Volete cercare la domanda e risposta pertinente nella vostra lingua? Basta cambiare la lingua nel menu a tendina in alto.
The SPC is a public document and you cannot enter confidential information. The final SPC is approved by the evaluating Member State competent authority and will be published on the ECHA website.
Applicants who request for confidential information according to Article 66(4) of the Biocidal Products Regulation (BPR) to not be made publicly available, need to include confidentiality claims in their IUCLID technical dossier.
Further information on confidentiality claims can be found in the "BSM Process of confidentiality requests for biocides applications" in the ‘Process manuals' section.
Your national authorities have the means to modify the SPCs available in assets in R4BP 3. They can initiate an amendment of a national authorisation and upload the amended SPC in the related asset in R4BP 3. Note that the SPC available in a national authorisation asset in R4BP 3 will be made publicly available from November 2018. The updated information will be published in the next batch of publicly available information only once your national authorities have completed the relevant changes in R4BP 3.
A case number identifies a particular application or notification submitted to ECHA. A submission number relates to a particular application or notification, and identifies the number of a submission.
If you need to prepare two submissions for the same case (application or notification), e.g. the evaluating authority requests additional information, the following format applies:
Initial submission number: BC-YY 000000-11/1
Submission number for the additional information for the same case: BC-YY 000000-11/2
Note: the case number remains unchanged, while the submission number changes.
A task item relates to a case, requiring an action from you within a specific deadline, e.g. a request for additional information. Messages will provide you with information about the status of your case. Member state competent authorities and ECHA will send communications to your R4BP 3 message inbox. Requests for action will however be sent to your R4BP 3 task inbox. It is your responsibility to regularly monitor your message inbox and task items in your R4BP 3 account to make sure that you react promptly to any request from ECHA or national authorities.
"Tasks due to expire" includes up to 10 tasks where you are required to respond within 10 days.
The "My messages" box shows the latest 10 messages.
New messages are displayed in red while those you have read are displayed in black.
The "Related cases" sub-tab on the case details page will show you both open and closed cases that relate to the particular case/asset you are viewing. A case does not have a final decision yet. For example, a ‘Mutual recognition in parallel' case that is being evaluated in one MSCA can be viewed through the other related ‘Mutual recognition in parallel' cases being assessed in other MSCAs. The "Related assets" tab allows you to access assets related to a particular asset/case.
The following file types are supported: .i6z, .doc, .docx, .pdf, .xls, .xlsx, .ppt, .pptx, .txt and .xml.
File names must NOT exceed 150 characters or contain ASCII special characters.
It is recommended that your file does not exceed 3 GB. If your file is larger than 3 GB, contact ECHA for further support.
"D" stands for delegation, "T" stands for transfer and "N" stands for nomination.
For more information on delegations, nominations and transfers of cases and/or assets in R4BP 3, please refer to the Biocides Submission Manual - Technical Guide: using R4BP 3 for biocide applications.
You receive email notification alerts to the email addresses specified in the contact details of your account.
These emails inform the case owner about the completion of steps in an application or notification submitted through R4BP 3.
If you need to modify or delete a particular user, log in to R4BP 3 and select your user under the ECHA banner; then go to the ‘Contacts’ tab and remove or modify the entry.
Your authorities may request more information from you by using a communication functionality. You can find this message in your message tab.
If the message contains a deadline for your attention, you will find it in the tasks tab with the subject "reply to communication."
Since the communication functionality for authorities is built only to request additional information to support their assessment, you will not be able to upload the technical dossier or the SPC in an XML format. If you have to do so, please contact your authorities and ask them to complete their pending task (to request for additional information).
If you receive this message, it means that you are working with an SPC template migrated from R4BP 2, available in R4BP 3 and not all minimum information needed in the SPC has been provided.
If you include more than one SPC, e.g. in different languages, make sure that all the SPCs are complete.
You can update your company details using ECHA Accounts. Once you log into R4BP 3, select the legal entity under the ECHA banner and click on "Edit" to modify your company details. Here you can modify company billing or contact information.
If more than one contact person has been specified in ECHA Accounts, you can modify this person from the company detailscontacts tab within your case in R4BP 3.
In addition, remember that certain administrative changes, such as the authorisation holder transfer, name or address of the authorisation holder of national authorisations, require the approval of the relevant Member States.
Additional information can be found in Q&A 1474.
Messages in R4BP 3 include communications/decisions from authority users to the case owner. Most of the communications are related to the different steps in the submission process i.e. the format check, business rule failure, submission acceptance by ECHA, invoicing.
The final decision on your application/notification will also be communicated through the R4BP 3 message inbox.
Relevant search options are:
- Status: sent/received
- Message status: read or unread.
- Communication number: every communication/decision is identified in R4BP 3 with a unique communication number.
