NUGEN Disinfectant Products EMEA Region 20 January 2022
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NUGEN® Disinfectant Products EMEA Region 20 January 2022
Introduction to the EU Biocidal Products Regulation (BPR)
Active Substances and Biocidal Products
EU level approval of all Active Substances (AS) Authorisation of Biocidal Product (BP)
• “New* AS” - no marketing until AS approved • Only approved AS appearing on the Union List
& BPs authorized from Article 95 Listed suppliers can be included in a
• “Existing* AS” - Review Programme to approve BP submission
• Transitional Phase to allow Biocidal Products to stay on the • Primary Authorisation by nominated Member State
market during review process (MS) for initial (1st) authorization
• ECHA list (Article 95 list) of AS suppliers. You must • Mutual Recognition (MR) for additional MS
source from a listed supplier. • Or Union Authorisation - directly applicable in all MS upon
approval
*”Existing/new active substance” = was/not identified as on the market on 14 May 2000 as an active substance of a biocidal product
NUGEN® Disinfectant Products | 20 January 2022 2
New European Disinfectant Development Costs
Development, Data Generation and Registration Costs are not fixed
Product Development Data Generation at ECHA/R4BP 3 Costs
Single product Accredited Laboratories Registration/Evaluation Fees
€383k – 554k*
€200-250k + €100-150k + €83-154k =
Costs could be significantly greater, Higher costs would come from a (a Biocidal Product Family (BPF) would
depending on the claims and more extensive claim set and/or more cost €155k - €311k) depending on eCA
attributes than one Active Substance
+ Dossier Preparation
€40k – 70k
+ Annual Fees
€100k
(based on € 10k/yr)
*These authorisation costs are based on a Union Authorisation approach for a single product;
Products can also be authorised on a country-by-country basis, However the costs will vary on a case-by-case basis. = €523k* - 724k*
BPR data requirements are
not static!
NUGEN® Disinfectant Products | 20 January 2022 3
Survive the BPR™ with Arxada’s Support
Active Substances and Biocidal Products
Active Substances (AS) Formulated Solutions (FS)
• Technical and Regulatory Expertise • Complete Solutions of Biocidal Products (BP) that
• AS supported under BPR, REACH, local registrations are underpinned with data
• Support with AS information for customers’ • Registered in selected European Countries (product
own disinfectants specific registration footprint)
• Marketing support
Benefits of Formulated Solutions include
• Shared expertise
• Cost and resource savings
• Simplified registration path via Same Biocidal
Product (SBP) Authorisation
NUGEN® Disinfectant Products | 20 January 2022 4Same Biocidal Product Authorisation (SBP)
Arxada’s Chosen Regulatory Approach for its Formulated Solutions Programme
• Arxada will gain Primary Authorisation for the product(s). • An Authorisation gained via the SBP Regulation is an
• Customers can obtain their own Authorisation by applying for a independent authorisation, with trade names and authorisation
Same Biocidal Product Authorisation (SBP), linked to Arxada’s number(s) that are unique to the SBP applicant.
primary dossier (= Reference Product (RP)). • Once the SBP Application has been authorised, the link between
• A SBP allows two (or more) identical products or families to be the Reference Product (or family) and Same Biocidal Product is
placed on the market based on a single evaluation. cut. This means that a SBP Authorisation is an independent
authorisation, subsequent changes to the Reference
Authorisation will have no impact on the SBP Authorisation (and
vice-versa).
Customer owned
Arxada Biocidal Product Family
Authorisations, independent
(BPF) with a defined set of
of Reference Family.
Reference Products
SBP Applications
NUGEN® Disinfectant Products | 20 January 2022 5BPR Product Authorisation (PA) Process
From Active Substance Evaluation to Biocidal Product Approval
Publication in ECHA’s
BPC Opinion Official Journal Approval Date
Active Substance
PA Application Window
Dossier Evaluation
NUGEN® remains under
NUGEN® Reference Product on Market via Transitional Arrangements
Transitional Arrangements
NUGEN® Reference Product
Authorised
Sub-registration NUGEN®
PA Dossier BP Dossier Evaluation (up to 3 years)
Submission
Customer
Administrative Process Linked to
LOA SBP
Submission Reference Dossier Evaluation
NUGEN® Reference Product
Authorised
Customer Product also
Customer Product on Market via Transitional
remains on Market under
Arrangements
Transitional Arrangements
Where a disinfectant product is supported in more than one Product Types (PT), Arxada’s Authorisation dossier may only be submitted once relevant Active Substance Biocidal Product Committee
(BPC) Opinions have been formally published for all of the supported PTs. Any Same Biocidal Product (SBP) linked to this dossier cannot be submitted until after this time. Customers are advised to
include a PT2 use to their notification (if they do not already have one) for DDAC-based products so the timings for their product authorisation obligations align with Arxada’s.
NUGEN® Disinfectant Products | 20 January 2022 6Current Portfolio of Disinfectant Products for the EIMEA Region
The portfolio of products for the PT2 PT4
PT1 PT2
EIMEA Region includes a range Product Type of Product
Hand Hygiene Healthcare
Industrial and Food Service &
Institutional Processing
of Disinfectants, Disinfectant
Cleaners and Antimicrobial Hand NUGEN® HDS Foam
Antimicrobial
Hand Soap •
Soaps.
NUGEN® HDS Liquid
Antimicrobial
Hand Soap •
For the latest information on
which products will be supported NUGEN® DM 114-10 Disinfectant • • •
under the EU BPR please
contact your local Arxada
NUGEN® DR-19aB Disinfectant • •
representative. NUGEN® DR-25aN
Disinfectant
Cleaner • • •
NUGEN® DR-LS-13N
Disinfectant
Cleaner • • •
NUGEN® R-82G
Disinfectant
Cleaner • •
Bardac® 22-90
Disinfectant and
Green Remover • •
Bardac® 22-200
Disinfectant and
Green Remover • •
NUGEN® Disinfectant Products | 20 January 2022 7NUGEN® HDS Foam NUGEN® Disinfectant Products | 20 January 2022 8
NUGEN® HDS Foam
Professional Use
Customer Benefits/Value Proposition Function Ingredients %
• 1.5 ml to 3.0 ml dose allowing for dispenser flexibility
• Designed to closely match the natural pH of the skin Active Didecyldimethylammonium chloride 0.55
• Classified as non-hazardous according to the CLP Substances [CAS No. 7173-51-5]
Regulation 2-Phenoxyethanol 0.90
• Provides gentle clean feel on your hands: Perfect for [CAS No. 122-99-6]
frequent use
Inerts Water, non-ionic surfactant, pH adjusters, 98.55
• Rinses off easily helping to save water
humectant and chelating agent
• Dermatologist Tested
• All components in this product are readily biodegradable
Efficacy
• Proven efficacy against Bacteria, Yeast and Enveloped
Viruses at 30 seconds
• Passes EN 1499 at 1.5 ml dose
NUGEN® Disinfectant Products | 20 January 2022 9NUGEN® HDS Foam
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Belgium, Croatia,
Czech Republic, France,
Germany, Ireland, Italy,
Liechtenstein,
Luxembourg, Malta,
Slovakia, Switzerland, UK
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact us for details of the
latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 10NUGEN® HDS Foam An Innovative Formulation designed to closely match the natural pH of the skin whilst providing proven fast acting efficacy at 30 seconds against bacteria, yeast, and enveloped viruses.* NUGEN® HDS Foam also rinses off easily helping to save water and provides a gentle clean feel on your hands. Perfect for frequent hand washing typical of professional users. NUGEN® Disinfectant Products | 20 January 2022 11
NUGEN® HDS Foam
Types of User: Professional Directions:
Organic Load: Medical dirty conditions, 3.0g/l bovine albumin (BSA) and +3.0 g/l sheep erythrocytes 1. Wet hands before use.
