An Industry view on the progress towards achieving the objectives of the BPD and prospects for the new Regulation Dr Andy Adams Bayer Environmental Science,

An Industry view on the progress towards achieving the objectives of the BPD and prospects for the new Regulation

Dr Andy Adams

Bayer Environmental Science, Lyon, France

Workshop on REACH and EU Biocides legislation, Belgrade 31st May – 1st June 2012

page 2 • Title • 21 April 2023

Introduction

Who am I ??

The BPD: What were we trying to achieve?

A catalogue of non-successes

What went wrong?

Environmental Risk – a leap into the unknown

How are biocidal products actually used?

How the Regulation could address the shortcomings of the BPD (or not!)

Prospects and Proposals

Who am I ??

Born in London, trained as a zoologist with PhD in insect physiology from Imperial College, London.

Post-doctoral research in horticulture, insecticide resistance, spray application technology.

Joined Wellcome Environmental Health as a biologist in 1990.

Mergers, takeovers through Roussel Uclaf, AgrEvo, Aventis to Bayer, mostly in the non-agricultural R and D business.

Head of European Regulatory Affairs since 2005 and Chairman of the European Biocidal Products Forum (EBPF) of Cefic since 2008.



The BPD: What were we trying to achieve …. ?

Need for risk management of non-agricultural pesticides

Harmonise regulatory standards to foster free-trade within the Union

High level of protection for humans, animals and the environment

Biocidal products should not be placed on the market for use unless they have complied with the relevant procedures of the Directive

Apply simplified procedures where appropriate. Encourage low risk products.

Provide common principles for evaluation and authorisation to ensure a harmonised approach by member States

Close co-ordination with other Community legislation and in particular with 91/414/EEC

Whereas biocidal products are necessary … they can pose risks …

Where did we start from ….. ??

Before May 2000, most biocidal products were subject to little or no data/dossier requirements by the EU 15. Countries like UK regulated less than half the 23 product types.

Germany and France needed a letter of notification before a biocidal product could be placed on the market. No dossier, no evaluation or authorisation for many products.

Most disinfectants were un-regulated across the EU (and PT2, alone, accounts for 50% of the tonnage of biocidal active substances on the EU market)

So, the new Directive meant a massive change for all stakeholders in terms of the data requirements per dossier and the scope of products that would need to be regulated. A correspondingly massive impact upon the costs to support actives/products and the resources needed to prepare and evaluate dossiers.


Remember ….

Initially, the focus was on non-agricultural uses of pesticides, and the Directive was largely driven by the format of 91/414 for plant protection products.

Evaluating (« Rapporteur ») Member States were expected to review the same actives for biocidal use that they had already evaluated for plant protection uses.

Then came the idea to extend the scope to cover lots of other types of product that could also be considered as « biocides » and which were not currently regulated.


Presentation • April 21, 2023 • Slide 7

98/8/EC - BPD product types and groups

GROUP 1: Disinfectants and general biocidal products 1: Human hygiene biocidal products2: Private area and public health area disinfectants and other biocidal products3: Veterinary hygiene biocidal products4: Food and feed area disinfectants5: Drinking water disinfectants

GROUP 2: Preservatives6: In-can preservatives7: Film preservatives8: Wood preservatives9: Fibre, leather, rubber and polymerised materials preservatives10: Masonry preservatives11: Preservatives for liquid-cooling and processing systems12: Slimicides13: Metalworking-fluid preservatives

GROUP 3: Pest control14: Rodenticides15: Avicides16: Molluscicides17: Piscicides18: Insecticides, acaricides and products to control other arthropods19: Repellents and attractants

GROUP 4: Other biocidal products20: Preservatives for food or feedstocks21: Antifouling products22: Embalming and taxidermist fluids23: Control of other vertebrates

Presentation • April 21, 2023 • Slide 8

BPD Timetable (initial)

28/03/2004 30/04/2006 31/07/2007 31/10/2008

Completeness check

Evaluation

Comments

Decision-making

3 12 38,14

16, 18, 19, 21

1-6, 13

7, 9-12, 15, 17, 20, 22, 23

6-18

Annex I listing

Product Registration

PTs

List 1:

Initially, attention focussed on « best known » PTs

List 1 includes just 2 PTs for wood preservatives and rodenticides – active ingredients that were well known to regulators and already subject to authorisation procedures.

