Draft addendum to the technical guide “using the SPC editor

Transcription

Draft addendum to the technical guide “using the SPC editor
Addendum to the technical guide “Using the SPC editor”
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Introduction
This addendum illustrates the new features and upgrades introduced to the SPC
Editor in the latest versions (1.2.0 and 1.3.0). The addendum also gives advice on
where to find further information.
The following list highlights the topics that will be described in more detail in the next
chapters:
New features:

Multilingual SPCs

Multilingual user interface

Possibility to edit the product name

Comparing two SPCs

“Cloning” another XML SPC file
Upgrades:

Updated list of active substances

Product family single value concentration range

Improved compatibility with certain text editors (e.g. Microsoft Word and
Adobe) for copy and paste

Pick list values in the function’s fields for “Substances of concern” and “Other
substances”.

“Substance of concern” and “Other substances” panels’ mandatory fields
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2.1
New features
Multilingual SPC creation
The SPC editor enables you to prepare the SPC in any of the 23 official languages
currently in use for the European biocides legislation (all EU languages and
Norwegian).
Please be aware that, as decided by the Coordination Group, the “Target organism”
field is not translated. The user needs to edit the name of the target organism in the
required languages.
Please also note that the free-text fields will not be translated automatically.
2.2
Multilingual user interface
You can select the language for the user interface of the SPC editor as shown below
(top right corner- language selection). This functionality must not be confused with
the document language selection described above (e.g. you can have the user
interface in French and prepare an SPC in English or any other language).
2.3
Product name editing
To ensure that the SPC product is unique, R4BP 3 has an internal control that
assumes that there can be only one biocidal (family) product SPC for a given
combination “Product UUID” / “Market area” / “Authorisation Holder” (LE UUID)1.
The “Product Name” has so far been uniquely associated to the Product UUID and it
was therefore not possible to change the “Product Name”.
Now it is possible to change the product name in an already existing SPC without
changing the Product UUID. This functionality should be used only to fix issues
related to misspelling or migration problems (e.g. a trade name was mistakenly used
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Since R4BP 3.3 an exception to the rule has been introduced for a SBP held by the same
authorisation holder in the same market area as the authorisation it is based on.
as a product name and migrated incorrectly from R4BP 2). Also consider that R4BP 3
has an internal control that ensures the same product name in the uploaded SPC is
used for linked applications, such as mutual recognitions: make sure that the edited
product name is the same in such applications.
N.B.: Notwithstanding this control on the product name, different trade names can
be used whenever applicable.
To edit the product name, click on the pencil icon next to the “Product name”, edit
the new name and tick it.
2.4
Comparing two SPCs
This new SPC editor functionality indicates the differences between two SPCs
(particularly useful for identifying the changes between two versions of an SPC or for
mutual recognition and same biocidal products).
Once a second SPC file is opened from the prompted window, a system of colour
codes will tell you if and where changes have been introduced in an SPC.
2.5
“Cloning” another XML SPC file
You can import in one go all data except the product name, market area and
language from another XML SPC file with the “Import XML” taskbar button, enabling
you to re-use and edit an existing SPC for a similar product.
This requires a complete SPC XML file created by the SPC editor or the IUCLID Report
Generator2.
Please note that the “data import” functionality is limited to the same type of SPC:
(i.e. from a single product SPC file into another single product SPC or from a family
product SPC file into another family product SPC). Therefore, to create a biocidal
product family (BPF) SPC for a single product SPC, you will need to manually copy
and paste the relevant sections.
The SPC editor will alert you if you are trying to import from a wrong SPC file type.
Clicking the “Import XML” button will open a window that allows you to browse your
local IT environment.
Specific section of the SPC can also be imported separately as illustrated for example
in figure 17 of the SPC technical guide “using SPC”.
2
This specific “report generator” (5.5.3) is available on the IUCLID website. It only
generates single product SPC.
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3.1
Upgrades
Updated list of active substances
The list of active substances has been updated. On the “Product information” tab,
you can select the active substance components of the product from the updated list
by clicking on the blue “+ Add Active substance” strip. The list contains all approved
and under evaluation existing, new and Annex I active substances. If you want to
make an application for a new active substances (which is not present in the list yet)
you will need to submit a compliant requests to the ECHA Helpdesk.
3.2
Product family single value concentration range
For all those cases where the company wishes to have authorised a product family
containing a fixed concentration of an active substance, the SPC editor allows you to
enter the same value for the minimum and the maximum concentration range.
3.3
Improved compatibility with certain text editors (e.g. Microsoft Word and
Adobe) for copy and paste
Most copy and paste issues from Microsoft word and Adobe Acrobat occurring with
certain browsers have been fixed.
Nonetheless, should you still experience limitations when pasting information copied
from Microsoft Word and Adobe Acrobat documents; we remind you that you can
overcome the issue by using Notepad as an intermediate step (i.e. pasting to
Notepad and copying the content from Notepad to be finally pasted in the SPC).
3.4
Pick list values in the function’s fields for “Substances of concern” and
“Other substances”.
With version 1.3.0, new fields for the “Pigment and Perfumes” function in the
“Product information” tab have been added to the pick list to increase the accuracy of
the description of the product’s components.
3.5
“Substances of concern” and “Other substances” panels’ mandatory fields
The “CAS and EC number” fields are no longer mandatory in the “Substance of
concern” and “Other substances” panels. This requirement has been lifted since not
all the substances have those two identifiers. The “Content (%)” field is still
mandatory. A minimum value of 0% for the concentration of the “Substance of
concern” and “Other substance” is now allowed for product family SPCs.
NOTE: Limitation in the precautionary and hazard statements
For the time being, a few precautionary and hazard statements modified by CLP ATP 4 and 5 (the latest legally relevant) are not available. Pending their availability in
the next release of the SPC editor, you can add in the “Other information” tab a
statement which is not present in the dropdown lists of the “Hazard Statements” tab.
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More information

SPC editor:
https://r4bp.echa.europa.eu/spc/#/home

SPC editor webpage:
http://echa.europa.eu/support/dossier-submission-tools/spc-editor

Youtube-video tutorials:
https://youtu.be/viXYwigrZIk?list=PL42B2FF693B785C5F
https://youtu.be/gsGBc3TzNAc?list=PL42B2FF693B785C5F