Product Types(s): PT1 2. Apply 1.5 to 3ml of product dispensed as foam.
Industries: Healthcare, I&I, F&B 3. Rub in well across all parts of the hands for 30 seconds.
Dose: 1.5ml 4. Rinse hands thoroughly with clean running water.
5. Dry hands thoroughly.
Microbiological Claim* (Antimicrobial Hand Soap) PT1 Comments
Bactericidal (EN 1499: 2013) • Tested against required standard EN test organism: Escherichia coli K121
Bactericidal (EN 13727: 2012 + A2:2015) • Tested against required standard EN test organisms: Staphylococcus aureus,
Escherichia coli K12, Enterococcus hirae, Pseudomonas aeruginosa2
Yeasticidal (EN 13624: 2013) • Tested against required standard EN test organism: Candida albicans.
Virucidal against Enveloped Viruses (EN 14476: 2013 + A1: 2015) • Tested against required standard EN test organism: Vacciniavirus, strain Ankara
(MVA)3
1. All the data generated for NUGEN® HDS Foam are in line with EN 14885:2018 to support a Hygienic Handwash
claim in the medical, food, industrial domestic and institutional areas. EN 1499:2013 is the Phase 2 Step 2
European norm used to claim bactericidal activity along with the relevant Phase 2 Step 1 norm in that area.
There are currently no Phase 2 Step 2 norms to support yeasticidal and virucidal claims.
2. A general bactericidal claim based on EN 13727:2012+A2:2015 and EN 1499:2013 includes most vegetative
bacteria including common food poisoning organisms such as Campylobacter jejuni, Listeria monocytogenes,
and Salmonella enterica.
3. Products that show activity against vacciniavirus and therefore support an enveloped virus claim may also claim
activity against other enveloped viruses including Influenza A (H1N1) and Coronavirus species.
NUGEN® Disinfectant Products | 20 January 2022 *All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all 12
registered Member States.NUGEN® HDS Liquid 02 NUGEN® Disinfectant Products | 20 January 2022 13
NUGEN® HDS Liquid
Customer Benefits/Value Proposition Function Ingredients %
• An innovative formulation designed to closely match the
natural pH of the skin Active Didecyldimethylammonium chloride 0.55
• Classified as non-hazardous according to the CLP Regulation Substances [CAS No. 7173-51-5]
• Provides a clean feeling during washing and leaves your 2-Phenoxyethanol 0.50
hands feeling soft and cared for [CAS No. 122-99-6]
• Dermatologist Tested
Inerts Water, non-ionic surfactant, pH adjusters, 98.95
• >99.4% (w/w) of the components in this product are readily thickener, humectant and chelating agent
biodegradable
Efficacy
• Proven efficacy against Bacteria, Yeast and Enveloped
Viruses at 30 seconds
• Passes EN 1499 at 3.0 ml dose
NUGEN® Disinfectant Products | 20 January 2022 14NUGEN® HDS Liquid
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Croatia, Czech
Republic, France,
Germany, Luxembourg,
UK
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 15NUGEN® HDS Liquid Rinse off Hand Disinfectant Soap with proven efficacy to kill 99.9% bacteria and enveloped viruses which includes Coronavirus at fast 30 second contact time. Independently certified according to European Standard EN 14476 and dermatologist approved. Innovated to closely match the natural pH of the skin and without the potential drying effects of high alcohol concentrations. Balancing proven efficacy with skin feel to leave your hands feeling soft and cared for. NUGEN® Disinfectant Products | 20 January 2022 Patent Pending 16
NUGEN® HDS Liquid
Types of User: Professional Directions:
Organic Load: Medical dirty conditions, 3.0 g/l bovine albumin (BSA) and + 3.0 g/l sheep erythrocytes 1. Wet hands before use.
Product Types(s): PT1 2. Apply 3ml of liquid onto hands.
Industries: Healthcare, I&I, F&B 3. Rub in well across all parts of the hands for 30 seconds.
Dose: 3ml 4. Rinse hands thoroughly with clean running water.
5. Dry hands thoroughly.
Microbiological Claim* (Antimicrobial Hand Soap) PT1 Comments
Bactericidal (EN 1499: 2013) • Tested against required standard EN test organism: Escherichia coli K121
Bactericidal (EN 13727: 2012 + A2:2015) • Tested against required standard EN test organisms: Staphylococcus aureus,
Escherichia coli K12, Enterococcus hirae, Pseudomonas aeruginosa2
Yeasticidal (EN 13624: 2013) • Tested against required standard EN test organism: Candida albicans.
Virucidal against Enveloped Viruses (EN 14476: 2013 + A1: 2015) • Tested against required standard EN test organism: Vacciniavirus, strain Ankara
(MVA)3
1. All the data generated for NUGEN® HDS Liquid are in line with EN 14885:2018 to support a Hygienic Handwash *All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered
claim in the medical, food, industrial domestic and institutional areas. EN 1499:2013 is the Phase 2 Step 2 Member States.
European norm used to claim bactericidal activity along with the relevant Phase 2 Step 1 norm in that area.
There are currently no Phase 2 Step 2 norms to support yeasticidal and virucidal claims.
2. A general bactericidal claim based on EN 13727:2012+A2:2015 and EN 1499:2013 includes most vegetative
bacteria including common food poisoning organisms such as Campylobacter jejuni, Listeria monocytogenes,
and Salmonella enterica.
3. Products that show activity against vacciniavirus and therefore support an enveloped virus claim may also claim
activity against other enveloped viruses including Influenza A (H1N1) and Coronavirus species
NUGEN® Disinfectant Products | 20 January 2022 17NUGEN® DM 114-10 Disinfectant 03 NUGEN® Disinfectant Products | 20 January 2022 18
NUGEN® DM 114-10 Disinfectant
Customer Benefits/Value Proposition Function Ingredients %
• NUGEN® DM 114-10 disinfectant is a convenient concentrated
pH-neutral formula, allowing for easy dilution. Active Didecyldimethylammonium chloride 3.3
• It demonstrates excellent compatibility with wide range of Substances [CAS No. 7173-51-5]
sensitive materials like plastics (including acrylic glass), Alkyl (C12-C16) dimethylbenzyl ammonium chloride 3.3
elastomers etc. [CAS No. 68424-85-1]
• All components in this product are readily biodegradable.
Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium 3.3
Efficacy chloride [CAS No. 85409-23-0]
• High performance against Bacteria, Yeast and Enveloped Inerts Solvent and Water 90.1
Viruses.
NUGEN® Disinfectant Products | 20 January 2022 19NUGEN® DM 114-10 Disinfectant
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Czech Republic,
France, Germany, Ireland,
Italy, Liechtenstein,
Luxembourg, Malta,
Poland, Portugal,
Slovakia, Spain,
Switzerland, UK
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 20NUGEN® DM 114-10 Disinfectant
Test Results for Healthcare, I&I and F&B
* Basic microbiological claim requirement for PT2 Healthcare, PT2 I&I and PT4 F&B
Types of User: Professional ** Basic microbiological claim requirement for PT2 Healthcare and PT4 F&B; Optional organism claim for PT2 I&I
Organic Load: Medical and I&I clean conditions, 0.3 g/l bovine albumin (BSA) *** Optional organism claim for PT2 Healthcare and PT2 I&I; this claim cannot be made for PT4 F&B
**** Supports a claim for non-medical instrument dipping
Product Types(s): PT2, PT4
Industries: Healthcare, I&I, F&B
+ Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Result (%)
1 2,1 EN 13727 0.5
S.aureus, P.aeruginosa, E.hirae 2,2 EN 13697 2.0
5
2,2 EN 16615 1.0
Bactericidal* 2,1 EN 1276 1.0
S.aureus, E.coli,
5 2,2 EN 13697 2.0
P.aeruginosa, E.hirae
2,2 EN 16615 1.0
S.aureus, P.aeruginosa, E.hirae 15 2,2 EN 14561**** 2.0
2,1 EN 13624 0.3
1
2,1 EN 1650 0.2
Yeasticidal** C.albicans 2,2 EN 16615 1.0
5
1. All the data generated for NUGEN® HDS Liquid are in line with EN 14885:2018 to support a Hygienic Handwash *All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered
2,2 EN 13697 1.5
claim in the medical, food, industrial domestic and institutional areas. EN 1499:2013 is the Phase 2 Step 2 Member States.
European norm used to claim bactericidal activity along with the relevant Phase 2 Step 1 norm in that area.
There are currently no Phase 2 Step 2 norms to support yeasticidal and virucidal claims
15 2,2 EN 14562**** 1.5
2. A general bactericidal claim based on EN 13727:2012+A2:2015 and EN 1499:2013 includes most vegetative
bacteria including common food poisoning organisms such as Campylobacter jejuni, Listeria monocytogenes,
2,1 EN 14476 2.0
Virucidal against
and Salmonella Enveloped
enterica
5
3.Viruses*** Modified
Products that show activity against vacciniavirus and therefore supportVaccinia ankara
an enveloped virus claim may also claim 2,2 EN 16777 3.0
activity against other enveloped viruses including Influenza A (H1N1) and Coronavirus species
15 2,2 EN 16777 2.5
NUGEN® Disinfectant Products | 20 January 2022 21NUGEN® DM 114-10 Disinfectant
I&I and F&B
Types of User: Professional Dilution: 1.0-3.0%
Use Instructions: Pre-Clean prior to disinfection
Product Types(s): PT2, PT4
Industries: I&I, F&B
PT2 PT2 PT2 PT2
PT4
Microbiological Claim+ Industrial & Industrial & Industrial & Industrial &
Food & Beverage
(Disinfectant) Institutional Institutional Institutional Institutional
2.0% / 15 mins
1.0% / 5 mins 3.0% / 5 mins 2.0% / 15 mins 2.5% / 15 mins
Bactericidal (EN 1276, EN 16615)*
Mechanical action • • • • •
Bactericidal (EN 1276, EN 13697, EN16615)*
Mechanical and non-mechanical action • • • •
Bactericidal (EN 14561)***
Non-medical instrument claim • •
Yeasticidal (EN 1650, EN 16615)**
Mechanical action • • • • •
Yeasticidal (EN 1650, EN 13697, EN16615)**
Mechanical and non-mechanical action • • •
Yeasticidal (EN 14562)***
Non-medical instrument claim • •
Virucidal against Enveloped Viruses
(EN 14476, EN 16777)**** • •
* Basic microbiological claim requirement for PT2 I&I
** Basic microbiological claim requirement for PT4 F&B; Optional organism claim for PT2 I&I
*** Supports a claim for non-medical instrument dipping
NUGEN® Disinfectant Products | 20 January 2022 **** Optional organism claim for PT2 I&I; an enveloped virucidal claim cannot be made for PT4 F&B 22
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member States.
Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test NormsNUGEN® DM 114-10 Disinfectant
Healthcare
Types of User: Professional Dilution: 1.0-3.0%
Use Instructions: Pre-Clean prior to disinfection
Product Types(s): PT2
Industries: Healthcare
PT2 PT2 PT2 PT2 PT2
Microbiological Claim+
Healthcare Healthcare Healthcare Healthcare Healthcare
(Disinfectant)
1.0% / 5 mins 2.0% / 5 mins 3.0% / 5 mins 2.0% / 15 mins 2.5% / 15 mins
Bactericidal (EN 13727, EN 16615)*
Mechanical action • • • • •
Bactericidal (EN 13727, EN 13697, EN 16615)*
Mechanical and non-mechanical action • • • •
Yeasticidal (EN 13624, EN 16615)*
Mechanical action • • • • •
Yeasticidal (EN 13624, EN 13697, EN 16615)*
Mechanical and non-mechanical action • • •
Virucidal against Enveloped Viruses
(EN 14476, EN 16777)** • •
* Basic microbiological claim requirement for PT2 Healthcare
** Optional organism claim for PT2 Healthcare
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all
registered Member States. Different application methods align to either Phase 2, Step 2 mechanical or non-
mechanical EN Test Norms
NUGEN® Disinfectant Products | 20 January 2022 23NUGEN® DR-19aB Disinfectant 04 NUGEN® Disinfectant Products | 20 January 2022 24
NUGEN® DR-19aB Disinfectant
Customer Benefits/Value Proposition Function Ingredients %
• NUGEN® DR-19aB disinfectant is supplied as a convenient
concentrated formula, for easy dilution. Active Didecyldimethylammonium chloride 4.5
• Benefit from its extensive registration position including the Substances [CAS No. 7173-51-5]
Netherlands and Belgium and its future inclusion within Inerts Surfactant, builder, complexing agent, 95.5
Arxada’s DDAC Biocidal Product Family 1 under the BPR. solvent, water
• All organic components in this product are readily
biodegradable.
