Biocides submission manual : process of dissemination : how todetermine what will be published on the ECHA website from IUCLID sections 9-13 of an active substance application and biocidal product authorisation dossier.
Date: 2016-04-12
Institutions: European Chemicals Agency
Subjects: European Chemicals Agency, Internet site, activity report, chemical industry, chemical product, dissemination of information, environmental risk prevention, industrial research, research and development, testing, user guide

MANUAL 

Biocides Submission 
Manual 

Process of dissemination – How to 
determine what will be published on the 
ECHA website from IUCLID sections 9-13 of 
an active substance application and biocidal 
product authorisation dossier 

 
2 

Biocides Submission Manual 

Version 

Changes 

Version 1.0 

First version 

Version 1.0  

Date 

November 2015 

BSM Process of dissemination – How to determine what will be published on the 
ECHA website from IUCLID sections 9-13 of an active substance application and 
biocidal product authorisation dossier 

Reference: ECHA-15-B-19-EN 
Catalogue number: ED-01-15-839-EN-N 
ISBN: 978-92-9247-653-3 
DOI: 10.2823/5671 
Publ. date:   November 2015 
Language:   EN 

© European Chemicals Agency, 2015 

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). 

Reproduction is authorised provided the source is fully acknowledged in the form  
“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written 
notification is given to the ECHA Communications Unit (publications@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, 00121 Helsinki, Finland 
Visiting address: Annankatu 10, Helsinki, Finland 

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Table of Contents 

Introduction ............................................................................................................... 5 

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

Biocides Submission Manuals .......................................................................................... 5 

Article 67 of the Biocidal Products Regulation (BPR) ........................................................... 6 

The Dissemination portal ................................................................................................ 6 

Web address ................................................................................................................. 6 

Searching in the portal ................................................................................................... 7 

Intellectual property rights ............................................................................................. 7 

The Dissemination process ............................................................................................. 7 

When is the information published? ................................................................................. 7 

Filtering ....................................................................................................................... 7 

Publication .................................................................................................................... 8 

Dissemination plugin for IUCLID ...................................................................................... 8 

How to determine what will be published on the ECHA website from IUCLID sections 

9-13 of an active substance application and biocidal product authorisation 
dossier ................................................................................................................ 10 

Legend ..................................................................................................................... 11 

9.

  Ecotoxicological studies (also in Biocidal Product) ............................................. 12 

9.1. Toxicity to aquatic organisms .................................................................................. 14 

9.1.1. Short-term toxicity testing on fish (also in Biocidal Product under 9.2.1.1.) ................ 14 

9.1.2. Short-term toxicity to aquatic invertebrates (also in Biocidal Product under 9.2.1.2.)... 18 

9.1.3. Growth inhibition study on algae (also in Biocidal Product under 9.2.1.3.) .................. 23 

9.1.5. Inhibition of microbial activity (also in Biocidal Product under 9.2.1.5.) ...................... 27 

9.1.6. Further toxicity studies on aquatic organisms (also in Biocidal Product under 9.2.1.6) . 31 

9.1.6.1. Long-term toxicity testing on fish (also in Biocidal Product under 9.2.1.6.1.) ........... 32 

9.1.6.2. Long-term toxicity testing on invertebrates (also in Biocidal Product under 9.2.1.6.2.)37 

9.1.7. Bioaccumulation in appropriate aquatic species (also in Biocidal Product under 9.2.1.7.)41 

9.1.8. Effects on any other specific, non-target organisms (flora and fauna) believed to be at 

risk (also in Biocidal Product under 9.2.1.8.) .............................................................. 46 

9.1.9. Studies on sediment dwelling organisms (also in Biocidal Product under 9.2.1.9.) ....... 50 

9.1.10. Effects on aquatic macrophytes (also in Biocidal Product under 9.2.1.10.) ................ 55 

9.2. Terrestrial toxicity, initial tests ................................................................................. 60 

9.2.1. Effects on soil microorganisms (also in Biocidal Product under 9.2.2.1.) ..................... 60 

9.2.2. Effects on earthworms or other soil-dwelling non-target invertebrates (also in Biocidal 

Product under 9.2.2.2.) ........................................................................................... 64 

9.2.3. Acute toxicity to plants (also in Biocidal Product under 9.2.2.3.) ............................... 68 

9.4. Effects on birds (also in Biocidal Product under 9.2.4.) ............................................... 73 

9.5. Effects on arthropods (also in Biocidal Product under 9.2.5.) ....................................... 78 

 
 
 
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9.6. Bioconcentration terrestrial (also in Biocidal Product under 9.2.6.) ............................... 83 

9.8. Effects on other non-target, non-aquatic organisms (also in Biocidal Product under 9.2.8.)87 

9.10. Identification of endocrine activity (also in Biocidal Product under 9.2. Further 

Ecotoxicological studies) ........................................................................................ 91 

10.