List 2 included the insecticides and the belief was that these represented non-agricultural uses of actives that were already well known due to their agricultural use.

Where an active substance had already been submitted for evaluation under 91/414/EEC fopr crop protection uses, it was assigned to the same Rapporteur Member State for the biocide evaluation. The expectation was that this would ensure synergy and reduce administrative load.


Alternatively, REACh considers tonnage as a surrogate for risk …..

Almost 90% of the tonnage of biocides is used as PTs 2, 5, 10 and 11

PT2 Private area and public health area biocidal products

PT5 Drinking water disinfectants

PT10 Masonry preservatives

PT11 Preservatives for liquid cooling and processing systems

Should we be focussing our attention there?



What went wrong?Most rodenticides were not defended for plant protection uses, so there was no PPP reference dossier

More than half the insecticides defended for biocidal use did not have plant protection uses (eg. photolabile pyrethroids for aerosols), so there was no reference PPP dossier for them, either

Most manufacturers/formulators had little experience of PPP dossiers (a very different industry)

An additional 12 MS joined the EU after the Directive entered into force …… and found themselves as Rapporteurs for many of the least regulated PTs in lists 3 and 4.

Most MS were unable to resource to meet the levels necessary to conduct evaluations to the standards (‘gold plated’) and timelines forseen in the legislation.

In many MS, the competent authority (CA) for biocides was different to that for PPPs (eg. Ministry of Health instead of Ministry of Agriculture/Environment)


A catalogue of non-successes?

1000 actives identified

400 notified

270 defended (finally 700 ai – PT dossiers) … success, failure, both or neither?!

First dossiers submitted 4 years after the 10 review begain (March 2004)

Clock stopped on incomplete dossiers, often several times.

Member States under-resourced even with many fewer dossiers than expected.

Member States develop ‘conservative’ risk assessments at same time as conducting evaluations.

False « new » notifiers buying time

Annex IA (low risk) virtually redundant; Inclusion into Annex I of 91/414 of no value

Free-riders undermining competitveness of participants

Commission unable to manage dossier evaluations to BPD timeline

Mini-revision extends to 2014

Then Commission acknowledges it may actually be 2024 before all ais are reviewed.


A catalogue of non-successes ….. ?Supposed low risk substances (eg. plant oils) not supported

Risk mitigation for rodenticides far from harmonised

Register For Biocidal Products (R4BP) overloaded before 10 actives start product authorisation

4000 mutual recognition applications already!

Still addressing scope issues (oxygen scavengers …)

Protracted discussions on chromium, creosote …

Over-conservative ESDs (cockroach baits, fence posts ..)

24 months after the BPD was due to be completed, less than 10% of dossiers have reached inclusion decisions.

« Cannot see the wood for the trees!! »


What went wrong ……. and can the new Regulation help?

Somewhere, we forgot that if it had not been evaluated and shown to meet the necessary standards (acceptable risk) it was supposed to be withdrawn …

Instead, we piled restrictions onto those that were being evaluated

Net result was a huge incentive, even a reward, to those who delayed, delayed, stalled, performed poorly or, even better, did not participate at all!


What went wrong?

Inexperience leads to focus on data requirements and details without placing the active and its use in context. Follow the rules, not the spirit of the rules.

Costs out of proportion to the market size. Very little new chemistry versus 75% loss of existing substances.

Over-conservative approaches in Environmental Risk Assessment where we had to deal with a lot of unknowns ….


Sewage Treatment Plants

What happens to biocides?What happens to biocides?

Environmental Risk Assessment (ERA) for indoor use of insecticides (PT18): Emission Scenario Document (ESD)

Identifies key exposure pathways (indoor uses shown below)

– Provides default values for emissions for different formulations

– Key issues: number of sources in STP catchment, localised soil exposure


The Environmental Risk Assessment - a leap into the unknown

ERA according to ESD

Initial intention is to characterise environmental impact of different uses with sufficient safety margin.

When PT18 dossiers were submitted in 2006, the ESD did not exist, thus risk evaluation was done by applicants to the best of their knowledge (expert assumptions and technical know how)

When ESD arrived as a moving target (or living document) the RA-approach had to be re-thought by the applicant and often no time for thorough mitigation left.

