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CEN/TR 17296:2018

(Main)

Chemical disinfectants and antiseptics - Differentiation of active and non-active substances

Chemical disinfectants and antiseptics - Differentiation of active and non-active substances

This document defines how to exclude or confirm that an excipient in a biocidal product is an active substance within the frame of the European Biocidal Product Regulation and other regulations.

Chemische Desinfektionsmittel und Antiseptika - Differenzierung von aktiven und nicht-aktiven Substanzen

Dieses Dokument beschreibt Möglichkeiten, festzustellen, ob ein Hilfsstoff in der Konzentration, in der er in einem Produkt vorhanden ist, ein aktiver Wirkstoff im Rahmen der Europäischen Biozid Produktverordnung und/oder anderer Vorschriften ist oder nicht.

Antiseptiques et désinfectants chimiques - Différenciation des substances actives et des substances non actives

Kemična razkužila in antiseptiki - Razlikovanje med aktivnimi in neaktivnimi snovmi

Ta dokument opredeljuje način izključitve ali potrditve, da je pomožna snov v biocidnem pripravku aktivna snov v okviru evropske uredbe o biocidnih pripravkih in drugih uredb.

General Information

Status
Withdrawn
Publication Date
13-Nov-2018
Withdrawal Date
26-Jul-2022
ICS
11.080.20 - Disinfectants and antiseptics
71.100.35 - Chemicals for industrial and domestic disinfection purposes
Technical Committee
CEN/TC 216 - Chemical disinfectants and antiseptics
Drafting Committee
CEN/TC 216/WG 5 - Strategy Group
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
27-Jul-2022
Ref Project
SIST-TP CEN/TR 17296:2019 - Chemical disinfectants and antiseptics - Differentiation of active and non-active substances

Relations

Replaced By
EN 14885:2022 - Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
Effective Date
03-Nov-2021

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 17296:2019
01-januar-2019
.HPLþQDUD]NXåLODLQDQWLVHSWLNL5D]OLNRYDQMHPHGDNWLYQLPLLQQHDNWLYQLPL
VQRYPL
Chemical disinfectants and antiseptics - Differentiation of active and non-active
substances
Chemische Desinfektionsmittel und Antiseptika - Differenzierung von aktiven und nicht-
aktiven Substanzen
Antiseptiques et désinfectants chimiques - Différenciation des substances actives et des
substances non actives
Ta slovenski standard je istoveten z: CEN/TR 17296:2018
ICS:
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
SIST-TP CEN/TR 17296:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 17296:2019

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SIST-TP CEN/TR 17296:2019


CEN/TR 17296
TECHNICAL REPORT

RAPPORT TECHNIQUE

November 2018
TECHNISCHER BERICHT
ICS 11.080.20; 71.100.35
English Version

Chemical disinfectants and antiseptics - Differentiation of
active and non-active substances
Antiseptiques et désinfectants chimiques - Chemische Desinfektionsmittel und Antiseptika -
Différenciation des substances actives et des Differenzierung von aktiven und nicht-aktiven
substances non actives Substanzen


This Technical Report was approved by CEN on 12 October 2018. It has been drawn up by the Technical Committee CEN/TC 216.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 17296:2018 E
worldwide for CEN national Members.

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SIST-TP CEN/TR 17296:2019
CEN/TR 17296:2018 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and Definitions . 4
4 Requirements . 4

2

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SIST-TP CEN/TR 17296:2019
CEN/TR 17296:2018 (E)
European foreword
This document (CEN/TR 17296:2018) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
3

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SIST-TP CEN/TR 17296:2019
CEN/TR 17296:2018 (E)
1 Scope
This document describes ways to establish whether or not a co-formulant in the concentration that is
present in the product is an active substance within the framework of the European Biocidal Product
Regulation and/or other regulations.
2 Normative references
There are no normative references in this document.
3 Terms and Definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
4 Requirements
When applying for authorization of a microbicidal product the applicant provides a composition
statement in which one or more active substances and/or one or more co-formulant(s) are identified. In
some cases the Competent Authority might regard one or more of the co-formulants as additional active
substance(s). In some cases an explanation can be given and accepted. In cases where this is
insufficient, tests can be performed to demonstrate the “non-activity” of the co-formulant
...

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