 Environmental fate and behaviour (also in Biocidal Product) ............................. 93 

10.1. Fate and behaviour in water and sediment .............................................................. 93 

10.1.1. Degradation, initial studies ................................................................................. 93 

10.1.1.1. Abiotic ........................................................................................................... 93 

10.1.1.1.a Abiotic: Hydrolysis as a function of pH and identification of breakdown products .... 93 

10.1.1.1.b Abiotic: Phototransformation in water, including identification if transformation 

products ................................................................................................................ 98 

10.1.1.2. Biotic  Ready / Inherent biodegradability ...................................................... 103 

10.1.2. Adsorption / desorption .................................................................................... 107 

10.1.3. Rate and route of degradation including identification of metabolites and degradation 

products .............................................................................................................. 112 

10.1.5. Field studies ................................................................................................... 116 

10.2. Fate and behaviour in soil ................................................................................... 118 

10.2.1. Laboratory study on rate and route of degradation including identification of the 

processes involved ................................................................................................ 118 

10.2.3. Soil accumulation studies (also in Biocidal Product under 10.1. Foreseeable routes of 

entry into the environment on the basis of the use envisaged) ................................... 123 

10.3. Fate and behaviour in air .................................................................................... 126 

10.3.1. Phototransformation in air ................................................................................ 126 

10.3. Biocidal Product – Leaching behaviour .................................................................. 130 

10.4. Additional information on environmental fate and behaviour (also in Biocidal Product 

under 10.2 Further studies on fate and behaviour in the environment) ...................... 134 

10.4. Biocidal Product – Testing for distribution and dissipation ........................................ 136 

10.6. Monitoring: Identification of all degradation products (>10%) in the studies on 

degradation in soil, water and sediments ............................................................... 138 

11.

 Measures to protect humans, animals and the environment (also in Biocidal 
Product) ........................................................................................................... 141 

11.

 Biocidal Product – Measures to protect humans, animals and the environment 143 

12.

 Classification & Labelling .................................................................................. 145 

12.1. GHS ................................................................................................................. 145 

12.1. Biocidal Product – GHS ....................................................................................... 149 

12.3. Biocidal Product – Packaging (12.7. in Annex III of BPR) ......................................... 153 

13.

 Summary and evaluation (also in Biocidal Product) ......................................... 154 

13.1. PBT assessment ................................................................................................. 155 

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Introduction 

Objective 

This  manual  gives  guidance  on  the  online  access  provided  by  ECHA  to  information  on  active 
substances approved, and biocidal products authorised, under the Biocidal Products Regulation 
(BPR)  (where  the  data  is  in  IUCLID).  It  is  aimed  at  industry,  and  in  particular,  at  managers 
and  technical  experts  in  companies  who  are  responsible  for  making  sure  that  comprehensive 
information is entered in the dossiers. 

Biocides Submission Manuals 

This  manual  is  part  of  the  Biocides  Submission  Manual  (BSM)  series  concerning  technical 
guides, application instructions and process manuals and also includes: 

Technical guides: 

Using IUCLID, 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. 

Using  R4BP  3,  which  describes  how  to  create  user  accounts  in  R4BP  3  through  ECHA 
Accounts and gives a detailed description of the various functionalities of the system. 

Using  the  SPC  Editor,  which  describes  how  to  prepare  a  summary  of  the  product 
characteristics (SPC) required for certain application types. 

Application instructions: 

Application  instruction  manuals  give  guidance  on  how  to  submit  applications  concerning 
various processes concerning active substance approvals and biocidal product authorisations. 

•  Active substances 

•  National authorisations 

•  Simplified authorisations 

•  Union authorisations 

•  Technical equivalence and chemical similarity 

Process manuals: 

Invoicing  in  R4BP  3,  which  describes  the  general information  related  to  invoices  and  credit 
notes issued by ECHA following the submission of an application. 

