Regulation and the future of timber treatment in the UK

Wood preservatives. What’s happening?● New EU regulations have been coming into force

since 2000● What’s it all about?● What does it mean for the future?

History of regulation in the UKPre-1986 1986 to 2000 2000 to present day

No biocide-specific regulation Control of Pesticides Regulations 1986 (COPR)

Biocidal Products Directive/Regulation BPD/R

Virtually any chemical formulation could be sold as a biocide although certain other regulations - e.g. Health & Safety at Work Act - placed limited restrictions in practice.

Active ingredient manufacturers needed to submit toxicological + efficacy data for their active ingredients.

Data was also required for formulations, but could largely be “read across” from active ingredient dossier.

Cost of product registration typically £500 to £2000.

More stringent requirements for active ingredient data.

Review of efficacy/safety of all existing active ingredients.

More stringent and costly registration/data costs for product formulations. Typically >£100,000 per product

In practice COPR and BPD/R continue to co-exist. COPR still applies for formulations containing certain active ingredients.

Aims of BPD/BPRThe Biocidal Products Regulation (98/8/EC) was introduced in May 2000. It was superseded by the Biocidal Products Regulation (BPR) in September 2013.

Key aims of BPD/BPR are as follows:

● Ensure that biocides are sufficiently effective to justify the risk that their use poses - i.e. introduction of

mandatory efficacy testing

● Restrict or prohibit sales/use of products that pose an unacceptably high risk

● Introduce biocidal regulation to member states where it didn’t previously exist

● Harmonised product registration in all EU Member states - allowing single internal market for biocidal

products to operate - elimination of non tariff barriers caused by differing registration systems operating

within the EU

How BPD/BPR Works (Highly Simplified)Active Ingredient Manufacturer:Submits toxicological and efficacy data to "Rapporteur Member State" with aim of getting active ingredient listed on Annex 1.Cost = £ Several Million

Product Formulator:Picks active ingredients from Annex 1 and uses these to formulate product. Submits his own dossier to regulatory authorities with toxicological/efficacy data for his specific formulation.Cost = £100,000 to £200,000

Formulator must select actives from correct Product TypeMAIN GROUP 1: Disinfectants and general biocidal products

● Product-type 1: Human hygiene biocidal products● Product-type 2: Private area and public health area

disinfectants and other biocidal products● Product-type 3: Veterinary hygiene biocidal products● Product-type 4: Food and feed area disinfectants● Product-type 5: Drinking water disinfectants

MAIN GROUP 2: Preservatives

● Product-type 6: In-can preservatives● Product-type 7: Film preservatives● Product-type 8: Wood preservatives● Product-type 9: Fibre, leather, rubber and polymerised

materials preservatives● Product-type 10: Masonry preservatives● Product-type 11: Preservatives for liquid-cooling and

processing systems● Product-type 12: Slimicides● Product-type 13: Metalworking-fluid preservatives

MAIN GROUP 3: Pest control

● Product-type 14: Rodenticides● Product-type 15: Avicides● Product-type 16: Molluscicides● Product-type 17: Piscicides● Product-type 18: Insecticides, acaricides and products

to control other arthropods● Product-type 19: Repellents and attractants● Product-type 20: Control of other vertebrates

MAIN GROUP 4: Other biocidal products

● Product-type 21: Antifouling products● Product-type 22: Embalming and taxidermist fluids

Annex 1 - Product Type 8 - Wood Preservatives● (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)

● (RS)-α-cyano-3phenoxybenzyl-(1RS)-cis,

trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Cypermethrin)

● 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole

(Propiconazole)

● 2-octyl-2H-isothiazol-3-one (OIT)

● 2-thiazol-4-yl-1H-benzoimidazole (Thiabendazole)

● 3-iodo-2-propynylbutylcarbamate (IPBC)

● 4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro-2-octyl-2H-isothiazol-3-one

(DCOIT))

● 4-bromo-2-(4-chlorophenyl)-1-ethoxy-

methyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)

● Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-16))

● Basic Copper carbonate

● Bifenthrin

● Boric acid

● Boric oxide

● Coco alkyltrimethylammonium chloride (ATMAC/TMAC)

● Copper (II) oxide

● Copper hydroxide

● Creosote

● Cu-HDO

● Cyproconazole

● DDACarbonate

● Dichloro-N-[(dimethylamino)sulphonyl] fluoro-N-(ptolyl)methanesulphenamide

(Tolylfluanid)

● Didecyldimethylammonium chloride(DDAC)

● Disodium octaborate tetrahydrate

● Disodium tetraborate

● Disodium tetraborate decahydrate

● Disodium tetraborate pentahydrate

● Etofenprox

● Fenoxycarb

● Fenpropimorph

● Flufenoxuron

● Granulated copper

● Hydrogen cyanide

● K-HDO

● N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)

