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Results for tag Active substance approval
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Legislation Legislation BPR Legislation
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...
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11/06/19
List of active substance suppliers - download List of active substance suppliers - download List of active substances and suppliers
I have read and I accept the legal notice . Download the list of active substances and suppliers Download the list of active substances and suppliers [PDF][EN] 20 May 2019...
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21/05/19
Understanding BPR - external links Understanding BPR - external links Understanding BPR
See also Getting started with EU chemicals legislation European Commission - Biocides Biocidal Products Directive (Directive 98/8/EC) Biocides Relevant Document Links R4BP 3...
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03/05/19
ECHA accounts manual ECHA accounts manual ECHA accounts manual (4,975.7k)
ECHA Accounts Manual 2 ECHA Accounts Manual Version 5.0 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 |...
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30/04/19
Biocides - maintenance Biocides - maintenance Biocidal Active Substances
Due to a technical problem, which is under investigation, substance/product-type combinations previously evaluated by the United Kingdom in the framework of the Review Programme...
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12/04/19
PPR- Changes of elements of the Review Programme PPR- Changes of elements of the Review Programme Existing active substance
Changes of elements of the Review Programme Change in participant for a substance/product-type combination Joining or replacing participants by mutual agreement A prospective...
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12/04/19
BPR - AS - list of approved active substances - related links BPR - AS - list of approved active substances - related links List of approved active substances
Related Biocidal Active Substances List of notifications [PDF]
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11/04/19
BPR - upcoming dadlines - footnotes BPR - upcoming dadlines - footnotes Upcoming deadlines
* 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...
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11/04/19
Active substances meeting the following exclusion criteria should normally not be approved: carcinogens, mutagens and reprotoxic substances categories 1A or 1B according to the...
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12/02/19
Approval of active substance - general provisions Approval of active substance - general provisions Approval of active substances
Active substances need to be approved before an authorisation for a biocidal product containing them can be granted. The active substances are first assessed by an evaluating...
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19/12/18
Active substances - Submit your application Active substances - Submit your application Active substances
Approval of an active substance Prepare your IUCLID dossier. Log into R4BP 3. From the ‘NEW APPLICATION' tab, select ‘AS-APP – Approval of active substance' to launch the...
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14/11/18
Existing active substance - succesful declat Existing active substance - succesful declat ECHA’s open invitations for notifications
The proposed combinations that appear in the table below are considered eligible for inclusion in the Review Programme and they result from either "successful declarations of...
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25/06/18
Regulations - BPR - passed deadlines Regulations - BPR - passed deadlines Passed deadlines
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/...
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13/06/18
BPR - AS - dossier submission - links BPR - AS - dossier submission - links Same biocidal products authorisation
Related Submit a dossier - R4BP 3 Practical Guide chapter on SBP SPC Editor manual SBP applications Comparative assessment
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30/01/18
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Treated articles:...
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13/11/17
Article 93 transitional measure - links Article 93 transitional measure - links Article 93 transitional measure
Related Commission CA paper [DOC] Article 93 list [PDF] List of compliant notifications
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30/10/17
BPR - research and development - related links BPR - research and development - related links BPR - Research and development
Related R4BP 3
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05/09/17
Previous consultations on derogation to the exclusion criteria Previous consultations on derogation to the exclusion criteria Previous consultations on derogation to the exclusion criteria
The closed public consultations on the derogations to the exclusion criteria as laid down in Article 5(2) of the BPR are listed in the table below. Current consultations
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31/08/17
1 (23) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Recommendation of the BPC...
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11/08/17
Submit applications - Related links Submit applications - Related links Technical equivalence and chemical similarity
Related Appeals Data sharing ECHA Helpdesk National helpdesks
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10/08/17
BPR - Annex I amendment - submission - links BPR - Annex I amendment - submission - links Dossier submission
Related Prepare a dossier - IUCLID Submit a dossier - R4BP 3 Biocides Submission Manuals
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03/08/17
BPR - Annex I amendment - links BPR - Annex I amendment - links Annex I amendment
Related Simplified authorisation Biocidal Product Committee
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03/08/17
In situ generated active substances - link In situ generated active substances - link In situ generated active substances
Related ECHA's open invitation page Notification procedure List of active substances and suppliers CA document on management of in situ generated active substances [DOC] CA...
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03/08/17
Approval of active substances - external links Approval of active substances - external links New active substance
Related Practical Guide chapter on approval of active substance [PDF] [EN]
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03/08/17
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu Biocidal products benefitting from...
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08/05/17
Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation (175.2k)
Submission of information in the public consultation on potential candidates for substitution under the Biocidal Products Regulation Version 3.0 May 2017 2 ...
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28/04/17
Notification of substances that benefitted from the derogation for food and feed Notification of substances that benefitted from the derogation for food and feed Notification of substances that benefitted from the derogation for food and feed (187.6k)
1 (4) Public 23 January 2017 Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ...
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24/01/17
List of substances deadlines List of substances deadlines List of substances deadlines (259.6k)
1 (2) Active substances following a declarations of interest under Article 16(1)(b) of Regulation (EU) No 1062/2014 open for notification Article...