Confidentiality  requests  for  biocide  applications,  which  describes  how  to  make 
confidentiality claims in IUCLID and which dossier information can be claimed confidential. 

All  of  the  Biocides  Submission  Manuals,  including  the  technical  guides, 
application  instructions  and  related  processes  can  be  found  from  the  ‘ECHA 
website’.  

 
 
  
 
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Article 67 of the Biocidal Products Regulation (BPR) 

Article  67  of  the  Biocidal  Products  Regulation  (BPR)  stipulates  that  the  European  Chemicals 
Agency  (ECHA)  shall  publish  certain  information  it  holds  on  approved  biocidal  active 
substances  and  authorised  biocidal  products  free  of  charge  over  the  internet.  This 
dissemination of information, (online access to the public) is achieved through ECHA’s website, 
in the section ‘Information on Chemicals’. 

This manual provides information about the online access to information on active substances 
approved, and biocidal products authorised, under the BPR.1 The document will help readers to 
understand: 

• 

the basic rules ECHA applies when it disseminates information on approved active 
substances and authorised biocidal products; 

•  which information will be made publicly available on the ECHA website; and 

• 

the steps in the (largely) automated dissemination process. 

Where urgent action is essential to protect human health, safety or the environment, such as 
emergency  situations,  ECHA  may  disclose  additional  information,  in  accordance  with  Article 
66(2).  This  will,  however,  not  happen  in  an  automated  way,  and  is  therefore  not  covered  in 
this manual. 

Because  of  technical  progress  with  IUCLID  and  the  Dissemination  portal,  this  manual  will  be 
regularly updated. We recommend that you check our website regularly to make sure that you 
have the most recent version of the document. 

In  addition  to  this  manual,  a  specific  tool  will  be  made  available  for  applicants  in  the  near 
future. This tool will enable applicants to verify – when preparing a dossier in IUCLID – which 
information  will  be  disseminated  on  the  ECHA  website,  as  explained  further  below  (see 
Dissemination pugin for IUCLID). The tool is a dissemination plug-in for  IUCLID 6 and will be 
available for download from the IUCLID website at: http://iuclid.echa.europa.eu.  

This  manual  presents  what  ECHA  directly  publishes  from  the  IUCLID  dossiers  and  it does  not 
cover information from other documents such as SPCs2, assessment reports, etc.  

The Dissemination portal 

Web address 

Information on chemicals can be accessed through the ECHA website; detailed information on 
approved active substances or authorised biocidal products can be accessed through the ECHA 
website following the below paths: 

Active  substances:  ECHA  Website  >  Information  on  Chemicals  >  Biocidal  Active  Substances: 
http://echa.europa.eu/information-on-chemicals/biocidal-active-substances 

1 The dissemination obligations under Article 67 of the BPR also apply to information on active substances and biocidal 
products  where  the  approval/authorisation  application  was  submitted  under  the  Biocidal  Products  Directive  (BPD) 
(Directive 98/8/EC). The process for doing so is different to that described in this manual due to the use of IUCLID for 
the BPR dossiers. 

2 The information contained in the SPC associated with the authorisation of a biocidal product will be disseminated on 
the ECHA website. It is the responsibility of the authorisation holder and Member State competent authority to make 
sure that this document does not contain confidential information.  

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Biocidal products: ECHA Website > Information on Chemicals > Biocidal Products: 

http://echa.europa.eu/information-on-chemicals/biocidal-products 

Searching in the portal 

Before  you  can  begin  to  search  for  active  substances  and/or  biocidal  products  in  the 
Dissemination  portal,  you  have  to  acknowledge  that  you  have  taken  note  of  the  Legal  Notice 
explaining the nature of the information, the right to use the information, and possible limits to 
the right to use the information. 

You  can  search  for  an  active  substance  in  the  portal  by  its  name,  EC  number,  CAS  number, 
type, biocide ID and approval information.  

A  biocidal  product  can  be  searched  by  its  name,  asset  number,  product-type  and  name,  EC 
number or CAS number, approval ID of its active substance as well as by authorisation data.  

A  list  of  all  the  active  substances  or  biocidal  products  in  the  database  can  be  obtained  by 
searching without entering any search criteria.  

