denoted  by  a  unique  case  number,  industry  users 
can monitor the progress of the application (case). 

The legal entity submitting the application under the BPR. It is the legal entity 
that  creates  the  case  and  follows  it  through  its  processing;  ensuring  invoices 
are  paid,  providing  any  additional  information  requested  by  authorities, 
commenting on any draft evaluation reports or  opinions, etc. The  case  owner 
may  be  either  the  prospective  asset  owner  or  a  representative  of  the  asset 
owner acting on behalf of the asset owner. 

Case 

Case owner 

 
  
 
 
 
Glossary of terms and identifiers 

         33 

Event 

Evaluating 
MSCA 

An event is a step whereby information (that is needed in the processing of an 
application)  is  submitted.  Examples  include  the  submission  of  an  application, 
the submission of additional information at the request of the authorities, fee 
payment, and the communication of a decision. 

The Member State competent authority that has been chosen by the applicant, 
and who has confirmed agreement to act as the competent authority that will 
evaluate  the  application  for  approval  of  active  substance,  renewal  of  active 
substance  approval,  Union  authorisation  of  a  biocidal  product,  or  renewal  of 
Union authorisation of a biocidal product. 

Industry user 

The legal entity registered with R4BP 3 via REACH-IT (a case owner and/or an 
asset owner). 

Letter of 
access 

An  original  document,  signed  by  the  data  owner  or  its  representative,  which 
states  that  the  data  may  be  used  for  the  benefit  of  a  third  party  by  the 
European  Chemicals  Agency,  Member  State  competent  authorities  or  the 
Commission, for the purposes of the BPR (Article 3(1)(t) of the BPR). 

MSCA 
concerned 

All  of  the  Member  States  in  which  the  biocidal  product  is  authorised  and 
changes to the authorisation, or mutual recognitions are sought. 

Product type 

One  of  the  product-types  specified  in  Annex  V  of  the  BPR  (Art  3(1)(q)  of  the 
BPR). 

R4BP 3 

Register  for  biocidal  products,  version  3,  established  and  maintained  by  the 
European Chemicals Agency, as per Articles 71 and 79 of the BPR. 

Receiving 
MSCA 

The  Member  State  competent  authority  for  which  an  application  for  the 
national authorisation of a biocidal product has been submitted to. 

Reference 
MSCA 

In the context of mutual recognition applications, the Member State competent 
authority which evaluates the initial application for authorisation of the biocidal 
product.  

Target 
processing 
time 

Task 

In the context of an application for a change to an authorisation, the Member 
for 
State  competent  authority  which  evaluates  the 
authorisation of the biocidal product, or where the changes to an authorisation 
are  not  sought  in  that  Member  State,  the  Member  State  competent  authority 
chosen by the applicant and having agreed to be the reference Member State 
competent authority.  

initial  application 

The time within which the European Chemicals Agency would normally be able 
to  undertake  the  chemical  similarity  check.  It  starts  from  the  date  when  the 
European  Chemicals  Agency  has  all  necessary  information  available,  either 
from the applicant or from Member State competent authorities. 

A  working  item  created  by  an  authority  user  and  assigned  to  a  specific  case 
owner’s  account.  A  task  is  created  in  order  to  complete  certain  actions  (e.g. 
request for additional information) required from that case owner. These task 
items must be completed within a specific time period defined by the authority 
user who initiated the task; in compliance with the BPR. The task is identified 
by the task name and is related to a particular case number. 

  
 
 
 
 
34 

Numeric identifiers 

Number 

Description 

Asset number 

Glossary of terms and identifiers 

Case number 

The number relates to an individual application and is created after the 
submission of an application. 

Communication/  
Decision number 

The number is created when a message is sent to an asset owner/case 
owner by an authority user. It is in the following format: 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Glossary of terms and identifiers 

         35 

Number 

Description 

Company UUID 

The UUID number is a random string of letters and numbers automatically 
generated and assigned to a ‘company’ account during the account creation 
stage. When the account is created in REACH-IT, it is in the following 
format:  

e.g. ECHA-ae10d0b4-b1cf-4141-a0d7-f0fd2a22ae7c 

When the account is created via the IUCLID website, it is in the following 
format: 

e.g. IUC5-bfa610ea-fe3c-36b3-8fa2-6faf50bbe66c 

Submission number 

The number relates to a particular case and case number with additional 
digits, indicating the number of submissions.  

Note that it is the same case number (BC-YY000000-11), but a different 
submission number. 

Task number 

The number relates to a particular task item. It is in the following format: 

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