Version 1.1, 09.01.2017/MDA

e-Dossier: Guidance on electronic application for transitional authorisation AN

An application for a transitional authorisation AN can only be submitted for biocidal products that contain at least one notified active substance for which a decision on inclusion in the list in Annex 1 or 2 of the Ordinance on Biocidal Products (OBP; SR 813.12) is still outstanding.

Click here for more information about authorisation AN. Click here to see the unofficial, consolidated list of notified active substances.

Before you can submit an electronic application, you will need to have access to the product register for chemicals (RPC). To obtain access, follow the instructions for Opening a user account.

Go to the following internet page:

www.rpc.admin.ch

If the biocidal product only contains active substances in the lists in Annex 1 or 2 of the Ordinance on Biocidal Products, then an application for this biocidal product must be submitted using harmonised European procedure. The following transitional provisions apply to biocidal products that have been placed on the Swiss market under a transitional authorisation.

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Contents The public product register for chemicals (RPC) ................................................................................................................................................. 3

Master data ............................................................................................................................................................................................................... 4

Classification of the biocidal product ........................................................................................................................................................................10

Composition .............................................................................................................................................................................................................12

GHS labelling of the biocidal product .......................................................................................................................................................................22

Labelling ..................................................................................................................................................................................................................27

Information on use ...................................................................................................................................................................................................28

Uses ........................................................................................................................................................................................................................29

Additional information ..............................................................................................................................................................................................30

Documents...............................................................................................................................................................................................................31

Notes .......................................................................................................................................................................................................................33

Summary .................................................................................................................................................................................................................34

Sending ...................................................................................................................................................................................................................35

PDF record ..............................................................................................................................................................................................................37

Supplying documents retroactively ...........................................................................................................................................................................38

General ....................................................................................................................................................................................................................39

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Registered user

ID

Select language

What’s new in and about the public

register for chemicals

The public product register for chemicals (RPC)

Click to submit an electronic biocidal product application AN

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Master data Applicant; product name

1 The name of the applicant, i.e. the person applying in Switzerland, will be entered automatically.

2 Name of the biocidal product; if the product name is different in the languages selected, it must be added for each language by removing

the .

3 The information entered must be confirmed by clicking “Save”. The system will now generate the specific CPID number.

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Chemical Product

IDentificator

General help on all

topics

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Master data CPID number

1 The CPID number and the main designation have been added to the data set. The specific CPID number must be included in all

correspondence concerning the biocidal product.

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Master data Chemical manufacturer (of the product)

1 Clicking on “Edit” opens a new tab (2) in which the chemical manufacturer can be edited.

3 Companies that are already in the system can be searched for under “Search for manufacturer”. In exceptional cases, a company that has

not been found using the search function can be added in the “Add manufacturer” section.

4 Search field

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Master data Chemical manufacturer (of the product)

1 Enter the search term and confirm the search by pressing Enter (parts of words can be searched for using *xxx).

2 After a short time, a selection of possible companies is displayed. The required entry must then be marked by clicking on it and confirmed

by clicking on “Select”. The entry will now appear under the “Selected manufacturer” tab. Only one entry can be put into the system.

3 When you click on “Update”, the selected entry is automatically transferred to the master data mask (4) to which you will be returned

automatically. Important: Only one chemical manufacturer can be stated.

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Master data Product specification, contact information

Status Rights

“In progress” The company can enter/modify all data

“Under review” The company can only add missing documents (see Navigation Documents) because

the e-dossier has been sent.

“Qualified” The product has been authorised; the company can only enter amendments that have

been notified in advance (see Notifications of changes to existing biocidal

authorisations AN/ACon our website)

1 Only the Authority may assign and manage authorisation numbers.

2 State the aggregate state of the product.

3 If the product consists of several parts (in situ manufacture), a separate e-dossier “Component of a kit” must be submitted for each

component and an e-dossier (KIT) must be submitted for the commercial product. Select “Normal notification” for all other cases.

4 Full contact details of the applicant in Switzerland must be given (additional specialists may be named optionally).

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Master data Product identif iers, descriptors

1 Internal company identifiers can be entered here.

2 Define descriptors using this tab.

3 Save the master data section, wait for confirmation that the data have been saved and move to the next section on the navigation bar.

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Classification of the biocidal product GHS classification

1 Switch to the GHS section (DSD is no longer required).

2 Select the hazard class(es) and hazard category/ies. As soon as this has been done, the associated H-phrases (3) appear. These can be

added by clicking on them. Repeat this process if several phrases are required.

