implications

Practical Implications - an Active

Substance Suppliers Perspective

Dr Mike Baldry, Regulatory Affairs Consultant, DuPont Chemicals &

Fluoroproducts

Informa 18th Annual Conference on the Biocidal Products Directive

Barcelona

7th September 2011

7 September 2011 BPD Conference, Barcelona, Sept 2011 2

The position of suppliers of active substances

Where are we?

Where have we come from?

Options for suppliers of active substances

What happened with the review programme?

Where are we going?

Concluding the Annex I inclusion process

Active substances and biocidal product authorisation

Moving to the Biocidal Products Regulation


The current position

The review programme for existing active substances is not completed

Dossiers on existing active substances have been submitted

44 existing (and 4 new) active substances have been accepted for

inclusion on Annex I

699 (active substance / Product Type) dossiers remain under review

Experiences are limited and uneven

Most work has been on the review of active substance dossiers - few

biocidal products have been authorised

Most progress with wood preservatives, rodenticides and insect control

agents disinfectants and preservatives remain under national legislation


The Past looking back


Options for active substance suppliers (1)

1. Do nothing, products containing that active withdrawn in December 2004

Unaware of legislation

Decision to withdraw from market or not support biocidal applications

2. Identity active substance before March 2002 (provide basic information) -

products containing that active withdrawn in September 2006

Decision to withdraw gradually from market

Means of keeping options open while clarification sought of applicability

or needs

The database of identified active substances was never used usefully!

An (identified) active substance is not necessarily used as a biocidal

active substance


Options for active substance suppliers (2)

3. Notify active substance before January 2003 (supply basic dossier) and commit to supply full dossier when required. Active substance enters review programme

3a. Active substance not accepted when reviewed because:

Applicant's decision not to submit full dossier due to costs, relevance of BPD, change of circumstances, delayed withdrawal from market

Rapporteurs decision that dossier is inadequate or incomplete, and applicants decision not to upgrade

Assessment that substance posed an unacceptable risk, or not within scope of BPD

Products withdrawn on a case by case basis

3b. Active substance reviewed and accepted in Annex I of BPD

Products authorised in accordance with inclusion decision


Consequences

The choice of active substances available to a biocidal

product manufacturer for use in a biocidal product has

been massively reduced

Specific Product Type

Satisfactory risk assessment for product

Required efficacy

Acceptable cost

Suitable supplier

Active substance manufacturers are in a changed

competitive market place


What can we learn about flexibility (or confusion)?

The BPD provided a framework for a very varied range of (biocidal) products

The text was designed to be imprecise and flexible to allow for the easy

provision of guidance as experience developed and questions arose

Decision making, clarification and provision of guidance was a slow

process, often arriving too late to be used effectively in preparing and in

support of active substance dossiers

Guidance developed in response to specific questions and over time

may be inconsistent

Flexibility has been shown on fitting existing biocidal products and uses

into the existing regulatory regime


What can we learn about avoiding delays?

One intention when developing the BPD was to avoid the extensive delays

that were occurring during the implementation of 91/414, so deadlines

were set

The Review Regulation gave:

Time slots and deadlines for the submission of a complete dossier

Three months for the completeness check, with possible extension to

six months

Basic one year for the evaluation

Specified that the Commission would prepare the draft (non-)inclusion

decision without undue delay, after consulting with experts from the

Member States to address any problems remaining unresolved

Assessment report modelled on dossier structure to streamline the process


Was the available time used well?

Directive

agreed

Review regulation

published

Dossiers submitted End of

transitional

period

16 Feb 98 8 Sep 00 28 Mar 04 31 Oct 08 14 May 10

2 3 4 1


But what went wrong?Inadequate resources within the regulatory agencies

Some Member States have insufficient people

Some Member States lacked knowledge of biocidal products and experience of their regulation

Regulators did not keep to the timelines in the Review Regulations

Inefficiencies through repeated stopping of the clock

Member States not working as a single unit

Prolonged process from CA Report to SCB vote, sometimes with a lack of agreement on methods and processes review or reassess?

Experiences from the national regulation of biocidal products not pooled to develop best practices for the BPD

Commission unable to drive review programme forward


Does it matter?