MSs tend to take the ESD as written in stone despite its status as a living document and lose focus of protection goals (single earth worm)

Over conservative. When carrying out reality checks , e.g. with tonnage approach, huge overestimation has been demonstrated.


ERA - Positive signs

Adaptation of the catchment structure to a more realistic scenario: Reduction of numbers of houses, large buildings and size of large buildings. Still, who of 4000 housings really has a 130 m² apartment/house?

Simultaneity factors: Refinement possible based on exact knowledge of application pattern. However this still remains a consumer based application frequency non-adapted to professional uses.

Application surfaces: treated areas reviewed to more realistic and consistent first tier use patterns

Cleaning efficiency: refinement as a function of the precise use description on label possible

Possibility to use certain relevant ai properties for refinements


ERA - where the problems are?

Overestimation of the environmental exposure, why?

Lack of knowledge on product “reality” leads to most unrealistic first tier assessments :

extensive use of default values based on rough assumptions

data inappropriate for the use assessed

e.g., Simultaneity factors consumer based- Consumer behaviour changed since enquiry

- Are French consumers representative of Europe?

- Professional uses can’t reasonably be assessed on this basis


ERA - where the problems are?

Compilation of worst case scenarios to an overall exposure inevitably results in overkill

e.g., Cumulation of out and indoor uses in improbable configurations:

All outdoor amount applied goes directly into surface water without passing through the STP

Accumulates in the same waterbody either via STP or direct release

Outdoor uses:

Wash off governed by what, Hardspec?

Wood preservatives have shown reduced wash off

Protection of single individuals and not of a population in its habitat, e.g. earthworms in a small zone around the house or fencepost instead of earthworms in a garden.


ERA - a few suggestions

Industry explains and, why not, trains authorities to have a better knowledge of product use which will ease discussions and facilitate acceptance of mitigation

Clarify protection goals

Simultaneity factors for professional uses needed

STP is still a black box: knowledge of processes involved and influence on a.i. fate. To heavy for one player alone. Costs to generate the data are prohibitive.

Realism of a.i. losses after application

Indoor cleaning efficiency: differentiation of accessibility and effectiveness of cleaning as such.

Outdoor Wash-off: factors of influence (hardspec model?)

Who generates better data: Industry? Single player can’t afford to create generic data, will authorities trust approach solely created on Industry initiative?


Where are we?

What were we trying to achieve?

A catalogue of non-successes

What went wrong?

Environmental Risk – a leap into the unknown

How the Regulation could address the shortcomings of the BPD (or not!)

Prospects and Proposals


What were we trying to achieve …. ??

Need for risk management of non-agricultural pesticides

Harmonise regulatory standards to foster free-trade within the Union

High level of protection for humans, animals and the environment

Biocidal products should not be placed on the market for use unless they have complied with the relevant procedures of the Directive

Apply simplified procedures where appropriate. Encourage low risk products.

Provide common principles for evaluation and authorisation to ensure a harmonised approach by member States

Close co-ordination with other Community legislation and in particular with 91/414/EEC

Whereas biocidal products are necessary … they can pose risks …

?


Biocides in use

It is a common misconception that insecticides for BPD are just agriultural products re-labelled. But half the actives defended under PT18 have no agricultural uses in Europe (eg photolabile pyrethroids), and most formulation types are different (more suspension concentrates, fewer emulsifiable concentrates, more bait gels etc)

Many PTs were not regulated prior to BPD in any MS (only 13/23 PTs were regulated in Sweden, less than 10/23 in UK, virtually none in Germany …)

Many of the preservatives and disinfectants are familiar and in common use across Europe. Many are freely available in supermarkets, or occur in goods purchased by consumers without even thinking about it!! (in-can preservatives).

It is disproportionate and unnecessary to scrutinse such products in every Member State when the use and risk are so similar.

From Directive to Regulation

The BPD expires in 2014, but in fact will be superseded by the new Regulation which will apply from September 1st, 2013.