Efficacy
• Effective against Bacteria, Yeast and Enveloped Viruses.
NUGEN® Disinfectant Products | 20 January 2022 25NUGEN® DR-19aB Disinfectant
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Belgium, Cyprus,
Czech Republic, Estonia,
France, Germany,
Greece, Ireland, Italy,
Latvia, Liechtenstein,
Luxembourg, Malta,
Netherlands, Poland,
Portugal, Slovakia, Spain,
Switzerland, UK
BPR Product Authorisation
Approach:
Union Authorisation as
part of Arxada’s DDAC
BPF 1
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 26NUGEN® DR-19aB Disinfectant
Test Results for I&I and F&B
Types of User: Professional
Organic Load: I&I clean conditions, 0.3 g/l bovine albumin (BSA)
I&I dirty conditions, 3.0 g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: I&I, F&B
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling Conditions Result (%)
2,1 EN 1276 I&I Dirty 4.0
5 2,2 EN 13697 I&I Dirty 5.0
2,2 EN 16615 I&I Dirty 2.0
2,1 EN 1276 I&I Dirty 3.0
S.aureus, E.coli,
Bactericidal* 10 2,2 EN 13697 I&I Dirty 3.0
P.aeruginosa, E.hirae
2,2 EN 16615 I&I Dirty 2.0
2,1 EN 1276 I&I Dirty 2.0
15 2,2 EN 13697 I&I Dirty 3.0
2,2 EN 16615 I&I Dirty 2.0
* Basic microbiological claim requirement for PT2 Healthcare, PT2 I&I and PT4 F&B.
NUGEN® Disinfectant Products | 20 January 2022 27NUGEN® DR-19aB Disinfectant
Test Results for I&I and F&B
Types of User: Professional
Organic Load: I&I clean conditions, 0.3 g/l bovine albumin (BSA)
I&I dirty conditions, 3.0 g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: I&I, F&B
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling Conditions Result (%)
2,1 EN 1276 I&I Dirty 3.0
5
2,2 EN 16615 I&I Dirty 2.0
2,1 EN 1276 I&I Dirty 2.0
Yeasticidal** C.albicans 10
2,2 EN 16615 I&I Dirty 2.0
2,1 EN 1650 I&I Dirty 2.0
15
2,2 EN 16615 I&I Dirty 2.0
2,1 EN 14476 I&I Clean 1.0
Virucidal against Enveloped 5
Modified Vaccinia ankara 2,2 EN 16777 I&I Clean 3.0
Viruses***
15 2,2 EN 16777 I&I Clean 3.0
** Basic microbiological claim requirement for PT4 F&B; Optional organism claim for PT2 I&I
*** Optional organism claim for PT2 I&I (testing conducted in I&I Clean conditions); an enveloped virucidal claim
cannot be made for PT4 F&B
+ Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
NUGEN® Disinfectant Products | 20 January 2022 28NUGEN® DR-19aB Disinfectant
I&I
Types of User: Professional Dilution: 3.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT2
Industries: I&I
PT2 PT2 PT2 PT2
Microbiological Claim+
Industrial & Institutional Industrial & Institutional Industrial & Institutional Industrial & Institutional
(Disinfectant)
4.0% / 5 mins 5.0% / 5 mins 3.0% / 10 mins 2.0% / 15 mins
Bactericidal (EN 1276, EN 16615)*
Mechanical action • • • •
Bactericidal (EN 1276, EN 13697)*
Non-mechanical action • •
Yeasticidal (EN1650, EN 16615)**
Mechanical action • • • •
* Basic microbiological claim requirement for PT2 I&I
** Optional organism claim for PT2 I&I
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member States.
Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
NUGEN® Disinfectant Products | 20 January 2022 29NUGEN® DR-19aB Disinfectant
I&I
Types of User: Professional Dilution: 3.0%-4.0%
Use Instructions: Pre-Clean prior to disinfection
Product Types(s): PT2
Industries: I&I
PT2 PT2 PT2
Microbiological Claim+
Industrial & Institutional Industrial & Institutional Industrial & Institutional
(Disinfectant)
4.0% / 5 mins 3.0% / 10 mins 3.0% / 15 mins
Bactericidal (EN 1276, EN 13697, EN 16615)*
Mechanical and Non-mechanical action • • •
Yeasticidal (EN 1650, EN 16615)**
Mechanical action • • •
Virucidal against Enveloped Viruses **
(EN 14476, EN 16777) • •
* Basic microbiological claim requirement for PT2 I&I
** Optional organism claim for PT2 I&I
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member States.
Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
NUGEN® Disinfectant Products | 20 January 2022 30NUGEN® DR-19aB Disinfectant
F&B
Types of User: Professional Dilution: 3.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT4
Industries: F&B
PT4 PT4 PT4
Microbiological Claim+
Food & Beverage Food & Beverage Food & Beverage
(Disinfectant)
4.0% / 5 mins 3.0% / 10 mins 2.0% / 15 mins
Bactericidal (EN 1276, EN 16615)*
Mechanical action • • •
Bactericidal (EN 1276, EN 13697)*
Non-mechanical action • •
Yeasticidal (EN1650, EN 16615)*
Mechanical action • • •
• Basic microbiological claim requirement for PT4 F&B
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member States.
Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
NUGEN® Disinfectant Products | 20 January 2022 31NUGEN® DR-LS-13N Disinfectant Cleaner 05 NUGEN® Disinfectant Products | 20 January 2022 32
NUGEN® DR-LS-13N Disinfectant Cleaner
Customer Benefits/Value Proposition Function Ingredients %
• NUGEN® DR-LS-13N disinfectant cleaner based on a non-
QAC Active Substance that provides cleaning and disinfection Active N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine 6.75
all in a convenient concentrated formula, for easy dilution. Substances [CAS No. 2372-82-9]
• All components in this product are readily biodegradable. Inerts Surfactants, complexing agent, water 93.25
Efficacy
• Performance against Bacteria, Yeast and Enveloped Viruses.
NUGEN® Disinfectant Products | 20 January 2022 33NUGEN® DR-LS-13N Disinfectant Cleaner
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Belgium, Croatia,
Czech Republic, Estonia,
France, Germany, Ireland,
Italy, Latvia,
Liechtenstein,
Luxembourg, Poland,
Portugal, Slovakia, Spain,
Switzerland, UK
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 34NUGEN® DR-LS-13N Disinfectant Cleaner
Test Results for Healthcare, I&I and F&B
* Basic microbiological claim requirement for PT2 Healthcare, PT2 I&I and PT4 F&B
Types of User: Professional ** Basic microbiological claim requirement for PT2 Healthcare and PT4 F&B; Optional organism claim for PT2 I&I
Organic Load: Medical and I&I dirty conditions *** Optional organism claim for PT2 Healthcare and PT2 I&I; this claim cannot be made for PT4 F&B.
