authorization of biocidal products - brenntag · authorization of biocidal products ......

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


http://www.loreal.fr/

http://www.bp.com/home.do?categoryId=1&contentId=2006973

http://www.bing.com/images/search?q=SHELL+logo&view=detailv2&&id=9ED5AAB23B4B165EB0318E3277563A9F57A812E7&selectedIndex=1&ccid=AOtrIM6V&simid=608018845869804939&thid=OIP.M00eb6b20ce952fbe5ebffdc30cef79d9H0

Biocidal Product Authorization Strategy

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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?


http://bussolati.com/?attachment_id=2067

Timeline: latest 2 years after inclusion decision of the Active Substance

by EC a dossier for the Biocidal Product needs to be submitted

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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


Timeline for product authorization – example hypo

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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


Why does cooperation make sense under BPR?

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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!

€€€€€€€↓

€€€


Biocidal product family - flexibility

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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


Biocidal Product support for Isopropanol

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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


BPF from Brenntag for IPA disinfectants

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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


Regulatory concept of marketing authorization

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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


Regulatory concept – same product authorization SBP – EU 414/2013

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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


New option for SBP after October 2016

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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


https://echa.europa.eu/de/support/dossier-submission-tools/r4bp/national-authorisation-same-biocidal-product

Product authorization based on Family authorization

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SPA


Benefit of a support scenario in the supply chain

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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?


Biocides Portfolio Brenntag

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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


More to come?

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OUTLOOK

Glutardialdehyde

CMIT/MIT

Ethanol

H2O2

Formaldehyde

Sodium hypochlorite

Peracetic Acid

Chlorine Dioxide

Lactic acid


https://upload.wikimedia.org/wikipedia/commons/2/21/Ethanol-alternative-3D-balls.png

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.


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

authorization of biocidal products - brenntag · authorization of biocidal products ......

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