Since 3 December 2014, all data for on-going applications and authorisations from R4BP2 have been migrated to R4BP 3. You need to access R4BP 3 to search for this information: search for assets if you are looking for authorisations, search for cases if you are looking for on-going applications.
If you cannot find a case or an asset corresponding to one of your ongoing applications or authorisations in R4BP that have been recorded in R4BP2, you need to send a request for each of the cases or assets to the competent authority responsible for this case or asset; When doing so, please include the following files:
- Ongoing application (case): use the template file "case correction". Include the applicant LE UUID, authorisation holder LE UUID and application number in R4BP2.
- Existing authorisation (asset): use the template file "asset correction". Include the authorisation number in R4BP2 and the LE UUID of the authorisation holder.
The LE UUID can be found in the legal entity details of an ECHA account. Further information can be found in the ECHA Accounts manual.
The responsible competent authority will assess your request. If they confirm your ownership of the case or asset, they will request ECHA to transfer your data to the R4BP 3 account corresponding to the LE UUID you have provided.
The European Commission sets the ECHA fees and charges payable under the Biocidal Products Regulation (EU) No 528/2012 (‘the BPR'). The charges are revised annually and agreed with the EU Member States and reflected in the Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013.
The fees for the chemical similarity check service are defined in the ECHA Management Board Decision 31/2013.
Unless specified otherwise, you must pay the fees within 30 days from the date of invoice; the payment due date is specified on the invoice PDF. If the payment is not made by the due date, your application might be rejected due to non-payment. The date of your payment is the date on which the full amount stated in your invoice is deposited in the bank account held by ECHA. (See Q&A 771).
Where the payment is delayed due to reasons outside of your control, ECHA needs sufficient evidence in which you prove that you have made the payment before the due date stated in your invoice.
You must pay your invoice by bank transfer. ECHA's full bank details are stated in the invoice.
ECHA recommends that you pay the invoice as a SEPA payment with shared cost. Within the Single Euro Payments Area (SEPA), the use of IBAN (International Bank Account Number) and BIC (Bank Identifier Code)/SWIFT code is mandatory. This payment method will ensure that ECHA receives the full invoiced amount without any deduction of bank charges. For further information regarding SEPA, please consult: http://www.ecb.int/paym/sepa/html/index.en.html.
If you choose another kind of bank transfer, please make sure that your company bears the full cost of the bank transfer. The invoice will not be considered paid until the full amount has been received by ECHA.
Bank: OP Corporate Bank Plc, Gebhardinaukio 1, 00510 Helsinki, Finland.
Account number: 500001-20275788
IBAN Code: FI58 5000 0120 2757 88
BIC/SWIFT Code: OKOYFIHH
Where an application for active substance approval or biocidal product authorisation or an application for a minor or major change of a product is rejected before or during the validation phase, ECHA will reimburse 90 % of the fee.
Where an application for active substance approval or biocidal product authorisation or an application for a major change of a product is withdrawn before the evaluating competent authority has transmitted its assessment report to ECHA, 75 % of the fee shall be reimbursed.
Where an application is withdrawn after the evaluating competent authority has transmitted its assessment report to ECHA, the Agency will not reimburse the fee.
ECHA is not a private company or a service provider but a European public authority. The exclusion of ECHA's activities and transactions from taxation also results from Article 13(1) of Directive 2006/112/EC (1) on a common system of value added tax, which stipulates:
"States, regional and local government authorities and other bodies governed by public law shall not be regarded as taxable persons in respect of the activities or transactions in which they engage as public authorities, even where they collect dues, fees, contributions or payments in connection with those activities or transactions".
As it is not a taxable person, ECHA does not have a tax residence in any Member State and thus has no taxation number in Finland.
The invoices that ECHA sends through R4BP 3 to companies are issued according to the BPR and the BPR Fee Regulation. Thus, they do not concern private transactions but are fees under public law applicable in all Member States. Based on Directive 2006/112/EC and particularly Article 13(1), these fees are not subject to taxation in any Member State. In the absence of taxation of the fees in any Member State or elsewhere, ECHA shall not be bound to complete any formalities imposed on taxable persons for the avoidance of double taxation.
1) OJ L 347, 11.12.2006, p. 1
On the basis of the daily electronic bank statement, ECHA’s system automatically matches your payment with your open invoice - provided you have indicated the correct payment reference (invoice) number in the free-text message/communications field and you have paid the correct amount.
An additional condition is that you pay each invoice separately as a single payment. One bank transaction per invoice therefore ensures the fast registration of your payment.
ECHA strongly advises you not to pay two or more invoices in the same transaction ("multiple invoice payment"). If you, however, include more than one invoice in the payment, make sure that the invoice references are mentioned in full. Otherwise, the payment has to be manually handled by ECHA's accounting department. This may delay the processing of your payment.
If you can only make multiple invoice payments and you are unable to indicate the full reference numbers in the payment, make sure you follow the instructions in Q&A 775.
