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Dow Microbial Control
Transition from national biocides legislation to BPR
Possible impact on preservatives availability
Bucharest, 8 June 2017
Rodolphe Quérou, Regulatory Affairs Manager EMEA Dow Microbial Control
Dow Microbial Control
Content
2
Copyright The Dow Chemical Company 2017
Introduction
Pre-BPR National legislations
Transition from national to BPR authorization
Impact on preservatives availability
Conclusion
Dow Microbial Control
Content
3
Copyright The Dow Chemical Company 2017
Introduction
Pre-BPR National legislations
Transition from national to BPR authorization
Impact on preservatives availability
Conclusion
Dow Microbial Control
Dow Microbial Control
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• 19 active substances supported
• > 100 biocidal products
• World class regulatory expertise
• Technical expertise
• First class customer service
• Supply chain excellence
Copyright The Dow Chemical Company 2017
Dow Microbial Control
The benefits of Biocides
Copyright The Dow Chemical Company 2017
5
Enabling chemistries which are an essential part of the
solution towards sustainable economies.
Positively impact the 3 pillars of sustainable development:
• Environmental protection
• Societal demand for hygienic environment and safety of
products and processes
• Direct and indirect economic impact
Dow Microbial ControlCopyright The Dow Chemical Company 2017
66
Energy and global
warming
Natural resources
Pollution and
ecosystems
Use of antifouling paints reduce fuel
consumption and CO2 emission by ships
Biocides maintain energy-efficiency of
cooling systems
Biocides increase durability of manufactured
and building products
Preservatives prolong lifetime of processing
fluids in industry
Biocides preserve water resource during
industrial activities (oil extraction, paper, …)
Biocides are needed to preserve environmentally-
friendly products
Antifouling prevent spreading of invasive species
…
Biocides and environmental protection
Dow Microbial Control
Biocides and social demand for hygiene
7
Rodenticides (PT14), insecticides (PT18) and repellents (PT19)
protect human or animal from vector-borne diseases such as
leptospirosis, malaria, dengue, leishmaniosis, chikungunya, … and
from the unwanted presence of harmful animals (mosquitos, fleas,
tick, bed bugs, …)
Disinfectants (PT1-5) are essential to prevent food- and water-borne
diseases (such as cholera, salmonellosis, listeriosis), hospital-
acquired infections (such as MRSA) or epidemics.
Preservatives keep healthy housing by preventing
microbial-driven deterioration
Visit CEFIC’s Microbial Control Executive Council (MCEC) at http://www.microbial-control.com/
Copyright The Dow Chemical Company 2017
Dow Microbial Control
Biocides economical impact
Copyright The Dow Chemical Company 2017
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Not limited to direct impact
Indirect impact on major industrial segments, including safety of products
Industrymanufacturing sector
Value added (employees)
Eurostat
Biocides used
Food/feed €150 Bn VA(4.8 Mn)
PT3-PT4-PT6-PT11-PT12-PT14-PT18
Motor vehicles €141 Bn VA(2.2 Mn)
PT2-PT6-PT11-PT9-PT13
Paper € 41 Bn VA(646 m)
PT2-PT6-PT7-PT9-PT11-PT12-PT18
Household and profess. cleaning and hygiene
~ € 15 Bn (VA) PT1-PT2-PT4-PT6 -PT11-PT12-PT18-PT19
Paints & coatings ~ € 10 Bn (VA) PT2-PT6-PT7-PT8-PT10-PT11-PT12-PT21
Dow Microbial Control
Content
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Copyright The Dow Chemical Company 2017
Introduction
Pre-BPR National legislations
Transition from national to BPR authorization
Impact on preservatives availability
Conclusion
Dow Microbial Control
The need for a harmonized scheme
10
Applications &
Product Types
Household
Disinfection
Food Industry
and Veterinary
Disinfection
Industrial
Preservation
Industrial Water
Treatment Comments
PT-2 PT-3 & 4 PT-6, 7, 9, 10 & 13 PT-11 & 12
Benelux (BE & NL) Registration needed Registration needed Registration needed Registration neededBPR like process,
very difficult
France, GermanyCertification required
for specific uses
Registration is
needed for specific
uses
Notification only Notification onlyLimited data
required
Finland No requirements No requirements No requirements Registration neededNo requirements to
BPR-like
Romania Registration needed Registration needed Registration needed Registration neededLimited data
required
UK No requirements
Registration is
needed for specific
uses
Registration is
needed for specific
uses
No requirementsNo requirements to
BPR-like
National Scheme – Current regulatory requirement for placing biocidal products on to the market in some EU countries
Limited to no requirements for placing biocidal products on the EU market
Limited data only (e.g. efficacy)
BPR like process: Efficacy data + use scenario, toxicity and risk assessments
Easy
Moderate
Difficult
Copyright The Dow Chemical Company 2017
Dow Microbial Control
The BPR 2-step regulatory process
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Active substance approval
Biocidal product
authorization
Placing on the market
Use
Copyright The Dow Chemical Company 2017
Dow Microbial Control
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Review program and transition period
The review program of existing active substances has been initiated under the BPD and
