Authorization of biocidal
products
Kai Mann, European Product Manager Biocides
Cleaning customer seminar, , 30.03.2017
▌ Option of biocidal product families
AGENDA
31/03/2017 2
AGENDA
▌Supply Chain for AS + BP
▌Biocides strategy – what do I need to know?
▌Timelines of some AS
▌Consortia for cost sharing
▌Biocidal product families
▌Example IPA support
▌Marketing authorization vs. Same Product Authorization
▌Support within the supply chain vs. consortia
Brenntag Holding GmbH, Biocidal product families for product authorization
Supply chain for biocides
31/03/2017 3
MARKET CHARACTERISTICS
Active Ingredient Manufacturer
End User
Actives Formulations
Sales Network
Distributor
Formulator Service Company
Brenntag Holding GmbH, Biocidal product families for product authorization
Biocidal Product Authorization Strategy
31/03/2017 4
STRATEGY
▌Understanding of the Regulation EU 528/2012
▌Overview on products, uses (PTs), actives and timelines, support options
▌Communication with customers, sales, marketing/PM, purchase, suppliers
▌PRIORIZATION of BIOCIDES portfolio
A) PREMIUM Products
B) STANDARD Products
C) NICHE Products
▌Cost for authorization – pay back?
▌What is the right approach for my portfolio?
Brenntag Holding GmbH, Biocidal product families for product authorization
Timeline: latest 2 years after inclusion decision of the Active Substance
by EC a dossier for the Biocidal Product needs to be submitted
31/03/2017 5
TIMELINE – BIOCIDE APPROVAL
Time 2015 2016 2017 2018 2019 2020 2021Decision -
lead region
Hydrogenperoxide PT 11,12 in 2020
Per acetic acid PAA Supplier
Ethanol NL, PT 1, 2, 4
1-Propanol Only blends
Sodiumhypochlorite Q1/17 – UK
Calcium hypochlorite Cooperation
Chlorine Iberia
Formaldehyde, PT 3 TBD – NL
TCCA, Isocyanurate PT3,4,5 (PT2 2020)
SDIC, Isocyanurate PT3,4,5 (PT2 2020)
Decision on Brenntag Biocide product registrations
Brenntag Holding GmbH, Biocidal product families for product authorization
Timeline for product authorization – example hypo
31/03/2017 6
TIMELINE – BIOCIDE AUTHORIZATION
Time 2016 2017 2018 2019 To do for
Define portfolio and PTs Biocide Team
Data gap analysis consultant
Analytics (active,
chlorate, residues, etc.)consultant
Efficiency data (claims) Team
Exposure data consultant
Waiving arguments consultant
Storage stability (-10%) Ext. Lab
Co-formulants Biocides team
Data generation consultant & lab
Dossier preparation +
submissionconsultant
Brenntag Holding GmbH, Biocidal product families for product authorization
Why does cooperation make sense under BPR?
31/03/2017 7
COOPERATION
▌Cost & risk sharing of dossier and fees (150 k€ - 1,5 Mio.€)
▌Resource sharing – dossier preparation
▌Data sharing – one, up to date, complete set of efficiency tests
▌Phys-chem data package (pour/spray/foam, liquid/gel, tissues)
▌Union Authorization vs. National Authorization
▌BPF allows variation of products
▌BPF covers different PTs
▌Dilute costs – reduce pain!
€€€€€€€↓
€€€
Brenntag Holding GmbH, Biocidal product families for product authorization
Biocidal product family - flexibility
31/03/2017 8
COOPERATION
▌Same active substance(s)
▌Similar product compositions: Type of formulation, AS concentration, co-
formulants (surfactant, chelate, thickener, perfume, dye, refatter)
▌Similar uses and claims - user, use conditions, dosage, application
▌Similar levels of risks and efficiency
▌Human & environmental risk, H-phrases,
▌Efficiency, target organisms, contact time
▌Common set of first aid, disposal, storage, shelf life
Brenntag Holding GmbH, Biocidal product families for product authorization
Biocidal Product support for Isopropanol
31/03/2017 9
PROCESS
Producer
• Exxon, Shell, Novapex (Ineos) – no regulatory position
Active Substance
• BRG GmbH member of ASD consortium
• Technical Equivalence for IPA ex Shell and Exxon submitted
Biocidal Product
• IPA customers can join product authorization of BRG for PT 1, 2, 4
SPA
• Derived authorization from BRG IPA disinfectants dossier
LoA
AS+
TE
LoA
BP
July
14 –
June 1
6
AS
Dossier
Brenntag Holding GmbH, Biocidal product families for product authorization
BPF from Brenntag for IPA disinfectants
31/03/2017 10
EXAMPLE
▌Active: IPA, 62,7 – 70 weight-%
▌SPC 1: PT 1, hand disinfection liquid + gel (excl. surgical hand disinfection)
▌SPC 2: PT 2 + 4, surface disinfection spray, (excl. surgical and medical instr.)