Your payment can be swiftly dealt with by ECHA if you follow the guidelines below when making your bank transfer:
- Pay one invoice per transaction (single payment);
- Indicate the correct reference number (eight digit invoice number in your invoice);
- Pay the full amount of the invoice;
- Instruct your bank to use a charger bearer code SHAR (shared costs) if the payment is made in a EURO value amount.
- If you discover a mistake after your payment has been made, please immediately contact ECHA using the ECHA Helpdesk webform available at http://echa.europa.eu/contact.
ECHA does not send confirmations of receipt of payment.
A message will be sent to your R4BP 3 Messages-Inbox informing you that your application/notification has been accepted by ECHA only after the payment has been received and accepted. You can follow up the status of your case under the events history tab in R4BP 3.
A payment advice can either be an extract from your accounts payable department attached to your email message in PDF format. Alternatively, it can be a list of the invoice numbers paid, their total amounts and the payment date in the email message itself.
A payment advice must be sent in the following cases:
- your payment reference (invoice) number was incorrect;
- in the case of a multiple invoice payment where each invoice number is not mentioned in the bank payment message;
- by request of ECHA's accounting department.
If you have indicated the reference (invoice) number in your payment message and it is correct, ECHA does not need any separate payment advice.
You must send a payment advice to ECHA's accounting department: payments (at) echa.europa.eu.
Please indicate 'Payment advice and the payment date' in the subject field. Example: "Payment advice 1 September 2013". No payment advice by conventional mail is required unless ECHA exceptionally requests it.
A proof of payment can either be a copy of your bank statement or a separate confirmation stamped by your bank.
The bank statement can serve as proof that you paid ECHA's invoice by the due date. The bank statement copy or the document stamped by your bank must clearly show the date when you ordered the bank transfer.
If ECHA has received your proof of payment but has not received the payment within a time period judged normal for bank transfers, ECHA's accounting department will contact you.
A payment advice printed from your accounting programme is not a valid proof of payment.
Proofs of payment should be sent as scanned PDF attachments to ECHA's accounting department: payments (at) echa.europa.eu.
No proofs of payment by conventional mail are required unless ECHA exceptionally requests them.
In this case, you must indicate the reference number of the latest invoice. The narrative in your invoice will explain the reasons why a new invoice was issued.
In certain cases of double payment or unclear overpayment, ECHA will refund the received amount paid in excess. Moreover, fees or charges paid after the payment deadline are “returned to sender” through the bank as undue payments.
Please also refer to Q&A 768.
For the payment of certain refunds, ECHA will request the bank account information of your company. In addition, ECHA requires your company to complete and sign the following two forms to process the refund: "Legal entities" that can be found at: http://ec.europa.eu/budget/contracts_grants/info_contracts/legal_entities/legal_entities_en.cfm
and "Financial identification" that can be found at: http://ec.europa.eu/budget/contracts_grants/info_contracts/financial_id/financial_id_en.cfm.
Please send the original signed and stamped forms to ECHA by regular post to the following address:
European Chemicals Agency
P.O. Box 400
We advice that you submit the documents to ECHA's accounting department at payments (at) echa.europa.eu before posting them.
To ensure the timely payment of your invoice, ECHA recommends that all the relevant information is visible in the invoice itself.
However, depending on your internal administrative procedures, it is advisable that your accounting/accounts payable department is ready to proceed with the payment of ECHA's invoices.
We therefore recommend that you set up ECHA's bank account information in the accounting system well in advance of the first invoice's due date. The following link contains ECHA's financial identification form with all the needed details:
If you use an external accounting company, please ensure that all required information about ECHA and the Biocidal Products Regulation is passed on. It is also advisable that clearly relate to ECHA's status as an EU body which is exempt from any national tax or any value added tax. Please refer to Q&A 769 and Q&A 770.
Please make sure that the persons handling the payments of ECHA's invoices are aware that the payment must comprise the full amount. Should additional bank charges apply to your payment, these must be included on top of the full amount of your invoice..
Please inform your accounting department that if the invoice is paid after the due date, the application/notification will be rejected.
The following information about your company is visible on the invoices and credit notes:
- Company name and billing address indicated by the applicant – the information appearing on the invoice is the one filled in the ‘Billing address’ tab in ECHA Accounts.
- Customer ID number – which is the same as the Legal entity UUID.
- DUNS number and VAT number – if provided by the registrant during the sign-up; can be modified later on in the Legal entity details section of ECHA Accounts.
- Purchase order number – if provided by the registrant when submitting the application/notification in R4BP 3.
If you are submitting an application/notification on behalf of the asset owner you can select either your billing address (case owner) or the billing address of the asset owner.
Additional information on how to update your company's general information in ECHA Accounts can be found in the section “How to update legal entity details” of the ECHA Accounts Manual.
When submitting an application/notification, you can indicate your own internal purchase order number. It is not possible to add any forgotten purchase order number or modify it afterwards.