4 If the product has not been classified, a can be inserted here.

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Classification of the biocidal product GHS classification

1 Enter the full classification of the product.

2 Save the Classification section and wait for confirmation that the data have been saved.

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Entries can be deleted by

clicking on X.

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Composition Search for components

1 Substances and preparations can be searched for under the heading “Select components”.

2 Use “Search term” to enter the name of a product or preparation and start the search by pressing Enter or clicking on “Search”. We

recommend searching for reference substances (to enter the composition) by CAS or EC numbers as chemical names often produce no

hits.

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Search for reference

substances:

Standard setting, the search is

only performed in the ideal

substance database.

Search for products:

The search is limited to the

preparations database. To be

used only in exceptional cases.

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Composition Search for components, search results

1 If the search was successful, all the hits will be shown in the list (which may comprise several pages; 2). Select the required component by

clicking on it; a new tab will open automatically:

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Composition Individual components, Content section

1 Headings that manage data entry for the selected substance or preparation

2 The operator must be “=” for normal applications for authorisation AN because the composition to 100% is required (exception: application

for authorisation AN for a biocidal product family).

3 + 4 Enter the content and normally the unit “g /100 g” (percentage unit) as standard. Separate decimal places with a point (e.g. 4.339).

5 Select the function of the substance or preparation. If none of the predefined functions applies, you can select “normal composition”.

Important: The product needs at least one component designated as a “biocidal active substance”

6 All biocidal active substances and hazard-determining substances in the end product must be declared ().

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Selected substance

or preparation

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Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95

BPR) section

1 Clicking on “Edit” will open a new tab named “Edit manufacturer”. Important: Active substance manufacturer(s) and/or active substance

supplier(s) must only be stated for the biocidal active substance(s). It is not essential to name the manufacturer(s) of all the other

components.

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Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95

BPR) section

Please note your obligations under Article 62d OBP. Click here for more information.

1 Companies that are already in the system can be searched for under “Search for manufacturer”. A company that has not been found using

the search function can be added in the “Add manufacturer” section.

2 Enter the search term and confirm by pressing Enter.

3 After a short time, a selection of possible companies is displayed. The required entry must then be marked by clicking on it and confirmed

by clicking on “Add”. The entry will now appear under the “Manufacturer” tab. Several manufacturers can be entered.

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Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95

BPR) section

1 Once all the active substance suppliers for the biocidal active substance have been selected, click on “Update”. This will add the

information to the substance or preparation and you will be automatically returned to the overview of headings for the selected substance or

preparation.

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Composition Individual components, Chemical manufacturer (of the biocidal active substance as stipulated in Article 62d OBP, Article 95

BPR) section

1 The active substance manufacturer(s) is/are now shown and can be modified as required by clicking on “Edit”.

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Composition Individual components, GHS classification heading

1 Select the hazard class and category for the substance or preparation as shown in the CLP Regulation EC 1272/2008.

2 The corresponding H-phrases will now appear and can be selected by inserting a .

3 Click on “Add” to transfer the selected classification into the lower field.

Important: It is no longer essential to state the DSD classification.

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Composition Individual components, GHS classification heading

1 If the substance or preparation has not been classified, or if the relevant data are not available, this can confirmed by inserting a .

2 The GHS classification is shown here; entries can be deleted by clicking on X or modified by clicking on the corresponding line.

3 Once the full GHS classification has been entered, confirm by clicking on “Update”. You will be automatically returned to the overview of

headings for the selected substance or preparation.

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Composition Other components

1 You are now back in the “Select component” section, where you can search for further components.

2 All the components that have already been selected are shown together here. The symbol in the “C/D” column shows you that this

component has been defined as “declared”.

3 Save your entries at the end of the process.

Important: The full composition to 100% must be given. It is not permitted to use ranges.

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Relevant information about the

composition can be entered here

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GHS labelling of the biocidal product H-phrases

1 Select the “H-phrases” drop-down list in the H-phrases section.

2 You can select the required H-phrase by searching in the appropriate field (you can search by number) or by scrolling through the list. Click

on the required phrase to confirm it and click on “Add”.

Important: It is no longer essential to use DSD labelling.

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GHS labelling of the biocidal product H-phrases, variables as a special case

The special case of H-phrases with variables:

The corresponding text must be stated analogously in all selected languages

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GHS labelling of the biocidal product H-phrases

1 All the selected H-phrases are shown here. They can be deleted again by clicking on the X. The Variables column also shows whether

there is an entry that you can read or modify by clicking on the appropriate line.