has been extended under the BPR until 31 December 2024. Coordinated by ECHA
The review of active substances takes place in 3 steps:
Notification
Submission
of a complete dossier,
evaluation and approval
Post-approval
procedures
Authorization of products
(within 3 years)
Copyright The Dow Chemical Company 2017
Transition phase: Until active substances are approved, biocidal products can be
placed or remain on the market (in compliance with national legislations)
Dow Microbial Control
Provisions of the BPR already applicable
• Come in addition to national requirements
• Article 95 (authorized suppliers)
• Classification and labelling (CLP and article 69)
• Data protection
• Treated article provisions
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
Enforcement of Article 95
• Since 1st September 2015, it is prohibited to place on the market a
biocidal product in EU if the supplier is not listed in Art 95 list
• Some countries with national registration scheme have imposed the
need to provide a proof of compliance in different forms
• In countries without such scheme, need for physical controls
• A supplier certificate is not sufficient and should be complemented by
a declaration of compliance from the biocidal product supplier
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
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BPR Compliance: Compliance Certificate
Customer name
Address of customer
Second line of address
Country
Copyright The Dow Chemical Company 2017
Dow Microbial Control
Content
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Copyright The Dow Chemical Company 2017
Introdution
Pre-BPR National legislations
Transition from national to BPR authorization
Impact on preservatives availability
Conclusion
Dow Microbial Control
Active Substances Review Program
17
Dossier Preparation
(2002 – 2008)
Dossier evaluation
by Rapporteur
Member States
(2004 – 2022)
Total program
takes 25 years
Peer Review - BPC
Working Groups
Existing Active
Substances
Review Program
Notification to EU
commission
(2000 – 2002)
Dossier Submission
(2004 – 2008)
ECHA Opinion
Approval Regulation – Adoption
and Publication by the EU
commission and Standing
Committee on Biocides
Copyright The Dow Chemical Company 2017
Dow Microbial Control
BPR Article 89: Transition period
• To prevent market disruption, BPR planned a transition period (Art 89)
• During the review program, biocidal products (BPs) containing existing
active substances can be placed/remain on the market
• To keep BPs on the market by the effective date of approval of the last
active substance dossiers for BPR authorization must be filed
• Can be Union or National authorization (with mutual recognition)
• If no dossier is filed for an existing BP in a given country, it will have to be
phased out in this country within 12 months
• Within 3 years from the date of approval, existing BPs must be authorized
under BPR.
• (Pre-BPR) national legislations continue to apply until BPR authorization
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
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Example: CMIT / MIT substance review program
14 May
2000
28 March
2002
31 July
2007
5 February
2015
2 February
2016
1 July 2017
CMIT/MIT in PT6
Total Cost
> €10MM
Total years
17 years
Copyright The Dow Chemical Company 2017
Dow Microbial Control
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CMIT/MIT Biocidal Product Authorizations
5 February 2015 1 July 2017 1 July 2020
CMIT/MIT in PT6
Total Cost
1500 k€ - 2000 k€
Total years
5
Cost
Dossier preparation (all CMIT/MIT products):
> 250 k€(tests)*
Fees:
> 600 k€
Resources:
> 100 k€
Cost
Annual fee:
5-20 k€
Annual resources:
50 k€(portfolio management)
Copyright The Dow Chemical Company 2017
Dow Microbial Control
Rules during transition (BPR art 89)
• CMIT/MIT products are placed on the market in most EU countries
according to national legislations (130 registrations owned by Dow)
• These products can remain on the market after 1st of July 2017 only if
a BPR dossier covering their use in relevant country is filed by July 1st
2017
• If no dossier is submitted, product have to be phased out within 12
months (including use of stocks)
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
Example in Romania
• Existing CMIT/MIT-based products are registered in Romania
• By 1st of July 2017 need to file for each of these products (each trade
name) and each relevant use either:
• A national authorization dossier in Romania
• A national authorization dossier in another EU country with a mutual
recognition in parallel application in Romania
• A Union authorization dossier
• Until final authorization these products can stay on the market in
Romania according to national rules.
• After final authorization, the Romanian authorizations are replaced by
new BPR National Authorization or covered by a Union Authorization
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
Content
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Copyright The Dow Chemical Company 2017
Introduction
Pre-BPR National legislations
Transition from national to BPR authorization
Impact on preservatives availability
Conclusion
Dow Microbial Control
The wider issue: the Reducing Palette and the Innovation Challenge: PT 6 example
• Downstream user industries voice concern on future ability to
adequately preserve their products and operate their plants.