As you register online in R4BP 3 you should not send any purchase orders by ordinary mail or email to ECHA. Please make sure that your system does not send any purchase orders automatically to ECHA. Your purchase order is only for your internal purposes.
If your invoice has not yet been paid, ECHA can cancel it and create a new one with your new company information. If the invoice has been accepted and paid, ECHA cannot modify the invoice.
ECHA is unable to update any company information on your behalf. It is the responsibility of the account owner within the company to make sure that the information is up-to-date.
Firstly, please update your company information in ECHA Accounts as soon as possible. You can easily update your information by signing into ECHA Accounts, selecting the legal entity under the ECHA banner and checking the "Billing address" section. Here you can modify and update your information by clicking on "Edit". Please save your changes at all times.
Immediately after updating your company details, you need to contact the ECHA Helpdesk by using the webform available on the ECHA website at: http://echa.europa.eu/contact.
The company size in your ECHA Accounts cannot be considered for invoicing purposes of applications/notifications submitted through R4BP 3 (further information can be found in FAQ 787). Additional information on how to update your company's general information in ECHA Accounts can be found in section 6.1 – "Updating legal entity details" of the ECHA Accounts Manual available at: http://echa.europa.eu/documents/10162/21721613/echa_accounts_en.pdf
You may indicate your company size in ECHA Accounts; however, this information will not be considered relevant for invoicing purposes of ECHA's fees for applications/notifications submitted through R4BP 3.
By default the company size will be considered as non-SME for all applications/notifications submitted through R4BP 3 where an ECHA fee is applicable, except for those applications/notifications where companies already have an SME status recognised by ECHA.
An SME reduction may be applied for applications for approval, renewal or inclusion in Annex I to Regulation (EU) No 528/2012 of an active substance or for Union authorisation of a biocidal product or biocidal product family only if your application contains a claim for SME reduction and if ECHA has already recognised the SME status. You must indicate the claim for SME reduction when you make the submission of the above-mentioned applications.
Your company is only eligible for an SME reduction, if your SME status has been recognised by ECHA before the submission of your applications. You will need to provide documentary evidence before ECHA can accept your eligibility for an SME reduction.
Recognition of the SME status is valid for a period of two years. Further information on this process can be found at: http://echa.europa.eu/support/small-and-medium-sized-enterprises-smes/sme-fees-under-bpr
For applications for approval, renewal or inclusion of an active substance in Annex I, the SME status is determined by reference to the active substances manufacturer in the Union that is represented by the prospective applicant.
For applications for product authorisation or a renewal of product authorisation, the question is determined by references to the prospective authorisation holder established in the Union.
Under the Biocidal Products Regulation (BPR), applicants can benefit from reduced fees established for SMEs. ECHA is responsible for checking the size of companies who claim to be eligible for reduced fees.
Before requesting recognition of SME status in R4BP 3, companies should familiarise themselves with the rules set by Commission Recommendation 2003/361/EC on the SME definition.
To support the request for SME recognition, companies should upload documentary proof of their SME status as part of the “SM-APP – SME Verification” application in R4BP 3.
The documentary evidence should include:
- Information about the ownership structure (upstream, downstream) at the time of the application.
- The financial statements (consolidated, if available) together with accompanying notes for the two latest accounting periods before the time of the application.
- Official certificate/information confirming the average number of employees for each of the two latest accounting periods before the time of application.
The above listed documents should be provided for all partner and linked enterprises, as defined by Article 3 of the Commission Recommendation 2003/361/EC.
In the case of an application for approval, renewal or inclusion of an active substance in Annex I to the BPR, the SME assessment should be done by referring to the headcount, turnover and balance sheet information of the active substance manufacturer established in the Union and its linked and partner enterprises.
If an application for product authorisation or renewal of product authorisation, the SME assessment should be done by reference to the headcount, turnover and balance sheet information of the prospective authorisation holder established in the Union and its linked and partner enterprises.
The list of documentary evidence accepted by ECHA and more information on company’s size assessment and links to relevant legislation can be found here:
You can find instructions on how to upload documents and other useful information about R4BP 3 in the Biocides Submission Manuals.
Only files that contain ASCII characters in its filename are accepted in R4BP 3. If the name of your SPC contains non-ASCII characters, just change the name and upload it again to R4BP 3.
If you are looking for a particular case, you need to use the "Cases" tab. Clicking on the case number link will direct you to the ‘Case details' page containing company details, product/substance details, dossier and supporting documents, events history, invoices related to your case and related cases.
You can verify the status of your application in your R4BP 3 message inbox. You can find your approved applications/notification under the “Assets” tab.
You can also find the status of your application when using the “Case” tab with the status “Closed – Approved”. In addition, you can search for on-going applications (“In progress”) as well as rejected applications/notifications (“Closed – Rejected”) in the “Cases” tab.