Search results can be reordered by clicking on the individual column headers. 

Intellectual property rights 

You  should  use  the  information  available  in  the  Dissemination  portal  with  care.  Reproduction 
and use or further distribution of the information is subject to copyright laws and may require 
the permission of the owner of that information. 

Data  protection  periods  apply  to  data  submitted  for  the  purposes  of  the  Biocidal  Products 
Directive (BPD) (Directive 98/8/EC) or of the BPR.  Remember that in line with Article 59(1) of 
the  BPR,  the  competent  authorities  may  not  use  that  data  for  the  benefit  of  a  subsequent 
applicant unless it has a letter of access or the data protection periods have expired.  

The  data  protection  periods  are  set  in  Article  60  of  the  BPR  (“Protection  of  Data  held  by 
competent  authorities  or  the  Agency”)  and  Article  95(5)  of  the  BPR  (“Transitional  measures 
concerning access to the active substance dossier”). 

The Dissemination process 

When is the information published? 

For  active  substances,  the  process  of  disseminating  information  from  an  application  dossier 
starts  as  soon  as  the  European  Commission  has  adopted  an  Implementing  Regulation 
providing that the active substance is approved. 

For  biocidal  products,  the  dissemination  process  starts  from  the  date  a  biocidal  product  is 
authorised. 

At this point, the associated dossier – which by now only contains confidentiality claims upheld 
by the relevant authority – is prepared for dissemination, as described below: 

Filtering   

The most important step in the dissemination process of the IUCLID information is the filtering 
step. This is simply a process to remove information that is not required to be published under 
Article  67  of  the  BPR  and  to  remove  information  that  is  claimed  confidential.  The  filtering  of 
IUCLID dossiers is performed by an IT tool. 

 
 
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Figure 1:  Filter rules 

Filter rule processing applied to IUCLID field
Filter rule processing applied to IUCLID field

Input
Input

Field content
Field content

Filter
Filter
Rule
Rule

Output
Output

Field content, or
Field content, or
modified content
modified content

Published
Published

Not published
Not published

Confidential
Confidential
flag(s)
flag(s)

Other
Other
field(s)
field(s)

Other
Other
condition(s)
condition(s)

Control inputs to filter rule (determines output)
Control inputs to filter rule (determines output)

A  filter  rule  is  applied  to  each  field  in  the  IUCLID  dossier.  In  this  manual  (consisting  of  four 
separate parts), you can see the filter rule that applies for all IUCLID fields. The filter rules are 
explained in the legend. 

  Dossier filtering (the removal of information not to be published) is an automated 
process  and  is  independent  of  which  text  you  provide  in  a  certain  field.  Please 
review  your  dossier  before  you  submit  it,  to  make  sure  the  correct  content  is 
provided.  If  you  provide  confidential  information  in  a  field  which  will  be 
disseminated  (e.g.  the  guidance  on  safe  use),  the  information  will  become 
visible on the internet. 

After the filtering step is completed, the filtered dossier will contain only the information from 
the fields that is to be published. 

Publication 

ECHA  disseminates  information  at  substance/product  level.  All  documents  and  information 
from  a  IUCLID  dossier  will  be  linked  to  other  relevant  substance  data  identifiers.  After  the 
filtering step, the dossier is processed to create a set of html web pages. A batch of these web 
pages is regularly published on the ECHA website. As part of the same step, the relevant data 
and metadata are published to allow the search results to be searched and filtered. 

Dissemination plugin for IUCLID 

ECHA is developing a IUCLID plugin tool to enable applicants to verify which information from 
their  IUCLID  dossier  will  be  removed  during  filtering,  and  which  information  will  be  made 
public  on  the  internet.  The  IUCLID  plugin  will  allow  applicants  to  use  it  while  they  are 
preparing  their  BPR  dossier  in  IUCLID.  The  purpose  of  the  plugin  is  to  help  applicants  to 
prepare dossiers that can be disseminated without revealing confidential business information. 

