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.
Other documents that may be required or relevant in your individual case
Documents that are required for compliance / to enable processing
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] | 05 May 2020 |
AA-TRS | List of active substances and suppliers | Supporting document for applications for transfer of Article 95 assets [DOC] | 05 May 2020 |
AS-APP | Amendment to the conditions of an approved active substance | Amendment to the conditions of active substance approval [DOC] | 03 December 2014 |
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] | 18 February 2022 |
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] | 18 July 2022 |
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] | 03 December 2014 |
RP-NOT | Notification to take over the role of participant / inclusion of Active Substance in the Review Programme | Notification to take over the role of participant or to include an active substance/product-type in the Review Programme [DOC] | 05 October 2016 |
NA-APP | National authorisation of biocidal products | Supporting document for national authorisation application [DOCX] | 08 May 2023 |
UP-APP/UP-BBS | Pre-submission phase for Union authorisation | Pre-submission phase for Union authorisation [DOCX] | 21 October 2016 |
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] | 18 April 2018 |
NA-APP UA-APP |
Provisional authorisation (National and Union) | Application for provisional authorisation [DOC] | 03 December 2014 |
NA-APP UA-APP NA-BBP UA-BBP |
Application for national authorisation Application for Union authorisation Authorisation of same biocidal product (pending) for national and Union authorisation |
List of existing_new products for NA_UA processes [XLSX] | 08 May 2023 |
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] | 22 May 2018 |
NA-BBP NA-BBS SA-BBP SA-BBS UA-BBP UA-BBS |
Authorisation of a same biocidal product (pending and authorised) (National, Union and simplified authorisation) | Application for authorisation of the same biocidal product under Regulation (EU) No 414/2013 [DOC] | 21 March 2017 |
NA-ADC | Administrative change on request (national authorisation) | Notification for an administrative change of a national authorisation [DOCX] | 08 May 2023 |
UA-ADC SA-ADC |
Administrative change on request (union/simplified authorisation) | Notification for an administrative change of a union/simplified authorisation [DOC] | 23 May 2018 |
NA-MIC | Notification for a minor change of a national authorisation | Notification for a minor change of a national authorisation [DOC] | 23 May 2018 |
UA-MIC SA-MIC |
Notification for a minor change of a Union/simplified authorisation | Notification for a minor change of a union/simplified authorisation [DOC] | 23 May 2018 |
NA-MAC |
Notification for a major change of a national authorisation | Notification for a major change of a national authorisation [DOCX] | 08 May 2023 |
UA-MAC SA-MAC |
Notification for a major change of a union/simplified authorisation | Notification for a major change of a union/simplified authorisation [DOCX] | 08 May 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] |
08 May 2023 |
NA-RNL | Renewal of a single national authorisation under Article 31 of BPR | 08 May 2023 | |
TE-APP | Assessment of technical equivalence, Tiers I and II | Technical equivalence [DOCX] | 30 October 2019 |
TE-APP | Assessment of technical equivalence, Tier II | Report template Tier II assessment [DOCX] | 18 October 2018 |
N/A | List of active substances and suppliers | Requests for corrections of entries on the Article 95 list [DOC] | 05 May 2020 |
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] |
14 January 2022 |
N/A | Additional information for invoicing | Declaration [DOC] | 9 December 2021 |