Product Types(s): PT2, PT4
+ Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
Industries: Healthcare, I&I, F&B
Contact Time
Microbiological Claim Organism(s) Phase / Step+ EN Norm Soiling Conditions Result (%)
(Mins)
2,1 EN 13727 Medical Dirty 1.0
S.aureus, P.aeruginosa, E.hirae 5 2,2 EN 13697 Medical Dirty 5.0
Bactericidal* 2,2 EN 16615 Medical Dirty 5.0
S.aureus, E.coli, 2,1 EN 1276 I&I Dirty 1.0
5
P.aeruginosa, E.hirae 2,2 EN 13697 I&I Dirty 1.5
2,1 EN 13624 I&I Dirty 1.0
5 2,2 EN 13697 I&I Dirty 4.0
Yeasticidal** C.albicans 2,2 EN 16615 I&I Dirty 5.0
2,1 EN 1650 I&I Dirty 0.5
15
2,2 EN 13697 I&I Dirty 1.0
Virucidal against Enveloped 2,1 EN 14476 Medical Dirty 3.0
Modified Vaccinia ankara 5
Viruses*** 2,2 EN 16777 Medical Clean Testing ongoing
NUGEN® Disinfectant Products | 20 January 2022 35NUGEN® DR-LS-13N Disinfectant Cleaner
Healthcare, I&I and F&B
Types of User: Professional Dilution: 1.0-5.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT2, PT4
Industries: Healthcare, I&I, F&B
PT2
Industrial &
PT2 PT2 Institutional PT2
PT2
Microbiological Claim+ Industrial & Industrial & Industrial &
Healthcare
(Disinfectant Cleaner) Institutional Institutional PT4 Institutional
5.0% / 5 mins
1.5% / 5 mins 3.0% / 5 mins Food & Beverage 3.0% / 15 mins
1.5% /
15 mins
Bactericidal (EN 1276, EN 13697)*
Non-mechanical action • • • •
Bactericidal (EN 13727, EN 13697, EN 16615)*
Mechanical and non-mechanical action •
Yeasticidal (EN 1650, EN 13697)**
Non-mechanical action • •
Yeasticidal (EN 13624, EN 13697, EN 16615)**
Mechanical and non-mechanical action •
Virucidal against Enveloped Viruses
(EN 14476)*** • • •
* Basic microbiological claim requirement for PT2 Healthcare, PT2 I&I and PT4 F&B
** Basic microbiological claim requirement for PT2 Healthcare and PT4 F&B; Optional organism claim for PT2 I&I
*** Optional organism claim for PT2 Healthcare and PT2 I&I; this claim cannot be made for PT4 F&B. EN 16777 data generation is ongoing.
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member States.
Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
NUGEN® Disinfectant Products | 20 January 2022 36NUGEN® DR-25aN Disinfectant Cleaner 05 NUGEN® Disinfectant Products | 20 January 2022 37
NUGEN® DR-25aN Disinfectant Cleaner
Customer Benefits/Value Proposition Function Ingredients %
• NUGEN® DR-25aN disinfectant cleaner provides cleaning and
disinfection all in a convenient concentrated formula, for easy Active Didecyldimethylammonium chloride 6.9
dilution. Clean and disinfect in a single, time-saving step. Substances [CAS No. 7173-51-5]
Aldehyde free. Broad material compatibility including metals, Inerts Surfactant, builder, complexing agent, solvent, 93.1
plastics and elastomers. water
• Benefit from its extensive registration position including the
Netherlands and Belgium and its future inclusion within
Arxada’s DDAC Biocidal Product Family 1 under the BPR.
• All organic components in this product are readily
biodegradable.
Efficacy
• Broad efficacy performance against a wide range of
pathogens, including Non-Enveloped Viruses (incl. Polio virus,
Adeno virus and Norovirus), Enveloped Viruses (incl.
Influenza viruses, BCoV the surrogate for other
Coronaviruses), Bacteria (incl. MRSA), Bacteriophages and
Yeast.
NUGEN® Disinfectant Products | 20 January 2022 38NUGEN® DR-25aN Disinfectant Cleaner
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Belgium, Croatia,
Cyprus, Czech Republic,
Estonia, France,
Germany, Greece,
Ireland, Italy, Latvia,
Liechtenstein,
Luxembourg, Malta,
Netherlands, Poland,
Portugal, Slovakia, Spain,
Switzerland, UK
BPR Product Authorisation
Approach:
Union Authorisation as
part of Arxada’s DDAC
BPF 1
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 39NUGEN® DR-25aN Disinfectant Cleaner
Test Results for I&I and F&B
* Basic microbiological claim requirement for PT2 I&I and PT4 F&B
Types of User: Professional ** Basic microbiological claim requirement PT4 F&B; Optional organism claim for PT2 I&I
Organic Load: I&I dirty conditions, 3.0 g/l bovine albumin (BSA);
I&I clean conditions, 0.3g/l bovine albumin (BSA) + Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
++ Supports a claim for non-medical instrument dipping
Product Types(s): PT2, PT4
Industries: I&I, F&B
Contact Time
Microbiological Claim Organism(s) Phase / Step+ EN Norm Soiling conditions Result (%)
(Mins)
2,1 EN 1276 I&I Dirty 2.0
1 2,2 EN 13697 I&I Dirty 4.0
2,2 EN 16615 Medical Dirty 1.0
S.aureus, E.coli,
Bactericidal* 2,1 EN 1276 I&I Dirty 1.0
P.aeruginosa, E.hirae 2
2,2 EN 13697 I&I Dirty 3.0
5 2,2 EN 13697 I&I Dirty 2.0
15 2,2 EN 14561++ I&I Clean 2.5
2.1 EN 1650 I&I Dirty 2.0
1
2,2 EN 16615 I&I Dirty 1.0
Yeasticidal** C.albicans 5 2,2 EN 13697 I&I Dirty 4.0
2,2 EN 13697 I&I Dirty 3.0
15
2,2 EN 14562++ I&I Clean 3.0
NUGEN® Disinfectant Products | 20 January 2022 40NUGEN® DR-25aN Disinfectant Cleaner
Test Results for I&I and F&B
*** Optional organism claim for PT2 I&I; an enveloped virucidal claim cannot be made for PT4 F&B
Types of User: Professional **** Optional organism claim for PT4 F&B
Organic Load: Medical dirty conditions, 3.0g/l sheep erythrocytes +
3.0 g/l bovine albumin (BSA);
+ Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
I&I dirty conditions, 3.0 g/l bovine albumin (BSA); ++ Supports a claim for non-medical instrument dipping
I&I clean conditions, 0.3g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: I&I, F&B
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling conditions Result (%)
2,1 EN 14476 Medical Dirty 1.0
5
2,2 EN 16777 I&I Clean 3.0
Virucidal against Enveloped
Modified Vaccinia ankara 2,2 EN 16777 I&I Dirty 4.0
Viruses***
10 2,2 EN 16777 I&I Clean 2.0
++
15 2,2 EN 17111 I&I Clean 1.0
Lactococcus lactis subsp.
