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IUCLID 5
Guidance and Support
Report Generator
Summary of Product
Characteristics (SPC)
User Manual
March 2015
Version 1.2
IUCLID 5 is developed by the European Chemicals
Agency in association with the OECD
Report Generator User Manual – SPC
March 2015
PREFACE
The aim of this guidance document is to provide insight into what kind of information the Report
Generator plug-in captures from IUCLID 5 documents to create an xml file that can be imported in the
SPC Editor. This xml file is not a standalone draft Summary of Product Characteristics (SPC), but
contains data that are required to be included in the SPC. Edition of these data can be carried out in
the SPC Editor.
This guide also provides hints and tips on how to optimise data entry in the IUCLID 5 source records
in such a way that any manual revision work in the SPC Editor is limited to a minimum.
RELATED DOCUMENT
The installation of the Report Generator is described in the Report Generator Installation Guide
available on the IUCLID website: http://iuclid.eu.
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GENERAL INTRODUCTION
1.1 SPC REQUIREMENTS UNDER BPR
The scope of the summary of the biocidal product characteristics (SPC) is defined by the article 22 of
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the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). Since 3 of December 2014, with
the release of R4BP version 3.2, a new SPC format (xml) is mandatory for all companies wishing to
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apply for product authorisations . The tool used for submitting an SPC is the SPC Editor (SPC Editor),
an on-line application published on the ECHA website. The data relevant to the SPC, stored in IUCLID
can be retrieved by newly developed SPC module of the Report Generator, and then uploaded to the
SPC Editor. The outcome of this new SPC module is the xml file that can be imported in the SPC
Editor, edited and saved.
All information that appears in the generated xml file has to be previously inserted into IUCLID, in a
structured way.
1.2 PURPOSE OF THE REPORT GENERATOR (IN THE SCOPE OF THE SPC)
The Report Generator has been designed to assist in preparing a draft SPC by collecting all relevant
information that is stored in IUCLID.
The content of the generated xml file reflects the underlying data contained in the relevant IUCLID
documents. The SPC xml file can be generated several times, if some corrections are needed in the
data source in IUCLID.
Hint:
It is good to start by generating an SPC xml file based on a biocidal product
dataset (instead of a biocidal product authorisation dossier), to see if all fields
are filled-in correctly, and then insert all missing information in the relevant
IUCLID fields. It is strongly recommended to update the IUCLID dataset any
time if there is a need of update the SPC content. Be aware of the risk that any
manual changes made to IUCLID 5-born information in the SPC may result in
inconsistencies, if the IUCLID 5 records are not updated accordingly.
The capture of IUCLID 5 data is controlled by a number of rules used to extract and transfer the most
relevant information. Nevertheless, the user is responsible to verify the quality of the SPC created in
the SPC Editor, on the basis of the SPC xml file generated in IUCLID.
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HOW TO INSTALL AND RUN THE SPC MODULE OF THE REPORT GENERATOR
A separate manual which gives guidance on how to install and run the plug-in (Report Generator
Installation Guide) is available on the IUCLID website: http://iuclid.eu).
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with the exception of application for biocidal product’s renewal
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GENERAL RULES UNDERLYING THE SPC XML FILE GENERATION
In this section the general rules underlying the generation of an xml file containing data required for
the SPC are explained and exemplified. It is demonstrated how the Report Generator works and what
kind of IUCLID 5 information is captured.
3.1 LAYOUT AND FORMAT OF THE GENERATED SPC XML FILE
3.1.1 Structure
The Report Generator generates an xml file that contains the data reqired for the SPC report; these
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sections, used by the SPC Editor , are listed below:
1.
Product information
1.1.
Formulation type
1.2.
Active substances

Common name

IUCPAC name

CAS number

EC number

Content (%)
1.3.
Substances of concern

Function

Common name

IUPAC name

CAS number

EC number

Content (%)
1.4.
2.
Other substances

Function

Common name

IUPAC name

CAS number

EC number

Content (%)
Hazard statements
2.1.
Classification
2.2.
Labelling

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Signal word
There is no numbering in the SPC Editor; here the numbering is added to make the structure in a readable way
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3.

Pictograms

Hazard statements

Precautionary statements
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Authorises uses (for each use)
3.1. Authorised use’s identification

Title for use

Product type

Where relevant, an exact description of the authorised use

Field of use

Field of use description

User categories
3.2.
Target organisms

Scientific name

Common name

Development stage
3.3. Application methods

Method

Detailed description of the method

Application dose

Dilution (%)

Number and timing of application
3.4. Packagings

Type, material and size of packaging

Further description of the packaging

Safety features
3.5. Directions for use
4.