For more information on how to find messages in R4BP 3, please refer to: Biocides Submission Manual – Technical Guide: using R4BP 3 for biocide applications.
By default, R4BP 3 displays information based on certain criteria. In particular:
- Tasks: filtered by "open tasks";
- Messages: received within the last two months;
- Cases: status "in progress"; and
- Assets: status "active".
To find further information, you may change the search criteria in R4BP 3.
For the migration of assets from R4BP2 to R4BP 3 special rules apply. Further details can be found in the Q&A migration to R4BP 3.
Only notification procedure (RP-NOT) can be found as assets in R4BP 3. All other related case types related to the review programme, i.e., declarations of interest to notify (DI-SUB), changes of participants (PA-CHG) or active substance evaluation under Regulation (EU) No 1602/2014 can be found as cases. Select "Closed – Approved" as search criteria to find more on your case.
Information on the review programme is also publicly available in the existing active substance website.
For active substance applications, i.e., application for approval of active substance (AS-APP) or active substance evaluation under the Review programme (AS-EVA), the messages "active substance in dossier not recgonised" will be displayed in the ‘Format checks' step if the active substance to be included is not recognised yet in R4BP 3. Once ECHA completes the assessment on the substance identity your application will be processed as usual.
You will need to:
- Select the AS-EVA case (Active substance evaluation under the review programme).
- Click on <Create new case> and select "PA – CHG Change of participants." If you need to add a participant, enter the company UUID. New participants will need to create an account in R4BP 3 and provide you with the primary legal entity associated to their account.
ECHA will make an assessment of your request. Once completed, the participant will be added or removed from the AS-EVA case.Only one change can be applied until ECHA takes a decision.
Note: Changes of participants reported to ECHA prior July 2015 via ECHA webforms will not be updated in R4BP 3. In order to include properly this information in R4BP 3 the case owner of the related AS-EVA case will need to include the list of participants submitting a PA-GHG case.
In the R4BP 3 context, an asset is a positive regulatory decision on an application (with a unique asset number). This decision is related to either an active substance (e.g. a decision on technical equivalence or the approval of an active substance) or a biocidal product (e.g. a national authorisation or a Union authorisation).
The asset owner is the legal entity in whose name an application or notification is made under the Biocidal Products Regulation i.e. in the case of an application for a product authorisation, the asset owner will be the product authorisation holder. If the asset owner does not appoint a representative, the asset owner and the case owner can be the same.
The case owner is the legal entity that submits an application through R4BP 3 and follows it through its processing. This could be either the future asset owner or a third party, such as a consultant.
If the asset owner is different to the case owner i.e. a representative or consultant is appointed, you need to specify the identity of the asset owner when you submit a new application. You can do this in Step 1 of the application wizard, under "Asset owner details". If the case owner is different from the asset owner, the former will need to enter the asset owner UUID during the submission of an application/notification through R4BP 3.
The family SPC ensures that minimum information is provided in the different levels of a family SPCs. The meta SPC level is complete if minimum required data is provided in the products within a meta SPC and the meta SPC; the family SPC is complete if all the meta SPCs, administrative information and product information are considered as complete.
To provide the active substance name in the “Administrative information” section, first fill in the product information section.
Also, consider that the active substance concentration of a meta SPC cannot be specified until the concentration of the active substance is provided in the product information section. Likewise, the active substance concentration of the product cannot be provided until the active substance concentration range is specified within the related meta SPC the products belong to.
The SPC editor tool is supported by Internet Explorer 10, Firefox 29 and above or Google Chrome 35 and above. Compatibility issues may appear if you use Internet Explorer 11: just select the compatibility view icon to display the page correctly. If the compatibility view icon is not available, go to tools >> compatibility view settings and add "europa.eu" (or display all websites in compatibility view).
- For Internet Explorer:
- Click on the gear icon in the upper right corner, then click/tap on <View downloads>.
- Click on the <Browser> and define the location
- For Firefox and Google Chrome:
- From the Menu bar, select <Option>, then <General> and click on <Browse> to define the location.
If you submit an initial application where the SPC is required, go to the SPC editor, select “New” and provide all the minimum required information. Save the file and upload it in R4BP 3 when required by the wizard.
If you need to prepare an SPC when a case or asset is already in R4BP 3, you must edit the existing SPC in R4BP 3. This is the case when: you apply for a change on request; an authority asks you for further information, or the case has been migrated from R4BP2.
If the above applies, please follow these steps:
- Download the SPC from R4BP 3. Go to the case or asset, select the “SPC documents” sub-tab and click on “Download SPC”. Save it on your desktop.
- Go to the SPC editor, select “Open” and provide the minimum required information. Save the changes on your desktop.
- Upload your SPC XML file when required by the R4BP 3 wizard.
To technically pass the R4BP 3 upload step, you have to populate all mandatory fields. The SPC editor tool has a built-in feature that allows you to determine whether you have provided the minimum required information. If the error icon is displayed in the relevant tab () you are not providing the minimum information required.