Virucidal (bacteriophages**** 15 2,1 EN 13610 I&I Dirty 3.0
lactis phage P001 & P008
NUGEN® Disinfectant Products | 20 January 2022 41NUGEN® DR-25aN Disinfectant Cleaner
Test Results for I&I and F&B
***** Optional organism claim for PT 2 I&I and PT4 F&B
Types of User: Professional
Organic Load: Medical dirty conditions, 3.0g/l sheep erythrocytes + + Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
3.0 g/l bovine albumin (BSA); ++ Supports a claim for non-medical instrument dipping
I&I dirty conditions, 3.0 g/l bovine albumin (BSA);
I&I clean conditions, 0.3g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: I&I, F&B
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling conditions Result (%)
5 2,1 EN 14476 I&I Clean 2.0
Murine Norovirus 30 2,2 EN 16777 I&I Clean 8.0
60 2,2 EN 16777 I&I Clean 8.0
Limited Virucidal***** 15 2,1 EN 14476 I&I Clean 2.0
30 2,2 EN 16777 I&I Clean 8.0
Adenovirus
60 2,1 EN 14476 Medical Dirty 2.0
60 2,2 EN 16777 I&I Clean 8.0
NUGEN® Disinfectant Products | 20 January 2022 42NUGEN® DR-25aN Disinfectant Cleaner
Test Results for Healthcare
* Basic microbiological claim requirement for PT2 Healthcare
Types of User: Professional ** Optional organism claim for PT2 Healthcare
Organic Load: Medical dirty conditions, 3.0g/l sheep erythrocytes +
3.0 g/l bovine albumin (BSA); + Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
I&I clean conditions, 0.3g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: Healthcare
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling Conditions Result (%)
2,1 EN 13727 Medical Dirty 2.0
1
2,2 EN 16615 Medical Dirty 2.0
2,1 EN 13727 Medical Dirty 2.0
Bactericidal* S.aureus, P.aeruginosa, E.hirae 5
2,2 EN 13697 Medical Dirty 3.0
2,1 EN 13727 Medical Dirty 1.0
60
2,2 EN 13697 Medical Dirty 1.0
2.1 EN 13624 Medical Dirty 4.0
1
2,2 EN 16615 Medical Dirty 2.0
2,1 EN 13624 Medical Dirty 1.0
Yeasticidal** C.albicans 5
2,2 EN 13697 Medical Dirty 3.0
2,1 EN 13624 Medical Dirty 0.25
60
2,2 EN 13697 Medical Dirty 1.0
NUGEN® Disinfectant Products | 20 January 2022 43NUGEN® DR-25aN Disinfectant Cleaner
Test Results for Healthcare
** Optional organism claim for PT2 Healthcare
Types of User: Professional
Organic Load: Medical dirty conditions, 3.0g/l sheep erythrocytes + + Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
3.0 g/l bovine albumin (BSA);
Medical clean conditions, 0.3g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: I&I, F&B
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling conditions Result (%)
2,1 EN 14476 Medical Dirty 1.0
Virucidal against Enveloped 5
Modified Vaccinia ankara 2,2 EN 16777 Medical Clean 3.0
Viruses**
10 2,2 EN 16777 Medical Clean 2.0
5 2,1 EN 14476 Medical Clean 2.0
15 2,1 EN 14476 Medical Dirty 2.0
Murine Norovirus
30 2,2 EN 16777 Medical Clean 8.0
60 2,2 EN 16777 Medical Clean 8.0
Limited Virucidal** 15 2,1 EN 14476 Medical Clean 2.0
15 2,1 EN 14476 Medical Dirty 4.0
Adenovirus 30 2,2 EN 16777 Medical Clean 8.0
60 2,1 EN 14476 Medical Dirty 2.0
60 2,2 EN 16777 Medical Clean 8.0
NUGEN® Disinfectant Products | 20 January 2022 44NUGEN® DR-25aN Disinfectant Cleaner
Test Results for Healthcare
** Optional organism claim for PT2 Healthcare
Types of User: Professional
Organic Load: Medical dirty conditions, 3.0g/l sheep erythrocytes + + Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
3.0 g/l bovine albumin (BSA);
Medical clean conditions, 0.3g/l bovine albumin (BSA)
Product Types(s): PT2, PT4
Industries: I&I, F&B
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling conditions Result (%)
15 2,1 EN 14476 Medical Clean 2.0
Murine Norovirus
30 2,2 EN 16777 Medical Clean 8.0
Full Virucidal** 5 2,1 EN 14476 Medical Clean 5.0
Adenovirus
30 2,2 EN 16777 Medical Clean 8.0
Poliovirus 60 2,1 EN 14476 Medical Clean 5.0
NUGEN® Disinfectant Products | 20 January 2022 45NUGEN® DR-25aN Disinfectant Cleaner
I&I
Types of User: Professional Dilution: 1.0-4.0%
Use instructions: One step clean and disinfect
Product Types(s): PT2
Industries: I&I
PT2 PT2 PT2 PT2 PT2 PT2
Microbiological Claim+ Industrial & Industrial & Industrial & Industrial & Industrial & Industrial &
(Disinfectant Cleaner) Institutional Institutional Institutional Institutional Institutional Institutional
2.0% / 1 min 4.0% / 1 min 1.0% / 2 min 2.0% / 5 mins 4.0% / 5 mins 3.0% / 15 mins
Bactericidal (EN 1276, EN 16615)
Mechanical action* • • • • • •
Bactericidal (EN 1276, EN 13697)
Non-mechanical action* • • • •
Yeasticidal (EN 1650, EN 16615)
Mechanical action** • • • • •
Yeasticidal (EN 1650, EN 13697)
Non-mechanical action** • •
Virucidal against Enveloped Viruses
(EN 14476, EN 16777)** •
* Basic microbiological claim requirement for PT2 I&I
** Optional organism claim for PT2 I&I
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
NUGEN® Disinfectant Products | 20 January 2022 all registered Member States. Different application methods align to either Phase 2, Step 2 mechanical or 46
non-mechanical EN Test NormsNUGEN® DR-25aN Disinfectant Cleaner
I&I
Types of User: Professional Dilution: 2.0-8.0%
Use Instructions: Pre-Clean prior to disinfection
Product Types(s): PT2
Industries: I&I
PT2 PT2 PT2 PT2
Microbiological Claim+ Industrial & Industrial & Industrial & Industrial &
(Disinfectant Cleaner) Institutional Institutional Institutional Institutional
2.0% / 1 min 3.0% / 5 mins 3.0% / 15 mins 8.0% / 30 mins
Bactericidal (EN 1276, EN 16615)
Mechanical action* • • • •
Bactericidal (EN 1276, EN 13697)
Non-mechanical action* • • •
Yeasticidal (EN 1650, EN 16615)
Mechanical action** • • • •
Yeasticidal (EN 1650, EN 13697)
Non-mechanical action** • • •
Virucidal against Enveloped Viruses
(EN 14476, EN 16777)** • • •
Bactericidal, Yeasticial, Virucidal against Enveloped Viruses
(EN 14561, EN 14562, EN 17111)*** • •
Limited Virucidal
(EN 14476, EN 16777)** •
* Basic microbiological claim requirement for PT2 I&I
** Optional organism claim for PT2 I&I
*** Supports a claim for non-medical instrument dipping
NUGEN® Disinfectant Products | 20 January 2022 + All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in 47
all registered Member States. Different application methods align to either Phase 2, Step 2 mechanical or