▌Bactericidal, yeasticidal and limited virucidal claims supported with EN 1276, EN
13727, EN 1650, EN 13624, EN 13697, EN 1500, EN 14476, EN 14348 tests (60 sec)
▌opaque HDPE packaging, 0,1l – 1l (plus 2,5l – 1000l for refilling)
▌Hazard cat. Flammable liquid 2, Eye irritant, STOT SE3
▌Hazard statement – H225, H319, H336
▌Rub on & spray (excl. aerosols, pour on solutions, no wipes)
▌Private, public, professional, institutional, healthcare area
Brenntag Holding GmbH, Biocidal product families for product authorization
Regulatory concept of marketing authorization
31/03/2017 11
DISTRIBUTION
▌Dossier prepared and submitted before the deadline
▌Brand names of customer products covered in the dossier allows products to
remain compliant on the market during dossier review (2,5 - 3 years)
▌No change of product labels before authorization (for supported claims)
▌National authorizations in transitional period remain customers responsibility
▌New label after authorization incl. authorization-holder and -number
▌Responsibility for placing products on the market with authorization holder
▌Maintenance and costs of the dossier remain responsibility of AH*
▌Low cost and resource BUT transparency of AH
* Additional fees for enforcement control on national level might be charged and need to be paid by customers in the countries they sell
Brenntag Holding GmbH, Biocidal product families for product authorization
Regulatory concept – same product authorization SBP – EU 414/2013
31/03/2017 12
DISTRIBUTION
▌SBP is possible with a LoA to the BP dossier
▌Evidence for sameness of the BP and reference product on all aspects
▌LoAs to all data of the related reference dossier (e.g. LoA to AS dossier, TE)
▌Summary of the product characteristics for the same product
▌Preparation and submission of the SBP
▌Fees for UA (10/20 k€/a) or NA (0 – 5k€)
▌PRO – Cost and resource efficient compared to own dossier
▌PRO – own independent authorization number, variations & changes possible
▌CON – commercial agreement more complex, NOT simple and cheap
Brenntag Holding GmbH, Biocidal product families for product authorization
New option for SBP after October 2016
31/03/2017 13
ECHA NEWS
▌SBP from a single member of a BPF
▌National authorization(s) from a „master“ Union authorization
▌ https://echa.europa.eu/de/support/dossier-submission-tools/r4bp/national-authorisation-same-biocidal-product
Brenntag Holding GmbH, Biocidal product families for product authorization
Product authorization based on Family authorization
31/03/2017 14
SPA
Brenntag Holding GmbH, Biocidal product families for product authorization
Benefit of a support scenario in the supply chain
31/03/2017 15
VALUE PROPOSITION
▌No negotiations within a consortium
▌Compliant supply chain for Active Substances (min. 2 TE sources)
▌European supply chain for AS
▌Combined supply chain for technical, cosmetic, biocidal (possibly pharma) use
▌RISK and cost sharing model for customers with reasonable premium for AS + BP
▌Individual agreements with different compensation models
▌Premium on AS supplied, lump sum payment or combination of both
▌Commitment from customers needed min 2 years in advance
▌Can this solve all BPR questions – maybe not but likely some?