In the example below, the error icon is displayed in the “H & P statements” tab because at least one hazard and precautionary statement must be provided (see the text in red in the example below).
When you enter <+Add hazard statement> and <+Add precautionary statement>, if applicable, the SPC will consider this minimum information as correctly entered.
To prepare an SPC that R4BP 3 will accept as a valid format, you need to use:
- a single numerical value or a single letter in the free-text fields; or
- a value from the respective dropdown lists.
Note: Ensure that the format of your file is correct following the instructions included in Q&A 1054.
You need to complete the following steps:
- Open the SPC file saved on your computer with the SPC online editor.
- Select New >> Draft from final SPC (only if you are working with a final SPC downloaded from R4BP 3).
- Click on New >> Market area version and press
when the editor asks you to discard your current changes.
- Enter the target language and press <OK>.
Once you complete these steps, the free-text fields in the ‘Authorised uses’ and ‘Directions for use’ tabs will still contain the same text as the original SPC: you will need to manually complete the translation of these sections.
Final SPCs are read-only documents that cannot be edited. A lock icon under the language labelling section below the ECHA logo indicates that you are working with a final SPC. To edit a final SPC, you need to select:
- New >> Draft for changes, renewals – if you apply for changes on request or renewals;
- New >> Draft for simplified authorisations – if you modify a simplified authorisation; or
- New >> Draft from final SPC – for any other case that requires the modification of a final SPC.
Once you have added the first product type or type of formulation, click on the blank space next to the selected item to enter more options.
The SPC online editor may open a blank page depending on the cookies available in your web browser. You will need to remove the cookies following these instructions:
You may alternatively open your browser in private mode to bypass the blank page to be opened, using the following keyboard shortcuts (pressing the keys at the same time):
- In Internet Explorer and Firefox: Ctrl + Shift + P.
- In Chrome: Ctrl + Shift + N.
- Check for your relevant application type in the R4BP 3 support page.
- Check the Biocides submission manuals for further information on minimum information requirements and submission through R4BP 3.
As part of the formal process of application acceptance ECHA ensures that a series of steps are fulfilled before it submitts an application to competent authorities – i.e. national authorisation application, or to ECHA for further assessment.
At a glance the steps include:
- Virus scan
- File format check:
- Virus scan
- Business rules confirmation
- Application acceptance
- Invoice assessment (where applicable)
- Confidentiality claim screening
At the end of this process, you will receive a message saying "Submission accepted by ECHA" if the application has been successful, or "Case rejected by ECHA" if the application has been rejected.
For more information, please refer to chapter 6 of the Biocides Submission Manual – Technical Guide: using R4BP 3 for biocide applications.
Accepted applications will be forwarded to the respective evaluating authority – i.e. to the MSCA nominated by the applicant during the submission process or to ECHA, e.g. for an assessment of technical equivalence. Once forwarded, the application will be validated and then evaluated.
It is the case owner's responsibility to regularly check the ‘Message list' in R4BP 3, to monitor the status of the application (messages are sent after each processing step) and the ‘Tasks' tab in order to complete certain actions (e.g. requests for additional information).
The following steps will normally be performed by your competent authority when your case is processed:
- Acceptance: your case is accepted or rejected for further processing;
- Validation: validation on whether you have provided the correct information for the assessment of your case;
- Evaluation: formal assessment on the quality and adequacy of the data and the related conclusions related to your case.
You can monitor the progress of your case through the ‘Events history' sub-tab in R4BP 3.
The ‘Events history' sub-tab provides you with a list of all the actions that your case has gone through in chronological order (e.g. BRC confirmation started, Invoice sent (when applicable), Submission format verified, etc.). This is a very useful sub-tab, helping you to follow the application processing steps.
If you wish to view submitted documents or financial related documents, go under other sub-tabs, e.g. ‘Documents' or ‘Financial management'.
In addition, depending on the application type, you may receive the following messages:
- New task: an action is required from your side, i.e. provide additional information;
- New information from authority, i.e. invoice delivered if required in your case.
For every step your authority complets you will receive a message. You can check the history of all messages sent to you when clicking on the ‘Events history' tab.
Note: Some applications related to changes on request or simplified authorisation do not include the validation step.
Notifications and some simplified authorisation cases will only include the evaluation step for your authorities.
An informative deadline based on the legal text is included to inform you when a step is expected to be completed by an authority. It is a reminder for information purposes. No action is required from your side.
You can search for your case details in R4BP 3 and select the "Events history" sub-tab. You will find a chronological description of the events related to your case, including the topic, the subject of the message and the sender.
The case owner will also receive a message (in their R4BP 3 account) for every relevant step of the process. You need to check the tasks in order to identify any requests for action you have received from your authority.
You will receive notifications to your email address based on the details provided in your R4BP 3 account.