● N-(Dichlorofluoromethylthio)-N′,N′- dimethyl-N-phenylsulfamide (Dichlofluanid)

● N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate

(Polymeric betaine)

● Penflufen

● Permethrin

● Poly(oxy-1,2-ethanediyl), .alpha.-[2-(dide- cylmethylammonio)ethyl]- .omega.-

hydroxy-, propanoate (salt) (Bardap 26)

● Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate)

● Sulfuryl fluoride

● Tebuconazole

● Tetrahydro-3,5-dimethyl-1,3,5-thiadia-zine-2-thione (Dazomet)

● Thiacloprid

● thiamethoxam

Wood preservative product formulator has theoretical choice of over 40 active ingredients.

Registering a new Product FormulationCreate shortlist of actives that:

● Are effective against target organism● Have a good toxicological profile● Have no threats looming on the horizon - e.g. reclassification of similar

molecules, concern from other regulatory bodies (EPA etc…) ● Are cost-effective● Chemically compatible with proposed formulation type - e.g. microemulsion● Have dossier that supports proposed use - e.g. remedial treatment of indoor

timbers against wood-boring insects

Over 40 actives to choose from● (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin)

● (RS)-α-cyano-3phenoxybenzyl-(1RS)-cis,

trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Cypermethrin)

● 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole

(Propiconazole)

● 2-octyl-2H-isothiazol-3-one (OIT)

● 2-thiazol-4-yl-1H-benzoimidazole (Thiabendazole)

● 3-iodo-2-propynylbutylcarbamate (IPBC)

● 4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro-2-octyl-2H-isothiazol-3-one

(DCOIT))

● 4-bromo-2-(4-chlorophenyl)-1-ethoxy-

methyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)

● Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-16))

● Basic Copper carbonate

● Bifenthrin

● Boric acid

● Boric oxide

● Coco alkyltrimethylammonium chloride (ATMAC/TMAC)

● Copper (II) oxide

● Copper hydroxide

● Creosote

● Cu-HDO

● Cyproconazole

● DDACarbonate

● Dichloro-N-[(dimethylamino)sulphonyl] fluoro-N-(ptolyl)methanesulphenamide

(Tolylfluanid)

● Didecyldimethylammonium chloride(DDAC)

● Disodium octaborate tetrahydrate

● Disodium tetraborate

● Disodium tetraborate decahydrate

● Disodium tetraborate pentahydrate

● Etofenprox

● Fenoxycarb

● Fenpropimorph

● Flufenoxuron

● Granulated copper

● Hydrogen cyanide

● K-HDO

● N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)

● N-(Dichlorofluoromethylthio)-N′,N′- dimethyl-N-phenylsulfamide (Dichlofluanid)

● N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate

(Polymeric betaine)

● Penflufen

● Permethrin

● Poly(oxy-1,2-ethanediyl), .alpha.-[2-(dide- cylmethylammonio)ethyl]- .omega.-

hydroxy-, propanoate (salt) (Bardap 26)

● Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate)

● Sulfuryl fluoride

● Tebuconazole

● Tetrahydro-3,5-dimethyl-1,3,5-thiadia-zine-2-thione (Dazomet)

● Thiacloprid

● thiamethoxam

Shortlist based on suitability for remedial treatment against wood-boring insects

● Permethrin● Borates - arguably the safest treatments once applied, but Repro Tox Cat 1B (by ingestion) of the

supplied products places restrictions on use and requires expensive and uncertain “comparative assessment” before registration can be granted.

● Cypermethrin - unpopular with professional applicators as alpha-cyano group produces sensitivity in a large number of operatives. Therefore no longer sold commercially in the UK for professional use.

● Bifenthrin - listed by EPA as a category C carcinogen - makes it commercially unviable.● Thiacloprid - category 3 carcinogen status makes it commercially unviable.● Flufenoxuron - limited benefit as a remedial preservative as it only affects certain stages of the

insect life-cycle.

Shortlist based on suitability for remedial treatment against wood-boring insects

● Permethrin● Borates - arguably the safest treatments once applied, but Repro Tox Cat 1B (by ingestion) of the

supplied products places restrictions on use and requires expensive and uncertain “comparative assessment” before registration can be granted.

● Cypermethrin - unpopular with professional applicators as alpha-cyano group produces sensitivity in a large number of operatives. Therefore no longer sold commercially in the UK for professional use.

● Bifenthrin - listed by EPA as a category C carcinogen - makes it commercially unviable.● Thiacloprid - category 3 carcinogen status makes it commercially unviable.● Flufenoxuron - limited benefit as a remedial preservative as it only affects certain stages of the

insect life-cycle.