Use-specific instructions for use

Where specific to the use, the particulars of likely direct or indirect effects, first aid
instructions and emergency measures to protect the environment

Where specific to the use, the instructions for safe disposal of the product and its
packaging

Where specific to the use, the conditions of storage and shelf-life of the product under
normal conditions of storage
General directions for use

Instructions for use

Particulars of likely direct or indirect effects, first aid instructions and emergency
measures to protect the environment

Instructions for safe disposal of the product and its packaging
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
5.
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Conditions of storage and shelf-life of the product under normal conditions of storage
Administrative information
5.1. Trade names of the product
5.2. Manufacturers of the product

Name of the manufacturer

Address

Postal code

City

Country

Location of the manufacturing sites
-
Address
-
Postal code
-
City
-
Country
5.3. Manufacturers of the active substance
6.

Name of the manufacturer

Address

Postal code

City

Country

Location of the manufacturing sites
-
Address
-
Postal code
-
City
-
Country
Other information
Please note that the following information, required by the SPC Editor, is not available in IUCLID, so it
will not be transferred to the SPC Editor:

BAS number of an active substances (will be retrieved from the SPC Editor based on EC
number and CAS number transferred form IUCLID, or should be inserted manually)

Use-specific risk mitigation measures and general risk mitigation measures
Please be aware that in some cases the direct mapping between IUCLID and the SPC Editor was not
possible, therefore:

‘Field of use description’, in the SPC Editor, is populated with the content of the additional field
next to option ‘other:’ of ‘Field of use’ in IUCLID, section 7.1
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
‘Substance name’ under ‘Manufacturers of the active substance’ will be retrieved from the
SPC Editor based on EC number and CAS number transferred from IUCLID, or should be
inserted manually

‘Directions for use’ – in the SPC Editor there are two sections where ‘Directions for use’ are
stored; in IUCLID each direction for use is inserted only once: or in section 7.6 (use-specific)
or in section 11 (relevant for all uses). The content of the IUCLID field ‘Proposed instruction for
use’ from section 7.6 will be transferred to the SPC Editor field ‘Use-specific instructions for
use’ under the ‘Authorised uses’ tab. The content of the following IUCLID fields from section
11:
-
‘Recommended methods and precautions concerning storage of biocidal product;
shelf-life of biocidal product’
-
‘Particulars of likely direct or indirect adverse effects’
-
‘First instructions, antidotes’
-
‘Emergency measures to protect environment in case of accident’
will be transferred to the appropriate fields in the SPC Editor tab ‘Directions for use’

