Transition from national biocides legislation to BPR ...€¦ · • CMIT/MIT products are placed...

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


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


Content

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Introduction




Conclusion



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• 19 active substances supported

• > 100 biocidal products

• World class regulatory expertise

• Technical expertise

• First class customer service

• Supply chain excellence



The benefits of Biocides


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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


Biocides and social demand for hygiene

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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/


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Biocides economical impact


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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


Content

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Introduction




Conclusion


The need for a harmonized scheme

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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



The BPR 2-step regulatory process

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Active substance approval

Biocidal product

authorization

Placing on the market

Use


http://patentlawcenter.pli.edu/wp-content/uploads/2011/07/EU-Flags.jpg

http://patentlawcenter.pli.edu/wp-content/uploads/2011/07/EU-Flags.jpg


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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)


Transition phase: Until active substances are approved, biocidal products can be

placed or remain on the market (in compliance with national legislations)


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


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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


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BPR Compliance: Compliance Certificate

Customer name

Address of customer

Second line of address

Country



Content

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Introdution




Conclusion


Active Substances Review Program

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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



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


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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



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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)



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)


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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


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Content

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Introduction




Conclusion


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


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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


Innovation roadmap


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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


Diversity of the biocides market


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One solution not appropriate for many


Diversity in Product Type 6


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• Several sub-types, requiring different formulations:Detergents, paints, mineral slurries, adhesives, fuel….

Formulation considerations

Microbial spectrum of activity


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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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


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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


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Content

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Introduction




Conclusion


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


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ThankYouRodolphe Qué[email protected]

For more information visit www.AreYouReadyForBPR.com or contact your local sales representative.


mailto:[email protected]

http://www.areyoureadyforbpr.com/


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

Transition from national biocides legislation to BPR ...€¦ · • CMIT/MIT products are placed...

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