Supporting documents
Supporting documents
Supporting documents
The table below provides a link to the key supporting document needed for each of the application types under the Biocidal Products Regulation. Additional documents are often needed but depend on the specific application type. Further information on this topic is comprehensively outlined in the relevant Biocides Submission Manual.
Please confirm that you are using the latest version of the document template, otherwise your application may not be accepted.
Application code | Process | Supporting document | Date of publication |
---|---|---|---|
AA-ADC | List of active substances and suppliers | Supporting document for applications for administrative change of Article 95 asset [DOC] | 14 November 2023 |
AA-TRS | List of active substances and suppliers | Supporting document for applications for transfer of Article 95 assets [DOC] | 14 November 2023 |
AS-APP | Amendment to the conditions of an approved active substance | Amendment to the conditions of active substance approval [DOC] | 14 November 2023 |
AS-APP |
Active substance approval Renewal of an active substance approval Annex I inclusion |
Approval of new active substances (AS-APP)/ Renewal of approval of active substances (AS-RNL)/ Annex I inclusion (AN-APP) [DOC] | 14 November 2023 |
AS-ACC | Inclusion in the Article 95 (active substance suppliers) list | Supporting document for applications for Article 95 inclusion (AS-ACC) with reference to a dossier for which all data protection periods have expired [DOC] | 14 November 2023 |
CC-APP | Classification of a change of a products | Request to ECHA to provide an opinion on the classification of a change of a products [DOC] | 14 November 2023 |
NA-APP | National authorisation of biocidal products | Supporting document for national authorisation application [DOCX] | 14 November 2023 |
UP-APP | Pre-submission phase for Union authorisation | Pre-submission phase for Union authorisation [DOCX] | 14 November 2023 |
UA-APP | Union authorisation application for a single product | Justification of the claim that the product is identical with (one of) the representative product(s) [DOCX] | 14 November 2023 |
NA-APP UA-APP |
Provisional authorisation (National and Union) | Application for provisional authorisation [DOC] | 14 November 2023 |
NA-APP UA-APP NA-BBP UA-BBP |
Application for national authorisation |
List of existing_new products for NA_UA processes [XLSX] | 22 January 2024 |
NA-NPF, SA-NPF, UA-NPF | Notification of a product in a biocidal product family | Notification of a product in a biocidal product family [DOC] | 14 November 2023 |
NA-BBP NA-BBS SA-BBP SA-BBS |
Application for national or simplified authorisation of a same biocidal product | Application for national or simplified authorisation of a same biocidal product [DOC] | 22 January 2024 |
UA-BBP UA-BBS |
Application for Union authorisation of a same biocidal product | Application for Union authorisation of a same biocidal product [DOCX] | 22 January 2024 |
NA-ADC | Administrative change on request (national authorisation) | Notification for an administrative change of a national authorisation [DOCX] | 14 November 2023 |
UA-ADC | Notification of an administrative change to a Union authorisation | Notification of an administrative change to a Union authorisation [DOCX] | 22 January 2024 |
SA-ADC | Notification of an administrative change to a simplified authorisation | Notification of an administrative change to a simplified authorisation [DOCX] | 22 January 2024 |
NA-MIC | Application for a minor change of a national authorisation | Application for a minor change of a national authorisation [DOC] | 14 November 2023 |
UA-MIC | Application for a minor change of a union authorisation | Application for a minor change of a union authorisation [DOC] | 14 November 2023 |
SA-MIC | Application for a minor change of a simplified authorisation | Application for a minor change of a simplified authorisation [DOC] | 14 November 2023 |
NA-MAC |
Application for a major change of a national authorisation | Application for a major change of a national authorisation [DOCX] | 14 November 2023 |
UA-MAC | Application for a major change of a union authorisation | Application for a major change of a union authorisation [DOCX] | 14 November 2023 |
SA-MAC | Application for a major change of a simplified authorisation | Application for a major change of a simplified authorisation [DOCX] | 14 November 2023 |
NA-RNL | Grouped renewal of several authorisations subject to mutual recognition under Article 2 of Regulation (EU) No 492/2014 |
Grouped renewal of several authorisations subject to mutual recognition [DOCX] |
14 November 2023 |
NA-RNL | Renewal of a single national authorisation under Article 31 of BPR | 14 November 2023 | |
TE-APP | Assessment of technical equivalence, Tiers I and II | Technical equivalence [DOCX] | 14 November 2023 |
TE-APP | Assessment of technical equivalence, Tier II | Report template Tier II assessment [DOCX] | 14 November 2023 |
N/A | List of active substances and suppliers | Requests for corrections of entries on the Article 95 list [DOC] | 14 November 2023 |
N/A | Authorisation of biocidal products family | Template overview of the biocidal product family [XLS] Instructions for the template overview of the biocidal product family [PDF] |
9 December 2021 |