non-mechanical EN Test NormsNUGEN® DR-25aN Disinfectant Cleaner
F&B
Types of User: Professional Dilution: 2.0-4.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT4
Industries: F&B
PT4 PT4
Microbiological Claim+
Food & Beverage Food & Beverage
(Disinfectant Cleaner)
2.0% / 1 min 4.0% / 5 mins
Bactericidal (EN 1276, EN 16615)
Mechanical action* • •
Bactericidal (EN 1276, EN 13697)
Non-mechanical action* •
Yeasticidal (EN 1650, EN 16615)
Mechanical action* • •
Yeasticidal (EN 1650, EN 13697)
Non-mechanical action* •
* Basic microbiological claim requirement for PT4 F&B
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
all registered Member States. Different application methods align to either Phase 2, Step 2 mechanical or
NUGEN® Disinfectant Products | 20 January 2022 non-mechanical EN Test Norms 48NUGEN® DR-25aN Disinfectant Cleaner
F&B
Types of User: Professional Dilution: 2.0-8.0%
Use Instructions: Pre-Clean prior to disinfection
Product Types(s): PT4
Industries: F&B
PT4 PT4 PT4 PT4
Microbiological Claim+
Food & Beverage Food & Beverage Food & Beverage Food & Beverage
(Disinfectant Cleaner)
2.0% / 1 min 4.0% / 5 mins 3.0% / 15 mins 8.0% / 30 mins
Bactericidal (EN 1276, EN 16615)
Mechanical action* • • • •
Bactericidal (EN 1276, EN 13697)
Non-mechanical action* • • •
Yeasticidal (EN 1650, EN 16615)
Mechanical action* • • • •
Yeasticidal (EN 1650, EN 13697)
Non-mechanical action* • • •
Virucidal
(EN 14476, EN 16777)** •
* Basic microbiological claim requirement for PT4 F&B
** Optional organism claim for PT4 F&B
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
NUGEN® Disinfectant Products | 20 January 2022 all registered Member States. Different application methods align to either Phase 2, Step 2 mechanical or 49
non-mechanical EN Test NormsNUGEN® DR-25aN Disinfectant Cleaner
Healthcare
Types of User: Professional Dilution: 1.0-8.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT2
Industries: Healthcare
PT2 PT2 PT2
Microbiological Claim+
Healthcare Healthcare Healthcare
(Disinfectant Cleaner)
4.0% / 1 min 3.0% / 5 mins 1.0% / 60 mins
Bactericidal (EN 13727, EN 16615)*
Mechanical action • •
Bactericidal (EN 13727, EN 13697, EN 16615)*
Mechanical and non-mechanical action • •
Yeasticidal (EN 13624, EN 16615)*
Mechanical action • •
Yeasticidal (EN 13624, EN 13697, EN 16615)*
Mechanical and non-mechanical action • •
* Basic microbiological claim requirement for PT2 Healthcare
** Optional organism claim for PT2 Healthcare (testing conducted in Medical clean conditions)
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
all registered Member States. Different application methods align to either Phase 2, Step 2 mechanical
NUGEN® Disinfectant Products | 20 January 2022 or non-mechanical EN Test Norms 50
* All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
all registered Member States.NUGEN® DR-25aN Disinfectant Cleaner
Healthcare
Types of User: Professional Dilution: 1.0-8.0%
Use Instructions: Pre-Clean prior to disinfection
Product Types(s): PT2
Industries: Healthcare
PT2 PT2 PT2 PT2 PT2
Microbiological Claim+
Healthcare Healthcare Healthcare Healthcare Healthcare
(Disinfectant Cleaner)
4.0% / 1 min 3.0% / 5 mins 8.0% / 30 mins 1.0% / 60 mins 8.0% / 60 mins
Bactericidal (EN 13727, EN 16615)*
Mechanical action • • • •
Bactericidal (EN 13727, EN 13697, EN 16615)*
Mechanical and non-mechanical action • • • •
Yeasticidal (EN 13624, EN 16615)*
Mechanical action • • • •
Yeasticidal (EN 13624, EN 13697, EN 16615)*
Mechanical and non-mechanical action • • • •
Virucidal against Enveloped Viruses
(EN 14476, EN 16777)** • • •
Limited Virucidal
(EN 14476, EN 16777)** • •
Full Virucidal
(EN 14476, EN 16777)** •
* Basic microbiological claim requirement for PT2 Healthcare
** Optional organism claim for PT2 Healthcare
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
all registered Member States. Different application methods align to either Phase 2, Step 2 mechanical
NUGEN® Disinfectant Products | 20 January 2022 or non-mechanical EN Test Norms 51
* All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in
all registered Member States.NUGEN® R-82G Disinfectant Cleaner 06 NUGEN® Disinfectant Products | 20 January 2022 52
NUGEN® R-82G Disinfectant Cleaner
Customer Benefits/Value Proposition Function Ingredients %
• NUGEN® R-82G disinfectant cleaner is a unique product in
our range as it can be placed on the market in both North Active Alkyl (C12-C16) dimethylbenzyl ammonium chloride 8.7
America and Europe. It allows customers to clean and Substances [CAS No. 68424-85-1]
disinfect in a single, time-saving step and is targeted at the I&I Didecyldimethylammonium chloride (C8C10 DDAC) 13.0
and F&B segments. [CAS No. 68424-95-3]
• Active Substance is analysed by HPLC to allow an easier day-
Inerts Surfactant, builder, complexing agent, solvent, 78.3
to-day QC method for customers who wish to manufacture water
themselves.
• All organic components in this product are readily
biodegradable.
Efficacy
• Performance against several pathogens such as Bacteria,
Yeast and Viruses substantiated using both EU (EN) and US
(UDT) Test Norms.
NUGEN® Disinfectant Products | 20 January 2022 53NUGEN® R-82G Disinfectant Cleaner
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Austria, Belgium, France,
Germany, Ireland,
Liechtenstein,
Luxembourg, Poland,
Switzerland, UK
US EPA Registration #:
6836-381
CDPR (California)
Registered
Canadian DIN #:
02491826
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 54NUGEN® R-82G Disinfectant Cleaner
Test Results for I&I and F&B
* Basic microbiological claim requirement for PT2 I&I and PT4 F&B
Types of User: Professional ** Basic microbiological claim requirement for PT4 F&B; Optional organism claim for PT2 I&I
*** Optional organism claim for PT2 I&I; this claim cannot be made for PT4 F&B
Organic Load: I&I dirty conditions, 3.0 g/l bovine albumin (BSA) **** Optional organism claim for PT2 I&I and PT4 F&B
Product Types(s): PT2, PT4
+ Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms
Industries: I&I, F&B * All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member
States. Additional data is available using US Test Norms. Please refer to the product brochure for details.