Some of the key areas in the debate leading to the new Regulation:

Exclusion (“Cut-off” criteria)

Free-riders

Slow progress

Central Agency and Mutual Recognition

Low risk

Fees

SMEs


page 27 • BPR • 2 February 2012

Article 5: Exclusion criteria (cut-offs)

Kept the interim definition for ED. However, no later than 13 December 2013, the Commission shall adopt measures specifying scientific criteria for determination of endocrine disrupting properties.

No additional cut-offs added in comparison to 1107/2009 (POP a cut-off criteria under 1107/2009).

A substance shall not be approved if:

CMR Cat 1A or 1B

Endocrine Disruptor

PBT or vPvB in accordance with REACH


Article 5: Exclusion criteria (derogations)

Use of a biocidal product containing these active substances shall be restricted to those Member States where the conditions of the derogation are met.

The derogations go further than those in 1107/2009, specifically because of the need for rodenticides in Member States, which could all have been lost had we only had the derogation for negligible exposure.

Where at least one of the following is met:

1. The risk to humans or the environment from exposure, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release to the environment.

2. It is shown by evidence that it is essential to prevent or control a serious danger to public or animal health or to the environment

3. Not approving would cause disproportionate negative impacts for society when compared to the risk to human health or the environment arising from the use of the substance.

Suitable and sufficient alternative substances and technologies shall be a key consideration.

Key Issue – free riders

A loophole in the BPD meant that as long as one company defended an active for a specific use (product type, PT) then any other company could continue to sell the same active, without contributing to any of the costs (studies, fees, dossier compilation, dossier defence).

Subsequent EU legislation (REACh) began with the « no data, no market » principle so only companies that notified substances (via task forces, or « Substance Information Exchange Fora », SIEFs) could place those substances on the market.

The EU Commission undertook to resolve this issue in the new Regulation but decided not to addresss it in the « mini-revision » which extended the BPD review to 2014.


Free-riders, what happened …


From the 1st September 2013 any person wishing to place active substances on the Union market or in biocidal products shall submit a dossier, LoA or reference to a dossier (if protection periods have expired).

The Agency will publish a list of persons that have made submissions of a dossier and includes the participants in the work programme.

As of 1st September 2015 no biocidal products on the market unless the active substance is from a ‘person’ on the published list of participants..

New applicants have the opportunity to gain access to the data needed to become an approved source, in return for a compensation payment because, for all existing active substances mandatory data sharing shall apply to all toxicological and ecotoxicological studies including any studies not involving tests on vertebrate animals.

Free-riders – the industry view

Much better to ensure that everyone participates in the process

The main concern is that mandatory access to data can be granted within a few months, even without agreement on data compensation, and guidance on what is « fair » compensation is far from finalised.

Data compensation could be left to national courts (expensive, slow, who wins??) and reference is made to REACh guidance ……….

But REACh began with the « no data, no market » principle, so everyone had to participate from day 1 or leave the market whereas under BPD, non-participant free-riders will have enjoyed market access since the BPD entered into force in 2000 without any cost.


Key issue - slow progress

60 decisions done, 650 to go …..

And that is just the actives – then you get the product authorisations!

Add the comparative assessment of rodenticides, 5 years after inclusion,

Add that those dossiers need to be submitted 15 months before expiry of inclusion …..

Currently, a « good » standing committee meeting votes on 5 dossiers

There are 5 standing committee meetings per year

COM projected 2024 for the last inclusion decision, but that assumes more than 50 decisions per year ……… at 25 decisions per year, the projection slips to 2038!!



BPR: a chance to optimise the use of scarse resources

Choice of RMS

- quasi Central Agencies (already UK clearly preferred as lead RMS)

- focus resources and expertise (many MS welcome MR)

- ECHA to oversee and assist with timely resource re-allocation

- all submissions via ECHA ensures consistency and record-keeping

- SMEs can still deal with local CA, in local language


Biocidal Product Family

Risk envelope concept

Don’t evaluate again if the use is the same (or close), efficacy reaches accepted level for claims, risk is equal to, or less than, something you’ve already done!

Allows variations in colours, some co-formulants, concentration of active, even removal of an active, perhaps even change of active, RTU and concentrates … without adding unnecessary administrative burden.

Estimates from an AISE-Cefic survey suggest that as much as 75% reduction of product evaluations could result, without increased risk or second-rate scrutiny!!


Reducing administrative burden and time to market

Smart use of R4BP

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?