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GHS labelling of the biocidal product P-phrases

You can enter P-phrases in the same way as H-phrases.

Note: Since the P-phrases stated for biocidal products are determined independently by the future

authorisation holder, and are accordingly not imposed, it is the responsibility of the future authorisation

holder to ensure that the entries are correct (i.e. they will not be checked by the Authority).

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GHS labelling of the biocidal product Hazard pictograms

1 You can select the pictograms you require by inserting a symbol under the relevant pictograms in the “Hazard pictograms” section.

2 Select the appropriate signal word. If no signal word will be used, select “No signal word”.

3 Confirm your entries by clicking on “Save”.

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Labelling User categories, container sizes

1 Select user category/ies When selecting the container sizes, you can select all the entries in the column by inserting a in the grey area at

the top. Otherwise you can add the manually.

2 Confirm your entries by clicking on “Save”.

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Information on use

Note: The Authority completes this section once the product has been evaluated. This information also

forms part of the official decision.

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Uses Uses, areas of use, methods of use, objectives of use

1 Select the appropriate subsections of the biocidal product type(s) here. You can modify the selection options on the right.

2+3+4 Select the required use(s).

5 If a use does not feature under any of the headings, note the fact here, stating the heading concerned.

6 Confirm your entries by clicking on “Save”.

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Additional information

Note: This area is not available yet.

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Documents Uploading documents

Documents relevant for an application for authorisation AN:

Signed printout of the the last page of the record (see chapter on PDF record and Sending

section)

A draft of the label (including information and instructions for use)

Safety data sheet

If appropriate, documentation of efficacy (disinfectants and wood preservatives)

Where appropriate, documentation of the product labelling

The completed supplementary document

1 Click on “Select” to navigate to your personal files, which you can then mark and add to the submission by clicking on “Upload” (2). Most

common formats (such as Word, Excel, PDF, ZIP etc.) can be used. We recommend using self-explanatory file names (such as SDB_D,

SDB_F, Study_EN1650, Label_Front etc.).

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Documents Uploading documents

1 Once documents have been uploaded successfully, they can be renamed.

2 Select document type.

3 Mark to show whether the document should be available to the public (this is the applicant’s responsibility). The document can be deleted

by clicking on X.

4 All uploaded documents are shown together here.

5 Once all the documents have been uploaded, confirm your entries by clicking on “Save”.

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Notes

Note: This is where you can enter additional information about the biocidal product that is connected to

the application for authorisation AN.

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Summary

Note: The summary shows all the information that has been entered so far on a single page in a clear, concise form.

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Sending

You can send the product as soon as you have entered all the relevant data. The status will then change from “In progress” to “Under review” and

the data will be sent to the Notification Authority for Chemicals.

Important: After you have sent the data, you can only “Send documents retroactively”; all the other sections are in read-only mode and can no

longer be edited.

If you get any error messages you will not be able to send the product. Eliminate all the errors, which will be clearly listed, and send the

product again.

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Sending

The following information will appear if you have sent the product successfully:

The following information must now be sent by e-mail to the Notification Authority for Chemicals:

Proprietary name and CPID number of the biocidal product

Confirmation that this is the first application for an authorisation AN

Excel template providing information on the active substance supplier (click here for more

information)

The last page of the scanned product record (see PDF record section)

To the e-mail address: cheminfo@bag.admin.ch

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PDF record

Click on the words “PDF record”

The PDF record will now be generated automatically

Save the document and print out at least the last page

Select the language in which you wish to receive the official decision and sign where indicated.

Important: for legal reasons, only the signature of the applicant in Switzerland can be accepted

Scan this page

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Supplying documents retroactively Supplying documents retroactively (PDF record etc.)

Please note that documents uploaded to the “Documents” tab (where these exist) can be read by

other sub-users.

As described in the “Documents” section, you can add the PDF record subsequently to the product documents that have already been uploaded.

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General

Do not add any other documents while the review is ongoing or after you have received the official decision unless you are requested to do

so by the Authority.

You are likely to incur additional charges if dossiers are incomplete.

Please do not hesitate to contact us if you have any questions or anything is unclear:

cheminfo@bag.admin.ch

+41 (58) 462 73 05

(Mon - Fri: 08.00 am - 12.00 am (noon))