Microbiological Claim Organism(s) Contact Time (Mins) Phase / Step+ EN Norm Soiling Conditions Result (%)
2,1 EN 1276 I&I Dirty 1.0
1
2,2 EN 13697 I&I Dirty 2.0
S.aureus, E.coli,
Bactericidal* 2,1 EN 1276 I&I Dirty 0.5
P.aeruginosa, E.hirae
5 2,2 EN 13697 I&I Dirty 0.5
2,2 EN 16615 Medical Dirty 1.5
2,1 EN 1650 I&I Dirty 0.4
Yeasticidal** C.albicans 5 2,2 EN 13697 I&I Dirty 0.5
2,2 EN 16615 Medical Dirty 1.5
Virucidal against Enveloped 2,1 EN 14476 I&I Dirty 0.5
Modified Vaccinia ankara 5
Viruses*** 2,2 EN 16777 I&I Dirty 2.0
2,1 EN 14476 I&I Dirty 3.0
Murine Norovirus
2,2 EN 16777 Medical Dirty 5.0
Limited Virucidal**** 30
2,1 EN 14476 I&I Dirty 3.0
Adenovirus
2,2 EN 16777 Medical Dirty 5.0
NUGEN® Disinfectant Products | 20 January 2022 55NUGEN® R-82G Disinfectant Cleaner
Tiered Claims for I&I
Types of User: Professional Dilution: 0.5-5.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT2
Industries: I&I
PT2 PT2 PT2 PT2 PT2
Microbiological Claim+ Industrial & Industrial & Industrial & Industrial & Industrial &
(Disinfectant Cleaner) Institutional Institutional Institutional Institutional Institutional
2.0% / 1 min 0.5% / 5 mins 1.5% / 5 mins 2.0% / 5 mins 5.0% / 30 mins
Bactericidal (EN 1276, EN 13697)*
Non-mechanical action • • • • •
Bactericidal (EN 1276, EN 13697, EN 16615)*
Mechanical and non-mechanical action • • •
Yeasticidal (EN 1650, EN 13697)**
Non-mechanical action • • • •
Yeasticidal (EN 1650, EN 13697, EN 16615)**
Mechanical and non-mechanical action • • •
Virucidal against Enveloped Viruses
(EN 14476, EN 16777)** • •
Limited Virucidal
(EN 14476, EN 16777)** •
* Basic microbiological claim requirement for PT2 I&I
** Optional organism claim for PT2 I&I
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all
registered Member States. Different application methods align to either Phase 2, Step 2 mechanical or non-
mechanical EN Test Norms. Additional data is available using US Test Norms. Please refer to the product
NUGEN® Disinfectant Products | 20 January 2022 brochure for details. 56NUGEN® R-82G Disinfectant Cleaner
Tiered Claims for F&B
Types of User: Professional Dilution: 0.5-5.0%
Use Instructions: One step clean and disinfect
Product Types(s): PT4
Industries: F&B
PT4 PT4 PT4
Microbiological Claim+
Food & Beverage Food & Beverage Food & Beverage
(Disinfectant Cleaner)
0.5% / 5 mins 1.5% / 5 mins 5.0% / 30 mins
Bactericidal (EN 1276, EN 13697)*
Non-mechanical action • • •
Bactericidal (EN 1276, EN 13697, EN 16615)*
Mechanical and non-mechanical action • •
Yeasticidal (EN 1650, EN 13697)*
Non-mechanical action • • •
Yeasticidal (EN 1650, EN 13697, EN 16615)*
Mechanical and non-mechanical action • •
General Virucidal
(EN 14476, EN 16777)** •
* Basic microbiological claim requirement for PT4 F&B.
** Optional organism claim for PT4 F&B; Note an enveloped virucidal claim cannot be made for PT4 F&B
+ All of the data presented has been generated using standard EN Test Norms. Not all claims are valid in all registered Member
States. Different application methods align to either Phase 2, Step 2 mechanical or non-mechanical EN Test Norms. Additional
NUGEN® Disinfectant Products | 20 January 2022 data is available using US Test Norms. Please refer to the product brochure for details. 57Bardac® 22-90 Disinfectant 07 NUGEN® Disinfectant Products | 20 January 2022 58
Bardac® 22-90 Disinfectant
Customer Benefits/Value Proposition Function Ingredients %
• Bardac® 22-90 disinfectant is a concentrated formula that can
be manufactured by customers by diluting Bardac® BD-50S in Active Didecyldimethylammonium chloride 4.5
deionized water. Substances [CAS No. 7173-51-5]
• Authorised for both consumer and professional users Inerts Solvent and water 95.5
• Benefit from its registration position in the Netherlands and
Belgium and its future inclusion within Arxada’s DDAC
Biocidal Product Family 2 under the BPR.
• All components in this product are readily biodegradable.
Efficacy
• Authorized as a hard surface disinfectant with claims against
Bacteria & Yeast as well as a Green Remover for exterior
surfaces. The claims must match those already filed with the
NL and BE authorities.
NUGEN® Disinfectant Products | 20 January 2022 59Bardac® 22-90 Disinfectant
Registration Footprint
EU BPR Transitional Period
National Notifications:*
Belgium, Netherlands
BPR Product Authorisation
Approach:
Union Authorisation as
part of Arxada’s DDAC
BPF 2
*The registration footprint of this product, under
the National Schemes, continues to evolve as
new registrations are approved and existing
ones maintained. Contact Arxada for details of
the latest registration position.
NUGEN® Disinfectant Products | 20 January 2022 60Bardac® 22-200 Disinfectant 08 NUGEN® Disinfectant Products | 20 January 2022 61
Bardac® 22-200 Disinfectant
Customer Benefits/Value Proposition Function Ingredients %
• Bardac® 22-200 disinfectant is a highly concentrated formula
that can be manufactured by customers by diluting Bardac® Active Didecyldimethylammonium chloride 10.0
BD-50S in deionized water. Substances [CAS No. 7173-51-5]
• Authorised for use by professional users. Inerts Solvent and water 90.0
• Benefit from its registration position in the Netherlands and
Belgium and its future inclusion within Arxada’s DDAC
Biocidal Product Family 2 under the BPR.
• All components in this product are readily biodegradable.
Efficacy
• Authorized as a hard surface disinfectant with claims against
Bacteria & Yeast as well as a Green Remover for exterior
surfaces. The claims must match those already filed with the
NL and BE authorities.
NUGEN® Disinfectant Products | 20 January 2022 62You can also read