Will this need to be mandatory?

Can we afford to ignore this opportunity?


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


Union Authorisation (UA) – the opportunity

Could apply to a product from any PT with proviso of similar use – but some limitations were introduced during the debate (phasing of PTs)

Can apply immediately without unnecessary burden – because we’ve barely got 60 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 feature few (if any) contentious issues

Could speed up the program, and allow CAs to focus on the more contentious products/uses

Central Agency will be ECHA

Industry wanted a Central Agency:

To take on the role of project manager

To expedite review of « simple » dossiers via Union Authorisation (UA)

To reduce time to market

To ensure consistency of reviews and dossier quality

To keep the evaluations to the prescribed timeline

So, what is Union Authorisation, and how do the (theoretical) timelines for National authorisation, mutual recognition and UA compare?



The unfortunate reality …

As currently presented in BPR:

UA timeline = 605 days

National authorisation = 425 days

Parallel application = 515 days****

(authorisation + MR applications at the same time)

MR alone = 180 days

(first authorisation already granted – MRs not granted until all MSs have agreed)

**** 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€

ECHA annual fee (product) = 10k€ (100k€ during authorisation??!!)

National authorisation = 30k€****

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

= 62.5k€ (ECA + 13 MS)

(authorisation + MR applications at the same time)

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

ECA = Evaluating Competent Authority


ECHA – stifling, not stimulating.

ECHA has its procedures. These are not designed for biocides (yet).

ECHA can prepare for tasks forseen under the Regulation.

ECHA will need resources and training.

ECHA will need financial support.

ECHA forsees 25 mio€ per annum being fully supported via fees by 2021.

ECHA will not do any dossier evaluation work

So industry is expected to come up with 25 million euros pa, plus the evaluation fees levied by evaluating Member States ?


ECHA – create the opportunity, don’t lose it!!

Industry is looking for:

- quality (no use if no-one recognises the result)

- interaction … let’s talk!

- speed to market (return on investment, reduced risk, win-win)

- respect timelines ….. Predictability

- incentive to innovate

- value for money, return on investment

Currently, ECHA is not offering this. Some MS are.

UA offers opportunity, but is in danger of pricing itself out of the market.

Low Risk

An objective of the Directive was to encourage the use of low risk substances and the development of low risk products.

An « own goal » … 2 actives are considered « low risk », and many other «botanical oils were not supported (too costly to defend for niche markets, no protected data)

So, another approach ……….. In effect, a « what we think is a low risk active » list:



Annex ICategory I: Substances authorised as food additives

Lactic acid Category 5: Pheromones

Oct-1-en-3-ol

Sodium acetate Webbing clothes moth pheromone

Sodium benzoate Category 6: Substances included in Annex I or IA of the Biocides Directive

Carbon dioxide

Tartic acid Nitrogen

Acetic acid (Z,E)-Tetradec-9,12-dienyl acetate

Propionic acid Category 7: Other Baculovirus

Category 2: Substances included in Annex IV of REACH

Ascorbic acid Bentonite

Linseed oil Citronellal

Category 4: Traditionally used substances of natural origin

Lavender oil Iron sulphate

Peppermint oil


Articles 24 - 26: Eligibility, application & making available of products in accordance with the Simplified authorisation procedure (SAP)

Authorisation of Low Risk products

To be eligible the active substance should be included in Annex I, contain no substance of concern, no nanomaterial, effective and does not require personal protective equipment.

An application is made to the Agency and the evaluation by a ECA is 90 days.

A biocidal product authorised under the SAP may be made available on the market in all Member States without the need for mutual recognition.

Authorisation holder shall notify each Member State no later than 30 days before placing on the market.


Article 27: Amendment of Annex I Active substances can be added to Annex I if there is evidence that they do not give rise to concern. No timelines in the text on how long this process takes.

Rise to concern is determined as:

Under CLP they are:

Explosive/highly flammable

Organic peroxide

Acutely toxic of category 1, 2 or 3

Corrosive of category 1A, 1B or 1C

Respiratory sensitiser

Skin sensitiser

Germ cell mutagen of category 1 or 2

Carcinogen of category 1 or 2

Human reproductive toxicant of category 1 or 2

Specific target organ toxicant by single or repeated exposure

Toxic to aquatic life category 1

Fulfil any of the substitution criteria

Have neurotoxic or immunotoxic effects

Meets the criteria if there are equivalent concerns arising

Fees charged by the ECHA

The objective is 100% cost recovery ie fee for service, with no more Union subsidy after 2020.