Similar situation for remedial fungicides

● Propiconazole - Current proposal to classify as Repro Tox Cat 1B - Suspected endocrine disruptor

● Borates - arguably the safest treatments once applied, but Repro Tox Cat 1B (by ingestion) of the supplied products places restrictions on use and requires expensive and uncertain “comparative assessment” before registration can be granted.

● Tebuconazole - Repro Tox Cat 2B - Suspected endocrine disruptor● IPBC - Anticholinesterase activity restricts use by people with certain medical conditions.● Quats - e.g. BAC, DDAC - limited spectrum of activity means that they cannot be relied on to

protect against wet rot or dry rot in timber.

Letter of access● Once active ingredients have been

chosen it will be necessary to get a letter of access from the active manufacturer to access their Annex 1 dossier.

● This will usually entail signing a sole supplier agreement - which is reasonable as the active ingredient producers need to to recover the high costs of producing their dossiers.

● Costs of active ingredients will therefore increase - feeding into higher prices for formulations.

Efficacy data● One of the advantages of BPR/R is that all

formulations now require efficacy data.● Most commonly carried out to agreed European

Standards after EN73 aging procedure.● Cost ranges from £10,000 for a single insect test

to £25,000 for a set of fungal tests.● Insect tests can be “curative” or “preventative”● Hylotrupes is standard insect test species -

although anobium is often included for commercial reasons.

● Serpula lacrymans is NOT one of the standard fungal species tested.

EN 113 test using Gloeophyllum trabeum - Materialprüfanstalt Brandenburg GmbH

CurativeBS EN 1390: House Longhorn Beetle (Hylotrupes bajulus)BS EN 370: Common Furniture Beetle (Anobium punctatum)

PreventativeBS EN 46: House Longhorn Beetle (Hylotrupes bajulus)BS EN 118: Termites (Reticulitermes flavipes)

Example suite of efficacy tests for a commercial woodworm treatment product

Toxicology & Environmental FateRegulatory authorities will require evidence that the risk of using the product to people & the environment is low enough to justify use:

● Chemistry / Storage Stability● Toxicology● Environmental Fate

Much of this can be “read across” from the active ingredient dossier or calculated using modelling.

However expensive tests for leaching and dermal penetration are usually required. Even simple tests such as viscosity need to be carried out by accredited labs - adding to cost.

Limitations of BPD/BPRBPD/R could be seen as just a more robust version of COPR with more stringent data requirements and higher costs.

Limitations of BPD/BPRBPD/R could be seen as just a more robust version of COPR with more stringent data requirements and higher costs.

Reality has been rather different:

Phasing In period between COPR and BPR will take over 20 years

List of active ingredients that would be supported has only started to become clear in last few years

Use Categories were not always clear - e.g. is a masonry sterilant for dry rot a masonry treatment or a wood preservative?

Comparative assessment - no guidance given by EU when it became a requirement

Non standard products - e.g. boron rods - no agreement over test methods

High cost of product registration

Promised single market did not materialise - EU member states continue to impose non-tariff barriers

Fundamental Problem with BPD/R

Cost and risk of product registration outweighs the benefits (i.e. potential profit).

Fundamental Problem with BPD/RBPD/R doesn’t take account of niche markets such as specialist timber treatment

● Professional use woodworm treatment fluid market in UK approx. £1 Million per year.

● Professional use remedial fungicide market in UK <£250,000 per year● Typical cost of product registration £100,000 to £200,000.

Fundamental Problem with BPD/RFormulator’s £100,000 to £200,000 investment is constantly at risk of any of the active ingredients in the formulation being:

● Withdrawn● Having new labelling requirements● Having restrictions placed on their use

Reformulation with a new active will mean going back to square one with a new £100,000 to £200,000 investment

What it all means for the industryInvestment in new active ingredients and product formulations is an increasingly high-cost and high-risk venture.

Therefore it is unlikely that new actives and formulations will replace those that are withdrawn at the same rate as they did in the past.

LindaneDieldrinTBTOPCP

PermethrinPropiconazole

IPBC ?Replaced by Replaced by

What it all means for the industryProduct formulation is a high cost, high risk venture.

Therefore formulations for niche applications may not be supported.

Woodworm Treatment

Dual Purpose

Fungicide for timber Pastes

❌Professional market too small?

✓Large DIY market

? Yes, but contains propiconazole

✓Large DIY market

Estimated product availability for professional use timber treatment market once BPD/R fully implemented.Excludes borates as these are under review.

Three scenarios for the future

Scenario 1 - Nothing much changes● Recent ECHA decision not to reclassify glyphosate suggests

possible softening of stance● Permethrin remains the main active ingredient used for the

treatment of wood-boring insects● IPBC + possibly azoles continue to be used for treatment of

wood-rotting fungi● Possibly we even manage to keep borates for professional

use

Life goes on as normal except for price increases to pay for active/product dossiers.