Existing active substances can remain on the market during review

Dossier development provided a thorough re-examination of active

substances

Little return on investment made in developing and supporting dossier

Continued competition from free-riders

Uncertainty over long term situation (results of assessment, new

guidance, implementation of BPR)

Available data, waiving options, risk assessment methods, C&L

proposals sometimes overtaken by REACH and CLP

Individual Member States still applying specific national requirements

for biocidal products, complicated by adaptations to BPD


The future the journey continues


The Biocidal Products Regulation

The BPR represents the evolution of the BPD, drawing upon experience from not

just the BPD itself, but also REACH

The basic structure is too entrenched to change but are also the problems?

Involvement of many stakeholders and final outcome still uncertain

Many existing actives and products have been lost

Future unknown!


Concluding the Annex I inclusion / active substance

approval process (whichever it will be)

Expect Annex I inclusion decisions for disinfectant active substances between 2012 and 2024 with peak around 2016/7

Questions remain on how the transition will occur

What will be the role of ECHA in providing advice and guidance move the process forward or more hurdles to jump?

How and when might the exclusion criteria and more structured data requirements of the BPR and newer guidance be applied?

What happens when renewal is due new dossier to latest BPR requirements?

Why is the last active substance inclusion decision in 2024?

Is there a lack of commitment and resources to complete the review of existing active substances?

The long transition process postpones achieving the aims of the BPR and brings a long period of market distortion


Is it better to use an authorised active substance?

In general, existing national regulatory requirements for disinfectant products

are less demanding (e.g. notification or limited efficacy data) than the

requirements for product authorisation under the BPR

If a Biocidal Product contains an active substance still under evaluation,

it is regulated under existing national legislation

If a Biocidal Product contains only authorised active substances, BPR

product authorisation is required (data package, fees, market freeze)

Unless BPR product authorisation is quick, harmonised and gives certainty,

BPR gives advantage to those actives that remain, through concerns or

chance, under review and have not been authorised / included in Annex I


Addressing free-riders

The value of Annex I inclusion is that it allows an active substance to be used in biocidal products

The BPR indicates that all suppliers of active substances must have (access to) a dossier by 2013 and product manufacturers can buy actives only from suppliers meeting this requirement from 2015

Removes the free-rider problem and provides fair competition between active suppliers, if enforced (including legitimate access to data)

Builds on REACH experience of competitors working in SIEFs and consortia

Develop a structure for working together to meet needs of BPR

Need to demonstrate technical equivalence in early part of process

REACH has tonnage bands and lower volume suppliers require less data = lower cost, even if overall total volume is high

BPR has no tiered data requirements, and generally few suppliers of any active, so high cost per supplier could lead to withdrawal from the market of lower volume suppliers


REACH is more inclusive process than the BPR

REACH

One substance, one core dossier, one or more registrations

Pre-registration, SIEF, possible consortium, Lead Registrant

Registration of substance, possible evaluation or authorisation

Use and exposure information communicated upstream, Exposure

Scenarios communicated downstream

End users comply with their suppliers or their own Exposure Scenarios

BPD/BPR

One active substance, one or more dossiers, one Annex I inclusion

Notification, late joining, possible consortium

Annex I inclusion of active substance after evaluation (authorisation)

Products require authorisation, with LoA to active substance dossier

End users comply with conditions of product authorisation


From Active Substance to Biocidal Product

Many disinfectant active substances

have other, non-biocidal uses,

covered by REACH

Each application for Annex I

inclusion of an active substance

requires an application for a

representative biocidal product in

the product type(s) of interest

To simplify the Annex I process, only

some products were typically

included in the active substance

dossier

non-biocidal

representative biocidal

other biocidal

REACH

BPD

Not yet

assessed


From Active Substance Dossier to Product Dossier

When considering the biocidal product it is also necessary to consider:

1) Restrictions in the Annex I Inclusion Decision (legal and mandatory)

2) Limitations advised in the Rapporteurs assessment report

3) Factors not considered when the Annex I inclusion decision was made

The active substance assessment should only restrict what is not

acceptable, not only allow what is acceptable, based on the contents of

the dossier if no assessment of a specific case = no decision

For example, the representative product may be a concentrated liquid

for professional use in disinfecting poultry sheds and pig sties whereas

the product of interest may be a ready to use disinfectant spray for

consumer use on pets hutches and dogs kennels


Working through the Supply Chains

If a biocidal product has been described in the active substance dossier, the

BP authorisation dossier should be straightforward

If a biocidal product or use has not been described in the active substance

dossier

More work for product authorisation

BP dossier may require use of data in AS dossier, not just a LoA

Use of BP may require revision of the AS dossier and assessment

report how, who and who pays, role of rapporteur / other Member States?

