general
Related List of product-types Similar conditions of use Comparative assessment CA documents on Biocidal product family concept Overview of Article 44 (5) requests
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16/04/24
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general
See also Getting started with EU chemicals legislation European Commission - Biocides Biocidal Products Directive (Directive 98/8/EC) Biocides Relevant Document Links R4BP 3 user manuals Guidance...
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15/03/24
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general
Authorisation of biocidal products Prepare your IUCLID dossier. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘SA-APP – National authorisation - simplified procedure'. The application...
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08/02/24
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general
Make sure that you have everything you need before making your application. The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Simplified...
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08/02/24
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general
Getting started – pre-submission Prepare your SPC file. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘UP-APP – Pre-submission for union authorisation' to launch the application ‘wizard',...
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08/02/24
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general
Make sure that you have everything you need before making your application. The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Union Authorisation'....
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08/02/24
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general
Notification for a product in a product family Create your SPC file from the authorised SPC of the reference family asset. From the ‘ASSETS' tab, search for the relevant national authorisation...
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07/02/24
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general
IT-Tools IUCLID R4BP 3
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07/02/24
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general
Make sure that you have everything you need before making your application. The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for National Authorisation...
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07/02/24
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general
Regulations Biocidal Products Regulation - Annex I Regulation (EU) 528/2012
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31/08/23
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general
Afin de répondre aux besoins des entreprises et de réduire leurs charges administratives, le règlement relatif à l'autorisation des mêmes produits biocides (le règlement n° 414/2013, modifié par le...
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07/06/23
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general
Le règlement relatif aux produits biocides définit le renouvellement d’une autorisation nationale comme «une demande adressée par le titulaire d’une autorisation ou en son nom en vue d’obtenir le...
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01/06/23
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general
Related Submit a dossier - R4BP 3 BPR Coordination Group
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01/06/23
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general
Autorisation nationale Les entreprises qui envisagent de commercialiser leurs produits dans un État membre de l'Union européenne doivent déposer une demande d'autorisation de produit dans le pays...
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01/06/23
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Active substance approval
Biocidal Products Regulation Consolidated version of the Biocidal Products Regulation The consolidated version of the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22...
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13/01/23
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general
Related Prepare a dossier – IUCLID Submit a dossier – R4BP 3 Biocides Submission Manuals CA documents on biocidal product families Practical Guides
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02/09/22
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general
Related Prepare a dossier - IUCLID Submit a dossier - R4BP 3 Guidance on Information Requirements Biocides Submission Manual Nanomaterials and the Biocidal Products Regulation Biocidal product...
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02/09/22
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general
Manuals and guidance Biocides Submission Manuals Guidance on biocides legislation Practical Guides on BPR ECHA accounts and EU Login Q&A Supporting documents
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01/09/22
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general
Dès que l'ACEM de référence a validé la demande de renouvellement de l’autorisation nationale d’un produit biocide (ou d’une famille de produits biocides) octroyée par la voie de la reconnaissance...
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10/06/22
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general
Le règlement sur les produits biocides [RPB, règlement (UE) n° 528/2012] concerne la mise sur le marché et l'utilisation des produits biocides, qui sont utilisés pour protéger l'homme, les animaux,...
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08/06/22
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general
Related Bridging the endocrine disruptor assessment of biocidal non-active substances with REACH (agreed at 91st CA meeting) [PDF][EN] Guidelines for assessing confidentiality claims [EN][PDF]...
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12/04/22
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general
See a problem or have feedback?
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08/04/22
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Biocidal product authorisation
Authorisation of biocidal products family
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14/01/22
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Biocidal product authorisation
Authorisation of biocidal products family
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14/01/22
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Biocidal product authorisation
Proposal to bridge the endocrine disruptor assessment of biocidal non-active substances with REACH screening and assessment
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22/04/21
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Active substance approval
Suivez-nous: Lire ECHA Weekly actualités > S’abonner à nos actualités
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08/04/21
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Biocidal product authorisation
Further information Authorisation of Biocidal Products Products types BPR Regulation Q&A Biocidal Products Regulation BPC opinions on Union authorisation
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15/04/19
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Active substance approval
About us Biocidal Products Committee Working groups
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15/04/19
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Active substance approval
* The comprehensive list of the applicable deadline for each of the compliant notification is given in List of notifications ** Article 3(2) RPR applications can only be made by the successful...
