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SIST-TP CEN/TR 17296:2019

(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Withdrawn
Public Enquiry End Date
12-Sep-2018
Publication Date
09-Dec-2018
Withdrawal Date
15-Aug-2022
ICS
71.100.35 - Chemicals for industrial and domestic disinfection purposes
Technical Committee
KDS - Cosmetics, chemical disinfectants and surface active agents
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
11-Aug-2022
Due Date
03-Sep-2022
Completion Date
16-Aug-2022
Ref Project
CEN/TR 17296:2018 - Chemical disinfectants and antiseptics - Differentiation of active and non-active substances

Relations

Replaced By
SIST EN 14885:2022 - Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
Effective Date
01-Sep-2022

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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.

---------------------- Page: 1 ----------------------

SIST-TP CEN/TR 17296:2019

---------------------- Page: 2 ----------------------

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.

---------------------- Page: 3 ----------------------

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

---------------------- Page: 4 ----------------------

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

---------------------- Page: 5 ----------------------

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 a
...

SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 17296:2018
01-september-2018
.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
Ta slovenski standard je istoveten z: FprCEN/TR 17296
ICS:
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
kSIST-TP FprCEN/TR 17296:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TP FprCEN/TR 17296:2018

---------------------- Page: 2 ----------------------
kSIST-TP FprCEN/TR 17296:2018
Error! Reference source not found./TC Error! Reference source not found.
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found.

---------------------- Page: 3 ----------------------
kSIST-TP FprCEN/TR 17296:2018
FprCEN/TR 17296:2018 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Requirements . 4
2

---------------------- Page: 4 ----------------------
kSIST-TP FprCEN/TR 17296:2018
FprCEN/TR 17296:2018 (E)
European foreword
This document (FprCEN/TR 17296:2018) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Vote on TR.
3

---------------------- Page: 5 ----------------------
kSIST-TP FprCEN/TR 17296:2018
FprCEN/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 Requirements
When applying for authorization of a microbicidal product the applicant provides a composition
statement in which one or more active substances are identified and one or more co-formulant(s). 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(s). For
chemical disinfectants the following strategy has been developed:
A) Three kinds of tests have been identified. The applicant may choose one, two or all of them – as
necessary and appropriate.
Each test should be performed as a phase 2, step 1 test under the test conditions (test organism,
interfering substance/soiling, contact time, concentration of the product) used for a product claim.
Product claim means for example: “bactericidal activity: 1,5 %, 3 min, dirty conditions.” For the purpose
of the differentiation of active and non-active substa
...

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   etc.
c)   other industrial areas:
   packaging material;
   biotechnology (yeast, proteins, enzymes, etc.);
   pharmaceutical;
   cosmetics and toiletries;
   textiles;
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   etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
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