authorization of biocidal product

Dare we miss the opportunity for Union Authorisation of Biocidal Products?

Dr Andy Adams

Bayer Environmental Science, Lyon, France

Informa 18th Annual Conference on Biocides, Barcelona,

September 2011

• Title • 19 August 2011

Introduction

The growing mountain of product authorisations

Will mutual recognition work?

Reducing administrative burden and time to market

Union Autorisation (UA): a single evaluation for « similar use »?

Fees and procedures

Proposals


The growing mountain ….

We know it’s taking longer than originally planned … we need a faster route to

the top …………

How many products per active/PT?

How much duplication? The case of difenacoum ….


How many products?

Member State registers

20 – 30,000 in MS with little national regulation

<10,000 in more demanding MS

COM estimation

20,000 current products on EU market


How many products for UA?

AISE-Cefic survey

93 respondents representing approx. 40% of current products:

Project approx. 1100 of the current 8000 products for UA

71% of products could be grouped into « families »

One could extrapolate to 2750 from 20000 products would be submitted for UA.

Recent estimates from DG Environment anticipate that the last inclusion decisions under BPD would occur in 2024, so the last product dossiers would be submitted in 2026, evaluations through to 2028.

BPR enters into force in 2013, so UA would apply to 2750 dossiers over 14 – 15 years,

ie, approx. 200 per year, without product families


The risk of duplication

The case of difenacoum ….

Several companies can grant access to a. s. dossier

Some may defend end use products themselves

Or supply a.s. to formulators who defend their own products

Net result: less than 10 formulation types with slight variations (block, pellet,

paste, grain …) at the same concentration of active substance. 10 evaluations

would be plenty. But, more than 100 dossiers submitted!!


What could be done?

We can introduce mandatory data sharing of vertebrate data to reduce unnecessary animal suffering …….

So why should evaluating staff and the European citizens they serve be exposed to unnecessary suffering?

Evaluating essentially the same thing, 10 times does not mean employing 10x the staff, it means 10x the cost, and 10x the time.

Repeat evaluations are avoidable, we have the tools to avoid it, use of R4BP is a core feature for product authorisations under BPR.

We just need the will and a little imagination.


Will mutual recognition work?

Experience so far:

Indoxacarb: new active, and the products were already reviewed with the active

to secure inclusion, then needed a further year for full approval, and many MS

took more than the additional 120 days to grant approvals via MR

Carbon dioxide: Annex IA active, with the « low risk » use (mousetrap) reviewed

with the active for inclusion. Again, full approval took an additional year, MR was

late in almost half MS.

Dichlofluanid: Eevaluating MS took much longer than a year to grant approval;

One MS forced companies to withdraw products from sale when MR was not

completed before end of compliance period


Reducing administrative burden and time to

market

The product family concept

Multiple products can be covered by a single evaluation if they fall within the envelope (equal or less risk; acceptable efficacy; same active, lower concentrations in end product, same end use rate, for example a concentrate for professional use could cover the RTU for consumer use)

Makes sense?

Smart use of R4BP (and a little altruism?)

COM (today) and the ECHA (for BPR) informed of submissions

Can alert evaluating CA that similar products are submitted elsewhere

Evaluating CAs could share review, or agree on « Rapporteur »

Better to evaluate 10 different products than the same product, 10 times?

But …. Who gets what fees? Who owns the authorisation(s)? What about risk mitigation measures? Data access, protection ….. ?


Did I say « altruism »?

And if every Member State acted like this …………………. ?

Supported (even approved) products are forced off the shelves

Delayed evaluations and poor dossiers are unaffected

Better the environmental risk you don’t know, than the one you do!?

If we don’t do any work, you pay 75% of the fee

(PS ….. we’ll tell you what the fee is later!)

A little understanding, pragmatism, incentive to comply perhaps?

Industry also needs to be prepared to share costs, co-operate to avoid multiple

submission of the same use which will end up with the same label anyway.


UA and similar conditions of use

Principle is clear

Applicant justifies that product qualifies for UA (similar conditions)

Dossier is evaluated by a Member State CA (« ECA ») on behalf of the EU

Evaluation is reviewed by Biocidal Products Committee (all MS represented)

Approval, once granted, applies throughout the Member States

Basic minimum, this should reduce time to authorisation since mutual recognition

step is removed.

Intuitively, should be reduced fees because mutual recognition step is removed.


A single evaluation for a single use?

It makes sense

Simple examples

consumer products available in supermarkets

disinfectants

in-can preservatives

anti-bacterial soaps

cockroach bait station


UA – the opportunity

Can apply to a product from any PT with proviso of similar use

Can apply immediately without unnecessary burden – because we’ve barely got

50 inclusions so far!

Many of the products concerned are widely considered to present little or no risk

since they were not subject to national regulations pre-BPD.

Evaluations should be more straightforward, less debate, few (if any) contentious

issues (it’s all relative!!)

Could help to speed up the evaluation program, allow CAs to focus on the more

contentious products/uses


The unfortunate reality …

As currently presented in BPR:

UA timeline = 605 days

National authorisation = 425 days

Parallel application = 515 days****

(autorisation + MR applications at the same time)

MR alone = 180 days

(first authorisation already granted)

**** Timeline assumes that first authorisation cannot be granted until all MS

have agreed on MR and does not include time for validation ….. Which is

nominally 90 days so total timeline would then be 605 days


And what does it cost?

Fees remain a grey area but indications are the following:

UA = 80k€ ECHA + 30k€ ECA/RMS = 110k€

National autorisation = 30k€****

Parallel application = 95k€ (ECA + 26 MS)

= 62.5k€ (ECA + 13 MS)

(autorisation + MR applications at the same time)

MR alone = 180 days

(first autorisation already granted)

**** 30k€ is a high end cost, today, but unlikely to decrease!!


Fees and procedures

UA should reduce administrative burden, shorten evaluation time

So why does the latest proposal anticipate a longer evaluation time and

increased fees compared with the current mutual recognition procedure?

Surely, we aren’t adding administrative load are we????


Proposals

Publish fees in advance so applicant can include cheque with application

(potential to save 60 days)

ECHA prepares an opinion on product authorisation within 90 days of receiving

the assessment report from the ECA (potential to save 90 days)

Allow MS to approve products once their evaluation is completed (not be delayed

by the last country to grant approval)

Encourage UA with reduced admin costs, reduced time to approval to provide an

incentive

Maximise use of product family concept.


Proposals

A little imagination

Make the most of technology

Reviewing committees do not have to be « physically » in Helsinki

Travel time is more cost, and less time

Resources are already over-stretched

Act upon R4BP alerts on « repeat » dossiers

Try to run completeness checks and evaluations in parallel, not in series

Encourage use of UA, co-operative evaluations, multiple dossier « owners »

Member State CAs still « own » the evaluations

Most of all:

The mindset to make it work, because we all win if it does!!

Thank you!

authorization of biocidal product

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