Registration Manual
The Registration Manual informs you about the application processes (including application and assessment process). The tool 'How to apply?' leads you through a series of questions to the relevant application type. Both manuals are only available in English.
Index
Biocidal product Regulation
- National product authorisations
- Union authorisations
- Re-registration and renewals
- Mutual recognition (in sequence and parallel)
- Major changes
- Minor and administrative amendments on request
- Simplified authorisations for products containing low tox substances
- Authorisation of new product identical to existing authorised product ('Same biocidal product')
- Parallel Trade Permit
- Derogation – Exemptions for trial purposes
- Export certificates
- Request for information on animal testing
Active Substance Approval
Transitional legislation / national legislation
- Limited assessment procedure national authorisation and amendments
- Full assessment procedure national authorisations and amendments
- Parallel trade authorisation
- Derived trade authorisation
- Minor and administrative amendments
- Frame formulations
- Derogation – Exemptions for trial purposes
- Derogation – Emergency situations
- Export certificates
- Request for information on animal testing
General
- Scope BPR
- Direction for submission
- Summary of Product Characteristics
- In situ generated biocides
- Biocidal product family
- Assessment of equivalence of active substances or additive
- Comparative assessment for products containing “Candidates for Substitution”
- Substance of Concern
- Fees
- Letter of Access
- Data Protection, Data Sharing and Public Access
- National Specific Issues
- Grace period
- Classification, Labelling and Packaging
- Reporting new information
- Objection and appeal
Changes over previous version
The registration and evaluation of plant protection products and biocidal products is based on uniform principles. To take into account the developments originating from the ongoing process of European harmonisation and developments in science and technology, the procedures for registration and the methodology for evaluation of products changes and improves continuously.
To make sure the changes are we documented, an updated version of the registration manual for biocidal products is released once a month. The updates are planned at the beginning of each month.
In this new release, several points are amended / added. In the overview presented on this page, you will find an explanation and a designation of the exact location in the manual for each amendment or addition.
The former versions of the registration manuals are made available in the “archive” of manuals.
Publication December, previous change: September 2021.
1. Same biocidal product (EDITORIAL)
Renewals of same biocidal products are explained. A.o. the situations in which the SBP is no longer equal to the reference product. (according to the outcome of meeting CA93, Sep. 2021).
Manual parts:
- Biocidal product Regulation – Reregistration and renewals
- Biocidal product Regulation – Authorisation of new product identical to existing authorised product ('Same biocidal product')
2. General information on in situ products: information about washing machines added.
In response to an e-consultation about the use of precursors dosed in an industrial washing machine, this information has been given by ECHA.
Manual parts:
- General – Scope BPR
- General – In situ generated biocides