  Very  Important:  Any  confidentiality  claim  must  be  justified  and  the  claim  will 
only  be  implemented  if  it  is  upheld  by  the  relevant  authority.  Therefore,  the 
IUCLID  plugin  tool  will  only  be  illustrative  and  should  not  be  considered  as  a 
definitive  confirmation  of  the  data  that  will  eventually  be  published.  For  guidance 
on  confidentiality  claims,  please  see  the  Biocides  Submission  Manual  on  the 

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Process of confidentiality requests for biocide applications.3 

The  plugin  will  simulate  the  filtering  done  by  ECHA  when  publishing  information  from  the 
IUCLID dossier on the ECHA website. It will use the same filter rules that ECHA uses and will 
produce  a  filtered  dossier  that  will  show  which  information  will  be  made  publicly  available  by 
ECHA  over  the  internet.  The  dissemination  plugin  will  also  produce  a  report,  listing  all 
information whether it was removed from or left in the dossier. 

The dissemination plugin will work with IUCLID 6 and will be made available, free of charge, on 
the IUCLID website at: http://iuclid.echa.europa.eu. 

3 http://echa.europa.eu/documents/10162/14938692/bsm_10_confidentiality_requests_en.pdf 

 
 
 
                                           
 
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How  to  determine  what  will  be  published  on  the  ECHA 
website  from  IUCLID  sections  9-13  of  an  active  substance 
application and biocidal product authorisation dossier 

In  this  manual,  you  can  find  the  filter  rule  –  illustrated  with  screenshots  –  for  every  field  in 
sections 9, 10, 11, 12  and 13 of the  IUCLID 5 dossier.  The  filter rule  which is applied by the 
filter  tool  to  automatically  determine  if  the  content  of  the  field  is  published  on  the  ECHA 
website or not.  

The legend on the next page briefly explains the different filter rules.  

Unless otherwise stated, the rules of the section refer to the active substance dossier.  

To  allow  for  easy  navigation,  the  sections  in  this  manual  use  the  same  numbering  as  the 
sections  in  IUCLID  in  the  appropriate  BPR  view.  For  information  on  the  other  sections  of  the 
IUCLID dossier, please consult the relevant part of the manual (the manual is divided into four 
parts, each dealing with separate groups of IUCLID sections). 

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Legend 

Is always automatically disseminated. 

•  This rule concerns information listed in Article 67(1) and (2). 

Is not automatically disseminated. 

•  This rule concerns information normally deemed to undermine the 

protection of the commercial interests of the persons concerned, or 
information which does not relate to the hazard and safe use of the 
substance. 

Is automatically disseminated unless confidentiality has been claimed on 
this section. 

•  This rule concerns information listed in Article 67(3) and (4). 

Fields that are always automatically disseminated in the active substance 
endpoint sections can be claimed confidential in the biocidal product endpoints 
study records. Confidentiality flags will be disseminated. 

 

•  This rule concerns information listed in Article 67(4). 

The bibliographic references author, title, and source are disseminated 
according to the following rule, with the most important criteria listed first: 

1.1 are not disseminated if the endpoint record is claimed confidential, 

unless the reference type is publication, review article or handbook; 

1.2 are not disseminated if the reference type is study report or company 

data; 

1.3 are not disseminated if at least one of following is provided: testing 

lab, report number, owner company or study number. 

Currently data retrieved from other source (e.g. SPC, R4BP). 

Any confidentiality claim must be justified and the claim will only be implemented if it is upheld 
by the relevant authority. Justifications for claiming the confidentiality are not disseminated. 

 
 
 
 
 
 
 
 
 
 
 
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9.

 Ecotoxicological studies (also in Biocidal Product) 

NB: Biocidal Product           

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9.1. Toxicity to aquatic organisms 

9.1.1. Short-term toxicity testing on fish (also in Biocidal Product under 
9.2.1.1.) 

NB: Biocidal Product           

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9.1.2. Short-term toxicity to aquatic invertebrates (also in Biocidal Product 
under 9.2.1.2.) 

NB: Biocidal Product           

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9.1.3. Growth inhibition study on algae (also in Biocidal Product under 
9.2.1.3.) 

NB: Biocidal Product           

 
 
 
 
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9.1.5. Inhibition of microbial activity (also in Biocidal Product under 9.2.1.5.) 

NB: Biocidal Product        

 
 
 
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Release date: November 2015  31 

9.1.6. Further toxicity studies on aquatic organisms (also in Biocidal Product 
under 9.2.1.6) 

 
 
 
 
 
 
32  Biocides Submission Manual 

Version 1.0  

9.1.6.1. Long-term toxicity testing on fish (also in Biocidal Product under 

9.2.1.6.1.) 