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11/04/19
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Active substance approval
Les délais suivants sont mentionnés pour aider les entreprises à remplir leurs obligations au titre du règlement relatif aux produits biocides (RPB) et du règlement relatif au programme de...
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12/02/19
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Biocidal product authorisation
Authorisation cancellation on request Log into R4BP 3. From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the...
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23/11/18
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Biocidal product authorisation
Classification of a change to a product authorisation Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘CC-APP – Classification of a change to a product authorisation' to launch the...
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23/11/18
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Biocidal product authorisation
Renewal of authorisation(s) (including authorisations subject to mutual recognition) Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset you wish to renew....
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23/11/18
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Biocidal product authorisation
Mutual recognition in sequence Draft your SPC file from the authorised SPC of the reference asset. Log into R4BP 3. You can launch your application in two different ways: From the ‘NEW APPLICATION'...
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23/11/18
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Biocidal product authorisation
Mutual recognition in parallel Draft your SPC file from the SPC of the reference case. Log into R4BP 3. You can launch your application in three different ways: During the submission of an...
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23/11/18
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Biocidal product authorisation
Authorisation of biocidal products Prepare your IUCLID dossier. From the ‘NEW APPLICATION' tab, select ‘NA-APP – Application for national authorisation' to launch the application ‘wizard', which...
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23/11/18
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Biocidal product authorisation
Inquire to share data for a biocidal product Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘IN-REB – Inquire to share data (for biocidal product)' and enter the reference number (the...
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23/11/18
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Biocidal product authorisation
Parallel trade Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘PP-APP – Parallel trade' and enter the reference numbers (the national authorisation asset number in the Member State of...
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23/11/18
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Biocidal product authorisation
Notification of experiment or test Prepare your IUCLID dossier. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘ET-NOT – Notification of experiment or test' to launch the application...
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23/11/18
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Biocidal product authorisation
Notification of unexpected or adverse effect Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to notify unexpected or adverse effect.....
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23/11/18
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Biocidal product authorisation
Transfer of authorisation The owner of a national authorisation asset must first initiate a transfer process in R4BP 3, this is done in the ‘Delegation/ Nomination’ tab of the asset. Once the owner...
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23/11/18
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Biocidal product authorisation
Merge of product authorisation(s) in one product family Draft your SPC file from the authorised SPC of the reference asset. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘NA-MRG – Merge...
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23/11/18
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Biocidal product authorisation
Administrative change on request Draft your SPC file from the authorised SPC of the reference asset. Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset for...
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23/11/18
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Biocidal product authorisation
Minor and major change on request Prepare your IUCLID dossier. Log into R4BP 3. From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to request a change....
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23/11/18
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Biocidal product authorisation
Authorisation of the same biocidal product (pending and authorised) Create your SPC file from the authorised SPC of the reference family case or asset, using specific functionality in the SPC...
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22/11/18
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Active substance approval
These deadlines in Biocidal Products Regulation (BPR) and the Review Programme Regulation (RPR) have passed. AS = active substance PT = product type AS/PT = active substance/ product-type...
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13/06/18
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Active substance approval
Related R4BP 3
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05/09/17
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Active substance approval
Related Appeals Data sharing ECHA Helpdesk National helpdesks
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10/08/17
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Biocidal product authorisation
Related Guidance on Information Requirements Biocidal Product Committee Substitution criteria
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04/08/17
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Active substance approval
Related Approval of active substances Authorisation of biocidal products Technical equivalence Active substance suppliers Data sharing
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03/08/17
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