Previous version and overview changes
The registration manual will be updated monthly. An overview of the changes in comparison with the previous version will be presented together with each updated manual. Important changes will be preceded with announcements and clarifications in news items on our internet site and / or our e-zine. The updated version of the manuals will be published at the beginning of each month.
Archive and overview changes 2019 - 2021
Monthly update archived version registration manuals
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2021
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1. Parallel trade permits – BPR (EDITORIAL)
The application for parallel trade permits is more clearly explained for permits under Biocidal Product Regulation.
Manual parts:
- Biocidal product Regulation – Parallel trade permit
2. Trial permits and notifications (EDITORIAL).
Trial permits have to be applied for in R4BP. Extra explanation has been added.
Manual parts:
- Biocidal product Regulation – Derogation-Exemptions for trail purposes
3. Directions for submission (EDITORIAL).
Direction for submission have been classified in BPR and transitional legislation, for clarification.
Manual parts:
- General – Direction for submission
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Publication March 2021, previous change: February 2021.
1. Revised CLP appendix to the application for Biocides under transitional legislation.
The information about the application of calculation rules is more clearly explained.
Manual parts:
- Application under transitional legislation - instruction for submission - application form B and form C
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Publication February 2021, previous change: December 2020.
1. Working Procedure for resolving disagreements
Working procedure for cases where agreement on product characteristics (SPC and PAR) cannot be reached.
Manual parts:
- Application under regulation - mutual recognition - registration process
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2020
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1. Differentiated assessment process for applications under transitional legislation
Description: Description on the application process for changes has been adjusted as a result of the differentiated assessment process for applications under transitional legislation.
Manual parts:- Form W for amendments and withdrawals
- Applications under transitional legislation – minor and administrative changes (general and “instructions for submission”)
2. Parallel trade (BPR and transitional legislation)
Description: change of the process description to make it more clear and complete (EDITORIAL):
- Transitional legislation - national legislation - Parallel trade permits
- Biocidal product Regulation – parallel trade permit (NEW)
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1. Limited assessment procedure for applications under transitional legislations
Description: Application Form C added.
Manual parts:
2. Directions for submission Biocidal products (editorial)
Description: additional explanations has been added on the way of and location of submission of administrative applications.
Manual parts:
- General – Directions for submission
3. Parallel trade permit Biocides (editorial)
Description: amendment of the description of the process for new batches of parallel imported biocidal products
Manual parts:
- Transitional legislation / national legislation – parallel trade permits
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Renewal and Same Biocidal Products (SBP)
Description: Explanation added about the renewal of Biocidal product authorisations originating from Same Biocidal Product procedure.
Manual parts:
- Biocidal Product regulation – Re-registration and renewals
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2019
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Below you select an archived registration manuals and see which changes are made in comparison with the version of the previous month.
On Archive Web you can retrieve an archive version of the Ctgb site for every desired date. Choose a date and archiveweb shows the information that was online at that time. For example, you can consult the assessment framework that applies to applications submitted at that time.
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1. Editorial changes
Description: Scope document: information about food/ feed used as attractant or repellent is added.
Manual parts:
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Editorial changes
Description: frame formulations: link to Guidance is added; In situ: text revision and links to Guidance added; Simplified authorisations: links to Guidance added.
Manual parts:
- Transitional legislation / national legislation - Frame formulations
- General - In situ generation of biocides / active substance
- Biocidal product Regulation - simplified authorisations - characteristics
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1. Biocidal product families: pre-submission meetings – best practices
Description: Best practices for pre-submission meetings for applications concerning biocidal product families. Link to ECHA Guidance, concerning arrangement, planning, and content of a pre-submission meeting for BPF related applications.
Manual parts:
- General - Biocidal product family
2. Summary of product Characteristics (SPC): active substance content
Description: In “Note agreed by member states' competent authorities for biocidal products”the notation of the active substance content in de SPC is explained. The active substance content has to be expressed as % technical active substance.
Manual part:
- General - Summary of Product Characteristics
3. Editorial changes
Description: directions for submission are added; export certificates: text revision, permits for trial purposes: text revision.
Manual parts:
- Directions for submission
- Permits for trial purposes
- Export certificates
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1. Reporting of new information on authorisation
Description: Authorisation holders are obliged to report Ctgb immediately about indications of harmful or unacceptable effects concerning the specified biocidal product, the active substance or its metabolites or co-formulant.
Manual parts:
- Newly added: New information on authorisation
- Amended: 'How to apply', step 3.