If your email is not linked to the contact person in your R4BP 3 user account, you need to regularly monitor messages and tasks in R4BP 3.
By default, the “Messages” inbox displays the messages received in the last two months; the “Tasks” inbox displays all open tasks. Q&A 796 indicates the main differences between “Messages” and “Task” inboxes.
As a case owner, you can withdraw an ongoing case in R4BP 3 at any time.
To withdraw your case in R4BP 3, the action ‘Withdraw case’ should be initiated in the corresponding case details screen. The status of the case will change to ‘Closed – Withdrawn’.
According to Article 13 of the BPR Fee Regulation, only applications for active substance approval, Union authorisation, and minor and major changes can be partially refunded after a withdrawal. Useful information can also be found in Q&A 768. Fees already paid to ECHA for any application types other than the ones mentioned above will not be refunded.
Applications initiated within a case that has been withdrawn, i.e. when a delegation allows a different company to submit a related application, will also need to be withdrawn. If no action is taken, your authorities will be forced to reject these delegated applications.
The common reason why you receive this error message is because you have used an incompatible format. This happens when you copy/paste data from an external source into the SPC free-text fields.
While this action does not always trigger a format error, it is safest if you copy the data into “Notepad” to clear any format/style; then copy the data from Notepad into the SPC online editor.
Another reason may be that you are working with an SPC file created using the old SPC online tool version available before October 2016. If this is your case, you can:
- Download the SPC available in R4BP 3 and start working from this file using the current SPC online editor; or
- Use the <SPC version convertor> available in the SPC online editor.
IMPORTANT: When working with an SPC that contains an incorrect format, make sure that you completely remove ALL content in the free-text fields before you paste the content without a format or style.
R4BP 3 allows certain application types, such as mutual recognitions, to be grouped. In practice, you can include:
- a technical dossier (if required),
- supporting documentation, and
- as many SPCs as Member States you intend to submit your application to.
Remember that the market area of the SPCs needs to match the market area selected in the grouping during R4BP 3 submission.
As a result, R4BP 3 will automatically generate as many cases as SPCs as you have included in your submission.
The information related to the technical dossier and supporting documentation can be found in the reference asset; the SPCs can be found in every case.
Once these applications are processed by R4BP 3, they will be handled independently by your authorities.
This R4BP 3 message ensures that the SPCs uploaded in an application submitted through R4BP 3 belongs to the same product according to the submission criteria you define in the wizard. In particular, this error message appears in R4BP 3:
- If you apply for a mutual recognition in a different market area, please select a new market area version in the SPC editor from the original SPC to create an SPC in a different market area correctly.
Exceptions apply to special case types NA-MRG (conversion of a frame into a biocidal product family) and NA-NPF (addition of a family member to a biocidal product family). Further information on these case types can be found in the video tutorial: Processes in R4BP 3: merging assets via NA-MRG and the BSM application instructions: national authorisations.
- If you group submissions, include as many SPCs as market areas as you have selected in the application wizard for single product applications. You can easily create a new market area version of the original SPC in the SPC editor.
Further useful information on how to create an SPC can be found in the BSM technical guide: using SPC.
R4BP 3 ensures that you consider the terms and conditions of an already existing authorisation.
If you apply for a change on request or renewal of national authorisation, you need to modify the existing SPC in the reference asset (national authorisation).
If you create a new SPC or start from an invalid SPC, R4BP 3 will not accept your SPC. You need to search for your asset, download this SPC within the asset and edit it with the SPC editor.
To create your dossier, you will need to:
- Read the instructions provided in the Biocides Submission Manual BSM Technical guide: using IUCLID. This manual will help you to build basic minimum information in IUCLID, as well as how to include Annex II and Annex III information requirements or a letter of access when applicable.
- Depending on the case type you work with, you will find a basic IUCLID checklist available at the end of the BSM available in the applications instructions. This checklist contains the minimum criteria required by ECHA to successfully process your submission.
The authority responsible for validating your application can also provide support to you on what minimum information requirements are needed for your application.
The following two scenarios are likely:
- If the authorisations were migrated from R4BP2, ECHA has agreed on a process to make sure that the links between different assets can be created. Contact your authorities to know more on how to proceed.
- To re-unite former authorisaitions that were part of frame formulations in R4BP2, single product authorisation assets can be merged with the process NA-MRG (Conversion from frame formulation into a family). However, the merging does not take into account any linked mutual recognitions. These relations are lost. Make sure that you select the relevant market areas that should be linked as mutual recognitions where you intend to apply for a family application. If you need to To recover the links in R4BP 3, please contact ECHA for further analysis.
The following two scenarios may apply:
- If the authorisations were migrated from R4BP2, ECHA has agreed on a process to make sure that the links between different assets can be created. Contact your authorities to know more on how to proceed.