• Presentations to Competent Authorities meetings in 2014 and 2017
• Highlighting significant and ongoing reduction in active ingredients
and families of actives which have been the mainstay of effective
preservation
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
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Copyright The Dow Chemical Company 2017
964
(> 1300 PT/Substances)
416
Impact of the Review Program – reduction of actives
(685 PT/Substances)
265
(208 PT/Substances)
130
2002 - NotificationsNotifiers
Participants(Article 95 suppliers)
2000 – Identification
of existing substances
2004 – 2008 Substance dossiers submitted
and accepted in the review program
Substance dossiers reviewed and
approved as per June 7th 2017
30 PT/Substance dossiers reviewed and
NOT approved as per June 7th 2017
• Reduction driven by economics
as well as protection goals
• The current one-by-one assessment
does not identify an issue of super-critical
reduction until it is too late
Dow Microbial Control
Innovation roadmap
Copyright The Dow Chemical Company 2017
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Innovation is long term and costly. Incentives are not built in
• Innovating a new active ingredient can take 10-15 years
• Costs are high (> 10 M€)
• All regulatory data must be generated up-front (a full dossier is required), before
marketing and first sales (Return on Investment) can be achieved.
• Risk of non-approval is high: Conservative risk assessment models, and restrictive
protection goals. Continual evolution of guidance changes the goal posts
• Once approved, mandatory data sharing further reduces ability to return investment
• The figures speak for themselves: less than 1 new active per year
Dow Microbial Control
Diversity of the biocides market
Copyright The Dow Chemical Company 2017
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One solution not appropriate for many
Dow Microbial Control
Diversity in Product Type 6
Copyright The Dow Chemical Company 2017
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• Several sub-types, requiring different formulations:Detergents, paints, mineral slurries, adhesives, fuel….
Formulation considerations
Microbial spectrum of activity
Dow Microbial Control
What is industry doing to seek innovation?
Active Substance suppliers must have incentive to invest
• Investment must be made on a per-company basis: a competitive
market will remain the best incentive.
• Need clarity, predictability and stability (When ? How much ?)
Innovation is happening in Biocidal Products
• Complex formulations of several actives,
• Risk-mitigation through formulation techniques and delivery systems
However here too, the challenge is increased by the hazard cut-off
criteria, conservatism and changes in risk assessment models, …Copyright The Dow Chemical Company 2017
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Dow Microbial Control
Possible solutions… but first the reality
• Industry is calling for a new approach to the active substance review –
particularly for PT6, probably appropriate for Main Group 2, nevertheless
recognizing that
• Changes to the Regulation will not happen in any realistic, effective timeframe
• ECHA and the Member States have a review programme to run with very
ambitious targets, which cannot easily be re-directed.
• A number of active substances have already gone through the approval
process –difficult to implement a solution mid-way through
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
Possible solution
Down stream users and active substance suppliers call for a holistic
approach to the PT6 review:
-all actives assessed at one time (2019-2020) and consideration of
market need taken into account
In addition, we have a tool to do this –Article 23 –except it only applies in
a minority of cases, and Guidance so far is not detailed enough
Copyright The Dow Chemical Company 2017
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Dow Microbial Control
Content
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Copyright The Dow Chemical Company 2017
Introduction
Pre-BPR National legislations
Transition from national to BPR authorization
Impact on preservatives availability
Conclusion
Dow Microbial Control
CONCLUSION
• The value of biocides to sustainable economies needs greater recognition
• Risk management needs to be the commonly accepted approach (not
hazard-based, or de-facto zero-risk)
• Holistic view of the value of biocides and societal need should define
protection goals/risk boundaries
• Socio-economic analysis must be incorporated fully into the review
programme where critical reductions occur in a given PT
• Concerns of down-stream industry to adequately protect products and
consumers need serious consideration
• Important that efforts are taken to promote essential innovation in the global
active substance market, for manufacturing and consumer protection
Copyright The Dow Chemical Company 2017
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ThankYouRodolphe Qué[email protected]
For more information visit www.AreYouReadyForBPR.com or contact your local sales representative.
Copyright The Dow Chemical Company 2017
Dow Microbial Control
Disclaimer
The information contained herein is for informational purposes only and is not legal advice.
It represents a summary of the information available to us at the time of release, and does
not constitute an interpretation of the regulation. The information provided is not promised
or guaranteed to be correct or complete. It is your responsibility to identify and assess
regulations applying to your activities and your purchase and to abide by any law or
regulation, which may apply to the specific use you make of our product and your
organization. We moreover recommend that you verify on a regular basis, the latest
regulatory status of our product.
Use Biocides Safely. Always read the label and product information before use.
35Copyright The Dow Chemical Company 2017