Commission/ECHA estimates are that the Agency will be self-financing and receive 25 million€ in fees by 2021.

Some examples:

ECHA fee for approval of active substance: 120k€; 40K€ for additional PTs

Renewal of approval will cost 40k€ for a full evaluation, or 15k€ for a limited evaluation.

Union Authorisation fee: 80k€ per product plus 40k€ if comparative assessment is needed.

Major change to a product autorisation: 40k€

Minor change: 15k€


Remember – those fees are for the admin work!!

Member States will then charge their own fees for the evaluation work!

Product Authorisation fees are expected in the range 15 – 20k€ depending upon the Evaluating Member State.

Mutual recognition fees are usually in the range 1 – 5k€.

………. Plus all the study costs and time to compile your product dossier, and then the time to answer questions arising during the evaluation.


SMEs and the paradox of the BPR

Increased regulation invariably favours larger companies which have the resources to cope with the financial and logistical consequences of extra admin and higher standards.

There is a political will to support SMEs within Europe.

Fees charged are meant to reflect the work done to evaluate the dossier or manage the admin …… which should be independent of the financial resources of the applicant because the standards and data requirements are the same.

In its draft guidance on the fees payable to the ECHA, COM proposes some reductions for SMEs, while recognising that the biocides market is dominated (estimated 70%) by SMEs (very different to Plant Protection where 10 or so multi-nationals account for most of the sales of ag chem products).


SMEsIn practise, an SME is much more likely to be a formulator than a supplier of active

ingredient.

To develop a dossier for a product, plus the submission fees, can easily cost in excess of 100k€ and needs supply from an approved active substance source.

Mutual recognition offers the possibility to extend each product to other countries via links to third party marketing authorisations.

Important to decide which products to defend, directly, and which to take as a marketing authorisation (or toll manufacturer) to maintain « own brands », locally.

Also important to decide whether to defend in isolation or whether a task force is more appropriate



Prospects

List 3 – 4 dossiers may progress faster than lists 1 – 2

- generally considered to be less contentious substances

- MS have more experience now, but there is a backlog from earlier submissions!

Mutual recognition à la BPD may work more smoothly with experience

- getting used to R4BP, developing trust

A Central Agency, in principle, is broadly welcomed by Industry

- we need effective project management

- but not if it offers no incentive

Simplified procedures, in principle, are welcomed but …..

- not as a quick-fix to address the Annex IA disaster

- not where the central roles of risk assessment and efficacy are undermined

- not when unassessed actives are provided easy access to the market


Summary

The BPD has reduced the number of active substances from over 1000 to below 300.

The review program is running very slowly – just 60 inclusion decisions taken, with another 650 to come, maybe another 20 years before we « finish »????

With the BPR, we see attempts to learn the lessons of the BPD but the procedure remains slow, expensive and risks stifling innovation instead of providing incentives to develop new products that reduce risk.

Mutual recognition and a pragmatic use of the product family concept remain the best opportunities to reduce administrative burden. Union Authorisation has potential for some products if benefits exceed cost.

OpinionThe BPD has introduced an enormous increase in administrative burden for industry and

the authorities and has lost sight of the main objective – to reduce risk – by being too demanding, too ambitious, and by addressing too many products in a diverse industry.

Data requirements are modelled on plant protection but are probably out of proportion to the actual risks posed by most biocidal products.

Risk assessments (especially for environment) are inevitably over-conservative due to lack of information.

Innovation has been stifled by the cost of complying.

A greater, faster contribution to reducing risk will be to focus on the use phase to ensure that products are used responsibly, with better provision of information to amateur users (risks, benefits) and training to professionals.


Thank you!

An Industry view on the progress towards achieving the objectives of the BPD and prospects for the new Regulation Dr Andy Adams Bayer Environmental Science,

Documents

eecwhereas biocidal

scope of products

risks page

environmentbiocidal

plant protection products

biocidal use

low risk products

environmental risk