- To re-unite former authorisations that were part of frame formulations in R4BP2, single product authorisation assets can be merged with the process NA-MRG. However, the merging does not take into account any kind of linked mutual recognitions. These relations are lost unfortunately. To recover the links in R4BP 3, please contact ECHA.
R4BP 3 ensures that the information provided in your application is consistent. If you submit updated information related to a particular asset (i.e. changes on request, same biocidal product or renewal) the SPC available in this asset will be updated with the new information of the SPC available in the latest case approved by your authorities.
If you submitted several cases in parallel from the same asset, you need to take into consideration what information has been included in the SPC available in the asset. If you receive the warning message, you should download the SPC available in the asset and edit it.
Use the <Compare with> button available in the SPC editor to compare what information has changed in the SPC available in the asset and the case you are working with.
If you have submitted a family application based on the new family concept, ECHA has migrated all information on your behalf to the new family SPC. These migrated SPCs are available in R4BP 3.
The migration to the new structure provides data in the SPC to the best extent possible. However, you may still need to work on the SPC to report your family SPC correctly, i.e add more than one meta SPC, match products to the relevant meta or define the concentration limits of the active substance that applies to every meta SPC.
When you use the submitted grouped application for administrative changes as a new application in R4BP 3, you need to follow these steps in the upload SPC step:
1 – Browse and upload the SPCs related to your administrative change.
2 – Select the relevant asset under the “Selected assets” list.
3 – Click on the icon “Match SPC with the selected asset”.
4 – Upload the SPC associated to the asset displayed in selected assets area. If more than one SPC file is matched to an asset, then the master language SPC file must be indicated.
5 – Click on <Check selected SPC(s) & Asset>.
Steps 2 to 5 need to be completed for every asset/SPC combination until all asset/SPC combinations are matched and successfully checked (marked by a green “thumb up” icon). In the example below, an asset/SPC combination is still missing (marked by a red “thumb down” icon)
The case owner and the prospective asset owner in an ‘In progress’ case can be changed in R4BP 3 in certain scenarios. Please consider the following information when you complete the changes in R4BP 3:
- Case transfer is a two-step process – the case owner or prospective asset owner initiates a transfer using the delegation tab in the relevant case; an additional action then needs to be performed to accept the transfer.
- The current case/asset owner initiates the change; the new case/asset owner can then accept the transfer.
- Changing the case owner and the prospective asset owner are two different actions: when the case owner and prospective asset owner are the same company, you need to complete the <Add transfer> actions twice to transfer the case owner and the prospective asset owner.
There are certain scenarios where the prospective asset owner cannot be changed, i.e. in the case of certain notifications, changes on request, renewals or mutual recognitions.
IMPORTANT NOTE: Case owners/asset owners need to agree outside R4BP 3 on the terms and conditions to share the IUCLID technical dossier. A IUCLID technical dossier is not part of the transfer of a case to a different entity. Sharing the technical dossier needs to be considered as part of the agreement reached between parties outside R4BP 3.
The new case/asset owner will have access to all the information available in the different tabs related to a case. Pending tasks will be reallocated to the new case owner and new messages will only be delivered to the new case owner.
Additional information can be found in the chapter “Exchanging data with other entities” available in BSM Technical guide: using R4BP 3.
The following are the most common reasons for a virus check failure:
- A virus is part of any of the documents submitted in your application. Make sure that you check all the information to be submitted to ECHA with an antivirus software product.
- One or more files included in a IUCLID technical dossier is password protected.
When you submit data to ECHA through R4BP 3, only authorities will have access to your data. You can submit your data again making sure that it is not password protected.
For any other reasons, please contact ECHA.
Yes. This option applies to the submission renewals subject to mutual recognition. If the nomination of a case owner is not present, the authorisation holder can establish a nomination from the asset.
The case owner will be able to submit a renewal subject to mutual recognition with different authorisation holders provided that:
- a mutual recognition link is available between assets; and
- an active nomination to the same case owner is available in mutually recognised assets.
The case owner will be able to see when a nomination has been established if in step 1 of the R4BP 3 wizard for renewal there is an option to select the asset(s) under a different asset owner.
Case owners are responsible for following up any communications or requests for additional information from authorities.
Technically, additional Member States can be included in an existing renewal application subject to mutual recognition. It is important that you clarify the application submission with your concerned competent authority. If a draft application is continued, R4BP 3 will perform again the checks on existing data to ensure that the information is up to date. If the information is not valid, the wizard will suggest that you update certain information or simply delete the draft application to make a new submission, depending on the circumstances.
The application will be considered as submitted once a case number is created in R4BP 3.
No. A draft application allows you to save your work in progress and return to your application at a later date to edit and submit it, but it cannot be considered as a submission.
When you resume work on a draft application, R4BP 3 will perform the checks on existing data again to ensure that the information is up to date. If the information is not valid, the wizard will suggest that you update certain information or simply delete the draft application to make a new submission, depending on the circumstances.
The application will be considered as submitted once a case number is created in R4BP 3.