NB: Biocidal Product        

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

 
 
 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  33 

 
 
 
34  Biocides Submission Manual 

Version 1.0  

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

 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  35 

 
 
 
36  Biocides Submission Manual 

Version 1.0  

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

 
 
 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  37 

9.1.6.2. Long-term toxicity testing on invertebrates (also in Biocidal Product 
under 9.2.1.6.2.) 

NB: Biocidal Product        

 
 
 
38  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  39 

 
 
 
40  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  41 

9.1.7. Bioaccumulation in appropriate aquatic species (also in Biocidal 
Product under 9.2.1.7.) 

NB: Biocidal Product        

 
 
 
 
42  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  43 

 
 
 
44  Biocides Submission Manual 

Version 1.0  

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

 
 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  45 

 
 
 
 
 
46  Biocides Submission Manual 

Version 1.0  

9.1.8. Effects on any other specific, non-target organisms (flora and fauna) 

believed to be at risk (also in Biocidal Product under 9.2.1.8.) 

NB: Biocidal Product        

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

 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  47 

 
 
 
48  Biocides Submission Manual 

Version 1.0  

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

 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  49 

 
 
 
 
 
50  Biocides Submission Manual 

Version 1.0  

9.1.9. Studies on sediment dwelling organisms (also in Biocidal Product 
under 9.2.1.9.) 

NB: Biocidal Product        

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

 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  51 

 
 
 
52  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  53 

 
 
 
54  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  55 

9.1.10. Effects on aquatic macrophytes (also in Biocidal Product under 
9.2.1.10.) 

NB: Biocidal Product        

 
 
 
56  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  57 

 
 
 
58  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  59 

 
 
 
 
 
60  Biocides Submission Manual 

Version 1.0  

9.2. Terrestrial toxicity, initial tests 

9.2.1. Effects on soil microorganisms (also in Biocidal Product under 9.2.2.1.) 

NB: Biocidal Product        

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

 
Dissemination – How to determine what will be published 
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Release date: November 2015  61 

 
 
 
62  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  63 

 
 
 
 
 
64  Biocides Submission Manual 

Version 1.0  

9.2.2. Effects on earthworms or other soil-dwelling non-target invertebrates 
(also in Biocidal Product under 9.2.2.2.) 

NB: Biocidal Product        

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

 
Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  65 

 
 
 
66  Biocides Submission Manual 

Version 1.0  

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on the ECHA website 

Release date: November 2015  67 

 
 
 
 
 
68  Biocides Submission Manual 

Version 1.0  

9.2.3. Acute toxicity to plants (also in Biocidal Product under 9.2.2.3.) 

NB: Biocidal Product        

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

 
Dissemination – How to determine what will be published 
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Release date: November 2015  69 

 
 
 
70  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  71 

 
 
 
72  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  73 

9.4. Effects on birds (also in Biocidal Product under 9.2.4.) 

NB: Biocidal Product        

 
 
 
74  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  75 

 
 
 
76  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  77 

 
 
 
 
 
78  Biocides Submission Manual 

Version 1.0  

9.5. Effects on arthropods (also in Biocidal Product under 9.2.5.) 

NB: Biocidal Product        

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Release date: November 2015  79 

 
 
 
80  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  81 

 
 
 
82  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  83 

9.6. Bioconcentration terrestrial (also in Biocidal Product under 9.2.6.) 

NB: Biocidal Product        

 
 
 
 
84  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  85 

 
 
 
 
 
 
86  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  87 

9.8. Effects on other non-target, non-aquatic organisms (also in 
Biocidal Product under 9.2.8.) 

NB: Biocidal Product        

 
 
 
88  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  89 

 
 
 
90  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  91 

9.10. Identification of endocrine activity (also in Biocidal Product 
under 9.2. Further Ecotoxicological studies) 

NB: Biocidal Product        

 
 
 
 
92  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  93 

10.