Need to ensure competition law compliance and maintain confidentiality of

technology


Communicating new information

Other MS

BP formulator 2Active substance

supplier with LoA

Lead regulator for BP2

ECHA

BP formulator 1Active substance

dossier owner

Active substance

rapporteur

Lead regulator for BP 1

Parallel trade

National

authorisation

Mutual recognition

Union authorisationAS rapporteur(s) Commission


Member State Regulators the challenge

Member State regulators generally want to retain the right to control what is placed on the market in their country

Any such authority must be matched by the responsibility and accountability to all stakeholders for the regulatory bodies to be professional, effective, responsive and to work together

Stakeholders include those funding this part of the BPR process-applicants for product authorisation and companies supporting Annex I inclusions of active substances

Risks are

Never ending discussions and updating of dossiers

Union Authorisation and Mutual Recognition becoming unworkable and processes grind to a halt

Commercial decisions to withdraw products from countries with small markets and / or high barriers to entry


Consequences of New Authorisation Requirements for

Disinfectant Products

BPR product authorisation will require the development, submission and review of a dossier and payment of fees

Costs of product authorisation may lead to withdrawal of products due to investment needed and potential return for both SMEs and business units in larger companies some may leave the market completely

Need to find the required resources

Use of external consultants

Vertical integration between active substance and biocidal product manufacturers

Active substance suppliers develop and supply (basic) product dossiers within a supply agreement

Active substance suppliers obtain Union authorisation (when possible) for key biocidal product families and license biocidal product distributors


In situ products

Never considered in BPD, work around through guidance to review in situ active

and/or precursors

BPR requires dossier on in situ product on the market in 2012 to be submitted by 2017

What about new and lost products?

Is this just a product dossier - how much information is needed about the in situ active

substance and where does this come from?

The supplier of the precursors may have no interest in biocides

The supplier of an active substance may not supply the precursors for the in situ

generation of the active

The properties of a product containing percentages of an active substance may

be very different to those of a product generating that active in situ at ppm levels

More details of process needed


Application technology

How a disinfectant product is used may be as, or more important, than the basic

efficacy of the product

Equipment to generate in situ active substances

Equipment to monitor and control loading, dosing, pH, residuals etc - eg potable

water treatment, public swimming pool disinfection, cooling water treatment.

Commercial forms of active substance and biocidal product may be identical or

similar, but key knowledge rests with equipment manufacturer, service company

or customer applying product who seeks product authorisation?

How does the BPR contribute and add value to well established technologies?

EP proposal to exclude active substances produced in situ for the purpose of

disinfecting drinking water but why only these when amendment comments that Articles 7 and 10 of the Drinking Water Directive provide for proper and

appropriate use of disinfectants whether from the market or generated on site


In conclusion

Challenges ahead:

For active substance manufacturers to benefit from their investment in

supporting active substances

For biocidal product formulators to move fully into the highly regulated

world of the BPR

For active substance and biocidal product suppliers to work together to

obtain product authorisations and meet individual business objectives

To make progress without procrastination reach a decision

Regulators have a crucial role in ensuring that the aims of the BPR are met

The purpose of this Regulation is to improve the functioning of the internal market through the harmonisation of the rules on the placing on the

market, making available on the market and use of biocidal products,

whilst ensuring a high level of protection of both human and animal

health and the environment

The views given are those of the author and do not necessarily represent the settled

opinion of DuPont.

DuPont makes no warranties, express or implied, and assumes no liability in connection

with any use of this Information.

Copyright 2011 DuPont. The DuPont Oval Logo, DuPont, and The miracles ofscience are registered trademarks or trademarks of E.I. du Pont de Nemours andCompany or its affiliates. All rights reserved.

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