This is the most likely scenario in the short to medium term.

Istock - 471894272

Scenario 2 - No more biocides● Unlikely, but we need to be prepared● High dependency on permethrin as insecticidal active● Repro Tox Cat 1B classification proposal for Propiconazole was unexpected.

Could other azoles follow?● Market for fungicide-only formulations too small to attract formulators

Scenario 2 - No more biocidesCould we cope without biocides?

A biocide is defined in Article 2(1)(a) of the Biocidal Product Directive

(refined in the 2012 revision) as:

“Active substances and preparations containing one or more active

substances, put up in the form in which they are supplied to the user,

intended to destroy, deter, render harmless, prevent the action of, or

otherwise exert a controlling effect on any harmful organism by

chemical or biological means.”

Control by means of physical or mechanical action is excluded

Scenario 2 - No more biocidesNon-biocidal treatment of fungal decay:

Quite feasible if we look at:

● Drying methods

● Keeping moisture away from timbers

● Remote monitoring of timber moisture content

● New monitoring techniques - e.g. DNA analysis of

susceptible timbers

● Revising guarantee terms - e.g. annual inspection clause

Although retrofit insulation would add additional difficulties

Scenario 2 - No more biocidesNon-biocidal treatment of wood-boring insects:

A much harder proposition

● Option 1 - Heat treatments - A possibility, but extremely expensive and need careful control to prevent warping of timber

● Option 2 - Microwave / electromagnetic treatment - Difficult to use safely in the field and likely to fall foul of other regulations.

● Option 3 - Infestation management - Replace badly affected timbers, make life difficult for the remaining critters - e.g. keep timber dry, fill exit holes to disrupt egg laying, UV electrocutors to kill adult beetles - combined with monitoring. High on-going cost and uncertain efficacy - especially for more damaging pests such as Hylotrupes, and potentially termites.

Scenario 2 - No more biocidesProblems with non-biocidal approach:

● No means of providing protection against reinfestation (preventative treatment)

● Higher cost means some treatments will be economically unviable (either property owner can’t afford treatment or treatment cost is too high in relation to property value)

● Lack of legal biocidal option could push people towards cooking up their own biocides + illegal imports

● Would make it harder to conserve historical timbers● Certain types of infestation - e.g. Hyloptrupes, termites -

would be difficult to treat without biocides

Scenario 3 - Limited biocides - Restrictions on use● Would regulatory authorities leave us in a

position of having no biocidal options for timber treatment?

● Cost to the economy would be significant● Tighter regulation on use might be a better

option

http://www.derbypestcontrolservice.co.uk

Scenario 3 - Limited biocides - Restrictions on use● SGAR (Second Generation Anticoagulant Rodenticide) Stewardship

Scheme● Provides an example of how biocides of concern can continue to be

supplied for limited applications● In return industry needs to commit to providing stewardship for safe,

responsible professional use.

HSE Draft Information Document - December 2014

Scenario 3 - Limited biocides - Restrictions on use● Could a stewardship scheme work for wood preservatives?

Professional/Industrial users

Professional / industrial users are those people using biocides in the course of their job or business, who have received appropriate information, instruction and training in their use.

The type of training required should cover issues such as the law, correct use of biocides and how to carry out a risk assessment under the Control of Substance Hazardous to Health Regulations (COSHH). Those using biocides have a duty to properly assess each planned usage, considering the options for treatment and the potential risks involved. The product should then be able to be used in a way which reduces any risks from its use.

There are numerous courses in the UK on different aspects of biocide use, run by private consultants/firms, trade associations and training bodies. HSE is not able to recommend any specific training courses.http://www.hse.gov.uk/biocides/using.htm

● Industry-led scheme to ensure existing “Professional Use” wood preservatives are used by trained operatives could be a starting point.

Scenario 3 - Limited biocides - Restrictions on use● Main risks from wood-preservatives come from use and disposal - rather

than contact with treated timber.● Stewardship scheme could mitigate this risk● Strong case can be made for launching a voluntary stewardship scheme

pre-emptively○ Demonstrate industry commitment to safer use of wood preservatives○ Would allow industry to make a stronger case against potential withdrawal of key product

types/active ingredients○ Eliminate uncertainty over which firms can be supplied with Professional Use timber

treatments

Summary● BPD/BPR now starting to affect our industry● Reliance on fewer actives and formulations● Future availability of biocidal wood preservatives uncertain● Industry needs to act now if it wants a say in how biocidal wood

preservatives are regulated● ‘No more biocides” scenario unlikely - but we need to be prepared