 Environmental fate and behaviour (also in Biocidal 
Product) 

10.1. Fate and behaviour in water and sediment 

10.1.1. Degradation, initial studies 

10.1.1.1. Abiotic 

10.1.1.1.a  Abiotic: Hydrolysis as a function of pH and identification of 

breakdown products 

 
 
 
 
 
 
94  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  95 

 
 
 
96  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  97 

 
 
 
 
 
98  Biocides Submission Manual 

Version 1.0  

10.1.1.1.b  Abiotic: Phototransformation in water, including identification if 

transformation products 

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Release date: November 2015  99 

 
 
 
100  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  101 

 
 
 
102  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  103 

10.1.1.2. Biotic  Ready / Inherent biodegradability 

 
 
 
104  Biocides Submission Manual 

Version 1.0  

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on the ECHA website 

Release date: November 2015  105 

 
 
 
106  Biocides Submission Manual 

Version 1.0  

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

 
 
 
Dissemination – How to determine what will be published 
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Release date: November 2015  107 

10.1.2. Adsorption / desorption 

 
 
 
 
 
 
108  Biocides Submission Manual 

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Release date: November 2015  109 

 
 
 
110  Biocides Submission Manual 

Version 1.0  

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112  Biocides Submission Manual 

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10.1.3. Rate and route of degradation including identification of metabolites 

and degradation products 

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

 
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Release date: November 2015  113 

 
 
 
114  Biocides Submission Manual 

Version 1.0  

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116  Biocides Submission Manual 

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10.1.5. Field studies 

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118  Biocides Submission Manual 

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10.2. Fate and behaviour in soil 

10.2.1. Laboratory study on rate and route of degradation including 

identification of the processes involved 

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Release date: November 2015  119 

 
 
 
120  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
on the ECHA website 

Release date: November 2015  121 

 
 
 
122  Biocides Submission Manual 

Version 1.0  

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Dissemination – How to determine what will be published 
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Release date: November 2015  123 

10.2.3. Soil accumulation studies (also in Biocidal Product under 10.1. 
Foreseeable routes of entry into the environment on the basis of the use 
envisaged) 

NB: Biocidal Product        

 
 
 
124  Biocides Submission Manual 

Version 1.0  

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126  Biocides Submission Manual 

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10.3. Fate and behaviour in air 

10.3.1. Phototransformation in air 

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Release date: November 2015  127 

 
 
 
 
128  Biocides Submission Manual 

Version 1.0  

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130  Biocides Submission Manual 

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10.3. Biocidal Product – Leaching behaviour 

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Release date: November 2015  131 

 
 
 
132  Biocides Submission Manual 

Version 1.0  

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134  Biocides Submission Manual 

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10.4. Additional information on environmental fate and behaviour (also 
in Biocidal Product under 10.2 Further studies on fate and behaviour in 
the environment) 
NB: Biocidal Product        

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

 
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136  Biocides Submission Manual 

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10.4. Biocidal Product – Testing for distribution and dissipation 

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

 
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138  Biocides Submission Manual 

Version 1.0  

10.6. Monitoring: Identification of all degradation products (>10%) in 
the studies on degradation in soil, water and sediments 

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

 
Dissemination – How to determine what will be published 
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Release date: November 2015  139 

 
 
 
140  Biocides Submission Manual 

Version 1.0  

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

 
 
 
Dissemination – How to determine what will be published 
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Release date: November 2015  141 

11.

 Measures to protect humans, animals and the 
environment (also in Biocidal Product) 

 
 
 
 
142  Biocides Submission Manual 

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Dissemination – How to determine what will be published 
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Release date: November 2015  143 

11.

 Biocidal Product – Measures to protect humans, animals 
and the environment 

 
 
 
 
 
144  Biocides Submission Manual 

Version 1.0  

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Release date: November 2015  145 

12.

 Classification & Labelling 

12.1. GHS 

 
 
 
 
146  Biocides Submission Manual 

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Release date: November 2015  147 

 
 
 
 
148  Biocides Submission Manual 

Version 1.0  

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Release date: November 2015  149 

12.1. Biocidal Product – GHS  

 
 
 
 
150  Biocides Submission Manual 

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Release date: November 2015  151 

 
 
 
 
152  Biocides Submission Manual 

Version 1.0  

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Release date: November 2015  153 

12.3. Biocidal Product – Packaging (12.7. in Annex III of BPR) 

 
 
 
 
 
154  Biocides Submission Manual 

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13.

 Summary and evaluation (also in Biocidal Product) 

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Release date: November 2015  155 

13.1. PBT assessment 

 
 
 
 
 
156  Biocides Submission Manual 

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158  Biocides Submission Manual 

Version 1.0  

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160  Biocides Submission Manual 

Version 1.0  

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

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