Brenntag Holding GmbH, Biocidal product families for product authorization
Biocides Portfolio Brenntag
31/03/2017 16
OVERVIEW
Substance CAS Konz. [%] Supplier Active Substance
[PT]
Biocidal
Prod. [PT]
Dossier
Deadline
Ethanol* (MEK) 64-17-5 96/99 Var. 1, 2, 4 2020
2-Propanol* / IPA 67-63-0 99,9 Var. 1, 2, 4 1, 2, 4 30.06.2016
1-Propanol 71-23-8 99,9 Var. 1, 2, 4 01.05.2019
H2O2 7722-84-1 35/50 Var. 1-6, 11, 12 2, 3, 4, 5, 6 01.02.2017
Peracetic acid / PAA 79-21-0 Var. 1-6, 11, 12 01.10.2017
Formic acid 64-18-6 75/85 Var. 2, 3, 4, 5, 6 Q3 2019
L(+) Lactic acid 79-33-4 Var. Corbion 1, 2, 3, 4, 6 01.07.2017
Sodium hypochlorite* 7681-52-9 0,1 - 14,7 Various 1-5, 11, 12 31.12.2018
Calcium hypochlorite 7778-54-3 Var. 31.12.2018
Chlorine* 7782-50-5 99,9 Various 2, 5 31.12.2018
Chlorine dioxide Clorious
2
10049-04-4 0,6 Brenntag 2, 3, 4, 5,
11, 12
Sodium chlorite (in-situ
Chlorinedioxide generation)
7759-19-2 Var. 2, 3, 4, 5, 11, 12
Sodium chloride (in-situ
Chlorine generation)
7647-14-5 99,9 Var. 1-5
Sodium dichloro-
isocyanuric acid / SDIC
51580-86-8 Various 2, 3, 4, 5, 11, 12 01.11.2019
Symchlosene / TCCA 87-90-1 Various 2, 3, 4, 5, 11, 12 01.11.2019
Glutaraldehyde 111-30-8 24/50 Dow 2, 3, 4, 6, 11, 12 6, 11, 12 01.10.2016
Formaldehyde 50-00-0 37 Var. 3
CMIT/MIT 55965-84-9 1,5/14 Dow 2, 4, 6, 11, 12, 13 01.07.2016
MIT 2682-20-4 9,5/50 Dow 6, 11, 13
BIT 2634-33-5 20 Dow 6, 12, 13
OIT 26530-20-1 Dow 6, 7, 9, 11, 13
DCOIT 64359-81-5 Dow 7, 8, 9, 10, 11, 21 01.01.2016
Bronopol 52-51-7 30/100 Dow 2, 6, 9, 11, 12
DBNPA 10222-01-2 5/20 Dow 2, 4, 6, 11, 12, 13
OPP 90-43-7 100 Dow 1, 2, 4, 6, 13 01.07.2017
IPBC 55406-53-6 100 Dow 6, 7, 8, 9, 10, 13 6 01.07.2015
Methylbisoxazolidine /
MBO
66204-44-2 Schülke 2, 6, 11, 12, 13 01.07.2019
Phenoxyethanol 122-99-6 99,9 Dow 6, 13 TBD
Chlorhexidine
Digluconate / CHDG
18472-51-0 20 1, 2, 3, 2021/22
Ampholyt 20 139734-65-9 30 Evonik 2, 3, 4 01.01.2018
Copper sulphate
pentahydrate
7758-98-7 Manica 2 01.07.2015
Alkyldimethylbenzyl
ammoniumchlorid
ADBAC
68391-01-5 50/80 Var. 1, 2, 3, 4, 10, 11, 12,
22
Q1 2020
Alkyldimethylbenzyl
ammoniumchlorid
ADBAC/BKC
68424-85-1 50 Var. 1, 2, 3, 4, 8, 10, 11,
12, 22
Q1 2020
Didedyldimethyl
ammoniumchlorid DDAC
7173-51-5 50 Var. 1, 2, 3, 4, 6, 10, 11,
12
Q1 2020
Brenntag Holding GmbH, Biocidal product families for product authorization
More to come?
31/03/2017 17
OUTLOOK
Glutardialdehyde
CMIT/MIT
Ethanol
H2O2
Formaldehyde
Sodium hypochlorite
Peracetic Acid
Chlorine Dioxide
Lactic acid
Brenntag Holding GmbH, Biocidal product families for product authorization
31/03/2017 18
Thank you!
Please be informed that this presentation contains confidential information. The presentation shall be kept confidential and shall not be distributed without prior written
permission of Brenntag Holding GmbH.
Brenntag Holding GmbH, Biocidal product families for product authorization
EU 528/2012 – Biocidal Product Regulation BPR
31/03/2017Brenntag Holding GmbH, Biocidal product families for product authorization 19
GÖ
GLOSSARY OF TERMS
BPR: Biocidal product regulation – EU 528/2012
Political target to harmonise market and ensure safe & efficient biocidal products for humans and
the environment
Active substance (AS): Chemical substance harmful to microorganisms to produce a biocidal
product
Article 95: List of approved suppliers for actives substances after 1st Sept 2015
Biocidal product (BP): substance or mixture in it‘s delivered form to the end user with the intention to
destroy, prevent the action of or control harmful microorganisms – need for product registration
dossier 2 yrs after approval of AS
Product type (PT): 21 different use cases for biocidal products; for each PT there will be various use
scenarios
Dossier: Data package on AS or BP to evaluate risk assessment for evaluation by authorities
Product authorisation: positive assessment of product dossier on European or national level
Technical equivalence: process to ensure that AS used is equivalent as described in the dossier
Letter of access: Data access approval for authorities a) active substance b) biocidal product