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24/01/17
BPR - Annex I amendment - evaluation process BPR - Annex I amendment - evaluation process Evaluation process
The evaluation process starts when an application for amendment of Annex I to the BPR is considered to be valid by the evaluating competent authority. The evaluating competent...
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16/12/16
Practical guide on Biocidal Products Regulation Approval of active substance Practical guide on Biocidal Products Regulation Approval of active substance Practical guide on Biocidal Products Regulation Approval of active substance (427.3k)
PRACTICAL GUIDE ON BIOCIDAL PRODUCTS REGULATION Approval of active substance PRINCIPLES BEHIND THE OBLIGATION/PROCESS The basic principle in the Biocidal Products Regulation...
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31/10/16
��� EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE GENERAL Safety of the food chain Pesticides and Biocides �� CA-May16-Doc.5.1 - Final 64th meeting of...
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13/09/16
In situ active substance/precursor-combination open for notification In situ active substance/precursor-combination open for notification In situ active substance/precursor-combination open for notification (205.7k)
1 (4) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu In situ active substance/precursor-combination open...
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19/01/16
Existing act substance notification proc. links Existing act substance notification proc. links Notification procedure
Related links Guidance on information requirements Product-types How to submit a notification in the Review Program (Role of participant or for inclusion of a new Active...
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13/01/16
BPR - approved suppliers BPR - approved suppliers Active substances and suppliers
The Biocidal Products Regulation (BPR) aims to make sure that the costs of the data on active substances are fairly shared. Companies that have not already submitted their own...
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17/12/15
Suggested template letter of access for Article 95 of the BPR (complete substance dossier) Suggested template letter of access for Article 95 of the BPR (complete substance dossier) Suggested template letter of access for Article 95 of the BPR (complete substance dossier) (50.1k)
LoA template for Article 95 of the BPR (also for product authorisation in accordance with Article 95(4)) NOTE to the reader: The template LoA has an appendix. Please note...
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04/08/15
Active substance suppliers - Application and assessment procedure Active substance suppliers - Application and assessment procedure Application and assessment procedure
Companies will apply for inclusion on the list of active substance suppliers through R4BP 3. This graph shows an overview of the application procedure for inclusion on the list...
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23/03/15
Dossier submission for active substance approvals or inclusion in Annex I to BPR-toptext Dossier submission for active substance approvals or inclusion in Annex I to BPR-toptext Dossier submission
An application for the approval of an active substance (inclusion in the Union list of approved active substances) or for the inclusion in Annex I of the BPR (with the exclusion...
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06/03/15
Evaluation process for active substances under the review programme -main text Evaluation process for active substances under the review programme -main text Evaluation process
Active substances already in the review programme (Annex II part 1) and active substances which will be added to the programme after the submission of a compliant notification...
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06/03/15
R4BP - Annex I amendment -links R4BP - Annex I amendment -links Annex I amendment
Related documents Biocides Submission Manuals Guidance on biocides legislation Supporting documents table Biocidal Products Regulation explained Commission Implementing...
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28/10/14
Related documents Biocides Submission Manuals Supporting documents table Biocidal Products Regulation explained Commission Implementing Regulation (EU) No 564/2013 (Fee...
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28/10/14
Related documents Biocides Submission Manuals Supporting documents table Biocidal Products Regulation explained Commission Implementing Regulation (EU) No 564/2013 (Fee...
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28/10/14
R4BP - data sharing for active substance-links R4BP - data sharing for active substance-links Submit an inquiry to share data for active substance
Related documents Biocides Submission Manuals Guidance on information requirements Guidance on data sharing Supporting documents table Biocidal Products Regulation explained...
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28/10/14
R4BP - list of active substance suppliers-links R4BP - list of active substance suppliers-links Inclusion on the list of active substances and suppliers
Related documents Biocides Submission Manuals Guidance on biocides legislation Guidance on data sharing Supporting documents table Biocidal Products Regulation explained...
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28/10/14
R4BP- renewal as approval -links R4BP- renewal as approval -links Renewal of an active substance approval
Related documents Biocides Submission Manuals Supporting documents table Biocidal Products Regulation explained Active substance approval Commission Implementing Regulation...
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28/10/14
BPC opinions on active substance approval - link to assessment reports BPC opinions on active substance approval - link to assessment reports BPC opinions on active substance approval
The assessment reports can be found in the list of Biocidal Active Substances.
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02/05/14
BPC opinions on other requests under the Biocidal Products Regulation head text BPC opinions on other requests under the Biocidal Products Regulation head text Opinions on Article 75(1)(g)
The Biocidal Products Committee has issued the following opinions on questions that have arisen from the operation of the Biocidal Products Regulation (BPR) relating to...
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30/04/14
Dossier submission active substances - steps 1 Dossier submission active substances - steps 1 Dossier submission
Steps Dossier submission proceeds in several steps. Each step needs to be completed before the application can move to the next step. It is important that the applicant makes...
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27/11/13
BPR - AS - evaluation process - graph BPR - AS - evaluation process - graph Evaluation process
This graph shows an overview of the dossier evaluation process
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25/11/13
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