Other information – if in IUCLID, in section 13 there is any table, only its content will be
transferred to the SPC Editor “Other information”; the existing format will not be maintained.
3.1.2 File format
The file containing the SPC relevant data will be created in XML format (Extensible Markup
Language). It can be read outside of the SPC Editor, but it is recommended to import the file to the
SPC Editor and edit it only there.
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GUIDANCE ON SPECIFIC IUCLID SECTIONS
An xml file containing information required for the SPC has to be created based on the IUCLID data
stored in a biocidal product dataset or dossier.
The following sections show how to create or open a biocidal product dataset in IUCLID, and which
IUCLID fields shall be filled before the xml file with SPC related data is generated.
All data appearing in the below example are used for exemplification purposes only. The data might
be unrealistic.
Hint:
Please see refer to the ‘BPR dossier creation IUCLID Quick Guide’ on the
IUCLID website before creating a biocidal product dataset, if you are not familiar
with IUCLID. A video-tutorial is also available.
http://www.iuclid.eu/index.php?fuseaction=home.documentation#bprmanual
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4.1 PRODUCT DATASET CREATION
To start inserting data in the biocidal product dataset follow the path shown on the screen shots below,
starting from the home page of IUCLID.
If you need to create a new biocidal product, select New. If you have already created a biocidal
product for which you aim to generate an xml file, select Update to retrieve your dataset.
Figure 1: IUCLID home page with the icon Mixture/Product
Select the product you would like to edit.
Figure 2: A biocidal product dataset in the Navigation window in IUCLID
Double click to open a document. The Section tree appears. Make sure you select the ‘BPR Biocidal
product authorisation’ view as illustrated below.
Figure 3: Navigation window in IUCLID – ‘BPR Biocidal product authorisation’ template selected
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On the left side of the window you can see the sections where the information should be inserted. To
see them all, select ‘Expand all’.
Figure 4: Navigation window in IUCLID – managing a view of the sections
Each time you aim at inserting data in IUCLID, switch to the Edit mode.
Figure 5: ‘Edit item’ in IUCLID
4.2 SPC EDITOR: PRODUCT INFORMATION (IUCLID SECTION 2.3 BIOCIDAL PRODUCT
COMPOSITION )
The information described in this chapter will be transferred from IUCLID section 2.3 to the first tab in
the SPC Editor ‘Product information’.
Figure 6: IUCLID section tree of a biocidal product dataset: section 2.3 Biocidal product composition
Note: The small dot next to section 2.4 means the visual link between section 2.4 and
2.3. Therefore the information on formulation type should be inserted in section 2.3. To
see detailed guide how to create the composition of the biocidal product please refer to
the BPR dossier creation IUCLID Quick Guide on the IUCLID website.
http://www.iuclid.eu/index.php?fuseaction=home.documentation#bprmanual
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Figure 7: IUCLID section 2.3 Biocidal product composition: element transferred to the SPC xml file
Only one biocidal product composition endpoint is allowed for a single biocidal product dataset.
Please note that if there is more than one endpoint in section 2.3 Biocidal product composition, only
the first block will be transferred to the xml file.
Figure 8: IUCLID section tree of a biocidal product dataset: the first endpoint in section 2.3 Biocidal product composition is transferred to
the SPC xml file
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The generation of SPC for an entire product family is not supported by the Report Generator. The
composition of the first biocidal product from the family is transferred to the xml file and then to the
SPC Editor, and can be there edited as a biocidal family product composition (with composition
range). The exact composition of each product has to be added manually in SPC Editor.
Figure 9: IUCLID section tree of a biocidal product family dataset: the first endpoint in section 2.3 Biocidal product composition is
transferred to the SPC xml file
Finally, note that in the current version of the Report Generator information related to all substances
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being components of the biocidal product are transferred to the xml file.
4.3 SPC EDITOR: HAZARD STATEMENTS (IUCLID SECTION 12.1 GHS)
The information on the classification and labelling of the product according to the regulation (EC)
1272/2008 will be transferred from IUCLID section 12.1 to the second tab in the SPC Editor ‘Hazard
statements’.
Figure 10: IUCLID section tree of a biocidal product dataset: section 12.1 GHS
Please note that if there is more than one endpoint in section 12.1 GHS, only the first block will be
transferred to the xml file generated by the Report Generator.
Figure 11: IUCLID section 12.1: the first block is transferred to the SPC xml file
An example of the data transferred from section 12.1 to the SPC has been divided in smaller parts and
presented below.
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In the previous version of the Report Generator only active substances and substances of concern were
transferred to the draft SPC
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Figure 12: IUCLID section 12.1: Hazard categories: physical hazards
Figure 13: IUCLID section 12.1: Hazard categories: health hazards
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Figure 14: IUCLID section 12.1: Hazard categories: reproductive toxicity, germ cell mutagenicity, carcinogenicity
Figure 15: IUCLID section 12.1: Hazard categories: specific target organ toxicity – single and repeated
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Figure 16: IUCLID section 12.1: Hazard categories: environmental hazard
Figure 17: IUCLID section 12.1: Labelling: signal word
IUCLID (Labelling: hazard statement, precautionary statements)
Figure 18: IUCLID section 12.1: Labelling: hazard statement, precautionary statements
Note that pictograms are added automatically in the SPC Editor based on the Classification
transferred from IUCLID. Therefore, it is important to check carefully content of the ‘Hazard
statements’ tab in the SPC Editor. The new entries can be added accordingly to needs.
Hint:
More information about adding entries and editing data in the SPC Editor can
be found in the manual available on the ECHA website:
http://www.echa.europa.eu/documents/10162/14938692/bsm_03_using_spc_en.pdf
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4.4 SPC EDITOR: AUTHORISED USES (IUCLID SECTIONS 7.1, 7.6, 6.1
AND
12.3)
The information used in the SPC Editor tab ‘Authorised uses’ will be transferred from following IUCLID
sections:

7.1 Field(s) of use envisaged for biocidal products and treated articles

7.6 Method of application and a description of this method

6.1 Function and mode of control

12.3 Packaging (12.7 in Annex III of BPR)
Figure 19: IUCLID section tree of a biocidal product dataset: section 7
Note: The small dots next to some sections, e.g. 7.2 or 7.3 mean the visual link between
these sections and section mentioned in the brackets (7.1). Therefore the information
related to these sections should be inserted in the section mentioned between brackets.
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The fields that have to be fileld in in IUCLID section 7.1 to be transferred to the xml file, and then to
SPC Editor are marked in red in the screenshot below.
Figure 20: IUCLID section 7.1: fields transferred to the SPC xml file
Each row in the above displayed table (i.e. each use) should have its corresponding endpoint study
record in section 7.6.
Figure 21: Intended uses of the biocidal product listed in section 7.1 and corresponding endpoints study records in section 7.6
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In each document of section 7.6 there is an indication to which use(s) this very specific endpoint
relates to.
Figure 22. Section 7.6 of the biocidal product dataset: reference to the intended uses in section 7.1
If the all content of the section 7.6 is the same for more than one use, then the endpoint can be linked
to several relevant uses.
The fields that have to be fileld in in IUCLID section 7.6 to be transferred to the xml file, and then to
SPC Editor, are marked in red in the screenshot below.
Figure 23: IUCLID section 7.6: fields transferred to the SPC xml file
Please note, that the ‘Proposed instruction for use’ field should contain all the necessary instructions
for use. For example: period of time needed for the biocidal effect; the interval to be observed between
applications of the biocidal product or between application and the next use of the product treated, or
the next access by humans or animals to the area where the biocidal product has been used,
including particulars concerning decontamination means and measures and duration of necessary
ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning
precautionary measures during transport; precautions to be taken to avoid the development of
resistance.
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Figure 24: IUCLID section tree of a biocidal product dataset: section 6.1 Function and mode of control
Note: The small dot next to section 6.3 means the visual link between this section and
section mentioned in brackets (6.1). Therefore the information related to target
organism(s) should be inserted in section 6.1.
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Figure 25: IUCLID section 6.1: fields transferred to the SPC xml file
Please note that there is no link established between section containing information on target
organisms (6.1) and the uses in section 7.1. Therefore information on all target organisms will be
transferred to each use block in the SPC Editor. Please ensure that the content specific to each use is
inserted only to the relevant block, by adapting it manually.
The fields that have to be fileld in in IUCLID section 12.3 to be transferred to the xml file, and then to
SPC Editor are marked in red in the screenshot below.
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Figure 26: IUCLID section 12.3: fields transferred to the SPC xml file
Please note that there is no link established between section containing information on on the
packaging (12.3) and the uses in section 7.1. Therefore information on the packaging will be
transferred to each use block in the SPC Editor. Please ensure that the content specific to each use is
inserted only to the relevant block, by adapting it manually.
4.5 SPC EDITOR: DIRECTIONS FOR USE (IUCLID SECTION 11)
Figure 27: IUCLID section tree of a biocidal product dataset: section 11 Measures to protect humans, animals and the environment
The fields that have to be fileld in in IUCLID section 11 to be transferred to the xml file, and then to
SPC Editor are marked in red in the screenshot below.
Figure 28: IUCLID section 11: fields transferred to the SPC xml file
4.6 SPC EDITOR: ADMINISTRATIVE INFORMATION (IUCLID SECTIONS 1.1)
The information used in the SPC Editor tab ‘Administrative information’ will be transferred from
following IUCLID sections:

2.1 Trade name or proposed trade name

1.3 Biocidal product manufacturer

1.3 Active substance manufacturer (in the active substance dataset)
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The detailed instruction how to insert required data to those sections is presented below.
Open the section 2.1 of the biocidal product dataset:
Figure 29: IUCLID section tree of a biocidal product dataset: section 2.1 Trade name or proposed trade name
Go to ‘Other names’ and click ‘Add’:
Select ‘Trade name’ from the picklist ‘Name Type’, click OK. Then insert ‘Name’. You can also make a
selection in the ‘Country’ list if relevant.
The ready table looks like that:
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Open the section 1.3 of the biocidal product dataset:
Figure 30: IUCLID section tree of a biocidal product dataset: section 1.3 Biocidal product manufacturer
Click
to add a record.
Link a ‘Legal Entity’ clicking
.
Click on blue arrow to open the ‘Legal Entity’ information:
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Then fill in the information in the tab ‘Contact information’ as shown on the screenshot below:
Figure 31: IUCLID section 1.3 (biocidal product dataset, linked Legal Entity information): field transferred to the SPC xml file
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Information on Manufacturer(s) of the active substance(s) is linked to the Legal Entity (Legal Entities)
of this (these) substance(s).
The way of inserting data is similar to the one described above for the biocidal product manufacturer,
but the insertion of data should start in section 1.3 of the active substance dataset.
Figure 32: IUCLID home page with the icon Substance
Figure 33: IUCLID section tree of an active substance dataset: section 1.3 Active substance manufacturer
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4.7 SPC EDITOR: OTHER INFORMATION (IUCLID SECTIONS 13)
In IUCLID section 13, a field is available in which the user can insert any other information important
for the SPC.
Figure 34: IUCLID section 13: field transferred to the SPC xml file
Please be aware that the table format is not transferred to the SPC Editor, only the content.
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European Chemicals Agency
IUCLID 5 Guidance and Support
Report Generator – SPC
User Manual
March 2015 version 1.2
http://iuclid.eu
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