- Newly added: form Immediate Notification by Authorisation Holder
2. Editorial: links to working procedure union authorisations – ECHA site
Links have been added to the text about union authorisations of biocides in the Registration Manual, to the files containing working procedure and timelines for union authorisation, published by ECHA.
Manual part:
- Amended: Application under regulation – Union authorisations – Registration process
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1. Provisional authorisation
Information about provisional authorisations under BPR have been added. (product authorisation for max 3 years, when an a.i. is already in peer review phase with a positive advice of the rapporteur member state, in accordance with Art 55 of the BPR).
Manual parts:- Application under regulation - national product authorisations (BPR)
- How to Apply – Step 4
2. Re-registrations and renewals: expiry before decision-taking
Text added: “In case, beyond the control of the holder of a national authorisation, no decision is taken before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.“
Manual part:- Application under regulation - Re-registrations and renewals
3. Derived authorisations: changes in derived trade permits
Merely a name change.
Manual part: biocides registration manual:- Transitional legislation / national legislation: - Derived trade permit
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Archive and overview changes
Monthly update archived version registration manuals
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2017 - 2018
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Below you select an archived registration manuals and see which changes are made in comparison with the version of the previous month.
On Archive Web you can retrieve an archive version of the Ctgb site for every desired date. Choose a date and archiveweb shows the information that was online at that time. For example, you can consult the assessment framework that applies to applications submitted at that time.
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1. Same biocidal products: Explanation about administrative changes available
ECHA has published an explanation about administrative changes in same biocidal product applications; it gives instructions about how administrative changes should be described and classified for same biocidal products in the light of the “Change Regulation”: Reg. (EU) no 354/2013.
Manual parts:
- BP: Same Biocidal Products – Instructions for submission
2. Use of disinfectants in irrigation systems (Scope issue)
Products for the use of disinfectants in irrigation systems in agriculture and horticulture are regarded as a biocidal products.
Manual parts:
- Scope BPR – BPR scope documentation
3. General disinfection in veterinary practices or veterinary hospitals to product type 2 or 3 under the BPR? (scope issue)
Identical products applied for general disinfection of surfaces in the medical area (medical practices, hospitals) as well as of surfaces in veterinary practices or hospitals associated with examination and operation/treatment of the animals: PT2
general disinfection of surfaces associated with the housing and transportation of animals: PT3
Manual parts:
- Scope BPR – BPR scope documentation
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1. Request for information on animal testing
Hyperlink to the VIB form has been added: form for request for information on animal testing. Also an explanation of that form has been given.
Manual part:
Inquiry to share data (will be changed in “request for information on animal testing”)
2. Same biocidal products
Submission of an SPC is not requested for an application for a same biocidal product.
Manual part:
Same biocidal products – Instruction for submission
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Frame Formulations
Clarification about the conditions for frame formulations under transitional legislations.
Manual part:- Transitional legislation / national legislation: added: Frame Formulation
- How to apply: step 3: added: frame formulation
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1. Re-registrations according to Biocidal Products Regulation
Clarification about the conditions for active substances and PT groups in the applications for re-registration under BPR. Request for overview of the national authorizations/registrations re-registered under the BPR for the concerning product.
Manual part:
Biocidal product Regulation: Re-registration and renewals
2. Label claims on the Summary of Product Characterisation (SPC)Label claims about the product can be part of the SPC. The member states have agreed about the conditions for linking label claims to the SPC.
Manual part:
Biocides – Summary of Product Characterisation
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Same biocidal product: missing requirements added
The description of “same biocidal products” in the manual has been amended. Under “Instruction for submission” a few information requirements are added:
- “declaration “Article 95”; and “
- declaration that the product is identical to the reference product”.
Manual part:
Same biocidal product: instruction for submission.
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ECHA publishes information and guidance on in situ generated biocides.
ECHA has recently put in place extra information and recommendations on the risk assessment for “in situ’s“. In the registration manual is referred to the information of in situ’s on the website of ECHA.
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Registration manual version February 2018.
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Registration manual version January 2018.
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Registration manual version December 2017.
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Vertebrate studies: request for information (transitional legislation)
Before new vertebrate studies are carried out, applicant has to request information about availability of studies on the specific point to prevent duplication of vertebrate studies. In the manual the process for applying and assessing these requests under transitional legislation is described.
Efficacy studies per biocidal use - claim
Additional appendix H to the application form B (application for authorisation of biocidal product under transitional legislation):
- giving overview of the necessary efficacy studies per biocidal claim
- makes it easy to check if the required studies are available for each claim.
Registration manual version November 2017.
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Registration manual version October 2017.
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